Download International Guide on Health Industry Laws

Global Practice Guide
International Guide on Health Industry
Laws
A Global Practice Guide prepared by the
Lex Mundi Health Care and Life Sciences
Practice Group
This guide is part of the Lex Mundi Global Practice Guide Series which features
substantive overviews of laws, practice areas, and legal and business issues in
jurisdictions around the globe. View the complete series at:
www.lexmundi.com/GlobalPracticeGuides.
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About this Guide
Because each nation of the world faces unique challenges with respect to health care that must be
addressed using that nation’s resources, the health care systems around the world are as varied as the
nations themselves. Medical advancements and technological improvements are rapidly changing the face
of health care in many places, yet the cost of those advancements and improvements put them out of reach
for many.
This global practice guide will be updated from time to time. For the most up to date information, please
go the Lex Mundi web site (www.lexmundi.com) and access the Health Care Industries Practice Group web
page or from the Publication and Resources page. If you need assistance, please contact the Lex Mundi
office 1.713.626.9393.
This publication is not intended to represent a comprehensive guide nor legal advice on the matters
covered, but rather provide a general overview on the subject. They may only be used as an indication and
advice should always be sought from the appropriate Lex Mundi member law firm.
Please note that each response was provided on a different date, and therefore the answers to the survey
refer to laws and regulations in force on that specific date.
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Table of Contents
Argentina...................................................................................................................................................... 3
Canada ....................................................................................................................................................... 12
Colombia .................................................................................................................................................... 20
Cyprus ........................................................................................................................................................ 23
Ecuador ...................................................................................................................................................... 29
Estonia ....................................................................................................................................................... 36
Finland........................................................................................................................................................ 42
Israel ........................................................................................................................................................... 47
Korea .......................................................................................................................................................... 58
Malaysia ..................................................................................................................................................... 64
Mexico ........................................................................................................................................................ 75
Philippines ................................................................................................................................................. 80
Poland ........................................................................................................................................................ 87
Romania ..................................................................................................................................................... 94
Singapore ................................................................................................................................................. 108
Switzerland .............................................................................................................................................. 114
Thailand.................................................................................................................................................... 123
United States Federal Laws for Health Care ........................................................................................ 130
USA, Arizona ........................................................................................................................................... 133
USA, Colorado ......................................................................................................................................... 138
USA, Connecticut .................................................................................................................................... 152
USA, Indiana ............................................................................................................................................ 156
USA, Iowa ................................................................................................................................................. 159
USA, Kentucky ........................................................................................................................................ 169
USA, Massachusetts ............................................................................................................................... 178
USA, Michigan ......................................................................................................................................... 182
USA, New Hampshire.............................................................................................................................. 188
USA, New Jersey ..................................................................................................................................... 195
USA, New York ........................................................................................................................................ 199
USA, North Carolina ................................................................................................................................ 204
USA, Puerto Rico .................................................................................................................................... 211
USA, Rhode Island .................................................................................................................................. 215
USA, South Carolina ............................................................................................................................... 219
USA, Tennessee ...................................................................................................................................... 224
USA, Vermont .......................................................................................................................................... 229
Vietnam .................................................................................................................................................... 233
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International Guide on Health Industry Laws
Argentina
Prepared by Lex Mundi member firm Marval, O’Farrell & Mairal
1. Provide an introduction on health law in your jurisdiction.
The Republic of Argentina is comprised of 23 provinces and the Federal Capital: the Autonomous
City of Buenos Aires. There are also more than 1,500 municipalities, which usually administer
their own resources and have the authority toprogram and carry out health actions
independently.
Argentina is organized as a federal republic with a democratic political system. The Argentine
Constitution (adopted in 1853), provides in its present form for a tripartite system of government
consisting of an executive branch headed by the President, a legislative branch and a judiciary.
The Argentine national healthcare system can be divided into three sectors: public, social security
and private.
Public sector:
The public sector includes the national and provincial ministries as well as public
hospitals (which also provide services to those that are covered by social or private
health insurance) and primary healthcare entities which provide assistance to uninsured
population. This sector is mainly financed through taxes. The public sector has been
decentralized in the past decades, transferring the administration of national public
hospitals to the provincial and municipal levels.
Social security sector (Obras Sociales - Law No. 26,660):
It is operated by trade unions and covers all workers of the formal economy and their
families. The social security sector is financed through mandatory payroll contributions
from employee and employers (insurance schemes) and provides quite a fairly important
coverage in the Argentine system. The national health insurance system was created
by Law No. 23,661.
Health-related social security includes national insurance providers (obras sociales
nacionales -“OSN”) and the National Institute of Social Security for Retired Persons and
Pensioners (“INSSJP” or “PAMI”) under the jurisdiction of the national government. At
the provincial level, social security consists of individual provincial health insurers (obras
sociales provinciales - “OSP”).
The INSSJyP is a special health insurance fund for the retired and their dependents. In
addition, this fund organizes health services as well as recreation, geriatric and funeral
services. It mainly contracts out to private providers, although the demand for health
services is also partly met by the public sector. The INSSJyP is the largest OSN in the
country. Like the other OSNs, the INSSJyP is regulated by the Superintendence
of Health Services (Superintendencia de Servicios de Salud - “SSS”), a government
agency created in 1996 by Decree No. 1615.
Each OSN has to comply with the Mandatory Medical Plan (Plan Médico Obligatorio
- “PMO”) since 1996. The PMO guarantees basic coverage in the areas of preventive
care, diagnosis, medical treatment, dental care and drugs. In 2002, due to the economic
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crisis and the financial problems of many funds, the Emergency Mandatory Medical Plan
(Plan Médico Obligatorio de Emergencia - “PMOE”) was implemented. The PMOE
is time mostly based on practices that are cost-effective and evidence based. The SSS
is the authority in charge of controlling the compliance with the PMO/PMOE.
Private sector:
The private sector mainly includes all those private providers offering health services
(includes private insurance agencies - Prepaid Medicine Enterprises). This sector is
financed through voluntary contributions to private services providers. The private sector
encompasses private health facilities.
The private providers shall also comply with the PMO which, as previously mentioned,
guarantees coverage in the areas of preventive care, diagnosis, medical treatment,
dental care and access to medicines.
The three different sectors in which is fragmented the healthcare system in Argentina leads to
an overlap in membership, with some affiliates of the public sector or social security, insuring
themselves with private insurers as well due to a shortage of certain services or the deficient
quality of others.
A health emergency is currently in effect due to social and economic factors (Decree No. 486/02
as amended). The response to this emergency includes an adaptation of the PMO to the
available financial resources of the obras sociales plans.
In Argentina there is a variety of (federal, provincial and municipal) laws and regulations
in diverse fields such as social security, hospitals and procurement, the medical profession as
well as pharmaceuticals and medical devices. Health is considered as a social right with
constitutional recognition and thus, Argentinean legislation regulating pharmaceuticals and
medical devices primarily serves to protect public health.
The relevant laws and regulations on manufacturing, import, export, distribution, marketing,
warehouse and trade of pharmaceutical products and medical devices impose a number of
substantial burdens and responsibilities on manufacturers and importers. For example, for both
pharmaceutical products and medical devices, companies require to be previously duly license
by the health authority to engage in any of such activities and also are subject to obtain the
approval or certification from the health authorities over each product before they can be
manufactured or imported for commercialization purposes in the country.
Main relevant health authorities
-
The National Ministry of Health is the main health authority. However, in the year 1992 the
National Agency of Medicines, Food and Medical Technology (ANMAT) was created by
Decree No. 1490/1992 (recently amended and complemented by Decree No. 1271/2013).
The ANMAT is an independent government agency and is granted with jurisdiction to control
the safety, efficacy and quality of medicines and to control the activities, process and
technologies performed for the supply, production, manufacturing, fractioning, import and/or
export, warehousing and commercialization of products and materials used for human
medicine. Additionally, the ANMAT is the national health authority in charge of registering
and/or granting authorization to the persons and companies which are involved in the supply,
production, manufacturing, fractioning, importation and/or exportation, warehousing and
commercialization of pharmaceutical products and medical devices and controlling the
execution of such activities.
-
Each province has its own health authority that works on a par with ANMAT, and
is competent to pass legislation.
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-
Also, under the scope of the National Ministry of Health, the Superintendence of Health
Services (SSS) has monitoring, control and enforcement capacities over insurers of the
National Health Insurance System, and has authority over the OSNs and PAMI. At the
provincial level, the SSS does not have regulatory authority over the OSPs.
-
The Secretariat for Programming Drug Abuse Prevention and the Fight against Drug
Trafficking (SEDRONAR), is the national agency acting on behalf of the Executive Branch
that controls all operations with certain chemical substances capable of being used in
the illicit manufacture of narcotic drugs and psychotropic substances.
2. Provide a check list of laws with a short summary of the general requirements of each.
a. Healthcare system - Main regulations
-
Law No. 23,661 and 23,660: Creation of the national health insurance system and
regulation of social security insurance providers (Obras Sociales).
-
Law No. 26,682 -as amended- and Regulatory Decree No. 1993/2011: Regulation
of private healthcare providers (Prepaid Medicine Enterprises).
-
Ministry of Health Regulation No. 1991/2005: Mandatory Medical Plan (Plan Médico
Obligatorio - PMO), as amended and complemented, and complementary laws No.
24,455 and 24,754.
-
Decree No. 486/02 as amended (National Health emergency) and Ministry of Health
Regulation No. 201/2002 (Emergency Mandatory Medical Plan - Plan Médico
Obligatorio de Emergencia - PMOE).
b. Pharmaceuticals (both OTC and Rx) - Main national regulations
-
Law No. 16,463 (Law on Medicines; as amended and complemented by its Regulatory
Decree No. 9,763/64 and others): This law governs the activities of import, export,
production, manufacturing, fractioning, commercialization and/or storage of drugs,
chemical products, reactives, pharmaceutical forms, medicines, diagnosis devices and
any other product for use or application to medicine on human beings and whoever
participates (individuals or corporations) in said activities. Those regulated activities can
only be performed upon the prior authorization and control of the health authority, in
premises duly licensed by the health authority and under the technical direction and
management of a professional with a university degree (technical director), registered
with the Ministry of Health. It is forbidden to promote medicines sold under prescription
to the general public.
-
Decree No. 1299/1997, as amended: This decree sets up the main rules for the
commercialization chain of medicines, requiring the prior and duly license issued by
the health authority to engage in such activities. Pharmaceutical laboratories shall only
commercialize their manufactured or imported products (medicines), by themselves
or through (licensed) distributors -acting in their account and order-, exclusively with
pharmacies, drugstores and/or public or private sanitary or healthcare institutions, duly
authorized by the corresponding health authority.
-
Law No. 25,649 (Law on Generics): It establishes that it is mandatory to use the generic
name of the pharmaceutical products in: (a) any primary or secondary packaging, label,
or any document used by the pharmaceutical industry for medical information or
promotion of medicines; (b) all legal texts, including registrations and approvals relating
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to the manufacture, fractioning, marketing, export and import of drugs; (c) any
advertisement or promotion directed to the general public (OTC). This Law also sets forth
the obligation for the physician to include the generic name of the drug -by active
ingredients instead of referring only to the commercial name- when prescribing a drug
to a patient.
-
Decree No. 150/1992 (as amended and complemented): This regulation complements
the Law on Medicines and regulates special procedures for registering medicines with
the health authority (for approval of marketing authorization certificates), depending on
different factors, such if the medicines will be locally manufactured or imported (and from
which country), novelty, similar or bioequivalent to products already registered in the
country, fast-track procedures, etc. Decree No. 150/92 (in accordance with Confidentially
Law No. 24,766 -“ACL”-) provides that as long as the product for which marketing
approval is sought has been approved in any of the countries included in Annex I of
Decree 150/92, any person may apply for marketing approval without time limitations,
submitting minimum information (bioavailability data and a project of label, leaflet and
prospect). The list of countries includes, inter alia, Denmark, Japan, the U.S.A., Germany,
the U.K., Spain, Italy and France.
It is our understanding that the ACL and Decree No. 150/92 could be considered
unconstitutional if the Courts interpret that there is a conflict with Section 39.3 of
the TRIPS Agreement. The Argentine legal system grants higher hierarchy to
international treaties over internal law. Therefore, in case of conflicts between the
TRIPS Agreement and the ACL or Decree No. 150/92, the former (TRIPS Agreement)
should prevail. The conflict between Section 39.3 of the TRIPS Agreement and the ACL
would be that the reliance on third parties' data allowed by the ACL for purposes of
approving new medical products could be considered as unfair commercial use of
confidential information. Nevertheless, there are some recent case law from the Federal
Court of Appeals -second instance- (it should be noted that there are still several pending
cases) which expressly considered that the similarity regime under Decree No. 150/92
is not contrary to Section 39.3 of the TRIPS Agreement. Consequently, there is no
effective data protection in Argentina.
- Regulation No. 5755/1996 (as amended): This regulation complements Decree
No.
150/92 and regulates the proceedings to register medicines before the health authority
providing different pathways for filing the application form.
-
Regulation No. 7075/2011 (as complemented by Regulation No. 3397/2012, among
others): This regulation sets forth the main requirements for the registry of biological and
biotechnological products.
-
Regulation No. 7729/2011: It regulates the requirements for registry of biosimilars.
-
Regulation No. 5743/2009 (as amended): This regulation sets forth the requirements
to proceed with the “first batch technical inspection” in order to obtain the approval of
the health authority to start the commercialization of the product (authorization for
commercialization). Such technical inspection consists on the verification of control,
manufacturing methods, stability tests and operational capacity, either for the local
manufacture of pharmaceutical products or for quality control in the case of imported
products.
-
Regulation No. 2819/2004 (Guidelines for Good Manufacturing Practices for
manufactures and importers/exporters of medicines -“GMPs”- and its complementary
regulations): The GMPs are applicable to manufacturing operations of medicines in all
of its definitive pharmaceutical forms, including big scale process at hospitals and
preparation of supplies for using at clinical trials. The activities must be performed at a
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designated facility duly authorized and under the management of an authorized technical
director. A quality control director should also be appointed to control and guarantee
compliance.
- Ministry of Health Regulation No. 435/2011 (regulated by ANMAT Regulation
No.
3683/11, ANMAT Regulation No. 1831/2012, ANMAT Regulation No. 247/2013, among
other complementary regulations): Mandatory traceability system to be implemented
by individuals or legal entities involved in the commercialization chain of medicines
(manufacturing, importations, distribution, dispense, etc).
- Ministry of Health Regulation No. 627/2007: This regulation sets forth the “Good
Practices Guidelines for Promotion of Medicines Sold Under Prescription”. This
regulation basically regulates the relationship between pharmaceutical companies and
health care professionals. The promotion of Rx Products should comply with several
requirements, such as:
 only be addressed to professionals duly licensed to prescribe or dispense
medicines;
 have the corresponding marketing authorization certificate and
obtained the commercialization authorization by the health authority
(first batch approval);
 be carried out in scientific events and publications as provided in local
regulations;
 all contents of the promotion of medicines shall adjust to the
characteristic identifying data appearing in the certificate of registration;
and
 In any case, the promotion of medicines shall favor the rational use,
presenting them objectively within the framework of their
pharmaceutical
properties, therapeutic sphere and indications so approved (on-label).
In
this sense, the technical-scientific information necessary for the
addressees to know about the therapeutic properties of the medicine
shall be provided.
HCPs as government employee or government official: the Argentine Criminal Code sets
forth that the terms “public official” and “public employee”, designate anyone that
participates, on an accidental or permanent basis, in the exercise of public functions,
either by popular vote or by appointment made by competent authority. Similarly, under
the Public Ethics Law No. 25,188, the term “public official” includes any officer or
employee of the Argentine Federal government (including the executive, legislative and
judicial branches), that renders services on a permanent or temporary basis, and has
been appointed and/or elected to carry out remunerated or ad-honorem activities or
functions on behalf or in the service of the Argentine State, at any level of its hierarchy.
The Ethics Code (Decree 41/99) contains a similar definition. Thus, a state employed
physician would not need to fulfill a certain percentage of their time working for the
government to be considered as such (i.e. whether they render services to the
government on a permanent or on an accidental basis). Pursuant to Argentina’s political
system, administrative regulations, including, inter alia, the public ethics regulations,
differ in each jurisdiction (at the federal, provincial and, in some cases, municipal level).
- Regulation No. 4980/2005: It set forth the general principles for the promotion of drugs
sold over the counter (OTC), among others (e.g. medical devices, cosmetic products,
foods, etc.).
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-
Ministry of Health Regulation No. 538/1998 (Distribution): This regulation applies
to distribution companies who operate at a national or inter-provincial level, including
within the City of Buenos Aires, and who act on behalf of pharmaceutical laboratories
which are manufacturers or importers of such products, as set forth in Decree 1299/97.
The regulated activities must be performed at a designated facility duly authorized and
under the management of an authorized technical director. This regulation created the
National Registry of Medicines Specialties’ Distributors. The procedure to be listed as
distributor of medicines specialties is the same as for granting an authorization to a
manufacturing plant of medicines specialties.
-
Regulation No. 7439/1999 (Distribution): Sets forth the requirements to obtain the health
authority authorization to operate as a “Distributor” and/or as a “Logistics Operator” for
pharmaceutical products. Distribution implies an engagement of storage services at an
establishment duly authorized by the health authorities (ANMAT). The distribution and
logistics companies should appoint a technical director duly authorized by the health
authority to perform their professional activities. Distributors and/or Logistics Operators
should comply with the Good Practices for Warehousing, Transport and Distribution
established in Annex I of this regulation. They should also inform the health authority on
a regular basis detail of the pharmaceutical companies (manufacturers and importers)
with whom they are commercially linked.
-
Regulation No. 6677/10 and Ministry of Health Regulation No. 1480/11: These
regulations set forth the good clinical practices for conducting clinical trials in human
beings in the country and are harmonized with international regulations such as the
Helsinki Declaration, Nüremberg Declaration, “Operational Guidelines for Ethics
Committees that review biomedical research” (W HO-World Health Organization, 2000),
the “International Ethical Guidelines for Biomedical Research in Human Beings” (CIOMS
- Council for International Organizations of Medical Sciences, 2002), among many
others. At a regional level, complementary regulations can be applicable.
-
Law No. 26,689 (rare diseases): This law aims to promote integral healthcare of people
with rare diseases and establishes the obligation of prepaid medical services and health
insurances to provide assistance coverage to patients with this condition, including
at least those determined by the competent authority.
-
Regulation No. 4622/12 (registration of orphan drugs): orphan drugs are defined by
this regulation as medicines or medicinal specialties aimed at preventing, diagnosing
and/or treating rare or serious diseases for which there is no secure or effective
treatment available. It sets forth some special conditions and documentation for
registering orphan drugs (regulatory pathway) that will be assigned to the category of
products authorized “under special conditions”. This regulation created the Commission
responsible for evaluating drug products and medicines to be registered “under special
conditions”.
-
Regulation No. 840/1995 (compassionate use of drugs): Through this regulation,
ANMAT regulated the exemptions for individual prescription and/or importation of drugs
not sold within the Argentine Republic. The rule provides that the strictly individual use
of a drug, limited to only one patient, provided the specific requisites expressly listed
by ANMAT Resolution Nº 840/1995 are met, constitutes the so-called “compassionate
use of drugs”. Under Joint Resolution No. 942/2001 of the Ministry of Health and No.
426/2001 of the Ministry of Economy, imports of drugs for Compassionate Use have
been exempted from the payment of import dues and port services tariffs, statistics tariffs
and fees for destination verification. Through Regulation No. 2324/97, ANMAT
authorized non-profit civil associations for requesting authorization to import medicines
for compassionate use on behalf of its affiliates at a cost price.
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c.
-
Law N° 26,045: Created the National Register of Chemical Substances (RENPRE) under
the scope of SEDRONAR. Companies and any person that operate with chemical
substances capable of being used in the illicit manufacture of narcotic drugs and
psychotropic substances (according to Decree N° 1095/96 as amended by Decree No.
1161/00) must be previously registered in RENPRE and comply with related regulations
and requirements (e.g.: submitting reports on a regular basis of different operations with
chemical substances -importing, commercialization, etc.-).
-
Law on Drugstores No. 17,565 (as amended and complemented by regulatory Decree
No. 7,123): This law states that the preparation of prescriptions and the delivery and sale
of drugs, medicines and pharmaceutical products to the public can only be carried out
in drugstores duly licensed. The sale and delivery of said products in other places
is deemed an illegal practice of pharmacy, punished with the penalties set forth in the
Law on Drugstores.
-
Law N° 22,802 (Fair-Trading Law) and Law N° 24,240 (Consumer Protection law) are
also applicable to the commercialization of pharmaceutical products and medical
devices.
Medical devices - Main national regulations
-
Law on Medicines No. 16,463: (sections 1 and 2), specifically sets forth that the
importation, exportation, production, manufacture, fractionation, marketing or storage for
local or inter-provincial commerce of drugs, chemical products, reagents,
pharmaceutical products, medicines, diagnosis devices and any other product used
or applied to medicine on human beings, can only be carried out, upon the prior
authorization and control of the Ministry of Health, in premises licensed by said
Ministry and under the technical direction and supervision of a professional with a
university degree, registered with the Ministry of Health.
-
Regulation No. 2319/02 (as amended): for being the holder of the certificates and
commercialize medical devices, it is required to be previously and duly registered with
the health authority to import and/or manufacture medical devices.
-
Regulation No. 2318/02 (as amended by ANMAT Regulation No. 1285/04): defines what
is considered as a “medical device” (i.e. any health product such as equipment,
apparatus, material, instrument or medical use or application system, dental or
laboratorial, used to prevent, diagnose, treat, rehabilitation or contraception and which
does not use pharmacological, immunological or metabolic means to perform its primary
function in human beings and being able, meanwhile, to be assisted by such means).
We have four types of medical devices (Type I, II, III or IV) depending on the intrinsic
risk for human health. Accordingly, all medical devices to be implanted are included in
type III or IV depending on their intrinsic characteristics (e.g.: could have a biological
effect, are intended to suffer chemical modifications in the human organism, etc.). The
instruments (intended to integrate and complement the medical device) are classified
and registered separately from the medical device they integrate.
-
Regulation No. 727/2013: specifically sets forth the requirements for the registration
of medical devices at the National Registry of Manufacturers and Medical
Devices (“Registro Nacional de Productores y Productos de Tecnología Médica” RPPTM-) as well as the necessary documentation to be submitted in case of
modifications to the marketing authorization certificates (MACs) already issued by the
health authority. The requirements and documentation to be submitted to the health
authority will vary depending on the type of medical device subject to registration.
According to Regulation No. 2318/02 (t.o. 2004), any modification made by the
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manufacturer or the importer of the characteristic identifying data of the medical device,
must be informed to the health authority within thirty (30) business days.
-
Ministry of Health Regulations No. 2175/2013 and 2303/2014: Implementation
of traceability system.
-
Regulation No. 4980/05 (promotion/advertising: it is only allowed to promote or advertise
to the general public medical devices that by their intrinsic nature and indications can
be use directly -or indicated for their direct use- by the patient and/or a not professional
user.
d. Medical profession - Main national regulations
-
Law No. 17,132 (and its complementary regulations): governs the practice of the
medicine profession, dentistry and many of the collaboration activities related to the same
in the City of Buenos Aires and federal territories. The National Ministry of Health is in
charge of controlling such activities and of the registration of health care professionals’
licenses. According to Law No. 17,132 only physicians (who hold a valid degree and who
are duly licensed by the health authority) are allowed to prescribe medicines. Since
Argentina is a federal government, each province has its own regulation which applies
to the practice of the health care professions. Even though at a provincial level the
requirements for the registration in order to practice any of the health care professions
could be, in some aspects, different to the conditions required at the federal level, in one
case or in the other, to be considered as a health care professional, the professional
requires to be duly licensed by the health authority in every single jurisdiction where the
health care professional desires to practice its activity.
-
MoH Regulation No. 404/2008 as amended (complementary regulation of Law 17,132):
through this regulation, the Ministry of Health established the requirements for registering
and obtaining the mandatory license necessary to practice any professional activity in
the art of healing in all federal territory and national institutions or departments which
are dependent of the National Government.
-
The National Criminal Code (section 208) punishes the practice of the medicine
profession without being duly licensed.
-
The Civil Code contains general provisions on contractual or tort liability that can
be applicable to the medical profession.
3. Provide any special issues which arise in your jurisdiction.
New regulations applicable to biological, biotechnological and biosimilars product’s
registration:
By Regulation No. 7075/2011 (as complemented by Regulation No. 3397/2012, among
others) and Regulation No. 7729/2011, a new regulatory framework became in force for the
registry of biological, biotechnological and biosimilar products. The first biosimilar registered
in the country under the new regulatory framework was approved in October 2013 but until
today the authorization for commercialization has not been granted yet (first batch approval).
New traceability system for medicines and medical devices:
The implementation of the traceability system for medicines and medical devices is one of
the main issues which arose in the last years. This system aims to reduce the
commercialization of illegitimate medical products in the local market and consists on the
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individual and unique identification of every unit to be locally commercialized, in order to
allow tracking in real time every such unit during all the commercialization chain.
Guidelines for the examination of chemical-pharmaceutical applications:
By Joint Regulation No. 118/2012, 546/2012 and 107/2012 of the Ministry of Industry, Ministry
of Health and the Argentine Patent Office, new Argentine guidelines for the examination
of chemical-pharmaceutical applications were approved. These new guidelines severely
restrict the patentability of several categories of inventions in the pharmaceutical field. While
the guidelines put into writing the current Patent Office’s practice, they also impose
new restrictions on patentable subject matter. Thus, the actual changes, while significant,
are less than it seems at first sight.
4. Are mobile health applications regulated under the law of your jurisdiction? If so,
provide a brief summary as to how they are regulated.
Argentina has no specific health regulations concerning mobile health applications.
Contact Information
Martín Bensado - Partner
[email protected]
Ricardo Ostrower - Partner
[email protected]
Marval, O’Farrell & Mairal
Av. Leandro N. Alem 928
(C1001AAR) Buenos Aires, Argentina
Tel 54.11.4310.0100 Fax 54.11.4310.0200
Firm Website www.marval.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Canada
Prepared by Lex Mundi member firm Blake, Cassels & Graydon LLP
1. Provide an introduction on health law in your jurisdiction.
The federal and provincial governments in Canada share powers over health-related issues such
as the provision of health care services, the regulation of drugs and medical devices, and
occupational health and safety.
While the delivery of health care services to Canadians is exclusively a provincial responsibility,
the federal government contributes to the cost of each province’s health care insurance plan and
in doing so imposes national standards on the provinces as a condition of accepting the federal
contribution. These standards are enacted in the Canada Health Act, which requires a provincial
health care insurance plan to satisfy five criteria in order to qualify for a full cash contribution by
Canada to the province: (1) public administration; (2) comprehensiveness; (3) universality; (4)
portability; and (5) accessibility. Each Canadian province has in turn enacted a health care
insurance plan, which governs the delivery of hospital and physician services and some other
medical services to all residents of the province. The provinces are not permitted to bill patients
directly, and extra-billing and user fees are prohibited, meaning that health care providers cannot
charge patients fees over and above the fees provided by the government.
Drugs and medical devices are regulated in Canada under the federal Food and Drugs Act, the
Food and Drug Regulations, and the Medical Devices Regulations. Prescription and nonprescription drugs require prior market authorization identified by a Drug Identification Number
(DIN) which must appear on the product packaging. The location of sale of drugs and the
professions involved in the prescribing and sale of drugs, such as physicians and pharmacists, are
regulated under provincial legislation and frequently by self-regulatory professional colleges.
“Natural health products” such as vitamins and minerals, herbal remedies, homeopathic medicines
and traditional medicines (e.g. traditional Chinese medicines) are regulated under the Natural
Health Products Regulations. Natural health products require prior market authorization identified
by a product registration number (NPN) or, in the case of a homeopathic medicine, by the letters
DIN-HM, which must appear on the product packaging.
The federal government also regulates the sale of drugs, medical devices and related products
under its criminal law power. The Food and Drugs Act, the Controlled Drugs and Substances Act
and the Criminal Code establish prohibitions and penalties to protect public health.
Relevant authorities and associations:
-
Health Canada is the federal government department responsible for national public health. It
administers federal legislation and develops regulations at the federal level relating to the
health and safety of all Canadians. Health Canada has a number of federal branches and
agencies including the following key entities: the Biologics and Genetic Therapies Directorate,
the Health Protection and Food Branch Inspectorate, the Therapeutic Products Directorate, the
Medical Devices Bureau, the Marketed Health Products Directorate and the Natural Health
Products Directorate. Among other duties, Health Canada regulates and approves the use of
various health products, including drugs, medical devices, and natural health products.
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-
The federal Minister of Health, Deputy Minister of Health, Associate Minister of Health and the
Chief Public Health Officer acting under Health Canada are responsible for overseeing Health
Canada and enforcing the Public Health Agency of Canada, the Canada Health Act and
Canada’s publicly funded universal health insurance system. Provincial ministries of health
are responsible for administering the health care system and providing health services to their
respective provinces.
-
The Patented Medicine Prices Review Board (PMPRB) is a federal agency with the dual
mandate of: 1) ensuring that prices charged by patentees for patented medicines sold in
Canada are not “excessive”; and 2) reporting on pharmaceutical trends of all medicines and on
research and development spending by pharmaceutical patentees. The PMPRB has
jurisdiction under the Patent Act and Patented Medicines Regulations to regulate the price that
a Canadian patentee charges for patented medicines sold in Canada to wholesalers, hospitals,
pharmacies and others. The PMPRB does not dictate the price that must be charged by a drug
manufacturer for any given transaction but does ensure, through means of reports that must
be filed by the drug manufacturer, that the average price charged is “non-excessive”. The
PMPRB does not have authority over the price of non-patented medicines or prices charged
by wholesalers or retailers.
-
Intellectual property is protected pursuant to the Patent Act and the Trade-marks Act. These
pieces of legislation are administered by the Commissioner of Patents and the Registrar of
Trade-marks respectively.
-
The federal Competition Bureau enforces the Competition Act, which regulates business
conduct across all sectors. In recent years, the Competition Bureau has shown increased
interest in business practices within the pharmaceutical industry.
-
Provincial regulatory colleges regulate health professionals including physicians, pharmacists,
dentists, nurses, optometrists, and opticians. Most health professions in Canada are selfregulated – their regulatory colleges are governed by members of the profession and
government-appointed public members. These regulatory colleges set minimum education
and competency requirements including guidelines and requirements for continued
competency, assess applicants for registration, and monitor and enforce standards of practice.
-
National health care professional associations, such as the Canadian Medical Association and
the Canadian Dental Association, provide leadership and guidance to health care professionals
while advocating for their members and the public.
-
Canada’s Research-Based Pharmaceutical Companies (Rx&D) is a trade association of
leading innovative pharmaceutical companies. Membership in Rx&D is voluntary but
companies who choose to be Rx&D members must comply with the 2010 Rx&D Code of Ethical
Practices, which governs all interactions with health care professionals and is a key program
of industry self-regulation. Rx&D is a member of the International Federation of Pharmaceutical
Manufacturers Associations.
-
Medical Technology Companies (MEDEC) is a Canadian trade association for medical device
companies. Membership in MEDEC is voluntary. MEDEC has published the MEDEC Code of
Conduct on Interactions with Healthcare Professionals (MEDEC Code) for its members, who
are strongly encouraged but not required to adopt the MEDEC Code.
-
The Pharmaceutical Advertising Advisory Board (PAAB) is an independent body responsible
for reviewing and pre-clearing drug advertising materials directed at health care professionals,
as well as patient information provided through health care professionals. The PAAB
administers the PAAB Code of Advertising Acceptance, a code of advertising guidelines for
prescription and non-prescription pharmaceutical products, biologicals and natural health
products.
-
Advertising Standards Canada (ASC) is an agency that reviews advertising material for nonprescription drugs and natural health products directed at consumers, among other materials.
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ASC has set out a voluntary advertising code to provide guidance for compliance with
regulatory regimes.
-
The Canadian Association of Medical Publishers (CAMP) represents Canada’s most influential
medical journals and publications. CAMP has published guidelines to set standards for
advertising in publications directed to health care professionals.
-
The Public Health Agency of Canada is a federal agency responsible for public health,
emergency preparedness and response, and infectious and chronic disease control and
prevention.
-
The Canadian Public Health Association (CPHA) is a national, independent, not-for-profit,
voluntary association representing public health in Canada with ties to the international public
health community. CPHA advocates for the improvement and maintenance of personal and
community health according to the public health principles of disease prevention, health
promotion and protection, and health public policy. CPHA acts as a liaison with the provincial
and territorial public health associations, and in collaboration with other national and
international agencies, disciplines and organizations.
2. Provide a check list of laws with a short summary of the general requirements of each.
a. Laws regulating drugs, medical devices, and natural health products
Food and Drugs Act and Food and Drug Regulations
The Food and Drugs Act, RS 1985, c F-27 (FDA) and the Food and Drug Regulations, CRC c 870
(FDR) regulate the production, import, export, transport across provinces and the sale of drugs.
Prior to drug products being authorized by Health Canada for sale in Canada, manufacturers must
present substantive scientific evidence of the drug product’s safety, efficacy and quality as required
by the FDA and FDR.
The FDA makes it an offence to advertise, label, package, or sell a drug or medical device in a
manner that is “false, misleading or deceptive or is likely to create an erroneous impression
regarding the character, value, quantity, composition, merit or safety” of the product. The FDA also
generally prohibits the advertising of any drug or device to the general public as a treatment,
preventative or cure for any of the diseases, disorders or abnormalities listed in Schedule A to the
FDA, including cancer, asthma and depression.
The FDR provides details regarding the manner in which prescription drugs are permitted to be
advertised to the public. Specifically, direct-to-consumer advertising of prescription drugs is limited
to name, price and quantity.
The FDR also regulates controlled drugs and substances by specifying permitted circumstances
involving controlled drugs and the requirements for obtaining licences for import, export, production,
sale, manufacture or distribution, and prescriptions of controlled substances.
The FDR further provides for the granting of establishment licences to entities in Canada that
fabricate, package, label, distribute, import, wholesale and/or test drugs.
Medical Devices Regulations
The Medical Devices Regulations, SOR/98-282 divide medical devices into four classes, with Class
I devices representing the lowest risk and Class IV devices representing the highest risk. The
manufacturer of Class II, III, and VI medical devices must have a device license in order for the
device to be imported into or sold in Canada. Class I devices do not require a medical device
license but, subject to certain exceptions, an importer or seller of a medical device must have an
establishment license in order to import or sell a medical device of any class.
Natural Health Products Regulations
“Natural health products” such as vitamins and minerals, herbal remedies, homeopathic medicines
and traditional medicines (such as traditional Chinese medicines) are regulated by the Natural
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Health Products Regulations, SOR/2003-196. These regulations also provide for the granting of
site licenses to Canadian sites that manufacture, package, label and/or import such products.
Patented Medicines Regulations
The Patented Medicines Regulations, SOR/94-688, made under the Patent Act, RSC 1985, c P-4,
set out the price review process for patented medicines, as well as associated reporting
requirements. Only patented medicines are subject to these regulations.
Patented Medicines (Notice of Compliance) Regulations
The Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, made under the Patent
Act, govern drug submissions for listing on the patent register. These regulations aim to balance
effective enforcement of patents for new and innovative drugs with the timely market entry of their
generic competitors.
Controlled Drugs and Substances Act
The Controlled Drugs and Substances Act, SC 1996, c 19 (CDSA), restrict the possession, import,
export, production and distribution of controlled drugs and substances. The Food and Drug
Regulations also govern the permitted circumstances for the use of controlled drugs and
substances and the issuance of licences. Regulations under the CDSA also provide for additional
regulatory control over certain controlled drugs and substances such as benzodiazepines and
narcotics.
Competition Act
The Competition Act, RSC 1985, c C-34, addresses anti-competitive business practices across all
industry sectors, including the health care sector.
b. Hospital and Insurance Law
Canada Health Act
The Canada Health Act, RSC 1985, c C-6, imposes national standards on the provinces as a
condition of accepting the federal contribution for the cost of each province’s health care insurance
plan. It requires provincial health care insurance plans to satisfy five criteria in order to qualify for
full federal contributions: (1) public administration; (2) comprehensiveness; (3) universality; (4)
portability; and (5) accessibility.
Provincial health insurance legislation
The administration and delivery of health care services is the responsibility of each province or
territory, guided by the provisions of the Canada Health Act. The provinces and territories fund
these services with assistance from the federal government in the form of fiscal transfers. The
Canada Health Act requires that a province’s health insurance plan, as provided under its health
insurance legislation, be comprehensive and universal, meaning that residents are entitled to
coverage of all insured hospital, medical and surgical-dental services based on need rather than
ability to pay. Each province and territory in Canada has enacted health insurance legislation.
Provincial hospital legislation
The Canadian provinces have regulatory authority over hospitals. Provincial hospital legislation
provides a framework for the operation of hospitals including public, private and psychiatric
hospitals. Funding for hospitals is provided by the provincial government through annual budget
allotments. As such, the provincial governments have complete discretion to raise or lower hospital
funding.
Provincial formulary regulation
There is no universal drug benefits plan in Canada. Instead, each province and territory provides
coverage to specific subgroups of the population. Under each public drug plan, a formulary is
developed to specify the drugs that are eligible for coverage and the conditions for reimbursement.
With the exception of Quebec, all provinces and territories currently participate in the Pan-Canadian
Pricing Alliance (PCPA). The PCPA conducts joint provincial/territorial negotiations on pricing and
reimbursement of drugs for listing on provincial formularies to achieve greater value for publicly
funded drug programs and patients.
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c. Laws regulating the medical profession
Provincial regulation of health care professionals
Provinces are given constitutional authority to regulate health care professionals. As such,
provinces have enacted regulated health care professions legislation to provide overarching
legislative frameworks under which all regulated health care professions in a province must
function. This legislation aims to protect the public from harm and from unqualified, incompetent
or unfit health care providers.
Provincial pharmacy legislation
Provinces have enacted pharmacy legislation setting out standards, regulations and specific
requirements for the accreditation and operation of pharmacies.
Regulated health profession colleges
Regulated health profession colleges governing each health care profession have been established
in each province and territory. These colleges are directed by councils or boards of directors, which
consist of member-elected professionals and government-appointed members of the public who
represent the public interest. All regulated health care professions, including physicians and
surgeons, optometrists, dentists, nurses, medical laboratory technologists, chiropractors and
pharmacists, are governed by colleges, and all health care professionals must be registered in their
respective colleges. Regulatory colleges have authority over their members and the following
general responsibilities: 1) setting and enforcing standards and guidelines for the practice and
conduct of their members; 2) ensuring that regulated health care professionals successfully meet
training and educational standards before practicing and using a professional title; 3) providing
continued professional development programs to assist members in improving their skills and
knowledge; and 4) acting on behalf of the public should any concerns arise regarding the provision
of health care services by their regulated professionals.
d. Public Procurement Law
Contractual Principles
The law in Canada with respect to competitive procurement/tendering has been in development
since 1981 and, in all provinces and territories except Quebec, is based entirely on common law.
In other words, there is no single piece of legislation that governs competitive bidding. What is
somewhat unique to Canadian law is that competitive procurement processes create two contracts:
(i) the bidding contract which sets out the “rules” that apply up until the completion of the competitive
procurement process, and (ii) the substantive contract entered into between the procuring authority
and successful bidders. This contractual framework applies to both the public and private sector
when issuing or responding to competitive procurement processes.
In the province of Quebec, procurement by public bodies (including hospitals) is governed by
legislation (the Act respecting contracting by public bodies and its regulations) which imposes
conditions applicable with regard to public contracts and predetermined offer selection mechanisms
applicable to public tenders over a certain value. This Act also imposes certain eligibility
requirements for contractors and subcontractors in specific situations in order to ensure the integrity
of the public contracting process.
Trade Agreements
Since the regulation of public (and quasi-public) sector purchasing contributes to the elimination
and management of trade barriers, various domestic and international trade agreements impose
additional requirements on procurement processes in the public and quasi-public sectors. Such
agreements include the North American Free Trade Agreement (NAFTA), the World Trade
Organization Agreement on Government Procurement (WTO-AGP), and the Agreement on Internal
Trade (AIT). These and other agreements may impose overlapping procurement requirements on
health sector entities. For instance, the AIT, which applies to certain publicly-funded academic,
health and social services entities, as well as various government ministries and agencies, requires
all procurement opportunities exceeding certain thresholds to be accessible to all Canadian
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suppliers through the use of a public tender process. Generally speaking, the AIT requires such
processes to be fair and based on a high degree of competition, efficiency and effectiveness, as
well as to adhere to the principles of transparency and non-discrimination between the provinces.
While the applicability of the AIT to a particular entity must be determined on a case-by-case basis,
in practice, many publicly-funded entities have adopted the requirements of the AIT.
Provincial Procurement Directives
Various provincial procurement directives establish overarching principles (e.g. accountability and
transparency) for health-sector entities, including hospitals, health care providers, and publicly
funded educational institutions. These directives also impose procedural requirements for soliciting
products and services for and on behalf of such facilities and institutions. The extent of these
directives, as well as their specific requirements, may vary between provinces.
Entity-Specific Procurement Policies
Many public sector entities in Canada have their own specific procurement policies, which are
policies that the organization is required to follow in procurement of goods and services. Generally
speaking, such policies are consistent with government procurement directives, but may also
contain specific directives that are related to the organization, for example, relating to procurement
of environmentally-sensitive products, procuring from local sources, etc.
3. Provide any special issues which arise in your jurisdiction.
•
Increasing regulation of drugs and medical devices
On December 6, 2013, the government introduced proposed amendments to the Food and
Drugs Act under Bill C-17, the Protecting Canadians from Unsafe Drugs Act. Bill C-17 proposes
granting the Minister substantial new powers, including the ability to conduct recalls, order
modifications to labels and packaging, and require the submission of health and safety data
post-approval. In addition, Bill C-17 was amended in June 2014 to permit disclosure of
confidential business information relating to drugs and medical devices under certain
circumstances. Bill C-17 has currently passed 2nd reading in the Senate.
•
Marihuana for Medical Purposes: Regime Change
In April 2014, the federal government changed the medical marihuana legislative regime by
replacing a system of small-scale home growers with a commercial network of licensed
producers. The introduction of the new Marihuana for Medical Purposes Regulations brings
the supply and distribution system for medical marihuana closer in line with similar systems for
pharmaceutical products by replacing in-home and government-subsidized grow operations
with regulated commercial enterprises, and permitting doctors and potentially nurse
practitioners to issue “medical documents” that allow patients to purchase quantities of medical
marihuana from licensed producers.
•
E-prescribing
The Canadian Medical Association and the Canadian Pharmacists Association have
announced their support for the implementation of electronic prescribing (e-Prescribing) in
Canada. e-Prescribing is the secure electronic creation and transmission of a prescription
between an authorized prescriber and a patient’s pharmacy of choice using a clinical electronic
medical record. Due to issues relating to the use and authentication of electronic physician
signatures, e-prescribing has not been fully adopted across all provinces. Certain provinces,
such as Ontario, are more advanced than others in piloting and implementing e-prescribing
initiatives.
•
Improved access to health care for remote communities
The geography of Canada poses unique issues with access to health care for remote
communities. Strategic solutions are continually being developed and implemented to improve
access to those living in northern and remote parts of the country. Technological advances
have allowed for telehealth services and electronic medical records. These technical services
allow physicians and other health care professionals to obtain patients’ complete medical
histories, despite these patients having medical records at many different clinics. In addition,
the installation of drug dispensing machines in some remote communities have allowed
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patients to access pharmacists and medication through a phone link and computer touch
screen.
Another key issue is the difficulty of accessing physician care in remote and northern
communities. In attempting to remedy this problem, the provincial colleges for nurses and
pharmacists have pushed for increased scopes of practice to allow these professions to
perform certain acts that are generally limited to physicians, such as prescribing medication.
Some provinces and territories have successfully implemented these expanded scopes of
practices not just for remote areas but province-wide, while others are continuing their efforts.
•
Advertising of drug products over social media
The Pharmaceutical Advertising Advisory Board (PAAB) has issued guidance for advertising
drug products using social media. For example, new provisions have been added to discuss
the difference between static online content and dynamic online content, including sitegenerated content (SGC) and user-generated content (UGC). Where promotional content is in
areas that are within the sponsor’s control, all current requirements that exist for drug
advertising apply equally to online dynamic content and content through traditional media. New
provisions have also been added to discuss search engine optimization and search engine
marketing, including prohibiting keywords and other meta data tags that refer to competitor
products.
•
Loyalty points for pharmacy purchases
Many retailers have loyalty points for customers who purchase their products. Many
pharmacies wish to award loyalty points for pharmacy related purchases (e.g. prescription
drugs) but the permissibility of this is an issue in a number of provinces and there have been a
number of changes in policy/regulation on this issue in recent years. Some critics of loyalty
programs are of the view that providing loyalty points to patients for receiving prescriptions
(especially those that receive prescriptions without cost because they have drug insurance)
encourages prescription purchases and/or unfairly benefits those persons.
•
Canada’s Anti-Spam Legislation
On July 1, 2014, Canada’s Anti-Spam Legislation came into force. There is a $10 million
maximum administrative monetary penalty and, as of July 1, 2017, a private right of action will
exist (enabling class actions to be brought against non-compliant companies). This impacts
the sending of communications electronically not just to consumers but also to businesses, and
so has a significant impact on how companies can communicate with health care professionals,
among others. Further, the law applies not just to commercial electronic messages sent from
Canada but also to such messages sent from other jurisdictions to Canada.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Mobile health applications (“apps”) raise a number of legal and regulatory considerations in
Canada. Depending on functionality and branding, an app may be regulated as a medical device
and/or viewed as labeling or advertising for a particular drug.
In Canada, software that is intended or represented for use in the diagnosis or treatment of an
abnormal physical state of a patient meets the definition of a medical device under the FDA and
must therefore comply with the requirements of the Medical Device Regulations. Health Canada
has taken the position that software is regulated as a medical device if it:
1) provides the only means and opportunity to capture or acquire data from a medical
device for aiding directly in diagnosis or treatment of a patient; or
2) replaces a diagnostic or treatment decision made by a doctor.
As such, many mobile health apps can potentially be regulated as medical devices. In addition,
since the FDA and FDR restrict the advertising of drugs, there is the risk that branded health apps
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will contravene direct-to-consumer advertising laws if they are viewed as promotional rather than
informational or educational.
Health Canada may be particularly concerned with mobile health apps that claim to be substitutes
for traditional medical devices without having undergone the rigorous testing required for traditional
medical devices. It is currently working with regulators from various jurisdictions and organizations,
including the European Union and the World Health Organization, to find a coordinated solution for
keeping pace with mobile health technologies.
In addition, the patchwork of privacy legislation found across Canada can trigger numerous privacy issues
with the use of mobile health apps.
Contact Information
Marie-Hélène Constantin, Partner
[email protected]
Alice Tseng, Partner
[email protected]
Laura Weinrib, Partner
[email protected]
Blake, Cassels & Graydon LLP
199 Bay Street
Suite 4000, Commerce Court Wes
Toronto, Ontario Zip Code M5L 1A9
Tel 1.416.863.2400 Fax 1.416.863.2653
Firm Website www.blakes.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry and Life Sciences Laws
Colombia
Prepared by Lex Mundi member firm Brigard & Urrutia
1. Introduction
The National Constitution of Colombia (1991) provides that all citizens have the fundamental right to benefit
from healthcare services. Thus, the State must direct, coordinate and control the rendering of healthcare
services, in coordination with private entities. The Constitution also provides that healthcare services shall
be rendered under principles of efficiency, universality, solidarity, integrality and unity.
2. Summary of Laws
The scope of healthcare as a fundamental right is set forth by the Health Statutory Law, recently reviewed
by the Constitutional Court and waiting to be approved by the President.
The system for providing healthcare services to the population (Social Security Healthcare System –
SSHS), along with the General Pensions System and the Professional Risk prevention System, form the
Integral Social Security System, governed by Law 100 of 1993.
The System is formed by public and private entities, known as specialized service providers (IPS, for their
Spanish acronym), healthcare professionals and insurer companies (EPS, for their Spanish acronym), who
operate under a broad spectrum of regulations issued by the government, mainly the Ministry of Health.
Surveillance of the IPS and EPS is carried out by the National Health Superintendence and by the
competent agencies for each territorial administrative jurisdiction (namely, departments and municipalities).
Two regimes exist for funding the system and they are based on the payment capacity of the citizens:
-
Contributory regime, which covers generally all of the population with an employment or
independent source of income (including retired citizens who receive a pension).
Subsidized regime, which covers population with no income, or with minimum income, not bearing
payment capacity.
The contributory regime is funded by contributions paid to the EPS that was chosen by the beneficiary, as
follows: (i) for employees, the employer must contribute an amount equivalent to 8.5% of the base income,
and 4% is contributed by the employee; (ii) retired citizens receiving a pension, shall contribute an amount
equivalent to 12% of their base income; (iii) for independent workers, the base income is equivalent to 40%
of the monthly amount of their income and they shall contribute an amount equivalent to 12.5% thereof.
The subsidized regime is funded by public funds of the territorial entities, and from a portion of the funds of
the contributory regime (up to 1.5%) and other special regimes (namely, the regime applicable to armed
forces, inter alia)
All citizens are entitled to a basic coverage plan (known as Mandatory Health Plan or POS for its acronym
in Spanish), which is comprised by a number of services, treatments, medicines and supplies. It is to note
that individuals are allowed to acquire private insurance plans to obtain additional or higher-quality
coverage, additional to the POS.
In the event that a particular patient requires treatment, medicine or supplies not covered by the POS, the
case must be submitted to a Scientific Technical Committee (Resolution 3099 of 2007) of the EPS, formed
by a representative of the insurer, a representative of the IPS and a patient advocate. The costs of all of
the treatments, medicines and supplies not covered by the POS must be reimbursed from a special fund,
known as FOSYGA, Fund of Solidarity and Guaranty.
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On the other hand, if the EPS or the Committee rejects to authorize certain treatment, medicine or supply,
the citizen may pose a special, proprietary request to a judge, through the commencement of a
constitutional action (Tutela) with the purpose of protecting their fundamental right to receive healthcare.
The EPS (insurer) must cover the basic POS of their affiliates, providing the required services, treatments,
medicines and supplies, through a network of IPS and product suppliers. The EPS may be vertically
integrated with the IPSs up to 30% of the interest. All of the IPS of the system must comply with the quality,
financial and administrative standards set forth by the law, and be registered with the national Registry of
Health Providers, as will be explained further below.
IPS are subject to the Mandatory System for the Guaranty of Quality Healthcare Services (SOGCS),
governed by Decree 1011 of 2006, and therefore, they must comply with the legal standards and
requirements set forth by the Ministry of Health in connection with (i) technological and scientific proficiency;
(ii) Financial capacity, and (iii) administrative proficiency (namely, legal standing, accounting compliance).
Applicable regulations govern the proceedings for the compliance and verification of said standards, and
said proceeding is known as “habilitation”.
The Ministry of Health consolidates the Registry of Providers of Healthcare Services, with the information
collected by the territorial health entities. Each IPS must apply for registration, once they have completed
an auto-evaluation proceeding in connection with the compliance of standards that are set forth service by
service. An IPS must register with every territorial authority that has jurisdiction in the locations where the
IPS operates a facility. The registry must be renewed every 4 years, and the IPS must report any relevant
amendment to the declared standards.
Finally, IPS are subject to a broad spectrum of specific regulations in connection with drugs, medical
devices, related services (pharmacy, laboratory, etc.) and their relationship with EPS, individual health
professionals, transportation services providers, suppliers and patients.
As regards medical liability, in Colombia, it is determined by a doctor’s failure to exercise a reasonable
standard of care while treating a patient. Medical liability can occur through many types of medical errors.
These errors can include delayed medical treatment, misdiagnosis, unnecessary surgery, failure to
recognize a symptom, prescription drug errors, failure to act, hospital acquired infections, or the failure to
diagnose a serious health problem.
Generally, under Colombian Law, a doctor is not required to guarantee that the outcome of any intervention
or treatment will be positive or beneficial for the health of the patient; nor will the doctor be measured in
terms of the results, but rather in terms of his proficiency and diligence and the support given towards the
improvement of the patient's condition. Taking into account the above, the evaluation is based on the means
devoted to cure a patient and not the results.
Medical liability is linked to the binding and legal frameworks and relates to both the provision of services
and the protection of fundamental rights, particularly when in most cases, the professional practice is linked
to a fundamental and inalienable right to life. Consequently, in the Colombian case, medical liability is not
limited to ethics but encroaches on the legal field. Therefore, if the performance of the doctor is not
consistent with the guidelines established for the particular discipline, the medical liability will be
compromised.
3.
Provide any special issues which arise in your jurisdiction.
The main discussion arising in Colombia with respect to the Healthcare System, is how to modify the
structure thereof as to diminish the number of tutelas (judicial actions to filed by patients to obtain not
covered services, or services covered in the basic plan, bad denied by the EPS.
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The judicial decisions have a high impact on the economics of the system. Currently the government is
implementing a number of amendments to guaranty that services are timely rendered, with the minimum
of expenses.
4.
Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Mobile health applications are not expressly regulated in Colombia.
Contact Information
Maria F Castellanos, Partner
[email protected]
Brigard & Urrutia
Calle 70A # 4 - 41
Bogota, Colombia
Tel 57.1.3462011 Fax 57.1.7422200
www.bu.com.co
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Cyprus
Prepared by Lex Mundi member firm Dr. K. Chrysostomides & Co. LLC
1. Provide an introduction on health law in your jurisdiction.
There is a wide range of applicable Cyprus national and EU laws and regulations which govern the
various areas of the healthcare industry to include laws regulating the medical profession, the licensing
of pharmaceutical products and medical devices, public procurement of pharmaceutical products and
medical services, labelling requirements etc.
The health care system in Cyprus consists of two parallel delivery sectors: the public and the private
one.
The public sector is being administered by the Ministry of Health, which is responsible for ensuring
access to health services for all those entitled and is exclusively financed by the state budget. Under
this scope, the Ministry is responsible for the planning, organization, administration and regulation of
the healthcare sector, as well as the provision of services in health centres and hospitals which are
under its direct control, in the form of primary care, specialists’ services, diagnostic tests, paramedical
services, emergency services, hospital care, pharmaceutical care, dental care, rehabilitation and home
care.
The private sector is mostly financed by out-of-pocket payments while Health services are provided by
private hospitals, polyclinics, clinics, diagnostic centres, pharmacies and independent practitioners,
which are under the inspection, regulation and licensing of the Ministry of Health.
The government is working extensively towards the implementation of a General Health Insurance
System (GHIS) in the near future. The system will receive funding from the compulsory health insurance
contributions and will also provide comprehensive medical care to the entire population at all levels of
healthcare, with its basic characteristics being the efficiency in delivery, the high standards of services
and the containment of cost.
2. Provide a check list of laws with a short summary of the general requirements of each.
a. Social Security Law
Council Directive 92/49/EEC (EU level)
The third European Non-life Insurance Directive contains provisions on the deregulation of national
insurers and allows EU Member States to opt for a system of private health insurers as an alternative
to the statutory health care system.
National Level
Τhe Social Insurance Law Νο.59(I)/2010, as amended.
The Social Insurance Scheme covers compulsorily every person gainfully occupied in Cyprus either
as an employed person or as a self-employed person. Persons working abroad in the service of Cypriot
employers and persons who interrupt their compulsory insurance are allowed, under certain conditions,
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to be insured voluntarily. The insured persons are classified in three categories; employed persons,
self-employed persons and voluntary contributors.
The Scheme is financed by contributions payable by the employers, the insured persons and the State.
The rate of contribution for the employed persons as from the 1st of April 2009 is 17,9% and for the
self-employed persons as from the 6th of April 2009 is 16,9% on their insurable earnings.
The Scheme provides cash benefits for marriage, maternity, sickness, unemployment, widowhood,
invalidity, orphanhood, old age, death and employment injury. The Scheme provides also free medical
treatment for persons receiving invalidity pension and for employed persons who sustain injuries as a
result or an employment accident or an occupational disease.B
Τhe Social Pension Law Νο. 25(Ι)/95, as amended.
Pursuant to the Law, Social Pension is payable to persons who have their habitual residence in the
Republic of Cyprus, have completed the age of 65, are not entitled to a pension or other similar payment
from any source the amount of which is equal or higher to the amount of social pension and satisfy the
residence conditions specified in the Law.
The General Health Care Scheme Law N.89(I)/2001, as amended.
This law establishes the Health Insurance Organization (HIO) and provides the legal framework that
governs the HIO and the implementation of the General Health Care System.
b. Hospital Law
The Private Hospitals (Establishment and Operation Control) Law No. 90(I)/2001
This law lays down the rules governing the establishment and operation of Private Hospitals, covering,
inter alia, licensing matters, monitoring and inspection, as well as the general obligations of Private
Hospitals.
Law No. 1(I)/2005 on The Safeguarding and Protection of the Patients’ Rights
This Law addresses issues regarding patient rights, such as the rights to health care and treatment,
access to health care services, prohibition of unfavourable discrimination, confidentiality and privacy of
patients etc.
Law 149 (1)/2013 has been enacted for the purposes of harmonization with Directive 2011/24/EU on
the Application of Patients' Rights in Cross-border Healthcare, which clarifies patients’ rights to access
safe and good quality treatment across EU borders, and be reimbursed for it.
c. Laws regulating the medical profession
There are various laws governing the medical profession as well as other healthcare related
professions, to include:
The Law on the registration of doctors, Cap.250 as amended
The Law on the registration of dentists, Cap. 249 as amended
Law No. 16/67 on Doctors (Associations, Discipline and Pension Fund), as amended.
Law Νo. 68(Ι)/95 on the registration of Professional Psychologists, as amended.
S. 51(b) of the Civil Wrongs Law, Cap. 148, as amended, provides for civil liability in case of professional
negligence.
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S. 236(e) of the Criminal Code, Cap. 154, as amended, provides for criminal liability in case of medical
negligence.
d. Public Procurement Law
Procurement Directives (EU level)
In December 2011 the Commission proposed the revision of Directives 2004/17/EC (procurement in
the water, energy, transport and postal services sectors) and 2004/18/EC (public works, supply and
service contracts), as well as the adoption of a directive on concession contracts. The directives were
voted by the European Parliament on 15 January 2014 and adopted by the Council on 11 February
2014. The Member States have until April 2016 to transpose the new rules into their national law (except
with regard to e-procurement, where the deadline is September 2018).
Procurement Laws (national level)
Law No. 12(I)/2006 on the Coordination of Procedures for the Award of Public Works Contracts, Public
Supply Contracts and Public Service Contracts and for Related Matters Law, as amended.
Law No. 12(I)/2006, as amended, transposes EU Procurement Directives 17/2004 and 18/2004 and is
the relevant legislation governing public procurement contracts in Cyprus.
Law No. 104(I)/2010 on the Procedures concerning the award of public procurement
This law transposed Directive 2007/66/EC with regard to improving the effectiveness of review
procedures concerning the award of public contracts. It sets out, inter alia, the powers and structure of
the Tenders Review Authority as well as the procedures it is required to follow.
Public procurement of pharmaceuticals is centrally handled by the Pharmaceutical Services
Department of the Ministry of Health. Public procurement of medical equipment, consumables and
external medical services is centrally handled by the Purchasing and Supply Directorate of the Ministry
of Health. Purchases are primarily made with the use of open procedure. The contracting authority
may in appropriate circumstances make use of negotiated procedure (with or without prior publication
of a contract notice)
e. Pharmaceutical Law
Cyprus pharmaceutical laws and Regulations are in line with corresponding EU legislation.
Medicinal Products for Human Use Laws
Law 70(I)/2001 on Medicinal Products for Human Use (Control of Quality, Supply and Prices), as
amended, transposes into Cyprus Law Directive 2001/83/EC on Medicinal Products.
The aforementioned Law establishes the Drugs Council which is responsible, inter alia, for examining
applications and issuing marketing authorizations for medicinal products for human use; amending or
revoking such marketing authorizations; examining and issuing licenses for the manufacturing and
importation of medicinal products coming from third countries etc.
The Law also deals with parallel imports, labeling, and advertisement of medicinal products, wholesale
and agency of medicinal products, price controls and related matters.
The Narcotic Drugs and Psychotropic Substances Laws
Law 29/1977 on narcotic Drugs and Psychotropic Substances, as amended, deals with ‘controlled
substances’, as these are defined and categorized therein. The law includes strict provisions on the
importation, exportation, manufacturing, possession and use of such substances and introduces
several offences and respective sentences in relation to controlled substances.
The Pharmacy and Poisons Laws Cap. 254
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Cap. 254 on Pharmacy and Poisons, as amended, establishes the regulatory framework for the
operation of pharmacies and the exercise of the profession of a pharmacist in Cyprus, the sale of
pharmaceuticals and/or poisons, drug distribution, prescriptions and labeling.
Law 39/1972 on the Pharmacists’ Associations, Disciplinary Rules and Pension Funds, as amended.
f.
Medical devices legislation
•
In the European Union, the core legal framework on Medical devices consists of three
Directives: Directive 90/385/EEC regarding active implantable medical devices, Directive
93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic
medical devices. These 3 main directives have been supplemented over time by several
modifying and implementing directives. The obligations under these Directives are
implemented into Cyprus law by Law 30(I)/2002 on the Basic Requirements that Certain
Categories of Products Should Fulfill, as amended, and pertinent regulations concerning
Medical Devices.
•
The Cyprus Medical Devices Competent Authority (CYMDA) is the government authority which
is responsible for ensuring the safety of the medical devices and operates according to the
national and European imposing fines or other sanctions. Further information on the
competences of CYMDA is available on its official website at: http://cymda.eu/legislation.
•
CYMDA’s role is to monitor the market and protect consumers from unsafe products as far as
possible. This is achieved by inspecting manufacturers, importers and distributors, by checking
and testing products and by taking measures against violations of the rules. Such measures
include recalling unsafe products from consumers, withdrawing them from the shelves,
destroying dangerous goods and imposing fines or other sanctions.
Regulation 598/2003
•
Regulation 598/2003 (as amended by subsequent regulations, collectively referred to as ‘The
Basic Requirements (Medical Devices) Regulations of 2003 to 2013’) transposes European
Council Directive 93/42/EEC concerning medical devices into Cyprus law.
•
A medical device is defined as: 'any instrument, apparatus, appliance, material or other article,
whether used alone or in combination, including the software necessary for its proper
application intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or
handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its function
by such means.
Regulation 597/2003
•
Regulation 597/2013, as amended by Regulation 358/2012, collectively referred to as ‘The
Basic Requirements (in vitro diagnostic medical devices) Regulations of 2003 to 2012’
transposes European Council Directive 98/79/EC into Cyprus law.
Regulation 599/2003
•
Regulation 589/2003, as amended by subsequent regulations, collectively referred to as ‘The
Basic Requirements (Active Implantable Medical Devices) Regulations of 2003 to 2013’
transposes, inter alia, European Council Directive 90/385/EEC, as amended.
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3. Provide any special issues/recent developments which arise in your jurisdiction.
Major health care reforms are expected to be implemented within the next few years with the
implementation of the proposed National Health System (NHS). This will be an insurance-based system
which has been designed to address the current challenges, distortions and deadlocks in the healthcare
sector. This will be achieved by adopting good practices of other national health systems and adjusting
these to the needs of the local population whilst taking into account social and economic conditions.
The main principles and characteristics of the proposed NHS are briefly described below:
• Universal coverage: All Cypriot citizens will become beneficiaries of the NHS.
• Comprehensive benefits package: The NHS benefits package will cover a broad spectrum
of
healthcare services including primary care, outpatient specialist care,
pharmaceuticals, clinical
laboratory tests, allied health professionals, accident &
emergency care, ambulance care,
inpatient care and limited dental care.
• Equal treatment of beneficiaries: All beneficiaries will have the same rights in respect
of the
provision of healthcare services and therefore reducing the health inequalities
within the NHS.
• Free choice of healthcare providers: Beneficiaries will have the right to choose their
healthcare providers from both the public and the private sector.
• Solidarity: Beneficiaries will contribute to the NHS according to their income level.
Hence,
beneficiaries with higher income will contribute more to the benefit of beneficiaries with lower income.
Access to healthcare services by beneficiaries will take place after enrolment to the system, followed
by registration with a Family Doctor (FD)/Pediatrician Family Doctor (PFD). As a rule, the beneficiaries
will visit directly the FD/PFD and if then required will be referred to other healthcare providers within
the system depending on his/hers specific medical needs.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Mobile health applications constitute an emerging and rapidly developing field. Although such applications
are not explicitly regulated under a specific Cyprus law. Nonetheless, they may fall within the ambit of
several existing national laws, which largely follow the corresponding EU directives.
Useful guidance regarding mobile health applications and mobile health in general is mainly to be drawn
by the recent Green Paper published by the European Commission on mobile health and accompanying
Commission staff Working Document on the existing EU legal framework applicable to lifestyle and
wellbeing apps.
Following the above, some mobile health applications may fall under the definition of a medical device or
of an in-vitro diagnostic medical device and therefore may have to comply with the safety and performance
requirements of Directive 93/42/EEC concerning medical devices or Directive 98/79/EC on in vitro
diagnostic medical devices respectively and the relevant Cyprus laws, as described in section 2(f) above.
In addition, mobile health applications developers should be aware of the various rights that mobile health
applications users have in their capacity as consumers. Such rights pertain to privacy and data protection
rights (under the Processing of Personal Data (Protection of the Individuals) Law 138(I)/2001 as amended),
consumer protection rights (as envisaged under the Consumer Rights Law 133(I)/2013, the Electronic
Commerce and Associated Matters Law No. 156(I)/2004, as amended and the Unfair Commercial Practices
Law No. 103(I)/2007, as amended.
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Contact Information
Alexandros Georgiades, Partner
[email protected]
Ioanna Sapidou, Associate
[email protected]
Dr. K. Chrysostomides & Co LLC
1, Lampousas Street, 1095 Nicosia - Cyprus
P.O.Box 22119, 1517 Nicosia - Cyprus
Tel 357.22.777000 Fax 357.22.779939
Firm Website www.chrysostomides.com.cy
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Ecuador
Prepared by Lex Mundi member firm Pérez, Bustamante & Ponce
1. Provide an introduction on health law in your jurisdiction.
The Ecuadorian health care system is characterized by a combination of mandatory public health
insurance for workers and their family members (Instituto Ecuatoriano de Seguridad Social) with
its correspondent public hospitals, and the private sector where you can find important private
hospitals and many local and multinational insurance companies.
Every aspect related to health is heavily regulated in Ecuador. The most important government
institution in charge of the health industry is called the ARCSA. In recent years a lot of public money
has been invested in public hospitals and health in general. Private insurance companies are also
under the tight gasp of the central government. Pharmaceutical companies have been also subject
to strict scrutiny under the current government, there has been a strong emphasis on promoting
generic medicines and a lot of price control for privately developed drugs. In the area of medical
research we have also witnessed important amounts of public funding. On the other hand, the
regulation of the medical profession has been harshened creating animosity between the medical
professional’s community and the government.
Relevant authorities and associations:
- Ministry of Public Health (Ministerio de Salud Púbilca) is responsible for the planning,
management, coordination and control of public health nationwide. The Ministry is headed by the
Minister of Public held, and composed by vice-ministers, and other smaller entities within the
Ministry.
-
Public entities which are separate from the Ministry but ascribed to it are:
-
National Sanitary Regulatory Surveillance and Control Agency, (Agencia Nacional de
Regulación, Control y Vigilancia Sanitaria “ARCSA”), ARCSA’s mission is: Protecting the
health of the population by regulating and controlling the quality, safety, efficacy and safety of
products for human use and consumption, and the sanitary conditions of facilities subject to
surveillance and disease control in the field of action.
-
National Institute of Public Health Research (Instituto Nacional de Investigación en Salud
Pública “INSPI”) INSPI’s directs the institutional planning and management for the
implementation of the research, science, technology and innovation, and is the national
reference laboratory that provides specialized health services under the National Health Policy
and Health Research.
-
National Institute of Organs Donation and Transplant, Tissues and Cells (Instituto Nacional de
Donación y Transplante de Órganos, Tejidos y Células “INDOT”). The INDOT is under the
Ministry of Public Health, it is responsible for regulation, coordination, monitoring, advocacy,
monitoring and evaluation of transplant activity at a national level.
-
National Control of Vector-Borne Arthropod Diseases System (Servicio Nacional de Control de
Enfermedades Transmitidas por Vectores Artrópodos “SNEM “) it´s objective is contributing to
the reduction of the presence of vector-borne arthropod populations located in areas at risk of
disease transmission; through actions of prevention, control and surveillance, to improve the
quality of life of the population, focused on ensuring health rights and the fulfillment of the goals
of the National Development Plan for Good Living.
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-
Center for Information and Advice on Toxic Substances (Centro de Información y
Asesoramiento Toxiocologico)
-
Technical Secretariat of the National Council for Fixation and Price Review for Medicines
(Secretaría Técnica del Consejo Nacional de Fijacion y Revisión de Precios de Medicamentos)
-
Ecuadorian Institute of Social Security (Instituto Ecuatoriano de Seguridad Social “IESS”). The
Ecuadorian Institute of Social Security is an entity whose organization and operation are based
on the principles of solidarity, obligation, universality, equity, efficiency, subsidiarity and
sufficiency. It is responsible for implementing the General Compulsory Insurance System as
part of the national social security system.
-
Panel medical practitioners are organized in the Ecuadorian Medical Federation (Federación
Médica Ecuatorina).
-
Regarding market access (pre-market) and active marketing of pharmaceuticals and medical
devices:
•
-
Ecuadorian Institute for Standardization (Instituto Ecuatoriano de Normalización)
Competent for Standardization, Technical Regulations and Metrology, to ensure
compliance with safety-related rights; the protection of life and health amongst others;
Regarding implementation and post-market monitoring of pharmaceuticals and medical
devices, the relevant authority is the National Pharmacovigilance System (Sistema Nacional
de Farmacovigilancia), it is also ascribed to the Ministry of Public Health.
2. Provide a check list of laws with a short summary of the general requirements of each.
a. Social Security Law
Social Security Law
This is the basic piece of legislation that regulates the mandatory health insurance for workers and their
families the principles that inspire the Law are solidarity, compulsorily, universality, equity, efficiency,
subsidiarity and adequacy.
•
The Social Security Law – Statutory Health Insurance (Instituto Ecuatoriano de Seguridad
Social) provides the legal framework for statutory health insurers.
•
The duty to become a member of the statutory health insurers originates from taking up an
employment. All persons who receive income through the execution of works or the provision of
physical or intellectual services, with or without employment are subject to the mandatory health
insurance.
•
The insurers are primarily financed through the following sources, especially by membership
contributions. Contributions are income-related and divided between the employer and the
employee.
o
o
o
o
o
o
a. The mandatory individual contributions of members;
b. The compulsory employer contribution, private and public, for each insurance when
members are employees covered by the Labor Code;
c. The compulsory employer contribution of public employers, for each insurance when
members are servants under the Civil Service and Administrative Career;
d. The mandatory financial contribution of the State, for each insurance, in cases stipulated
by this Act;
e. Technical reserves of the pension scheme for intergenerational solidarity;
f. The balances of the individual accounts of members of the scheme mandatory individual
retirement savings;
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o
o
o
o
o
o
o
g. Income from the payment of dividends of public and private debt owed to the IESS, on
account of employer obligations;
h. Income from dividend payments of the debt of the national government with the
Ecuadorian Social Security Institute;
i. The income of any class that the properties, fixed assets, and stocks and shares in
companies managed by the IESS produce;
j. Revenues from the sale of the assets of each insurance administered by the IESS;
k. Revenue from health services provided by medical units,;
l. The resources of all kinds which they are assigned to each insurance under special laws
for the accomplishment of its purposes; and,
m. Inheritances, legacies and donations.
General Insurance Law
The General Insurance Law (Ley General de Seguros) regulates the establishment, organization,
activities, performance and liquidation of the legal entities that provide private health insurance and the
operations and activities of the individuals that make up the private insurance system; which shall be
subject to the laws of the Republic and the supervision and control of the Superintendency of Banking
and Insurance.
Contribution to IESS by employees subject to the Labor Code, IESS regulation
This IESS regulation contains provisions on the minimum annual income required for a person working
in different areas of the private sector to be subject to the mandatory health insurance.
Contribution to IESS by employees of the public sector, IESS regulation
This IESS regulation contains provisions on the minimum annual income required for a person working
in the public sector to be subject to the mandatory health insurance.
b. General Health Legislation
Health Act (Ley Orgánica de la Salud)
The Health Act regulates the constitutional right to health and its enforcement. All members of the
National Health System are subject to: the provisions of this Act and the regulations and standards set
by the national health authority for the implementation of activities related to health.
Organic Law of the National Health System (Ley Orgánica Del Sistema Nacional De Salud)
This Act is to establish the principles and general rules for the organization and operation of the National
Health System to govern the entire national territory.
Patient´s Rights Protection Act (Ley de Derechos y Amparo del Paciente)
The Act regulates the rights that are recognized to Hospital patients, the special protection they receive
when they are going through an emergency and the sanctions that can be imposed to hospitals for
violating the patient´s rights or failing to provide the necessary medical attention.
Organic Law on Donation and Transplantation of Organs, Tissues and Cells (Ley Orgánica de Donación
y Trasplante de Órganos, Tejidos y Células)
The provisions of this Act are mandatory for all National Health System on the issues concerning the
process of donation and transplantation. This law includes the new practices or techniques that the
National Health Authority recognized as linked to the implementation of organs or tissues in humans
Law of Voluntary Blood Donors (Ley de Donantes Voluntarios de Sangre)
It’s a short law which provides that there should be blood donating groups in every high school and
university.
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c. Laws regulating the medical profession
Criminal Code (Código Integral Penal)
Medical interventions are stipulated as specific exceptions to bodily injury. Homicide is explicitly
regulated for the medical profession, as well as abortion and the alteration or fabrication of medicines
without a license is criminalized. The relevant articles of the COIP are: 146, 147, 148, 149, 150, 152,
217, 422, 463, 643.
Civil Code (Código Civil)
In Ecuador the Civil Code acts as a default rule for cases that are not found in other more specialized
laws.
Laws which regulate the different medical specialties:
•
Law of the Ecuadorian Medical Federation (Ley de la Federación Médica Ecuatoriana)
•
Professional Practice Act for Nurses in Ecuador (Ley de Ejercicio Profesional de las Enfermeras y
Enfermeros del Ecuador)
•
Professional Practice Act for Medical Anesthesiologists (Ley de Ejercicio Profesional de Médicos
Anestesiólogos)
•
Professional Practice Act for Chemical, Biochemical and Pharmaceutical Workers (Ley Ejercicio
Profesional de Químicos, Bioquímicos y Farmacéuticos)
•
Professional Practice Act for Medical Technologists (Ley de Ejercicio Profesional de Tecnólogos
Médicos)
•
Act of the Ginecological Federation of Ecuador Imposing an Eight Hour Day For Health
Professionals (Ley de Federación de Obstetrices del Ecuador Jornada de Ocho Horas Diarias
Para Profesionales de la Salud)
d. Public Procurement Law
National System of Public Procurement Act (Ley Orgánica del Sistema Nacional de Contratación
Pública)
This is the Act that regulates public procurement in Ecuador, thus it applies when contracting with public
health institutions. The aim of the Act is to create a procurement system in Ecuador that articulates and
harmonizes all instances, agencies and institutions in the areas of planning, programming, budgeting,
control, administration and execution of the procurement of goods and services and in implementing
public works undertaken by public funds.
Other laws related to the public sector:
•
Law Regulating Private Prepaid Medicine Companies (Ley que Regula las Empresas Privadas
de Salud y Medicina Prepagada)
Healthcare and prepaid medicine companies are those companies incorporated in the national
territory that grant their affiliates funding for health services and medical care in general. This
Law regulates the organization and operation of private health and prepaid health companies
which finance the provision of health services; and serves to guarantee the rights and
obligations of the users of these companies.
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•
Regulations that Approve Internal Regulations of Health Facilities (Reglamento para la
Aplicación del Proceso de Licenciamiento en los Establecimientos del Sistema Nacional de
Salud)
Act for the Regulation And Control Of Market Power
The Act against Restraints on Competition (Ley Orgánica de Regulación y Control del Poder
de Mercado) in general applies to every market including the public health market, there are
some especial consideration for mergers and acquisitions of hospitals or private insurance
companies.
e. Pharmaceutical Law
Law Regulating Human Generic Drugs (Ley De Medicamentos Genéricos De Uso Humano)
The Ecuadorian State shall promote the production, importation, marketing and sale of generic drugs
for human use. This law regulates the prices of generic drugs and it is meant to support national
research and development of generic drugs.
Regulations on the pharmaceutical industry:
f.
•
Regulation for the functioning of drug stores (Funcionamiento de Droguerías)
•
Regulations for the Implementation of the Licensing Process in Establishment of the
National Health System (Reglamento para la Aplicación del Proceso de Licenciamiento en
los Establecimientos del Sistema Nacional de Salud)
•
Regulation for Drug Advertisng (Promoción De Medicamentos En General)
•
Rules for Classifying Drugs in General, Organic Products Processed for Medicinal Use and
Homeopathic Drugs as "Over the Counter" (Reglamento para Clasificar los Medicamentos
en General, Productos Naturales Procesados de Uso Medicinal y Medicamentos
Homeopáticos como “de Venta Libre”)
•
Regulations for Pricing Drug suitable for Human Use (Reglamento para la Fijación de
Precios de Medicamentos de Uso y Consumo Humano)
•
Acquisition Regulation for Basic Drugs (Reglamento para la Adquisición De Medicamentos
Básicos)
Medical devices legislation
Sanitary Regulations and Control of Medical and Dental Devices (Reglamento y Control Sanitario de
Dispositivos Médicos y Dentales)
The provisions of these rules govern all matters relating to the registration and health checks on the
following products:
a) Medical Devices;
b) Biochemical and diagnostic reagents (for use in vitro); and,
c) Dental Products.
3. Provide any special issues/recent developments which arise in your jurisdiction.
•
New Ecuadorian Criminal Code introduces in Art. 146 a new type of homicide for
professional mal practice and criminal responsibility for legal entities such as Hospitals:
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The new Ecuadorian Criminal Code, which just came into force on august 2014, caused major
controversy with the professionals of the health industry. The most important change it introduced
was to create a specific crime for negligent homicide by professionals. Many strikes and protests
were held by medical doctors and health professionals in general to try to prevent the enactment
of the rule, however, in the end the code was enacted with the following article:
“Art. 146.- Negligent homicide due to professional malpractice.- The person who violating an
objective duty of care in the exercise or practice of his profession, causes the death of another,
shall be punished with imprisonment from one to three years.
The qualification process to return to their work after completion of their sentence shall be
determined by law.
A person shall be punished with imprisonment of three to five years if the death is caused by
unnecessary, dangerous and illegitimate actions. For the determination of the breach of the
objective duty of care the following circumstances must concur:
1 The mere production of the result does not convey infringement of the objective duty of care.
2 Failure to follow laws, regulations, orders, manuals, technical rules or the lex artis applicable
to the profession.
3. The harmful outcome must directly result from the breach of the objective duty of care and
not from other independent or related circumstance.
4. In each case diligence, the degree of professional training, the objective conditions,
predictability and preventability of the event will be analyzed.”
After the Code was approved the main discussion was the difference between the general crime
with 1 to 3 years in prison and the aggravated crime punished from 3 to 5. A question was raised
to Ecuador’s National Court (Highest Court in the State). So that it clarify the difference the Court
said that it was correct to understand the article as created a general and an aggravated type of
homicide but simply repeated that the difference lay in if the conduct was illegal, dangerous or
unnecessary, without further defining the meaning of the terms.
•
New Pricing Regulations Applicable to Drugs for Human Use:
These Regulations establish new pricing regimes and their application. They
.
are:
Regulated Pricing Regime: This regime establishes a price ceiling for each segment of registered and
new strategic medicinal drugs in the market.
-
Registered medicinal drugs: The price ceiling will be equivalent to the average selling prices in
the market. Once the ceiling has been established, no medicinal drug can be sold with a higher
selling price. Such drugs whose selling prices are lower than the ceiling cannot increase them.
-
New medicinal drugs: It is necessary to analyze if there is a therapeutic advantage of such drugs
being evaluated in order to determine their prices. The price ceiling will be established on the
basis of existing lower-priced therapeutic alternatives. In the event that the drug does not
demonstrate actual therapeutic advantages, the price ceiling will be determined after conducting
a pharmaceutical-economic analysis.
-
Direct Pricing Regime: This is an exceptional regime. It consists of unilateral determination carried out
by the National Pricing and Price Revision Council with respect to the price of new medicinal drugs for
human use and consumption. It will be applied when medicinal drugs are sold with a price over and
above the established price ceiling, or in the event of an increase of prices greater than the accrued
inflation, marketing of new drugs with no prior price ceiling, falsehood in the information furnished to
the Council, among other aspects.
-
Free Pricing Regime: This Regime includes such medicinal drugs that are not contemplated in the
other regimes. Prices will be freely determined and notified to the Council.
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•
New Rules for Classifying Drugs in General, Organic Products Processed for Medicinal
Use, and Homeopathic Drugs as “Over-the-Counter”:
Freely sold (“over-the-counter”) medicinal drugs are those that by reason of their composition and the
pharmacological action of their active principles are authorized to be sold without a doctor’s
prescription. The Regulations set forth the criteria that a medicinal drug, a natural processed product
for medicinal use, or a homeopathic medicine must meet in order to be classified as “over-the-counter”.
The following are included among them:
(a)
Efficacy and safety when used to prevent or to alleviate symptoms or signs of easily identifiable
mild illnesses;
(b) Broad dosage margin that can be adapted to the patient’s age and weight;
(c) They should not generate tolerance or dependency and must not be liable to abuse;
(d) They must not mask serious illnesses or delay the diagnosis or treatment of a condition requiring
medical care;
(e) Pharmaceutical forms must be meant for oral or topic use and not for intravenous or intramuscular
administration;
(f)
The active principle must have been sold with a doctor’s prescription during at least ten years
demonstrating favorable safety and efficacy indices.
By reason of their pharmacologic condition, any medicinal drugs comprising psychotropic and narcotic
substances cannot be sold over-the-counter.
The Regulations state that the National Agency for Sanitary Regulation, Control and Surveillance
(“ARCSA”) must classify such products that can be sold over-the-counter while undergoing their sanitary
registration process according to the same methods established for that purpose.
Contact Information
Diego Pérez Ordoñez
[email protected]
PBP LAW
República del Salvador 1082,
Quito, Ecuador
Tel 59.32.382.7640..Fax 59.32.225.8038
Firm Website www.pbp.law.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Estonia
Prepared by Lex Mundi member firm LAWIN
1. Provide an introduction on health law in your jurisdiction.
Health Care System and Services
Estonian health care system is built on compulsory solidarity based health insurance and general
accessibility of health care services provided by private service providers. The Ministry of Social
Affairs manages and conducts supervision over the health care system and develops health
policies. Health care services are mainly financed through the independent Estonian National
Health Insurance Fund (hereinafter "ENHIF").
Health care services are divided into four main categories:
(i)
emergency medical assistance;
(ii)
primary medical assistance or general medical assistance mainly provided by general
practitioners;
(iii)
special medical assistance, including secondary and tertiary medical assistance, and
(iv)
nursing assistance.
Health care services may be provided only by persons or institutions acting as private legal entities,
foundations or registered self-employed persons. As such, most of the hospitals are either public
limited liability companies owned by local governments or foundations established by state, local
governments or other public organizations. Thus, hospitals are managed as public institutions
either for profit generating or non-profit purposes. Most of out-patient medical assistance providers
are privately owned. All general practitioners are either private entrepreneurs or salaried employees
of companies owned by the general practitioners. Such companies may only provide general
medical and nursing services.
The provision of health care services is being controlled by the State through the Health Board
which decides upon the allocation of general practitioner service areas in counties and through the
Minister of Social Affairs who decides upon the number of emergency medical service brigades
financed from the state budget. The State’s influence is most evident upon granting activity licenses
for special medical assistance and nursing care, supervision and financing from public sector funds.
Health care professionals are allowed to provide health care services only if they are registered in
the National Register of Health Care Professionals. Registration grants a health care professional
the right to provide health services within the limits of his or her qualification and in the registration
certificate issued upon registration.
Activity licenses are required for the provision of emergency medical services, general medical care
on the basis of a practice list of a family physician, specialized medical services, independent
nursing services and independent midwife services.
General practitioners work in a designated area and on the basis of a list of patients. In order to
grant the right to establish a patient list, Health Board organizes public competitions for general
practitioners. As a result of such competitions the Health Board approves the patient lists and
designated areas for the respective general practitioners, who assume the right to work as general
practitioners as of the moment such approval comes into force.
Estonia has in place a digitalized health information system called "eHealth", where data related to
health care is processed for the purposes of the provision of health services, guaranteeing the
quality thereof as well as the rights of patients and for the protection of public health, including for
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maintaining registers concerning the state of health, for the organization of health statistics and for
the management of health care.
Estonian health care system is mainly financed by the public sector funds. The major part thereof
derives from social tax which forms over 60% of the whole financing of the health care system.
Health insurance system is organized by the ENHIF. Health insurance in Estonia is compulsory
(voluntary health insurance is mostly connected to travel insurance; there are no tax incentives for
health insurance schemes provided by employers) and its purpose is to:
(i)
cover the costs of health services provided to insured persons;
(ii)
prevent and cure diseases;
(iii)
finance the purchase of medicinal products and medical technical aids, and
(iv)
provide the benefits for temporary incapacity for work and similar needs.
Medicinal products are reimbursed if they are included in the List of Reimbursable Medicinal
Products, approved by the ENHIF, containing different medicinal products used for out-patient
services. Most of the medicinal products reimbursed are those provided on a prescription-only
basis, but a limited number of over-the-counter medicines are also covered. The compensation for
the medicinal products is based on a system of reference prices, whereby the public sector will,
through the ENHIF, compensate a fixed amount regardless of the different prices established by
various manufacturers. The law also governs the system of price agreements, which provides that
in certain cases application of a discount to a medicinal product is subject to a price agreement
with the manufacturer of that product. Discounts rates vary from 50% up to 100 %. The patients
also have to pay a fixed prescription fee and cover the percentage of the difference between the
retail price and the reference price. There is no rebate system in Estonia. The insured person has
to pay his / her own co-payments to pharmacy and the ENHIF pays the discounted part to the
pharmacy after receiving the relevant prescriptions electronically. Generally, similar principles are
also applied to medical devices as well as the provision of medical services, including dental care.
Manufacturing Medicinal Products
Medicinal products may be manufactured only by the holder of the respective activity license. The
manufacturing of medicinal products, including intermediate products, the sterilization, packaging,
labelling, re-packaging, re-labelling and quality control of medicinal products, and the release of
batches together with the related purchase, receipt, storage and dispensing of materials is
considered as the manufacture of medicinal products. The activity license for the manufacturing of
medical products refers to the license issued for the total or partial manufacturing including the
manufacturing of active ingredients or medicinal products intended for the clinical trials. The
products have to be manufactured in accordance with the Good Manufacturing Practice standards.
The Minister of Social Affairs has established the rules for manufacturing the medicinal products in
compliance with the Good Manufacturing Practice valid in the European Union.
An activity license for the manufacturing of medicinal products is not mandatory if the activities
regarded as manufacturing are carried out by the holder of the activity license of general pharmacy,
hospital pharmacy or veterinary pharmacy either for the preparation of medicinal products as
magisterial formulae or officinal formulae in accordance with a medicinal prescription, or for
dividing-up into packages for dispensing. An activity license for the manufacturing of medicinal
products is optional for the manufacture of medicinal products intended for clinical trials if the
packaging, labelling, re-packaging or re-labelling of the medicinal products is carried out in a
hospital pharmacy, and the medicinal products are used exclusively in the hospital operated by the
person who formed the hospital pharmacy.
The holders of activity licenses may be state authorities, local governments and other legal persons
in public law, also self-employed persons and other legal persons in private law, but activity licenses
may not be issued for non-profit associations.
As a rule, the holder of the activity license is permitted to hold only one type of activity license at a
time. The holder of the activity license for the wholesale trade in medicinal products may however
concurrently hold the activity license for altering the labelling and outer packages of medicinal
products, for re-packaging of starting materials used for manufacturing of medicinal products and
for the import of medicinal products from third countries to Estonia and release thereof. The holder
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of the activity license for a hospital pharmacy may hold, concurrently with the activity license for
provision of pharmacy services, an activity license for manufacturing of full blood and blood
components and for packaging, labelling, re-packaging or re-labelling of medicinal products
intended for the clinical trials.
The holder of the activity license for a pharmacy or a subsidiary cannot be at the same time a
shareholder or a member of a private legal entity holding an activity license for manufacture of
medical products. The holder of an activity license for manufacturing of medical products or
provision of health services or a person qualified to prescribe medicinal products is not allowed to
be a shareholder or member of a private legal entity holding an activity license for a general
pharmacy.
Activity licenses are issued by the State Agency of Medicines. The State Agency of Medicines
makes a decision to issue an activity license within 60 days after the receipt of all necessary
documents. The activity license is issued or renewed for a period of up to five years. The term of
validity of the activity license for the manufacturing of medicinal products issued to the holder of
the activity license for wholesale trade in medicinal products cannot be longer than the term for the
activity license for wholesale trade in medicinal products.
Marketing Medicinal Products
In order to market a medicinal product in Estonia it is generally mandatory to have a marketing
authorization. Procedure of granting marketing authorizations in Estonia is closely linked with
international guidelines and is generally similar to that of other EU Member States. A marketing
authorization can be granted to a person residing or registered in an EEA Member State. In the
case of suspending or terminating the marketing of a medicinal product, the State Agency of
Medicines must be notified at least two months in advance.
The procedures of applying for the marketing authorizations are:
•
•
•
National procedure – application for the marketing authorization is submitted to the
Estonian State Agency of Medicines in the event the marketing authorization is applied for
the respective product only in Estonia or in the event Estonia is chosen as a reference
country in order to start a mutual recognition procedure in the future;
Mutual recognition procedure (hereinafter – MRP) and decentralized procedure
(hereinafter – DCP) – application for the marketing authorization is submitted to one of the
agencies in the European Union (reference country) which drafts an evaluation report that
other EU Member States recognize provided that no danger to public health exists. In the
case of the MRP at least one Member State has already issued the marketing authorization
and thereafter applications are submitted to other Member States. In the case of the DCP
no Member State has issued the marketing authorization yet;
Centralized procedure – application for the marketing authorization is submitted to the
European Medicines Agency (hereinafter – EMA). This procedure is mandatory for
biotechnological and other high technology medicines, as well as to new active substances
meant for treatment of HIV, tumors, diabetes, neurodegenerative diseases or rare
diseases. Evaluation of applications by experts from the Member States is coordinated by
the EMA and the marketing authorization is issued by the European Commission granting
the right to market the medicine in all Member States.
Upon applying for a marketing authorization, the applicant must provide scientific evidence that the
medicinal product is safe and effective and that the quality of the product conforms to the
requirements set by the legislation.
An applicant does not need to provide any data in order to prove the efficiency and safety of the
medicinal product for marketing authorization in cases where:
•
The ingredients of the medicinal product have a well-established medicinal use and they
have been used in another EEA Member State for at least 10 years;
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•
The medicinal product is similar to a medicinal product in respect of which marketing
authorization was granted in Estonia or another EEA Member State at least 8 years ago.
Based on the application and the materials submitted the State Agency of Medicines assesses
whether the product is in conformity of the efficacy, safety and quality requirements established in
the legislation. The State Agency of Medicines submits the assessment of the product to the
marketing authorization committee for an opinion. The marketing authorization committee for
medicinal products for human use is an advisory committee and its opinion is not binding on the
director of the State Agency of Medicines upon making a decision. After evaluating the submitted
materials the director of the State Agency of Medicines makes a decision whether to grant the
marketing authorization or not.
After successful conclusion of the assessment process of the medicinal product the marketing
authorization is granted and pharmaceutical product is entered in the register. The Medicines
Register is processed by the State Agency of Medicines. The register is maintained to keep a
record of licensed medicines and for the provision of information to the public. The register contains
all the medicines that have been granted the marketing authorization by Estonian State Agency of
Medicines or the European Commission.
The State Agency of Medicines shall issue the marketing authorization within 210 days from the
date of acceptance the application. The State Agency of Medicines classifies the medicinal product
as not a subject to medical prescription, subject to medical prescription or subject to restricted use.
A marketing authorization of a medicinal product shall be issued for five years. After the first period
of five years the authorization will be renewed for an unlimited period of time; however as an
exception, in certain cases, the State Agency of Medicines could decide that another five-year
renewal period is necessary. In the case of applying for a renewal the application must be submitted
to the State Agency of Medicines at least 180 before the expiry date. If the marketing authorization
holder chooses not to renew a marketing authorization, the State Agency of Medicines must be
notified of the reasons thereof – especially if the reasons are related to changes in the
circumstances that formed the basis of the issue of the marketing authorization or if new data
regarding the medicinal product indicates that it has an insufficient risk-benefit ratio considering the
contemporary level of medical science or that it is not as effective or safe as it was considered to
be based on the data submitted when applying for the authorization.
Clinical Trials
The Estonian regulation of the clinical trials is in full compliance with the respective EU legislation.
The sponsor of the clinical trial must be a resident of a Member State of the European Economic
Area. Before the start of a new clinical trial the sponsor chooses the doctors conducting the
investigation who are responsible for the clinical trial. Thereafter, an application must be submitted
for authorization and the justification for carrying out the investigation in Estonian research centers
to the State Agency of Medicines at least two months before the beginning of the planned trial.
Informed consents from trial subjects and approval by the Ethics Committee also need to be
obtained. The trial may not be commenced without the consent from the Ethics Committee and the
State Agency of Medicines.
The sponsor of the clinical trial is liable for the conformity of all aspects of the clinical trial and the
conduct thereof. It is also an obligation of the sponsor to notify the State Agency of Medicines as
well the Ethics Committee in the event any serious unexpected adverse events occur in the course
of the trial. The sponsor is obliged to terminate the trial in case it could in its opinion endanger the
life and health of the subjects. The completeness and accuracy of the information collected in the
course of the trial, the quality of collected information and the protection of the personal data of the
trial subjects needs to be ensured by the sponsor. At the end of the trial, the sponsor has to draft
the final report on the trial.
The clinical trials, medicines used in the clinical trial and other necessary expenses connected with
the research are financed by the sponsor. The sponsor also must ensure the trial subjects health
insurance protection in the event of damage to health related to the trial.
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Clinical trial medication should be manufactured in compliance with the standards of the Good
Manufacturing Practice and the trials should be performed and the data generated in compliance
with the Good Clinical Practice standards to ensure the ethical and scientific integrity of the trial.
The State Agency of Medicines has the right to inspect all aspects of the clinical trial as well as the
performance of the Ethics Committees. The State Agency of Medicines is entitled to immediately
suspend or terminate the clinical trial of a medicinal product in case it poses a danger to life and
health of the trial subjects. The person conducting the trial is required to suspend or terminate the
trial immediately after receiving a corresponding decision of the State Agency of Medicines.
2. Provide a check list of laws with a short summary of the general requirements of each.
•
Medicinal Products Act - regulates the handling of medicinal products, issue of medical
prescriptions, grant of marketing authorization for medicinal products, clinical trials and
advertising of medicinal products, and supervision over and liability in the area of medicinal
products with the aim to guarantee the safety, high quality and efficacy of medicinal
products used in Estonia and to promote the rational use of medicinal products for their
intended purposes.
•
Medical Devices Act - stipulates requirements for medical devices and accessories and
the manufacture thereof, placing on the market and putting into service of medical devices,
providing clinical evaluation of medical devices, the professional users of medical devices
and the sale of medical devices on the basis of medical device card. The Act serves to
transpose the European Council Directives 90/385/EEC (active implants), 93/42/EEC
(other medical devices) and 98/79/EC (In vitro Diagnostic Medical Devices – IVD) into
Estonian law.
•
Health Services Organization Act - provides the organization of and the requirements for
the provision of health services, and the procedure for the management, financing and
supervision of health care.
•
Health Insurance Act - regulates the Estonian solidarity-based health insurance system;
among other matters, regulates the reimbursement of health care services, medicinal
products and medical devices, most notably the procedure for determining the reference
prices and reimbursement rates of medicinal products, the inclusion thereof into the List of
Reimbursable Medicinal Products as well as the conclusion of price agreements between
the manufacturers of medicinal products and the Estonian Ministry of Social Affairs.
3. Provide any special issues which arise in your jurisdiction.
As a general characterization, it can be highlighted that while the Estonian market is not that
large, competition between the holders of marketing authorizations of medicinal products is quite
high. Otherwise, there are no particularly notable special issues with regard to Estonian health
care system and law.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Mobile health applications are not specifically regulated under Estonian law at this time.
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Contact Information
Pirkko-Liis Harkmaa
Associate Partner / Attorney-at-law
[email protected]
LAWIN
Niguliste 4
Tallinn, Estonia, 10130
Tel +372 6306460 Fax +372 6306463
www.lawin.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
www.lexmundi.com
Page 41
© 2016 Lex Mundi
International Guide on Health Industry Laws
Finland
Prepared by Lex Mundi member firm Roschier, Attorneys Ltd.
1. Provide an introduction on health law in your jurisdiction.
Introduction:
The Finnish health care system is largely characterized by its public nature. This is reflected in the
Finnish health laws, where responsibility for the population’s health is delegated mainly between the
authorities as well as the municipalities. Private health care constitutes only a minimal part of the
Finnish health care system. The private health care sector, which comprises of some 14 000
companies and practitioners, provides approximately every fifth health care service in Finland.
One of the objectives of the Health Care Act (1326/2010) is to ensure universal access to the health
services required by the Finnish population and to improve service quality and patient safety. Another
objective is to promote and maintain the Finnish population’s health and welfare, as well as the
people’s work ability, functional capacity, and social security. The Health Care Act applies to the
implementation of health care services by local authorities as obliged by the Primary Health Care Act
(66/1972) and the Act on Specialized Medical Care (1062/1989).
Primary health care is defined in the Primary Health Care Act as health promotion addressing
individuals, the population and their living environment, including illness and injury prevention, and
medical care for individuals. The protection of the health of individuals and their living environment is
to some extent also laid down in various other laws, while the provisions on the organization of
specialized medical care and related operations are laid down in the Act on Specialized Medical Care.
In Finland medicinal products are regulated under the Medicines Act (395/1987) and Medicines Decree
(693/1987). A medicinal product is defined as a product or substance intended to cure, alleviate or
prevent a disease or its symptoms in humans or animals, as well as to restore, correct or modify the
vital functions of humans or animals through pharmacological, immunological or metabolic influence
or to determine the state of health or the reason for a disease. The provisions of medicinal products
also apply in ambiguous cases, where a product corresponds to the definition of both a medicinal
product and another product.
The provisions for medical devices are laid down in the Finnish Medical Device Act (629/2010), which
defines a medical device as any instrument, apparatus, appliance, software, material or other article,
whether used alone or in combination, intended by the manufacturer to be used for human beings for
the purpose of: i) diagnosis, prevention, monitoring, treatment or alleviation of disease; ii) diagnosis,
monitoring, treatment, alleviation of or compensation for an injury or handicap; iii) investigation,
replacement or modification of the anatomy or of a physiological process; or iv) control of conception.
Relevant authorities:
The Ministry of Social Affairs and Health is responsible for general planning, guidance and
supervision of primary and specialized medical care.
The Regional State Administrative Agencies are responsible for planning, guidance and
supervision of specialized medical care within their area of operation, while guidance and supervision
concerning primary health care within each province is the responsibility of the State Provincial Office.
The National Supervisory Authority for Welfare and Health (“Valvira”) operates under the Ministry
of Social Affairs and Health with the purpose of supervising and providing guidance to healthcare and
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social services providers, alcohol administration authorities and environmental health bodies and
manages related licensing activities. Valvira also guides the operations of the Regional State
Administrative Agencies in order to harmonize their principles of operation, procedures and decision
practices in the guidance and supervision of specialized medical care. Valvira’s general task is to
guarantee all Finnish residents with a living environment that promotes health and welfare and to
assure access to safe and adequate social and healthcare services. Valvira is also the regulatory
authority for medical devices in Finland.
The Finnish Medicines Agency (“Fimea”) is the national competent authority for regulating
pharmaceuticals. As a central administrative agency operating under the Ministry of Social Affairs and
Health it promotes the health and safety of the population by regulating medicinal, blood and tissue
products, and by developing the pharmaceuticals sector. It also grants the authorizations and licenses
required to operate within the pharmaceutical market.
The Social Insurance Institution of Finland (“Kela”) is responsible for the duties related to the
implementation of health insurance. The Social Insurance Institution also monitors and controls
compliance with and implementation of the Health Insurance Act and the decrees and regulations
issued thereunder.
2. Provide a check list of laws with a short summary of the general requirements of each.
a. Healthcare laws
The Health Insurance Act (1224/2004, as amended) lays down provisions regarding the right to
reimbursement of expenses incurred in treating an illness as well as loss of income due to short-term
incapacity for work, pregnancy and child care. Persons resident in Finland and other persons meeting
the requirements of the Act are insured by the Health Insurance Act and are therefore entitled to
reimbursement. Reimbursement for occupational health care services and for annual holiday
expenses accrued during parental leave is also regulated under the Health Insurance Act.
The Health Care Professionals Act (559/1994) sets out the provisions for the education and
necessary training of health care professionals in order for them to have adequate professional
qualifications and other knowledge and skills necessary for practicing their profession, hence
promoting the safety of patients and improving the quality of health care services. Supervision and
facilitation of cooperation between health care professionals within health and medical care are also
regulated under the Health Care Professionals Act. A health care professional is defined as a person
who has been given the right or authorization to practice a profession or a person who is entitled to
use the occupational title of a health care professional, as regulated under the Health Care
Professionals Act.
The Health Care Act (1326/2010, as amended) applies to the implementation of health care services
by local authorities as obliged under the Primary Health Care Act (66/1972) and the Act on Specialized
Medical Care (1062/1989).
The Primary Health Care Act (66/1972, as amended) sets out provisions concerning health
promotion addressing individuals, the population and their living environment, including illness and
injury prevention, and medical care for individuals.
The Act on Specialized Medical Care (1062/1989, as amended) lays down provisions on the
organization of specialized medical care and related operations.
The Act on the Status and Rights of Patients (785/1992, as amended) states that every person
permanently resident in Finland is without discrimination entitled to good quality health and medical
care required by his state of health within the resources available to health care at the time in question.
According to said Act such care shall be arranged to the patient in a manner that does not violate
his/her human dignity and respects his/her conviction and privacy.
Private Health Care Act (152/1990, as amended) lays down the provisions concerning private health
care and the conditions for the granting of licenses required for the provision of private health care
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services. Such private health care services include inter alia laboratory operations, occupational
healthcare and services provided by physicians or dentists.
The Decree on Private Health Care (744/1990, as amended) sets out additional provisions
concerning private health care in Finland.
The Decree of the Ministry and Social Affairs on Private Health Care (7/2006, as amended) lays
down more specific provisions concerning the content, form and realization of license applications,
notifications and annual reports.
b. Pharmaceutical Laws
The Medicines Act (395/1987, as amended) is aimed at maintaining and promoting the safety and
proper use of medicinal products, as well as to ensure the appropriate manufacture and availability of
medicinal products in Finland. Provisions on marketing authorizations and registration of medicinal
products are also regulated under the Medicines Act.
The Medicines Decree (693/1987, as amended) holds additional provisions on the manufacturing,
sale, distribution, and marketing of medicines.
The legislation applicable to medicines is complemented by the regulations and guidance issued by
Fimea and the Code of Ethics issued by the Pharma Industry Finland (“the PIF Code”), which is the
industry organization for companies operating within the (innovative) pharma industry. The PIF Code,
which contains detailed provisions especially on the marketing of medicines, is based on marketing
guidelines issued by the European Federation of Pharmaceutical Industries and Associations
(“EFPIA”) and the International Federation of Pharmaceutical Manufacturers and Associations
(“IFPMA”).
c. Medical Device Laws
The Medical Device Act (629/2010, as amended) lays out the provisions for the manufacturing, sale,
distribution and marketing of medical devices. Prior to admitting medical devices into trade, a medical
device must meet the essential requirements applicable to it under Annex 1 of the Medical Devices
Directive (93/42/EEC), In Vitro Medical Devices Directive (98/79/EC) or Active Implantable Medical
Devices Directive (90/358/EEC), respectively. The device must also be fit for its intended purpose, and
must achieve the intended functionality and performance when used for its intended purpose, and
must not endanger health or safety of a patient, user or other person. The manufacturer must prove
compliance with the essential requirements by accompanying the medical device with a CE-marking.
Except for in vitro medical devices, a clinical assessment is required to show that a medical device
meets the applicable essential requirements.
The Medical Device Act is complemented by governmental guidance issued by Valvira and by industry
guidelines (i.e. the Code of Ethics (“Sailab Code”) issued by Sailab ry, which is the industry
organization for product suppliers within the hospital and laboratory industry.
3. Provide any special issues/recent developments which arise in your jurisdiction.
Special Issues:
In Finland medicines may only be manufactured industrially by a medicinal product manufacturer that
has acceptable production facilities and equipment and a manufacturing license granted by Fimea.
Further, the manufacturing of medicines for clinical trials also requires a license. A manufacturing
license is granted by Fimea provided that the applicant meets the requirements.
Furthermore, the distribution and wholesale of medicines may only be carried out under a license
granted by Fimea. In order to obtain a sales license, applicants must have appropriate facilities and
equipment for storage of medicines and for ensuring operations and the personnel required for
operations. Distributors and wholesalers must also have a responsible pharmacist who ensures that
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all actions are taken in line with the applicable legislation. In Finland the distribution of medicines is
operated through a ‘single-channel’ system. This means that nearly all pharmaceutical companies
make exclusive distribution agreements with only one wholesaler at a time and their products are thus
available only through that channel.
Pharmacies in Finland are regulated under the Medicines Act and supervised by Fimea. A pharmacy
can only be owned by a qualified pharmacist, who can own one pharmacy and a maximum of three
subsidiary pharmacies. The operation of pharmacy business requires a pharmacy license granted by
Fimea. A license can be granted if a license of another qualified pharmacist becomes available or if
Fimea sees it necessary to announce a new license available.
In order for medicines to be eligible for reimbursement by the Social Insurance Institution, a reasonable
wholesale price and a reimbursement status must be obtained for the medicine from the
Pharmaceutical Pricing Board. The medicine prices are in practice affected by generic substitution,
according to which pharmacies shall replace a prescription medicine with a less expensive generic
equivalent, if there is one included in the list of interchangeable medicines compiled by Fimea. Such
substitution may however be specifically prohibited by the physician or consumer. The wholesale price
shall be the same to all pharmacies and it shall include all rebates, refunds and other benefits granted
to pharmacies. Pharmaceutical companies may grant discounts only to individual welfare or health
units, such as hospitals.
A reference price system for medicines was introduced in Finland in April 2009. The aim of the price
system is to control the increase in medical costs reimbursed by Kela. The system is based around
price reference groups comprised of interchangeable medicines. All of the medicines in a price
reference group share the same active ingredient and are equivalent with each other. Interchangeable
medicines are eligible for reimbursement by Kela, which is paid according to the reference price of the
particular group of medicines confirmed by the Pharmaceutical Pricing Board. If a patient wants to
purchase a more expensive medicine prescribed by a doctor, the cost in excess of the reference price
is paid by the patient himself or herself.
Recent developments:
In March 2014 the Finnish government agreed upon a reform of the social welfare and health care
sector, with the objective of better access to effective social welfare and health care in Finland. The
central provisions and future actions were decided in June 2014. The new social welfare and health
care model allocates the organizing responsibility to five social welfare and health care regions, while
the municipalities and joint municipal authorities hold the responsibility for producing such services.
Each municipality funds the operation of the social welfare and health care regions with payments
based on the amount, age, health and need of services of the residents in each municipality. The social
welfare and health care regions in turn fund the provision of the services. The government proposal
concerning said reform was circulated for comments in August 2014, and will be considered by the
Parliament in November. It has been planned that the new social welfare and health care regions
would start operating as of 1 January 2017.
The Finnish health sector is also currently under pressure from cost-savings. The government deemed
in March 2014 that additional cost-savings are required in medicines reimbursement, therefore
requiring restrictions on reimbursement. The objective is to ensure that persons using medicines only
occasionally and in small amounts would in the future pay slightly more of their medicines, while people
dependant on medicines would pay relatively less. The Government Bill to change the Health
Insurance Act shall be given to the parliament in the fall of 2014, while the reform would take place as
of the beginning of 2016.
In 2012 the Finnish government published a program to enhance healthy competition in specific
markets, one of them being the pharmacy market. Based on said program, the Ministry of Social Affairs
and Health has, as of the beginning of 2014, been examining the possibilities of enhancing competition
within the pharmacy sector. In response to the Ministry’s request to receive comments from interest
groups, the Finnish Pharmacists' Association commented to accept freeing of competition within the
pharmacy sector. Such change would in practice mean that the owner of a pharmacy would no longer
need to be a qualified pharmacist and that the restrictions on the number of pharmacies owned would
be removed. The Finnish Pharmacists' Society has however strongly objected to such a change,
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stating that the quality of service would deteriorate and competition would rather decrease than
increase. It remains to be seen what the Ministry decides.
A new decree to amend the current decree 1088/2010 on medicine prescription is to be passed in the
fall of 2014, giving nurses with adequate experience and who have completed required supplementary
training the right to prescribe, with certain restrictions, medicines to their patients in health centers.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
In Finland there are no specific regulations concerning mobile health applications. However, the
Medical Device Act applies also to applications, which fall within the ordinary definition of a medical
device. Thus, an application is considered as a medical device, if the application is intended by the
manufacturer to be used for human beings for the purpose of: i) diagnosis, prevention, monitoring,
treatment or alleviation of disease; ii) diagnosis, monitoring, treatment, alleviation of or compensation
for an injury or handicap; iii) investigation, replacement or modification of the anatomy or of a
physiological process; or iv) control of conception.
Contact Information
Mikael Segercrantz
[email protected]
Roschier, Attorneys Ltd.
Keskuskatu 7A
00100 Helsinki
Finland
Tel +358 20 506 6000 Fax +358 20 506 6100
www.roschier.com
Anna Haapanen
[email protected]
Elli Välimäki
[email protected]
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Israel
Prepared by Lex Mundi member firm S. Horowitz & Co
1. Provide an introduction on health law in your jurisdiction.
Introduction
The principal goals of the healthcare system in Israel are the improvement and further advancement
of national health, equality and solidarity and the assurance of quality and satisfaction of both
caregivers and patients alike.
The public healthcare system in Israel is characterized by a combination of mandatory and
complementary health insurances, all of which are largely provided by means of four Sick Funds.
Mandatory health insurance provides for an equal, yet basic, basket of medical services for every
Israeli citizen or legal resident, the scope of which is determined by law and regulations and is
updated annually. Said healthcare basket of medical services includes, inter alia, medical diagnosis
and counseling, the provision of medications, the supply of medical equipment and devices,
rehabilitation, hospitalization, etc. In a recent government decision dated January 2014, it was
decided to expand the healthcare basket of services, so as to include diverse new services,
technologies and medications.
Optional complementary health insurance varies from one SICK FUND to another—each offering its
own unique additional health package otherwise known as a ”complementary health services plan”
or “CIP”.
In addition to the public healthcare system, Israeli law permits, subject to certain restrictions, the
provision of private healthcare services, funded mainly by insurance companies within the context of
private insurance policies, or by the patients themselves. Nevertheless, as shall be clarified below,
certain restrictions apply to private healthcare services provided by public health institutions. The
Ministry of Health is currently crystallizing a policy aimed at curbing the provision of private healthcare
services, in an attempt to buttress and strengthen the public healthcare system.
The healthcare system in Israel is highly regulated by a variety of laws, regulations and guidelines in
diverse fields, such as social security, laws regulating the medical profession, as well as laws
governing pharmaceuticals, medical devices, patients' rights, food and food supplements—all as
specified below.
According to the OECD databases and the Israeli Central Bureau of Statistics, Israel's total
expenditure on health, per capita, has been on the rise in recent years, and, as of 2012, stood at
US $2,304 per capita.
Relevant authorities and associations
o
The Ministry of Health (“the MOH”)—the MOH is responsible for the determination of
healthcare policy, the development of healthcare regulation, issuing licences and the
supervision of various health-related professions, products and services. As the Israeli
government is the owner of various health institutes, the MOH also has responsibility for the
supply of certain medical services (e.g., general hospitalization services, mental health
services, mother and child health services) and, in certain circumstances, for providing healthinsurance related services (i.e., the MOH is responsible for the supply of preventive medical
services, nursing hospitalization and rehabilitation equipment). In addition, the MOH is
responsible for the preparation of recommendations, by appointing an experts committee,
regarding the basket of medical services provided under the mandatory health insurance. Said
recommendations are subject to the government approval, following the approval of the Health
Council and the consent of the Minister of Finance.
o
Sick Funds—there are four Sick Funds currently operating in Israel, namely: Clalit Health
Services (which is also the largest Sick Fund in Israel), Maccabi Health Services, Meuhedet
Health Services and Leumit Health Services. As a general rule, the Sick Funds are responsible
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for the supply of health services and ambulatory health services, either directly to patients or
through hospitals.
o
o
Public Health Institutions—various institutions and non-profit organizations, such as public
hospitals and “Magen David Adom” (Israel’s national organization for providing emergency
medical and ambulance services).
Private Health Institutions—various privately-owned institutions and organizations such as
private hospitals.
Financing
Healthcare services in Israel are provided to the public mainly by the Sick Funds and the MOH. Sick
Funds are largely funded by a progressive, income-based health tax, which is distributed amongst
them on a capitation basis, according to the number and age of their insured members. Additional
funding is received from the MOH’s budget and from paid complementary health services plans
provided by the Sick Funds. Additional and separate funding is received annually for health services
specifically earmarked for the treatment of severe diseases.
The budgeting of the basket of medical services is updated annually, in accordance with the health
cost index, whose components are listed in the Fifth Addendum to the National Health Insurance
Law, 1995 (“the NHI”). Since the health cost index does not take into account demographical growth
and technological advancement, the NHI empowers the Ministers of Finance and Health to update
the health cost index or the actual budget, concomitant with demographical changes. In addition,
since 1998, additional funding has been received annually to take into account technological
advancement and in order to maintain and ensure an appropriate level of medical care and services.
2. Provide a check list of laws with a short summary of the general requirements of each.
Checklist of Laws
•
Public Health Ordinance, 1940:
The Public Health Ordinance, 1940 regulates the scope of activities of the MOH and the Ministry
of Environmental Protection, with respect to the control of public health and related
environmental issues, such as the licensing and maintaining of medical institutions (e.g.,
laboratories, health clinics, hospitals, etc.), laying down technical specifications for medical
devices (in consultation with the Israeli institute of standards), burial arrangements, the spread
of infectious diseases, sanitary requirements and other public health-related issues.
Based on this Ordinance, various regulations were enacted, regulating essential issues, such
as licensing of Special Medical Devices, e.g. MRIs and CT scanners; basic requirements for the
registration and certification of hospitals and health clinics; basic requirements under which
clinical Trials in human beings can be performed; etc.
•
Public Health Ordinance (Food) [New Version], 1983:
The Public Health Ordinance (Food) [New Version], 1983, regulates issues relating to the
manufacture, importation, storage, distribution, sale advertising and marking of food products
as well as the supervision of nutrition-related matters.
Based on this Ordinance, various regulations were enacted, regulating issues such as Dietary
Supplements (listing conditions under which the sale of dietary supplements, such as vitamins
and minerals, is allowed); and Prohibition on Attributing Therapeutic Properties to Food
Products, by way of advertisement.
•
National Health Insurance Law, 1995 (“the NHI”):
Medical insurance under the NHI is based on principles of justice, equality and mutual
assistance. The NHI regulates the financing of the basic basket of medical services that Sick
Funds are required to provide to all Israeli citizens and/or residents (“the Health Package”).
Under the NHI, it is mandatory for a resident from the age of 18 and above to obtain health
insurance from any of the four Sick Funds of his/her choice. An Israeli citizen or resident is
further obliged to procure medical insurance for his/her children from any of the aforesaid Sick
Funds. Under section 5 of the NHI, an Israeli citizen or resident may revoke his membership
and move to another Sick Fund of his/her choice twice annually.
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Under section 10 of the NHI, each Sick Fund is entitled to offer, at an additional cost,
complementary healthcare services which are not included within the basic basket of services
thus providing increased medical coverage to those of its members wishing to purchase such
supplementary services.
•
Third Schedule to the NHI:
Pursuant to the Third Schedule to the NHI, the MOH is responsible for the supply of the
following health services: preventive healthcare, geriatric services, mental health services 1
and the supply of rehabilitation devices and mobile medical equipment.
•
National Health Insurance Order (Health Package Budget), 1995:
The National Health Insurance Order (Health Package Budget), 1995, mandates the total
annual budget required to be allocated towards the Health Package.
•
National Health Insurance Order (Health Council Financing), 2002:
The National Health Insurance Order (Health Council Financing), 2002, mandates the total
annual budget required to be allocated towards the Health Council.
•
Supervision of Prices on Services and Products Law, 1996 (“the Prices Supervision Law”):
Under section 6 of the Prices Supervision Law, the Minister of Health and the Minister of
Finance), may regulate the prices of medical services and products by issuing a relevant order.
Section 7 of the Prices Supervision Law sets out three optional means of regulation: price
fixing by the regulator; the duty to submit an application for increasing prices above the fixed
price; or the duty to report on prices and profits.
The Order for the Supervision of Prices on Products and Services (Application of the Law to
Preparations), 2001 and the amendment thereto enacted in 2006, set the supervisory
procedures that apply in the field of medicinal preparations:
o
With regard to prescription (Rx) medicinal preparations, price fixing has been applied.
o
With regard to over-the-counter (OTC) medicinal preparations, the duty to submit an
application before increasing prices above a fixed price has been applied.
o
With regard to General-Sales-List (GSL) medicinal preparations, the duty to report on
prices and profits has been applied.
On July 30, 2014, a bill which addresses an amendment to the Economic Plan Law was
published, in an attempt to broaden the regulatory powers of the relevant supervisory body.
For example, the bill suggests that a request to increase prices of an OTC product may result
not only in the option of partial or full acceptance or rejection of the request, but also the
possibility of a reduction in the fixed price of an OTC medicinal product (currently, the latter
option is not available to the relevant supervisory body).
•
Businesses Licensing Law, 1968:
Under the Businesses Licensing Law, the operation of certain kinds of businesses requires a
business licence.
According to the Businesses Licensing Order (Businesses Requiring Licence), 2013, the
operation of certain pharmaceutical-related businesses require a business licence, e.g.
pharmacies, businesses engaging in the manufacture and storage of cosmetics, businesses
engaging in the manufacture and storage (except for the purpose of retail sale), sale,
distribution and assembly of medicinal preparations and medical devices.
•
Limitation on Advertising and Marketing of Tobacco Products Law, 1983 (“the Tobacco
Products Law”):
The Tobacco Products Law regulates certain aspects of the tobacco field and focuses largely
on the advertisement and marketing of tobacco products.
The Tobacco Products Law includes, inter alia, the duty to include a health warning notice as
part of the advertisements of tobacco products, the prohibition on the sale of tobacco products
1
In 2012, the National Health Insurance Order was issued by the Minister of Health, with the objective of transferring the
responsibility for the provision of mental health services from the MOH to the Sick Funds.
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to minors and the duty of a manufacturer or importer of tobacco products to report annually
about expenses spent by them on advertising their products.
The Tobacco Products Law also imposes criminal sanctions (i.e., fines) on persons who fail to
comply with its provisions.
•
•
Patient’s rights
Patient’s Rights Law, 1996 (“the Patient’s Rights Law”):
The purpose of the Patient’s Rights Law is to define the rights of any human being seeking or
receiving medical care, and to protect his/her dignity and privacy.
The Patient’s Rights Law specifies the relationship between any human being seeking or
receiving medical care and his caregiver, be it a medical doctor or any other medical
professional accredited by the MOH.
The Patient’s Rights Law lays down the following principles which, together, comprise the
basic pillar of every patient’s right:
o
the right to receive proper medical care as well as the right to continuity of proper
medical care;
o
the right to receive information on the clinician’s identity;
o
the right to receive a second medical opinion;
o
the right to dignity and privacy;
o
the right to receive medical care in an emergency or when in grave danger;
o
the right to an informed consent; 2
o
the right to access medical information;
o
the right to medical confidentiality;
o
the right to disclosure of information to a third party; and
o
the prohibition on any medical facility or clinician to discriminate between patients on
the ground of religion, race, sex, nationality, country of birth or such other grounds.
Medical Professions
Medical professions in Israel are regulated by legislation, which allows a medical practitioner to
practice only with a valid license or by meeting several specific standards.
•
Criminal Law, 1977:
Coupled with the criminal sanction provisions as included in specific legislation attributable to
medical professions (as listed below), specific criminal sanctions as enumerated in the General
Criminal
Law,
also
apply
with
respect
to
medical
practitioners.
•
The Torts Ordinance [New Version]:
Under Israeli law, medical negligence constitutes part of the general body of law regulating the
tort of negligence and applies to all medical practitioners, as well as manufactures, importers
and resellers of medicinal products, including, inter alia, medications, supplements, cosmetics
and medical devices.
•
Physicians Ordinance [New Version], 1976 (“the Physicians Ordinance”):
Medical doctors (physicians) are supervised by the MOH and are subject to the provisions of
the Physicians Ordinance. The Physicians Ordinance concerns specifically physicians, having
the status of practitioners engaging in human medicine. Practicing as a physician requires
possession of an appropriate licence. The Physicians Ordinance contains rules that regulate,
inter alia, the admittance requirements and medical licensing of physicians, provisions and
limitations applicable to them and to medical interns and also defines the ability to employ
nurses and associated health professionals. In addition the Physicians Ordinance includes
administrative disciplinary measures, particularly revocation of the licence and a section
dedicated to “crimes, prosecution and punishment” that deals with the consequences of failing
to comply with certain of its provisions.
2
As a rule, medical care will not be provided without a patient’s consent (including a patient’s implied consent).
Nevertheless, in exceptional circumstances, such as where there is grave danger to a patient’s health, medical care may be
administered without the patient’s consent. At the other end of the spectrum—there are treatments that require the express written
consent of the patient.
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•
The Veterinarians Law, 1991 (“the Veterinarians Law”):
The Veterinarians Law serves as parallel legislation to the Physicians Ordinance, by regulating
the field of veterinary occupation. The Veterinarians Law deals with the licensing procedure,
and certain obligations which veterinarians are required to undertake in order to be accepted
as practitioners. The Veterinarians Law similarly includes administrative disciplinary
measures, particularly revocation of the licence and a section dedicated to “crimes,
prosecution and punishment” that deals with the consequences of failing to comply with certain
of its provisions. 3
•
Pharmacists Ordinance [New Version], 1981 (“the Pharmacists’ Ordinance”):
The Pharmacists’ Ordinance is wider in scope than the other pieces of legislation referred to
above, since it is not limited to regulation of the pharmacist’s profession. Moreover the
Pharmacists’ Ordinance contains rules related to the pharmacy field and procedures in
general, as detailed in other sections of this guide below.
The Pharmacists’ Ordinance regulates the pharmaceutical profession in the pharmaceutical
industry as well as pharmacies that are responsible for the retail supply of medicinal products
in Israel. The Pharmacists’ Ordinance similarly contains provisions relating to the pharmacist’s
profession, the licensing of pharmacists and their assistants, the medical supervision of
pharmacists and the ownership and management of pharmacies.
Vast regulation has been enacted in this field and pursuant to which the relevant provisions of
the Pharmacists’ Ordinance apply. Regulation concerning the actual profession focuses on
licensing, the issuance of prescriptions, conditions for managing and owning pharmacies, etc.
•
Dentists Ordinance [New Version], 1979 (“the Dentists Ordinance”):
The Dentists Ordinance contains certain provisions focusing on, inter alia, licensing, medical
supervision, advertising and disciplinary measures. The Dentists Ordinance also contains
provisions regarding the licensing of dental hygienists and the employment of dental
assistants.
In addition, the Dentists Ordinance includes administrative disciplinary measures, in particular,
revocation of the licence and a section dedicated to “crimes, prosecution and punishment” that
deals with the consequences of failing to comply with certain of its provisions.
•
Psychologist Law, 1977 (“the Psychologist Law”):
The Psychologist Law regulates the principles of this profession, including registration,
licensing and defining recognized specialties whilst emphasizing the aspect of secrecy within
this profession. The Psychologist Law also includes a section for imposing administrative and
criminal sanctions on those who fail to comply with certain of its provisions.
In addition to the Psychologist Law, there have also been enacted regulations (Psychologist
Regulations Regarding Professional Ethics, 1991) that contain rules with respect to a patient’s
wellbeing, professional skills and other similar provisions.
•
Nursing Regulations:
The Public Health Regulation (Nursing Practitioners in Hospitals), 1988—defines proper
nursing training and sets out the licensing requirements with respect to each of the different
types of nursing professions—a licensed nurse, a practical nurse, a nursemaid, a midwife, etc.
The said Regulation also contains certain provisions relating to practitioners.
Public Health Regulation (Nursing Staff in Clinics), 1981—contains mainly education, training
and registration requirements.
Public Health Regulation (Specialist Licensing Degree in Nursing), 2013—addresses the
eligibility to acquire the title of a specialist, internship, training and other related provisions.
•
Midwifery Ordinance:
3
Both the Physicians Ordinance and the Veterinarians Law are supported by specific regulations that implement its
provisions, such as licensing examination regulations, advertising regulations, etc.
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The Midwifery Ordinance regulates the profession of a midwife, including the licensing
requirements to practice as a midwife, the registration requirements and other related
provisions.
•
Genetic Information Law, 2000 (“the Genetic Information Law”):
The Genetic Information Law contains provisions encompassing this entire field, and inter alia,
lays down provisions as to who may be deemed professionally qualified to offer genetic
counseling and, specifically, provisions with respect to geneticists who are doctors, clinical
geneticists and genetic counsellors.
In addition, the Genetic Information Law contains provisions on the manner in which DNA
samples must be taken, delivered and generally handled. The Genetic Information Law also
includes a section on criminal sanctions that may be imposed should certain of its provisions
not be complied with, including with regard to the required professional conduct to be
maintained, as referred to above.
•
Optometric Practice Law, 1991:
The Optometric Practice Law sets out the licensing requirements, areas of specialization and
other related provisions. The said Law also contains administrative and criminal sanctions.
•
Regulation of the Health Professions Law, 2008 (“the Health Professions Law”):
The Health Professions Law stipulates, as its purpose, the regulation of health professions
that are not otherwise regulated in the pertinent Israeli legislation, in order to ensure that an
appropriate level of professional conduct is maintained.
The First Addendum to the Health Professions Law lists those professions that qualify as
health professions (in addition to other specific legislation mentioned therein), as follows—
occupational therapy, physiotherapy, speech therapy, nutrition, clinical criminology, podiatry,
surgical podiatry and chiropractic medicine.
The Health Professions Law regulates the proper training, qualification, discipline and ethics
to be maintained in respect of the listed health professions.
•
Medical Ethics Rules, 2009:
The Ethics Board of the Israeli Medical Association (“the IMA”) has published binding rules
which include general duties and obligations to be complied with by a physician in relation to
the following: physician-patient relations; physician public relations; physician-physician
relations; physician, science and research; physicians and commercial companies; physicians
and the legal system; physicians and the media; and physicians and the medical system.
•
Common Ethical Convention, 2014:
The IMA together with representative organizations of the pharmaceutical companies
operating in Israel, published a Common Ethical Convention consolidating the ethical rules of
the IMA with respect to the relationship between physicians and pharmaceutical companies,
largely in order to prevent conflicts of interest arising in connection with a physician’s duties to
his/her patients. In this context, the Common Ethical Convention refers, inter alia, to
conferences and seminars, clinical trials, advertising, benefits and donations.
•
MOH Guidelines for Contracts with Commercial Companies, dated April 2010 (“the 2010
Guidelines”):
The 2010 Guidelines deal with agreements entered into amongst the various MOH institutes
and Clalit Health Services with commercial entities and businesses.
The 2010 Guidelines stipulate that any engagement with commercial entities regarding, inter
alia, the performance of clinical trials, requires the approval of the joint committee established
and operating under the supervision of the MOH’s General Manager, whose members
comprise representatives from both the MOH and Clalit Health Services.
•
Medicinal Preparations
The Pharmacists Ordinance:
The principles for the regulation of medicinal preparations in Israel are set out in the
Pharmacists Ordinance.
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The term “medicinal preparation” is defined in section 1 of the Pharmacists Ordinance as
“including a preparation for use in veterinary medicine and a nutritional preparation intended
for intravenous injection (other than a medical device)”; the term “preparation” is defined as
including “any form of processed medicaments, including a medicinal preparation and
medicinal food preparation”.
Under the Pharmacists Ordinance, a medicinal preparation may be marketed in Israel only if
it is registered in the Registry of Preparations, managed by the MOH. Operative instructions
for the marketing of medicinal preparations are entrenched both in regulations and in
guidelines published by the MOH.
Nonetheless, section 47A of the Pharmacists Ordinance empowers the MOH, under
corresponding regulations and guidelines, to approve the marketing of a medicinal preparation
even if not registered, or not in accordance with its registration, provided that the medicinal
preparation falls within the exceptions specified in the Pharmacists Regulations (as defined
below) (e.g., for private consumption, research, off-label use, essential medical treatment,
exportation, etc.), and provided further that the contemplated medicinal preparation does not
harm public health.
The Israeli Law distinguishes between distribution of prescription medicinal preparations (Rx)
and over-the-counter (OTC) medicinal preparations to the end customer, which can only be
performed by a Pharmacist according to the Pharmacists Ordinance, and the distribution of
General-Sales-List (GSL) medicinal preparations, which can be performed not in a Pharmacy
or by a Pharmacist, according to the corresponding regulations and MOH guidelines.
The pharmaceutical industry in Israel is mostly generic. However, the Pharmacists Ordinance
contains a data exclusivity rule that grants exclusivity over data submitted to the MOH in the
framework of the registration procedure to the registration holder of innovative medicinal
preparations.
•
The Pharmacists Regulations (Preparations), 1986 (“the Pharmacists Regulations”):
The Pharmacists Regulations largely regulate the basic requirements for filing an application
for the registration of medicinal preparations with the MOH, namely that: the medicinal
preparation satisfies the quality requirements, as examined by the Institute of Inspection and
Standards of Medicinal Preparations (a unit within the MOH) and is found to be appropriate for
medical use; the medicinal preparation is found to be safe and efficient for its intended use
and its name is not misleading; the medicinal preparation is manufactured in accordance with
good manufacturing practices; and the registration holder maintains a pharmacovigilance
system ("PV").
Under the Pharmacists Regulations, an application to register a medicinal preparation with the
MOH may only be filed by an Israeli resident or by a company registered in Israel.
In addition, according to the Pharmacists Regulations, the MOH may prescribe conditions
under which the manufacturing and marketing of medicinal preparations is permitted. For
example, marketing only to the hospitalization system; marketing only under prescription;
setting package type, quality, labeling, shape and safety; regular and continuous supply; and
any other condition concerning the correct and safe use of the preparation.
The Pharmacists Regulations further regulate, inter alia, the packaging and marking
requirements of medicinal preparations; renewal of registrations, cancellation of any
registration if the above requirements are not met; and PV of registered medicinal
preparations.
•
MOH’s Guideline for Filing Applications for the Registration of Medicinal Preparations (including
Amendments and Renewals) (“the Registration Guideline”):
The Registration Guideline sets out the registration requirements to be complied with under
the Pharmacists Regulations. The Registration Guideline distinguishes between generic and
innovative medicinal preparations. For the registration of an innovative medicinal preparation,
the registration holder is required to prove the safety and efficacy for its intended use, by
submitting a registration file comprising evidence proving the above. The registration of a
generic medicinal preparation is an abbreviated procedure, comprising mainly proof of
bioequivalence of the generic medicinal preparation to the reference innovative medicinal
preparation (i.e., the difference in the rate and extent of absorption of the active drug substance
is not significant).
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•
MOH’s Procedure for Reporting on Adverse Events and New Safety Information (“Guideline No.
6”):
Guideline No. 6 contains a list of PV requirements to be complied with under the Pharmacists
Regulations.
•
The Pharmacists Regulations (Good Manufacturing Practice), 2008 (“the GMP Regulations”):
The GMP Regulations were issued as part of Israel’s process of becoming party to the
Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation
Scheme (“PIC/S”) and the subsequent entry into of a mutual recognition agreement with the
European Union regarding Good Manufacturing Practice audits performed by the MOH, which
necessitated the conformity of the pertinent Israeli legislation to European Directive
2003/94/EC.
The GMP Regulations largely include conditions under which a manufacturer or an importer
can obtain Good Manufacturing Practice approval from the MOH, as well as the basic
requirements to be complied with for manufacturing and testing medicinal preparations, in
order to ensure the quality and safety of such medicinal preparations. Said requirements
concern, inter alia, infrastructure and equipment, human resources, the manufacturing
department, quality assurance and quality control, documentation and complaints.
•
MOH Guidelines and Circulars:
In addition to the various MOH Guidelines as referred to above, the MOH Guidelines and
Circulars regulate, inter alia, the following matters: product recalls, the manufacture and
importation of experimental products, packaging inserts, first batch authorizations, etc.
Medical Devices
•
The Medical Devices Law, 2012 (“the Medical Devices Law”):
The Medical Devices Law regulates the authority of the MOH to supervise the manufacture
and marketing of medical devices as well as their usage, and authorizes the MOH to impose
administrational and criminal sanctions in the event of breach of its provisions.
The term “medical device” is defined broadly in section 1 of the Medical Devices Law as
including each of the following (other than a medicinal product, as defined in the Pharmacists
Ordinance): a device (including an accessory, a chemical material, a biological material or a
biotechnological material) used for medical treatment, as well as a device or a computer
program used for the operation of said device; contact lenses; and an electronic device
emitting ionizing or non-ionizing radiation, used for cosmetic treatment.
Under section 2 of the Medical Devices Law, a medical device may be marketed in Israel only
if it is registered with the MOH, unless it is listed in the Second Addendum to the Law, which
includes a limited group of specific products. Furthermore, section 4 of the Medical Devices
Law enables the MOH, under corresponding regulations, to approve the manufacturing and
marketing of medical devices which are unregistered or the use of medical devices not in
accordance with their registration, as specifically exempted therein (e.g., medical devices
related to R&D, essential medical care, off-label use, etc.). Regulations to such effect have
already been drafted, but have nonetheless not yet been approved by the relevant committee
in the Israeli Parliament.
Under section 3 of the Medical Devices Law, an application to register a medical device with
the MOH may only be filed by an Israeli resident or by a company registered in Israel.
The Medical Devices Law also sets out, under section 6 thereof, basic requirements and
criteria for the registration of medical devices, namely that: the benefit to be gained from use
of the medical device outweighs the risks associated therewith; the medical device has been
found to be efficient and to be of a quality that is appropriate for its intended use; the medical
device has been manufactured applying Good Manufacturing Practice; and the name of the
medical device is not misleading with regard to its characteristics, in a manner which may harm
public health.
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However, under the Medical Devices Law, if the medical device is registered or approved for
marketing in one of the countries listed in the First Addendum to the Law (“a Recognized
Country”) 4 and is being marketed in such Recognized Country, then the MOH will, at most,
register the aforesaid medical device for the same period as approved in such Recognized
Country.
Section 11 of the Medical Devices Law further instructs the registration holder, under
corresponding regulations, to maintain a system for the follow-up of registered medical
devices, and to report to the MOH of any related special event coming to his/her knowledge,
including serious malfunctions, use which caused or might have caused unexpected or
significant damage to a patient and new safety data. Regulations to such effect have not yet
been drafted by the MOH.
Under corresponding regulations to the Medical Devices Law (i.e., in section 21 thereof), the
registration holder is obliged to appoint a “contact person” (who must be an Israeli resident)
responsible for filing the relevant registration applications with the MOH, and for
communicating with the MOH concerning the registered medical device. With respect to a
specific medical device, the contact person should be an “appropriate skilled person”
possessing the necessary qualifications, as set out in section 22.
Although the Medical Devices Law will only enter into force 60 days after the enactment of
regulations concerning the use of medical devices which are unregistered or not in accordance
with their registration, the MOH published Circular No. 07/2014, directing that the principles of
the Medical Devices Law be implemented with effect from April 10, 2014.
•
The Medical Devices Regulations (Registration of Medical Devices and the Renewal thereof),
2013 (“the Medical Devices Regulations”):
The Medical Devices Regulations list the basic requirements for filing an application for the
registration of medical devices with the MOH, as well as conditions and limitations under which
the manufacturing and marketing of medical devices are permitted.
For example, in order to market a medical device, it will be necessary to obtain a certificate
from the health authority or equivalent regulatory body of the country in which the medical
device was manufactured, certifying that the manufacturer’s Good Manufacturing Practice
standards accord with the requirements of ISO 13485.
3. Provide any special issues which arise in your jurisdiction.
•
•
Special Issues
A proposed bill for amendment of the Pharmacists Ordinance (Punitive Measures,
Administrative Enforcement and Supervisory Authorities), 2013:
Pharmaceutical crime, particularly counterfeit medicinal preparations, is a worldwide
phenomenon, which has extended also to Israel. The object of the bill is to deal with this
phenomenon, by laying down a hierarchy of criminal offences or infringements of the
Pharmacists Ordinance, as well as by the imposition of corresponding punitive measures, both
criminal and administrative.
The bill suggests the reinforcement of punitive measures for pharmaceutical crime in Israel,
based on the type and nature of the offence, thereby creating a stronger and better deterrence
in comparison with the current status. For example, the bill suggests a maximum prison
sentence of three years (instead of only six months), as well as increased fines, while
discriminating between individuals and corporations. The bill further adds administrative
enforcement powers, in the form of monetary sanctions for infringement of orders under the
respective Pharmacists Ordinance and Pharmacists Regulations.
Recycling of Disposable Medical Devices:
4
The Recognized Countries include: Austria; Italy; Iceland; Ireland; the USA; Belgium; Britain; Germany; Denmark; The
Netherlands; Greece; Norway; New Zealand; Spain; Portugal; Finland; France; Canada; Sweden; and Switzerland.
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Under section 4A of the Medical Devices Law, the Minister of Health is authorized to enact
regulations for the recycling of disposable medical devices. At this stage, said regulations have
not yet been drafted.
The contemplated regulations will need to define the conditions under which the recycling of
disposable medical devices will be permitted, while balancing two main colliding interests: On
the one hand, the public interest requires that a medical device which, based on its
components and characteristics, has been defined and registered as disposable, will be limited
for such disposable use only, in accordance with the manufacturer’s instructions. On the other
hand, the healthcare system has limited resources and, thus, the need for minimizing costs
will need to be taken into account.
•
Private Medical Services
As noted above, the NHI grants every Israeli resident the right to receive comprehensive health
services comprised of the mandatory Health Package and an elective complementary health
services plan which varies from one Sick Fund to another.
The NHI does not however, grant an Israeli resident, the right to elect his/her attending
physician or surgeon. Private medical services (“PMS”), commonly known by the Hebrew
acronym “sharap”, offers exactly that—i.e., it entitles a patient to choose his/her attending
physician or surgeon, in consideration for an additional fee on top of the premiums payable
under the Health Package. Naturally the additional fee paid by the patient is used for the
purpose of choosing the most experienced and highest ranking doctors from amongst the
medical practitioners in the relevant field.
As mentioned above, equality and solidarity are counted as constituting the principal goals of
the Israeli healthcare system. Arguably, by granting the privileged access to more experienced
doctors, PMS may, in fact, undermine those goals.
It should be noted that on June 25, 2014, the “Committee to Strengthen the Public Healthcare
System in Israel”, headed by the current Minister of Health, Yael German, published its
recommendations. Regarding PMS, the committee recommended restricting such services in
public hospitals.
It still remains to be seen when and how said recommendations will be introduced into the
current legislation.
•
Medical Tourism:
Israel is fast emerging as an important destination for “medical tourists”. Israeli public and
private hospitals have been offering medical tourism services for years. It is estimated that the
general income from medical tourism in Israel totals approximately US $50 million annually.
In recent years, this medical domain has undergone somewhat of a revolution with respect to
regulation imposed on it, in an endeavor to regulate this particular field. The purpose of such
regulation was to provide guidance with respect to the operation and promotion of this medical
domain, in parallel to promoting public healthcare resources for the use of Israeli civilians, by
applying the means allocated for medical tourism.
A committee focusing on strengthening the public health system, published its
recommendations in June 2014, including a chapter dealing with medical tourism, in which the
committee presented its recommendations that included new suggestions as well as issues
dealt with in previous drafts, as follows:
o
regulating the activity of medical tourism agents—the registration and responsibility of
agents, relations between agents, hospitals and doctors, with an intent on formulating
an ethical code,
o
regulating the activity of hospitals—licensing, sanctions, priority for Israelis, separate
accounting treatment, pricing of procedures, special taxes on using specific
infrastructure, application of the regulation concerning the quality of treatment in a
particular field;
o
regulating the private system—responsibility, VAT cancellation, prohibiting the denial of
services to Israelis;
o
regulating the public system—scope of activity dependent on the availability for Israelis,
licensing, preservation of data, limiting income growth, priority of Israeli patients, income
diversion towards Israeli patients, investment in hospitals based on the MOH’s
“development plan”, only offering procedures that are available for Israelis;
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o
o
regulating the medical staff—priority of Israeli patients, preventing financial incentives;
and
regulating the management of this field—establishing a government information site,
priority to plans focusing on peripheral areas, patient ID card that will ensure proper
care, establishing a permanent committee that will continue to examine the policy and
implementation of the recommendations.
The above recommendations are supported by the Minister of Health, and are expected to
take shape in the near future.
•
Clinical trials:
Clinical trials in Israel are largely regulated by the Public Health Regulations (Clinical Trials in
Human Beings), 1980 as well as by MOH guidelines and circulars.
Updated MOH Guidelines for Medical Trials in Humans (“the Guidelines”) were recently
published by the MOH, and will enter into force in November 2014.
The Guidelines regulate, inter alia, the manner of filing applications for the conduct of clinical
trials in Israel and their approval process, as well as the control and supervision of the
performance of clinical trials. In addition, the Guidelines specify certain obligations to be
undertaken by the relevant institution at which the clinical trial is to be conducted; the
investigator in charge of the clinical trial; the Helsinki Committee of the institution; and the
entity sponsoring the clinical trial, before, during and after performance of a clinical trial.
The Guidelines further stipulate that any clinical trial must be conducted strictly in accordance
with the Helsinki Declaration; the Public Health Regulations (Clinical Trials in Human Beings),
1980, including all supplements thereto; the Genetic Information Law; ICH-GCP E6 and the
updated Standard for Clinical Trials with Medical Devices (ISO 14155-1, 14155-2) (Clinical
Investigation of Medical Devices for Human Subjects) 5 as well as additional circulars and
guidelines as may be published by the MOH from time to time. 6
In a nutshell, the changes in the Guidelines contribute to the expediency and efficiency of the
MOH proceedings in connection with the approval process of clinical trials; further reinforce
the role of the sponsor in a multicenter trial (and particularly with respect to synchronizing the
decisions reached by the Helsinki Committees and the MOH); and also provide for an overall
uniform and more efficient computerized application process.
Contact Information
Adv. Dovev Apel
[email protected]
S.Horowitz &Co.
31 Ahad Haam Street
Tel-Aviv, Israel
Tel 972.3.5670876 Fax 972.3.5660974
Firm Website www.s-horowitz.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
5
Thus, in the event of any inconsistency between the Guidelines [the new guidelines I assume?] and the relevant
international standards, the Guidelines expressly provide that their provisions will prevail. However, with regard to issues not
specifically referred to in the Guidelines, provisions contained in the international standards will apply.
6
The MOH has also published guidelines relating to clinical trials involving genetic data and human somatic cell therapy
medicinal products.
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International Guide on Health Industry Laws
Korea
Prepared by Lex Mundi member firm Hwang Mok Park P.C.
1. Provide an introduction on health law in your jurisdiction.
The health security system of Korea consists of the following: (i) National Health Insurance
Program, (ii) Medical Aid Program, and (iii) Long-Term Care Insurance Program. The National
Health Insurance Program is a compulsory social insurance, which covers the entire population
living in the country, while the Medical Aid Program is a form of public assistance scheme to secure
the minimum livelihood of low-income households and to assist with self-help by providing medical
services. The Long-Term Care Insurance Program was adopted in July 2008 to ease the financial
burden on a family caregiver with no income, which was designed to satisfy the needs of Korean
senior citizens who have difficulty performing their daily activities due to geriatric diseases.
There are various laws, regulations, rules, and directives in Korea which regulate health security
system, healthcare professionals, pharmaceutical industry and medical devices industry. As one
of the endeavors to banish rebates from the pharmaceutical and medical devices industry, the
Korean government implemented a scheme that any illegal rebates may result in a reduction in the
National Health Insurance Price (“NHIP”). Fighting against rebates in the pharmaceutical and
medical devices industry has been one of the main issues in which the Korean government has a
keen interest, and 2 major investigations by the Korea Fair Trade Commission resulted in significant
statutory and regulatory changes as follows: (i) the so called “dual punishment scheme” under the
Pharmaceutical Affairs Act (the “PAA”), Medical Devices Act (the “MDA”), and Medical Service Act
(the “MSA”); (ii) rebate-related suspension of or exclusion from the NHIP (so called the “Rebate
Two Out System”); (iii) rebate-related NHIP reduction under the National Health Insurance Act
(the “NHIA”); (iv) NHIP overall reduction; and (v) Actual Transaction Price (“ATP”) Incentive System
(which was abolished recently).
Relevant authorities and associations:
• The Ministry of Health and Welfare (the “MOHW”) is responsible for the development of health
care regulations including healthcare policies, social welfare policies and population polices,
and supervises all health care agencies and institutes.
• The Ministry of Food and Drug Safety (the “MFDS”) also implements regulations, rules and
directives to govern pharmaceutical, medical devices, cosmetics, biopharmaceutical, agrolivestock and fishery industry. The MFDS is responsible for regulatory issues arising from the
industries aforementioned, including the registration or approval of new enterprisers who wish
to enter into the relevant industry.
• The Korea Fair Trade Commission (the “KFTC”) formulates and administers competition
policies, and deliberates, decides, and handles antitrust cases such as rebates.
• The National Health Insurance Service (the “NHIS”) aims to increase the quality of life of the
Korean people by securing health insurance sustainability, providing life-long custom
integrated health service, reinforcing long-term recuperation insurance and enhancing public
centered service. It is responsible for the National Health Insurance Program and Long-Term
Care Insurance.
• The Health Insurance Review and Assessment Service (the “HIRA”) is responsible for review
and assessment of medical service fees claimed by healthcare institutions.
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• The Korea Pharmaceutical Manufacturers Association (the “KPMA”) is one of the major
associations in the Korean pharmaceutical industry which have Korean pharmaceutical
manufacturing companies as members. The KPMA’s Fair Competition Code and its Working
Guidelines have been approved by the KFTC, and provide specific requirements and
limitations for various activities of pharmaceutical companies.
• The Korean Research-Based Pharmaceutical Industry Association (the “KRPIA”) has
multinational pharmaceutical companies as its member companies, and also has its own Fair
Competition Code and Working Guidelines which have been approved by the KFTC.
• The Korea Medical Devices Industry Association (the “KMDIA”) is the largest association in
the Korean medical devices industry having domestic and multinational medical devices
companies as its members whose total market share in the Korean medical devices market
exceeds 80%. Its Fair Competition Code and Working Guidelines have been approved by the
KFTC.
• The National Food Safety Information Service is responsible for collecting and providing
comprehensive information service regarding the food safety, and operates the food
traceability system which covers the entire food chain continuum from farm to table.
• The Medical Device Information and Technology Assistance Center is an agency established
to provide comprehensive information and technology related assistance in relation to the
domestic or international trend regarding medical devices newly developed, and clinical
information.
• The Korea Institute of Drug Safety and Risk Management is responsible for collection,
management, analysis, evaluation and provision of various information of drug safety and risk
of medicine and medical supplies such as side effects and the item permit information thereof.
2. Provide a check list of laws with a short summary of the general requirements of each.
a. Social Security Law
National Health Insurance Act
The NHIA and its subordinate laws regulate the matters related to the National Health Insurance
Program. It provides details of the qualification for the insured, the affairs and organization of the
National Health Insurance Service, insurance benefits, etc.
Regulations on the Standards for the Insurance Benefits of the National Health Insurance
These regulations provide details of the insurance benefits under the National Health Insurance
Program, including the payment procedures, the scope of insurance benefits, limitations and
exceptions.
Framework Act on Social Security
The Framework Act on Social Security defines the rights of citizens and the responsibilities of the State
and local governments on social security, and prescribes basic matters on the establishment and
implementation of social security policies and their related systems.
Act on Long-Term Care Insurance for the Aged
The purpose of this Act is to pursue the improvement of health of elderly citizens and the stabilization
of their livelihood during post-retirement life, relieve family members from the burden of supporting the
elderly, and enhance the quality of life of citizens by providing for matters concerning long-term care
benefits, such as aid provided in physical activities and household chores to elderly citizens who have
difficulties in carrying on with daily life on their own due to old age or senility.
b. Medical Professions related Legislation
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Medical Service Act
In order to ensure that all Korean people can enjoy benefits of high-quality medical treatment and
thereby protect and improve public health, the MSA provides for matters related to medical service,
including the definition of and requirements for medical profession and medical institutions, the license
and qualification for medical profession, rights and obligations of medical profession, limitation of
medical practice, and establishment of medical institutions.
Criminal Code
Under Korean law, medical treatment and procedures generally do not constitute a bodily injury subject
to criminal penalties based on the consent of the patients.
If physicians receive rebates, physicians may become subject to criminal penalties under the Korean
Criminal Code depending on the type of medical institutions which they belong to, and whether or not
they are government officials.
Civil Code
The Civil Code contains general provisions on the contract or tort liability which may apply to medical
practitioners. In cases of a breach of contract or tortious liability, a patient can claim compensatory
damages or compensation of non-pecuniary damage for errors in treatment or for a failure to be
properly informed.
c. Pharmaceutical Industry related Legislation
Pharmaceutical Affairs Act
The PAA is the basic act which governs matters related to the pharmaceutical industry. Specifically, it
provides detailed matters, including without limitation the qualification and license for pharmacists and
herb pharmacists, registration and duties of pharmacies, preparation of drugs, requirements for
manufacture, importation, sale, etc. of pharmaceutical products, and handling of pharmaceutical
products.
In order to manufacture pharmaceutical products, permission for the manufacturing business must be
obtained, and manufacturer/importer of pharmaceutical products should procure product registration
for the relevant products, or make a filing for the same depending on the type of the pharmaceutical
products.
Regulations on the Safety of Pharmaceutical Products
These Regulations provide the detailed matters delegated by the PAA, such as the detailed procedures
for permission for the manufacturing business of pharmaceutical products, or product registration/filing,
post-marketing surveillance (PMS) study, standards for clinical studies, labeling and packaging
requirements, advertisements, etc.
Act on the Control of Narcotics, Etc.
The purpose of this Act is to contribute to improving the health of the general public by placing narcotics,
psychotropic drugs, marijuana, or other basic substances for such narcotics, etc. under appropriate
control and handling, thus preventing harm and danger to the public health that may arise from the
misuse or abuse thereof.
Monopoly Regulation and Fair Trade Act
The purpose of the Monopoly Regulation and Fair Trade Act (the “MRFTA”) is to promote fair and free
competition, to encourage thereby creative enterprising activities, to protect consumers and to strive
for balanced development of the national economy, by preventing any abuse of market-dominating
positions by enterprisers and any excessive concentration of economic power, and by regulating undue
collaborative acts and unfair trade practices.
The MRFTA may directly apply to rebates constituting an act of unfairly inducing customers by providing
unfair economic benefits which is a breach of the MRFTA. The KFTC’s investigations on the rebates
provided by the pharmaceutical companies are conducted based on the alleged violation of the MRFTA,
and administrative fines are imposed on the pharmaceutical companies based on the breach of same.
Fair Competition Code and the Working Guidelines of KMPA and KRPIA
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These Fair Competition Codes and the Working Guidelines of KPMA and KRPIA have been approved
by the KFTC, and the pharmaceutical companies’ activities are deemed compliant with the applicable
laws of Korea in terms of the dual punishment system if such activities are in accordance with these
Codes. Therefore, even though only the member companies of the KMPA and the KRPIA are obligated
to comply with the respective Codes and the Working Guidelines, non-member companies also tend to
comply with the provisions thereof in order to avoid regulatory issues and minimize any legal risks that
may arise in relation to marketing activities.
These Codes and the Working Guidelines of the KMPA and the KRPIA provide specific standards
(including the limitations and the relevant reporting procedures) for the marketing activities and other
activities of pharmaceutical companies, such as the provision of samples, donations, support for the
hosting or operation of academic conferences, sponsorship for participation in academic conferences,
product presentations, provision of pharmaceuticals for clinical activities, market surveys, PMS studies,
exhibitions/advertisements, etc.
In addition to the Fair Competition Code and the Working Guidelines, the KRPIA adopted the Voluntary
Regulations on Labeling and Advertisement of Pharmaceutical Products (which also have been
reviewed by the KFTC), and the Guidelines on Clinical Activities for the purpose of providing its member
companies with more detailed and clear guidance on the relevant activities.
d. Medical Devices Industry related Legislation
Medical Devices Act
The MDA regulates the manufacture, importation and sale of medical devices in order to contribute to
the improvement of public health by efficiently managing medical devices.
In detail, the MDA provides matters, including the requirements and procedures to obtain permission
for the manufacturing/importation business of medical devices, manufacturers’ obligations, reporting
requirements and procedures for repairing/distribution/leasing business of medical devices, handling
requirements of medical devices such as packaging and labeling requirements, description and
advertisement requirements, and control and inspection of medical devices.
Regulations on Maintenance of Distribution and Sale Order of Medical Devices
These Regulations provide the scope of economic benefits that may be provided to the healthcare
professionals as provided in the MDA.
Monopoly Regulation and Fair Trade Act
The MRFTA may also apply to the act of providing unfair economic benefits to healthcare professionals
in relation to medical devices.
Fair Competition Code and the Working Guideline of KMDIA
The Fair Competition Code and the Working Guidelines of KMDIA (the “KMDIA Code”) have been
approved by the KFTC, and the medical devices companies’ activities are deemed compliant with the
applicable laws of Korea in terms of the dual punishment system if such activities are in accordance
therewith. Therefore, even though only the member companies of the KMDIA are obligated to comply
with the KMDIA Code, non-member companies also tend to comply with the provisions thereof in order
to avoid regulatory issues and minimize any legal risks that may arise in relation to marketing activities.
The KMDIA Code provide specific standards (including the limitations and the relevant reporting
procedures) for the marketing activities and other activities of medical devices companies, such as the
provision of samples, donations, support for the hosting or operation of academic conferences,
sponsorship for participation in academic conferences, product presentations, training and education,
provision of lecture fees and consulting fees, provision or rental of medical devices for clinical trials,
market surveys, PMS studies, exhibitions/advertisements, etc.
3. Provide any special issues/recent developments which arise in your jurisdiction.
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•
Dual Punishment – PAA, MDA and MSA
The PAA, MDA and MSA were amended in 2010 in response to the major question from the
pharmaceutical and medical devices industry that why only pharmaceutical/medical devices
companies are punished while the hospitals and/or physicians are not punished based on
rebates. The basic principle in those statutes is that it is illegal for pharmaceutical/medical
devices companies to provide economic benefits to hospitals or physicians for the purpose of
promoting sales, unless they are specifically permissible under the Enforcement Rules to the
PAA, MDA and MSA (e.g., provision of samples, sponsorship for participation in academic
conferences, sponsorship for clinical studies, product presentations, PMS fees, etc.)
In accordance with such amendments to the PAA, MDA and MSA, the Korean Prosecutor’s
Office prosecutes the management personnel of pharmaceutical companies as well as
physicians for breach of the dual punishment system regulations under the PAA and MSA (i.e.,
provision and acceptance of rebates), and the Korean courts sentence criminal penalty against
the hospital management and the physicians.
•
Rebate Two Out System
Under the Rebate Two Out System, which has been newly adopted in the amended NHIA and
its Enforcement Decree, if a pharmaceutical company becomes subject to an administrative
disposition or a criminal penalty that is heavier than a criminal fine due to rebates provided
thereby in relation to a specific pharmaceutical product, payment of NHIP for such
pharmaceutical product will be suspended for a prescribed period, or such pharmaceutical
product will be excluded from the NHIP list, depending on the amount of the rebate and the
number of administrative disposition/criminal penalty imposed in relation to the relevant
pharmaceutical product. For example, if the amount of the rebate exceeds KRW 100 million,
payment of NHIP for the pharmaceutical product in question will be suspended for 12 months,
and if the rebate is provided for the same pharmaceutical product once more, then such
pharmaceutical product will be excluded from the NHIP list.
There are strong objections from the pharmaceutical industry against this Rebate Two Out
System, and one of the main reasons of such objection is based on the co-promotion/comarketing relationship between a multinational pharmaceutical company and a Korean
pharmaceutical company. Co-promotion/co-marketing is commonly used in the Korean
pharmaceutical industry, and under the Rebate Two Out System, if the Korean pharmaceutical
company provides rebates regarding the pharmaceutical product subject to such copromotion/co-marketing, then the multinational pharmaceutical company must share the
penalty of such rebate in the same form as the co-promotion/co-marketing product being
excluded from the NHIP list or the payment of NHIP for the same being suspended for a certain
period of time, regardless of whether the multinational pharmaceutical company was aware of
the rebate.
•
NHIP Reduction
Any illegal rebates may result in a reduction in NHIP under the NHIA. The maximum reduction
in NHIP is 20%, and the reduction in NHIP is calculated as follows: [value of rebates] / [amount
of sales/prescription by medical institution(s) of the product relating to such rebates].
In addition, due to financial difficulties of the reimbursing authority (i.e., the NHIC), and the
Korean government’s belief that reducing drug NHIPs will help eradicate illegal rebates, NHIP
is reduced in overall.
•
Abolishment of Actual Transaction Price (ATP) Incentive System
The Actual Transportation Price (ATP) Incentive System was a yearly adjustment system,
which also leads to the reduction of NHIP. If a hospital purchases drugs at prices lower than
NHIP, then 70% of the difference will be given to the hospital as an incentive, and the following
year, the NHIP will be reduced by 80% of such difference up to a maximum of 10% of the NHIP.
Due to strong objections by the pharmaceutical industry, and unwanted side effects, including
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requests for excessive discounts by medical institutions and the supply of drugs at lower price
by pharmaceutical companies, the MOHW has recently decided to abolish the same by
amending the NHIA in September 2014, and implemented alternatives such as the provision
of incentives to hospitals which reduce the amount of drugs used, and the increase of the
reward amount to be provided to a person who reports unfair claim for NHIP by medical
institutions.
•
Remote Medical Services
The MOHW proposed an amendment to the MSA for encouraging “remote medical services”
on October 29, 2013, based on changing healthcare circumstances such as increasing
convenience for patients and the development of medical technologies, and will start a pilot
project to implement such remote medical services in September 2014. However, there are
strong objections from the Korean healthcare industry based on that (i) medical expenses will
increase as a result of hospitals’ purchasing expensive medical devices, and (ii) the medium
and small sized hospitals will collapse or be merged into the large hospitals resulting in the
quality of medical service becoming worse.
Contact Information
Jeeseon Choi, Attorney at law
[email protected]
Hwang Mok Park P.C.
Shinhan Bank Building
20, Sejong-daero 9-gil,Jung-gu
Seoul, 100-724, Korea
Phone: +82-2-772-2700
Direct: +82-2-772-2854
Fax: +82-2-772-2800
Firm Website www.hmpj.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Malaysia
Prepared by Lex Mundi member firm Skrine
1. Provide an introduction on health law in your jurisdiction.
The Malaysian health industry is broadly divided between the public health care system and the
private-for-profit / non-governmental health care system. Whilst legislation and regulation in many
areas equally applies to both sectors, some health legislation addresses only the latter (e.g. Private
Healthcare Facilities and Services Act 1998).
(A) High Level Overview of Public Sector
The Federal Government is primarily responsible for public health & medicine, disease control, and
law enforcement. Various state health departments and district health offices all over Malaysia aid in
carrying out this role.
The main divisions of the Ministry of Health include Public Health, Medical, Research, Oral Health,
Pharmaceuticals and Food Safety & Quality. The Ministry of Health largely oversees:i.
Public health and disease prevention.
ii.
Majority of public/government hospitals.
iii.
Public health clinics and rural clinics.
iv.
Special institutions e.g. leprosy, psychiatry, tuberculosis, heart and specialized
maternal and child health facilities.
v.
Licensing, registration, enforcement and supervision of pharmaceuticals and
cosmetics, medical devices.
vi.
Development, regulation and supervision of medical practice and other personnel
including nurses and medical assistants.
vii.
Licensing of private health care facilities including private hospitals.
Several other Ministries and governmental departments govern specific areas and special institutions
relating to health. This includes the Ministry of Education who oversees university hospitals and
medical schools. The National Anti-Drugs Agency under the Ministry of Home Affairs is responsible
for various public clinics and rehabilitation centers. Occupational Safety and Health is regulated and
administered by the Department of Safety and Health under the Ministry of Human Resources.
Specialist hospitals such as Military Hospitals and Hospitals for Indigenous People also involve the
armed forces and the Department of Indigenous Peoples respectively.
(B) High Level Overview of Private Sector
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Private healthcare can be broadly broken down into:
i.
ii.
iii.
Private Hospitals
Private Medical Practitioner Clinics
Other Non-Governmental Facilities e.g. dialysis centers, drug rehabilitation centers,
charitable facilities etc.
Private practice also includes private / non-governmental dental practitioners, pharmacists,
laboratories, x-ray surgeries, nursing homes, medical schools, and various practitioners of traditional
and alternative medicine.
(C) Legislation, Regulations, Health Policies & Guidelines
The various parliamentary acts governing the health industry include legislation over the
administration and conduct of the medical profession, private healthcare facilities, fees,
pharmaceuticals, advertising, telemedicine and medical devices. Under many of these legislative
instruments, the Minister of Health and/or other administrative bodies (e.g. the Malaysian Medical
Council in relation to the Medical Act 1971) is empowered to enact regulations, rules and orders to
carry out the provisions of the principal acts.
Policies, guidelines and circulars governing the profession and industry are also issued by the
Secretary General of Health, the Director General of Health and/or specific divisions of the Ministry
of Health [Reference: Publications, Ministry of Health http://www.moh.gov.my/]. Regulatory bodies in
Malaysia may have internal policies, guidelines and practices which are not circulated to the public.
The legal system in Malaysia is a common law system which follows the practice of case law
precedents. This is important to Tort Law and the laws relating to medical negligence in Malaysia.
(D) Statutory / Administrative Bodies
The Malaysian Medical Council (“the Council”) is generally responsible for the practice of medicine
and regulates the conduct, qualifications, standards and registration of medical practitioners. The
Council is a body corporate established under the Medical Act 1971.
The National Pharmaceutical Control Bureau is the licensing authority for pharmaceutical,
medicinal and therapeutic products, as well as cosmetics. The Bureau carries out the role of
Secretariat to the Drug Control Authority.
Other statutory / administrative bodies in health care include the Pharmacy Board Malaysia, Medicine
Advertisements Board, Poison Board, Medical Assistant Board, Malaysia Nursing Board, Malaysian
Dental Council, and the Malaysia Optical Council.
2.
Provide a check list of laws with a short summary of the general requirements of each.
As set out in Paragraph 1 (C) above, the health industry is administered and regulated by numerous
Acts, regulations and orders made under said Acts, policies, circulars, codes, and guidelines. We list
below a few of the primary health industry laws.
I. HOSPITALS
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A.
Private Healthcare Facilities And Services
The Private Healthcare Facilities and Services Act 1998 (“PHFSA”) repealed the Private Hospitals
Act 1971. The PHFSA provides for the regulation and control of private healthcare facilities and
services.
The PHFSA defines private healthcare facilities as healthcare facilities other than any facility
established, maintained, operated or provided by the Government. Government facilities under the
PHFSA do not include privatized or corporatized Government healthcare facilities.
(i)
Licensing and Registration
The PHFSA sets out approval and licensing requirements relating to the establishment and operation
of:a. private hospitals;
b. private psychiatric hospitals;
c. private ambulatory care centers;
d. private nursing homes;
e. private psychiatric nursing homes;
f. private maternity homes;
g. private blood banks;
h. private hemodialysis centers;
i. private hospices;
j. private community mental health centers;
k. any other private healthcare facilities or services or health-related services may be
specified by the Ministry in the Gazette; and
l. private healthcare premises incorporating any two or more of the facilities or services in
paragraphs (a) to (k).
The PHFSA also stipulates registration requirements for private medical clinics and private dental
clinics that do not form part of a licensed private healthcare facility. A certificate of registration for a
private medical clinic will only be issued to a registered medical practitioner.
(ii) Fees
The Seventh Schedule of the Private Healthcare Facilities and Services (Private Medical Clinics or
Private Dental Clinics) Regulations 2006 prescribe the fees to be charged by any private medical
clinic or private dental clinic. For several categories, a range of fees are prescribed. For many other
categories, the maximum fee chargeable is prescribed. Subject to the prescribed schedule of fees,
each private clinic is required to have a written policy on its quantum of fees to be charged.
Similarly, the Thirteenth Schedule of Private Healthcare Facilities and Services (Private Hospitals
and Other Private Healthcare Facilities) Regulations 2006 stipulates maximum fees chargeable at
private hospitals and health care facilities.
B.
Public Healthcare
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(i)
Officers of Government Hospitals / Clinics
Government General Orders General Orders are enacted pursuant to Article 132(2) of the Federal
Constitution. These orders govern the conditions for service of government servants (e.g.
appointment, promotion, leave, working hours and overtime, etc.) In particular, the Government
General Orders Chapter F (Medical) 1974 prescribes the qualifications for appointment and
conditions of service in relation to the public health care system.
(ii)
Patient Fees
The Fees (Medical) Order 1982 was made under the powers conferred by the Fees Act 1951. The
Fees (Medical) Order 1982 stipulates fees payable at any government hospital, including any
teaching hospital of a University, Government clinic and any other Federal Medical Institution.
However the Fees (Medical) Order 1982 does not apply to Government servants, Government
pensioners and members of their families, employees of local authorities, statutory bodies and
members of their families, and certain other persons whose medical privileges are provided for in
other written law. This is because under Government General Orders, Chapter F (Medical) 1974,
government servants, pensioners from government service and their family members are eligible for
free medical facilities at a Government hospital/clinic (with the exception of nominal ward charges
that apply in stipulated circumstances).
Fees (Medical) (Full Paying Patient) Order 2007 provides for fees at specific government hospitals
in circumstances where a patient is offered the privilege of the option to be treated by a specialist of
his choice and executive/first class facilities services.
II. MEDICAL PRACTITIONERS & RELATED PERSONNEL
A.
Medical Practitioners
(i) Medical Act 1971
The Medical Act 1971 (“MA 1971”) sets out the law relating to the registration of medical practitioners,
the control and regulation of the practice of medicine as well as disciplinary proceedings of medical
practitioners. The MA 1971 also established the Malaysian Medical Council (“the Council”). Under
Section 36 of the MA 1971, the Council is empowered to make regulations with the approval of the
Minister of Health.
The Medical Regulations 1974 prescribes the procedure for nominating and voting for the members
of the Council. These regulations further prescribe the forms of registration of medical practitioners,
the practicing certificate and its fees. Part IV of the Regulations sets out the process of disciplinary
inquiries before the Council.
(ii) Qualifications for Medical Practitioners
The Second Schedule to the MA 1971 sets out accepted qualifications that entitles provisional
registration as a practitioner in Malaysia e.g. Bachelor of Medicine and Bachelor of Surgery
qualification from University of Malaya. The list sets out various qualifications both from training
teaching institutions in Malaysia as well as other countries including Australia, Canada, India, Ireland,
Pakistan, Russia, Taiwan, Ukraine, the United Kingdom, the U.S.A.
The MA 1971 also allows for medical undergraduates trained from institutions not listed in the Second
Schedule to be eligible for provisional registration if they sit and pass a qualifying examination or
assessment. The conduct of such examination is currently prescribed by the Medical (Setting of
Examination for Provisional Registration) Regulations 2012.
The MA 1971 prescribes that following provisional registration, a person is required to carry out at
least a one-year residency in any approved hospital or institution in Malaysia; four months of such
period shall be spent in a resident surgical post, four months in a resident medical post and four
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months in a resident obstetrical and gynecological post. At the conclusion of satisfactory service, as
certified by the Medical Qualifying Board, the provisionally registered person may be entitled to a
practicing certificate / full registration.
Under the MA 1971, a fully registered practitioner may be required to assume a post in public service
for at least three years unless otherwise exempt by the Director General.
(iii) Ethical Conduct & Professional Codes
Various professional codes of conduct are adopted by the Council to which medical practitioners are
required to comply. These include the Code of Professional Conduct 1986, various ethical guidelines,
confidentiality guidelines, good medical practice, guidelines on consent, etc. [Source: Ethical Codes
& Guidelines, Malaysian Medical Council http://mmc.gov.my/]
Breach of the codes of conduct may be grounds for disciplinary punishment by the Council pursuant
to Section 29 and 30 of the MA 1971.
(iv) Disciplinary Actions
Under the MA 1971, the Council is empowered to inter alia strike off the name of a medical
practitioner from the register, suspend a registered medical practitioner, and/or reprimand a
registered medical practitioner.
Section 31 of the MA 1971 stipulates that any person who is aggrieved by an order by the Council in
the exercise of its disciplinary jurisdiction may appeal to the High Court, and the High Court may
affirm, reverse or vary the Council’s order.
(v) Medical Negligence
A medical practitioner has a common law duty of care to patients who submit to his direction and
treatment i.e. he owes a duty to the patient to use diligence, care, knowledge, skill and caution in
administering the treatment. A patient who is caused injury or damage as a result of a breach of this
duty of care may bring a civil claim against the medical practitioner in Court to recover damages.
This would be a separate action from a complaint being lodged with the Council so that a disciplinary
inquiry takes place.
Under common law, a hospital may be vicariously liable for the acts of its employees. This applies
similarly to public and private hospitals and health care facilities. Whether a medical practitioner
constitutes an employee or an independent contractor / consultant of the hospital depends on various
factors including the method of remuneration of the medical practitioner, or the level of control the
hospital has over the treatment and management of the patients.
Section 34B of the MA 1971 specifically provides that where a registered practitioner is not a public
officer but who, at the request of or by arrangement with the Government, treats any patient in any
Government hospital, clinic or health center, the Government shall be liable in respect of the acts of
that practitioner in the course of such investigation, examination, treatment or management.
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B.
(i)
Other Medical Personnel
Nurse Act 1950 and Midwives Act 1966
The Nurses Act 1950 provides for the establishment of the Nursing Board. It also sets out the law
relating to the qualification and registration of nurses for the sick. The Midwives Act 1966 sets out
the law relating to the registration of midwives and the conduct of midwifery.
(ii) Medical Assistants (Registration) Act 1977, the Medical (Instruments) (Exemption)
Regulations 1986 and Estate Hospitals Assistants (Registration) Act 1965
This act provides for the Medical Assistants Registration Board and governs the registration of
medical assistants employed in Government and private hospitals, health centers or other
Government and private institutions for the care, treatment or rehabilitation of patients, as well as
medical assistants to any registered medical practitioner.
The Medical (Instruments) (Exemption) Regulations 1986 sets out the conditions and medical
instruments that may be handled by registered and trainee medical assistants in carrying out their
duties.
The Estate Hospitals Assistants (Registration) Act 1965 separately provides for the registration of
estate hospital assistants and probationer estate hospital assistants. An ‘estate hospital’ is defined
under the act as “a hospital or dispensary maintained by an employer on or in the neighbourhood of
an estate for the treatment of labourers thereon and includes a hospital or dispensary maintained by
two or more employers for the treatment of labourers on their estates”.
C. Other Acts not yet in Force
(i) Telemedicine Act 1997 (not yet in force)
Whilst the Telemedicine Act 1997 was given royal assent and gazette in June 1997, the date of its
coming into force has yet to be passed. The Act is intended to regulate ‘telemedicine’, defined as the
practice of medicine using audio, visual and data communications. This Act intends that only a
registered medical practitioner or a certified medical practitioner (for those registered outside
Malaysia) is allowed to practice telemedicine.
(ii)
Traditional and Complementary Medicine Act 2013 (not yet in force)
The Traditional and Complementary Medicine Act 2013 is intended to regulate the practice of
traditional and complementary medicine services i.e. health-related practice designed to prevent,
treat or manage ailment or illness or preserve the mental and physical well-being of an individual,
including practices as traditional Malay medicine, traditional Chinese medicine, traditional Indian
medicine, homeopathy, and complementary therapies, but excludes medical and dental practices
used by a medical and dental practitioner respectively. The PHFSA will not apply to the practice of
traditional and complementary medicine including the use of any premises, building and facility for
such medical practice.
Currently, registration as a traditional and complementary medicine practitioner is voluntary. [Source:
Traditional & Complementary Medicine Division, Ministry of Health http://tcm.moh.gov.my/]
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III.
A.
PHARMACEUTICALS
Pharmacists
The Registration of Pharmacists Act 1951 (“RPA”) relates to the establishment and constitution of a
Pharmacy Board. This RPA also regulates the qualifications and registration of pharmacists. Under
the RPA, a fully registered pharmacist may be required to assume a post in public service for at least
three years by the Director General or Health.
The RPA also stipulates that every incorporated company that is in the business of keeping, retailing,
dispensing and compounding poisons, dangerous drugs or therapeutic substances must be
registered.
B.
Pharmaceutical, Medicinal and Therapeutic Products
(iii) Poisons Act 1952
The Poisons Act 1952 (“PA”) provides for the establishment and constitution of the Poisons Board.
The PA also contains control provisions and licensing requirements for the importation, manufacture,
compounding and sale of poisons. The Poison List is set out in the First Schedule to the PA. Poisons
are also defined to include any preparation, solution, compound, mixture or natural substance
containing such substance listed under the Poison List, unless exempted by the Second Schedule.
Amongst the restrictions set out by the PA, only registered pharmacists, registered medical
practitioners or persons working under the supervision of registered pharmacists or registered
medical practitioners shall dispense poisons for the purpose of medical treatment.
The Poison Regulations 1952 sets out, amongst others, conditions relating to labelling, transport,
storage, and colouring of poisons. The Poison Regulations also set out further provisions relating to
the supply of poisons in hospitals and institutions.
(iv) Sales of Drugs Act 1952
The Sale of Drugs Act 1952 (“SDA”) sets out offences relating to the sale of drugs i.e. any substance,
product or article intended to be used or capable, or purported or claimed to be capable, of being
used on humans or any animal, whether internally or externally, for a medicinal purpose.
The related Control of Drugs and Cosmetics Regulations 1984 (“the Drug Regulations”) stipulates
that a person may only manufacture, sell, supply, import or possess or administrator any
pharmaceutical product if said person has been issued with the appropriate license and if the product
in question has been registered with the National Pharmaceutical Control Bureau (“NPCB”).
Both pharmaceutical products which contain scheduled poisons as defined in the PA (i.e. prescription
drugs) and pharmaceutical products that do not contain scheduled poisons (i.e. over-the-counter
products) are required to be registered. Cosmetic products, traditional medicines and veterinary
medicines are also required to be registered.
Pursuant to the latest Drug Registration Guidance Document published by the NPCB, an entity
seeking to register a pharmaceutical product must be locally incorporated. [Source: NPCB Guidance
Document July 2014, News & Publication http://portal.bpfk.gov.my/]
(v) Dangerous Drugs Act 1952
The Dangerous Drugs Act 1952 (“DDA”) provides further regulation over the importation, exportation,
manufacture, sale, and use of certain dangerous drugs and substances (e.g. opium, cannabis,
cocaine, methamphetamines). It further makes special provision relating to the jurisdiction of courts
in respect of offences relating to dangerous drugs.
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(vi) Medicines (Advertisement and Sale) Act 1956
The Medicines (Advertisement and Sale) Act 1956 (“MASA”) sets out conditions for medical
advertising. Approval by the Medical Advertisements Board is required for advertisements relating to
medicines or appliances for diagnosis of certain diseases set out in the Schedule to MASA such as
heart diseases, kidney disease, diabetes etc. Advertisements relating to the condition or functioning
of the human kidney or heart, to contraception or improving the sexual function or sexual
performance of human beings also require approval by the Medical Advertisements Board.
Advertisements relating to abortion are prohibited. Advertisements relating to special skills and/or
services are prohibited unless otherwise approved by a professional body sanctioned by the Minister,
or the Medical Advertisements Board.
MASA also stipulates certain disclosure requirements and labelling requirements in the sale of
medicines.
IV.
(i)
MEDICAL DEVICES
Medical Device Act 2012
Medical Device Act 2012 is an Act to regulate medical devices, the industry and to provide for matters
connected to medical devices and the industry. It provides that no medical devices shall be imported,
exported or placed in the market, unless they are registered under the Act.
The Act also provides for manufacturer’s obligations, requirements for registration, the application
procedure and provisions relating to enforcement of the Act. The Act further provides for registration
of Conformity Assessment Body, Establishment License, Designated Medical Device Permit and
Export Permit.
(ii)
Medical Device Regulations 2012
The Medical Device Regulations 2012 provides for the conformity assessment procedure,
registration of medical device, registration of Conformity Assessment Body, Establishment License,
Export Permit and labelling requirements among others. The Schedules to the Medical Device
Regulations 2012 also set out the categorization and grouping of medical devices. The conformity
assessment and fees required are dependent on a device’s categorization and grouping.
(iii)
Medical Device Authority Act 2012
Medical Device Authority Act 2012 establishes the Medical Device Authority for the control and
regulation of medical devices, the medical device industry and its activities. The Medical Device
Authority also carries out the role of medical device law enforcement.
The Medical Device Authority handles registration of medical devices, issues licenses, inspects
establishments, monitors sale, operation, usage and disposal of medical devices, and is involved
with the drafting of laws and standards relating to medical devices.
V.
(i)
MEDICAL INSURANCE
Private Insurance
Medical illness, hospitalization or other health related insurance are by and large at the option of
each private individual. The various health related insurances are regulated together with all other
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insurances under the Financial Services Act 2013 (or the Insurance Act 1996 in relation to older
insurance policies). Bank Negara Malaysia, the Central Bank, regulates insurance.
(ii)
Workmen’s Compensation Act 1952
The Workmen’s Compensation Act 1952 provides for the payment of compensation to foreign
workers earning less than RM500 a month for injury suffered in the course of their employment;
(iii)
Employees’ Social Security Act 1969
The Employees’ Social Security Act 1969 (“ESSA”) provides for social security protection of
Malaysian employees by social insurance. The insurance system is to aid employees involved in an
accident at work, or who develop a work-related disease in ways which may include financial
compensation and assistance, the provision of artificial aids, rehabilitation etc.
Contribution to partake in this social insurance scheme is primarily only mandatory for employees
earning less than RM3000 a month. Those earning more than RM3000 may voluntarily opt in to this
scheme however once a person has opted in, that person cannot opt out of the scheme.
VI.
OTHER LEGISLATION
Other health related primary legislation include:(i)
The Dental Act 1971 relating to the registration and practice of dental practitioners;
(ii)
The Mental Health Act 2001 which consolidates the laws relating to mental disorder and to
provide for the admission, detention, lodging, care, treatment, rehabilitation, control and
protection of persons who are mentally disordered and for related matters;
(iii)
The Optical Act 1991 for the registration of opticians and optometrists, and to control the
practice of optometry;
(iv)
The Human Tissues Act 1974 which provides for the use of parts of human bodies of
deceased persons for therapeutic purposes and for purposes of medical education and
research (i.e. organ donation);
(v)
The Malaysian Health Promotion Board Act 2006 which established the Malaysian Health
Promotion Board;
(vi)
Occupational Safety and Health Act 1994 and its related regulations which sets out
provisions for securing the safety, health and welfare of persons at work, for protecting
others against risks to safety or health in connection with the activities of persons at work,
and establishes the National Council for Occupational Safety and Health;
(vii)
Persons with Disabilities Act 2008 provides for the registration, protection, rehabilitation,
development and general well-being of persons with disabilities, as well as establishes the
National Council for Persons with Disabilities.
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VII.
PUBLIC PROCUREMENT
Broadly speaking the Federal Government’s financial authority is vested with the Ministry of Finance.
There are various types of procurement in under the Malaysian Public Procurement Regime including
through direct procurement for supplies and services up to the value of RM50,000 or works up to
RM20,000 with a registered contractor; through a quotation regime for the procurement of supplies
and services above the value of RM50,000 and up to RM500,000 or the procurement of works
between RM20,000 to RM500,000. Procurement of works, supplies or services above RM500,000
must be done through a tender process.
[Source: Malaysia’s Government Procurement Regime, Ministry of Finance Publication
http://www.treasury.gov.my/pdf/lain-lain/msia_regime.pdf]
According to the Ministry of Health, medicines procurement for the ministry is done through open
tender by generic name most of the time to encourage healthy competition in drug pricing. [Source:
Malaysia’s Health 2008 Publication, Ministry of Health]
3.
Provide any special issues which arise in your jurisdiction.
(i) Telemedicine:
As highlighted above at Question 2 Part II(C), legislation in relation to telemedicine has been
published in the gazette more than 17 years ago but has yet to come into force. This piece of
legislation may now be very welcome in light of increased use of telecommunications and information
technologies, although amendments may be required based on the more advanced landscape of
information and communication technology compared to 1997.
(ii) PHFSA:
The Schedule of Fees prescribing maximum fees under the PHFSA was recently increased in early
2014 by a reported average of 14.4%. This was received with mixed review and has increased the
disparity in fees between the public and private health sector.
(iii) 10th Malaysia Health Plan
The 10th Malaysia Health Plan is intended to cover the period of 2011 – 2015. In it, the plan identifies
that Malaysian healthcare requires reshaping from a system that is largely disease-based medical
care focused on illness, facilities and healthcare providers to personalized healthcare that is focused
on wellness, people and the capacity to deliver services into people’s homes.
The numerous challenges identified include the issues relating to the public–private dichotomy. A
proposed model for reform was put forward for an integrated health care system in 2012, including a
proposed mandatory social health insurance. Whether these changes will be implemented is still
unknown. There will be a probable overhaul in health legislation and regulations if such reform does
take place.
4.
Are mobile health applications regulated under the law of your jurisdiction? If so, provide a
brief summary as to how they are regulated.
We assume that “mobile health applications” refer to application software to be installed in mobile
phones or tablets, which may monitor physical health stats such as weight, menstrual cycle, and
heart rate, provide diagnoses, or dispense other medical advice.
There is currently no specific legislation or regulation which governs the standards, distribution, sale,
advertisement, or use of mobile health applications.
However, mobile health applications may fall within the scope of medical devices due to their
functionality and characteristics. Section 2 of the Medical Device Act 2012 broadly defines “medical
device” as:
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“(a)
(b)
any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent
or calibrator, software, material or other similar or related article intended by the
manufacturer to be used, alone or in combination, for human beings for the purpose
of—
(i)
diagnosis, prevention, monitoring, treatment or alleviation of disease;
(ii)
diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
(iii)
investigation, replacement or modification, or support of the anatomy or of a
physiological process;
(iv) support or sustaining life;
(v)
control of conception;
(vi) disinfection of medical device; or
(vii) providing information for medical or diagnostic purpose by means of in-vitro
examination of specimens derived from the human body, which does not
achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means, but that may be assisted
in its intended function by such means; and
any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent
or calibrator, software, material or other similar or related article, to be used on the
human body, which the Minister may, after taking into consideration issues of public
safety, public health or public risk, declare to be a medical device by order published
in the Gazette.” (emphasis added)
As such, mobile health applications may have to be registered as a medical device as section 5(1)
of the Medical Device Act 2012 further provides that “No medical device shall be imported, exported
or placed in the market unless the medical device is registered under this Act”
This is regardless of whether the mobile health application is available free of charge or for a fee.
Section 3 defines “place in the market” as “to make available a medical device in return for payment
or free of charge with a view to distributing, using, supplying or putting it into service, in Malaysia,
regardless of whether it is new or reprocessed, but does not include to make available for use for
clinical research or for performance evaluation of a medical device. It is also an offence under Section
44 to advertise a medical device unless the medical device has been registered and complied with
the requirements of the Act. Furthermore, advertisements on medicines, remedies, appliances, skill
and services relating to diagnosis, prevention and treatment of diseases or conditions affecting the
human body are under the authority of the Medicine Advertisements Board.
The above does not constitute as legal advice for interested parties intending to place their mobile
health applications on the Malaysian market. Please ensure that legal advice is sought from parties’
respective advisors.
Contact Information
Mr. Khoo Guan Huat, Partner, Head of the Lex
Mundi Intellectual Property Dispute Resolution
Practice Group
[email protected]
Skrine
Unit No.50-8-1, 8th Floor
Wisma UOA Damansara,
50 Jalan Dungun,
Damansara Heights,
50490 Kuala Lumpur,
Malaysia
Tel 603.2081.3999 Fax 603.2094.3211
Firm Website www.skrine.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Mexico
Prepared by Lex Mundi member firm Basham, Ringe and Correa S.C.
1. Provide an introduction on health law in your jurisdiction.
The Mexican health care system is comprised of public and private institutions, all regulated by the
Ministry of Health. Public health services are rendered by means of three principal institutions:
Mexican Social Security Institute (“IMSS”), Social Security Institute for State Employees (“ISSSTE”)
and Social Security Institute for the Armed Forces (“ISSFAM”).
The Federal Commission for the Protection against Sanitary Risks (“COFEPRIS”) is the Federal
Agency in charge of enforcing regulatory measures for medicines, medical devices, foods,
beverages, tobacco, alcoholic beverages, vegetable nutrients, pesticides, pharmaceutical
products, cosmetics, additives, adjuvants, ingredients and other health related products as well as
all processes related to them.
There is a variety of (federal and federal state) laws, regulations, directives and Mexican Official
Standards (“NOMS”) in diverse fields such as social security, hospitals and procurement,
pharmaceuticals, publicity, labeling of products, medical devices, pesticides and products and
services, same that are detailed below.
Relevant authorities and associations:
- The Federal Ministry of Health (Secretaría de Salud) is responsible for the development of health
care regulation at federal level and supervises all federal health care agencies and institutes.
- The State Ministries of Health (Secretaría de Salud del Estado) are also competent to pass
legislation. Furthermore, they are required to execute all health care legislation and to supervise
municipal health authorities.
- The Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la
Protección Contra Riesgos Sanitarios) in charge of enforcing regulatory measures for medicines,
medical devices, foods, beverages, tobacco, alcoholic beverages, vegetable nutrients, pesticides,
pharmaceutical products, cosmetics, additives, adjuvants, ingredients and other health related
products as well as all processes related to them.
- The Mexican Social Security Institute (Instituto Mexicano del Seguro Social), the Social Security
Institute for State Employees (Instituto de Seguridad y Servicios Sociales de los Trabajadroes del
Estado) and the Social Security Institute for the Armed Forces The Federal Insurance Agency
(Instituto de Seguridad Social para las Fuerzas Armadas Mexicanas) are responsible for the
medical attention of their affiliates and also for the allocation of Federal funds.
-
The Mexican Inter-institutional Commission for the Basic Catalogue of Medical Supplies for the
Health Sector (Comisión Interinstitucional del Cuadro Básico y Catálogo de Insumos del Sector
Salud). Social Security Institutes may only prescribe medicines and other medical supplies to
patients that have been previously authorized by this Inter-institutional Commission for complying
with required medical and economical standards.
2. Provide a check list of laws with a short summary of the general requirements of each.
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a) General Health Law: Contains health principles and rights regarding the National Health System,
the rendering of medical services and social protection, investigation, human genome, health
promotion and information, prevention of accidents and diseases, care of terminal patients, social
assistance, rehabilitation, extraordinary measures in terms of general health, programs against
addictions, health control of products and services as well as their importing and exporting,
publicity, organ donation, authorizations and certificates, health vigilance, safety measures,
sanctions and health crimes.
b) National Institutes of Health Law: regulates and organizes the National Health Institutes, as well
as the promotion of investigation, teaching and rendering of health services.
c) Law for the Biosecurity of Genetically Modified Organisms: regulate the activities for the
confined use, experimental release, pilot program release, commercial release, distribution,
importing and exporting of genetically modified organisms, as to prevent avoid and reduce any
possible risks that this activity might induce to human health and/or the environment, as well as
biological diversity, animal, vegetable and environmental health.
d) Social Assistance Law: regulates the rendering of social security services, distribution of Federal,
State and local attributions amongst health institutions, both private and public.
e) Public Procurement Law: regulates the application of Constitutional Article 134 of the Mexican
Constitution for the acquisition, lease and procurement of goods and services carried out by
Federal Institutions.
f)
Customs Law: provides legal and technical requirements for the importing and exporting of health
products. Enforced by the Ministry of Finance in borders and access points alongside with the
Ministry of Health and COFEPRIS.
g) Federal Administrative Procedures Law: regulates relations between particulars and
governmental authorities and establishes administrative principles that also apply to Health
Authorities.
h) Rulings for the Sanitary Control of Products and Services: regulates, controls and promotes
health aspects of the process, importing and exporting, as well as activities, services and
establishments related with the following products: Milk, eggs, meat, fish, fruits, vegetables, plants,
non-alcoholic beverages, cereals, snacks, oils and edible fats, cacao, coffee, tea, prepared foods,
prepared foods ready for consumption, baby food, condiments, dressings, sweeteners, dietary
supplements, alcoholic beverages, tobacco, perfumes, cosmetics, insect repellents, additives and
their derived products.
i)
Rulings for Medical Supplies: regulates the health controls applicable to medical supplies as well
as herbal remedies, as well as the establishments, activities and services related to them.
j)
Rulings for the General Health Law in terms of Health Controls for disposal of human
organs, tissue and human corpses: regulates the control and sanitary disposal of organs, tissue,
their components and derived products, as well as human body corpses for therapeutic, research
or educational purposes.
k) Rulings for the General Health Law in terms of Health Investigations: regulates medical
investigation in terms of the General Health Act for public, social and private institutions.
l)
Rulings for the General Health Law in terms of Rendering of Medical Services: regulates the
rendering of medical services, whether private or public.
m) Rulings for the General Health Law in terms of Publicity: regulates publicity and sanitary control
of products, services and activities comprised within the General Health Law.
n) Rulings for the General Health Law in terms of International Health: Regulates health controls
in terms of international health in terms of immigration, ports, borders and other authorized places
foth international transport of people and freight.
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o) Rulings for the New Molecules Committee: regulates the New Molecules Committee, an
administrative organ for consult and opinion for the registration of new medicines and other health
supplies filed before the Ministry of Health and that may contain new molecules and or ingredients
in terms of the Rulings for Medical Supplies.
p) Rulings for the Operation of the Mexican Inter-institutional Commission for the Basic
Catalogue of Medical Supplies for the Health Sector: regulates and standardizes the necessary
processes for the elaboration, renewal and publicity of the Basic Catalogue of Medical Supplies for
the Health Sector as well as the Commission in Charge of incorporating and updating this
document.
q) Rulings for the registration, importing and exporting authorizations, and certificates for
exportation for Pesticides, Vegetable Nutrients and Toxic or Hazardous Materials or
Substances: As its name points out, these rulings provide a legal background for the registration,
importing and exporting of pesticides, vegetable nutrients and toxic or hazardous materials or
substances.
r)
Pharmacopeia for the Mexican United States: Compilation issued by the Ministry of Health which
includes general analysis methods and requirements in terms of identity, purity and quality of
medicines, additives, pharmacological substances, biological products and other health supplies.
s) Mexican Official Standards: Technical, regulatory and legal aspects concerning to a specific
product or service such as manufacturing, measurement, Pharmacovigilance, environmental
health, amongst others. Below some examples of products and services regulated by Mexican
Official Standards
a. Water
i.
ii.
iii.
iv.
v.
vi.
vii.
Water for human consumption.
Water for human consumption distributed by public systems.
Water and ice for human consumption packed for distribution.
Handling of water for human consumption.
Sampling of water for human consumption.
Filters and germicides for domestic treatment of water.
Health requirements for pools.
b. Alcohol
i. Processing of ethanol.
ii. Sanitary requirements for denaturalized alcohol, antiseptic and germicides (used
as healing supplies)
c.
Foods and beverages
i. Metallic wrappings for foods and beverages.
ii. Iodized salt.
iii. Labeling of foods and beverages (commercial and health information)
iv. Modified foods and beverages.
v. Methods for investigation in foods and beverages.
vi. Thermal sealing of foods and beverages.
vii. Milk formulas and baby food.
viii. Labeling of vegetable nutrients.
ix. Products and services in particular (cacao, eggs, flours).
x. Processing of meats.
xi. Processing of fish and other sea products.
xii. Cereals and their products.
xiii. Hygienic requirements for processing of foods and beverages.
d. Alcoholic Beverages
i. Health and commercial labeling for alcoholic beverages.
e. Good Practices
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i.
ii.
iii.
iv.
f.
Good manufacturing practices for medicines.
Good manufacturing practices for pharmacological substances.
Good manufacturing practices for herbal remedies.
Good manufacturing practices for beverages, foods, alcoholic beverages and
dietary supplements.
Air quality
i. Ozone determination and maximum levels.
ii. Carbone monoxide determination and maximum levels.
iii. Sulfur dioxide determination and maximum levels.
iv. Nitrous Dioxide determination and maximum levels
v. Suspended particles and maximum levels
vi. Lead contents in air.
g. Pottery and clay
i. Permissible limits of lead and cadmium in pottery, glass and clay.
h. Containers
i. Metallic containers for foods and beverages.
ii. Thermal packing of foods and beverages.
i.
X-ray Equipment
i. Requirements for installing and operating x-ray machinery for medical diagnosis.
j.
Medical and Surgical instruments
i. Reactivity testing
k.
Labeling
i. Labeling of paints, tints, varnish and coatings
ii. Labeling of foods and beverages
iii. Labeling of herbal remedies
iv. Labeling of medical and surgical instruments
v. Labeling of cosmetics
vi. Labeling of alcoholic beverages
vii. Labeling of vegetable nutrients
viii. Labeling of cleaning products
ix. Labeling of pesticides.
l.
Pharmacovigilance
i. Establishing and operating a pharmacovigilance program
m. Toys and school supplies
i. Lead testing in toys and school supplies
ii. Heavy metal testing in toys and school supplies
n. Laboratories
i. Health standards for a pathology laboratory
ii. Calibration standards for measurements in clinical laboratories.
o. Medicines
i. Stability of medicines and herbal remedies
ii. Health requirements for the manufacturing, warehousing and distribution of
pharmacological substances.
iii. Interchangeability requirements and methods
iv. Sterile solutions.
p. Pesticides
i. Labeling of pesticides
ii. Health conditions for companies and personnel dedicated to the control of pests.
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q. Meat
i. Sacrifice of animals for the production of meat.
ii. Test methods for processed meat products.
r.
Fish and other products of the sea
i. Risks and control of critic processes in the production of fishing products.
ii. Test methods for processed sea products.
s.
Toxic Substances
i. Biological standards of inorganic solvents in exposed personnel.
ii. Health regulations for processing and use of asbestos
iii. Maximum limits for hydrocarbons in soil.
3. Provide any special issues which arise in your jurisdiction.
Health Care and Life Sciences practice in Mexico is complex and requires an overall understanding of
diverse institutions, laws and regulations. Professional assistance is advised when dealing with such
matters within the country. Life Sciences and health care usually require a license or operation notice for
carrying out their activities within the country.
We do not have different regulatory agencies as some other countries do, so COFEPRIS regulates foods,
beverages, tobacco, alcohol, health supplies, medicines, drugs, pharmaceutical products, pesticides,
vegetable nutrients, cosmetics, biotechnological products and other relevant regulatory areas. This
translates into exhaustive applications and long periods for evaluation. COFEPRIS is also a regulatory
standard for other jurisdictions in Latin America.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Mobile health applications are not yet regulated in Mexico.
Contact Information
Rodolfo Barreda Alvarado
[email protected]
Julio J. Copo Terrés
[email protected]
Basham, Ringe y Correa S.C.
Paseo de los Tamarindos no. 400-A, 9th floor
Col. Bosques de las Lomas, Del. Cuajimalpa
México, Distrito Federal, 05120
Tel +52 55 5261 0400
Fax + 52 55 5261 0496
Firm Website www.basham.com.mx
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Philippines
Prepared by Lex Mundi member firm Romulo Mabanta Buenaventura Sayoc & de los
Angeles
1. Provide an introduction on health law in your jurisdiction.
The Philippine Health Law is composed of all laws, rules and regulations relating to the health of
the Filipinos. Reigning supreme over this mass of laws, rules and regulations is the 1987 Philippine
Constitution, which dictates the State’s policies concerning health.
Article II, Section 15 of the 1987 Philippine Constitution declares that it is the State’s policy to
protect and promote the Filipinos’ right to health and to instill health consciousness among them.
Section 16 of the same article provides that the State shall protect and advance the right of the
people to a balanced and healthful ecology. Under Article XIII of the Philippine Constitution, there
are three sections on Health that provide for, among others, the adoption of an integrated and
comprehensive approach to health development which shall endeavor to make essential goods,
health and other social services available to all the people at affordable cost; the establishment and
maintenance of an effective food and drug regulatory system; and, the establishment of a special
agency for the disabled.
Laws, rules, and regulations seek to carry out the above policies enshrined in the Constitution.
Philippine Health Law can be divided into several broad categories: (1) Those that directly provide
for the health care of the citizens; (2) Those that regulate the personnel, facilities, equipment, drugs
and other products used for health care; (3) Those that safeguard the health of the citizens; and
(4) Those that concern the business of health care.
The Philippine Congress is the principal source of laws that promote and protect the right to health
of the citizens. The Executive Department, through is various departments, bureaus and attached
agencies, carry out the laws enacted by Congress. These departments, bureaus and attached
agencies issue rules and regulations that form part of the Philippine Health Law. The Local
Government Units (barangays, municipalities, cities, provinces) also enact and enforce ordinances
that promote and protect the right to health of the inhabitants in their respective spheres.
The Department of Health (DOH) is the main provider of government health care. The DOH and its
different bureaus and attached agencies, such as the Bureau of Health Facilities and Services, and
the Food and Drug Administration, issue majority of the rules that regulate the facilities, medical
equipment, devices, drugs and other medical products used for healthcare.
The Professional Regulations Commission (PRC) primarily governs the licensing and regulation of
professionals who provide health care. The various professional groups, such as the Philippine
Medical Association, the Philippine Nursing Association, etc., also issue rules and regulations that
that set the professional and ethical standards with which their members must comply.
The Securities and Exchange Commission (SEC) is responsible for the registration of corporate
entities, including those that provide health care, while other government agencies, such as the
Philippine Economic Zone Authority (PEZA), Tourism Infrastructure and Enterprise Zone Authority
(TIEZA) and the Board of Investments (BOI), approve fiscal incentives for qualified health care
business entities.
2. Provide a checklist of laws with a short summary of the general requirements of each.
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The following is a sampling of Philippine Health Laws from the different categories:
Directly Promoting Health Care
Republic Act No. 10606, amending Republic Act No. 7875 (The National Health Insurance Act of
2013)
The law declared it a policy of the State to adopt an integrated and comprehensive approach to
health development, which shall endeavor to make essential goods, health and other social
services available to all the people at affordable cost and to provide free medical care to paupers.
Towards this end, the State shall provide comprehensive health care services to all Filipinos
through a socialized health insurance program that will prioritize the health care needs of the
underprivileged, sick, elderly, persons with disabilities (PWDs), women and children and provide
free health care services to indigents.
Republic Act No. 10354 (The Responsible Parenthood and Reproductive Health Act of 2012)
This law guarantees universal access to methods of contraception, fertility control, sex education
and maternal care. The passage of this law was controversial, especially the provisions on birth
control. The Supreme Court upheld its validity except for eight provisions.
Republic Act No. 9502 (Universally Accessible Cheaper and Quality Medicines Act of 2008)
This law amended three laws, the Intellectual Property Code of the Philippines, the Generics Act
of 1988 and the Pharmacy Law, with the aim of adopting appropriate measures to promote and
ensure access to affordable quality drugs and medicines for all.
Republic Act No. 9442 (An Act Amending Republic Act No. 7277, Otherwise Known as the Magna
Carta for Disabled Persons and for Other Purposes)
Granted persons with disabilities a discount of at least 20% for the purchase of medicines in all
drugstores.
Republic Act No. 9288 (New Born Screening Act of 2004)
The law provides for a comprehensive policy and national screening system for ensuring newborn
screening for the early detection and treatment of congenital disorders. The DOH issued
Department Circular No. 333, series of 2004, which contained the rules and regulations
implementing the New Born Screening Act of 2004.
Republic Act No. 8423 (Traditional and Alternative Medicine Act of 1997)
This law seeks to improve the quality and delivery of health care services to the Filipino people
through the development of traditional and alternative health care and its integration into the
national health care delivery system.
Republic Act No. 8344 (An Act Prohibiting the Demand of Deposits or Advance Payments for
Confinement or Treatment in Hospitals and Medical Clinics in Certain Cases)
The law ensures that for emergency cases, patients who cannot afford to pay the deposits or
advance payments required by hospitals will still get the necessary treatment.
Republic Act No. 8291 (Revised Government Service Insurance Act of 1997)
Strengthened the Government Service Insurance System (GSIS), the pension fund that secures
the future of all employees of the Philippine government. The GSIS provides and administers a
pension fund that has the following social security benefits: compulsory life insurance, optional life
insurance, retirement benefits, and disability benefits for work-related accidents and death benefits.
Republic Act No. 8282 (Social Security Act of 1997)
Strengthened the Social Security System (SSS), which was established to promote social justice
and provide meaningful protection to members and their beneficiaries against the hazards of
disability, sickness, maternity, old age, death, among others. It is the counterpart of the GSIS fund
for private employees and those who are self-employed. Private employers can provide additional
health insurance for their employees, on top of the benefits provided by the SSS.
Republic Act No. 7883 (Barangay Health Workers’ Benefits and Incentives Act of 1995)
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The law seeks to provide incentives to the barangay health workers who act as frontliners in the
Primary Health Care Approach, the major strategy adopted by the government towards health
empowerment, which emphasize the need to provide accessible and acceptable health services
through participatory strategies.
Republic Act No. 7305 (Magna Carta of Public Health Workers)
The law aims: (a) to promote and improve the social and economic well-being of the health workers,
their living and working conditions and terms of employment; (b) to develop their skills and
capabilities in order that they will be more responsive and better equipped to deliver health projects
and programs; and (c) to encourage those with proper qualifications and excellent abilities to join
and remain in government service.
Republic Act No. 7160 (Local Government Code of 1991)
Under this law, the local government units shall ensure and support, among other things, the
promotion of health and safety of their inhabitants, and shall enhance the right of the people to a
balanced ecology.
Republic Act No. 6675 (Generics Act of 1988)
The law seeks to ensure the adequate supply of drugs with generic names at the lowest possible
cost, and endeavors to make them available for free to indigent patients.
Presidential Decree No. 442 (Labor Code of the Philippines)
Some provisions of the law and its implementing rules and regulations provide for maternity leave
benefits, family planning services for employees, health benefits (medical and dental), and
occupational health and safety at the workplace.
Regulating the Personnel Who Provide Health Care
Article XII, Section 14 of the 1987 Philippine Constitution
This provides the rule that the practice of all professions in the Philippines is limited to Filipino
citizens, save in cases prescribed by law.
Republic Act NO. 8981 (PRC Modernization Act of 2000)
Modernized the Professional Regulation Commission (PRC) with the power to administer,
implement and enforce the regulatory policies of the national government with respect to the
regulation and licensing of the various professions and occupations under its jurisdiction, including
the enhancement and maintenance of professional and occupational standards and ethics. Section
7, paragraph (j) of the law allows the PRC, upon recommendation of the Professional Regulatory
Board concerned, and subject to certain conditions, which include reciprocity with the country of a
foreigner, to approve the registration of and authorize the issuance of a certificate of
registration/license and professional identification card to such foreigner.
The Laws Governing Specific Professions:
• Medicine – Republic Act No. 2382 (The Medical Act), as amended by Republic Act No.
4224 and Republic Act No. 5946.
• Medical Technology – Republic Act No. 5527, as amended. (Philippine Medical
Technology Act of 1969)
• Dentistry – Republic Act No. 9484 (Philippine Dental Act of 2007)
• Midwifery – Republic Act No. 7392 (Philippine Midwifery Act of 1992)
• Nursing – Republic Act No. 9173 (Philippine Nursing Act of 2002)
• Nutrition and Dietetics – Presidential Decree No. 1286 (Nutrition and Dietetics Decree of
1977)
• Optometry – Republic Act No. 8050 (Revised Optometry Law of 1995)
• Pharmacy – Republic Act No. 5921 (An Act Regulating the Practice of Pharmacy and
Setting Standards of Pharmaceutical Education in the Philippines and for Other Purposes)
• Physical and Occupational Therapy – Republic Act No. 5680 (Philippine Physical and
Occupational Therapy Law)
• Radiologic and X-Ray Technology – Republic Act No. 7431 (Radiologic Technology Act of
1992)
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The different societies and organizations for health professionals also prescribe professional and
ethical standards for their respective members.
Regulating Facilities, Equipment, Drugs and Other Products Used for Health Care
Republic Act No. 4688 (An Act Regulating the Operation and Maintenance of Clinical Laboratories
and Requiring the Registration of the Same with the Department of Health, Providing Penalty for
the Violation Thereof, and for Other Purposes)
The law regulates the operation and maintenance of clinics and laboratories. To implement this
law, the DOH issued Administrative Order No. 0027-07 (Revised Rules And Regulations Governing
The Licensure And Regulation Of Clinical Laboratories In The Philippines) and its amendment,
Administrative Order No. 2007-0027-A.
Republic Act No. 4226 (Hospital Licensure Act)
This law deals with the regulation of the construction and operation of hospitals.
The DOH, through its Bureau of Health Facilities and Services (BHFS), issues administrative orders
that implement the Hospital Licensure Act. In relation thereto, the BHFS issued the following:
•
•
•
•
•
•
Administrative Order No 70-A, s. 2002 (Revised Rules And Regulations Governing The
Registration, Licensure And Operation Of Hospitals And Other Health Facilities In The
Philippines).
Administrative Order No. 147, s. 2004 – Introduced amendments to Administrative Order
No 70-A, s. 2002.
Administrative Order No. 2005-0029 – Introduced amendments to Administrative Order No.
147, s. 2004.
Administrative Order No. 2006-0004 or the “Guidelines for the Issuance of Certificate of
Need to Establish New Hospital”, as amended by Administrative Order No. 2006-0004-A.
– The objective of this issuance is to ensure access to and availability of hospital services
to the Filipinos by regulating the establishment of new hospitals based on a set criteria.
Administrative Order No. 2007-0021 (Harmonizing and Streamlining of the Licensure
System for Hospitals).
Administrative Order No. 2012-0012 (Rules and Regulations Governing the New
Classification of Hospitals and Other Health Facilities in the Philippines).
The BHFS also issued administrative orders for the following health facilities and services:
• Ambulatory Surgical Clinics (Administrative Order No. 183, s. 2004)
• Blood Service Facilities (Administrative Order No. 2008-0008)
• Clinical Laboratory (Administrative Order No. 2007-0027, as amended by Administrative
Order No. 2007-0027-A)
• Dental Laboratory (Administrative Order No. 2008-0010)
• Dialysis Clinic (Administrative Order No. 2012-0001)
• Drug Testing Laboratory (Administrative Order No. 2010-0024)
• HIV Testing Laboratory (Administrative Order No. 2005-0027, as amended by
Administrative Order No. 2005-0027-A)
• Health Maintenance Organizations (Administrative Order No. 34, s. 1994, and its
amendment, Administrative Order No. 36, s. 1996).
• Human Stem Cell and Cell-Based or Cellular Therapy Facility (Administrative Order No.
2013-0012)
• Kidney Transplant Unit (Administrative Order No. 2008-0034)
• Laboratory for Drinking Water Analysis (Administrative Order No. 2006-0024)
• Medical Facility for Overseas Workers and Seafarers (Administrative Order No. 181, s.
2004, as amended by Administrative Order No. 2005-0024)
Republic Act No. 7719 (National Blood Services Act of 1994)
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The law seeks to: (1) promote voluntary blood donation; (2) provide for an adequate supply of safe
blood; and (3) regulate blood banks. Pursuant to the law, the BHFS issued Administrative Order
No. 2008-0008 or the Rules and Regulations Governing the Regulation of Blood Service Facilities.
Presidential Decree No. 1542 (Providing for the Regulation and Licensing of Dental Prosthetic
Laboratories)
The law endeavors to protect the health of the public, specifically, oral health, by: (1) mandating
the formulation of rules and regulations, and the standards for the establishment and operations of
dental prosthetic laboratories; (2) requiring the registration and licensure of the existing dental
prosthetic laboratories; and (3) providing for the supervision and inspection of the dental prosthetic
laboratories. Administrative Order No. 2008-0010 is the latest issuance that contains the Revised
Rules and Regulations Governing the Registration and Licensure of Dental Laboratories in the
Philippines.
Presidential Decree No. 480 (Creating a Radiation Health Office in the Department of Health), as
amended by Presidential Decree No. 1372.
The law created a Radiation Health Office that has the following functions, among others: (1)
prescribe measures to regulate production, importation and exportation of radiation-emitting
apparatus, as well as non-ionizing radiation devices; (2) register and inspect the above apparatus;
(3) issue rules and regulations with the aim of protecting radiation workers; (4) establish and
maintain a National Radiation Standard; and (5) formulate policies which are necessary to
effectively upgrade the quality of the practice of radiology in the Philippines which is essential in
the primary health care of the Filipinos.
Republic Act No. 3720 (Food, Drugs and Devices, and Cosmetics Act), as amended by, among
others, Executive Order No. 175, s. 1987 and Republic Act No. 9711 (Food and Drug Administration
(FDA) Act of 2009)
This is the main law that provides for the regulation of medical devices and health products.
With the restructuring of the DOH via, the Bureau of Health Devices and Technology (BHDT) was
created. The BHDT issued Administrative Order No. 2007-0003 (Policies and Guidelines
Governing the Registration and Licensing of Establishments Dealing with Medical Devices). The
BHDT requires the registration of medical devices, and issues the license to operate to medical
device establishments (importers, exporters, wholesalers, manufacturers, traders, and re-packers).
The Food and Drug Administration (FDA) became the main agency for the regulation of
pharmaceutical drugs in the Philippines and has issued numerous administrative orders therefor.
DOH Administrative Order No. 56-89 (Revised Guidelines for the Licensing of Drug Establishments
and Outlets.
This administrative order provides the standards and the requirements in securing a license to
operate for drug establishments (manufacturers, wholesalers, traders, importers, exporters).
Safeguard the Health of the Citizens
Republic Act No. 10152 (Mandatory Infants and Children Health Immunization Act of 2011)
The policy of the law is to adopt a comprehensive, mandatory and sustainable immunization
program for all infants and children for vaccine-preventable diseases, which include tuberculosis,
diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, hepatitis-B, and H. influenza type B.
Republic Act No. 9482 (Anti-Rabies Act of 2007)
The law implements the National Rabies Prevention and Control Program, a multi-agency effort in
controlling and eliminating rabies that includes the following activities: (1) mass vaccination of dogs;
(2) establishment of a central database system for registered and vaccinated dogs; (3) impounding,
field control and disposition of unregistered, stray and unvaccinated dogs; (4) conduct of
information and education campaign on the prevention and control of rabies; (5) provision on preexposure treatment to high risk personnel and Post Exposure Treatment to animal bite victims; (6)
provision of free routine immunization or Pre-Exposure Prophylaxis (P.E.P.) of schoolchildren aged
five to fourteen in areas where there is high incidence of rabies as well as the (7) encouragement
of the practice of responsible pet ownership.
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Republic Act No. 9211 (Tobacco Regulation Act of 2003)
The objectives of the law include the following:
• Promote a healthful environment;
• Inform the public of the health risks associated with cigarette smoking and tobacco use;
• Regulate and subsequently ban all tobacco advertisements and sponsorships;
• Regulate the labeling of tobacco products;
• Protect the youth from being initiated to cigarette smoking and tobacco use by prohibiting
the sale of tobacco products to minors;
Republic Act No. 9165 (Comprehensive Dangerous Drugs Act of 2002)
The law aims to safeguard the well-being of the Filipinos, particularly the youth, from the harmful
effects of dangerous drugs; to enhance further the efficacy of the law against dangerous drugs; to
pursue an intensive and unrelenting campaign against the trafficking and use of dangerous drugs
and other similar substances through an integrated system of planning, implementation and
enforcement of anti-drug abuse policies, programs, and projects; and, to achieve a balance in the
national drug control program so that people with legitimate medical needs are not prevented from
being treated with adequate amounts of appropriate medications, which include the use of
dangerous drugs.
Republic Act No. 8203 (Special Law on Counterfeit Drugs)
The law seeks to safeguard the health of the Filipinos by strengthening the protection against
counterfeit drugs. It provides for both administrative and penal sanctions against those who violate
the act.
Regulating the Business of Health Care
Republic Act No. 8799 (The Securities Regulation Code)
The law endowed the Securities Exchange Commission with jurisdiction and supervision over all
corporations, partnerships or associations that are the grantees of primary franchises and/or a
license or permit issued by the government. The SEC has the power to approve, reject, suspend,
revoke or require amendments to registration statements, and registration and licensing
applications.
Republic Act No. 9593 (The Tourism Act of 2009)
The law recognizes tourism as an indispensible element of the national economy and seeks to
harness it as an engine for socioeconomic growth by generating investment, foreign exchange and
employment. It allows for certain areas to be designated as Tourism Enterprise Zones (TEZ). Under
the 2011 Guidelines for the Designation and Supervision of Tourism Enterprise Zones and the
Administration of Incentives Under R.A. 9593, a TEZ may be a Health and Wellness Tourism Zone
that will allow visitors to avail of quality but affordable mainstream, traditional, or alternative
healthcare services for treatment of illnesses and health problems. Hospitals and clinics inside such
zones may be granted various incentives.
Republic Act No. 7916 (Special Economic Zone Act of 1995), as amended by Republic Act No.
8748.
The law created special economic zones within the Philippines wherein locators enjoy special
incentives. The law established the Philippine Economic Zone Authority (PEZA), a body attached
to the Department of Trade and Industry, which was to set the policies on the establishment and
operation of the economic zones, and to issue the rules and regulations to implement the law. The
PEZA has designated medical tourism economic zones wherein qualified locators may be given
incentives.
Executive Order No. 226 (The Omnibus Investments Code of 1987)
The law seeks to promote investments in the Philippines, particularly in certain preferred activities
that are identified in the Investments Priorities Plan (IPP). Those who invest in the preferred areas
of investments or the mandatory list are given incentives, subject to certain conditions. The Board
of Investments (BOI) prepares the IPP and its guidelines. Under the 2013 IPP, Hospitals and
Medical Services to be established outside of Metro Manila belong to the preferred activities.
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Included in the mandatory list is the establishment and operation of health and wellness
enterprises, such as destination spas, hotel spas, therapeutic centers, traditional healing centers,
and other healing and medical care service.
3. Provide any special issues which arise in your jurisdiction.
Medical Tourism and Telemedicine are relatively new areas of development, which some
companies have begun to explore. As yet, the DOH has not issued any definite rules or guidelines
specific for their regulation.
Contact Information
RICARDO J. ROMULO, Senior Partner
[email protected]
BETRAND HANS B. CAGAYAN, Associate
[email protected]
ROMULO MABANTA BUENAVENTURA
SAYOC & DE LOS ANGELES LAW OFFICES
21/F Philam Life Tower, 8767 Paseo de Roxas
Makati City, Philippines 1226
Tel: +63 2 555-9555 Fax: +63 2 815-3172
Firm Website: www.romulo.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Poland
Prepared by Lex Mundi member firm Wardyński & Partners
1.
Provide an introduction on health law in your jurisdiction
1.1.
Introduction
The health sector in Poland is extensively regulated. Regulations regarding standard setting and
implementation mainly concern health professions, the training of medical personnel, the conditions in
which health services are delivered to patients, the operation of service providers, health care financing,
assuring availability of health care services and medicines; and assuring observance of patient rights.
The right to health is stipulated in Article 68 of the Constitution, which states that everyone has right to
health protection. Equal access to health care financed from public funds shall be ensured by public
authorities to citizens, irrespective of their material situation. Special health care shall be provided to
children, pregnant women, handicapped persons and the aged. Children under 18 and pregnant women
(Polish citizens) are entitled to free treatment, regardless of whether they are insured or not. Likewise, prehospital emergency services are covered by the state and free access is also available to everyone
(regardless of citizenship) in the case of alcohol or drug addiction, selected psychiatric treatment, certain
infectious diseases (such as tuberculosis), as well as to prison inmates and refugees.
Poland has a mandatory social and health insurance system financed by income-related contributions that
covers almost the entire population. Polish individuals contribute 9% of their personal income to the Social
Security Authority (Zakład Ubezpieczeń Społecznych). The Social Security Authority then transfers money
to the payment institution – the National Health Fund (Narodowy Fundusz Zdrowia). The National Health
Fund then transfers these funds to voivodship branches (Polish territorial branches). Private health
insurance companies also operate on the market, however, the market share is below 1%.
The National Health Fund covers the cost of the health services required by a person in case of illness
regardless of the amount of social security paid by that person. The purpose of health insurance in Poland
is to cover the costs of health services provided to insured persons, prevent and cure diseases, finance the
purchase of medicinal products and medical technical aids, and provide benefits to those temporarily
incapacitated and unable to work.
Health and medical care costs account for about 7% of Poland’s gross domestic product (GDP). Public
expenditure on health accounts for about 71% of total expenditure. The rest is covered by households
(24%), private health insurance (0.7%), and companies other than those engaged in health insurance (3%).
The Pharmaceutical Law Act of 6 September 2001 is the main law regulating the medicinal products market
in Poland. It is adjusted to EU Regulations. There are numerous implementing provisions to the
Pharmaceutical Law, which provide more detailed regulations.
1.2.
Relevant authorities, institutions and agencies
•
Minister of Health (Minister Zdrowia) formulates and evaluates policies for health and the strategic
planning of health services, issues licences for clinical trials, issues marketing authorisations,
issues import licences.
•
National Health Fund (Narodowy Fundusz Zdrowia) transfers money for medical treatment given
to patients by healthcare institutions, medicine reimbursement.
o
Relevant regional branch offices of the National Health Fund guarantee health services to
insured persons and members of their families in particular regions of the country.
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•
Social Security Authority (Zakład Ubezpieczeń Społecznych) collects social insurance and health
contributions and allocates benefits (e.g. old-age pension, disability pension, sickness benefits or
maternity benefits) in the amounts and in compliance with generally applicable provisions of law.
•
The Agricultural Social Insurance Fund (Kasa Rolniczego Ubezpieczenia Społecznego) was
established to insure farmers.
•
Chief Pharmaceutical Inspector (Główny Inspektor Farmaceutyczny) supervises the manufacture
of medicinal products, compliance with Pharmaceutical Law, issues decisions to withdraw and
terminate marketing of medicinal products. It is supported by the Chief Pharmaceutical Inspectorate
(Główny Inspektorat Farmaceutyczny)
•
The Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products
(Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych) deals
with the registration process of decisions adopted by the Minister of Health on the marketing
authorisation of medicinal products, medical devices and biocidal products; provides information
about the documents and steps required to market medicinal products, medical devices and
biocidal products. The Office reports directly to the Minister of Health.
•
State Sanitary Inspection (Państwowa Inspekcja Sanitarna) is an inspecting authority accountable
to the Minister of Health, mainly tasked with protecting public health, in particular by supervising
the health quality of food and nutrition. It is headed by the Chief Sanitary Inspector (Główny
Inspektor Sanitarny), who is assisted by the Chief Sanitary Inspectorate (Główny Inspektorat
Sanitarny).
•
Agency for Health Technology Assessment in Poland (Agencja Oceny Technologii Medycznych) is
a state-financed agency tasked mainly with preparing recommendations on financing all health care
services from public funds for the Minister of Health, particularly those that apply for entry onto the
reimbursement list.
•
Patent Office (Urząd Patentowy) issues decisions on awarding patents and trade mark protection,
e.g. for new medicinal products.
•
The Public Procurement Office (Urząd Zamówień Publicznych) is a government body dealing with
public contracts.
•
The National Centre for Quality Monitoring in Health Care (Centrum Monitorowania Jakości w
Ochronie Zdrowia) is a central unit of the Ministry of Health established to inspire and support
actions aimed at improving the quality of health services of the Polish health care system.
•
The National Institute of Public Health – National Institute of Hygiene (Narodowy Instytut Zdrowia
Publicznego – Państwowy Zakład Higieny) plays a fundamental role as the central government’s
expert and supervisory institution.
•
The Polish Chamber of Physicians (Naczelna Izba Lekarska) is a professional, self-governing
organisation of physicians and dental practitioners.
2.
Provide a check list of laws with a short summary of the general requirements of
each
2.1.
Social Security Law
The detailed regulations governing individual areas of social security are contained in separate laws. The
most important include:
The Social Insurance System Act of 13 October 1998 (J. of Laws 1988 no 137, item 887, as amended)
• specifies the social insurance principles as well as the rules for setting contributions and benefits
and entitlement to social insurance;
• employees are subject to mandatory pension, disability, health and accident insurance.
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The Pensions from the Social Security Fund Act of 17 December 1998 (J. of Laws 1998 no. 162, item
1118, as amended)
• specifies rules for determining conditions required for granting the right to a pension.
The Social Insurance of Farmers Act of 20 December 1990 (J. of Law 1991 no 7, item 24, as amended)
• social insurance of farmers and members of their household who work with them.
The Health Care Benefits Financed from Public Funds Act of 27 August 2004 (J. of Laws 2004 no 210,
item 2135, as amended)
• regulates the conditions and scope of provisions of health care benefits financed from public funds,
as well as the rules and methods of financing those benefits;
• services are fully covered except for specific medicinal products and auxiliary medicinal devices,
as well as sanatorium treatments and certain dental procedures and materials;
• medical services financed from public funds are provided only at healthcare facilities that have
signed a contract with the National Health Fund, which finances them from public funds.
2.2.
Health care providers regulation
The Medical Activity Act of 15 April 2011 (J. of Laws 2011 no 112, item. 654, as amended)
•
health care services are provided by public and non-public health care units as well as by individual
and group medical practices;
•
public medical entities can be established by authorities at regional and central level, by a state
university active in the field of medicine or by the Medical Centre of Postgraduate Education.
The Patient’s Rights and the Patient’s Rights Ombudsman Act of 6 November 2008 on (J. of Laws
2009, no 52, item 417, as amended)
• provides that patients have the right to obtain information on their health status, diagnosis, available
diagnostic and treatment methods, and the potential consequences of their application or nonapplication; likely results of treatment, and prognosis;
• such information must be conveyed in a clear and straightforward manner;
• patients may also decide who else may receive such information.
2.3.
Laws regulating the medical profession
The Medical and Dental Professions Act of 5 December 1996 (J. of Laws 1997, no 28, item 152, as
amended)
•
defines the forms of private medical practice and health service delivery other than those based on
salaried employment in health care institutions;
•
only persons who have a licence to practice a medical profession and permission to run a medical
practice may establish such practices and they must be registered with a regional chamber of
physicians and dentists;
•
sets requirements and conditions for practising physicians and dentists.
The Medical Code of Ethics
• physicians and dentists are associated in professional bodies which represent their interests. These
chambers establish educational standards, maintain registers of licensed and active physicians
and dentists, and monitor their participation in continuous education. Chambers develop ethical
codes of practice and may impose disciplinary measures on their members. Membership in the
chambers is compulsory for all practising physicians and dentists.
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2.4.
Pharmaceutical and medical devices regulations
The Pharmaceutical Law Act of 6 September 2001 (J. of Laws 2001, no 126 item 1381, as amended)
• regulates the pharmaceutical sector in compliance with relevant EU regulations;
• defines good practices that ensure appropriate quality of products authorized for sale in Poland
(Good Distribution Practice, Good Laboratory Practice, Good Clinical Practice-;
• medicinal products are classified into 5 categories:
o Rp: prescription drugs;
o Rpz: prescription drugs for restricted use;
o Rpw: prescription drugs containing narcotic or psychotropic substances;
o Lz: used exclusively in hospital treatment under direct medical supervision;
o OTC non-prescription drugs (i.e. sold to patients without prescription);
• provides three procedures for registering medicinal products in Poland: via centralized,
decentralized and mutual recognition, all three complaint with EU standards;
• regulates advertising of medicinal products;
• retail trade of medicinal products is generally accessible in pharmacies and pharmacy outlets.
The Reimbursement of Medicines, Foodstuffs intended for Particular Nutritional Uses and Medical
Devices Act of 12 May 2011 (J. of Laws 2011, no 122, item 696, as amended)
• the reimbursement system covers all medicinal products on the list of reimbursable medicines set
out in the Minister of Health regulation;
• the Minister of Health decides whether to enter a medicine on a list;
• a product can be reimbursed if:
o it is authorized for marketing or remains on the market;
o it is available on the market;
o has the EAN identification code (European Article Number) or other unique code (an
equivalent of the EAN code) which allows a reimbursed product to be distinguished from
different products;
• applications to place medicines on the reimbursable medicines list can be submitted to the Minister
of Health by:
o Marketing Authorisation Holders (MAHs);
o MAHs representatives;
o importers
• official prices are set for medicines reimbursed from public funds at both wholesale and retail level;
the prices set are maximum prices.
The Medical Devices Act of 20 May 2010 (J. of Laws 2010, no 107, item 679, as amended)
•
•
•
describes two different ways of market entry for a medical device:
o
making a medical device available for use or distribution for the first time;
o
putting into service – means the stage at which a medical device is available to the final
user as being ready to use;
only those medical devices that are compliant with Polish law i.e. both the Medical Devices Act and
any other regulations in force that are relevant to a specific device may be sold. The three major
requirements of medical devices are:
o
Compliance with the so-called “basic requirements” mentioned in the Minister of Health
regulation, especially regarding designing, manufacturing, packaging and labelling of such
product;
o
a declaration of conformity;
o
a “CE” label;
relevant provisions of the Pharmaceutical law apply to medical devices.
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The Industrial Property Law Act of 30 June 2000 (J. of Laws 2001, no 49, item 508, as amended)
• Poland agreed to introduce supplementary patent protection (Supplementary Protection
Certificate), which grants up to five years additional patent protection over the normal 20 year
protection period.
2.5.
Public Procurement Law
The Public Procurement Law Act of 29 January 2004 (J. of Laws. 200, no 19, item 177, as amended)
•
applies when health care providers and health insurance institutions or agencies organise tenders
for contracts financed from public funds which exceed EUR 14,000.
•
there are two basic procedures - open tendering and restricted tendering, for awarding public
contracts;
•
the procurement procedures are transparent, information is published on the Public Procurement
Office portal.
3.
Provide any special issues/recent developments which arise in your jurisdiction
3.1.
Computerisation in healthcare
3.1.1.
The main goals of ongoing reforms are:
•
•
•
•
3.1.2.
to arrange the existing system of collection, processing and use of information in healthcare;
to optimise expenditures on computerisation of the healthcare sector and development of an
information society in the area of healthcare with emphasis on ensuring cost efficiency;
to develop a stable information healthcare system characterised by a flexible approach to
organisation of the healthcare resources protection system, including the mode of financing
services from public funds, while withstanding disorders arising in the course of data collection and
filing caused by healthcare system changes;
to establish clear and transparent legal grounds for current and future medical registers.
Act on the health care information system of 28 April 2011 (J. of Laws 2011, no 113, item
657, as amended)
The primary objectives of the Act are as follows:
•
to establish an "Electronic Platform for Collection, Analysis and Sharing of Digital Medical Record"
(P1), together with a number of IT systems and registers operating within the scope of health
information systems;
•
Digital Medical Records should consist of e-prescriptions, e-referral for examinations, e-orders; it
was to be introduced on 1 August 2014, however, the government decided to postpone this date
due to the scale of changes (dates are specified below).
3.1.3.
Amendment and further draft amendments to the Act on health care information
•
the next step toward developing e-Health in Poland is a draft amendment to the act on the health
care information system adopted by the Council of Ministers (Rada Ministrów) on 24 June 2014; it
establishes principles for a Health Insurance Card, Medical Specialist Card, electronic
prescriptions, and electronic referral for examinations, electronic orders and telemedicine;
•
an Electronic Health Insurance Card (KUZ) will be a single document for all patients confirming the
right to medical treatment;
•
a Medical Specialist Card (MSP) will ensure provision of a given medical service by confirming
participation of a medical specialist in treatment – electronic signature confirmed by a certificate
issued by an authorised entity;
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•
the draft assumes introduction of medical services by telemedicine;
•
from 1 August 2016 prescriptions will only be issued in electronic form (in certain pre-defined
situations paper prescriptions will be allowed until 1 January 2020);
•
from 1 March 2017 referral for an examination and orders will be issued electronically;
•
from 31 July 2017 medical records will be only held electronically.
3.1.4.
Main concerns of the Act on health care information
There is a pending case at the Constitutional Tribunal regarding the protection of patient personal data by
the above Act. The Constitutional Tribunal shall decide whether current regulations authorising the Minister
of Health to issue, create and maintain medical records by ordinances complies with the Constitution, or
whether such action (including Digital Medical Records) should be regulated by an act adopted by
Parliament (Sejm).
3.2.
Pharmaceutical market after implementation in the Reimbursement of Medicines Act
Implementation in 2012 of the Reimbursement of Medicines Act has reduced the National Health Fund
expenditure on reimbursed medicines. As a result of the growth in sales of non-reimbursed prescription
drugs and over-the-counter medicines, many companies have turned to these areas in search of better
growth prospects. Nevertheless, with 98% health insurance coverage, the reimbursed market segment will
continue to play a major role on the pharmaceutical market.
3.3.
Impact of the parallel trade pharmaceutical market in Poland
The Reimbursement Act resulted in an initial 8% cut in average prices of reimbursed drugs following initial
price negotiations and considerably more reductions with each bi-monthly update to the reimbursement list
following its implementation. These factors have resulted in a huge surge in parallel exports of medicines
with their value in 2012 estimated by IMS Health to have reached PLN 2 billion (USD 645.9 million).
Medicines such as insulin, anti-epileptics, drugs to treat high cholesterol, and asthma treatments are all
among those reportedly affected by shortages due parallel exports from Poland. Legislation to prevent
medicines in short supply in Poland– resulting from increased parallel exports – is subject to ongoing work,
although the implementation date is not yet known.
4.
Are mobile health applications regulated under the law of your jurisdiction? If so,
provide a brief summary as to how they are regulated
Telemedicine in Poland remains at an early stage of development. Presently, telemedicine is not explicitly
regulated in Polish law. However, one can find regulations which may apply to telemedicine in various
regulations. According to Article 42 of the Act on the professions of physicians and dentists, doctors issue
a statement on a patient’s state of health upon personal examination of patients, except as provided in
other regulations. Thus, one may interpret that unless a final statement on a patient’s state of health is not
made, medical consultancies via mobile devices are not forbidden. One should however keep in mind that
present legal status of telemedicine is not clear and may be subject to uncertainties and controversies.
The legal status of telemedicine is subject of ongoing work on an amendment to the Act on health care
information. The draft amendment assumes the introduction of telemedicine allowing doctors to provide
medical services without personal examination of patients, e.g. to monitor blood pressure or blood sugar.
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Contact Information
Ewa Butkiewicz, Ph.D.
[email protected]
Wardyński & Partners
Aleje Ujazdowskie 10
00-478 Warsaw, Poland
Tel +48 22 437 82 00
Fax +48 22 437 82 01
Firm Website www.wardynski.com.pl
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Romania
Prepared by Lex Mundi member firm Nestor Nestor Diculescu Kingston Petersen
1. Provide an introduction on health law in your jurisdiction.
Health legislation in Romania is very broad and detailed and has been constantly amended in past
years. The general legal framework of health industry is regulated by Law No. 95/2006 on health
reform, as further amended and supplemented (“Law 95/2006”), as well as specific government
decisions enacted every two years that regulate the conditions for granting medical assistance
within the social health insurance system in Romania.
There is a variety of laws, government ordinances, government emergency ordinances,
government decisions, orders and decisions issued by the public authorities (such as Ministry of
Health, president of the Scientific Council of National Health Insurance House (“CNAS”) or National
Agency for Medicinal Products and Medical Devices (“ANMDM”)), European Regulations in diverse
fields such as health insurance system, hospitals, medicinal products, medical devices, laws
regulating medical professions (such as physicians, dentists, pharmacists, medical assistants), the
most relevant legislation being mentioned and detailed below.
Relevant authorities and associations:
•
•
•
•
•
•
•
•
The Romanian Parliament is the legislative body competent to enact laws in different fields of
activity, including health industry (e.g. Law 95/2006).
The Romanian Government is also competent to pass legislation with the same juridical force
as laws (government emergency ordinances in justified emergency cases when there is not
enough time for the procedure of enacting a law to be followed), as well as legislation with
inferior juridical force such as government ordinances or government decisions.
The Ministry of Health is responsible in general for the development of health care legislation
at national level (issues orders, drafts the proposals for new laws, government decisions or
ordinances or for amending the current ones), supervises the implementation of the legislation
by the health care agencies and institutes and issues different permits, approvals and
authorization in the health care field.
National Health Insurance House (“CNAS”) is responsible for managing the health insurance
system in Romania.
National Agency for Medicinal Products and Medical Devices (“ANMDM”) is the agency
competent in regulating the activities in the field of medicinal products and medical devices
(through the Ministry of Health who issues orders) and for supervising the implementation and
compliance with the legal provisions relating to medicinal products and medical devices.
ANMDM is also the authority responsible for health technology assessment and for issuance
of authorizations, approval and permits for activities related to medical products (e.g.
marketing, manufacturing/import, wholesale distribution authorizations for medicinal products,
approvals for advertising materials for medicinal products and educational materials etc).
County and Bucharest directorates of public heath - responsible for supervising the health
activity at local level and for the issuance of sanitary authorizations.
The National Public Health Institute is the institution responsible for prevention, supervision,
monitoring and control of the public health, including prevention and control of diseases.
Romanian Association of the International Manufacturers of Medicinal Products (“ARPIM”) is a
non-profit organization who is affiliate member of the European Federation of Pharmaceutical
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•
•
•
Industries and Associations (“EFPIA”). ARPIM issued a code of ethics regarding the relation
between their members (pharmaceutical companies) and the health care professionals, as well
as a code of ethics regarding the interaction of their members with the patient organizations.
Although these codes do not represent statutory regulations, such are usually observed by the
pharmaceuticals companies acting in Romania (even if they are not members of ARPIM), as
such are considered good practice codes.
Romanian Association of the Manufacturers of Generic Medicinal Products (“APMGR”) also a
non-profit organization, having as members generics manufacturers. APMGR issued a code of
ethics for regulating the relation of their members with the health care professionals.
Technical Office of Medical Devices Certification (“OTDM”) is responsible for conformity
assessment of medical devices, systems management and specific activities of the personnel.
There are also a series of institutions and agencies responsible for specific fields of activity
such as National Transplant Agency Bucharest, National Institute for Blood Transfusion,
National Institute for Sports Medicine etc.
2. Provide a check list of laws with a short summary of the general requirements of each.
Law No. 95/2006 on healthcare system reform, as further amended and supplemented (“Law
95/2006”) represents the legal framework for the Romanian national healthcare system,
establishing the general requirements on specific fields of activity. Please find herein below the
general requirements regulated under Law 95/2006, as well as the special legal acts detailing such
conditions:
A. PUBLIC HEALTH
In what concerns public health, Law 95/2006 regulates the following aspects: general aspects and
principles of the public health system, the control and monitoring of public health, medical care,
pharmaceutical care and specific legal and natural persons’ obligations in this area.
Public health assistance is coordinated by the Ministry of Health and is achieved through all types
of public or private health units.
The medical assistance is ensured through ambulatory medical cabinets for family physicians and
for other specializations, centers of diagnosis and treatment, medical centers, health centers,
laboratories, as well as other private or public health units, public or private health units with beds,
specialized units for recovery, emergency, blood transfusions, special cabinets organized in the
school and academic units. The public health assistance is guaranteed by the state and financed
by the state budget, local budgets, the sole national insurance fund, the own revenues,
reimbursable or non-reimbursable external funds, as well as by personal contributions and direct
payments according to the law.
The monitoring activity conducted by the specialist personnel empowered by the competent
institutions can result, if identifying a risk situation, in specific measures such as: the temporary or
definitive suspension of risky activity, the withdrawal of products which present a risk for the public
health.
Any employer, legal or natural person, has the obligation to ensure the funds and necessary
conditions for:
 conducting regular medical examination;
 applying measures of hygiene, disinfection and regular deratization control;
 vaccination and specific prevention risks imposed from work.
Using mass-media in public healthcare’s interest.
Campaigns of information, education and communication regarding the themes that concern public
health must be approved by the Ministry of Health. For promoting such campaigns the public radio
and television societies are compelled to reserve free broadcasting space within their program
B. SOCIAL HEALTH INSURANCE SYSTEM
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According to the Romania legislation, the social health insurances are the main public healthcare
financing system. Social health insurances are mandatory and are functioning as a unitary system.
•
Single National Health Insurance Fund
The Single National Health Insurance Fund is a special fund whose creation and use fall under the
provisions of the Law 95/2006. The Fund is constituted by contributions paid by the insured
persons, subsidies from the State budget and other sources. The management of the Fund is
ensured by CNAS.
•
The insured persons
Law 95/2006 establishes the categories of insured persons. In order to benefit from the advantage
of an insured person, such have to prove the payment of the contribution owed to the Single
National Health Insurance Fund.
There are certain categories of persons who benefit by health insurance without being obliged to
pay the contribution to the Fund. The Law provides, in detail, the necessary conditions a person
has to fulfill in order to be exempted from the payment of contributions.
∗ Special legal provisions
The rights of the insured persons are established based on multiannual framework agreements
approved by means of government decisions. For the years 2014 and 2015, the government issued
the Decision No. 400/2014 for the approval of the Service Packs and of the Framework Agreement
regulating the conditions for granting medical assistance within the social health insurance system
for 2014-2015.
•
The minimal and base service packs
Further to paying the contribution for social health insurances, the insured person receive access
to the base insurance pack consisting of medical services, healthcare services, medicinal products,
sanitary materials, medical devices and other services to which the insured persons are entitled.
For the persons that cannot prove the quality of insured patients it is established a minimal service
pack consisting of healthcare services, medicinal products and sanitary materials only in case of
medical and surgical emergencies and of potentially endemoepidemic diseases, monitoring of
pregnancy and of confinement (in Romanian “lauzie”), family planning services and prevention
services.
∗
Special legal provisions
Government Decision No. 400/2014 for the approval of the Services Packs and the Framework
Agreement regulating the conditions for granting medical assistance within the social health
insurance system for 2014-2015 and Order No. 619/360/2014 of the Minister of Health and the
President of CNAS for the approval of Methodological Rules for the implementation in 2014 of the
Government Decision No. 400/2014, provide specific details on the minimal and base service
packs.
Government Decision No. 720/2008 for the approval of the List comprising the international
nonproprietary names (INNs) corresponding to the medicinal products of which benefit the insured
persons, with or without personal contribution, based on medical prescription, in the social health
insurance system provides the list will all the INNs corresponding to medicinal products fully or
partially reimbursed in the health insurance system and the percentages of reimbursement
applicable to the reference price/compensation price, whereas the reference prince/compensation
price is the lowest price among the prices for the medicinal products corresponding to the same
INN.
Order No. 615/2010 for the approval of the calculation method of the reference price for medicines
with or without personal contribution prescribed in the outpatient treatment.
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Order No. 1275/2011 for the approval of the list and of the compensation prices of the medicines
granted to patients within the national health programs and the calculation methodology for such.
•
The evaluation of suppliers of medical services, medical devices, medicinal
products and sanitary materials within the Social Health Insurance System
The suppliers of medical services, medical devices, medicinal products and sanitary materials have
to fulfill certain conditions established by CNAS and Ministry of Health in order to enter into
contracts with the health insurance houses. The evaluation can be conducted only after the
suppliers pay an evaluation fee. The suppliers can be:
 public or private sanitary units;
 pharmacies and distributors and producers of medicinal products and sanitary
materials;
 other natural or legal persons which provide medical services, medicinal products or
medical devices.
Relationship between the suppliers and the health insurance houses is established and conducted
pursuant to the civil law based on a contract.
∗
Special legal provisions
Framework Agreement regulating the conditions for granting medical assistance within the social
health insurance system for 2014-2015 approved by Government Decision No. 400/2014, sets forth
specific rules in relation to the eligibility rules for the providers that wish to enter in agreements with
the health insurance houses, the necessary documents for concluding the agreement with the
national insurance houses, obligations and rights of the providers of medical assistance, medicinal
products and medical devices, obligations of the health insurance houses, the reimbursement of
the medical services, medicinal products and medical devices, the applicable sanctions regarding
the execution of the agreement and the conditions of termination and suspension of the
agreements.
Order No. 619/360/2014 of the Minister of Health and the President of CNAS for the approval of
Methodological Rules for the implementation in 2014 of the Government Decision No. 400/2014
establishes detailed rules and provides forms for the application of the Framework Agreement.
•
National public health programs
National health programs represent a set of multiannual actions oriented towards main areas of
intervention of public health care such as prevention, surveillance and control of communicable
and non-communicable diseases, monitoring the health of the population, providing specific
treatment for different diseases with major impact such as Tuberculosis and HIV / AIDS, multiple
sclerosis, cancer etc, promoting health and a healthy lifestyle; monitoring the determinant factors
for the life and work environment etc. The national programs are elaborated, coordinated and
evaluated by Ministry of Health through a specialized department.
The implementation of the national health programs is made by means of specialized units based
on the agreements concluded with health insurance houses. The public institutions that are
implementing the national health programs ensure all the necessary services for conducting the
activity, free of charge.
∗
Special legal provisions
Government Decision No. 124/2013 for the approval of the national health programs for the years 2013 and
2014.
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Order No. 422/2013 on Technical Norms for conducting national public health programs for the
years 2013 and 2014.
Order No. 190/2013 on Technical Norms for conducting national therapeutic health programs for
the years 2013 and 2014.
•
Financing of medical services, medicinal products and medical devices
Law 95/2006 establishes the sources of funding for medical services, medicinal products and
medical devices, as follows: contribution of natural and legal persons, subsidies from the State
budget, interests, donations, sponsorships, revenues obtained by exploiting the patrimony of
CNAS, amounts from the Ministry of Health.
Law 95/2006 regulates the obligation of every employer, natural or legal person, to calculate and
transfer to the National Health Insurance Fund the contribution established by the law considering
the employees hired. Failure to comply these legal provisions represents a contravention and may
be sanctioned with fine ranging between RON 30,000 to RON 50,0000 (approx. EUR 6,000 to EUR
11,000).
•
The European and the National Health Insurance Card
The European Health Insurance Card is individually issued by the health insurance houses in case
the insured travels for purposes of temporary stay in a Member State of European Union. The
European Health Insurance Card guarantees that the card holder receives in the Member State of
stay the same treatment as persons covered by the health insurance scheme of the respective
Member State.
Please note that the European Health Insurance Card is a paper, while the National Health
Insurance Card is an electronic card. The National Card constitutes a proof of the quality of insured
person and can be used only within the territory of Romania. Unfortunately, in practice the national
insurance cards are not yet being used.
C.
VOLUNTARY HEALTH INSURANCE
The system of voluntary health insurances represents an optional scheme through which an insurer
constitutes, based on mutualisation principle, an insurance fund following the contributions of a
certain number of contributors exposed to the risk of sickness and indemnifies those who suffer a
prejudice pursuant to the clauses stipulated within the insurance contract. The relationship between
the insurer and the insured within the voluntary insurance system is governed by the contractual
clauses.
According to the provisions of the Law 95/2006, any natural or legal person can have the quality of
an insurer within a voluntary insurance scheme as long as the person:
 is authorized to conduct insurance activities pursuant to the provisions of Law No.
32/2000 on the insurance activity, as further amended and assumes financial liability
to cover the costs of medical services stipulated within the voluntary health insurance
contract; or
 is a branch of an insurance company or of a mutual company headquartered within the
territory of a Member State of the European Union or of the European Economic Area
and received an authorization from the competent authority of that Member State.
All suppliers which enter into contractual relationships with the insurers within the voluntary health
insurance system have to be authorized by the Ministry of Health pursuant to the provisions of the
law currently in force. The entire responsibility related to the medical act belongs to the supplier of
medical and pharmaceutical services. In this respect, the insurer has the right to constantly verify
the quality of services provided by the suppliers to the insured persons.
∗
Special legal provisions
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Order No. 365/2007 approving the Methodological Norms on voluntary health insurances
D. SPECIALIZED OUTPATIENT CARE
The specialized outpatient care is ensured through clinical, dental and laboratory services which
can be provided within the medical structures established by the law by specialized doctors along
with other specialized and authorized personnel. A specialized doctor or a dental practitioner shall
carry out such activities as an independent/authorized natural person or as an organized
specialized cabinet.
∗
Special legal provisions
Government Ordinance No.124/1998 on the organizing and functioning of the medical cabinets.
Order No. 153/2003 on the approving of Methodological Instructions for the setting up, organizing and
functioning of the medical cabinets.
Order No. 544/2004 on the approving of the Methodological Instructions for evaluation the medical cabinets’
accreditation.
Order No. 1149/2007 on approving the Instructions concerning the setting up, authorization, organization
and functioning of the extern points of harvesting of the laboratories which conduct medical analysis in
outpatient care.
Order No. 2071/2008 on approving the Notification Procedure for the scheme testing the competence of the
medical laboratories.
Order No. 1301/2007 on approving the Instructions on functioning of the medical analysis laboratories.
E. PROCUREMENT AND TRANSPLANTATION OF HUMAN ORGANS, TISSUES AND CELLS
Law 95/2006 contains provisions on the procedure of donation and transplantation of human
organs, tissues and cells and also on the persons which can donate organs, tissues and cells.
There are also provided certain mandatory conditions which must be fulfilled in order to carry out a
transplantation process, namely a specific age of the donor or the written consent of the donor.
Breach of the condition related to the written consent of the donor constitutes a criminal offence.
The transplantation of human organs, tissues and cells can be conducted both in public and private
accredited transplantation units.
∗
Special legal provisions
Law No. 104/2003 on the manipulation of the human bodies and the procurement of the tissues from human
bodies for transplantation.
Government Decision No. 451/2004 on the approval of the Methodological Instructions for the implementation
of the Law No.104/2003 on the manipulation of the human bodies and the procurement of the tissues from
human bodies for transplantation.
Order No. 1763/2007 on the establishment of the technical conditions for the donation, procurement, testing,
processing, conservation, distribution, codification and traceability of the tissues and cells of human origin
used for the therapeutic purposes and on the notification of serious adverse incidents and reactions occurring
during their transplantation.
Law No. 282/2005 on the organization of activity of blood transfusions and donations of blood and blood
components of human origin and quality assurance and health security, to their therapeutic use, as
republiched.
Order No. 1226/2006 approving the Methodological Instructions on the procurement, biological monitoring,
preparation, conservation, distribution and transport of the blood and blood component of human origin.
Government Decision No. 1364/2006 on approving the rights and obligations of blood donors.
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Order No. 1132/2007 approving the Methodological Instructions on the standards and specifications in
respect of the quality system of the medical institutions which conduct activities within the area of blood
transfusion.
Order No. 441/2007 approving the Methodological Instructions in respect of the right of every blood donor to
receive a food receipt in the form of meal tickets.
F. HOSPITALS
According to the provisions of Law 95/2006, a hospital is a health unit with beds, having public
utility, which provides medical services.
Hospitals in Romania are organized on the basis of various criteria established by Law 95/2006.
Thus, hospitals can be public, public with private sections or compartments, or private. However,
emergency hospitals are established and operate only as public hospitals. Hospitals are organized
and are functioning, depending on the specific pathology, as general hospitals, emergency
hospitals, specialized hospitals and hospitals for patients with chronic conditions.
The Ministry of Health has competence both on public hospitals and private hospitals. The setting
up and dissolution of a public hospital shall be based on a Government Decision adopted following
the initiative or the authorization of Ministry of Health. A private hospital can be set up only after
obtaining an authorization from the Ministry of Health. The law provides the possibility of organizing
a private section/compartment within a public hospital.
The law contains general provisions regarding the accreditation procedure (a mandatory procedure
for the certification that every hospital operates pursuant to quality standards established by the
law). The maximal period of accreditation is of 5 years.
∗
Special legal provisions:
Order No. 919/2006 on approving the Methodological Instructions for the recording, storing and transmission
of the information related to the hospital activity.
Order No. 914/2006 on the functioning structure of the compartments and services within a hospital.
Government Decision No. 1148/2008 on the competence, duties and the organization and functioning of the
National Committee for Hospitals Accreditation.
Order No. 972/2010 on approving the Procedures, standards and methodology of accreditation of the
hospitals.
Order No. 1091/2010 on the centralization of the consumption of medicinal products within the sanitary units
with beds.
G. PHYSICIANS
Law 95/2006 contains provisions regarding the profession of physician, namely the conditions to
be fulfilled in order for a natural person to qualify as a physician, categories of persons who can
practice the profession, the monitoring procedure of the physician’s activity, incompatibilities and
disqualifications, the conditions to be fulfilled in order for a physician, citizen of another Member
State, to practice the profession within the territory of Romania.
Law 95/2006 also includes provisions on the organization and the functioning of the Romanian
College of Physicians (“CMR”), namely the legal statute of the organization, the duties of the
organization, the conditions to be fulfilled in order for a physician to become a member of CMR,
the rights and obligations of the members of CMR etc.
∗
Special legal provisions
Government Emergency Ordinance No. 83/2000 on the organizing and functioning of the free-practice cabinet
for services related to the medical act.
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Order No. 979/2004 on the issuance of the authorization for free-practice.
Government Decisions No. 899/2002 on the organization of the specialised medical, dental and
pharmaceutical post-graduate education.
Government Ordinance No. 18/2009 on the organization and financing the training of junior physicians.
Decision No. 1/2009 of the National Council of the Romanian Physicians’ College on the issuing of the
certificate proving the quality of member of the Romanian Physicians’ College.
Government Decision No. 2/2012 adopting the Statute and Code of Medical Deontology of the Romanian
College of Physicians.
Order No. 1388/2007 on the approving the Methodological Instructions regarding the functioning structure of
the dental medical cabinets.
The Code of Ethics of 15 May 2010 of the dental physician.
H. PHARMACISTS
Law 95/2006 contains provisions on the pharmacist profession, namely the conditions to be fulfilled
in order for a natural person to qualify as a pharmacist, categories of persons who can practice the
profession, the monitoring procedure of the pharmacist’s activity, incompatibilities and
disqualifications, the conditions to be fulfilled in order for a pharmacist, citizen of another Member
State, to practice the profession within the territory of Romania.
∗
Special legal provisions
The Statute of Romanian Pharmacists’ College adopted on 15 June 2009, approved by Decision No. 2/2009
of the National General Assembly of the Romanian Pharmacist’ College.
The Code of Ethics of the Pharmacist adopted in 15 June 2009, approved by the Decision No.2/2009 of the
National General Assembly of the Romanian Pharmacist’ College.
I. THE LIABILITY OF THE MEDICAL PERSONNEL
•
Disciplinary liability
According to Law 95/2006, the disciplinary liability of medical personnel may be triggered any time
when the respective professional infringes the laws and regulations or the ethical codes or statutes
governing their profession, of for noncompliance with decisions of the national colleges or orders
(e.g. CMR, CFR etc).
Any complaint against medical personnel shall be submitted to the corresponding college (e.g.
CMR for physicians, CFR for pharmacist etc.). The penalties provided by the legal provisions vary
from the mild penalties, such as reprimand, to the serious penalties, such as the prohibition to
exercise the profession for a determined period.
•
Civil liability
The malpractice is defined by Law 95/2006 as the professional error manifested during the
conduction of the medical / medical-pharmaceutical act which involves the civil liability of the author
of the medical act and/or of the supplier of medical, sanitary and pharmaceutical products and
services, as long as the patient was prejudiced. The civil liability shall be activated irrespective if
the medical act has been committed with intention or by negligence.
The civil liability of medical personnel can also be triggered following a breach of certain obligations
such as the obligation of confidentiality, the obligation of ensuring the informed consent of the
patient or the obligation of providing healthcare assistance.
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Romanian Civil Code (Law No.287/2009) provides general rules in respect of civil liability of a
natural person also applicable to medical personnel.
•
Criminal liability
The Law expressly states that the civil liability shall not exempt the criminal liability as long as the
action causing damages can be legally qualified as criminal offence.
Romanian Criminal Code (Law No. 286/2009) provides general rules with respect to the criminal
liability for criminal offences such as bodily injury committed by natural persons, which may also
apply to medical personnel.
J. MEDICINAL PRODUCTS
Law 95/2006 transposes the European provisions of Directive 2001/83/EC on the establishment of
a Community Code concerning the medicinal products for human use as regard to the prevention
of the entry into the legal supply of chain of medicinal products which are falsified.
•
Marketing authorization
For a medicinal product to be placed on the market in Romania, it is necessary to have a valid
marketing authorization issued by ANMDM or a marketing authorization issued through the
centralized procedure in accordance with Regulation (EC) No.726/2004 of the European
Parliament and of the Council of 31 March 2004 laying down Community procedures for the
authorization and supervision of medicinal products for human and veterinary use and establishing
a European Medicines Agency.
Law 95/2006 also regulates a mutual recognition procedure and a decentralized procedure (for the
case when the applicant seeks to obtain the marketing authorization in Romania and in other
European Union member states) as well as the simplified procedure (for homeopathic medicinal
products and herbal medicinal products for traditional use complying with certain conditions
stipulated by the law).
Law 95/2006 also provides certain exceptions regarding medicinal products that do not need a
marketing authorization, for example radiopharmaceutical medicines prepared at the time of use
by a person or institution which, according to the national law, is authorized to use these medicines
according to the manufacturer’s instructions in an accredited health center and starting exclusively
from radionuclide generators, kits or authorized radionuclide precursors.
ANMDM may also issue temporary authorizations for distributing unauthorized medicines where
there is suspicion or confirmation of an epidemic of pathogens or toxins, or chemical agents or
nuclear radiation that may endanger public health or in other cases of necessity not covered by the
authorized products. In addition, placing on the market of medicinal products used to solve special
needs is also exempted from the obligation of holding a marketing authorization.
∗
Special legal provisions
Order No. 263/2003 for approving the Regulations on the marketing authorization, supervision, advertising,
labeling and package leaflet of medicinal products for human use.
Order No. 181/2004 approving the Regulations on the issuance of the marketing authorization by the National
Medicine Agency for the medicinal products for human use already authorized within Member States of
European Union through centralized procedure.
Order No. 895/2006 on the marketing authorization and the supervising of the medicinal products for human
use.
Order No. 1206/2006 approving the Instructions concerning the manner of resolving the applications for the
marketing authorization transfer.
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Order No. 1810/2006 on the introduction in Romania and maintenance in the therapeutic drug circuit of the
manufactured medicinal products prior to approval by the National Medicinal Products Agency of the marketing
authorization transfer.
Order No. 903/2006 approving the Principles and detailed guidelines concerning the good practice within the
clinical study on medicinal products of human use for clinical investigation and the requirements for the
fabrication and import of those medicinal products.
Order No. 904/2006 on the implementation of the rules of good practice on clinical studies conducting with
medicinal products for human use, transposing the Directive 2001/20/EC on the harmonization of the
legislation, the regulations and administrative measures of the Member States concerning the implementation
of the rules of good practice on clinical studies conducting with medicinal products for human use.
Order No. 905/2006 approving the Principles and the guidelines of good practice on the fabrication of
medicinal products of human use, including the medicinal products used for clinical investigation.
Order No. 75/2009 approving the Instructions concerning the manner of calculating prices for the medicinal
prices of human use.
Decision No. 29/2010 on approving the Regulation concerning the authorization of the clinical studies by the
ANMDM / the notification submitted to ANMDM of the non-interventional studies conducted with medicinal
products for human use in Romania.
Order No. 85/2013 for the approval of the application of art. 699 para. (1) and (2) of Law No. 95/2006 on
healthcare reform on the medicinal products used to solve special needs.
•
Manufacturing/import authorization
The manufacturing of medicinal products on the territory of Romania can be conducted solely by
the holders of manufacturing authorizations, irrespective of whether the manufactured medicinal
products are intended exclusively for the export activities. Also, an import authorization is required
for the import of medicinal products in Romania from third countries (other countries than the
European Economic Area member states). Law 95/2006 set forths certain conditions to be met by
the applicant in order to obtain the manufacturing or import authorizations, as the case may be.
∗
Special legal provisions
Order No. 312/2009 on the manufacturing/import authorization for the producers and importers of medicinal
products, including the medicinal products for clinical investigation, and granting of the good practice
manufacturing certificate for the manufacturers of medicinal products and/or active substance.
Order no. 1962/2008 approving the Procedure for parallel import permits for medicines for human use
•
Wholesale distribution of medicinal products
Law No.95/2006 regulates the general regime of the wholesale distribution of medicinal products
in Romania. In addition, specific legal provisions are contained in Order No. 1964/2008 for the
approval of Norms regarding the establishment, organization and operation of units for wholesale
distribution of medicinal products for human use and within Order No. 1963/2008 for the approval
of the guide regarding good wholesale distribution practice of medicine.
The wholesale distribution of medicinal products can be carried out in Romania by the holders of
an authorization for wholesale distribution issued either within the European Economic Area or in
Romania by ANMDM and only for medicinal products that have a valid marketing authorization in
Romania.
The wholesale distribution authorization is required for every wholesale operator from the
distribution chain, including intermediary agents and traders, performing activities with medicinal
products for human use, such as sale or purchase transactions; wholesale distribution; holding
(storage) and handling, including delivery and export.
∗
Special legal provisions
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The Order No. 1964/2008 on the setting up, organization and functioning of the wholesale distribution
establishments of the medicinal products for human use
The Order No. 1963/2008 on the good wholesale distribution practice of the medicinal products for human use
•
En detail distribution of medicinal products
En detail distribution of OTC medicinal products may be done only by means of pharmacies, their
working points or by means of drugstores (in Romanian “drogherii”), whereas Rx medicinal
products may be distributed only by pharmacies and in the presence of the pharmacist or
pharmacist’s assistant, under the pharmacist’s supervision.
∗
Special legal provisions
Pharmacy Law No. 266/2008 establishes general rules in relation to the activity of pharmacies in Romania.
Order No. 962/2009 on the constitution, organization and functioning of the pharmacies provides specific
conditions for implementation of the general rules established by Pharmacy Law No.266/2008.
Order No. 75/2010 on the approval of the Rules concerning the good pharmaceutical practice provides specific
good pharmaceutical practice rules.
•
Advertising of medicinal products
Law 95/2006 establishes specific rules for advertising of medicinal products to
consumers/professionals, mainly depending on their OTC/Rx qualification. In addition, there are
specific rules provided by the special legal provisions as well as by ethics codes of practice in
industry.
∗
Special legal provisions
Order No. 263/2003 for approving the Regulations on the marketing authorization, supervision, advertising,
labeling and package leaflet of medicinal products for human use.
ANMDM Scientific Council’s Decision no. 18/08.08.2013 for the approval of the Guide for the evaluation of the
advertising of human use medicines, as further amended by Decision no. 27/ 11.10.2013.
Ethics codes of practice are: APMGR Code of Ethical Conduct approved by the APMGR General Assembly
on 29.01.2014 (http://www.apmgr.org/en/cod), ARPIM Ethics Code adopted by ARPIM Council on 03.12.2013
and ratified by ARPIM Statutory General Assembly on 12.12.2013 (http://arpim.ro/codul-de-etica/) and EFPIA
Code on the promotion of prescription-only medicines to, and interactions with, healthcare professionals
adopted by EFPIA Board on 5 July 2007, and ratified by the EFPIA Statutory General Assembly of 19 June
2008, as further amended (http://www.efpia.eu/topics/building-trust/codes-of-practice).
•
Pharmacovigilence
Law 95/2006 establishes for the marketing authorization holder the obligation to have a
pharmacovigilence system for conducting a scientific evaluation of all information related to the
medicinal product subject to the authorization and also to permanently and continuously have at its
disposal a qualified person within the pharmacovigilence area, as well as to operate a system of
risk-management for every medicinal product.
∗
Special legal provisions
Order No. 179/2004 on the activity of pharmacovigilence inspections carried out at the owner of the marketing
authorization.
Order No. 411/2005 on approving the Regulations concerning the pharmacovigilence activity.
Decision No. 25/2007 of the Scientific Council of ANMDM on approving the Guideline concerning the rapid
alert system and non-emergency information within the farmacovigilence area.
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There are also a series of Decisions issued by the Scientific Council of ANMDM for adopting the different
chapters of the Pharmacovigilence Good Practice Guidelines.
K. MEDICAL DEVICES
The medical devices shall be marketed, distributed, installed and maintained solely by the natural
or legal persons who obtained the operating permit from the Ministry of Health. The procedure for
obtaining the permit is regulated by Order No. 728/2014 on approving the methodological
instructions of the 9th Title of the Law 95/2006 concerning the medical devices.
In order for a medical device to be placed on the market and put into service in Romania, such
must comply with certain conditions (e.g. to bear the EC marking) and their placing on the
market/putting into service must be notified or registered to the Romanian competent authorities
(depending on the type of the respective medical device).
∗
Special legal provisions
Government Decision No. 798/2003 on the establishment of conditions for placing medical devices for in vitro
diagnosis on the market
Government Decision No. 54/2009 on the establishment of conditions for placing medical devices on the
market
Government Decision No. 55/2009 on the active implantable medical devices
Order No. 253/2010 on the registration of medical devices
L. PATIENTS’ RIGHTS
Patient’s rights are regulated by Law No. 46/2003 on patient’s rights. Further specific legal provisions are
provided by Order No. 386/2004 on approving the Instruction of implementing the Law No.46/2003 on patient’s
rights.
3. Provide any special issues which arise in your jurisdiction.
•
Claw-back tax
Currently, the marketing authorization holders for medicinal products or their legal representatives
have the obligation to pay a quarterly contribution (“claw-back tax”) for the medicines sold/used
through hospitals and/ or pharmacies financed by the government through the Single National
Health Insurance Fund or through the government budget, calculated based on the sales value by
using specific formulas.
The claw-back tax system was introduced in the Romanian legislation in October 2009 and since
then in was amended several times. The claw-back tax generated disputes between the marketing
authorization holders and CNAS in relation to the formulas for calculating the quarterly contribution.
In February 2013, the Constitutional Court of Romania decided that part of the legal provisions
imposing a contribution aimed at financing some expenses of the State healthcare system, were
unconstitutional. More specifically, the provisions mentioned by the Constitutional Court decision
referred to the inclusion of VAT in the taxable base for claw-back tax purposes. The decision
triggered the VAT exclusion from the calculation base of the claw-back tax.
•
Minimum three wholesale distributors
Pursuant to an amendment brought to Law 95/2006 from February 2014, the marketing
authorization holders / their representative in Romania, have the obligation to make sure that the
wholesale distribution of medicinal products reimbursed within the national health insurance system
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are distributed in Romania (except for medicinal products for special needs) though at least 3
authorized wholesale distributor.
•
Public service obligation
The marketing authorization holders / their representatives and the wholesale distributors in
Romania have the obligation to permanently ensure an adequate range of medicinal products to
meet the needs of a determined geographical area and to deliver in this whole area the requested
quantities in the shortest possible time from receipt of order. Please note that the public services
obligation was extended to marketing authorization holders as of February 2014 following an
amendment brought to Law 95/2006. It is important to note the sanctions imposed by the new
legislation for breach of this obligation - fine of between RON 50,000 and RON 100,000 (approx.
between EUR 11,300 and EUR 22,600), but also temporary suspension of the marketing/wholesale
authorization for up to 6 months.
• Declaration of sponsorship activities
Pursuant to an amendment brought to Law 95/2006 from February 2014, the manufacturers,
marketing authorization holders or their representatives in Romania, the wholesale and en detail
distributors of medicines, medical devices and medical supplies have the obligation to declare
to the Ministry of Health and to ANMDM all sponsorship activities and any other expenses
incurred for physicians, nurses, professional organizations, patient organizations and any
other organizations that are active in healthcare field. The beneficiary of these sponsorship
activities must also declare to the competent authorities mentioned above these activities.
Following the declaration to Ministry of Health, respectively ANMDM of the sponsorship activities,
the information about such should also be published on the websites of ANMDM, respectively
Ministry of Health, on the websites of the sponsor and of the beneficiary, if the case.
The legal provision establishes that the Ministry of Health will issue an order for approving a form
for the declaration of the sponsoring activities. Until now, such form was not issued (but it is
expected to be enacted soon), and in practice such declarations are not yet filed.
•
Interdiction of sponsoring certain healthcare professional
According to the legal provisions in force no direct or indirect sponsorship can be granted by the
companies commercializing pharmaceutical and/or sanitary materials, by companies representing
their interests or by companies commercializing medical equipment, to (i) physicians and chiefnurses of the emergency units, (ii) to the general manager and the steering committee members of
the county and Bucharest ambulance services and (iii) to the chiefs-physicians of the mobile
emergency resuscitation and extrication services, for participation at congresses, conferences and
other types of events.
In special circumstances, duly justified, hospitality may be offered to such health care professionals
only with the approval of Ministry of Health.
In 2014, Law 95/2006 was proposed as to be amended by including additional interdictions of
sponsoring other types of healthcare professionals. However, this proposal was withdrawn a few
months ago, following the appointment of a new minister of Health. It is uncertain whether such a
proposal will be considered again in the future.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Mobile health applications are not expressly regulated under the Romanian laws. Even though
there are no express provisions within the laws currently in force in Romania, the subject of mobile
health applications is discussed intensively in the context of the invitation launched by European
Commission to the Member States in respect of the mobile health (“m-health”). When launching
the invitation, the European Commission also pointed out the main problematic issues related to
the subject of mobile health applications, namely:
•
the protection of personal data collected by mobile health applications;
•
the possibility of qualifying the mobile health applications as medical devices.
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When answering to the invitation mentioned above, the Romania Senate has set out its point of
view on the issue of mobile health application stating that the issue in discussion is currently
considered a national priority and it will be included in the National Strategy within the area of
research, technological development and innovation for the period 2014-2020.
According to the Romanian Senate’s point of view, the mobile health applications shall be
considered as complementary solutions to the medical act. For ensuring the effectiveness of such
application in the area of public healthcare, the public institution considers that it should be carried
out certain strategic policies, such as:
•
conducting comparative surveys in order to establish the effectiveness of such applications
within the area of public health;
•
certification of such applications by the competent authority within the public healthcare
system;
•
conducting education and information campaigns within the persons to whom such
applications are addressed.
From a positive perspective, the Romanian Senate states that it would be necessary the industry
of mobile health application to be developed in order to ensure the equal access of the citizens to
the healthcare system, including the aged and disabled persons.
Contact Information
Ana-Maria Baciu, Partener
[email protected]
Oana Racheriu, Associate
[email protected]
Nestor Nestor Diculescu Kingston Petersen
Bucharest Business Park,
1A Bucuresti-Ploiesti National Road,
Entrance A, 4th Floor, 1st District,
Bucharest 013681, Romania
Tel +40 21 201 1200, +40 31 225 3300
Fax +40 21 201 1210, +40 31 225 3310
Firm Website www.nndkp.ro
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Singapore
Prepared by Lex Mundi member firm Rajah & Tann Singapore LLP
1.
Provide an introduction on health law in your jurisdiction.
Health laws in Singapore are primarily divided into laws that regulate the pharmaceutical industry and laws
that regulate the health care industry.
Pharmaceutical Laws
Pharmaceutical laws in Singapore mainly regulate the import, export and manufacturing of pharmaceutical
products, which include medicinal products, cosmetic products and medical devices.
The Sale of Drugs Act regulates the sale of drugs in its pure unadulterated state, to ensure that purchasers
are supplied with an appropriate quantity and quality of drugs on the market.
It works in tandem with the Medicines Act, which regulates the manufacturing, importing, exporting and
marketing of medicinal products. The Medicines Act also regulates biological agents/products, should
they serve a medical purpose or if they are used in the preparation of a substance or article that serves a
medical purpose.
The Health Products Act specifically regulates the manufacture, import, supply, presentation and
advertisement of medical devices and cosmetic products.
Two other pieces of legislation that govern pharmaceutical products are the Poisons Act, which regulates
a select group of substances (mainly medicinal drugs) and the Biological Agents and Toxins Act, which
governs biological agents and toxins that can cause harm to humans.
Health Care Laws
The other prong of Singapore's health laws comprises laws that regulate the health care profession as well
as social security laws/programmes that ensure that all Singaporeans are able to equitably partake in
Singapore's world class health care system.
The Medical Registration Act, Dental Registration Act, Nurses and Midwives Act, Pharmacists
Registration Act, Optometrists and Opticians Act, and the Traditional Chinese Medicine
Practitioners Act regulate the health care profession by mandating the registration of the various health
care professionals, subject to stringent requirements before these professionals are allowed to practise in
Singapore. The Private Hospitals and Medical Clinics Act further regulates the standards the private
health care establishments have to maintain in order to operate in Singapore.
To ensure that basic healthcare is within the reach of all Singaporeans, the Singapore government has also
put in place multiple tiers of social security measures and they include, amongst others: 1) Medisave:
Provides medical savings account scheme that is mandatory to all Singaporeans and permanent residents
for their future medical and hospitalisation needs; 2) MediShield: A low cost basic medical insurance
scheme that facilitates the payment of hospitalisation bills that could not be adequately covered by
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Medisave; and 3) Medifund which acts as a financial safety net for Singaporeans who are unable to pay
for their medical and/or hospitalisation bills despite the aforementioned schemes.
Relevant authorities and associations
The main regulatory authority for pharmaceuticals is the Ministry of Health. Subordinate to the Ministry of
Health is the Health Sciences Authority ("HSA"), which operates in tandem with the Ministry of Health to
regulate Singapore’s health and pharmaceutical industry.
2.
Provide a checklist of laws with a short summary of the general requirements of each.
Pharmaceutical Laws
Sale of Drugs Act
The Sale of Drugs Act regulates the sale of drugs in its pure unadulterated state. The purpose of this Act is
to ensure that purchasers are supplied with the appropriate quality and quantity of drugs that they require.
Under the Sale of Drugs Act, the sale of adulterated drugs is an offence when the purchaser is not fully
informed of the nature of the adulteration at the time of purchase.
Medicines Act
The Medicines Act regulates the manufacturing, importing, exporting and marketing of medicinal
products. Medicinal products are defined as substances or articles (not being a medical device) that
are to be administered to human beings and/or animals for a medicinal purpose, or which is used as
an ingredient in the preparation of a substance or article which is to be administered to one or more human
beings or animals for a medicinal purpose. A medicinal purpose includes any one or more of the following
purposes: 1) treating or preventing disease; 2) diagnosing disease or ascertaining the existence, degree or
extent of a physiological condition; 3) contraception; 4) inducing anesthesia; and 5) otherwise preventing
or interfering with the normal operation of a physiological function, whether permanently or temporarily. The
Medicines Act also regulates biological agents/products, should they serve a medical purpose or if they
are used in the preparation of a substance or article, which serves a medical purpose.
Under the Medicines Act, anyone seeking to either manufacture, import, export and/or market any medicinal
product in Singapore has to first obtain the relevant licences under the Act.
To import a medicinal product, a company must first obtain either Product Licence or an Import Licence.
A Product Licence allows a company to freely import and sell the said medicinal product within Singapore.
For the avoidance of doubt, each new medicinal product that enters Singapore will require its own Product
Licence. Alternatively, a company can obtain an Import Licence. The requirements for an Import Licence
are much less stringent than that of a Product Licence, as the Import Licence will only be issued to a local
importer who has been authorised by the Product Licence holder to import the licenced product (i.e. the
medicinal product in question will already have been approved by the HSA for sale in Singapore).
To manufacture a medicinal product in Singapore, a company needs to obtain a Manufacturer’s Licence.
A pre-requisite for the grant of such a Manufacturer's Licence is that the company’s manufacturing facilities
will need to be inspected and be certified as in compliance with the Pharmaceutical Inspection
Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for
Medicinal Products.
Health Products Act
The Health Products Act regulates the manufacture, import, supply, presentation and advertisement of
medical devices and cosmetic products. A cosmetic product is defined as any substance or preparation
that is intended to be placed in contact with the various external parts of the human body (epidermis, hair
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system, nails, lips, eyes and external genital organs) or with the teeth and the mucous membranes of the
oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance,
correcting body odours, protecting them or keeping them in good condition. Cosmetic products include
skincare products, make-up colours, bath and shower preparations.
Under the Health Products Act, companies or individuals who intend to sell or supply a cosmetic product in
Singapore are required to notify the HSA prior to selling or supplying the product in the local market.
They are also required to comply with the requirements under the ASEAN Cosmetic Directive.
The Health Products Act also regulates medical devices. A "medical device" means any instrument,
apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other
similar or related article that is intended by its manufacturer to be used, whether alone or in combination,
for humans for one or more of the specific purposes of (a) diagnosis, prevention, monitoring, treatment or
alleviation of any disease; (b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
(c) investigation, replacement, modification, or support of the anatomy or of a physiological process; (d)
supporting or sustaining life; (e) control of conception; (f) disinfection of medical devices; or (g) providing
information for medical or diagnostic purposes by means of in vitro examination of specimens derived from
the human body, and which does not achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its intended function by
such means. To import a medical device, a company needs to register the device with the HSA, and at
the same time obtain a Dealer’s Import Licence under the Health Products Act. Similarly, in order to
manufacture a medicinal device, a company will need to obtain a Manufacturer’s Licence under the
Health Products Act.
Poisons Act
The Poisons Act regulates a group of substances that are deemed to be potentially harmful so as to prevent
illicit use. Any company, unless exempted under the Poisons Act, would need a licence for the purpose of
import, possess for sale, sell or offer for sale of any substance that is listed in the Poisons Act. Many of
these substances are medicinal drugs and/or ingredients that are used regularly in the manufacture of
pharmaceutical products.
Biological Agents and Toxins Act
The Biological Agents and Toxins Act governs the possession, use, import, transhipment, transfer and
transportation of biological agents, inactivated biological agents and toxins, to provide for safe practices in
the handling of such biological agents and toxins. Various licences under this Act need to be obtained
before anyone may even handle any of the biological agents listed in the act. There are also stringent
requirements regarding the handling and transportation of such substances within Singapore.
Laws regulating the Medical Profession
Medical Registration Act
The Medical Registration Act stipulates that all doctors have to be registered with the Singapore Medical
Council and obtain a practising certificate (which must be renewed yearly) before they may practise
medicine in Singapore. This Act also stipulates the disciplinary procedures for errant doctors and the
powers that the Singapore Medical Council has in dealing with such doctors.
Dental Registration Act
Similar to the Medical Registration Act, the Dental Registration Act regulates all dentists and oral health
professionals wishing to practise in Singapore. This Act stipulates that all dentists and oral health
professionals have to be registered with the Singapore Dental Council and hold a practising certificate
before they may practise in Singapore, similar to the requirements for doctors.
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Nurses and Midwives Act
Under the Nurses and Midwives Act, all individuals wishing to practise as a nurse/midwife in Singapore
must first be either registered or enrolled with the Singapore Nursing Board. Registered nurses tend to be
more qualified and experienced nurses as compared to enrolled nurses. As with doctors and dentists,
nurses/midwives will also need to obtain and maintain a practising certificate in order to practise in
Singapore.
Pharmacists Registration Act
The Pharmacists Registration Act mandates that all pharmacists must be registered with the Singapore
Pharmacy Council and must hold and maintain a practising certificate in order to practise pharmacy in
Singapore.
Optometrists and Opticians Act
The Optometrists & Opticians Act was passed to regulate the practice of optometry and opticianry in
Singapore. This Act establishes the Optometrists and Opticians Board to regulate optometrists and
opticians. All optometrists and opticians providing eye care services will need to be registered with the
Optometrists & Opticians Board and hold a valid practising certificate to continue practising or to start
working as an optician or optometrist.
Traditional Chinese Medicine Practitioners Act
The Traditional Chinese Medicine Practitioners Act governs the practice of traditional Chinese medicine in
Singapore, which includes any of the following acts or activities: (a) acupuncture; (b) the diagnosis,
treatment, prevention or alleviation of any disease or any symptom of a disease or the prescription of any
herbal medicine; (c) the regulation of the functional states of the human body; (d) the preparation or supply
of any herbal medicine on or in accordance with a prescription given by the person preparing or supplying
the herbal medicine or by another registered person; (e) the preparation or supply of any of the substances
specified in the Schedule; (f) the processing of any herbal medicine; and (g) the retailing of any herbal
medicine, on the basis of traditional Chinese medicine. Any individual wishing the perform any of the above
must first be registered with the Traditional Chinese Medicine Practitioners Board and hold a valid practising
certificate.
Private Hospitals and Medical Clinics Act
All healthcare facilities such as hospitals, medical centers, community health centers, nursing homes,
clinics (including dental clinics), and clinical laboratories (including x-ray laboratories) are required to apply
for a licence under the Private Hospitals & Medical Clinics Act and abide by the regulations and standards
therein.
Social Security Laws/Programmes
Medisave
Medisave is a compulsory national medical savings scheme that helps individuals put aside part of their
income into their Medisave accounts to meet their future personal or immediate family's hospitalization, day
surgery and certain outpatient expenses.
Under the scheme, every employed individual must contribute 7% - 9.5% (depending on age group) of his
monthly salary to a personal Medisave account. Self-employed individuals have to voluntarily contribute
amounts to maintain a minimum balance in their Medisave accounts. These savings can be withdrawn to
pay the hospital bills of the account holder and his immediate family members, subject to certain minimum
balance requirements.
MediShield
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MediShield is a basic medical insurance scheme designed to help pay part of the expenses arising from
the insured’s hospitalisations and certain outpatient treatments for serious illnesses at approved medical
institutions. It is meant to complement a member’s Medisave savings, which may otherwise be depleted in
the event of prolonged illnesses that require longer-term medical treatment. While MediShield is not
compulsory, it is strongly recommended, especially for the middle to lower income individuals as it provides
an additional layer of protection for one's healthcare costs.
Currently, about 75 per cent of Singaporeans is covered under MediShield and other types of similar
insurance plans.
Medifund
Medifund is an endowment fund set up by the Government to help needy Singaporeans who are unable to
pay for their medical expenses. Medifund acts as a bottom safety net for those who cannot afford the
subsidised bill charges, despite Medisave and MediShield coverage. Those who still face difficulties with
hospital expenses, even after government subsidies, Medisave and MediShield, can approach a medical
social worker to help them apply for Medifund.
3.
Provide any special issues which arise in your jurisdiction.
MediShield Life
The Singapore government is in the process of implementing a new MediShield Life scheme that is set to
replace the existing MediShield scheme from 2015. MediShield Life aims to provide better protection for
Singaporeans against the steadily rising healthcare costs in Singapore.
Some features of the new MediShield Life scheme include:
•
Removing the lifetime claim limit of S$300,000;
•
Increasing the annual claim limit by 40%, from S$70,000 to S$100,000;
•
Increasing the daily claim limits for normal wards and ICU wards by up to 55%;
•
Increasing the claim limits for surgical procedures by between 25% and 93%;
•
Increasing the claim limits for outpatient cancer chemotherapy and radiotherapy treatments;
•
•
Increasing daily claim limits for community hospitals by 40%; and
Lowering co-insurance rates from the current range of 10-20% to 3-10%.
The Singapore government will also ensure that all Singaporeans remain covered under MediShield Life
for life via both existing and transitional subsidies offered by the Government.
Personal Data Protection Act (PDPA) 2012
The Personal Data Protection Act 2012 came into force on 2 July 2014, and aims at preventing any
illegitimate and unauthorised use of personal data. Personal data refers to data, whether true or not, about
an individual who can be identified from that data, or from that data and other information to which the
organisation has or is likely to have access.
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The PDPA provides that an organisation cannot collect, use or disclose an individual's personal data without
the consent of the individual in question. An organisation must also allow an individual to access and correct
his personal data at any time upon the request of such individual. Further, an organization must put in place
measures to ensure the accuracy and protection of personal data in its possession. An organization may
also not retain personal data for an indeterminate amount of time, and may not transfer personal data out
of Singapore without ensuring that such data being transferred out is accorded similar protection outside of
Singapore as in accordance with the PDPA.
The PDPA applies to all organisations, including healthcare institutions. As such, all healthcare institutions
in Singapore will have to implement measures to comply with the PDPA. Such measures will include
obtaining the consent of their patients and employees to collect, use and disclose their personal data, and
putting in place reasonable security arrangements to protect personal data in their possession/control etc.
4.
Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Mobile health applications are not generally regulated under Singapore law per se, i.e. there are no laws
regulating their creation or supply to the general public.
However, they may have to comply with certain guidelines/restrictions depending on the nature of their
content. For example, if the content of the mobile health application in question includes advertising of
medical products, such advertisement will require a special advertising permit, and have to comply with the
requirements under the Medicines (Medical Advertisements) Regulations and the HSA Guide on
Advertisements and Sales Promotion of Medicinal Products (Medical Advertisements Guidelines), to name
a few.
Contact Information
Lim Wee Hann, Partner
[email protected]
Rajah & Tann Singapore LLP
9 Battery Road
#25-01 Straits Trading Building
Singapore 049910
Tel: +65 6535 3600 Fax: +65 6225 9630
Firm Website: http://www.rajahtannasia.com/
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Switzerland
Prepared by Lex Mundi member firm Pestalozzi Attorneys at Law
1. Provide an introduction on health law in your jurisdiction.
In Switzerland, health insurance is compulsory for all persons residing in Switzerland 7. The Swiss
health care system is characterized by the principles of universality and equality by mandating
individuals to purchase health insurance on the private market, providing financial assistance to
those on lower incomes and regulating the insurance market in order to protect those with poor
health 8. The primary objective of the Swiss health care policy is to provide the people living in
Switzerland with high-quality healthcare at an affordable cost while also encouraging individual
responsibility 9.
The Swiss health system has a federal structure – meaning that the confederation and the cantons
are responsible for different areas of health care. The Federal Constitution (Bundesverfassung)
states which tasks need to be regulated on a federal level, such as, for example, the fight against
diseases, compulsory health insurance, reproductive and transplantation medicine. On the other
hand, the Federal Constitution declares the cantons to be sovereign to the extent their sovereignty
is not limited by federal law. Therefore, cantons have far-reaching authority in the field of
healthcare, in terms of hospital care, cutting edge medicine, the right of health professionals to
practice, prevention and health promotion. They often regulate their functions in a cantonal Health
Care Act 10.
Relevant Authorities:
7
8
9
10
11
-
The Federal Office of Public Health (FOPH) (Bundesamt für Gesundheit) is part of the
Federal Department of Home Affairs (Eidgenössisches Departement des Inneren). Along with
the cantons it is responsible for public health in Switzerland and for developing national health
policy. The FOPH plays the main role in organizing the health system at federal level and in
preparing political decisions 11.
-
The cantons have offices of public health as well. They, however, are free to decide how to
organize these offices. Depending on the respective cantonal legislation, cantons often attend
their
responsibilities
by
establishing
a
Cantonal
Department
of
Health
(Gesundheitsdirektion/Gesundheitsamt). Based on the particular cantonal Health Care Act,
cantons can devolve their power and delegate specific functions to municipalities.
-
The Swiss Conference of the Cantonal Healthcare-Directors (Schweizerische Konferenz
der kantonalen Gesundheitsdirektorinnen und -direktoren) aims to harmonize cantonal
differences and facilitates the cooperation between the 26 different cantons and other important
associations.
-
Swissmedic, the Swiss Agency for Therapeutic Products (Schweizerische Heilmittelinstitut),
is a public institution of the Swiss government that is affiliated to the Federal Department of
Home Affairs. The legal basis for Swissmedic's activities is the Federal Act on Medicinal
http://www.bag.admin.ch/themen/krankenversicherung/06377/index.html?lang=de.
DALEY, CLAIRE/GUBB, JAMES: Healthcare Systems - Switzerland, abrufbar unter
http://www.civitas.org.uk/nhs/download/switzerland.pdf.
http://www.bag.admin.ch/themen/gesundheitspolitik/index.html?lang=en.
Z.B. Gesundheitsgesetz des Kanton Zürich.
http://www.bag.admin.ch/index.html?lang=en.
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Products and Medical Devices (Heilmittelgesetz). Swissmedic is responsible for the
authorization and supervision of therapeutic products 12.
-
The Federal Social Insurance Office (FSIO) (Bundesamt für Sozialversicherungen) is also
affiliated to the Federal Department of Home Affairs. The FSIO is the supervising authority
responsible for policies related to old-age, invalidity and the family. The FSIO plans, manages
and monitors the corresponding social insurance systems to ensure that they function
effectively 13.
-
Concerning the supervision of health insurance, the Swiss Federal Office of Public Health is
responsible for compulsory basic health insurance and voluntary daily benefits insurance
pursuant to the Federal Health Insurance Act (Krankenversicherungsgesetz), while the Swiss
Financial Market Supervisory Authority (Eidgenössische Finanzmarktaufsicht) is
responsible for supplementary insurance policies that fall under the Federal Insurance
Supervision Act (Versicherungsaufsichtsgesetz).
Relevant Associations:
-
The Swiss Insurance Association (SIA) (Schweizerischer Versicherungsverband) is the
umbrella organization representing the private insurance industry. The SIA is committed to
ensuring an economically viable framework for the activities of the insurance industry. It works
to maintain and promote a liberal, socially responsible market and competition regime 14.
-
In the field of social insurance, all private insurance companies are organized in an association
named santésuisse. Santésuisse represents the interests of its members against Swiss
authorities through lobbying and cooperation 15.
2. Provide a check list of laws with a short summary of the general requirements of each.
a. Social Security Law
Federal Act on the General Part of the Social Security Law (Bundesgesetz über den Allgemeinen
Teil des Sozialversicherungsrechts, ATSG)
The Federal Act on the General Part of the Social Security Law aims to coordinate the various
fields of the social security system in Switzerland. However, it has no priority regarding the
individual acts. Therefore, it only applies if the individual acts provide so 16. The act, for example,
defines important terms, so that these can be uniformly utilized in the individual acts 17. Further, the
Federal Act on the General Part of the Social Security Law contains provisions regarding benefits
and contributions and sets out the procedure 18.
Federal Act on the Disability Insurance (Bundesgesetz über die Invalidenversicherung, IVG)
The aim of the Swiss disability insurance is the professional (re)integration of disabled individuals
as well as improving or restoring their earning capacity. The insurance payments are used for
adequate measures to avoid, lower or cure any invalidity. If this isn't fully possible, the payments
should compensate the remaining economic consequences of the disability 19.
Federal Health Insurance Act (Krankenversicherungsgesetz, KVG)
The Federal Health Insurance Act regulates the compulsory basic health insurance and the
voluntary daily sickness benefits insurance 20. It applies to situations of illness, accident (in case the
accident insurance does not cover for it), and maternity 21. The act stipulates the obligation for every
12
13
14
15
16
17
18
19
20
21
https://www.swissmedic.ch/ueber/00131/index.html?lang=en.
http://www.bsv.admin.ch/index.html?lang=en.
http://www.svv.ch/en/about-us/portrait.
http://www.santesuisse.ch/de/dyn_output.html?content.void=3270&53ed19dec7afdc833f86e1bb5b4b042a&navid=106.
Art. 2 ATSG.
Art. 1 lit. a ATSG.
Art. 1 ATSG.
Art. 1a IVG.
Art. 1a Abs. 1 KVG.
Art. 1a Abs. 2 KVG.
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Swiss resident to get insurance 22 and establishes the legal basis for the organization of
insurances 23 as well as the procedure for switching between insurances 24 (people can freely
choose their insurance). Further, the Federal Health Insurance Act contains a catalog of
performances and services, which have to be provided by insurances. Details about the singular
services are specified in several ordinances of the Federal Council.
Federal Insurance Contract Act (Versicherungsvertragsgesetz, VVG)
In Switzerland only basic insurance is mandatory. However, if people want to get additional
services, they can benefit from supplementary insurance contracts with a private provider. The
Insurance Contract Act provides the legal framework for such contractual relations with private
insurances.
Federal Insurance Supervision Act (Versicherungsaufsichtsgesetz, VAG)
As far as the Swiss federal law doesn't provide a more specific supervision act, the Insurance
Supervision Act (ISA) applies to every Swiss insurance company, whether its business segment is
direct-insurance or reinsurance. It also applies to insurance intermediaries and foreign companies
which offer direct insurances in Switzerland 25. The ISA takes a principles and risk-based approach.
In addition to traditional supervisory instruments such as granting licences and setting requirements
for tied assets and reporting, the ISA focuses on ensuring the solvency of insurances and on
protecting insured persons against abusive practices 26.
The competent supervisory authority is the Financial Market Supervisory Authority (Eidgenössische
Finanzmarktaufsicht, FINMA). However, when it comes to health insurance supervision, the Swiss
Federal Office of Public Health is responsible for the compulsory basic health insurance and the
voluntary daily sickness benefits insurance pursuant to the Federal Health Insurance Act, while the
FINMA is responsible for supplementary insurance policies which fall under the Insurance Contract
Act 27.
Federal Accident Insurance Act (Unfallversicherungsgesetz, UVG)
Accident insurance is compulsory for people who are gainfully employed in Switzerland. Accident
insurance is provided by the Swiss National Accident Insurance Fund (Schweizerische
Unfallversicherungsanstalt, SUVA) and approved accident insurance companies 28. The Accident
Insurance Act regulates the organization of the SUVA, the existence of other insurances that also
provide insurance performances and the obligation for employees to be insured. The Federal Office
of Public Health (Bundesamt für Gesundheit) supervises the health and accident insurance 29.
b. Hospital Law
Federal Health Insurance Act (Krankenversicherungsgesetz, KVG)
In Switzerland, no federal hospitals exist; hospitals are organized on a cantonal basis.
Nevertheless, hospitals have to comply with the requirements established by the Federal Health
Insurance Act (Krankenversicherungsgesetz), such as providing the necessary infrastructure and
specialized personnel 30.
Cantonal Laws
Each canton ensures its own health supply through cantonal (public) and private hospitals, which
are listed on a cantonal hospital list (kantonale Spitalliste). Only services provided by a listed
hospital are primarily paid by health insurances. Further, also the financing of hospitals is regulated
on a cantonal basis.
c. Laws Regulating the Medical Professions
22
23
24
25
26
27
28
29
30
Art. 3 KVG.
Art. 11 ff. KVG.
Art. 7 KVG.
Art. 2 VAG.
http://www.finma.ch/e/finma/taetigkeiten/pages/integrierte-versicherungsaufsicht.aspx.
http://www.finma.ch/e/finma/taetigkeiten/gb-versicherungen/krankenversicherungsaufsicht/Pages/default.aspx.
http://www.bag.admin.ch/themen/versicherung/00321/00335/index.html?lang=en.
SCARTAZZINI, GUSTAVO/HÜRZELER, MARC: Bundessozialversicherungsrecht, 4. Auflage, Basel 2012, § 11 N. 7.
Art. 39 KVG.
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Federal Medical Professions Act (Medizinalberufegesetz, MedBG)
The Federal Medical Professions Act regulates the education and continuing professional
development of doctors, veterinary surgeons, dentists, pharmacists and chiropractors 31. Among
others, this act stipulates the conditions for medical professionals to get a licence to practice in
Switzerland 32 and specifies the process of recognition of foreign medical diploma 33.
Federal Psychological Professions Act (Psychologieberufegesetz, PsyG)
The Federal Psychological Act entered into force in 2013 and regulates the education, advanced
training and advanced vocational training of professionals in the field of psychology and
psychotherapy 34.
Civil Code / Code of Obligations (Zivilgesetzbuch, ZGB / Obligationenrecht, OR)
Swiss law qualifies contracts between doctors and patient as a commission according to the Swiss
Code of Obligations. Doctors have to act carefully, but do not owe a precise outcome. They must
inform the patient about the type of procedure, the risks and the consequences. Otherwise, in case
of damages, doctors are liable.
However, it must be pointed out, that, if damages are caused through medical treatment in a
cantonal hospital, public law provides the rules of liability. On the other hand, if the damaging
treatment was carried out in a private hospital, the rules of private law apply. And thirdly, if a patient
is housed in a cantonal hospital but treated by a private doctor, it depends on the cause of the
damages – for damages caused by the treatment private law is applying, for those caused by the
housing public law.
Criminal Code (Strafgesetzbuch, StGB)
Swiss Law understands any medical procedure, which is not approved by the individual person, as
a bodily injury (informed consent principle). The informed consent covers procedures performed
with the necessary precaution and diligence. Further, the Swiss Criminal Code contains specific
rules that apply to doctors performing abortions 35, breaking professional confidentiality 36 or
producing false medical certificates 37.
d. Medical Products and Medical Devices
Federal Act on Medicinal Products and Medical Devices (Heilmittelgesetz, HMG)
The Therapeutic Products Act (TPA) aims to protect human and animal health and to guarantee
that only high quality, safe and effective therapeutic products are placed on the market. 38 The act
applies to the handling of therapeutic products (medical products and devices), particularly in their
manufacture and placing on the market as well as to narcotics, insofar as they are used as
therapeutic products, and to therapeutic treatments, such as gene therapy 39.
Manufacturers and distributors of medicinal products are obliged to get a license from the Swiss
Agency of Therapeutic Products (Swissmedic, Schweizerische Heilmittelinstitut) 40.
Further, the TPA also regulates the advertisement of medical products 41. Details regarding the
advertisement of medical products are specified in the respective Ordinance on the Advertising of
Medicines (Arzneimittel-Werbeverordnung).
Product Liability Act (Produkthaftpflichtgesetz, PrHG)
31
32
33
34
35
36
37
38
39
40
41
Art. 1 Abs. 1 und 2 MedBG.
Art. 12 ff. MedBG.
Art. 15 MedBG.
Art. 1 Abs. 2 PsyG.
Art. 118 ff. StGB.
Art. 321 StGB.
Art. 318 StGB.
Art. 1 Abs. 1 HMG.
Art. 1 Abs. 2 HMG.
Art. 5 Abs. 1 HMG.
Art. 31 ff. HMG.
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In Switzerland, there are no specific regulations for medical product liability. Therefore, the general
Swiss principle of liability for defective products is applicable 42. The Product Liability Act regulates
the liability of manufacturers regardless of their culpability for damages caused by a defective
product. A product is defective, if it does not provide the safety that can be reasonably expected,
taking into account all circumstances 43.
Federal Act on Patent for Inventions (Patentgesetz, PatG)
The purpose of the Patents Act (PatA) is to protect the rights to an invention and to create an
incentive for research and development in all areas of technology 44. The PatA contains rules about
the requirements and effects of obtaining a patent, the right of priority and the legal restrictions
conferred by the patent 45. Excluded from patentability, amongst others, are methods for treatment
by surgery or therapy and diagnostic methods practiced on the human or animal body 46.
Act on Narcotics (Betäubungsmittelgesetz, BetmG)
The Act on Narcotics contains rules for the creation, placing on the market and use of narcotics.
The handling with narcotics must be authorized by the Swiss Agency of Therapeutic Products
(Swissmedic). Doctors have access to narcotics without an authorization, if their use is medically
necessary 47. The use of narcotics as medical products is regulated by the Federal Act on Medicinal
Products and Medical Devices (Heilmittelgesetz).
e. Research Involving Human Beings
Federal Act on Research Involving Human Beings (Humanforschungsgesetz, HFG)
The purpose of the Human Research Act (HRA) is to protect dignity, privacy and health of human
beings involved in research 48. Further, it shall create favorable conditions for research involving
human beings and ensure the quality and transparency of this kind of research 49. The HRA applies
to research concerning human diseases and the structure and function of the human body, which
involves persons, deceased persons, embryos and foetuses, biological material, and health-related
personal data 50. The most important principle of this act is that research involving human beings
may only be carried out if the persons concerned have given their informed consent or, after being
duly informed, have not exercised their right to dissent 51.
Federal Act on Research Involving Embryonic Stem Cells (Stammzellenforschungsgesetz, StFG)
The Stem Cell Research Act specifies the conditions under which it is permissible for human
embryonic stem cells to be derived from surplus embryos and used for research purposes 52.
f.
Reproductive Medicine and Gene Technology in Human Beings
Federal Act on Medically Assisted Reproduction (Fortpflanzungsmedizingesetz, FMedG)
The Reproductive Medicine Act (RMA) specifies the conditions under which the techniques of
medically assisted reproduction may be used in humans 53. It protects human dignity, personality
and the family and prohibits misuses of biotechnology and gene technology 54. Further, the RMA
provides for the establishment of a national ethics commission (Nationale Ethikkommission) that
shall monitor developments in assisted reproductive techniques and gene technology and
comment from an ethical perspective on associated social, scientific and legal issues 55.
42
43
44
45
46
47
48
49
50
51
52
53
54
55
WANG MARKUS/FUCHS, PHILIPPE, Fehlerhafte Medizinprodukte – Eine Betrachtung aus regulatorischer und
haftpflichtrechtlicher Sicht, in: Jusletter vom 27. August 2012, S. 4.
Art. 4 PrHG; http://www.s-ge.com/en/exporthelp/Osec-ExportHelp/Product-Liability-Act-(PrHG).
https://www.ige.ch/en/patents/patents.html.
Art. 1 ff., 35 ff. PatG.
Art. 2a PatG.
POLEDNA, TOMAS/KIESER, UELI: Schweizerisches Bundesverwaltungsrecht, Band VIII, Gesundheitsrecht, Basel 2005,
Teil A, N. 43.
Art. 1 Abs. 1 HFG.
Art. 1 Abs. 2 HFG.
Art. 2 Abs. 1 HFG.
Art. 7 Abs. 1 HFG.
Art. 1 Abs. 1 StFG.
Art. 1 Abs. 1 FMedG.
Art. 1 Abs. 2 FMedG.
Art. 1 Abs. 3 FMedG, Art. 28 Abs. 2 FMedG.
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Federal Act on Human Genetic Testing (Bundesgesetz über die genetische Untersuchungen an
Menschen, GUMG)
The Federal Act on Human Genetic Testing (HGTA) stipulates the conditions under which human
genetic testing may be performed in the context of employment, insurance, liability, and in the
medical context 56. The creation of DNA profiles for the purpose of determining the filiation or identity
of an individual is also regulated by this act 57. The HGTA aims to protect human dignity and
personality, to prevent improper genetic testing and the improper use of genetic data, and to ensure
the quality of genetic tests 58. Any person who wishes to perform cytogenetic or molecular genetic
tests requires authorization from the competent federal authority nominated by the Swiss Federal
Council 59. However, the HGTA does not apply to genetic testing performed for research
purposes 60.
g. Transplantation
Federal Act on the Transplantation of Organs, Tissues and Cells (Transplantationsgesetz)
The Transplantation Act sets out the requirements for the use of organs, tissues or cells for
transplantation purposes 61. It is intended to contribute to the availability of human organs, tissues
or cells for transplantation purposes 62. Further, the Transplantation Act aims to prevent the
improper handling of organs, tissues or cells in the context of human transplantation medicine, in
particular commercial activities involving organs, and to protect human dignity, privacy and health 63.
A fundamental value of this act is the principle of non-commercialism of donations. Nobody shall
grant or derive financial gain or any other advantage from a donation 64. Furthermore, the trade with
organs is strictly forbidden 65.
h. Public Procurement Law
The Swiss regulations on public procurement govern the procedures and legal remedies for the
purchase of goods and services by public authorities. Hence, the regulations also apply to public
entities of the health care industry, e.g. public hospitals as well as privately owned hospitals that
provide public services 66. Public procurement is regulated on three levels: International treaties,
such as the Agreement on the Government Procurement of the WTO provide the basic framework
for federal, cantonal and municipal public procurements. On a national level, public procurement is
governed by the Federal Act on Public Procurement and its related ordinance. Further procurement
rules exist at the cantonal and communal level 67. The applicable regulations intend to make the
procedures transparent, to increase the competition between the bidders and to ensure the equal
treatment of all bidders 68.
3. Provide any special issues which arise in your jurisdiction.
Health Care Strategy "Health 2020"
In 2013, the Federal Council approved a comprehensive health care strategy called "Health 2020"
("Gesundheit 2020"). The project includes a total of 36 measures across all areas of the health
system, which aim to maintain quality of life, increase equal opportunities, raise the quality of care,
keep health care cost low and improve transparency. The measures that will be implemented in
the course of the next few years are intended to align the Swiss health care system with current
56
57
58
59
60
61
62
63
64
65
66
67
68
Art. 1 Abs. 1 GUMG.
Art. 1 Abs. 2 GUMG.
Art. 2 GUMG.
Art. 8 GUMG.
Art. 1 Abs. 3 GUMG.
Art. 1 Abs. 1 Transplantationsgesetz.
Art. 1 Abs. 2 Transplantationsgesetz.
Art. 1 Abs. 3 Transplantationsgesetz.
Art. 6 Transplantationsgesetz.
Art. 7 Transplantationsgesetz.
Art. 1 Federal Act on Public Procurement;
http://www.pestalozzilaw.com/uploads/media/LM_Public_Procurement_Guide__Switzerland_-_2013_.PDF.
http://www.pestalozzilaw.com/uploads/media/LM_Public_Procurement_Guide__Switzerland_-_2013_.PDF;
https://www.walderwyss.com/publications/567.pdf.
Art. 1 Federal Act on Public Procurement;
http://www.pestalozzilaw.com/uploads/media/LM_Public_Procurement_Guide__Switzerland_-_2013_.PDF.
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and future challenges such as the rising number of elderly people and chronic illnesses as well as
a lack of transparency and control 69.
Pre-implantation Genetic Diagnosis (PGD)
Pre-implantation Genetic Diagnosis (PGD) is a procedure used during artificial fertilization (in vitro
fertilisation) to examine the genetic material of embryos before they are implanted into the uterus
to allow a pregnancy. The purpose of this procedure is to ensure the future child will not suffer from
a serious hereditary condition carried by the parents.
PGD is currently banned in Switzerland. However, this prohibition is now under revision. In 2013,
the Federal Council has completed its preliminary work on the new regulation and passed the draft
legislation to Parliament. The draft legislation sets out restrictive conditions under which PGD can
be made available to affected couples and makes its use for other purposes a punishable offence 70.
Revision of the Federal Act on the Transplantation of Organs, Tissues and Cells
The current version of the Federal Act on the Transplantation of Organs, Tissues and Cells
stipulates the principle of equal treatment regarding the allocation of organs for people resident in
Switzerland. Foreigners, on the other hand, do not have the same privilege. This shall be changed
so that regular cross-border commuters shall be equally treated as people resident in Switzerland 71.
At the same time, the Federal Council is elaborating a strategy in order to increase the number of
organs available for transplantations 72. The Federal Council is, however, convinced not to change
the current procedure of consent, so that the system of the absence of opposition will not be
introduced in Switzerland 73.
Limitation of the Number of Self-employed Doctors (Health Insurance)
Self-employed doctors, who want to open a practice in Switzerland need to have an individual
authorization 74. In order to contain the number of medical practices and lower the costs for the
health care system, the Federal Council ordered a limitation of such authorizations. Authorization
will be given if the region, in which the practice should be opened, has a need for additional
doctors 75. However, the cantons are relatively free in the implementation 76.
Draft of the Federal Act on the Electronic Patient Record
The Federal Council elaborated a draft about the introduction of electronic patient records in
Switzerland, which should make the exchange of information between doctors themselves and
patients and doctors easier 77. However, participation in this project is voluntary. Patients shall have
the liberty to decide whether or not to have an electronic record, and who will have access to the
information 78. This project is part of the strategy program "Health2020" and the "eHealth" program
of the Federal Council 79.
Revision of the Federal Act on Medicinal Products and Medical Devices
The Federal Act on Medicinal Products and Medical Devices is in revision. In 2016, a new version
of the act will be released. The changes to the act will improve public access to medicines and
conditions for biomedical research and industry. The aim is to make it easier for complementary
and herbal medicines to enter the market and increase the availability of a wider range of medicines
suitable for children. There are also amendments to regulations on discounts and kickbacks, and
on self-medication 80. Furthermore, selected medicinal products now available only with prescription
will be sold by pharmacies without it, after a consultation with the pharmacist 81.
69
70
71
72
73
74
75
76
77
78
79
80
81
http://www.bag.admin.ch/gesundheit2020/index.html?lang=en ; Health2020 report, abrufbar unter
http://www.bag.admin.ch/gesundheit2020/index.html?lang=en.
http://www.bag.admin.ch/themen/medizin/03878/06152/index.html?lang=en.
http://www.bag.admin.ch/transplantation/00694/01739/11989/index.html?lang=de.
http://www.bag.admin.ch/aktuell/00718/01220/index.html?lang=de&msg-id=48059.
http://www.bag.admin.ch/aktuell/00718/01220/index.html?lang=de&msg-id=48059.
Art. 4 und 55a KVG; MEYER, ULRICH: Schweizerisches Bundesverwaltungsrecht, Band XIV, Soziale Sicherheit, Basel
2007, Teil E., N. 707.
http://www.bag.admin.ch/themen/krankenversicherung/00305/13489/index.html?lang=de.
http://www.bag.admin.ch/themen/krankenversicherung/00305/13489/index.html?lang=de.
http://www.bag.admin.ch/themen/gesundheitspolitik/10357/10360/index.html?lang=de.
http://www.bag.admin.ch/themen/gesundheitspolitik/10357/10360/index.html?lang=de.
Vgl. Botschaft des Bundesrates zum Bundesgesetz über das elektronische Patientendossier (EPDG) vom 29. Mai 2013,
BBl 2013, 5321, S. 5327; http://www.bag.admin.ch/themen/gesundheitspolitik/10357/10359/index.html?lang=de.
http://www.bag.admin.ch/themen/medizin/00709/04667/04672/index.html?lang=en.
http://www.bag.admin.ch/dokumentation/medieninformationen/01217/index.html?lang=de&msg-id=46605
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National Strategy Palliative Care 2013-2015
The Swiss Confederation and the Cantons have decided to promote palliative care, in order to
increase the quality of life of terminally ill and dying people 82. The offer will be increased, the
instruction and training of health care and social care professionals as well as the information of
the general public will be improved. The need of palliative care will increase in the coming years,
owing to the ageing of society 83.
Draft of a Federal Act on Health Care Professions
The Healthcare Professions Act, covering healthcare professions requiring qualifications from a
university of applied sciences, is being drafted in cooperation with the State Secretariat for
Education, Research and Innovation. The new act aims to increase the quality of instruction of
health care professionals 84. The professions subject to this act are, among others, nurses,
physiotherapists, ergotherapists, midwives and nutritionists 85. Currently, the instruction and training
are regulated differently by each canton 86.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Apart from general rules, such as general data privacy laws, which contain particular regulations
about health data, mobile health applications are not specifically regulated in Switzerland.
In 2007, the Federal Council launched together with the cantons a program called "eHealth". This
program is part of the nationwide new health care strategy "Health 2020" and aims to bring more
digital tools in the Swiss health care system 87, such as electronic patient records 88 or electronic
prescriptions for medicaments 89. However, the "eHealth" program does not contain any rules or
strategy about the regulation of mobile health applications.
As coordination organism for the "eHealth" program an organization named "eHealth Suisse" was
founded. "eHealth Suisse" is currently discussing the so called Green Paper on mobile health
("mHealth") of the European Union 90, which covers medical and public health practice supported
by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants,
and other wireless devices 91. However, "eHealth Suisse" has not yet published any results 92.
82
83
84
85
86
87
88
89
90
91
92
Schweizerische Konferenz der kantonalen Gesundheitsdirektorinnen und –direktoren, National Strategy for Palliative Care
2013-2015, Results 2010-2012 and need for action 2013-2015, abrufbar unter
http://www.bag.admin.ch/themen/gesundheitspolitik/13764/index.html?lang=en.
http://www.bag.admin.ch/themen/gesundheitspolitik/13764/index.html?lang=en; Schweizerische Konferenz der kantonalen
Gesundheitsdirektorinnen und –direktoren, National Strategy for Palliative Care 2013-2015, Results 2010-2012 and need
for action 2013-2015, S. 4.
http://www.bag.admin.ch/themen/berufe/14208/14209/14582/index.html?lang=de.
https://www.news.admin.ch/message/index.html?lang=de&msg-id=51402.
http://www.bag.admin.ch/themen/berufe/14208/14209/14582/index.html?lang=de.
http://www.bag.admin.ch/themen/gesundheitspolitik/10357/index.html?lang=de.
http://www.bag.admin.ch/themen/gesundheitspolitik/10357/index.html?lang=de.
Botschaft des Bundesrates zum Bundesgesetz über das elektronische Patientendossier (EPDG) vom 29. Mai 2013, BBl
2013, 5321, S. 5330.
http://www.e-health-suisse.ch/aktuell/00032/00156/index.html?lang=de.
http://ec.europa.eu/digital-agenda/en/news/green-paper-mobile-health-mhealth.
http://www.e-health-suisse.ch/aktuell/00032/00156/index.html?lang=de.
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Contact Information
Dr. Lorenza Ferrari Hofer, Attorney at Law
[email protected]
Pestalozzi Attorneys At Law
Loewenstrasse 1
CH-8001 Zurich, Switzerland
Tel +41 44 217 92 57
Fax +41 44 217 92 17
Firm Website www.pestalozzilaw.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
Thailand
Prepared by Lex Mundi member firm Tilleke & Gibbins International Ltd.
1. Provide an introduction on health law in your jurisdiction.
The health care industry is subject to a wide range of laws and regulations, including those related
to healthcare reimbursement, social security, hospital, pharmaceuticals, medical devices, and laws
regulating the practices of medical professionals. The National Health Act B.E. 2550 (2007) is
considered the principal healthcare law in Thailand. The Act codifies important rights and duties on
health that are not prescribed in any other laws, such as the right to live in a healthy environment,
the right to receive sufficient health information to make an informed decision to accept or refuse
any health service, etc. This is an important turning point in the Thai health system, as the National
Health Act extends the concept of health from medical and public health sectors to include other
sectors, abiding under the principle of “all for health and health for all.” This leads to a health
governance system with greater participation and better health policy decision-making.
The key turning point in the Thai healthcare system was in 2001, when the introduction of a
universal healthcare program, known as the THB 30 (USD 1) scheme, was initiated. Under this
scheme, patients may visit public hospitals and pay only THB 30 per visit, with the remaining costs
of the treatment being subsidized by the government. Apart from the THB 30 scheme, there are
three main schemes relating to the healthcare system in Thailand.
Social Security Scheme (SSS). This is administered by the Social Security Office. This scheme
was initiated to assure benefits for insured employees to relieve their difficulties, including sickness,
maternity, physical disability, unemployment, death, old-age pension, etc. This scheme is financed
by tripartite contributions from the government, employers, and employees.
Civil Servant Medical Benefit Scheme (CSMBS). This is a medical service welfare system for civil
servants and state enterprise employees and their dependents (including spouses, up to three
children, and parents). The budgets of the government and state enterprises are the sources of
funding.
Personal payment. People who have no other benefits or do not intend to use the benefits described
above pay medical expenses himself/herself or via private voluntary health insurance.
Thai legislation regulating pharmaceuticals and medical devices primarily serves to enforce
consumer protection, which aims to ensure that the public has access to safe and efficacious
products of high standards and to prevent product abuse. In order to be distributed, sold, and
marketed, the products must be registered with the appropriate government authorities. A
marketing authorization (MA) product registration dossier must be filed following the ASEAN
Harmonization requirements. In addition, a Certificate of Pharmaceutical Product or Certificate of
Free Sale is required for the registration of said products. For other health industry aspects,
Thailand imposes a variety of laws, regulations, and announcements in such diverse fields as the
social security scheme, sanatorium and hospitals, laws regulating the medical profession, and
pharmaceuticals and medical devices law.
Relevant Authorities and Associations:
The Ministry of Public Health (MoPH)
o The MoPH is the principal agency in the Thai public health system. Its role is to manage
Thai healthcare and formulate national health policies. The main functions of the MoPH
include promoting, supporting, controlling, and coordinating all activities related to physical
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and mental health, as well as the well-being of people. Within this ministry, there are four
separate departments including the Office of Permanent Secretary, Cluster of Medical
Services Development, Cluster of Public Health Development, and Cluster of Public Health
Services Support.
Office of Permanent Secretary
o This Office deals with strategic development, translation of the Ministry’s policies into
operational plans, the allocation and management of resources, the monitoring and
evaluation of program implementation of agencies under the Ministry, international
cooperation, and the amendment of relevant laws. Provincial Administration, which
consists of the Provincial Public Health Office and District Health Offices, also operates
under this Office.
Cluster of Medical Services Development
This cluster is comprised of three departments:
o Department of Medical Services
 This department is responsible for conducting research studies, developing and
transferring appropriate medical technologies, and providing complex, specialized,
or tertiary medical care.
o Department for Development of Thai Traditional and Alternative Medicine
 This department is responsible for taking actions with regard to the law relating to
the protection and promotion of Thai traditional medicine wisdom and to other
relevant laws; establishing and developing standards; making recommendations
on consumer protection, promoting, and supporting the provision of Thai traditional
medicine, folk medicine, and alternative medicine in the healthcare system.
o Department of Mental Health
 This department is responsible for conducting research studies, developing and
transferring knowledge and technologies relating to the promotion of mental health,
prevention, treatment, and rehabilitation of mental health problems, and providing
services, especially for serious or complicated cases of mental disorders.
Cluster of Public Health Development
This cluster comprises two departments:
o Department of Disease Control
 This department is responsible for conducting research studies, developing and
transferring knowledge and technologies for the surveillance, prevention, control,
diagnosis, and treatment of diseases and health risks, coordinating with relevant
agencies, international organizations and local administrative organizations in the
surveillance, prevention and control of diseases and health risks, as well as other
international health problems.
o Department of Health
 Apart from conducting research studies for health promotion and environmental
management that facilitate healthy status, this department also establishes and
develops the quality and standards for health impact assessments and supports
local administrative organizations, communities, and public/private sector
partnerships to participate in health promotion efforts and in environmental
management for health.
Cluster of Public Health Services Support
This cluster consists of three departments:
o Department of Health Service Support
 This department is responsible for promoting and coordinating efforts for the
development of the health services system, taking actions with regard to laws
relating to medical registration, healthcare facilities, and other relevant laws,
supporting the operation of programs on health education and health systems of
the people, conducting research studies, and conducting research and
disseminating knowledge and transferring appropriate medical technologies
relating to health service systems.
o Department of Medical Sciences
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
o
This department is responsible for establishing and developing the standards of
laboratory analyses and methods, developing knowledge and technologies
relating to health products, herbal medicine, and diagnostic investigations,
providing laboratory analysis services and serving as reference laboratories, and
developing laboratory quality assurance systems.
Thai Food and Drug Administration (TFDA)
 The TFDA is responsible for taking actions according to laws relating to foods,
drugs, cosmetics, hazardous substances, psychotropic substances, narcotics,
medical devices, and volatile substance abuse prevention and surveillance,
monitoring and inspecting the quality and standards of products, business places,
and advertisements, as well as adverse effects of health products, conducting
research studies and developing knowledge, technologies, and systems for
consumer protection relating to health products, and developing the potential of
consumers in selecting health products and protecting their rights.
2. Provide a checklist of laws with a short summary of the general requirements of each.
a.) Hospital law
Sanatorium Act B.E. 2541 (1998): (พรบ.สถานพยาบาล พ.ศ.๒๕๔๑)
i. This is the main Act that governs hospital activities, from operating to
managing a sanatorium. This Act classifies two types of sanatoriums: those
with overnight facilities (inpatient) and those with no overnight facilities
(outpatient).
ii. This Act requires a person who wishes to engage in a sanatorium business to
obtain a license from the grantor (Bureau of Sanatorium and Art of Healing,
Ministry of Public Health). Such person must be a qualified person, as
specified in this act; for example, he/she must not be less than 20 years old,
must be domiciled in Thailand, etc.
iii. In the consideration of the issuance of a license, the authority will look at the
action plan for the establishment, a sanatorium which possesses the
qualifications prescribed in the Ministerial Regulation, the medical instruments,
and medical supplies or vehicles. In addition, the medical practitioners must
meet the requirements of the Ministerial Regulations.
iv. The license to operate a sanatorium is valid for ten years. Extension and
transfer of the license is allowed, subject to the authority’s decision. The
licensee, manager, and practitioner can be the same person.
b.) Laws regulating medical profession
The laws in this area cover the practices and qualifications of medical professions, of which
are termed the Professional Practice of the Art of Healing. Since various councils of the medical
profession have been established, certain medical professions are regulated under their own
specific professional laws. Some examples are the Medical Professionals Act B.E. 2525
(1982), the Pharmaceutical Profession Act B.E. 2537 (1994), the Nursing and Midwifery
Profession Act B.E. 2528 (1985), and the Dental Profession Act B.E. 2537 (1994). The following
are definitions of Professional Practice of the Art of Healing, Medical Professional Act, and
Consumer Case Procedure Act.
Professional Practice of the Art of Healing Act B.E. 2542 (1999) (พรบ.การประกอบโรคศิลปะ
พ.ศ.๒๕๔๒)
•
This Act defines the practice of the art of healing as a professional practice
which is performed or intended to be performed on humans concerning a
medical examination, diagnosis, cure, prevention of diseases, health
promotion and rehabilitation, and obstetrics, but not including other
professional practices in medical and public health governed by laws on such
matters.
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Medical Professionals Act B.E. 2525 (1982) (พรบ.วิชาชี พเวชกรรม พ.ศ.๒๕๒๕)
•
•
Medical professionals are required to hold a professional medical license. The
license is obtained through the Medical Council of Thailand, which is regulated
by the Medical Professional Act B.E. 2525 (1982).
This Act defines the “medical profession” as a profession that performs the
following activities on human beings: examination, diagnosis, treatment and
prevention of disease, midwifery, insertion of contact lenses for visual
correction, and acupuncture for therapeutic or anesthetic purposes, and shall
include any act of surgical procedure, the use of radiation, the insertion or
injection of medicine or other matter, and the insertion of any matter inside the
body for the purposes of birth control, beautification, or physical fitness.
ู ริ โภค พ.ศ.2551)
Consumer Case Procedure Act B.E. 2551 (2008) (พรบ วิธีพิจารณาคดีผ้ บ
•
Any damage that occurs to life, the body, or health during the course of medical
practice falls under this Act. This is a procedure which allows a consumer or
other entity, such as the Consumer Protection Board, to bring a lawsuit on
behalf of a consumer who is injured by the wrongful practice of a medical
professional to bring a claim against them.
c.) Pharmaceutical law
Drug Act B.E. 2510 (1967) (พรบ.ยา พ.ศ.๒๕๑๐)
•
•
•
This is the most important Act in pharmaceutical law, as it covers all activities
relating to drugs, including importation, sales and manufacturing, marketing,
parallel import, advertising, product liability, drug packaging, and labeling.
The Thai Food and Drug Administration (TFDA) is the authority that is
responsible for overseeing all activities related to drugs under the Drug Act
B.E. 2510 (1967). A person who wishes to manufacture, sell, or import modern
medicine into Thailand is required to obtain a license from the TFDA. Specific
requirements are set for the applicant who wishes to apply for the license: such
person must be the owner of the business and have sufficient property or
status to be able to establish and operate the business, be at least 20 years of
age, reside in Thailand, etc.
Advertising must be approved by the TFDA before dissemination, as several
restrictions apply such as prohibitions on exaggerating the advertisement,
falsely declaring properties of the medicine, etc.
d.) Medical instrument law
Medical Instrument Act B.E. 2551 (2008)
•
•
•
(พรบ เครื่องมือแพทย์ พ.ศ.2551)
All importation and manufacturing of medical devices require a license from
the TFDA. The applicant must have a place of business registration (an
establishment license) by a local company.
The Act classifies medical devices into three classes: Class 1, Licensed
Medical Devices; Class 2, Notification Medical Devices; and Class 3, General
Medical Devices. Class 1 is the most rigorously-controlled class, and is
comprised mainly of condoms, HIV diagnostic kits, contact lenses, etc.
Required documents for this class are a certificate of free sale, certificate of
quality system of manufacture, such as the ISO certificate, clinical evaluation,
sterility, stability, raw material and finished product specifications, Thai label
leaflet, product photo, and manufacturing process. Meanwhile, Class 2 and 3
are under more lenient control. Examples of Class 2 devices include physical
therapy products, silicone breast implants, and alcohol detectors. Class 3
includes all medical products which are not classified as either Class 1 or Class
2. The required documents for Class 2 are similar to those of Class 1. For
Class 3, the following documents are required: certificate of free sale, product
catalogue and its photo, specifications, and ISO 13485 certification.
Currently, there are no specific regulations regarding IT and mobile medical
applications. According to the Medical Instrument Act, however, software and
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IT systems are also considered as medical devices, and the importer will
normally register them together with the main devices.
3. Provide any special issues which arise in your jurisdiction.
a) Compulsory Licensing
In 2006-2008, Thailand’s Ministry of Public Health issued the first set of compulsory licenses
on six patented drugs. The legitimacy of these compulsory licenses was questioned by the drug
originators who own the patents, international legal experts, and other experts in the
pharmaceutical industry.
Although the parameters within which a country may legally permit a compulsory license are
set out in the WTO’s TRIPs agreement, the TRIPs Agreement itself is not Thai Law. In the
context of compulsory licenses in Thailand, the relevant law is set out in the Patent Act B.E.
2522 (A.D. 1979), as amended in 1992 and 1999. This legislation permits various types of
voluntary and compulsory licenses in Sections 45-47 and 50-52.
The compulsory licenses pursued by the Ministry of Public Health were based on Section 51
of the Thai Patent Act. This section permits government ministries and departments to seek a
compulsory license subject to compliance with a number of preconditions.
The dispute regarding the legitimacy or validity of the compulsory licenses pursued by the
MoPH stems from the first paragraph of Section 51, which appears to authorize government
ministries and departments to exploit a patented invention by way of a compulsory license, but
requires the government department to pay a royalty after a period of negotiation with the
patent owner. The Ministry has interpreted this to confer authority on the Ministry to unilaterally
issue compulsory licenses without prior consultation with the patent owners or the Department
of Intellectual Property.
Moreover, the second paragraph of Section 51 specifically states that “… the ministry or bureau
or department shall submit its offer setting forth the amount of royalty and conditions for
exploitation to the Director-General.” Section 50 also sets out the process for negotiations
between the parties and the procedures which must be followed before a compulsory license
can be issued by the Director-General of the Department of Intellectual Property. Therefore, a
careful reading of Section 50 and Section 51 would seem to suggest that the Ministry of Public
Health has not taken the appropriate steps required by law when seeking to impose compulsory
licenses on patented drugs.
The Compulsory Licensing period was limited to a certain period—mostly until December 31,
2011—but for two patents, the period lasted until the patents had expired. Some patent owners
eventually negotiated with the MoPH to offer special programs that expanded public accession
to medicine. As a result, in some cases, the MoPH agreed to not import or manufacture generic
drugs of the patent owner, who also gave support.
b) Surrogacy
The issue of surrogacy has taken a foothold in the sphere of public debate in 2014 with news
of an Australian couple allegedly abandoning their disabled surrogate baby with his Thai
surrogate mother. The news has once again highlighted that Thai law has not kept up with
advancements in infertility treatments. Assisted reproductive technologies exist and are used
in Thailand, but falls into a legal grey area.
A draft piece of legislation, the Surrogacy Bill, seeks to specify the legal bases and clarify the
issue. The Surrogacy Bill has been entrenched in the drafting process for several years. It has
already been passed by the Cabinet and is currently under review and awaiting parliamentary
approval. Under the proposed legislation, legally married couples would be allowed to engage
a surrogate mother to carry a pregnancy on their behalf.
The Surrogacy Bill also sets out the rights of the social parents, surrogate mother, and newborn
child. Under present law, a child born via surrogacy is considered the legitimate child of the
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birth mother, meaning the social parents have no legal parental rights to the child. As a result,
the prospective parents have to go through the lengthy process of adoption to obtain the rights
to the child, which for foreign couples in particular can be burdensome and expensive.
Surrogacy arrangements have also yet to be tested in the Thai courts and an agreement or
contract entering into a surrogacy agreement before the Surrogacy Bill takes effect could be
deemed a violation of provisions of public order and/or good morals.
Based on the current draft wording of the Surrogacy Bill, all of the legal parental rights and
duties will be conferred to the social parents without the need to go through the adoption
process. In addition, the Juvenile and Family Court is granted jurisdiction to hear cases
involving any disputes related to parenthood as a result of surrogacy. The Bill allows a married
husband and wife to seek surrogacy, and it can be viewed that surrogacy under this Bill is not
allowed for same-sex couples.
As it stands, commercial surrogacy is not explicitly illegal under Thai law. The practice is,
however, regulated by the Thai Medical Council, which controls the medical practitioner, not
the surrogacy mother and prospective parents. The pertinent regulation provides that the
physician may perform the surrogacy under conditions. For instance, no payments or
compensation of any kind would be allowed to be made to the surrogate mother, with the
exception of those related to health maintenance costs at the time of pregnancy, delivery, and
post-delivery. Surrogacy mothers must have a blood (familial) connection with the couple
whose medical records confirm their infertility problems.
Under the new law, engaging in commercial surrogacy and brokering and advertising would be
strictly prohibited and would incur heavy penalties.
c) Clinical Trials
Another health-related issue in Thailand that is worth mentioning is the regulation of clinical
trials in Thailand. Currently, there is no centralized regulation for clinical trials. At least six
regulatory authorities have jurisdiction over various aspects of clinical trials, including:
• FDA of the MoPH;
• Department of Medical Sciences of the MoPH;
• Department of Communicable Diseases Control of the MoPH;
• Ethical Review Committee for Research in Human Subjects of the MoPH;
• National Sub-Committee of HIV Vaccine of the Ministry of Public Health; and
• Medical schools and hospitals with specific regulations and/or an ethics
committee.
To conduct a trial, drug developers/sponsors must obtain approval for clinical trials from the
Ethical Review Committee for Research in Human Subjects of the MoPH or from the ethics
committee of the research institute or university that will conduct the trial. Once the developer
receives approval from the relevant ethics committee, it can apply to the FDA for a license to
import investigational drugs into Thailand for research purposes.
Although the FDA does not have a direct mandate to regulate clinical trials in humans, the
FDA’s authority to control the import of drugs for research purposes is frequently used to
indirectly allow the FDA to regulate clinical trials of drugs in humans.
Moreover, Thailand follows the World Medical Association Declaration of Helsinki Ethical
Principles for Medical Research Involving Human Subjects 1964 and the International
Conference on Harmonization of Technical Requirements for the Registration of
Pharmaceuticals for Human Use, Guidelines on Good Clinical Practice 1996 (ICH GCP), even
though Thailand has not ratified them.
A draft bill covering human research is currently undergoing public hearing and will most likely
progress to the Cabinet and then to the Council of State and finally the parliament for
promulgation.
d) Stem Cell Research
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In Thailand, stem cell research and use for therapy is currently regulated by the Medical
Council’s Regulation on Medical Ethics Regarding Stem Cell Research for Human Treatment
B.E. 2552 (2009).
Persons who conduct stem cell research or persons who use stem cells for disease treatments
must be registered with the Medical Council of Thailand. The objective of this is to check and
stop persons who are not capable and have no experience with the proper training from
performing stem cell treatments. Additional draft regulations to further control the use of stem
cells in Thailand are pending approval at the MoPH.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Mobile health applications are new in Thailand and, generally speaking, mobile health applications
are used mainly by health professionals as a reference guide. The public does not yet use mobile
health applications as an alternative to consulting a health professional due to the prevalence of
medical facilities in all parts of the country and access to a Universal Healthcare System. As a
result, no issues have arisen from the use of mobile health technologies. The most commonly used
mobile health applications among the general public in Thailand are fitness and training aids.
Neither is regulated by any specific piece of legislation or regulation.
Contact Information
Alan Adcock
[email protected]
Areeya Pornwiriyangkura
[email protected]
Atthachai Homhuan
[email protected]
Tilleke & Gibbins International Ltd.
Supalai Grand Tower, 26th Floor, 1011 Rama 3
Road, Chongnonsi, Yannawa, Bangkok 10120,
Thailand
Tel +66 2653 5555
Fax +66 2653 5678
www.tilleke.com
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International Guide on Health Industry Laws
United States Federal Laws for Health Care
Prepared by Lex Mundi member firm Womble Carlyle Sandridge & Rice, LLP
Affordable Care Act
Patient Protection and Affordable Care Act (H.R. 3590), as amended by the Health Care and Education
Affordability Reconciliation Act of 2010 (H.R. 4872), Pub. L. 111-1522 (signed into law March 30, 2010,
and on June 28, 2012 the Supreme Court rendered a final decision to uphold the law)
Establishes comprehensive health insurance reforms
Establishment of the health insurance marketplace
Focus on paying physicians based on value not volume
Anti-Kickback Statute (AKS)
42 U.S.C. §1320a-7b
Makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to
induce or reward referrals of items or services payable by federal healthcare programs such as Medicare
or Medicaid
Intent-based (as opposed to strict liability)
Various safe harbors that protect against civil and criminal sanctions
Emergency Medical Treatment and Active Labor Act (EMTALA)
Section 1867(a) of the Social Security Act
Requires hospitals that receive Medicare funding and have an emergency department (ED) to provide an
appropriate medical screening examination to any individual who comes to the ED and requests one.
Stabilizing treatment must be provided to individuals with an emergency medical condition
Violations are punishable with civil penalties, program exclusion, and private lawsuits brought against
individual hospitals
False Claims Act (FCA)
Prohibition against presenting a false claim to federal health care program – applies outside health care
as well
Health care action under FCA resulted in largest FCA settlement ever ($900 million)
Provides for civil and criminal penalties
Whistleblower (qui tam) actions: private individuals may file suit on behalf of the government under the
False Claims Act. The government may intervene, and the individual will share in any recovery, usually
15% to 30%
The Family and Medical Leave Act (FMLA)
29 U.S.C. Chapter 28
Requires employers of 50 or more employees to give up to 12 weeks of unpaid, job-protected leave to
eligible employees for the birth or adoption of a child or for the serious illness of the employee or a
spouse, child or parent and the Fair Labor Standards Act enforcing the minimum wage and overtime laws
Family Educational Rights and Privacy Act (FERPA)
20 U.S.C. §1232g; 34 CFR Part 99
FERPA is a federal law that protects the privacy of students’ “education records.”
Education records fall under an exception of what is considered protected health information under
HIPAA
Genetic Information Nondiscrimination Act (GINA)
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Genetic Information Nondiscrimination Act of 2008, Pub. L. 110-223, 122 Stat. 881, Title II codified at 42
U.S.C. 2000ff et seq. (2008)
GINA protects individuals against discrimination based on their genetic information in health coverage
and in employment
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Pub. L. No. 104-191, 110 Stat. 139 (1996)
HIPAA applies to most health care providers, health plans, and health care clearinghouses
Many elements of HIPAA
Confidentiality: governs how individually identifiable health information may be used and disclosed
Security: sets national standards for the security of electronic protected health information, including
administrative, physical, and technical safeguards to ensure the confidentiality of electronic health
information.
Breach Notification: requires covered entities and business associates to provide notification to
individuals and the government following a breach of unsecured protected health information
Health Information Technology for Economic and Clinical Health Act (HITECH)
Pub.L. No. 111-5, 42 U.S.C. § 300jj et seq.
Purpose is to improve health care quality, safety, and efficiency to promote the adoption and meaningful
use of health IT
Internal Revenue Service:
A large number of hospitals are exempt from federal income tax because they are organized and
operated exclusively for charitable purposes
A tax exempt organization can be a public charity or a private foundation (different tests and requirements
for each)
Cannot engage in activity that benefits private interests
Exempt hospitals must pay reasonable compensation to its employees
Medicare
Medicare is a federal health insurance program that pays for hospital and medical care for elderly and
certain disabled Americans
Medicare Part A helps pay for hospital stays, and Medicare Part B pays for other medical services, such
as physician visits, home health care, and durable medical equipment
Medicare Part C helps offer some flexibility with respect to an individual’s Medicare coverage, and
Medicare Part D offers prescription drug coverage
Medicaid
Medicaid is a program providing certain low-income individuals and families with health and medical
services
Primary oversight of the program is handled at the federal level, but each state administers its own
Medicaid program
As a result, each state’s Medicaid program is slightly different in terms of eligibility, services provided, and
payment rates
Physician Payments Sunshine Act
Section 6002 of the Affordable Care Act requires the establishment of a transparency program, now
known as Open Payments. The program increases public awareness of financial relationships between
drug and device manufacturers and certain health care providers
Applicable manufacturers of covered drugs, devices, biologicals, and medical supplies must report
payments or other transfers of value they make to physicians and teaching hospitals to CMS
Applicable manufacturers and applicable group purchasing organizations (GPOs) to report to CMS
certain ownership or investment interests held by physicians or their immediate family members
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Applicable GPOs to report to CMS payments or other transfers of value made to physician owners or
investors if they held ownership or an investment interest at any point during the reporting year
Physician Self-Referral (Stark Law)
42 U.S.C. § 1395nn
Prohibits physicians from referring patients to receive designated health services payable by Medicare or
Medicaid from entities with which they or their family members hold a financial interest and prohibits
service providers from billing for services performed as a result of such referrals
Strict liability offense
Punishable by program exclusion and substantial civil penalties
Various exceptions
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, Arizona
Prepared by Lex Mundi member firm Snell & Wilmer
1. Provide an introduction on health law in your jurisdiction.
Arizona has attempted to balance the interests of patients, health care providers, and the general
public within the bounds of a somewhat unique constitutional framework. Arizona’s constitution
explicitly prohibits any cap on damages for personal injuries (including medical malpractice). In
addition, the Arizona Constitution prohibits the abrogation of any cause of action in existence prior
to the constitution’s adoption. Thus, Arizona has had to find other ways to protect health care
providers from frivolous malpractice suits while ensuring high quality care and maintaining patients’
rights to redress in the event of a legitimate wrong. To serve these sometimes competing interests,
Arizona has enacted statutes governing the conduct of malpractice suits, protecting physician peer
review, and guarding students and trainees from malpractice liability.
In response to the out-of-control cost of medical malpractice insurance, Arizona has made some
progress toward achieving tort reforms that make the state hospitable to the practice of medicine
without limiting the availability of damages to legitimate plaintiffs. For example, there are stringent
practice and experience standards for qualification as an expert witness in a medical malpractice
action. In addition, a preliminary expert opinion affidavit must be filed shortly after the complaint in
any case requiring expert testimony. Failure to file this affidavit results in dismissal of the complaint.
Since the passage of these restrictions, the number of malpractice filings has decreased by
approximately 50%. At the same time, awards to successful malpractice plaintiffs have grown.
Some commentators believe this is an indication that these statutes have been successful in
limiting unfounded claims without stifling legitimately ones.
To improve patient safety and quality of care, Arizona requires health care organizations to engage
in peer review. While the contents of these reviews may be used for disciplinary purposes by the
state’s licensing boards, neither the contents nor the records of the reviews are admissible as
evidence in any court of law. Further, those who conduct peer reviews are not subject to liability
for the carrying out the reviews. These statutes allow for analysis and improvement of the delivery
of health care without creating increased liability exposure.
In addition to providing protections for licensed professionals, Arizona has made efforts to create a
welcoming legal climate for trainees. Students in state-accredited programs are immune from
liability to patients while the student is participating in supervised patient care. A final example of
Arizona’s attempts to promote the effective delivery of health care without increasing fear of liability
is the “apology law.” Under this law, an apology or other statement indicative of responsibility or
sympathy made by a health care provider to a patient or a patient’s family member is not admissible
as evidence of liability, or as an admission against the provider’s interest.
Arizona’s unique constitutional limitations make some of the medical tort reforms enacted in other
states impossible. However, Arizona has created a statutory framework that seeks to encourage
the effective practice of medicine without unjustly limiting the ability of malpractice victims to
effectively recover for their injuries. As a result, Arizona is generally hospitable to medical training
and practice, though without true tort reform.
2. Provide a check list of laws with a short summary of the general requirements of each.
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Relevant Provisions of the Constitution for the State of Arizona
Ariz. Const. art. II, § 31 – Arizona lawmakers are prohibited from enacting any law limiting the
amount of damages recoverable in a civil action for wrongful death or personal injury.
Ariz. Const. art. XVIII, § 6 – This so-called “Anti-Abrogation Clause” prohibits Arizona lawmakers
from eliminating any cause of action that existed prior to the constitution’s adoption.
Relevant Statutes
A.R.S. § 12-352(A) – Judgments in contested medical malpractice actions in Arizona courts accrue
interest at a rate that is one percentage point higher than the federal post-judgment interest rate,
not to exceed nine percent.
A.R.S. § 12-542 – The statute of limitations for medical malpractice actions in Arizona is two years
from when the cause of action accrues.
A.R.S. § 12-561 – “Medical malpractice action” is defined by statute in Arizona to mean action for
injury or death against a licensed healthcare provider for negligence or breach of contract.
A.R.S. § 12-563 – This provision partially codifies the elements of proof in a medical malpractice
action to require (i) failure by the health care provider to exercise the degree of care, skill and
learning expected of a reasonable, prudent, health care provider in the profession or class to which
he belongs within the state acting in the same or similar circumstances, and (ii) a demonstration
that such a failure was the proximate cause of the injury.
A.R.S. § 12-564 – In order to bring a medical malpractice action against medical students for
actions they took while under instruction and supervision of health care providers, a claimant must
prove gross negligence by clear and convincing evidence. In addition, medical students in such
circumstances owe no independent duty of care to the patient if acting under the supervision of a
licensed health care provider.
A.R.S. § 12-566 – No complaint in a medical malpractice action in Arizona may include a specific
figure for damages other than to show that the minimum jurisdictional amount in controversy is
present.
A.R.S. § 12-568 – Any party in a medical malpractice action may move the court to determine the
reasonableness of each party’s attorneys’ fees.
A.R.S. § 12-572 – Medical malpractice claims against health care professionals, hospitals, and
hospital agents who provide emergency medical treatment must be proven by clear and convincing
evidence.
A.R.S. § 12-2291(6) – Peer review materials and documents relating to utilization review or quality
assurance are exempt from the definition of “medical records” in Arizona’s evidentiary law that
restricts access to medical records in the course of litigation.
A.R.S. § 12-2294(C)(6) – Health care providers are authorized to disclose medical records,
payment records, and laboratory results without patient authorization except as restricted under
federal health care and privacy law.
A.R.S. § 12-2294.01(B) – A subpoena for medical records or related payment records in Arizona
must meet one or more of the following requirements: (i) the subpoena contains a written
authorization by the patient’s health care decision maker, (ii) it contains a court or tribunal order
authorizing disclosure, (iii) it is a grand jury subpoena issued in a criminal investigation, (iv) it is
issued by a health care professional regulatory board, or (v) another applicable law authorizes
disclosure.
A.R.S. § 12-2602 – A party who brings a claim against a health care professional must file and
serve a written certification that designates whether expert testimony will be required to prove the
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cause of action. If expert testimony is necessary, the party must file and serve a preliminary expert
opinion affidavit within sixty days from filing the designation. This affidavit must detail (i) the expert’s
qualifications, (ii) the factual basis for each claim, (iii) the health care professional’s acts giving rise
to each claim, and (iv) the manner in which the health care professional’s acts caused or contributed
to claimed damages. If the party certifies that expert testimony is not necessary, the health care
professional defendant may move the Court to require the party to obtain an expert report.
A.R.S. § 12-2604 – In order to provide expert testimony in a medical malpractice action, an expert
must be a licensed health care professional in Arizona or another state and have devoted a majority
of the previous year of her time to the active clinical practice of medicine or the instruction of medical
students in qualifying, accredited medical research and training programs.
A.R.S. § 12-2605 – This so-called “Apology Law” provides that any expressions of sympathy by a
health care provider to a patient or a patient’s loved ones for an unexpected outcome of medical
care is inadmissible as evidence of an admission of liability in a medical malpractice action.
A.R.S. § 12-2802(A)(8) – Genetic test results may be released only in limited circumstances,
including to health care providers for the purpose of conducting peer review.
A.R.S. § 32-1407(17) – “Medical peer review” is defined under Arizona law as both (i) participation
by doctors in evaluation of patient management and patient care resources and (ii) activities related
to a health care institution’s decisions to grant privileges to practice at that institution.
A.R.S. § 36-445 – The governing body of each licensed hospital or outpatient surgical center in
Arizona shall require physicians admitted to practice at those facilities to participate in organized
peer review.
A.R.S. § 36-445.01 – Proceedings, records, and materials prepared in connection with medical
peer review are confidential and not subject to discovery except in certain licensing or privileging
actions.
A.R.S. § 36-445.02 – Individuals who participate in medical peer review are not liable in civil actions
for such participation. Health care facilities are liable only in actions for injunctive relief in
connection with the performance or nonperformance of duties related to medical peer review.
A.R.S. § 36-445.03 – Peer review results are not to be published except as provided by statute,
and patient identities must be kept absolutely confidential.
A.R.S. § 36-501 – Materials prepared in connection with peer review are exempt from the definition
of “records” under the mental health services chapter of Arizona health care law.
A.R.S. § 36-509(A)(19) – Health care entities are authorized to disclose medical records to a
person or entity for the purpose of conducting peer review.
A.R.S. § 36-2401(1)(d) – Peer review organizations are included in the definition of “health care
entity” for purposes of Arizona health care quality assurance statutes.
Selected Case Law
Seisinger v. Siebel, 220 Ariz. 85, 96, 203 P.3d 483, 494 (2009): Necessary elements detailed in
the expert qualification statute, A.R.S. § 12-2604, are substantive, rather than procedural rules and
are therefore not subject to attack under the Separation of Powers Doctrine.
Duncan v. Scottsdale Med. Imaging, Ltd., 205 Ariz. 306, 314, 70 P.3d 435, 443 (2003): The
Anti-Abrogation Clause of Arizona’s Constitution prohibits the Legislature from eliminating a
patient’s right to bring a simple battery action against a health care provider.
Shoeneweis v. Hammer, 223 Ariz. 169, 173-175, 221 P.3d 48, 52-54 (Ct. App. 2009): Arizona’s
restriction on discovery of medical records does not apply to autopsy reports or death certificates.
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Litigants must cite specific statutory and common law privileges against disclosure in light of
Arizona’s robust policy in favor of public records disclosure.
DeBoer v. Brown, 138 Ariz. 168, 170-71, 673 P.2d 912, 914-15 (1983) (en banc): The statute of
limitations for Arizona medical malpractice actions does not begin to accrue until the patient’s injury
resulting from the malpractice has begun to manifest.
Walk v. Ring, 202 Ariz. 310, 314-17, 44 P.3d 990, 994-97 (2002) (en banc): Whether a plaintiff in
a medical malpractice action reasonably should have known that she was injured within the
meaning of the statute of limitations is typically a question of fact for the jury.
Cornerstone Hosp. of Se. Arizona. L.L.C. v. Marner ex rel. Cnty. of Pima, 231 Ariz. 67, 290
P.3d 460, (Ct. App. 2012): Regarding Arizona statutes setting the manner and qualifications of
necessary expert testimony in medical malpractice actions, the same requirements apply to any
cause of action premised on allegations of medical negligence. In addition, a registered nurse (RN)
may qualify to testify about the standard of care applicable to a licensed practical nurse (LPN) or
certified nurse assistant (CAN).
Goodman v. Good Samaritan Health Sys., 195 Ariz. 502, 507-08, 990 P.2d 1061, 1066-67 (Ct.
App. 1999): Statutory grant of immunity for participation in medical peer review does not violate
the Anti-Abrogation Clause of Arizona’s Constitution.
Hourani v. Benson Hosp., 211 Ariz. 427, 432-35, 122 P.3d 6, 11-14 (Ct. App. 2005): Under
A.R.S. § 36-455.02(B), physicians may bring an action for injunctive relief to correct an erroneous
decision or procedure in peer review proceedings.
Peterson v. Tucson Gen. Hosp., Inc., 114 Ariz. 66, 72, 559 P.2d 186, 192 (Ct. App. 1976)
(quoting Sosa v. Bd. Of Mgrs. Of Val Verde Mem. Hosp., 437 F.2d 173 (5th Cir. 1971)): Hospital
properly denied physician’s reapplication for staff privileges. “The evaluation of professional
proficiency of doctors is best left to the specialized expertise of their peers, subject only to limited
judicial surveillance.”
3. Provide any special issues which arise in your jurisdiction.
Preliminary Expert Opinion Affidavit Certification
In Arizona, if a claim is asserted against a licensed professional in a civil action, the claimant must
file with the complaint a written statement certifying whether or not expert opinion testimony is
necessary to prove the licensed professional’s standard of care or liability for the claim. See A.R.S.
§ 12-2603.
Expert Witness Qualifications
In a medical-malpractice action, an expert witness must meet the criteria provided in A.R.S. § 122604(A), which include specializing in the same specialty or claimed specialty as the party against
whom the testimony as offered, and devoting a majority of their time in the year immediately before
the occurrence giving rise to the suit to either (1) active clinical practice in the same profession as
the defendant; or (2) instruction of students in an accredited health professional school or residency
in the same health profession as the defendant. Seisinger v. Siebel, 220 Ariz. 85, 203 P.3d 483
(Ariz. 2009) (en banc) (upholding constitutionality of A.R.S. § 12-2604 when challenged for
conflicting with Arizona Rule of Evidence 702 and violating the separation of powers doctrine); see
also Baker v. University Physicians Healthcare, 231 Ariz. 379, 296 P.3d 42 (Ariz. 2013) (en banc)
(upholding constitutionality of A.R.S. § 12-2604 when challenged for violating equal protection and
right of access to the court provisions).
Distinction Between Treating Physician as Fact Witness vs. Expert Witness
A treating physician giving testimony related to care and treatment of a patient is not automatically
an expert witness in Arizona. In Montgomery v. Whitten, 228 Ariz. 17, 262 P.3d 238 (Ariz. Ct. App.
2011), a criminal proceeding, the Court of Appeals noted that asking a treating physician the “who,
what, when, where, and why” regarding his own patient and medical records will generally elicit
fact-based testimony that has been acquired independent of the litigation, the parties, or the
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attorneys. The Whitten court thus found the treating physician to be a fact witness not entitled to
an expert witness fee. The Whitten court set forth the procedure to be followed to determine
whether a treating physician is a fact witness or an expert witness: prior to trial, the parties must
determine and disclose the capacity in which the physicians will be called as trial witnesses. These
disclosures will then dictate the parameters of the physician’s trial testimony. The Court of Appeals
followed suit in Sanchez v. Gama, 233 Ariz. 125, 310 P.3d 1 (Ariz. Ct. App. 2013), and ruled that
Whitten is also applicable to treating physicians in civil litigation.
Disclosure of Medical Records
Whether evidence, specifically medical/treatment records, sought under the Uniform Act to Secure
the Attendance of Witnesses from Without a State in Criminal Proceedings is privileged or protected
from disclosure is a determination for the state court requesting the summons, not for the state
court issuing the summons. Johnson v. O’Connor ex rel. Cnty., 235 Ariz. 85, 327 P.3d 218 (Ariz.
Ct. App. 2014). Thus, in Arizona, a summons for medical/treatment records can be issued under
the Uniform Act, and such records disclosed out-of-state, even if they are privileged.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
While U.S. federal agencies are in the process of developing regulations for mobile health applications,
currently there are no Arizona-specific laws or regulations for them.
Contact Information
Barry D. Halpern
Partner, Health Care Services Practice Group Leader
[email protected]
Snell & Wilmer
One Arizona Center
400 E. Van Buren Street
Phoenix, AZ 85004
USA
Tel 602.382.6345 Fax 602.382.6070
www.swlaw.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, Colorado
Prepared by Lex Mundi member firm Davis Graham & Stubbs LLP
1.
Background
Health care in Colorado is shaped by the State’s geography. Like many other states in the West, Colorado
is rural, with its eastern and western regions divided roughly in half by the north-south running Rocky
Mountains. Colorado’s main population centers are located along Interstate 25 at the base of the eastern
side of the mountains, including the largest in Denver, a metropolitan statistical area of approximately 2.6
million people. Grand Junction is the largest city on the Western Slope, with roughly 60,000 inhabitants.
Colorado has a relatively small but solid healthcare market for its size, owing perhaps to its rural character,
with a growing level of biotech activity in the Denver-Boulder corridor in recent years. Healthcare
professionals are educated at the University of Colorado at Denver School of Medicine, Rocky Vista
University College of Osteopathic Medicine, and the Colorado School of Public Health (University of
Colorado at Denver).
According to a recent study by the Colorado Health Foundation, in cooperation with the Colorado Health
Institute, the state ranks in the top third among all states in broad population health measures of
adolescents, adults, and the elderly, and ranks in the middle of the pack when it comes to infants and
children. The incidence of juvenile diabetes has come to the attention of public health officials in recent
years.
The payer mix among insured Colorado residents is typical of the Nation’s average. According to a recent
Colorado Health Access survey, 59% of the population has employer sponsored insurance. 1 in 5 Colorado
residents is enrolled in a public program such as Medicare, Medicaid, CHP+, or Tricare, and 1 in 7 Colorado
residents lack insurance altogether.
The Accountable Care Collaborative (ACC) is Colorado Medicaid's primary health care program. Care is
delivered through seven Regional Care Collaborative Organizations (RCCO), which connect Medicaid
clients to Medicaid providers and helps clients find community, behavioral and social services in the region.
Three of the regions are coordinated by Colorado Access, and the other regions are coordinated by Rocky
Mountain Health Plans, Integrated Community Health Partners, Colorado Community Health Alliance, and
Community Care.
As recently as 2011, there were 13,000 total active physicians (M.D. and D.O.) in the State. 3,300 of those
physicians practice primary care, and the State has roughly 2,500 active nurse practitioners and physician
assistants.
There are over 100 hospitals and health systems in Colorado, with the 70 or so hospitals participating in a
2013 Colorado Hospital Association survey having almost 11,000 licensed beds among them. Roughly 40
are rural hospitals, and 29 of those are designated as Critical Access. Many of the rural hospitals are
county-owned or owned by hospital districts. Unsurprisingly, rural hospitals are often the main employer in
the community. Colorado also has 18 Federally-Qualified Health Centers (FQHCs), according to 2012
grantee statistics reported by HRSA.
2.
Major health legislation in Colorado in the last 5 years
a.
AURORA THEATER SHOOTING
On July 1, 2014, House Bill 14-1271 became law, which expands a mental health provider’s duty to warn
against the violent behavior of a person receiving treatment from the provider to include persons identifiable
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by their association with a specific location or entity, such as a movie theater. The law also extends civil
immunity to mental health providers for failing to warn or protect a specific person or persons identifiable
by their association with a specific target against the violent behavior of a person receiving treatment from
the provider, and the provider “must not be held civilly liable for failure to predict such violent behavior
except where the patient has communicated to the mental health provider a serious threat of imminent
physical violence. . . .” Colo. Rev. Stat. § 13-21-117(2)(a). The new law puts to rest any uncertainty about
whether mental health providers have a duty to warn about against the violent behavior of a person
receiving treatment from the provider when the threat is directed at a specific location or entity, rather than
a specific person or persons.
b.
AMENDMENT TO COLORADO RULE OF CIVIL PROCEDURE 45
On January 1, 2013, Colorado Rule of Civil Procedure 45 was repealed and readopted with changes by the
Colorado Supreme Court reflected in Rule Change 2012(16). The rule change is significant for health care
providers. If a subpoena commands production of records from a person who provides services subject to
the physician-patient privilege established by Colo. Rev. Stat. § 13-90-107, or from the records custodian
for that person, the subpoena must be accompanied by an authorization signed by the patient or by a court
order authorizing production of such records. C.R.C.P. 45(c)(2)(B)(i). If a subpoena for privileged records
does not include a signed authorization or court order permitting the privileged records to be produced by
means of subpoena, the subpoenaed person “shall not appear to testify and shall not disclose any of the
privileged records to the party who issued the subpoena.” C.R.C.P. 45(c)(2)(B)(iii). Prior to this change,
no such provision existed in Rule 45, making health care providers’ (and their counsel) appearances in
court a frequent occurrence.
c.
STATE-RUN INSURANCE EXCHANGE (SENATE BILL 11-200)
Colorado was one of a handful of states around the Nation that decided to set up the state’s own health
insurance exchange after the Affordable Care Act was enacted. In 2011, Colorado passed Senate Bill 11200, which created a process for the implementation of the Colorado Health Benefit Exchange by
establishing the exchange's governance structure. The bill established the exchange as a nonprofit public
entity with a board of directors responsible for its operation. The exchange now operates under the name
“Connect for Health Colorado.” Senate Bill 11-200 also established the Legislative Health Benefit Exchange
Implementation Review Committee to guide the operation of the fledgling exchange.
d.
HEALTH INFORMATION EXCHANGES
Colorado has two regional health information exchanges (HIE), one on the Front Range and the other on
the Western Slope. In 2009, the HITECH Act provided approximately $36 billion for health information
technology nationwide. The non-profit Colorado Regional Health Information Organization (CORHIO) was
designated by the State of Colorado as the “state-level entity” to receive almost $11 million in HITECH
funds to facilitate cost-effective and secure implementation of health information exchange (HIE). Since
that time, CORHIO has been working towards linking to non-profit Quality Health Network, a fully functioning
regional HIE in western Colorado. CORHIO's long-term sustainability is dependent upon a fee-based
subscription model.
e.
MEDICAID REFORM AND ACCOUNTABLE CARE ORGANIZATIONS
In 2008, Colorado’s General Assembly passed Senate Bill 09-259, the Medicaid Value-Based Care
Coordination Initiative (now known as the Accountable Care Collaborative Program) as part of the FY 2009
budget request for Colorado’s single state agency, the Department of Health Care Policy and Financing
(HCPF). Under the Accountable Care Collaborative Program, HCPF contracts with seven regional
organizations to create networks of primary care providers and ensure care coordination for Medicaid
enrollees. Providers receive increased payments, and will eventually be eligible for incentives and shared
savings and risk agreements. According to a 2013 Commonwealth Fund study, results from November
2012 show reduced use of acute care, better control of chronic conditions, and lower total costs among
enrollees.
f.
RECREATIONAL MARIJUANA
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While only tangentially related to health law, the legalization of recreational marijuana in Colorado has had
at least one unforeseen effect on health care in the state. Initially, policymakers thought that medical
marijuana patients would begin to purchase marijuana in the retail market, but, as a recent study by the
Marijuana Policy Group prepared for the Colorado Department of Revenue notes, “it is increasingly clear
that this conversion will not occur as long as the large price differential persists and as long as retail
marijuana is not available in as many jurisdictions as medical marijuana.” Medical marijuana is taxed at
2.9 percent; retail marijuana is taxed at 15 percent on the wholesale level and 12.9 percent at the retail
level. In addition, medical marijuana patient licensing fees have declined to $15 plus doctor fees.
Provide a check list of laws with a short summary of the general requirements of each
1.
Licensure and Self-Regulation
a.
DIVISION OF PROFESSIONS AND OCCUPATIONS, COLO. REV. STAT. TITLE 12
All of the regulatory boards for healthcare professionals are located within the State of Colorado Department
of Regulatory Agencies (DORA), Division of Professions and Occupations, Title 12, Articles 29 through
43.9: http://cdn.colorado.gov/cs/Satellite/DORA-Reg/CBON/DORA/1251614750513
b.
PEER REVIEW AND PATIENT SAFETY
i.
Colorado’s Peer Review Statute, Colo. Rev. Stat. §§ 12-36.5-101 to -107
Title 12 is also home to Colorado’s peer review statute. The peer review statute was amended in 2012 to
apply to physician assistants and advanced practice nurses licensed pursuant to Articles 36 and 38 of Title
12, respectively. Prior to amendment, the use of peer review committees was limited to physicians.
The peer review statute is typical of the model act from the key perspectives of confidentiality of the
proceedings, and immunity from suit for the committee members and persons supplying information for the
proceedings. Peer review committees are required to register with DORA, and a list of those registered
committees
can
be
accessed
here:
http://www.dora.state.co.us
/pls/prcweb/prc_public_gui.committee_report_2
ii.
Patient Safety Organizations in Colorado
According to AHRQ, there were 42 Federally-listed Patient-Safety Organizations (PSO) that operate in
Colorado in September, 2014. A health care provider can only obtain the confidentiality and privilege
protections of the federal Patient Safety Act by working with a Federally-listed PSO. A list of Federallylisted PSOs covering Colorado can be accessed here: https://www.pso.ahrq.gov/listed
c.
110
MICHAEL SKOLNIK MEDICAL TRANSPARENCY ACT OF 2010, COLO. REV. STAT. § 24-34-
Also known as the act that authorized Colorado’s “Healthcare Professions Profiling Program,” each
healthcare professional listed in the Act who applies for a “new license, certification, or registration or to
renew, reinstate, or reactivate a license, certification, or registration” must provide to DORA detailed
information regarding, but not limited to, medical licenses ever held, current and active board certifications,
specialties, affiliations with hospitals and health-care facilities, business ownership in any business whose
mission relates to providing healthcare services or products, employment contracts related to healthcare,
disciplinary actions, actions against medical privileges, criminal conviction or plea arrangements, and
resolution of medical malpractice claims. The amount of any funds paid to resolve medical malpractice
claims is not required to be reported under the Act.
Reporting for most healthcare professionals has been in effect for several years. In 2014, Senate Bill 13026 amended the Act to add the following professions to the profiling program: athletic trainers, certified
nurse aides, massage therapists, occupational therapists, pharmacists, psychiatric technicians, respiratory
therapists, and surgical assistants.
2.
Kickbacks and fee-splitting
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a.
REPEALED ANTI-KICKBACK PROVISIONS OF COLORADO’S MEDICAL ASSISTANCE ACT
(MEDICAID/CHP+)
In 2010, the Colorado’s General Assembly enacted Senate Bill 10-167, which removed the anti-kickback
provisions of the state Medical Assistance Act previously codified at Colo. Rev. Stat. § 25.5-4-305. Prior
to this removal, Colorado’s law was consistent with the federal anti-kickback statute, prohibiting any
remuneration in return for referrals for any items or services reimbursable by Medicaid.
b.
ANTI-CORRUPTION & GRAFT, COLO. REV. STAT. § 25-1-114 AND § 25-1-516
It is unlawful for an officer or employee of Colorado’s Department of Public Health and Environment
(CDPHE) or any local, county or regional public health agency or board to accept any gift, remuneration, or
other consideration, directly or indirectly, for incorrect or improper performance of his or her public duties.
The reverse is also prohibited; a person, association or corporation, or officer thereof, may not pay, give,
present or convey to any of these health officers, employees or members “any gift, remuneration, or other
consideration” either directly or indirectly, in an effort to induce these public officials to improperly perform
his or her duties. Violations are punishable by a fine up to $5,000, imprisonment for up to eighteen months,
or both.
c.
FEE-SPLITTING
i.
Acupuncturists, Colo. Rev. Stat. § 12-29.5-106
Colorado law prohibits an acupuncturist from offering or accepting commissions, rebates, or other forms of
remuneration for the referral of a client. Acupuncturists may pay an independent advertising or marketing
agent compensation for advertising or marketing services, including compensation which is paid for the
results of performance of such services on a per patient basis. The director of the division of professions
and occupations may deny licensure or take disciplinary action against an acupuncturist for violations.
ii.
Chiropractors, Colo. Rev. Stat. § 12-33-117
This provision prohibits a chiropractor from offering, giving, or receiving commissions, rebates, or other
forms of remuneration for the referral of clients. However, chiropractors are allowed to compensate an
independent advisory or marketing agent for advertising or marketing services, which services may include
the referral of patients through such services. A chiropractor may also give an incidental gift to a patient in
appreciation for a referral. Upon any violation, the state board of chiropractic examiners may issue a letter
of admonition, or revoke, suspend, deny, refuse to renew, or impose conditions on a chiropractor’s license.
In addition to these penalties, the board may also impose a fine of no less than $1,000 for the first violation
and additional fines for subsequent violations.
iii.
Dentists and Dental Hygienists, Colo. Rev. Stat. § 12-35-129
The board of dentistry may deny the issuance or renewal of, suspend, or revoke a dental license, or may
reprimand, censure, place on probation, or issue a letter of admonition to, any dentist or dental hygienist
who shares professional fees with anyone except those with whom he/she is lawfully associated in the
practice of dentistry or dental hygiene. A dentist or dental hygienist is permitted to pay an independent
advertising or marketing agent compensation for advertising or marketing services, including compensation
which is paid for the results of performance of such services on a per patient basis.
iv.
Medical Practice, Colo. Rev. Stat. § 12-36-125 to -127
Anyone licensed by the state medical board is prohibited from compensating, through splitting fees or
compensation for his/her services, or through other direct or indirect means, any person, firm, association,
or corporation compensation for the referral of a client. A licensee may, however, pay an independent
advertising or marketing agent compensation for services rendered on his/her behalf, including
compensation which is paid for the results of performance on a per patient basis.
A violation of the law is a class 3 misdemeanor, punishable by up to 6 months in prison, or a $750 fine, or
both, and constitutes grounds for the suspension or revocation of a license or placing the licensee on
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probation. The person who paid such fee or compensation to the licensee may recover the amount
unlawfully paid from either the licensee or from the person to whom such fee or compensation has been
paid. It is also a class 3 misdemeanor, punishable by up to 6 months in prison, or a $750 fine, or both, for
any person, firm, association, or corporation that directly or indirectly receives any pay or compensation
given or paid by a licensee for the referral of a client.
v.
Mental Health Practitioners, Colo. Rev. Stat. § 12-43-222
Colorado law prohibits mental health practitioners, including psychologists, social workers, marriage and
family therapists, and licensed professional counselors, from offering or giving commissions, rebates, or
other forms of remuneration for the referral of clients. However, the law allows the payment of compensation
to an independent advertising or marketing agent for services rendered on the practitioner’s behalf,
including payment for the results of such services on a per patient basis. Violations shall be prima facie
evidence of grounds for disciplinary action, including denial of licensure.
vi.
Optometrists, Colo. Rev. Stat. § 12-40-118
It is unlawful to employ or offer compensation or merchandise of value to any salesman, runner, patient, or
other person to induce that person to assist in the solicitation of patronage. Sharing any professional fees
with any person, partnership, or corporation which sends or refers patients to the optometrist, except with
licensed optometrists with whom the optometrist may be associated in practice, is also prohibited.
vii.
Physical Therapists, Colo. Rev. Stat. § 12-41-115
A physical therapist is prohibited from offering, giving or receiving commissions, rebates, or other forms of
remuneration for the referral of clients. However, physical therapists may compensate an independent
advertising or marketing agent, including compensation for referrals of clients identified through such
services on a per client basis. A violation of this prohibition may result in letters of admonition, revocation,
or suspension of the physical therapist’s license, probation, or the imposition of a public censure or fine.
viii.
Podiatrists, Colo. Rev. Stat. § 12-32-107 and § 12-32-117
A podiatrist is prohibited from compensating, through splitting fees or compensation for his/her services, or
through other direct or indirect means, any person, firm, association, or corporation compensation for the
referral of a client. Violation is a class 3 misdemeanor, punishable by up to 6 months in prison, or a $750
fine, or both. Additionally, the Colorado podiatry board may refuse to issue or may revoke, suspend, or
refuse to renew a license to practice podiatry, or may issue a letter of admonition or a letter of concern, or
place the podiatrist on probation, for such offense.
3.
“Mini-Stark” and Referral Laws
a.
MINI-STARK, COLORADO MEDICAL ASSISTANCE ACT, COLO. REV. STAT. § 25.5-4-414
Colorado’s “mini-Stark” statute generally prohibits a Medicaid provider from making a referral to an entity
in or with which the provider or an immediate family member of the provider has a “financial relationship.”
However, this rule does not apply to any financial relationship that meets the requirements of an exception
under federal law or that would not violate federal law if the services were eligible for payment under
Medicare. An entity that provides designated health services as a result of a prohibited referral is prohibited
from billing the state or anyone else for the designated health services.
b.
16
REPEAL OF MANAGED CARE REFERRAL REGULATION, 3 COLO. CODE REGS. § 702-4:4-2-
Prior to January 1, 2014, Colorado’s Division of Insurance prohibited managed care plans from financially
penalizing, sanctioning, terminating, or rewarding a participating provider for making referrals based on the
volume and/or consequent expenditures incurred as a result of that provider’s referrals to participating
obstetricians, gynecologists, or certified nurse midwives.
4.
Fraud & Abuse
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a.
COLORADO MEDICAID FALSE CLAIMS ACT, COLO. REV. STAT. §§ 25.5-4-304 TO -310
In the last 4 years, Colorado’s General Assembly has amended and expanded the existing provisions of
Colorado law related to false Medicaid claims a number of times. As a result, Colorado’s law is now mainly
consistent with the federal False Claims Act.
Any person who knowingly violates the Colorado Medicaid False Claims Act (CMFCA) is subject to a civil
penalty of not less than $5,500 and not more than $11,000, plus treble damages. Id. These damages and
penalties apply to any violation regardless of the degree of scienter, as the statute defines “knowing” as (1)
having actual knowledge of the information; (2) acting in deliberate ignorance of the truth or falsity of the
information; or (3) acting in reckless disregard of the truth or falsity of the information. Colo. Rev. Stat. §
25.5-4-304(3)(a). “Knowing” does not require proof of specific intent to defraud. Id. § 25.5-4-304(3)(b).
Actions may be brought for violations of this law by either the Attorney General or by private individuals as
relators on behalf of the state in qui tam actions. Colo. Rev. Stat. § 25.5-4-306. If the state does not
intervene in the action brought by a relator, the relator may recover between 25% and 30% of the proceeds
of the action or settlement, plus reasonable expenses, attorneys’ fees and costs. Id. § 25.5-4-306(4)(b). If
the state does intervene in the action, the relator may recover between 15% and 25% of the proceeds of
the action or settlement, depending on the extent to which the relator substantially contributed to the
prosecution of the action. Id. § 25.5-4-306(4)(a)(I). Additionally, if the court finds the action based primarily
on information or disclosures other than the information provided by the relator, the relator may recover no
more than 10% of the proceeds of the action or settlement. Id. § 25.5-4-306(4)(a)(II).
The CMFCA allows a whistleblower “employee, contractor, or agent” to bring a private cause of action for
retaliation or discrimination to get all relief necessary to make the relator “whole,” including reinstatement
at the same seniority status the whistleblower would have had but for the discrimination, twice the amount
of back pay, and interest on the back pay, as well as compensation for special damages, including litigation
costs and attorneys’ fees. Colo. Rev. Stat. § 25.5-4-306(7).
This law gives Colorado’s Attorney General broad authority to investigate false Medicaid claims, including
the powers to issue subpoenas for documents and testimony pursuant to a civil investigative demand, and
to file lawsuits to enforce a civil investigative demand. Colo. Rev. Stat. § 25.5-4-309. Additionally, the
Attorney General must file a written report to the state legislature annually with information regarding actions
and amounts recovered in the previous year pursuant to the CMFCA. Id. § 25.5-4-310. Curiously,
information about the Attorney General’s recent activities under the CMFCA is more easily obtainable on
the web via the Medicaid Fraud Control Units FY2013 Annual Report by HHS OIG to Congress than through
the state’s information systems. In FY2013, HHS OIG reports that Colorado’s Attorney General opened
241 Medicaid fraud investigations, which resulted in 18 indictments, 13 criminal convictions, and 36 civil
settlements.
b.
INSURANCE FRAUD, COLO. REV. STAT. § 10-1-128
With regard to health professions and occupations, a fraudulent insurance act is committed if a person
knowingly, and with intent to defraud, presents any written statement in regard to the insurance (including
a claim for payment) that the person knows to contain false information concerning any material fact, or
knowingly or with intent to defraud conceals any information.
c.
CRIMINAL WAIVER OF COPAYS AND DEDUCTIBLES, COLO. REV. STAT. § 18-13-119
This provision of Colorado’s Criminal Code states that eliminating a patient’s healthcare plan copayment or
deductible is an abuse of health insurance if the healthcare provider (1) accepts the amount paid by a thirdparty payer as payment in full for services rendered; or (2) submits a fee to a third-party payer which is
higher than the fee he has agreed to accept from the insured patient with the understanding of waiving the
required deductible or copayment. A violation of this prohibition is classified as an abuse of health
insurance—a class 1 petty offense—carrying a fine up to $500 or imprisonment up to 6 months, or both.
Though this issue has attracted plenty of analysis under Stark, Colorado appears to be among a small
minority of states with separate provisions that criminalize such conduct.
The Criminal Code provision exempts reimbursements made pursuant to Colorado’s Medical Assistance
Act and Indigent Care Program, federal Medicare laws for inpatient hospitalization, and community mental
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health services purchased in accordance with article 66, title 27, Colorado Revised Statutes. In addition,
the following are exempt from the prohibition: (1) payments made in accordance with a contract between
an employer and an employee when the contract includes as part of an employee’s salary or employment
benefits terms that authorize a practice that would otherwise be prohibited by the statute; (2) payments
made in accordance with a contract between a town, city, city and county, or municipality or “special health
assurance district,” under terms that authorize a practice that would otherwise be prohibited by the statute;
(3) the waiver of any required deductible or copayment for charitable purpose, with certain limiting
requirements; and (4) the waiver of a required deductible or copayment for healthcare services provided by
a school-based health center, as defined in Colo. Rev. Stat. § 25-20.5-502.
Colorado’s Department of Public Health and Environment has the power to suspend, revoke, or refuse to
renew any license to a health facility if the facility has committed abuse of health insurance pursuant to
Colo. Rev. Stat. § 18-13-119, or if the facility has advertised that it will perform any act prohibited by that
statute. Colo. Rev. Stat. § 25-1.5-103(b). The regulatory boards of acupuncturists, podiatrists,
chiropractors, dentists and dental hygienists, medical practitioners, nurses, nursing home administrators,
optometrists, physical therapist, respiratory therapists, and mental health practitioners are similarly
empowered to take disciplinary action against a practitioner who commits abuse of health insurance or
insurance fraud, as set forth in § 18-13-119 or § 10-1-128, or who advertises that the practitioner will perform
an act that constitutes an abuse of health insurance.
A group of chiropractors who were charged criminally for regularly advertising their willingness to waive
payments of copayments and deductibles challenged the constitutionality of the criminal statute prohibiting
waivers of copayments and deductibles in the case of Parrish v. Lamm, 758 P.2d 1356 (Colo. 1988). The
Colorado Supreme Court concluded that the statute did not violate either the state or federal Constitutions,
and affirmed the district court’s ruling upholding the statute.
d.
COLORADO MEDICAID PROGRAM INTEGRITY – 10 COLO. CODE REGS. § 2505-10:8.076
i.
Prohibited Acts
The Colorado Medicaid program integrity regulations define a “false representation” as “an inaccurate
statement that is relevant to a claim for reimbursement and is made by a Provider who has actual knowledge
[that the statement is false]” or who acts “with deliberate ignorance of or with reckless disregard for the truth
of the statement.” 10 Colo. Code Regs. § 2505-10-8.076.1. The regulations state further that a provider
submits a claim with reckless disregard or deliberate ignorance “if the Provider fails to maintain records
required by the Department” or fails to become familiar with the Department’s rules, manuals, and bulletins.
Id.
ii.
Enforcement and Penalties
During an investigation of alleged false claims, Medicaid payments may be withheld if there is reliable
evidence “that the circumstances giving rise to the need for a withholding of payments involve fraud or
willful misrepresentation under the Medical Assistance program.” 10 Colo. Code Regs. § 2505-108.076.4.A. Payments may be withheld without first notifying the provider of the Department’s intention to
withhold such payments, but the provider will be granted appeal rights upon request. Id. Following
confirmation of false claims, the Department can terminate a provider’s participation agreement in the
Medicaid program. Id. § 2505-10-8.076.5.A.
e.
BALANCE BILLING, COLO. REV. STAT. § 25.5-4-301
A provider of medical services is generally prohibited from receiving or seeking to collect any costs of
providing medical service after Medicare, Medicaid, or a private insurer authorized under Medicaid has paid
for the service. Colo. Rev. Stat. § 25.5-4-301(1)(a)(I). Any provider who knowingly violates this rule “shall
be liable for the amount unlawfully received, statutory interest on the amount received from the date of
receipt until the date of repayment, plus a civil monetary penalty equal to one-half of the amount unlawfully
received.” Id. § 25.5-4-301(1)(a)(II.5)(A). This rule applies “regardless of whether Medicaid has actually
reimbursed the provider and regardless of whether the provider is enrolled in the Colorado medical
assistance program.” Id. § 25.5-4-301(1)(a)(II).
f.
NETWORK ADEQUACY, COLO. REV. STAT. § 10-16-704
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Although balance billing generally is prohibited, there are certain circumstances in which it is permitted.
Under Colorado’s Network Adequacy scheme, insurance companies are required to “maintain a network
that is sufficient in numbers and types of providers to assure that all covered benefits to covered persons
will be accessible without unreasonable delay.” Colo. Rev. Stat. § 10-16-704(1). However, when an insured
declines to use a participating provider and knowingly uses a nonparticipating provider, the insurance
company may balance bill the insured the portion of the bill not equal to the provider’s billed charges. Id. §
10-16-704(2)(k).
g.
OFFERING A FALSE INSTRUMENT FOR RECORDING, COLO. REV. STAT. § 18-5-114
It is unlawful to present or offer a written instrument that “contains a material false statement or material
false information . . . to a public office or a public employee, with the knowledge or belief that it will be
registered, filed, or recorded or become a part of the records of that public office or public employee.” Colo.
Rev. Stat. § 18-5-114. A person who violates this statute knowingly and with intent to defraud is guilty of a
felony. Id. § 18-5-114(2). A person who knowingly violates this statute without intent to defraud is guilty of
a misdemeanor. Id. § 18-5-114(4).
5.
Consumer Protection and Trade
a.
UNFAIR PRACTICES ACT, COLO. REV. STAT. §§ 6-2-101 TO -117.
The Unfair Practices Act prohibits the secret payment or allowance of rebates, refunds, commissions, or
unearned discounts where such payment or allowance tends to destroy competition. Colo. Rev. Stat. § 62-108. The Act further prohibits secretly extending special services or privileges not extended to all
purchasers, to the injury of a competitor. Id. Additionally, the Act prohibits “any person, partnership, firm,
corporation, joint stock company, or other association engaged in business within [Colorado] to sell, offer
for sale, or advertise for sale any product or service for less than the cost of the product or service with the
intent to both injure competitors and destroy competition and where the likely result of such sale would be
the acquisition or maintenance of a monopoly.” Id. § 6-2-105(1). Penalties for violations of these
prohibitions include fines and imprisonment up to six months. Id. Any contract—express or implied—in
violation of the Unfair Practices Act is void as an illegal contract. Id. § 6-2-109.
b.
COLORADO CONSUMER PROTECTION ACT: DECEPTIVE TRADE PRACTICES, COLO. REV.
STAT. § 6-1-105
The Colorado Consumer Protection Act defines deceptive trade practices broadly, including “knowingly
mak[ing] a false representation as to the characteristics, ingredients, uses, benefits, alternations, or
quantities of goods, food, services, or property.” Colo. Rev. Stat. § 6-1-105(1)(e).
c.
COLORADO ANTITRUST ACT OF 1992, COL. REV. STAT. §§ 6-4-101 TO -122
Colorado’s antitrust law is unremarkable. Moreover, Colorado’s Attorney General has not been very
aggressive about enforcing state antitrust laws, which means that antitrust matters in Colorado are largely
a function of federal law.
d.
ALL PAYER CLAIMS DATABASE, COLO. REV. STAT. § 25.5-1-204
In 2013, the General Assembly authorized the formation of an advisory committee for the all-payer health
claims database to support the Department of Health Care Policy and Financing and the database in the
mission of facilitating the reporting of health care and health quality data that results in transparent and
public reporting of safety, quality, cost, and efficiency information, as well as analysis of health care
spending and utilization patterns. Colo. Rev. Stat. § 25.5-1-204(1). The all-payer claims database became
operational in 2012, and is available to insurers, consumers, employers, providers, purchasers of health
care, and state agencies as a resource to allow for continuous review of health care utilization,
expenditures, and quality and safety performance in Colorado. Id. § 25.5-1-204(7).
The database incorporates and utilizes publicly available data, as well as administrative claims data from
payer data sources. Colo. Rev. Stat. § 25.5-1-204(6). Payers are subject to fines for failing to submit data
as required. Id. § 25.5-1-204(9).
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6.
Labor and Employment
a.
RETALIATION AGAINST HEALTHCARE WORKERS, COLO. REV. STAT. § 8-2-123
Healthcare providers are prohibited from taking “disciplinary action” against a healthcare worker who makes
a “good faith report or disclosure.” Colo. Rev. Stat. § 8-2-123(2)(a). “Good faith report or disclosure” is
defined as “a report regarding patient safety information or quality of patient care that is made without
malice or consideration of personal benefit and that the healthcare worker making the report has reasonable
cause to believe is true.” Id. § 8-2-123(1)(b). "Good faith report or disclosure" also includes, with respect to
patient care, a report regarding any practice, procedure, action, or failure to act with regard to patient safety
that concerns information regarding a generally accepted standard of care; a law, rule, regulation, or
declaratory ruling adopted pursuant to law; or compliance with a professional licensure requirement. Id.
“Disciplinary action” is defined broadly and includes “any direct or indirect form of discipline or penalty,
including but not limited to, dismissal, demotion, transfer, reassignment, suspension, corrective action,
reprimand, admonishment, unsatisfactory or below-standard performance valuation, reduction in force,
withholding of work, changes in work hours, negative reference, creating or tolerating a hostile work
environment, or the threat of any such discipline or penalty.” Colo. Rev. Stat. § 8-2-123(1)(a).
This law does not protect an employee who discloses information that the employee knows is false, or who
discloses information without regard to its falsity, or who discloses information without fully complying with
any written internal reporting procedures of the healthcare provider that have been provided to the
employee. Colo. Rev. Stat. § 8-2-123(2)(b). Moreover, nothing in this law grants immunity to a healthcare
worker for his or her own acts of medical negligence, for unprofessional conduct subject to professional
review activities, for a breach of a professional licensure requirement, or for a violation of any state or
federal law requiring confidentiality of patient information. Id. § 8-2-123(2)(c).
In making a good faith report or disclosure, a healthcare worker “shall follow the internal reporting
procedures of the healthcare provider . . . and shall exhaust such procedures prior to pursuing any further
reporting or disclosure activity.” Colo. Rev. Stat. § 8-2-123(3).
b.
EMPLOYEE PROTECTION FOR “PRIVATE ENTERPRISE UNDER CONTRACT WITH A STATE
AGENCY,” COLO. REV. STAT. § 24-114-101 TO -103
No private enterprise that has a contract with a state agency may retaliate against an employee because
the employee has disclosed information “which, if not disclosed, could result in the waste of public funds,
could endanger the public health, safety, or welfare, or could otherwise adversely affect the interests of the
state.” Colo. Rev. Stat. § 24-114-101(2); see also Id. § 24-114-102(1). An employee who wishes to be
protected by this law must “make a good faith effort to provide to his supervisor or appointing authority or
to a member of the general assembly the information to be disclosed prior to the time of its disclosure.” Id.
§ 24-114-102(2).
The law does not protect any employee who discloses information that the employee knows is false or who
discloses information with disregard as to whether it is true or false. Colo. Rev. Stat. § 24-114-102(1)(a).
The employee is also not protected if the information that is disclosed is confidential under another provision
of law. Id. § 24-114-102(1)(b).
If a private enterprise violates this law, the employee may bring a civil action in a state court. Colo. Rev.
Stat. § 24-114-103. If the action is decided in the employee’s favor, “the employee may recover damages,
together with court costs,” and may receive any other relief that the court believes is appropriate. Id.
7.
Corporate Practice of Medicine
a.
PROFESSIONAL SERVICE CORPORATIONS, COLO. REV. STAT. § 12-36-134
The corporate practice of medicine is prohibited in Colorado, subject to certain exceptions provided by
statute. Physicians licensed to practice medicine by the state medical board may form professional service
corporations under the Colorado Business Corporation Act. Colo. Rev. Stat. § 12-36-134(1). All
shareholders of the corporation must be persons licensed by the board to practice medicine, though
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physician assistants may be shareholders so long as physicians maintain a controlling share of the
corporation. Id.
b.
HEALTH CARE FACILITY EMPLOYMENT OF PHYSICIANS, COLO. REV. STAT. § 25-3-103.7
In addition, a health care facility may employ physicians, subject to the certain limitations. Colo. Rev. Stat.
§ 25-3-103.7(2)(a). Employment by a health care facility does not permit the facility to limit or otherwise
exercise control over the physician's independent professional judgment concerning the practice of
medicine, or to require physicians to refer exclusively to the health care facility or to the health care facility's
employed physicians. Id. § 25-3-103.7(3). Employment by a health care facility does not permit the facility
to offer the physician any percentage of fees charged to patients by the health care facility or other financial
incentive to artificially increase services provided to patients
Id. § 25-3-103.7(4). Finally, the medical staff bylaws or the policies of any health care facility that employs
physicians “shall not” discriminate with regard to credentials or staff privileges on the basis of whether a
physician is an employee of, a physician with staff privileges at, or a contracting physician with, the health
care facility. Id. § 25-3-103.7(5).
The corporate practice of medicine doctrine has been interpreted to shield corporations from vicarious
liability for the negligent acts of their physician employees. See, e.g., Estate of Harper ex rel. Al-Hamim v.
Denver Health & Hosp. Auth., 140 P.3d 273, 275 (Colo. App. 2006).
d.
MEDICAL PROVIDER NETWORKS, COLO. REV. STAT. §§ 6-18-301 TO -304
A “provider network,” or a group of health care providers formed to provide health care services to
individuals, is permitted to conduct business collaboratively in Colorado. Colo. Rev. Stat. § 6-18-302(1)(a).
Corporate practice of medicine prohibitions “shall not” apply to a provider network, provided that (1) there
is a written agreement containing language indicating that the relationship shall not affect the exercise of
the licensed or certified professional's independent judgment in the practice of the profession, (2) the
licensed or certificated professional's independent judgment in the practice of such profession is in fact
unaffected by the relationship, and (3) the licensed professional is not required to exclusively refer any
patient to a particular provider or supplier or take any other action the licensed professional determines not
to be in the patient's best interest. Id. § 6-18-303(2).
8.
eHealth, Privacy, and Security
This topic merits a Colorado desk reference of its own. Because of the preemption language in HIPAA that
refers back to state law and permits more stringent privacy standards than required under federal law, a
practitioner who references Colorado privacy law will observe that the State’s laws are almost always more
stringent than those found under HIPAA. Rather than repeat the list of pertinent provisions here, a handy
index of statutory sections regarding medical record confidentiality and health information is codified at
Colo. Rev. Stat. § 25-1-1202. Under Colorado law, health care facilities and individual health care providers
are considered “custodians” of medical records. Id. §§ 25-1-801 to -802.
9.
Health Care Contracts
a.
116
CONTRACTS BETWEEN PAYERS AND PROVIDERS, COLO. REV. STAT. §§ 25-37-101 TO -
Persons or entities that have “a primary business purpose of contracting with health care providers for the
delivery of health care services” are required by law to include a number of provisions, set forth in these
sections. Among other things, state law requires summary disclosures of material terms, fee schedules,
methods of payment calculation, modifications and terminations, and claims adjudication procedures.
i.
Medical Clean Claims Transparency and Uniformity Act, Colo. Rev. Stat. § 25-37-106
The executive director of Colorado’s Department of Health Care Policy and Financing is tasked with forming
a task force “to develop a complete set of uniform, standardized payment rules and claim edits to be used
by payers and health care providers in the processing of medical claims that can be implemented into
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computerized medical claims processing systems.” Colo. Rev. Stat. § 25-37-106(2)(b). In 2014, Colorado’s
General Assembly amended the Act to outline the task force agenda from 2014 through 2017. By
December 31, 2014, the task force shall have developed a complete set of uniform, standardized payment
rules and claim edits and recommended implementation in a report to the executive and legislative
branches.
Id. § 25-37-106(2)(d)(III); see Id. § 25-37-106(2)(b)(coding sources); Id. § 25-37106(3)(c)(II)(claim edits). Public comment and review will take place in 2015, a final report will be submitted
by the end of 2016, and biannual review and updating of the uniform rules and edits will begin in 2017.
b.
NON-COMPETE AGREEMENTS, COLO. REV. STAT. § 8-2-113
Covenants not to compete, with four narrow exceptions, are contrary to the public policy of Colorado and
are void. Colo. Rev. Stat. § 8-2-113(2). With regard to physicians, “[a]ny covenant not to compete provision
of an employment, partnership, or corporate agreement between physicians which restricts the right of a
physician to practice medicine . . . upon termination of such agreement, shall be void; except that all other
provisions of such an agreement enforceable at law, including provisions which require the payment of
damages in an amount that is reasonably related to the injury suffered by reason of termination of the
agreement, shall be enforceable.” Id. § 8-2-113(c). “Provisions which require the payment of damages
upon termination of the agreement may include, but not be limited to, damages related to competition.” Id.
c.
ARBITRATION OF HEALTH CARE DISPUTES CONCERNING PROFESSIONAL NEGLIGENCE,
COLO. REV. STAT. § 13-64-403
Agreements for the provision of medical services that contain a provision for binding arbitration of any
dispute as to professional negligence of a health care provider are not contrary to Colorado public policy,
provided that certain mandatory language is employed in such agreements. Colo. Rev. Stat. § 13-64403(2). Specifically, the following language must be used in order for such an agreement to be enforceable:
It is understood that any claim of medical malpractice, including any claim that medical services were
unnecessary or unauthorized or were improperly, negligently, or incompetently rendered or omitted, will be
determined by submission to binding arbitration in accordance with the provisions of part 2 of article 22 of
this title, and not by a lawsuit or resort to court process except as Colorado law provides for judicial review
of arbitration proceedings. The patient has the right to seek legal counsel concerning this agreement, and
has the right to rescind this agreement by written notice to the physician within ninety days after the
agreement has been signed and executed by both parties unless said agreement was signed in
contemplation of the patient being hospitalized, in which case the agreement may be rescinded by written
notice to the physician within ninety days after release or discharge from the hospital or other health care
institution. Both parties to this agreement, by entering into it, have agreed to the use of binding arbitration
in lieu of having any such dispute decided in a court of law before a jury.
Id. § 13-64-403(3). Immediately preceding the signature lines for such an agreement, the following notice
shall be printed in at least ten-point, bold-faced type:
NOTE: BY SIGNING THIS AGREEMENT YOU ARE AGREEING TO HAVE ANY ISSUE OF MEDICAL
MALPRACTICE DECIDED BY NEUTRAL BINDING ARBITRATION RATHER THAN BY A JURY OR
COURT TRIAL.YOU HAVE THE RIGHT TO SEEK LEGAL COUNSEL AND YOU HAVE THE RIGHT TO
RESCIND THIS AGREEMENT WITHIN NINETY DAYS FROM THE DATE OF SIGNATURE BY BOTH
PARTIES UNLESS THE AGREEMENT WAS SIGNED IN CONTEMPLATION OF HOSPITALIZATION IN
WHICH CASE YOU HAVE NINETY DAYS AFTER DISCHARGE OR RELEASE FROM THE HOSPITAL
TO RESCIND THE AGREEMENT.NO HEALTH CARE PROVIDER SHALL WITHHOLD THE PROVISION
OF EMERGENCY MEDICAL SERVICES TO ANY PERSON BECAUSE OF THAT PERSON'S FAILURE
OR REFUSAL TO SIGN AN AGREEMENT CONTAINING A PROVISION FOR BINDING ARBITRATION
OF ANY DISPUTE ARISING AS TO PROFESSIONAL NEGLIGENCE OF THE PROVIDER.NO HEALTH
CARE PROVIDER SHALL REFUSE TO PROVIDE MEDICAL CARE SERVICES TO ANY PATIENT
SOLELY BECAUSE SUCH PATIENT REFUSED TO SIGN SUCH AN AGREEMENT OR EXERCISED THE
NINETY-DAY RIGHT OF RESCISSION.
Colo. Rev. Stat. § 13-64-403(4). No health care provider may refuse to provide medical care services to
any patient solely because such patient refused to sign such an agreement or exercised the ninety-day
right of rescission. Id. § 13-64-403(7).
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10.
Telemedicine
Provisions for telemedicine are located in scattered sections throughout the Colorado Revised Statutes,
depending on the intersection between telemedicine and the particular type of service or mode of delivery.
a.
MEDICAL PRACTICE ACT
Under the Medical Practice Act, “telemedicine” means “the delivery of medical services and any diagnosis,
consultation, or treatment using interactive audio, interactive video, or interactive data communication.”
Colo. Rev. Stat. § 12-36-102.5(8).
b.
COLORADO MEDICAL ASSISTANCE ACT
Under Medicaid, “telemedicine” has the same meaning as set forth in the Medical Practice Act. Colo. Rev.
Stat. § 25.5-5-414. Since 2006, in-person contact between a health care or mental health care provider
and a patient is not required for services delivered through telemedicine that are otherwise eligible for
reimbursement under the Medicaid program. Id. § 25.5-5-320(1); see also Id. § 25.5-4-405. A number of
additional provisions governing its use apply. Medicaid managed care contracts with an organization
providing mental health services must also provide for payment for telemedicine services. Id. § 25.5-4405(1)(c)(1.5).
Hospital telemedicine services are eligible for payment by Medicaid. Colo. Rev. Stat. § 25.5-4-402(2)(a).
Home health telemedicine has been eligible for reimbursement under the state's Medicaid program since
August, 2010. Id. § 25.5-5-321. A number of additional provisions governing home health telemedicine
use apply. See id.
c.
INSURANCE
Since 2002, no health benefit plan issued to a person residing in a county with 150,000 or fewer residents
may require face-to-face contact between a provider and a covered person as a condition of coverage for
services appropriately provided through telemedicine, if such county has the technology necessary for the
provision of telemedicine. Colo. Rev. Stat. § 10-16-123(2). Any health benefits provided through
telemedicine shall meet the same standard of care as for in-person care. Id. Telemedicine providers may
be included in a managed care organization’s network for purposes of determining network adequacy
specialty ratios. Id. § 10-16-704(1)(a).
d.
MEDICAL RECORDS
Medical information transmitted during the delivery of health care via telemedicine is part of the patient's
medical record maintained by a health care provider. Colo. Rev. Stat. § 25-1-802(5).
e.
INTERSTATE COMPACTS
In 2005, Colorado’s General Assembly authorized DORA, together with the Colorado medical board and
the state board of nursing, and in consultation with representatives of other relevant state agencies, to
negotiate one or more interstate compacts endorsing model legislation to facilitate the efficient distribution
of health care services across state lines. Colo. Rev. Stat. § 24-60-3101; see also Id. § 24-60-3103(1)(b)
(authorizing interstate compact negotiation for telemedicine specifically).
11.
Behavioral Health, Article 65, Title 27, Colo. Rev. Stat.
Provisions concerning voluntary and involuntary treatment of persons with mental illness, whether on an
inpatient, outpatient, or residential basis, are located at Colo. Rev. Stat. §§ 27-65-101 to -131.
12.
Prescription Drug Monitoring Program, Colo. Rev. Stat. §§ 12-42.5-401 to -409
Colorado’s system for electronic monitoring of prescriptions for controlled substances (“Prescription Drug
Monitoring Program” or “PDMP”) is operated and maintained by the state board of pharmacy, and provides
a mechanism for practitioners to discover the extent of each patient's requests for drugs and whether other
providers have prescribed similar substances during a similar period of time. It also provides a mechanism
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for law enforcement officials and regulatory boards to efficiently investigate practitioner behavior that is
potentially harmful to the public.
By January 1, 2015, every practitioner in the state who holds a current DEA registration for controlled
substances and every pharmacist shall register and maintain a user account with the program. Colo. Rev.
Stat. § 12-42.5-403(1.5)(a). The program operates very similar to those implemented in other states; it
tracks the date a prescription was dispensed, the name of the patient and the practitioner, the name and
amount of the controlled substance, the method of payment, and the name of the dispensing pharmacy.
Id. § 12-42.5-403(1)(a) – (e).
13.
Compounded drugs
Manufacturing and wholesale distribution of manufactured drugs is not considered “compounding” under
Colorado law. Colo. Rev. Stat. §§ 12-42.5-102(20); 12-42.5-102(42)(b)(XII); 12-42.5-102(43). Physicians
may personally compound drugs. Id. § 12-42.5-118(6)(a). Other than these exceptions, only a registered
prescription drug outlet or “other outlet” registered with the state may compound or dispense a prescription.
Id. § 12-42.5-118(4).
Nonresident prescription drug outlets may not distribute compounded products into Colorado. 3 CCR §
719-1:21.00.20(a). Nonresident prescription drug outlets may dispense compounded products pursuant to
prescription orders and ship them into the state. Id.; see also 3 CCR § 719-1:5.00.01(c) (“Non-Resident
Prescription Drug Outlet . . . means any pharmacy outlet located outside this state that is registered
pursuant to CRS Title 12, Article 42.5, which ships, mails, or delivers, in any manner, drugs or devices into
this state pursuant to a prescription order.”). “Distribution” means “the transfer of a drug or device other
than by administering or dispensing.” Colo. Rev. Stat. § 12-42.5-102(12). “Dispense” means “to interpret,
evaluate, and implement a prescription drug order or chart order, including the preparation of a drug or
device for a patient or patient's agent in a suitable container appropriately labeled for subsequent
administration to or use by a patient.” Id. § 12-42.5-102(11).
Physicians do not need a license issued by the board of pharmacy to dispense drugs in Colorado, and are
exempt from the pharmacy act except for the section of the act that enumerates unlawful acts concerning
pharmaceutical care. Colo. Rev. Stat. § 12-42.5-118(6)(a). Physicians may delegate their authority to
prescribe and dispense drugs to physician assistants. Id. § 12-36-106(5)(a). Manufacturers, wholesalers,
registered prescription drug outlets, and hospital pharmacies (“licensed hospital other outlets”) may sell or
give any drug to a practitioner authorized by law to prescribe the drug. Id. § 12-42.5-118(2), (3) and (5).
However, a pharmacist may not dispense a prescription drug to a practitioner based on an order that does
not list a specific patient. 3 CCR § 719-1:3.00.20. A prescription order for “office use” is not a valid order.
Id.
Provide any special issues that arise in your jurisdiction
Nonresident counsel must be mindful of significant variations in Colorado law from other states concerning
(1) privacy of individually identifiable health information, (2) subpoena procedures for individually
identifiable health information, (3) non-compete agreements involving physicians, and (4) the corporate
practice of medicine doctrine. Nonresident counsel would also be wise to refer to the section above
detailing major health legislation in Colorado in the last 5 years prior to engaging local counsel.
Are mobile health applications regulated under the law of your jurisdiction? If so, provide a brief summary
as to how they are regulated.
Not specifically.
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Contact Information
Davis Graham & Stubbs LLP
1550 17th Street, Suite 500
Denver, CO 80202
Tel 1.303.892.9400 Fax 1.303.893.1379
Firm Website http://www.dgslaw.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, Connecticut
Prepared by Lex Mundi member firm Murtha Cullina LLP
1. Provide an introduction to health law in your jurisdiction.
In 2014, the legislature passed Public Act 14-168 which paved the way for for-profit health care institutions
to come into Connecticut and employ physicians without the risk of violating the corporate practice of
medicine doctrine, part of the reason Connecticut had not previously been an attractive location for-profit
entities. This Public Act allows for-profit hospitals and health systems to organize and become members
of Medical Foundations for the purpose of providing professional medical services, something previously
only allowed by non-profit institutions.
At the same time, Public Act 14-168 also increases Attorney General oversight over transactions involving
physician groups, requiring reporting in instances where a group of two or more physicians engages in a
merger, sale, employment relationship or other similar relationship with (i) another physician group resulting
in a group of eight (8) or more physicians or (ii) a hospital, health system, medical foundation, captive
professional corporation or similar entity.
While Connecticut has had a strong Certificate of Need (“CON”) program for many years, Public Act 14168 also imposes CON requirements on physician groups for the first time (outside of the acquisition of
imaging equipment which has been in place for many year). Physician groups of eight (8) or more must
now obtain a CON before joining with any entity other than another group of physicians.
Aside from the changes mentioned above, Connecticut has numerous other health care-related laws and
regulations. The state’s related regulatory agencies include the Department of Public Health and its many
professional licensing boards, the Department of Social Services (responsible for the state’s medical
assistance program), the Department of Mental Health and Addiction Services, the Office of the Attorney
General and the Office of the Healthcare Advocate, among others.
Connecticut has also been at the forefront of gun related legislation in the wake of the recent firearm
tragedies around the country and particularly in Newtown, Connecticut. See Public Act 13-3. As a result,
hospitals in Connecticut who voluntarily admit patients for psychiatric treatment must report such patients
to the Department of Mental Health and Addiction Services so that their names can be included in a
database aimed at prohibiting gun ownership by voluntary psychiatric patients for six (6) months. Conn.
Gen. Stat. § 17a-506. Previously, mental health-related gun restrictions were limited to patients who were
involuntarily committed – there was no such reporting on patients who sought help voluntarily. The law
also increased the length of the gun prohibition on individuals involuntarily committed from one (1) year to
five (5) years. See Conn. Gen. Stat. §§ 29-28; 29-38b.
2. Provide a check-list of laws with a short summary of the general requirements of each.
Connecticut General Statutes
Title 4 – Management of State Agencies; Chapter 54, Conn. Gen. Stat. § 4-166 et seq. (the Uniform
Administrative Procedure Act applicable to hearings and other operations of state agencies including the
Department of Public Health).
Title 17a – Social and Human Services and Resources; Chapter 319I, Conn. Gen. Stat. § 17a-450 et seq.
(statutes pertaining to persons with psychiatric disabilities, commitment, patients’ rights).
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Title 19a – Public Health and Well-Being (statutes pertaining to all types of public health matters including
emergency medical services, health care institutions and certificate of need).
Title 20 – Healing Arts (statutes pertaining to medical records, physicians and surgeons, podiatrists,
chiropractors, physician and occupational therapists, nurses, mental health professionals and various other
medical professionals).
Title 38a – Insurance; Chapter 698a, Conn. Gen. Stat. § 38a-175 et seq. (statutes pertaining to health care
and related service groups).
Title 38a – Insurance; Chapter 700c, Conn. Gen. Stat. § 38a-469 et seq. (statutes pertaining to health
insurance including mandatory coverage requirements).
Regulations of Connecticut State Agencies
Title 17 – Public Assistance (includes certain Connecticut Medical Assistance Program participation
requirements).
Title 17b – Social Services (includes certain Connecticut Medical Assistance Program payment
requirements).
Title 19 – Health and Safety (includes the licensure requirements for various health care entities including
hospitals, outpatient surgery centers, long-term care facilities and home health agencies, among others).
Title 19a – Public Health and Well-Being (includes the Department of Public Health Rules of Practice,
medical record retention requirements and adverse event reporting requirements for hospitals and
outpatient surgery centers).
Other Guidance:
Connecticut Medical Assistance Program
The website for the Connecticut Medical Assistance Program is located at the following link and contains
the state Medicaid Provider Manuals and other guidance:
https://www.ctdssmap.com/ctportal/Default.aspx?
Office of Health Care Access
The website for the Office of Health Care Access, the division of the Department of Public Health charged
with enforcement of the state Certificate of Need program is located at the following link and contains
recently filed Certificate of Need applications as well as prior decisions and determinations issued by the
agency:
http://www.ct.gov/dph/cwp/view.asp?a=3902&q=277344
Connecticut Medical Examining Board
The Connecticut Medical Examining Board maintains a website at the following link which includes licensure
information as well as regulatory actions reports detailing the discipline imposed by the Board against
physicians:
http://www.ct.gov/dph/cwp/view.asp?a=3143&q=388902
Connecticut Board of Examiners for Nursing
The Connecticut Board of Examiners for Nursing maintains a website at the following link which includes
licensure information, numerous Declaratory Rulings and regulatory action reports detailing the discipline
imposed by the Board against nurses:
http://www.ct.gov/dph/cwp/view.asp?a=3143&q=388910
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Office of Legislative Research
The Office of Legislative Research publishes a number of reports and “backgrounders” on various issues,
including many involving health law matters. A link to this Office’s website follows:
http://www.cga.ct.gov/olr/
3. Provide any special issues that arise in your jurisdiction.
State Law Patient Confidentiality Claims
The Connecticut Supreme Court recently concluded that a patient could sue her former OB-GYN physician
practice in state court for improperly disclosing her records, despite the fact that HIPAA does not permit
individuals to sue for HIPAA violations. Byrne v. Avery Center for Obstetrics and Gynecology, P.C., 314
Conn. 443 (2014). Prior to this decision, courts generally dismissed state law claims that essentially alleged
a HIPAA violation because HIPAA did not allow private lawsuits. Not only are these claims now permitted,
but the patient may also use the HIPAA regulations to show how providers should be ensuring privacy and
confidentiality of health records.
The trial court dismissed the plaintiff’s negligence and negligent infliction of emotional distress claims, ruling
that they were preempted by HIPAA, but the state Supreme Court disagreed. The Court explained that any
state law that protects the privacy and confidentiality of medical records is not contrary to HIPAA and, as a
result, permitting a patient to sue the practice under state law is not at odds with the spirit of HIPAA.
In addition to allowing the patient to pursue her negligence claims in state court, the Court went one step
further in acknowledging that the HIPAA regulations could be used to establish the standard of care for the
provider in that case. This ultimately means that if the provider did not comply with HIPAA requirements,
that failure can be used as proof that it acted negligently in the lawsuit brought by the patient.
The other two claims in this case involved the Notice of Privacy Practices: breach of contract and negligent
misrepresentation. Thus, in order to minimize the risk of a lawsuit by a patient for a confidentiality breach,
providers should not only comply with federal and Connecticut law, but they must also adhere to their own
Notice of Privacy Practices.
Hospital-Based Facility Fees
Connecticut law now requires a hospital or health system to notify individual patients and the public that it
charges a facility fee for outpatient services. See Public Act 14-145. The facility must notify a patient in
writing (1) that the facility is part of a hospital or health system that charges a facility fee, (2) about the
patient's potential financial liability, and (3) that the patient should contact his/her insurance company for
additional information. The Act also requires a hospital-based facility to (1) prominently display a sign
indicating it charges a facility fee and (2) market itself as a hospital-based facility.
Corporate Practice of Medicine
Connecticut’s corporate practice of medicine (“CPOM”) doctrine stems from a 1954 Attorney General
Opinion (Op. Atty. Gen. 248, Dec. 3, 1954). CPOM restrictions might not allow non-licensed corporations
to practice medicine or employ physicians to provide medical services. As a result, under CPOM, it is not
clear that medical services can be delivered other than by provider-owned PCs and PLLCs or other entities
authorized by law, such as licensed entities, and medical foundations. As set forth under Item 1 above,
only hospitals, health systems and medical schools can form medical foundations. Despite this, a number
of other entities provide health services in Connecticut, so the exact scope of CPOM is not clear.
To try to avoid allegations of the CPOM, entities have long set up captive professional corporations, referred
to as “captive PCs” in Connecticut. Here, the non-PC entity works with a physician owning all the stock of
the PC. The non-PC entity and the physician enter into an agreement whereby the non-PC entity has the
right to require the physician to transfer his/her stock in the PC as designated by the non-PC entity. The
non-PC entity will agree to supply management services and usually will also supply premises and
personnel needed for the practice, and the PC will bill for the services. The PC will pay fees to non-PC
entity for the services rendered by the non-PC entity. There are numerous entities that employ this structure;
provided, however, that these structures pose tax challenges and risks related to creditors of the PC owner.
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In addition, there is no formal opinion of any sort indicating that the captive PC structure will avoid CPOM
concerns if challenged.
Certificate of Need
Connecticut has a vigorous Certificate of Need program enforced by the Office of Health Care Access
Division of the Department of Public Health (“OHCA”). A Certificate of Need is required for a variety of
transactions including, but not limited to, establishment of a new health care facility, transfer of ownership
of a health care facility, establishment of cardiac services, acquisition of CT, MRI or similar imaging
equipment, termination of services by a hospital and certain physician practice transactions as described
under Item 1 above. See Conn. Gen. Stat. § 19a-638. OHCA has detailed information regarding this
process on its website at http://www.ct.gov/dph/cwp/view.asp?a=3902&q=277344.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide a brief
summary as to how they are regulated?
Some mobile health applications are regulated by federal law, but there are not yet any Connecticut-specific
laws or regulations in this area.
Contact Information
Stephanie Sobkowiak
[email protected]
Paul Knag
[email protected]
Murtha Cullina LLP
265 Church Street
New Haven, CT 06510
177 Board Street
Stamford, Connecticut 06901
Tel: 203.653.5407
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, Indiana
Prepared by Lex Mundi member firm Faegre Baker Daniels LLP
1.
Provide an introduction on health law in your jurisdiction.
The Indiana State Department of Health is by statute "the superior health department of the state, to which
all other health boards are subordinate." It is governed by an 11 person executive board, all of whose
members are appointed by the Governor. The Commissioner of Health, also appointed by the governor, is
secretary and executive officer of the Board. The Commissioner must hold an unlimited license to practice
medicine in Indiana.
2.
Provide a check list of laws with a short summary of the general requirements of each.
Indiana Statutes
Statutes governing health are generally contained in Title 16 of the Indiana Code. Title 16 is divided into
subject-matter Articles, as follows:
[1. – 17. Repealed]
18.
General Provisions and Definitions
19.
State Department of Health
20.
Local Health Departments
21.
Hospitals
22.
County Hospitals
23.
Municipal and Other Types of Hospitals
24.
Tuberculosis Hospitals
25.
Hospice Programs
26.
Home Health Agencies
28.
Health Facilities
29.
Certificates of Need
31.
Emergency Medical Services
32.
Persons With Disabilities
34.
Abortion
35.
Children's Health
36.
Medical Consent
37.
Vital Statistics
38.
Health Registries
39.
Health Records
40.
Other Reporting Requirements
41.
Public Health Measures for the Prevention and Control of Disease
42.
Regulation of Food, Drugs, and Cosmetics
46.
State Health Grants and Programs
48.
Other Health Care Providers and Services
49.
Child Fatality Reviews
Indiana Administrative Regulations
Administrative Regulations of the Indiana State Department of Health are generally contained in Title 410
of the Indiana Administrative Code. Title 410 is divided into subject-matter Articles as follows:
1.
2.
3.
Communicable Disease Control
Tuberculosis Control
Maternal and Child Health
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4.
5.
6.
7.
8.
9.
12.
13.
15.
17.
18.
19.
21.
22.
23.
24.
25.
26.
27.
28.
29.
31.
32.
33.
34.
3.2.
Children with Special Health Care Needs
3.6.
Women, Infants, and Children Program Rules for WIC
Industrial Hygiene
Radiological Health
5.1.
Radon
5.2.
Radiography, Nuclear Medicine, and Radiation Therapy Licensing
Sanitary Engineering
Food and Drugs
Dairy Products
Meat and Meat Products Inspection
Weights and Measures
12.1. Motor Fuel
Sanitary Bedding
Hospital Licensure Rules
15.1. Mobile Health Care Entity
16.2. Health Facilities; Licensing and Operational Standards
Home Health Agencies
Vital Records
General Provisions
Reporting
Child Care Facilities
Grants
Local Health Services
Artificial Insemination
Abortion Clinics
Birthing Centers
Reporting of Complications from Surgical Treatment of Morbid Obesity
Reporting, Monitoring, and Preventive Procedures for Lead Poisoning
Small Employer Qualified Wellness Program
Lead Based Paint Program
Indoor Air Quality Matters
State Trauma Registry
Indiana Selected Case Law
The Indiana Medical Malpractice Statute is constitutional (Johnson v. St. Vincent Hospital, 273 Ind. 374,
404 N.E.2d 585 (1980), and does not unconstitutionally obstruct a claimant's access to the courts or violate
the right to trial by jury (Hines v. Elkhart General Hospital, 465 F.Supp. 421 (N.D.Ind. 1979), aff'd 603 F.2d
646 (7th Cir. 1979).
An uninsured patient (who purports to represent a class of similarly situated citizens) does not state a claim
against a hospital for the unreasonableness of a hospital bill when she has executed in advance an
agreement to pay the amount dictated by the hospital's chargemaster, even though the amount might have
been significantly lower if she had been insured by an insurer that had negotiated a discount from
chargemaster pricing. Allen v. Clarian Health, No. 49S02 1203 CT 140, 980 N.E.2d 306 (Ind. 2012).
Where a hospital violates its duty to maintain a health record and that failure substantially interferes with
the plaintiff's ability to assert his claim for medical malpractice, the plaintiff does not have a claim against
the hospital separate from the underlying medical malpractice claim, and the claim as to the loss of the
record is part of the medical malpractice claim and subject to the Indiana Medical Malpractice Act. Howard
Regional Health System v. Gordon, No. 34S02 1009 CV 476, 952 N.E. 182 (Ind. 2011).
3.
Provide
any
special
issues
which
arise
in
your
jurisdiction.
Since 1975, Indiana has had the nation's lowest cap on damages for liability arising out of medical
malpractice. Under Indiana's system, a provider (individual or institutional) becomes "qualified" for
coverage under the Patient's Compensation Fund by paying a surcharge, which is a percentage of the
provider's annual malpractice insurance premium. The percentage is determined annually for each medical
specialty by the Indiana Department of Insurance. A qualified provider's liability is limited to $250,000 for
a single event of malpractice and $750,000 in annual aggregate. These limits apply to total liability,
including but not limited to out of pocket expenses, loss of income and companionship, other actual
damages, and punitive damages. A patient's total recovery for a single incident is capped at $1,250,000,
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with the $1 million in excess of the provider's liability limit coming from the Patient's Compensation Fund.
See Indiana Code Title 34, Article 18. Indiana no longer has a Certificate of Need program for hospitals.
The Indiana Medical Licensing Board generally makes the practice of medicine by unlicensed persons
unlawful. Ind. Code §§ 25-22.5-1-1.1(a), 25-22.5-8-1. This prohibition against “unlawful or unauthorized
practice of medicine” does not, however, apply to “a health care organization whose members,
shareholders, or partners are individuals, partnerships, corporations, facilities, or institutions licensed or
legally authorized by this state to provide health care or professional services” as an organization specified
in the statute. Ind. Code § 25-22.5-1-2(a)(22) (emphasis added).
4.
Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Indiana does not specifically regulate mobile health applications. Federal law, including the authority of the
Food and Drug Administration, applies.
Contact Information
Patrick S. Cross
Partner; Leader, Health & Life Sciences
Industry Team
[email protected]
Faegre Baker Daniels LLP
600 East 96th Street, Suite 600
Indianapolis, IN 46240
Tel .317. 569.4844 Fax 317.237.8444
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, Iowa
Prepared by Lex Mundi member firm Davis Brown Law Firm
1.
Provide an introduction on health law in your jurisdiction.
In 2010, Iowa created the “Insurance Information Exchange,” which provides information on its
website to consumers with a comparison of benefits. At that time, Governor Branstad expressed a
preference for a state exchange.
Iowa is currently operating under the Iowa Health Insurance Marketplace, which is the Federal
Health Insurance Marketplace. The Marketplace is a place for people to look for affordable minimum
essential coverage. Applicants shopping for insurance on the Marketplace have the choice of multiple
private insurers. Iowa operates a partnership exchange with the federal government. Iowa residents use
the federal marketplace, HealthCare.gov, to compare and purchase coverage. The state is responsible for
plan management, consumer assistance, and Medicaid eligibility determination. Iowa’s plan management
functions include selecting and monitoring the qualified health plans (QHP) that offer policies on the
exchange. Iowa’s role in consumer assistance is education and outreach, coordinating the in-person
consumer assisters, and overseeing the Navigator program. The federal government manages the
exchange website and call center, and funds the Navigator program.
Starting in 2015, four insurers will again sell policies through the Iowa marketplace: Avera Health
Plans, CoOportunity Health, Coventry, and Gundersen Health Plan. CoOportunity is a consumer operated
and oriented plan, formed with funding through the Affordable Care Act. Wellmark, the largest insurance
carrier in Iowa, will not join the marketplace in 2015.
The Iowa Health and Wellness Plan is a new plan implemented by the state that began January 1,
2014. It is available for adults ages 19-64. It was created to provide comprehensive health care coverage
for low-income adults. It is available for application on the Marketplace.
hawk-i is another plan implemented by the state, which provides health care coverage for
uninsured children of working families, wherein the family income must be below 300% of the Federal
Poverty Level. Children are covered through commercial health care and dental plans. hawk-i may also be
applied for on the Marketplace.
Iowa is occasionally mentioned as a state that may transition to a different model for its exchange.
In February 2014, Governor Branstad floated the idea of a regional exchange in conjunction with South
Dakota, Nebraska and Kansas. Bills to convert to a state-run exchange were introduced in Senate
committees in both 2013 and 2014, but neither advanced.
Iowa has a number of different health care regulatory agencies, including the Iowa Department of
Human Services, the Iowa Department of Public Health, Bureau of Administration, Regulation & Licensure,
the Bureau of Family Health, the Bureau of Chronic Disease Prevention and Management, the Bureau of
Emergency Medical Services, the Bureau of Health Care Access, the Bureau of Vital Records, the Division
of Health Facilities, the Governor’s Office of Drug Control Policy, Office of the Attorney General, the Office
of the Iowa State Medical Examiner, among others that regulate health care.
Iowa licensed health professionals are regulated by a number of regulatory boards.
2.
Provide a checklist of laws with a short summary of the general requirements of
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Iowa Law and Regulations
Anti-Kickback
Iowa Admin. Code r. 653-13.20 - Iowa Board of Medicine, Standards of Practice and
Medical
Ethics
Iowa Admin. Code r. 657-8.11(2, 3, 4 & 5) - Iowa Board of Pharmacy, Unethical Practice or
Conduct
Iowa Admin. Code r. 681-8.9 - Iowa Board of Regents: The University of Iowa Hospitals and
Clinics
Prohibitions on Self-Referral
Iowa Admin. Code r. 653-13.7(2) - Iowa Board of Medicine, Standards of Practice and
Medical
Iowa Admin. Code r. 653-13.20 - Iowa Board of Medicine, Standards of Practice and
Medical
Ethics
Ethics
Iowa Admin. Code r. 653-23.1 - Iowa Board of Medicine, Standards of Practice and
Ethics: Grounds for Discipline
Medical
False Claims/Fraud & Abuse
Iowa Code § 685 - Iowa False Claims Act
Iowa Code § 507E.2-3 - Insurance Fraud
Iowa Code § 249A.8 - Medical Assistance
Iowa Admin. Code r. 441-79.2(2) - Iowa Department of Human Services, Other Policies
Relating to Providers of Medical and Remedial Care
Iowa Code § 147.55 - Professional Licensure
Iowa Code § 272C.10 - Professional Licensure
Iowa Admin. Code r. 653-23.1(14 & 18) - Board of Medicine, Grounds for Discipline
Iowa Admin. Code r. 655-4.6(3) - Board of Nursing, Grounds for Discipline
Iowa Admin. Code r. 657-36.1(4) - Board of Pharmacy, Grounds for Discipline
General Whistleblower Protections
Iowa Code § 685.3(6) - False Claims
Iowa Code § 70A.28-29 - State Employees
Iowa Code § 729.6(7) - Genetic Testing
Iowa Code § 88.9(3) - Iowa OSHA
Iowa Code § 91A.10(5) - Wage Payment Claims
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Iowa Code § 135B.12 - Confidentiality of Reports to the Department of Inspections and
Appeals
Iowa Code § 216.11 - Civil Rights Laws
Iowa Code § 272C.8; Iowa Code § 147.135 - Peer Review Protection
Iowa Code § 915.23 - Witness in Criminal Proceedings
Jasper v. H. Nizam, Inc., 764 N.W.2d 751 (Iowa 2009); Berry v. Liberty Holdings, 803
106 (Iowa 2011) - State Public Policy Exception to Employment at Will
N.W.2d
Unfair Business Practices
Iowa Code § 551 - Unfair Discrimination
Iowa Code § 553 - Iowa Competition Law
Medical Records
Confidentiality of Medical Information
Iowa Code § 22.7 - Confidentiality of Medical Records
Duty to Keep Medical Records Confidential
Iowa Admin. Code r. 481-51.6 - Hospitals
Iowa Admin. Code r. 481-58.44 - Nursing Facilities
Iowa Admin. Code r. 481-62.18(2) - Residential Care Facilities for Persons with
Mental Illness (RCF/PMI)
Iowa Admin. Code r. 481-57.40 - Residential Care Facilities
Iowa Admin. Code r. 481-63.38 - Residential Care Facilities for the Mentally
or Physically Dependent (RCF/MR)
Iowa Admin. Code r. 481-65.20 - Intermediate Care Facilities for Persons with
Mental Illness (ICF/PMI)
Iowa Admin. Code r. 481-41.16 - Psychiatric Medical Institution for Children
(PMIC)
Restrictions on Release of Medical Information
Iowa Code §§ 135.40-.42 - Research Purposes
Iowa Code §§ 228.5, 230A.9(3); Op. Iowa Att’y Gen. 89-6-9 - Payment Purposes
Iowa Code §§ 228, 229.25 - Mental Health Information
Iowa Code §§ 141A.9 - HIV/AIDS Testing Information
Iowa Code ch. 125; Iowa Admin. Code r. 643 ch. 3 - Chemical Substance Abuse Information
Iowa Code § 125.33(1) - Minors
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Iowa Code § 598.41(1)(e) - Divorced Parent
Leaf v. Iowa Methodist Medical Center, 460 N.W.2d 892 (Iowa Ct. App.
1990)
Iowa Code § 321J.6 - OWI
Iowa Code § 622.10(3)(d) - Charging Fees for Release
Required Reporting of Medical Information
Iowa Code ch. 144 - Birth/Death Certificates
Iowa Admin. Code r. 641 ch. 1 - Reportable Diseases
Iowa Code §§ 139A.3, 139A.25, 139A.32 - Failure to report a simple
misdemeanor
Iowa Code § 235B; Iowa Admin. Code r. 441-176.4, 176.5 – Dependent Adult Abuse Reporting
Iowa Admin. Code r. 641-5.1 - Maternal Deaths
Iowa Code § 147.111 - Wounds of Violence
Iowa Code § 141A.6 - AIDS related conditions
Iowa Code §§ 139A.38, 136A.4, 136A.5 - Screening and Treatment of Newborns
Iowa Code §§ 232.67, 232.68, 232.69, 232.77; Iowa Admin. Code r. 441-175.23, 641-175 - Child
Abuse Reporting, Assessment and Rehabilitation
Retention of Medical Records
Iowa Admin. Code r. 481-51.12(1), 441-79.3(2) - Hospitals
Iowa Code § 614.1(9) - Statute of Limitations
Iowa Admin. Code r. 481-57.16 - Residential Care Facilities
Iowa Admin. Code r. 481-62.18(2) - Residential Care Facilities for Persons with Mental
Illness
Iowa Admin. Code r. 481-63.17 - Residential Care Facilities for the Mentally or Physically
Dependent
Iowa Admin. Code r. 481-65.20 - Intermediate Care Facilities for Persons with Mental
Illness
Medical Records in Investigative and Court Proceedings
Iowa Code ch. 622
Corporate Practice of Medicine
Iowa Code § 147.2 - License Required
Op. Iowa Att’y Gen. 91-7-1 (July 12, 1991) - Opinion on Corporate Practice of Medicine
Licensing of Health Care Providers
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Physicians: Iowa Code ch. 148; Board of Medical Examiner Regulations - Iowa Admin.
Code r.
653
Nurses: Iowa Code Ch. 152; Nursing Board Regulations - Iowa Admin. Code r. 655
Pharmacy: Iowa Code Ch. 155A; Pharmacy Examiners Board - Iowa Admin. Code r. 657
Physicians’ Assistants: Iowa Code § 148C; Iowa Admin. Code r. 645-325
Physical Therapy: Iowa Code § 148A; Iowa Admin. Code r. 645-200
Physical Therapy Assistants: Iowa Admin. Code r. 645-202
Occupational Therapy: Iowa Code § 148B; Iowa Admin. Code r. 645-201
Chiropractors: Iowa Code § 151; Iowa Admin. Code r. 645-40
Social Work: Iowa Code § 154C; Iowa Admin. Code r. 645-280
Psychology: Iowa Code § 154B; Iowa Admin. Code r. 645-240
Respiratory Care: Iowa Code § 152B; Iowa Admin. Code r. 645-260
Massage Therapy: Iowa Code § 152C; Iowa Admin. Code r. 645-130, 131
Podiatry: Iowa Code § 149; Iowa Admin. Code r. 645-220, 221
Osteopathy: Iowa Code §§ 150, 150A
Optometry: Iowa Code § 154; Iowa Admin. Code r. 645-180
Dentistry: Iowa Code § 153; Dental Board Regulations-Iowa Admin. Code r. 650-1 to 51
Nursing Home Administration: Iowa Code § 155; Iowa Admin. Code r. 645-140 to 143
Dietetics: Iowa Code § 152A; Iowa Admin. Code r. 645-80
Hearing Aids: Iowa Code § 154A; Iowa Admin. Code r. 645-120 to 121
Emergency Medical Care: Iowa Code § 147A; Iowa Admin. Code r. 641-132
Radiation Therapists, Diagnostic Radiographers and Nuclear Medicine Technologists:
Iowa Admin. Code r. 641-42
Speech Pathology and Audiology: Iowa Admin. Code r. 645-300 to 302
Professional Continuing Education Requirements: Iowa Code § 272C
Licensing of Health Care Facilities
Psychiatric Mental Institutions for Children: Iowa Code § 135H; Iowa Admin. Code r.
481-41
Hospitals: Iowa Code § 135B; Iowa Admin. Code r. 481-51
Birth Centers: Iowa Code § 135G; Iowa Admin. Code r. 481-52
Hospices: Iowa Code § 135J; Iowa Admin. Code r. 481-53
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Residential Care Facilities: Iowa Code § 135C; Iowa Admin. Code r. 481-57; physical
standards at Iowa Admin. Code r. 481-60
Nursing Facilities: Iowa Code § 135C; Iowa Admin. Code r. 481-58; physical standards
Admin. Code r. 481-61
at Iowa
Residential Care Facilities for Persons with Mental Illness: Iowa Code § 135C; Iowa
Code r. 481-62
Admin.
Residential Care Facilities for Mentally or Physically Dependent: Iowa Code § 135C; Iowa Admin.
Code r. 481-63
Intermediate Care Facilities for Mentally or Physically Dependent: Iowa Code § 135C; Iowa Admin.
Code r. 481-64
Intermediate Care Facilities for Persons with Mental Illness: Iowa Code § 135C; Iowa
Code r. 481-65
Admin.
Certificate of Need
Iowa Code §§ 135.63-75; Iowa Admin. Code r. 641-202 - Requirements which a facility must
establish and finding the State Health Facilities Council must make before granting
a Certificate of
Need.
Patient Care Issues
Patient’s Consent
Iowa Code § 147.137 - Informed Consent
Iowa Code 147A.10 - Emergency
Minors:
Iowa Code § 599.1 – Persons Married Prior to Age 18 and Persons Incarcerated
as Adults May Consent to Medical Treatment
Iowa Code § 232C.4 – Emancipation of Minor
Iowa Code §§ 135L.2, 135L.3 - Abortions
Iowa Code § 125.33 - Substance Abuse Treatment
Iowa Code § 142A.11 – Tobacco Cessation Coaching Services
Iowa Code § 139A.35 - Sexually Transmitted Disease
Iowa Code § 141A.7(3); Iowa Admin Code r. , 641-11.3(139A & 141A), 64111.4(141A) - Testing for HIV
Iowa Code § 915.35 – Provision of Services to Minor Victims Without Parental
Consent
Miscellaneous:
Iowa Code § 229.23(2) - Electro convulsive therapy/chemotherapy
Iowa Admin. Code r. 653-13.2(3)(c) - Chronic Pain
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Iowa Admin. Code r. 641-41.2(3)(d) - Experimental research (radioactive
material)
Iowa Code § 141A.8; Iowa Admin. Code r. 641-11.50 - Exposure of care
provider to bodily fluids
Iowa Code §§ 141A.6, 141A.7, 505.16; Iowa Admin. Code r. 191-15.12,
641-11.51(2) - HIV Testing
Iowa Admin. Code r. 441-78.1(16)(j) - Hysterectomy (Medicaid)
Iowa Code § 229.2; Iowa Admin. Code r. 441-29.2(218, 229), 441-24.1 - Mental
Illness
Iowa Code § 229.23; Iowa Admin. Code r. 481-65.25, 51.6, 59.44, 53.3 Patient’s Rights
Iowa Admin. Code r. 481-58.43 - Physical Restraints
Iowa Code § 227.11 - Psychiatric hospitals (transfer of patients)
Iowa Admin. Code r. 441-78.1(16) - Sterilization (Medicaid)
Iowa Admin. Code r. 481-58.39(9), 62.23, 65.25(6) - Residents’ Rights in General
Advanced Directives
Iowa Code § 144A.1-11 - Life Sustaining Procedures Act
Craig P. Goldman, Revising Iowa’s Life Sustaining Procedures Act:
Creating a Practical Guide to Living Wills in Iowa, 76 Iowa L. Rev. 1137
(1991).
Iowa Code § 144B - Durable Power of Attorney for Health Care
Iowa Code § 144.26-.34 - Definition of Death
Dead Bodies:
Iowa Code § 142 - Donation
Iowa Code § 144.56 - Autopsy
Medical Staff Issues
Iowa Code § 147.135 - Immunity
Appointment and Discipline:
Privileges, denial restricted: Iowa Code § 135B.7
Disciplinary Actions Against: Iowa Code § 135(3)
Fair Hearing Requirements:
Natale v. Sisters of Mercy of Council Bluffs, 52 N.W.2d 701 (Iowa 1952)
Judicial Review Regarding Denial of Privileges:
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Koelling v. Board of Trustees of the Mary Skiff Memorial Hospital, 146
N.W.2d 284 (Iowa 1966)
Unreasonable criteria for appointment:
Op. Iowa Att’y Gen. 219 (1940), 136 (1954)
Exclusion of Specific Disciplines:
Exclusive Contracts:
Randall v. Buena Vista County Hospital, 75 F.Supp.2d 946 (N.D.Iowa
1999).
Jefferson Parish Hospital District No. 2 v. Hyde, 466 U.S. 2 (1984).
Payment Issues
Medical Assistance
Iowa Code § 249A
Iowa Admin. Code r. 441-74 to 92
Insurance
Iowa Admin. Code r. 191-30 to 44 - Life and Health Insurance
Iowa Admin. Code r. 191-70 - Managed Health Care
Iowa Admin. Code r. 191-71 to 79 - Health Benefit Plans
Iowa Admin. Code r. 191-80 to 99 - Insurance Coverage for Pediatric Preventive
Services
Iowa Code § 509 - Group Insurance
Iowa Code § 509A - Group Insurance for Public Employees
Environmental Issues
Iowa Code § 455B.501, 503, 505 - Infectious Waste
Other Issues
Iowa Code § 347, 347A - References to County Hospitals
Iowa Code § 331 - Construction
Iowa Code § 331 - Bonding Issue
3.
Provide any special issues which arise in your jurisdiction.
Telemedicine
“Telemedicine” defined
Proposed rule 653-13.11(1) is available on the IBM’s website at www.medicalboard.iowa.gov.
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Summary. The proposed rule addresses technologies covered and not covered by its reach.
Telemedicine is the practice of medicine using electronic audio-visual communications and
information technologies or other means between a physician licensee in one location and a patient
in another location with or without an intervening health care provider. Telemedicine is not the
provision of medical services only through an audio-only telephone, email message, fax, postal
mail, or combinations thereof. “Telemedicine technologies” is separately defined as mechanisms
enabling secure electronic communications and information exchanges between a physician
licensee in one location and a patient in another location with or without an intervening health care
provider. In proposed rule 653-13.11(16), the IBM recognizes three current categories of
telemedicine technologies: store and forward, remote monitoring, and real-time interactive
services.
Considerations. These definitions, read in tandem, seemingly take in a wide range of
electronically-delivered medical services. Many Iowa physicians may now or soon in the future be
providing medical services via telemedicine as so defined. Do these definitions capture too wide of
a field of potential physician-patient exchanges for purposes of this regulations? Are each of the
many comprehensive requirements (i.e.,standards) imposed upon physicians in the proposed rule
appropriate to each of these many exchanges? Should the definitions of “telemedicine”
and/or“telemedicine technologies” be narrowed or more focused in this round of telemedicine
rulemaking to avoid an overly broad application of the rule’s requirements as well as to assure that
physicians know which standards apply to them in each of the various telemedicine exchanges
anticipated by the rule’s definition?
An overriding concern in reviewing the IBM’s proposed telemedicine rule in its entirety is that
physicians are held responsible,subject to licensee discipline, to a very wide range of expectations
associated with telemedicine delivery of medical services, yet in certain contexts,physician may
have little control over those elements. In that regard, lumping various types of telemedicine
exchanges together and imposing broadly stated requirements or standards upon physicians for
each form of telemedicine delivery may create confusion and, in some instances, may impose
unrealistic expectations on the physician licensee.
Physicians who “use” telemedicine.
Summary. The standards proposed by the rule apply to physician licensees who “use”
telemedicine.
Considerations. “Use” is not defined. The rule appears to be primarily directed to those physicians
who actually provide medical services utilizing telemedicine technologies. It is not clear the extent
to which physicians who refer patients for telemedicine services also might be subject to the rule’s
standard, if at all. It is important that physicians involved in telemedicine delivery of care, whether
in referring a patient or in actually providing the medical service via telemedicine, understand the
extent to which the rule’s provisions apply or do not apply to them.
Note. Later discussion through these postings will note that certain requirements and prohibitions
set forth in this proposed rule are not specifically limited in their applicability to physicians using
telemedicine but, rather, address all physicians within the rule’s broad telemedicine reach.
Iowa medical license required.
Proposed rule 653-13.11(3)
Summary. A physician who uses telemedicine in the diagnosis and treatment of a patient located
in Iowa shall hold an active Iowa medical license.
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Considerations. This requirement enforces licensure policy of the IBM in place since 1996 and is
consistent with the IBM’s position that the practice of medicine is where the patient is located, not
where the physician is located. That 1996 telemedicine policy statement notes that under the IBM’s
licensure rules, an out-of-state physician may provide medical consultation services “incidental” to
the care of patients without obtaining full Iowa medical licensure; however, medical reports used
for primary diagnostic purposes generally are not “incidental.”
The proposed rule is silent on the continued effectiveness of the 1996 telemedicine policy
statement on licensure. It may be helpful to clarify the extent to which other licensure provisions,
such as “incident to” exceptions and provisional licensure, may be available to out-of-state
physicians providing medical services via telemedicine.
Laws More Specific Than Federal Law
Iowa Code 228 and 229, which specifically regulate mental health information, are more specific
than federal law.
Iowa Code 141A relates to HIV/AIDS testing and is more specific than federal law.
Minor Consent
Minors can consent to an array of issues.
4.
Are mobile health applications regulated under the law of your jurisdiction? If so,
provide a brief summary as to how they regulated.
Some mobile health applications are regulated by U.S. Federal Law, but there are no Iowa-specific
laws or regulations for them.
Contact Information
Davis Brown Law Firm
The Davis Brown Tower
215 10th Street, Suite 1300
Des Moines, IA 50309
Tel 1.515.288.2500 Fax 1.515.243.0654
Firm Website http://www.davisbrownlaw.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, Kentucky
Prepared by Lex Mundi member firm Wyatt Tarrant & Combs, LLP
1. Provide an introduction on health law in your jurisdiction.
Certificate of Need. The Commonwealth of Kentucky requires any “person” to obtain a “certificate
of need” (CON) in order to, among other things, establish a “health facility”, make certain capital
expenditures, acquire major medical equipment, make substantial changes in bed capacity, a
health service or a project, or transfer an approved CON to establish a new health facility or replace
a licensed facility. KRS Chapter 216B. Originally, only private offices and clinics of physicians,
dentists and “other practitioners of the healing arts” were exempt from the CON law, but the
Kentucky General Assembly has added other exemptions over the years which include, among
others, assisted living residences, family care homes, primary care centers, rural health clinics,
community mental health centers, group homes. KRS 216B.020(1). The physician office
exemption has been the most litigated of the exemptions, primarily due to debates over whether a
physician office with an MRI is actually operating a “health facility” that is not exempt from
CON. See, e.g., John Gilbert, M.D. et al. v. Commonwealth of Kentucky Cabinet for Health and
Family Services et al., 291 S.W.3d 712 (Ky. 2008).
Medicaid Program.
Implementation of Managed Care and Expanded Medicaid. On November 1, 2011, the
Commonwealth of Kentucky implemented Medicaid managed care and contracted with five
Medicaid managed care organizations (“Medicaid MCOs”) to administer benefits for Medicaid
beneficiaries. Effective January 1, 2014, Kentucky implemented Medicaid expansion under
the Affordable Care Act of 2010 (“ACA”). The Cabinet for Health & Family Services’ (the
“Cabinet”) Department of Medicaid Services (“DMS”) is responsible for administering Kentucky’s
Medicaid program or contracting with Medicaid MCOs to do so.
Provider Participation. Providers with active Kentucky Medicaid billing numbers and who
provide services to Kentucky Medicaid beneficiaries, both traditional and expanded Medicaid, must
comply with applicable Medicaid rules and regulations governing provider participation in the
Kentucky Medicaid program. Reimbursement for most services provided to a Kentucky Medicaid
beneficiary requires that the provider contract with the beneficiary’s Medicaid MCO.
Reimbursement for most Medicaid Waiver Program Services (e.g., intellectual or developmental
disabilities, acquired brain injuries, in-home services for disabled elderly people or children, inhome ventilator care), however, is through DMS rather than a Medicaid MCO (see
http://chfs.ky.gov/dms/mws.htm). For new Kentucky providers who want to serve Medicaid
beneficiaries outside of these Medicaid waiver programs, the provider must contract with a
Medicaid MCO who will forward the new provider’s credentialing information to DMS for verification
and issuance of a Medicaid billing number. Each provider who participates in Kentucky Medicaid
must file an annual ownership disclosure statement with the Cabinet.
False Claims. The “Kentucky Control of Fraud and Abuse” applies to the Kentucky
Medicaid program. See, generally, KRS 205.8451 to 205.8483; 907 KAR 1:671. The federal Deficit
Reduction Act of 2005 allows a state with an False Claims Act (“FCA”) that is substantially
equivalent to the federal FCA to receive a greater percentage of false claims recoveries by the
federal government. Kentucky’s current fraud and abuse law is not substantially equivalent to the
federal FCA. Despite several attempts to have the Kentucky General Assembly pass a bill that is
substantially equivalent to the federal FCA, such bills have failed to get of Committee. Kentucky
has other laws that also prohibit and impose fines and criminal penalties for fraudulent activity in
connection with any medical assistance program. See, e.g., KRS 205.8463 through 205.8483 and
907 KAR 1:671 (regulation setting forth specific prohibited activities). Kentucky’s whistleblower law
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protects both public and private employees from retaliation. See KRS 205.8465; KRS 61.101 to
61.103.
Kickbacks and Mini-Stark Law. Kentucky also has laws that prohibit and restrict physicians
in regard to unlawful remunerations and self-referrals related to goods, facilities, services or items
for which payment may be made by Medicare or Medicaid, similar to the federal physician selfreferral law known as the Stark Law. These self-referral laws incorporate by reference the
exceptions set forth in the federal Anti-Kickback Statute and Stark Law. See KRS 205.8461 and
KRS 216.2950. These laws also prohibit making, offering or receiving a payment for referring a
Medicare or Medicaid recipient to another provider for the furnishing of benefits. See Section 2
below for additional information regarding fee splitting.
For additional information about the
http://www.chfs.ky.gov/dms/services.htm#programs.
Kentucky
Medicaid
program,
go
to
2. Provide a check list of laws with a short summary of the general requirements of each.
Kentucky Health Care Laws
Abortion – Abortions are addressed in KRS 311.710 et seq. Kentucky law prohibits health
insurance contracts, plan and policies issued or delivered in the Commonwealth from covering
“elective abortions” unless by an optional rider to the policy that requires payment of an additional
premium. An "elective abortion" is defined to mean “an abortion for any reason other than to
preserve the life of the female upon whom the abortion is performed.” KRS 304.5-160.
Adult Protection – The protection of vulnerable adults is addressed in KRS 209.005 et seq. and
KAR Ch. 5.
Advance Practice Registered Nurses (APRN) – The Kentucky Board of Nursing governs the
practice of nursing. KRS Chapter 314. APRN is the legal, licensure title for a Nurse Practitioner
(NP), Certified Nurse Midwife (CNM), Certified Registered Nurse Anesthetist (CRNA), and a
qualifying Clinical Nurse Specialist (CNS). APRNs are considered independent practitioners. KRS
314.195. APRNs practicing less than four years must enter into a collaborative agreement with a
physician in order to prescribe nonscheduled legend drugs, and all APRNs must enter into a
collaborative agreement in order to prescribe controlled substances. KRS 314.042. The
administrative regulation 201 KAR 20:057 establishes APRN scope and standards of practice.
(See section below on Kentucky Health Care Licensure Boards)
Any Willing Provider –The Kentucky Insurance Code has an “any willing provider” law, often cited
as one of the broadest in scope among state “any willing provider” laws. KRS 304.17A-270 reads:
“A health insurer shall not discriminate against any provider who is located within the geographic
coverage area of the health benefit plan and who is willing to meet the terms and conditions for
participation established by the health insurer, including the Kentucky state Medicaid program and
Medicaid partnerships.” The United States Supreme Court unanimously upheld this law in
Kentucky Association of Health Plans, Inc. v. Miller, 538 U.S. 329, 123 S.Ct. 1471 (2003).
Certificate of Need & State Health Plan – Kentucky requires a certificate of need (“CON”) in order
to establish certain health facilities and services or to incur major medical expenditures. CON laws
are set forth at KRS 216B.010 et seq. In particular, CON application review criteria are found at
KRS 216B.040. Applications must also be consistent with the Kentucky State Health Plan, which
is the official document that expresses the health planning policy of the Cabinet and, as defined in
KRS 216.015(28), is “the document prepared triennially, updated annually, and approved by the
Governor.” Since 1998, the current version of the State Health Plan has been incorporated by
reference in 900 KAR 5:020, and it has been amended more or less annually.
Certified Surgical Assistant – Surgical assistants are regulated by the Kentucky Board of Medical
Licensure. See KRS 311.864 et seq.
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Code of Medical Ethics – KRS 311.597(4) declares that it is dishonorable, unethical or
unprofessional conduct for a physician to violate the principles of medical ethics of the American
Medical Association.
Confidentiality, Patient – For uses and disclosures of information related to:
• Child abuse, neglect or dependency, see KRS 620.050.
• Clients or patients of the Cabinet, see KRS 194A.060.HIV/AIDs, see KRS 214.181
and KRS 214.625.
• Controlled substance prescriptions, see KRS 218A.280.
• Mental health or chemical dependency, see KRS 304.17A-555.
• Minors (diagnosis and treatment of disease, addictions, or other conditions), see
KRS 214.185.
• Pharmacy patient records and counseling, see 201 KAR 2:210.
• Psychotherapist-patient privilege, see Kentucky Rules of Evidence, KRE 507.
• Threats of violence by a patient, see KRS 645.270.
• Toxicology test results on pregnant women or newborn infants, see KRS 214.175.
Consent - All competent adults have the right to make decisions concerning their health care or
treatment, including the right to refuse any treatment. Kentucky law recognizes that medical
treatment decisions can be made by others on behalf of an incapacitated person, if appointed
before that incapacity, by a durable power of attorney (KRS 386.093) or a person named as a
health care surrogate under KRS 311.621, et seq. Parents or court-appointed guardians of children
may consent or refuse treatment for their children or wards. However, the law allows certain
information to be gathered as part of a medical evaluation or investigation of a report of child abuse
or neglect without the consent of the parent or custodian and may be introduced into evidence in
any subsequent judicial proceeding. Minors may consent to a sexual assault examination and
consent of the parent or guardian is not required (KRS 216B.400).
Corporate Practice of Medicine – Pursuant to KRS 311.560(1), no person shall engage or attempt
to engage in the practice of medicine unless the person holds a valid and effective license issued
by the Kentucky Board of Medical Licensure (“KBML”). Under Kendall v. Beiling, 175 S.W.2d 489,
493 (Ky. 1943), only an individual can be licensed to practice medicine and “a corporation cannot
lawfully engage in the practice of law or medicine.” An October 1993 private opinion letter from the
KBML, however, stated that it is acceptable for physicians to be full-time employees of hospitals,
and in fact the practice is quite common in Kentucky.
Drug and Device Distribution – Kentucky law requires a license from the Kentucky Board of
Pharmacy for the sale and distribution by manufacturers and wholesaler distributors of legend
drugs and “Rx only” devices. KRS Chapter 315; 201 KAR 2:320 (manufacturers); 201 KAR 2:105
(wholesale distributors). A “special pharmacy permit” is required to sell or distribute “medical
gasses” [sic]. 201 KAR 2:225. (See also below section on Kentucky Health Care Licensure Boards,
Board of Pharmacy.)
Electronic Health Records, Hacking and Unlawful Access – A person may be found guilty of a
misdemeanor or a felony, depending on the facts, for accessing without effective consent or
misusing a computer, computer system, computer software, program, or data. See KRS 434.840
et seq.
Emergency Care – The Good Samaritan Act is codified in KRS 411.148 et seq.
False Claims – Kentucky does not have a state False Claims Act per se, but does prohibit the
submission of false or fraudulent claims to the Medicaid program. See KRS 205.8451 to 205.848.
(See further discussion in Section 1 above.)
Fee Splitting – Regardless of the source of payment, Kentucky law permits physicians to share a
fee proportionate to the services each renders to the patient so long as the patient has full
knowledge of the division but Kentucky law otherwise prohibits fee-splitting as compensation for
sending, referring or otherwise inducing an individual to communicate with a physician or
osteopath. See KRS 311.595(19). Kentucky has similar fee-splitting prohibitions for the following
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licensed professionals: alcohol and drug counselors, chiropractors, diabetes educators,
professional counselors, marriage and family therapists, massage therapists, medical laboratories,
occupational therapists, optometrists, physical therapists and physical therapy assistants, social
workers, specialists in hearing instruments, speech-language pathologists and audiologists (See
“Kentucky Health Care Licensure Boards” in this Section 1 for the general statutory and regulatory
citations for each licensing board.)
Home Medical Equipment and Durable Medical Equipment – Kentucky requires home medical
equipment service providers to obtain a license from the Kentucky Board of Pharmacy. KRS Ch.
315; 201 KAR 2:350.
Hospitalists – KRS 304.17A.532 prohibits a contract between an insurer and a physician from
requiring the mandatory use of a hospitalist.
Insurance, Health – The Kentucky Insurance Code is housed at Chapter 304 with over fifty (50)
subtitles. This Code extensively regulates health care related insurance policies and coverage and
variations on the theme of “managed care”, including managed care organizations (“MCOs”), health
maintenance organizations (“HMOs”), preferred provider organizations (“PPOs”), point-of-service
(“POS”) plans, and exclusive provider networks (see also “Any Willing Provider” supra). A large
portion of health-care related insurance law is found within KRS Chapter 304.17A, which regulates
“health benefit plans” (defined at KRS 305.17A-005(22)), managed care plans, self-insured
employer-organized association groups, utilization review, payment of claims, and appeals of
“adverse determinations”. A “health benefit plan” is broadly defined to include “any hospital or
medical expense policy or certificate; nonprofit hospital, medical-surgical, and health service
corporation contract or certificate; provider sponsored integrated health delivery network; a selfinsured plan or a plan provided by a multiple employer welfare arrangement, to the extent permitted
by ERISA; health maintenance organization contract; or any health benefit plan that affects the
rights of a Kentucky insured and bears a reasonable relation to Kentucky, whether delivered or
issued for delivery in Kentucky.” Additional subtitles of KRS Ch. 304 regulate HMOs, limited health
service benefit plans, and nonprofit hospital, medical-surgical, dental and health service
corporations. Notably, the Code prohibits insurers with a local market share of a certain percentage
from enforcing a “most favored nation” clause against a provider, but the law does not prohibit an
insurer and provider from negotiating a rate that is more favorable than the rate negotiated between
the insurer and another provider. KRS 304.17A-560.
Insurance, Religious Organization Exemption – In Commonwealth of Kentucky v. Reinhold, 325
S.W.3d 272 (Ky. 2010), the Kentucky Supreme Court held that Medi-Share, a program operated
by the American Evangelistic Association and the Christian Share Ministry, provided a “contract for
insurance” as defined by KRS 304.1-030 and did not fall within the exemption under KRS 304.1020 which, at that time, was called the “religious publications exemption”. Subsequent to this
decision, the Kentucky General Assembly passed, and the Governor signed into law on April 5,
2013, an Act that deleted the “religious publication exemption” and substituted a “religious
organization exemption”; required a notice to all participants that sharing of medical expenses is
not insurance and established such notice requirements, among other changes.
Itinerant Physicians – KRS 311.260 provides that itinerant physicians may not practice medicine
in the state. The Kentucky Board of Medical Licensure does allow physicians to obtain a temporary
permit as a part of the regular medical/osteopathic license application and is offered to allow
physicians who are eligible the opportunity to practice prior to receiving approval by the full Board.
Temporary permits are unrestricted and are issued for up to 6 months.
Living Wills, Powers of Attorney and Advance Directives – KRS 311.621 et seq. addresses
living wills in Kentucky. In particular, a sample living will form is available at KRS 311.625. KRS
311.631 also sets forth a list, in order, of who may make health care decisions if a patient does not
have decisional capacity and has not executed an advance directive. A durable power of attorney
is another document that can allow a designee to make health care and other decisions; however,
it must specifically note that the “attorney-in-fact” has the authority to make health care decisions
and a blanket power to make all decisions is not considered to include health care decision
authority.
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Long-Term Care Facilities – Kentucky law (most of which is housed in KRS Chapters 216, 216B,
and 194A) and related implementing regulations require the licensing or certification, and regulate
the operations and services, of the following types of long-term care facilities: family care homes
(902 KAR 20:041); personal care homes (902 KAR 20:036); intermediate care facilities (902 KAR
20:056); skilled nursing facilities (902 KAR 20:026); nursing facilities (902 KAR 20:300);
intermediate-care facilities for the mentally retarded and developmentally disabled (902 KAR
20:086); assisted living facilities (KRS 194A.700 et seq.; 910 KAR 1:240); and continuing care
retirement communities (KRS 216B.330 et seq.; 900 KAR 6:115). Kentucky’s “residents’ rights”
law is set forth in KRS 216.515-.525 and 902 KAR 20:300 Section 3.
Malpractice, Health Care – Health care malpractice is defined in the Kentucky Insurance Code at
KRS 304.40-260. An action against a physician, surgeon, dentist, or hospital licensed pursuant to
KRS Chapter 216, for negligence or malpractice must be brought within one year pursuant to KRS
413.140. Kentucky law does not provide caps on compensatory or punitive damages, which have
been held to be violation of the Kentucky Constitution. During the 2014 Kentucky General
Assembly, the Senate passed a medical liability reform bill applicable to all health care providers
that would have required malpractice claims to be first heard by a pre-suit medical liability review
panel, but the bill failed to pass the House. Medical liability reform is expected to be a significant
issue before the upcoming Kentucky General Assembly due to year-over-year increases in the
volume and cost of medical liability claims, lawsuits and settlements involving Kentucky health care
providers.
Medical Records, Retention – Record retention requirements are scattered throughout Kentucky
statutes and regulations and differ based on the type of record and the type of provider. See, e.g.,
906 KAR 1:070(4)(d) requiring physicians to maintain patient health records for five years after
patient’s death or discharge.
Medical Staff – The Cabinet is responsible for promulgating regulations to ensure the safe,
adequate and efficient operation of hospitals, including qualification of medical staff personnel. See
KRS 216B.042(1)(c)(1). Such regulations require hospitals to “have a medical staff organized
under bylaws approved by the governing authority” and require such medical staff to govern the
quality of medical care provided to patients and the ethical and professional practice of its members
and to develop and adopt policies or bylaws, subject to the approval of the hospital’s governing
authority. See 902 KAR 20:016.
Mental Health, Hospitalization and Advance Directives – KRS Chapter 202A addresses
hospitalization of the mentally ill. This same chapter also allows adults to execute an advance
directive for mental health treatment that addresses such topics as: refusal of specific psychotropic
medications or electric shock therapy or stated preferences for psychotropic medications and
emergency interventions.
Minors, Treatment of – KRS 214.185 addresses when a minor may consent to medical treatment.
Physicians may treat minors for venereal disease, pregnancy, or alcohol or drug abuse or addiction
and may advise, prescribe for and treat these conditions and contraception and childbirth without
notifying the parent or obtaining the parent’s consent. The same is true for outpatient mental health
counseling for children ages 16 and older. However, the physician may choose to inform the
parent/guardian of any treatment given or needed where, in the judgment of the physician,
informing the parent/guardian would benefit the health of the minor. Note that minors who are
emancipated, have contracted a lawful marriage, or have borne a child may consent to treatment
for themselves or their children.
Nurses – See section below on Kentucky Health Care Licensure Boards.
Pain Management Facilities and Prescription Pain Pills – The registration and oversight of pain
management facilities is addressed in KRS 218A.175 and 201 KAR 9:250. Additionally, health
care providers must query the patient’s history of controlled substance prescriptions via the
Kentucky
All
Schedule
Prescription
Electronic
Reporting
(KASPER)
at
http://www.chfs.ky.gov/os/oig/KASPER.htm. Licensed health care professionals are regulated by
their applicable licensing board with regard to the prescription of Schedule II controlled substances
and Schedule III controlled substances containing hydrocodone. Exemptions apply to certain
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licensed providers in certain health care settings. For additional information about Kentucky’s
prescription pain pill law, which was passed in 2012 and amended in response to public reaction
in 2013, see Section 3 below on “Special Issues Which Arise in Your Jurisdiction.”
Physicians and Osteopaths – See section below on Kentucky Health Care Licensure Boards.
Physician Assistants – See section below on Kentucky Health Care Licensure Boards,
Physician Self Treatment, Family Members – While not a per se violation of Kentucky law, KRS
311.597(1)(C) states that self-prescribing and prescribing to immediate family members is contrary
to law when the physician “knows or has reason to know that an abuse of controlled substances is
occurring, or may result from such a practice.”
Prescriptions – Prescribing and dispensing standards for physicians and other prescribing
practitioners are set forth in KRS 218A.172 and 201 KAR 9:260.
Prompt Payment Laws – Generally, insurers must pay, deny or contest a clean claim (except for
an organ transplant claim) within 30 days from receipt of the claim. See KRS 304.17A-700, et seq.,
KRS 205.593 (Medicaid MCOs), KRS 304.14-135(d)(pharmacist clean claim), KRS 304.99-123
(penalties for non-compliance), and 806 KAR 17:360.
Stark Law – Kentucky has laws that prohibit and restrict physicians in regard to unlawful referrals
and self-referrals, similar to the federal physician self-referral law known as the Stark Law. These
self-referral laws incorporate by reference the exceptions set forth in the Stark Law. See KRS
205.8461 and KRS 216.2950.
Suicide, Physician Assisted – Physician assisted suicide is prohibited in Kentucky. KRS 311.639
specifically provides that KRS 311.621 to 311.643 shall not be construed to condone, authorize,
or approve mercy killing or euthanasia, or to permit any affirmative or deliberate act to end life other
than to permit the natural process of dying.
Telemedicine – Kentucky Medicaid covers telehealth services, including in-home telerehabilitation services, provided to Kentucky Medicaid beneficiaries if the services constitute
interactive video-conferencing. To be reimbursed, providers must become an approved member
of the Kentucky Telehealth Network. See KRS 194A.125(3)(b) and 907 KAR 3:170. Kentucky law
requires a treating physician who provides or facilitates the use of telehealth services to obtain
informed consent and to ensure appropriate processes, practices and technology is in place to
protect the confidentiality of such services. See KRS 311.5975.
Kentucky Health Care Licensure Boards
Chiropractic practice: KRS Ch. 312; 201 KAR Ch. 21 (http://kbce.ky.gov/Pages/default.aspx)
Dentistry: KRS Ch. 313; 201 KAR Ch. 8 (http://www.dentistry.ky.gov/)
Durable Medical Equipment/Home Medical Equipment Suppliers: Board of Pharmacy KRS
Chapter 315; 201 KAR 2:350 (effective July 12, 2012)( http://www.pharmacy.ky.gov)
Long-Term Care Administrators: KRS Ch. 216A; 201 KAR Ch. 6
(http://ltca.ky.gov/Pages/default.aspx)
Medical Licensure: KRS Ch. 311; 201 KAR Ch. 9. This Board also governs all allied health
professionals
(e.g.,
Certified
Surgical
Assistants
at
KRS
311.864
et
seq.)
(http://kbml.ky.gov/Pages/default.aspx)
Nursing: KRS Ch. 314; 201 KAR Ch. 20 (http://kbn.ky.gov/Pages/default.aspx)
Ophthalmic Dispensers: KRS Ch. 326; 201 KAR Ch. 13
(http://bod.ky.gov/Pages/default.aspx)
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Optometric Examiners: KRS Ch. 320; 201 KAR Ch. 5
(http://optometry.ky.gov/Pages/default.aspx)
Pharmacy: Board of Pharmacy, KRS Ch. 315 and 201 KAR Title 201, Ch. 2. This Board examines
and licenses pharmacies, individual pharmacists and pharmacy technicians, the latter which are
subject to certain supervision requirements (e.g., uncertified pharmacy techs must work under a
pharmacist’s “immediate supervision”). This Board also is responsible for licensing wholesale
distributors and manufacturers who distribute within Kentucky “drugs” and “devices” (see 201 KAR
2:105; 201 KAR 2:320) and “medicinal gases” (___). the Kentucky Food, Drug and Cosmetic Act
at KRS Ch. 217. (http://www.pharmacy.ky.gov)
Physical Therapy: KRS Ch. 327; 201 KAR Ch. 22 (http://pt.ky.gov/Pages/default.aspx)
Podiatry: KRS Ch. 311; 201 KAR Ch. 25
(http://podiatry.ky.gov/Members/Pages/default.aspx)
Psychology: KRS Ch. 319; 201 KAR Ch. 26 (http://www.psy.ky.gov/Pages/default.aspx)
Speech-Language Pathology & Audiology: KRS Ch. 334A; 201 KAR Ch. 17
(http://slp.ky.gov/Pages/default.aspx)
Social Work: KRS Ch. 335; 201 KAR Ch. 23 (http://bsw.ky.gov/Pages/default.aspx)
3. Provide any special issues which arise in your jurisdiction.
The “Pill Mill Bill” -- Kentucky was one of the first states to pass substantial reform related to the
abuse of prescription pain pills, specifically Schedule II controlled substances and any Schedule III
controlled substance containing hydrocodone. In 2012, the Kentucky General Assembly passed
House Bill 1, commonly referred to as the “Pill Mill Bill”, to fight pain prescription abuse through
stiffer regulation of pain management clinics and heightened regulation by licensing boards of a
health provider’s treatment and prescribing practices with regard to patient complaints of pain. After
passages of the landmark bill, health care providers and the public feared that the new laws were
overreaching and could lead to increased or unnecessarily prolonged suffering by patients,
especially in certain health care settings such as hospitals and nursing homes. Health care
providers also expressed concern that that the licensing board regulations mandated by House Bill
1 overly restricted a health care professional’s exercise of medical decision-making. Accordingly,
House Bill 1 was tweaked in 2013 with the passage of House Bill 217.
The pain prescription law and regulations are still somewhat complex, but, to summarize, before
the initial prescription of a Schedule II controlled substance or a Schedule III controlled substance
containing hydrocodone (the latter which the U.S. Drug Enforcement Agency rescheduled to
Schedule II effective October 6, 2014), the health care professional must obtain a recent medical
history and conduct a physical and mental examination. Additionally, to prevent “doctor shopping”
and other abuses, providers must query the patient’s history of controlled substance prescriptions
via KASPER. Licensed health care professionals must adhere to their licensing board’s special
pain prescribing regulations. The Kentucky Board of Medical Licensure created special webpages
to address the requirements of House Bill 1 and House Bill 217 (see
http://kbml.ky.gov/hb1/Pages/default.aspx). Exemptions apply to certain licensed providers in
certain health care settings. KRS Chapter 218 and each licensing board’s regulations must be
carefully consulted to ensure compliance.
Data Breach Laws – In 2014, Kentucky enacted two new data breach laws. Kentucky
governmental agencies, those doing business with governmental agencies, and persons simply
doing business in Kentucky should be aware of these added data security and breach notification
requirements. KRS 61.931 et seq. applies to state and local governmental agencies as well as
individuals and business who do business with those governmental agencies and goes into effect
on January 1, 2015. Those who are subject to this law must implement, maintain and update
security procedures and practices to protect and safeguard against security breaches in
compliance with applicable regulations (which as, of September 2014, had not been
promulgated). KRS 365.720 et seq., on the other hand, enacts general data breach notification
requirements for any person or business that conducts business in Kentucky. KRS 365.720 et
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seq. does not apply to state and local governmental agencies. Health care providers, health
insurance companies, banks, or others who are subject to either the Health Insurance Portability
and Accountability Act of 1996 (“HIPAA”) or Title V of the Gramm-Leach-Bliley Act of 1999 also
appear to be exempt from KRS 365.720; however, questions remain as to whether HIPAAcovered entities and banks are exempt from the governmental entity data breach law, KRS
61.931 et seq. when they have a contract with a state agency and receive personal information
from the agency.
Peer Review – Kentucky is one of the few states that does not protect peer review documents from
discovery in medical malpractice cases. KRS 311.377 provides: “At all times in performing a
designated professional review function, the proceedings, records, opinions, conclusions, and
recommendations of any committee, board, commission, medical staff, professional standards
review organization, or other entity . . . shall be confidential and privileged and shall not be subject
to discovery, subpoena, or introduction into evidence, in any civil action in any court or in any
administrative proceeding. . . .” Although this language clearly protects peer review from discovery
in “any civil action”, the Kentucky Supreme Court eroded the scope of this privilege by finding it
does not apply to medical malpractice actions. Sisters of Charity Health Systems, Inc. v. Raikes,
984 S.W.2d 464 (Ky. 1998).
A recent Kentucky case also erodes the protections extended to patient safety work product
reported to patient safety organizations (“PSOs”) under the federal Patient Safety and Quality
Improvement Act of 2005 (“PSQIA”). In Tibbs v. Estate of Luvetta Goff, et al., Case No. 2012-SC000603-MR (Ky. S.Ct. August 21, 2014) [To Be Published], the Kentucky Supreme Court held that
an occurrence report generated through the University of Kentucky HealthCare Patient Safety
Evaluation System by a surgical nurse on the day of the event was not protected from discovery
by plaintiff in a medical malpractice lawsuit. Essentially, the court held that occurrence reports and
other information collected pursuant to state law may not be protected even if reported to a PSO
because it is considered to be collected, developed or maintained separately. Look for future
developments in this case and area of law.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
With telehealth services first delivered in the Commonwealth in 1995, Kentucky was an early
adopter of interactive video conference technology to connect providers and patients and was the
first state in the U.S. to pass laws mandating coverage of such services by both Medicaid and
commercial health insurance plans. In 2000, the Kentucky General Assembly passed the
Kentucky Telehealth Network law. KRS 194A.125 (the implementing regulations are at 907 KAR
3:170). The Kentucky Telehealth Network manages four telehealth resource centers around the
Commonwealth to assist providers in setting up telehealth services. In 2013, Kentucky expanded
the scope of providers and services that are eligible to use telehealth. See, e.g. 907 KAR 3:170;
907 KAR 1:055; 907 KAR 9:005. At the 2014 KHIE Kentucky eHealth Summit held on September
17, 2014 (“KY eHealth Summit”), presenters described how Kentucky providers are serving rural
patients with the use of telehealth in behavioral health (“TelePsychiatry”) and even dentistry
(“TeleDentistry”). Representatives of the Kentucky Telehealth Network indicated at the KY
eHealth Summit that Kentucky telehealth regulations would be updated in the very near future in
order to bring them up to date with more recent developments in the use of telehealth and
telemedicine.
More recently, the Kentucky Board of Medical Licensure determined that the Model Policy on the
Appropriate Use of Telemedicine Technologies in the Practice of Medicine, adopted by the
Federation of State Medical Boards in April 2014, constitutes the standards of acceptable and
prevailing medical practice via telemedicine technologies. The Board issued this Telemedicine
Policy Statement: “Physicians living outside Kentucky but actively practicing medicine upon
patients within Kentucky should be required to meet the same statutory qualifications and should
be held to the same standards of acceptable and prevailing medical practice within the
Commonwealth as are resident physicians practicing within the state.”
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Contact Information:
Kathie McDonald-McClure
[email protected]
Wyatt, Tarrant & Combs, LLP
500 West Jefferson St., Suite 2800
Louisville, KY 40202
Margaret Young Levi
[email protected]
Jennifer Wintergerst
[email protected]
For a complete list of the members, services, and
resident offices of Wyatt, Tarrant & Combs, LLP,
including its Health Care Services Legal Team, go
to www.wyattfirm.com. Blog: Wyatt HITECH Law
@ www.wyatthitechlaw.com.
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, Massachusetts
Prepared by Lex Mundi member firm Foley Hoag LLP
1. Introduction
In 2006, then-Massachusetts Governor Mitt Romney signed Chapter 58 of the Acts of 2006, a
comprehensive health care reform law titled “An Act Providing Access to Affordable, Quality, Accountable
Health Care.” The law provided near-universal health insurance coverage for state residents.
Within a year of implementation, Massachusetts experienced a drop in the number of uninsured individuals
and, despite a national economic recession, Massachusetts had the lowest rate of uninsured residents of
any state in the United States. With more residents gaining insurance coverage, demand for health care,
particularly in underserved communities, increased. Safety net providers saw an increasing number of
patients. The state has attempted to increased medical school enrollment for students committed to primary
care and created loan repayment opportunities for providers working in underserved areas.
Massachusetts continues to struggle with rising health care costs. Per capita health care spending is 15%
higher than the United States’ average and Massachusetts has the highest individual market premiums in
the country.
Massachusetts put the second phase of health reform into action with Chapters 96, 118 and 224 of the Acts
of 2012. These laws enacted cost containment measures, promoted improvements in quality and health
outcomes, and increasing transparency in the health care marketplace, while aligning Massachusetts with
the provisions of the 2010 federal Patient Protection and Accountable Care Act (often referred to as
“ObamaCare”). These more recent Massachusetts laws also require the Massachusetts Medicaid program,
MassHealth, to continue to shift away from the traditional fee-for-service model towards alternative payment
methodologies.
Massachusetts has a number of different health care regulatory agencies, including the Executive Office of
Health and Human Services, the Office of the Attorney General, the Department of Mental Health, the
Department of Mental Retardation, the Department of Public Health, the Department of Social Services,
the Department of Transitional Assistance, the Department of Youth Services, the Division of Medical
Assistance, the Division of Health Care Finance and Policy, the Center for Health Information and Analysis
and the Group Insurance Commission, among others that regulate health care.
Massachusetts licensed health professionals are regulated by a number of regulatory boards.
2. List of selected laws
i) Massachusetts Law
The key law is Acts of 2006, ch. 58: An Act Providing Access to Affordable, Quality, Accountable Health
Care. The Massachusetts Mandated Health Insurance Law. Among other things, this law added Mass.
Gen. L. ch. 111M and amended many other sections. Key provisions of the law include subsidized health
insurance for residents earning less than 300% of the federal Poverty Level, and low-cost insurance for all
other residents who are not eligible for insurance through their employers.
Follow on reforms were included in Acts of 2012, ch. 224: An Act Improving the Quality of Health Care and
Reducing Costs through Increased Transparency, Efficiency and Innovation. Health Care Cost Reduction.
Mass. Gen. L, ch. 12, § 5N Office of the Attorney General, Civil Investigative Demands
Mass. Gen. L, ch. 12C, establishing Center for Health Information and Analysis
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Mass. Gen. L. ch. 17, Department of Public Health
Mass. Gen. L. ch. 19, Department of Mental Health
Mass. Gen. L. ch. 111-114, Public Health
Mass. Gen. L. ch. 118E-118I, Public Welfare
Mass. Gen. L. ch. 123, Mental Health
Mass. Gen. L. ch. 175H, Health Care False Claims
Mass. Gen. L. ch. 175I-176Q (Health insurance, including HMO, PPO, group, non-group).
ii)
Massachusetts Regulations
Title
Agency
101
Executive Office for Health and Human Services
102
104
Office of Child Care Services
Department of Mental Health
105
Department of Public Health
106
Department of Transitional Assistance
113
Health Facilities Appeals Board
114
Division of Health Care Finance and Policy
115
Department of Developmental Services
118
Disabled Persons Protection Commission
129
Health Care Quality and Cost Council
130
Division of Medical Assistance
iii) Professional Licensure Boards
233
Board of Registration of Chiropractors
234
Board of Registration in Dentistry
235
Board of Registration of Dispensing Opticians
243
Board of Registration in Medicine
244
Board of Registration in Nursing
245
Board of Registration of Nursing Home Administrators
246
Board of Registration in Optometry
247
Board of Registration in Pharmacy
249
Board of Registration in Podiatry
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251
Board of Registration of Psychologists
258
Board of Registration of Social Workers
259
Board of Registration of Allied Health Professionals
260
Board of Registration in Speech-Language Pathology and Audiology
261
Board of Respiratory Care
262
Board of Registration of Allied Mental Health and Human Services Professionals
263
Board of Registration of Physician Assistants
267
Board of Perfusionists
268
Board of Dietitians/Nutritionists
269
Board of Registration of Massage Therapy
270
Board of Registration of Genetic Counselors
956
Commonwealth Health Insurance Connector Authority
957
Center for Health Information and Analysis
958
Health Policy Commission
iv) Selected Case Law
Finch v. Commonwealth Health Insurance Connector Authority, 461 Mass. 232 (2012). Coverage for legal
immigrants. "Section 31(a) [of St.2009, c.65] cannot pass strict scrutiny. The discrimination against legal
immigrants that its limiting language embodies violates their rights to equal protection under the
Massachusetts Constitution."
Alberts v. Devine, 395 Mass. 59 (1985). A physician owes a duty of confidentiality to his patient.
Rogers v. Comm’r of the Dep’t of Mental Health, 390 Mass. 489 (1983) (limiting the power of the state to
treat those with mental illness)
Lampron-Dwyer Protocol (Rules for access to third-party records prior to trial in criminal cases, available at
http://www.mass.gov/courts/sjc/guide-to-evidence/1108.htm)
2) Special issues
Abortion and Contraception
Massachusetts has been at the forefront of expanding abortion rights and contraception. It has an abortion
clinic buffer zone case, McCullen v. Coakley, decided by the U.S. Supreme Court in June 2014 and
available at http://www.supremecourt.gov/opinions/13pdf/12-1168_6k47.pdf
Right to withhold treatment
Massachusetts law does not require the administration of medical treatment in all cases. Superintendent
of Belchertown State School v. Saikewicz, 373 Mass. 728 (1977).
Health Insurance
Massachusetts has more mandated coverage than other states. Out of state insurers frequently become
the subject of investigation and settlements by not providing coverage for all mandates.
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3. Mobile health applications
Some mobile health applications are regulated by U.S. federal law, but there are no Massachusetts-specific
laws or regulations for them.
Contact Information
Colin J. Zick, Partner, Co-Chair of Health Care
Practice
Email address [email protected]
Foley Hoag LLP
155 Seaport Boulevard
Boston MA 02210
Tel 1.617.832.1275 Fax 1.617.832.7000
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, Michigan
Prepared by Lex Mundi member firm Butzel Long
1. Provide an Introduction on health law in Michigan.
The Affordable Care Act (ACA) has substantially changed the landscape of Michigan health care law. The
ACA changed the way insurance is accessed, putting in place rules and limitations for both health insurance
providers and their customers. Health insurance was more of a state concern prior to the ACA, but states,
including Michigan, still have the authority to pass laws and regulations affecting health care.
Michigan’s private health care provider community is distinguished by several key features. The
hospital provider network has traditionally been exclusively non-profit, tax exempt until the last couple of
years when a few hospitals were acquired by out-of-state for-profit hospital systems. Michigan retains a
robust certificate of need program to control the entry of new private providers and new services in a number
of health care provider categories. Michigan also has a prohibition on the corporate practice of medicine by
private providers which affects the structure and relationship of health professionals to private institutional
providers. Hospitals and physician groups are in the middle of a process of consolidation into larger equity
and contractual systems and collaborations that can meet the requirements of accountable care
organizations (ACO). As a result of the ACA and market and economic trends, the health care landscape
in Michigan is in a state of flux.
Michigan’s public health system includes official Michigan government public health agencies at the state
and local level as well as public-sector agencies (such as schools, Medicaid and environmental protection
agencies, and land-use agencies) and private-sector organizations whose actions have significant
consequences for the health of the public. The major regulatory agency is the Michigan Department of
Community Health (MDCH). Its objectives include helping protect the public in the event of a public health
emergency, improving and protecting the public health, welfare, and environment through inspection
programs, educational outreach, enforcement powers, protecting and improving the health status of the
community; preventing and/or controlling the disease, disability and death associated with communicable
diseases, promoting healthy lifestyles, and regulating both health professions and health facilities, among
other functions.
Michigan’s public mental health system is administered by MDCH but most services are delivered
through 46 Community Mental Health Service Programs (CMHSPs), who contract with MDCH and receive
appropriations from the Michigan Legislature, a mix of general funds and federal Medicaid funds. The
CMHSPs serve persons with mental illness, developmental disabilities, and in conjunction with statewide
coordinating agencies, substance use disorders. Under the terms of both a Medicaid 1915(b) Freedom of
Choice Waiver and a 1915(c) Home and Community Based Service Waiver, Michigan has contracted with
counties and groups of counties across the state for the management of Medicaid services to people with
severe mental illness, serious emotional disturbance (SED), substance abuse disorders, and
developmental disabilities. The counties form Prepaid Inpatient Health Plans (PIHPs) under Medicaid rules,
and consumers are assigned to these plans when they meet clinical criteria. As of the date of this summary,
Michigan is working on a demonstration program for coordinated care for people “dual eligible” under both
Medicare and Medicaid.
Michigan’s Medicaid system has long used Medicaid managed care contracting, and as a result most
Medicaid recipients are assigned to a plan administered by one of the insurance companies that contract
with the state. Michigan did participate in the Medicaid expansion program of the ACA, and obtained a
waiver from the Centers for Medicare and Medicaid Services (CMS) for some of its features, with a plan
called “Healthy Michigan” effective April 1, 2014. This plan includes requiring Medicaid enrollees to
contribute in part to their coverage (with some exceptions for people with certain medical conditions and
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incentives for certain healthy behaviors). There are also some special programs for children with special
health care needs and other categories.
2. Provide a check list of laws with a short summary of the general requirements of each.
The Public Health Code of Michigan is the primary regulatory framework for health care in Michigan,
including regulation both of healthcare professionals and of health facility licensing. In addition to numerous
other roles, the Code primarily serves to “to protect and promote the public health.” The Code contains
provisions to safeguard patients’ rights. An index to the topics covered by the Code is:
http://www.legislature.mi.gov/(S(1x0x1n34j5jnyaujklye0q45))/mileg.aspx?page=GetObject&objectname=
mcl-act-368-of-1978
Since it was originally enacted in 1978, there have been many amendments and repeals passed, however
there has not been any coordinated review completed since the Code was created over 35 years ago. As
a result, Governor Snyder called for a complete review, and an Advisory Committee was assembled in
2013 to begin the high-level review and recommendation process. Based on feedback that will be gathered
from numerous stakeholders and the public, the Advisory Committee will conduct the review and prepare
a report of recommendations to the MDCH Director and Governor Snyder. The Advisory Committee will be
making
only
recommendations,
not
changes,
to
the
Public
Health
Code.
http://www.michigan.gov/mdch/0,4612,7-132-8347-307920--,00.html
The Mental Health Code of Michigan applies to persons with a diagnosis or possible diagnosis of mental
illness, including substance abuse, and to the institutions and licensed health professionals involved in
managing or treating patients with mental health disorders. An index to the topics covered by the Mental
Health
Code
is:
MCL
330.1001
et
seq.
http://www.legislature.mi.gov/(S(mreccf55yecev4ytykvqt3i4))/mileg.aspx?page=GetObject&objectname=
mcl-Act-258-of-1974
In Michigan, mental health services and payment are frequently interwoven with Michigan’s Medicaid
programs and waivers and the federal Mental Health Parity Act. The Michigan Mental Health Code contains
provisions to safeguard recipients’ rights.
3. Provide any special issues which arise in your jurisdiction.
Abortion and Contraception. Abortions are regulated in Michigan. MCL 750.14; MCL 722.901 et seq.;
MCL
333.17016.
http://www.legislature.mi.gov/(S(wqgozd45qjf1duat3bpm4xmf))/mileg.aspx?page=ExecuteSearch&legislat
ivesession=2013-2014&detailedcategory=Health,%20abortion Partial birth abortion is unlawful except to
save the life of a mother endangered by physical illness, physical injury, or physical disorder when no other
medical procedure will suffice. After viability, an abortion is only permitted when necessary to preserve life
of mother. No abortion may be performed on minor without her consent and that of one parent or guardian
except in medical emergency; however, a court may waive parental consent if minor is mature and wellinformed so as to be able to make the decision, or grant a waiver if it is in a minor's best interest. Only a
licensed physician may perform abortions; clinics must be licensed by the state in order to legally operate.
Women must purchase separate medical insurance coverage riders (add-ons) in order to have coverage
for abortions (state law prohibits all general insurance plans from covering the procedure).
Certificate of Need. An entity (health facility, physician, group practice HMO for some limited projects, etc.)
proposing any of the following types of projects must obtain a CON, regardless of the capital expenditure
proposed: (1) Increase in the number of licensed beds or the relocation of licensed beds from one site to
another. (2) Acquisition of an existing health facility. (3) Operation of a new health facility. (4) Initiation,
replacement, or expansion of covered clinical services. (5) Short-term nursing care program (Swing Beds).
In addition, capital expenditure projects (construction, renovation, etc.) that involve a health facility require
a CON. The capital expenditure threshold is indexed annually by the MDCH based on the Consumer Price
Index. The threshold effective January 1, 2014, is $3,160,000 for clinical service areas. MCL 333.22201 et
seq. http://www.michigan.gov/documents/mdch/Part_mcl-368-1978-17-222_420131_7.pdf
Consumer Complaints and Investigations. Complaints allegations of non-compliance with regulations
may be made verbally, in writing, or anonymously made by calling the Bureau of Health Care Services
Complaint Hotline at 800-882-6006 or by faxing to 517-241-0093. http://www.michigan.gov/lara/0,4601,7154-35299_63294_27647---,00.html
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Corporate Practice of Medicine. Any person required under Michigan law to provide professional services
under license from any state agency can form a corporation under the Michigan Business Corporation Act.
(BCA). In 2013, Michigan corporate law was changed to repeal the Professional Services Corporation Act
(PSCA) as a separate act and instead bring the PSCA into the body of the BCA as new Chapter 2A. MCL
450.1281-1289.
http://www.legislature.mi.gov/(S(rbf34g55rbod3l45r2hley55))/mileg.aspx?page=GetObject&objectname=
mcl-chap450
The BCA typically is amended on a three- to four-year cycle. The revised BCA and PA 566, 567 and 568
amend other statutes that formerly cross-referenced the PSCA as follows: Public Act 566 amended Section
721 (MCL 333.721) of the Occupational Code (1980 PA 299; MCL 339.101 et seq.), PA 567 amended
Section 4 (MCL 445.4) of the Carrying on Business Under Assumed or Fictitious Name Act (1907 PA 101;
MCL 445.1 et seq.), and PA 568 amended Sections 102 and 109 (MCL 450.4102 and 450.4902) of the
Limited Liability Company Act (1993 PA 93, MCL 450.4101 et seq.).
Any person required under Michigan law to provide professional services under license from any state
agency can form a limited liability company under the provisions of Article 9 of the Michigan Limited Liability
Company
Act,
MCL
450.4901
-4910
https://www.legislature.mi.gov/(S(jc3v5emlhxo3ofryhuwoscbv))/documents/mcl/pdf/mcl-23-1993-9.pdf
Euthanasia. Under the Michigan Penal Code, there is a general homicide law that specifically prohibits
assisted
suicide.
MCL
750.329a
(1)
and
(3).
http://www.legislature.mi.gov/(S(h0beah45vbcre145zulls5bm))/mileg.aspx?page=getObject&objectName
=mcl-750-329a The designation of a patient advocate shall not be construed to condone, allow, permit,
authorize, or approve suicide or homicide. MCL 333.5660.
Health Care Directives. Under the Durable Power of Attorney and Designation of Patient Advocate
provisions of the Estates and Protected Individuals Act, an individual 18 years of age or older who is of
sound mind may designate in writing another individual who is 18 years of age or older to exercise powers
concerning care, custody, and medical or mental health treatment decisions (with some limitations) for the
individual
making
the
patient
advocate
designation.
MCL
700.5501
et
seq.
http://www.legislature.mi.gov/(S(hdlosj55jwtiv1455mcwin45))/mileg.aspx?page=getObject&objectName=
mcl-386-1998-V-5. The appointment of a patient advocate can be revoked or changed at any time the
patient is competent and in any manner that evidences that intent.
A living will is a document documents expressing an individual's medical treatment preferences. Michigan
living will laws are not specifically addressed by statute, but are referenced in the Uniform Durable Power
of Attorney Act.
Health Care Fraud. In Michigan, healthcare fraud is civilly and criminally prosecuted by the Western and
Eastern District United States Attorney’s Offices. In 2007 the Health Care Fraud Prevention and
Enforcement Action Team (HEAT) program was created to investigate and prosecute the largest Medicare
fraud schemes. HEAT is a combination of efforts from the FBI, Department of Justice, and the Department
of Health and Human Services. One of the nine current HEAT programs is located out of the Eastern District
of Michigan in Detroit.
The Michigan Attorney General’s Office and the Michigan Medicaid Fraud Control Unit (MFCU) augment
fraud enforcement on the local level. Efforts are assisted by fraud control units within Blue Cross/Blue Shield
Michigan and other payers. In addition, the Michigan Medicaid False Claims Act permits private citizens to
bring qui tam actions on behalf of the State of Michigan to recover treble damages and civil penalties. MCL
400.603.
http://www.legislature.mi.gov/(S(vrqlwk55g4vkoxr3nqmpvar4))/mileg.aspx?page=getObject&objectName=
mcl-400-603
Five counties in the Detroit area are also included in the locations where CMS has issues a moratorium on
enrolling new home health care or ambulance providers (issued in January 2014 and extended in July
2014).
Health Facilities Licensure and Certification; Federal Certification: CMS contracts with the Michigan
Bureau of Health Care Services (BHCS) to evaluate compliance with the federal regulations by conducting
surveys and complaint investigations. The provider must be in compliance with the conditions and
standards set forth in the Conditions of Participation/Conditions for Coverage. Hospitals, surgery centers,
hospices, and other categories of providers/suppliers must be licensed with the State of Michigan before
Medicare certification is approved. These must first obtain a Certificate of Need prior to consideration for
licensure. The facilities must also be in compliance with the Life Safety Code and the Minimum Design
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Standards for Health Care Facilities in Michigan. Approval by additional state agencies, when applicable,
must be obtained prior to state licensure.
Health Professionals Licensing Boards/Scope of Practice. The Health Professions Licensing Division
in the Bureau of Health Care Services, in conjunction with state licensing boards, regulates 27 health
professions through 27 health professional licensing boards. Health professionals are licensed, registered,
or certified under Articles 7 and 15 of the Michigan Public Health Code and pharmacy related facilities. The
Health Professions Licensing Division also oversees the Michigan Medical Marihuana Program and the
Health Professional Recovery Program. http://www.michigan.gov/lara/0,4601,7-154-35299_63294_2752950941--,00.html
In Michigan, the scope of practice for licensed health professionals is undergoing reconsideration in relation
to the increased demand for health professionals and outdated restrictions on the scope of practice. As an
example, see nursing, http://www.michigan.gov/documents/mdch/TFNEFinlRpt_433532_7.pdf
Michigan Law Preemption of HIPAA. Some Michigan privacy laws are more stringent than the Health
Insurance Portability and Accountability Act (HIPAA) and, therefore, preempt HIPAA. 45 CFR 160.203.
Insurers, HMOs, and Self-Insured Employers. Health insurance in Michigan is regulated by the
Department of Insurance and Financial Services: http://www.michigan.gov/difs/0,5269,7-30313251_13262---,00.html This includes health insurance entities; medical, dental, and long-term care
insurers; HMOs; and others. Michigan is also one of a few states that has a Patient Bill of Rights that applies
to
all
health
insurance
sold
in
the
state.
MCL
550.1901
et
seq.
http://www.legislature.mi.gov/(S(xllmhd3ef1yf4szigmxee545))/mileg.aspx?page=getObject&objectName=
mcl-550-1901
Blue Cross/Blue Shield of Michigan (BCBSM) was traditionally regulated under a separate Non-Profit
Health Care Corporation Reform Act. MCL 550.1101 et seq. Effective January 1, 2014, BCBSM transitioned
to a nonprofit mutual insurer, regulated under the state Insurance Code. As part of this transition, it will be
required to contribute $1.5 billion over 18 years to a new Michigan Health Endowment Fund for the benefit
of children and seniors that will be overseen by a nine-member board, appointed by the governor.
In large part due to Michigan’s automotive industry, Michigan has many ERISA-regulated employers that
self-insure their employees. Third-party administrators (TPAs) process insurance claims or certain aspects
of employee benefit plans for self-insured employers and are regulated by Michigan law. MCL 550.901, et
seq.
http://www.legislature.mi.gov/(S(pfjva245w4yhit55myw4dx45))/mileg.aspx?page=GetObject&objectname
=mcl-Act-218-of-1984
Involuntary Inpatient, Outpatient and/or Emergency Mental Health Treatment. Michigan has civil
commitment laws that establish criteria for determining when court-ordered treatment is appropriate for
individuals with severe mental illness who are too ill to seek care voluntarily. Michigan’s involuntary
treatment standard is based on a person’s “need for treatment” rather than only the person’s likelihood of
being dangerous to self or others. MCL 330.1423; 330.1434(1); 330.1427(1).
Medical Marijuana. The Michigan Medical Marihuana Program (MMMP) is a state registry program within
the Health Professions Licensing Division in the Bureau of Health Care Services at the Michigan
Department of Licensing and Regulatory Affairs. The program administers the Michigan Medical Marihuana
Act.
MCL
333.26424
http://www.legislature.mi.gov/(S(tde0jy55uewvu555fogmam45))/mileg.aspx?page=GetObject&objectnam
e=mcl-333-26424
Medical Records. Michigan statutory law and case law regulate all aspects of medical records. MCL
333.26261
seq.
http://www.legislature.mi.gov/(S(ucbez0jy42fao3mqlsqbnzu3))/mileg.aspx?page=getobject&objectname=
mcl-Act-47-of-2004&queryid=14689745&highlight=Access The regulations include: access, privileged
communications and the expectation of privacy, physician-patient privilege (MCL 600.2157), mandatory
and discretionary reporting requirements, disclosures by health facilities (MCL 333.20201), and other
topics.
Medical staff peer review. Like most states, Michigan requires hospitals to have a peer review system in
place. The governing board of a licensed hospital must organize a medical staff to review professional
practices for the purpose of improving the quality of care; MCL 333.21513(d).
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4. To support that system, the Michigan Public Health Code grants confidentially, referred to as “peer
review privilege.” Records, data, and knowledge collected and analyzed are not public records and
are protected from subpoena: MCL 333.21515; with some limitations: Harrison v. Munson
Healthcare, — N.W.2d —, 2014 WL 340895 (Mich.App. 2014). There is also general immunity
granted to those who act in good faith to provide information or participate in the peer review
process: MCL 331.534 et seq. Michigan courts have traditionally adhered to a “judicial
nonintervention doctrine” and not questioned peer review decisions, but this is not unlimited, see:
Feyz v Mercy Memorial Hospital, 475 Mich 663, 680; 719 NW2d 1 (2006) and Haynes v. Neshewat,
477 Mich. 29, 729 N.W.2d 488 (2007).
Michigan Mini-Anti-Referral Laws. Michigan has its own "mini-Anti-Referral” laws addressing referrals to
health care entities in which the referring practitioner or other provider has an ownership or other financial
interest.
It
is
applicable
to
all
payers.
MCL
333.16221(E)(IV)
and
(V).
http://www.legislature.mi.gov/%28S%28iry3pqetmgk02svyyvseoajo%29%29/mileg.aspx?page=getobject
&objectname=mcl-333-16221&query=on&highlight=16221 Violations of the federal Stark laws constitute
“unprofessional conduct” under the professional licensing provisions of the Michigan Public Health Code.
Violations of these laws can results in disciplinary action under the laws governing physician licensure.
MCL 333. 16221(e)(iv).
State Plan Review and Permits: A plan review and construction permit are needed from the Health
Facilities Division, Health Facilities Engineering Section (HFES) before contracting for and initiating certain
regulated construction projects. http://www.michigan.gov/lara/0,4601,7-154-35299_63294_27656-47961-,00.html
Telemedicine. In a regulatory disconnect, Michigan health insurance providers are required to recognize
claims for health services delivered by telemedicine methods, Public Act 214 and 215 of 2012 (effective
6/28/2012), but as of August 2014 the individual State Licensing Boards have not issued any official
guidelines for their respective practitioners regarding the use of telemedicine in their specialties. Michigan
Medicaid provides reimbursement for telemedicine services under certain conditions.
www.michigan.gov/documents/MSA_06-22_155090_7.pdf. However, the Michigan Bureau of Health
Professions has convened a workgroup to study the use of technology and telemedicine in Michigan.
Treatment of Minors. In limited circumstances a minor in Michigan may validly consent to treatment
without parent or legal guardian authorization. A minor may consent to treatment for a substance abuse
problem or a venereal disease or HIV; MCL 330.1264 and 333.5127. A pregnant minor may consent to
prenatal and pregnancy-related care for herself and the fetus, defined as treatment or services intend to
maintain the life and improve the health of both the pregnant minor and the fetus ; MCL 333.9132. A minor
14 years or older may request mental health services on an outpatient basis, excluding pregnancy
termination referrals and the use of medication; MCL 330.1707. Michigan also has an emancipated minor
statute that may affect medical consent, although its application and use in healthcare settings is not that
common; MCL 722.4 et seq.
Voluntary employees' beneficiary associations (VEBAs) are an important source of employee benefits
for the workers and retirees in automotive industry and its suppliers in Michigan. A major use of the concept
was implemented in 2007 when the United Auto Workers agreed to form VEBAs for their workers. The
UAW Retiree Medical Benefits Trust, with more than $58.8 billion as of March 2014, is the world's largest
VEBA. While regulated by federal tax law, they remain a crucial component of the Michigan health care
payment and delivery network. http://www.uawtrust.org/sb.cn
Implications of the Federal Patient Affordable Care and Accountability Act (ACA) on Michigan
Health Laws. The ACA has had an impact on virtually all aspects of Michigan insurance law, including
benefit design, care coordination, eligibility and enrollment, health insurance exchange marketplaces,
health system capacity, coverage of pre-existing conditions, eliminating mental health and substance abuse
disparity, removal of lifetime limits, regulating premium increases, new coverage options for young adults
preventative care, drug availability for seniors, etc. Michigan did not establish its own healthcare exchange
marketplace, instead defaulting to the federal exchange, but as noted above it did implement Medicaid
expansion with the “Healthy Michigan” plan, effective April 1, 2014.
4. Are mobile health applications regulated under the law of your jurisdiction? If so,
provide a brief summary as to how they are regulated.
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Some mobile health applications are regulated by U.S. federal law, and the U.S. Food and Drug
Administration has published guidance indicating a risk-based classification for regulation mobile apps:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalAppl
ications/ucm255978.htm#e, but there are no Michigan-specific laws or regulations for them.
Contact Information
Butzel Long
150 West Jefferson, Suite 100
Detroit, MI 48226
Tel 1.313.225.7000 Fax 1.313.225.7080
Firm Website http://www.butzel.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, New Hampshire
Prepared by Lex Mundi member firm Sheehan Phinney Bass + Green, PA
1. Provide an introduction on health law in your jurisdiction.
As in other jurisdictions, the provision of health care is highly regulated in New Hampshire. Institutional
health care services are subject to regulation by the New Hampshire Health Services Planning and
Review Board (known as the “CON Board”). A “certificate of need” is required from the CON Board to
construct new healthcare facilities or to modify existing facilities at a cost in excess of the statutory
threshold, to acquire new medical equipment costing in excess of the statutory threshold, or to offer new
inpatient care beds or services.
In addition, health care facilities, ranging from walk-in clinics to skilled nursing facilities to general
hospitals are subject to licensing laws and regulations. Licensing is overseen by the NH Department of
Health and Human Services. While the licensing laws and regulations are numerous and complex, the
staff at NH DHHS are pleasant to work with and exhibit a high degree of professionalism.
As in other states, health care practitioners are subject to laws and regulations specific to their
professions and are supervised by regulatory boards with professional support staff. Unlike health care
facilities, physician practices and the practices of other types of providers are not subject to CON
requirements.
Finally, NH also has a number of statutes governing health insurance, health maintenance organizations
and other forms of managed care organizations, including continuing care retirement communities
(“CCRCs”). These laws are administered by the NH Department of Insurance.
2. Provide a check list of laws with a short summary of the general requirements of each.
New Hampshire Law
N.H. RSA Section 141-C:7
Reporting of Communicable Diseases
N.H. RSA Section 141-C:18
Sexually Transmitted Disease
N.H. RSA Section 141-F:7 (IV) Reports of HIV Positive Results
N.H. RSA Chapter 141-G
Notification of Emergency Response/Public Safety Workers After
Exposure to Infectious Disease
N.H. RSA Chapter 151 Licensing of Health Care Facilities (including home health providers)
N.H. RSA Section 151:1-41
N.H. RSA Section 151:2-b
N.H. RSA Section 151:2-d
N.H. RSA Section 151:5-c
Confidentiality
N.H. RSA Section 151:6-b
Residential Care and Health Facility Licensing
Home Health Care Provider and Individual Home Care Service Provider
Criminal Record Check Required
Proceedings of Residential Care Facility Quality Assurance Program;
Report of Disciplinary Action
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N.H. RSA Section 151:13-a
Proceedings
Proceedings of Hospital Committees; Confidentiality/Quality Assurance
N.H. RSA Section 151:13-b
Confidentiality
Proceedings of Home Health Care Provider Quality Assurance Program;
N.H. RSA Section 151:21
Patients’ Bill of Rights
N.H. RSA Section 151:21-b
Home Health Care Clients’ Bill of Rights
N.H. RSA Section 151:26
Transfer or Discharge of Patients
N.H. RSA Section 151:26-a
Discharge of Home Health Care Clients
N.H. RSA Section 151:27
Abuse of Facility Patients
N.H. RSA Section 151:31
Disclosure of Information; Hospitals and Physician Hospital
Organizations; to N.H. Attorney General
N.H. RSA Section 151:32
Reporting of Health Care Associated Infections
N.H. RSA Section 151:37
Adverse Events Reporting System
N.H. RSA Section 151:41
Drug-Free Workplace for Licensed Health Care Facilities and Providers:
Controlled Substance Abuse, Misuse, and Diversion Prevention
N.H. RSA Chapter 151-A
Nursing Home Administrators
N.H. RSA Chapter 151-C
Services
Certificate of Need Review of Proposed New Institutional Health
N.H. RSA Section 151-C:4
Moratorium on New Nursing Home Beds (set to expire June 30, 2016)
N.H. RSA Chapter 151-D
Ambulatory Care Clinics & QA Programs
N.H. RSA Chapter 151-E
Long Term Care
N.H. RSA Chapter 151-G
NH Health Care Quality Assurance Commission
N.H. RSA Chapter 151-H
Receivership of Nursing Homes and Other Residential Care Facilities
N.H. RSA Section 161-F:46
Reports of Adult Abuse; Investigations
N.H. RSA Section 169-C:29
Persons Required to Report
N.H. RSA Chapter 315 Podiatry
N.H. RSA Chapter 316-A
Chiropractic Practice
N.H. RSA Chapter 317-A
Dental Practice Act
N.H. RSA 318 Pharmacists and Pharmacies
N.H. RSA Section 318-B:12-a Treatment for Drug Abuse (permits minor to submit to drug abuse
treatment without parental consent)
N.H. RSA Chapter 326-B
Nurse Practice Act
N.H. RSA Section 326-B:37 (V) Disciplinary Action; Misconduct
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N.H. RSA Section 326-B:31
Continuing Education
N.H. RSA Chapter 326-C
Occupational Therapists
N.H. RSA Chapter 326-D
Midwifery
N.H. RSA Chapter 326-E
Respiratory Care Practice
N.H. RSA Chapter 326-F
Speech Language Pathology Practice
N.H. RSA Chapter 326-G
Athletic Trainers
N.H. RSA Chapter 326-H
Licensed Dieticians
N.H. RSA Chapter 326-I Interpreters for the Deaf
N.H. RSA Chapter 326-J
Recreational Therapists
N.H. RSA Chapter 326-K
Genetic Counselors
N.H. RSA Chapter 327
Optometry
N.H. RSA Chapter 327-A
Ophthalmic Dispensing
N.H. RSA Chapter 328-A
Physical Therapy
N.H. RSA Chapter 328-B
Massage Therapists
N.H. RSA Chapter 328-D
Physician Assistants
N.H. RSA Chapter 328-E
Naturopathic Health Care Practice
N.H. RSA Chapter 328-F
Allied Health Professionals
N.H. RSA Chapter 328-G
Acupuncture
N.H. RSA Chapter 328-H
Reflexologists, Structural Integrators and Asian Body Work Therapists
N.H. RSA Chapter 328-I Board of Registration of Medical Technicians
N.H. RSA Chapter 329 Physicians and Surgeons
N.H. RSA Section 329:17 (III)
Disciplinary Action; Remedial Proceedings
N.H. RSA Section 329:26
Physician/Patient Privilege
N.H. RSA Section 329:29-a
Quality Assurance Programs for Physician Practices
N.H. RSA Chapter 329-B
Psychologists
N.H. RSA Chapter 330-A
Mental Health Practice
N.H. RSA Section 330-A:35
Civil Liability; Duty to Warn
N.H. RSA Chapter 330-C
Alcohol and Other Drug Use Professionals
N.H. RSA Chapter 332-I
Organization Corporation
Medical Records, Patient Information and the Health Information
N.H. RSA Chapter 415
Accident and Health Insurance
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N.H. RSA Chapter 415-A
Standards for Accident and Health Insurance
N.H. RSA Chapter 415-D
Long Term Care Insurance
N.H. RSA Chapter 415-E
Multiple Employer Welfare Arrangements
N.H. RSA Chapter 415-F
Medicare Supplemental Insurance
N.H. RSA Chapter 415-H
Stop Loss Insurance
N.H. RSA Chapter 415-I
Discount Medical Plan Organizations
N.H. RSA Chapter 415-J
N.H. Telemedicine Act (requiring coverage for telemedicine services)
N.H. RSA Chapter 417-D
Women’s Health Care (requiring coverage for mammography, pregnancy
and post-mastectomy reconstructive surgery)
N.H. RSA Chapter 417-E
Coverage for Certain Biologically-based Mental Illnesses
N.H. RSA Chapter 417-F
Coverage for Emergency Services
N.H. RSA Chapter 420-A
Health Service Corporations
N.H. RSA Chapter 420-B
Health Maintenance Organizations
N.H. RSA Chapter 420-C
Preferred Provider Agreements
N.H. RSA Chapter 420-D
Continuing Care Retirement Communities
N.H. RSA Chapter 420-E
Licensure of Medical Utilization Review Entities
N.H RSA Chapter 420-FDelta
Dental Plan of New Hampshire
N.H. RSA Chapter 420-G
Portability, Availability and Renewability of Health Coverage
N.H. RSA Chapter 420-H
Explanation of Benefits
N.H. RSA Chapter 420-I
Prohibition of Exclusive Arrangements with Managed Care Insurers
N.H. RSA Chapter 420-J
Managed Care Law
N.H. RSA Chapter 420-K
Small Employer Health Insurance Pool
N.H. RSA Chapter 420-M
Purchasing Alliances (for purchase of health insurance)
N.H. RSA Chapter 420-N
Federal Health Care Reform
N.H. RSA Chapter 464-A
Guardians and Conservators
N.H. RSA Chapter 611-B
Office of the Chief Medical Examiner
N.H. RSA Section 631:6
Failure to Report Injuries
New Hampshire Regulations
Name and Rule Numbers
Agency
Ahp 101-301
Board of Directors, Office of Licensed Allied Health Professionals
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Ath 101-501
Governing Board of Athletic Trainers
Ch 101-408
Board of Chiropractic Examiners
Den 101-501
Board of Dental Examiners
Gen 101-502
Governing Board of Genetic Councelors
Hcp 101-502
Board of Hearing Care Providers
He-A 301-910
Former Office of Alcohol & Drug Abuse Prevention
He-C 201-6920
Commissioner, Department of Health and Human Services
He-E 501-807
Former Division of Elderly & Adult Services
He-Hea 101-2105
Health Services Planning & Review Board (CON)
He-M 201-1302
Former Division of Mental Health and Developmental Services
He-P 301-6003*
Former Division of Public Health Services
He-W 401-950
Former Division of Human Services
Ins 101-4901
Commissioner, Insurance Department
Med 101-612
Board of Medicine
Mhp 101-505
Board of Mental Health Practice
Nat 101-406
Naturopathic Board of Examiners
Nuh 101-501
Board of Examiners of Nursing Home Administrators
Nur 101-806
Board of Nursing
Occ 101-502
Governing Board of Occupational Therapists
Opt 101-601
Board of Registration in Optometry
Ph 100-1506
N.H. Pharmacy Board
Phy 101-501
Governing Board of Physical Therapists
Pod 101-501
Board of Podiatry
Psyc 101-505
Board of Psychologists
Rec 101-502
Governing Board of Recreational Therapists
Resp 101-502
Governing Board of Respiratory Care Practitioners
Spe 101-608
Governing Board of Speech Language Pathologists
*The regulations contained in He-P 800 are considered the key health care regulations in New Hampshire
for institutional health care facilities. The He-P 800 series of regulations apply to hospitals, nursing
homes, assisted living residences, non-emergency walk-in care centers, residential treatment and
rehabilitation centers, laboratories, home health care providers, birthing centers, dialysis centers,
ambulatory surgical centers, adult family care residences, community residences, educational health
centers, collection stations, adult day programs, case management agencies, individual home care
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service providers, home care service provider agencies, home hospice care providers, hospice houses,
and acute psychiatric residential treatment programs.
Selected Cases
•
•
Medical Record & Privilege Issues
o
In re Search Warrant for Medical Records of C.T., 160 N.H. 214 (2010) (search
warrant procedure for obtaining patient’s medical records).
o
Desclos v. Southern N.H. Med. Ctr., 153 N.H. 607 (2006) (piercing
psychotherapist-patient privilege allowed when the party seeking to pierce the
privilege establishes both that there is a reasonable probability that the records
sought contain information that is material and relevant to party’s defense or
claim, and the party seeking the records proves that the targeted information is
unavailable from another source and there is a compelling justification for
disclosure).
o
In re Berg, 152 N.H. 658 (2005) (despite HIPAA provision ostensibly allowing
disclosure of minor therapy records to parent of minor child, New Hampshire
therapist-client privilege prevented disclosure under HIPAA exception for
disclosures prohibited by state law).
o
In re Payne, 150 N.H. 463 (2004) (any subpoena served on hospital or medical
provider to obtain privileged medical records must also be served on individual
whose records are sought to give opportunity to object; if State can establish
grounds to override physician-patient privilege, court must conduct in camera
review to ensure that irrelevant and non-responsive information is not released).
o
Nelson v. Lewis 130 N.H. 106 (1987) (plaintiff who places her medical condition
at issue in an action for medical negligence waives physician-patient privilege to
the extent necessary to provide opposing party information essential to defend
action, but does not waive the privilege so as to permit opposing party to
interview treating physician ex parte).
o
In re Kathleen M., 126 N.H. 379 (1985) (physician-patient privilege will not be
maintained where a sufficiently compelling countervailing consideration is
identified such as ability to access patient records when assessing whether
recommit criminally insane).
o
In re Brenda H., 119 N.H. 382 (1979) (rev’d on other grounds) (physician-patient
privilege will not be maintained where a statute specifically requires disclosure of
medical records).
Non-Competition Clauses in Physician Contracts
o
•
Concord Orthopaedics, P.A. v. Forbes, 142 N.H. 440 (1997) (states three-part
New Hampshire test for reviewing non-competition clauses; enforce two-year, 25
mile restraint for existing patients of former practice, but allows physician to see
new patients within prohibited geographic territory during non-compete period
because former practice had no legitimate interest in new patients).
Treating Physician v. Expert Witness
o
Razzaboni v. Halle, 2006 WL 1506697 *7 (N.H. Super. Ct. May 16, 2006) (where
expert is retained to provide medical testimony at trial, or to the extent that a
treating physician’s testimony will exceed matters reasonably learned from
treatment, expert disclosure and reporting are required).
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o
•
Quality Assurance Privilege
o
•
•
State v. Martin, 142 N.H. 63 (1997) (medical professional may testify as lay
witnesses when they confine their testimony to personal observations which any
lay person would be capable of making; lay witnesses may not testify about a
medical diagnosis or draw conclusions which require the application of
specialized medical knowledge).
In re “K”, 132 N.H. 4 (1989) (a committee organized for the critical evaluation of
procedures affecting the transmissions of infections within a hospital may receive
testimony and generate records subject to the statutory quality assurance
privilege in N.H. RSA § 151:13-a).
Doctrine of Necessaries
o
Southern N.H. Medical Ctr. v. Hayes, 992 A.2d 596 (2010) (affirming application
of doctrine of necessaries and clarifying that provider must first seek payment
from debtor spouse and, if unpaid, provider may then seek payment from nondebtor spouse).
o
Cheshire Medical Ctr. V. Holbrook, 140 N.H. 187 (1995) (a husband or wife is not
liable for necessary medical expenses incurred by his or her spouse unless the
resources of the spouse who received the services are insufficient to satisfy the
debt under the common law doctrine of necessaries).
Sterilization of Minors
o
In re Penny N., 120 N.H. 269 (1980) (sets forth standard and procedures for
allowing probate court to approve sterilization of incapacitated minors).
3. Provide any special issues which arise in your jurisdiction.
New Hampshire law is often more restrictive than HIPAA, and generally requires authorizations.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Some mobile health applications are regulated by U.S. federal law, but there are no New Hampshire
specific laws or regulations for them.
Contact Information
Katherine M. Hanna
Chair of Health Care Practice Group
[email protected]
Sheehan Phinney Bass + Green
1000 Elm Street
Manchester, New Hampshire 03101
Tel 1.603.627.8106 Fax 1.603.627.8121
Firm Website http://www.sheehan.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, New Jersey
Prepared by Lex Mundi member firm Day Pitney LLP
1. Provide an introduction on health law in your jurisdiction.
The State of New Jersey is commonly referred to as the “Medicine Chest of the World” due to the
high concentration of healthcare and science-related professionals in the State. 93 The healthcare
industry and the various healthcare practices, such as the practice of medicine and the practice of
pharmacy, in New Jersey are highly regulated, requiring compliance with State laws and rules and
regulations promulgated by several State departments. These State departments include, but are
not limited to, the Department of Health, the Department of Human Services, the Department of
Banking and Insurance, the Department of Law and Public Safety, and several agencies and
boards within each of these departments. New Jersey healthcare professionals must comply with
strict licensing requirements in order to practice in the State. Furthermore, State Boards have been
established to monitor and regulate the practice of each healthcare profession in the State and to
ensure compliance with licensing and practice requirements. Healthcare facilities in the State of
New Jersey, including hospitals, ambulatory care facilities, hospices, and nursing homes, must
comply with similar licensing requirements and other Department of Health regulations in order to
operate in the State.
The largest industry in the State of New Jersey is the pharmaceutical and life sciences industry,
with “17 of the world’s 20 largest pharmaceutical leaders located in New Jersey ….” 94 New Jersey
is home to a concentrated group of companies that includes specialty pharmaceutical and
biopharmaceutical companies, research and development facilities, and other related
manufacturers, and the State is the site of approximately 2,200 open clinical trials. 95 The
pharmaceutical and life sciences industry is generally highly regulated. In New Jersey, in addition
to compliance with federal requirements, pharmaceutical and life science companies must file
registration statements with the Department of Health in order to engage in the business of drug
manufacturing in the State and must comply with other rules and regulations promulgated by the
Department of Health.
2. Provide a check list of laws with a short summary of the general requirements of each.
New Jersey Statutes
N.J.S.A. Title 24, Ch. 6A: New Drugs. Requires compliance with federal regulations to introduce
drugs into intrastate commerce.
N.J.S.A. Title 24, Ch. 6B: Drug Manufacturers and Wholesalers. Regulates drug manufacturing
and the wholesale drug business in New Jersey, requiring drug manufacturers and drug
wholesalers to file a registration statement.
N.J.S.A. Title 24, Ch. 6D: Counterfeiting and Misrepresenting Drugs, Cosmetics and Devices.
Creates a misdemeanor offense for, among other things, counterfeiting drug trademarks.
N.J.S.A. Title 24, Ch. 6E: Prescription Drugs. Codifies the Prescription Drug Price and Quality
Stabilization Act, which governs the advertising of prescription drugs.
93
New Jersey Business Action Center, NJ & Pharmaceuticals, STATE OF NEW JERSEY BUSINESS PORTAL,
http://www.state.nj.us/njbusiness/pdfs/industry/Pharma.pdf.
New Jersey Business Action Center, Pharmaceuticals, STATE OF NEW JERSEY BUSINESS PORTAL
http://www.state.nj.us/njbusiness/industry/pharmaceutical.
95
New Jersey Business Action Center, Pharmaceuticals, STATE OF NEW JERSEY BUSINESS PORTAL
http://www.state.nj.us/njbusiness/industry/pharmaceutical.
94
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N.J.S.A. Title 24, Ch. 21: Dangerous Substances Control. Codifies the New Jersey Controlled
Dangerous Substances Act, which regulates the registration and control of the manufacture,
distribution, dispensing, and labeling of controlled substances, including prescription drugs.
N.J.S.A. Title 26, Ch. 1A: State Department of Health. Describes the organization, functions, and
powers of the Department of Health.
N.J.S.A. Title 26, Ch. 2H: Health Care Facilities. Regulates the operation of health care facilities,
including hospitals, nursing homes, convalescent homes, hospices, and skilled nursing facilities.
N.J.S.A. Title 26, Ch. 2H-12.2b: Health Care Professional Responsibility and Reporting
Enhancement. Requires health care facilities to notify the Division of Consumer Affairs of the
Department of Law and Public Safety of certain actions that limit or restrict a health care
professional’s exercise of clinical privileges.
N.J.S.A. Title 26, Ch. 2I: New Jersey Health Care Facilities Financing Authority. Provides health
care institutions access to financial resources to improve the health and welfare of the citizens of
the State of New Jersey and to encourage the provision of modern health care facilities.
N.J.S.A. Title 26, Ch. 2J: Health Maintenance Organizations.
operations of health maintenance organizations.
Regulates the formation and
N.J.S.A. Title 26, Ch. 2S: Health Care Quality Act. Establishes certain rights and responsibilities
of health care professionals that contract with managed care organizations.
N.J.S.A. Title 26, Ch. 15: Health Care Coverage. Requires that all residents of the State of New
Jersey 18 years of age and younger obtain and maintain health care coverage.
N.J.S.A. Title 30, Ch. 13: Nursing Homes: Responsibilities and Rights of Residents. Establishes
responsibilities of nursing homes and a bill of rights for residents of nursing home.
N.J.S.A. Title 45, Ch. 5: Podiatrists. Regulates the practice of podiatric medicine.
N.J.S.A. Title 45, Ch. 6: Dentists. Regulates the practice of dentistry.
N.J.S.A. Title 45, Ch. 9: Physicians and Surgeons. Regulates the practice of physicians.
N.J.S.A. Title 45, Ch. 9, Section 22.5: Referral of Patient by Practitioner Regulated. The “Codey
Law” prohibits certain “self-referrals” by physicians of patients to health care services in which the
physician has a beneficial interest.
N.J.S.A. Title 45, Ch. 10: Midwives. Regulates the practice of midwifery.
N.J.S.A. Title 45, Ch. 11: Nurses. Regulates the practice of nurses.
N.J.S.A. Title 45, Ch. 12: Optometrists. Regulates the practice of optometry, including the
examination of the human eye for the purpose of treating deficiencies, deformities, diseases, and
abnormalities.
N.J.S.A. Title 45, Ch. 14: Pharmacists. Codifies the New Jersey Pharmacist Practice Act, which
regulates the practice of pharmacy in the State of New Jersey, including licensure of pharmacists
and the regulation of pharmacy practice sites.
N.J.S.A. Title 45, Ch. 16: Veterinarians. Regulates the practice of veterinary medicine and all
animal or veterinary facilities.
New Jersey Administrative Code
N.J.A.C. Title 8, Ch. 21: Food and Drugs. Rules and regulations promulgated by the Department
of Health in connection with the regulation of food, drug, cosmetic, and device labeling,
manufacturing, storage, and distribution.
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N.J.A.C. Title 8, Ch. 31B: Hospital Financing Reporting. Rules and regulations promulgated to
establish certain financial reporting obligations for hospitals.
N.J.A.C. Title 8, Ch. 34: Rules for Licensing Nursing Home Administrators and Rules Regulating
the Nursing Home Administrators Licensing Board. Rules and regulations promulgated to establish
minimum licensing requirements and disciplinary procedures for nursing home administrators.
N.J.A.C. Title 8, Ch. 36: Standards for Licensure of Assisted Living Residences, Comprehensive
Personal Care Homes, and Assisting Living Programs. Rules and Regulations promulgated to
establish minimum standards with which assisting living residences, comprehensive personal care
homes, and assisted living programs must comply.
N.J.A.C. Title 8, Ch. 39: Standards for Licensure of Long-Term Care Facilities. Rules and
regulations promulgated to establish minimum quality of care standards for long-term care facilities
(commonly known as nursing homes).
N.J.A.C. Title 8, Ch. 42C: Hospice Licensing Standards. Rules and regulations promulgated by
the Department of Health in connection with the provision of hospice services to residents of the
State.
N.J.A.C. Title 8, Ch. 43C: Registration Standards for Surgical Practices. Rules and regulations
promulgated by the Department of Health establishing registration standards for surgical practices.
N.J.A.C. Title 8, Ch. 43G: Hospital Licensing Standards. Rules and regulations promulgated to
establish minimum licensing standards for and to regulate the activities of general, psychiatric, and
special hospital facilities.
N.J.A.C. Title 8, Ch. 95: New Jersey Health Care Facilities Financing Authority. Requires health
care facilities receiving financial assistance from the Health Care Facilities Financing Authority to
pay a prevailing wage in all construction contracts related to such financial assistance.
N.J.A.C. Title 10, Ch. 52: Hospital Services Manual. Policies and procedures established by the
Division of Medical Assistance and Health Services for the provision of hospital services to
Medicaid and NJ Family Care beneficiaries.
N.J.A.C. Title 11, Ch. 10: Dental Services. Regulates persons and entities that offer plans for the
provision of dental services, and establishes licensing requirements and supervision of dental plan
organizations.
N.J.A.C. Title 11, Ch. 24: Health Maintenance Organizations. Rules and regulations promulgated
by the Department of Banking and Insurance that govern the establishment and operation of health
maintenance organizations.
N.J.A.C. Title 11, Ch. 24A: Health Care Quality Act Application to Insurance Companies, Health
Service Corporations, Hospital Service Corporations and Medical Service Corporations.
Establishes minimum compliance requirements in connection with the Health Care Quality Act,
N.J.S.A. § 26:2S-1 et seq.
N.J.A.C. Title 13, Ch. 30: New Jersey Board of Dentistry. Rules and regulations that regulate the
practice of dentistry in the State of New Jersey.
N.J.A.C. Title 13, Ch. 35: New Jersey Board of Medical Examiners. Rules and regulations
promulgated by the New Jersey Board of Medical Examiners that establish licensing requirements
for physicians and regulate the practice of medicine.
N.J.A.C. Title 13, Ch. 37: New Jersey Board of Nursing. Rules and regulations that establish
licensing requirements for nurses and regulate the nursing practice.
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N.J.A.C. Title 13, Ch. 38: New Jersey State Board of Optometrists. Rules and regulations
promulgated by the New Jersey State Board of Optometrists that regulate the practice of optometry.
N.J.A.C. Title 13, Ch. 39: New Jersey State Board of Pharmacy. Rules and regulations
promulgated by the New Jersey State Board of Pharmacy that regulate the practice of pharmacy.
N.J.A.C. Title 13, Ch. 45E: Health Care Professional Reporting Responsibility. Provides for the
interpretation and administration of the Health Care Professional Responsibility and Reporting
Enhancement Act.
3. Provide any special issues which arise in your jurisdiction.
N.J.S.A. Title 2A, Ch. 32C: False Claims. Codifies the New Jersey False Claims Act creating civil
liability for the submission of false or fraudulent claims to the government of the State of New
Jersey.
N.J.S.A. Title 45, Ch. 9, Section 22.5: Referral of Patient by Practitioner Regulated. The “Codey
Law” prohibits certain “self-referrals” by physicians of patients to health care services in which the
physician has a beneficial interest.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Mobile health applications are not currently regulated under the laws of New Jersey. However, the
U.S. Food and Drug Administration (the “FDA”) has issued a guidance document that explain its
position on mobile medical applications and how it intends to regulate certain mobile medical
applications. The FDA guidance document on mobile medical applications can be located at:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocume
nts/UCM263366.pdf.
Contact Information
Lori Braender, Partner
[email protected]
Day Pitney LLP
One Jefferson Road
Parsippany, New Jersey 07054
Tel 973.966.6300 Fax 973.966.1015
www.daypitney.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, New York
Prepared by Lex Mundi member firm Day Pitney LLP
1. Provide an introduction on health law in your jurisdiction.
New York has a complex and idiosyncratic healthcare regulatory scheme. Hospitals, nursing
homes and other licensed facilities are under the jurisdiction of the Department of Health, while
individual licensed professionals are regulated by the Department of Education. Article 28 of the
Public Health Law sets forth requirements for the licensure, establishment and operation of
hospitals, nursing homes, home care agencies, and diagnostic and treatment centers. New York's
Certificate of Need (CON) process governs the establishment, construction, renovation and major
medical equipment acquisitions of health care facilities.
New York’s fee-splitting prohibitions restrict licensed professionals from sharing fees derived from
professional services with anyone who does not have an equivalent license and does not practice
within the same professional entity. These prohibitions have been interpreted to apply to practice
management fees and other fees that are based on a percentage of a professional practice’s
collections. An opinion of the general counsel for the State Department of Health stated that these
prohibitions apply as well to paying a billing service company based on a percentage of collections.
New York prohibits the “corporate practice of medicine” and other licensed professions. Only
licensed individuals may own equity interests in professional practice entities and direct the
business operations thereof. A management service organization (MSO) may own the nonprofessional assets of a professional practice, and receive compensation for services provided to
it, but may not exercise control over operations or governance of the professional practice.
The “NY State of Health” website is the state’s “Official Health Plan Marketplace” established under
the Patient Protection and Affordable Care Act. The website’s Small Business Marketplace allows
employers to shop for health and dental insurance coverage for their employees.
2. Provide a check list of laws with a short summary of the general requirements of each.
New York Law
N.Y. Education Law, Title VIII, Article 131: Medicine. Defines the practice of medicine, establishes
the board of medicine to regulate the practice of medicine in the State of New York, and establishes
licensing requirements for physicians in the State.
N.Y. Education Law, Title VIII, Article 131-A: Definitions of Professional Misconduct Applicable to
Physicians, Physician’s Assistants, and Specialist’s Assistants. Provides for the revocation,
suspension, or annulment of a license and other penalties if a physician, physician’s assistant, or
specialist’s assistant is found to have committed “professional misconduct.”
N.Y. Education Law, Title VIII, Article 131-B: Physician Assistants. Establishes licensing
requirements for and regulates the practice of Physician Assistants in the State of New York.
N.Y. Education Law, Title VIII, Article 132: Chiropractic. Regulates the chiropractic practice in the
State of New York by establishing the Board for Chiropractic to oversee the practice and
establishes licensing requirements for chiropractors.
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N.Y. Education Law, Title VIII, Article 133: Dentistry and Dental Hygiene. Defines the practice of
dentistry and the practice of dental hygiene, establishes licensing requirements for dentists and
dental hygienists, and establishes the Board of Dentistry to regulate the practice of dentistry.
N.Y. Education Law, Title VIII, Article 135: Veterinary Medicine and Animal Health Technology.
Defines the practice of veterinary medicine, establishes licensing requirements for veterinarians
and veterinary technologists, and establishes the Board for Veterinary Medicine to regulate the
practice of veterinary medicine.
N.Y. Education Law, Title VIII, Article 137: Pharmacy. Defines the practice of pharmacy,
establishes requirements for a professional license, and establishes the Board of Pharmacy to
regulate the practice of pharmacy.
N.Y. Education Law, Title VIII, Article 139: Nursing. Defines the nursing practice, establishes the
requirements for registered professional nurses and licensed practical nurses, establishes
certificate requirements for nurse practitioners, and establishes the Board of Nursing to regulate
the nursing practice.
N.Y. Education Law, Title VIII, Article 140: Professional Midwifery Practice Act. Defines the practice
of midwifery, establishes licensing requirements, and establishes the Board of Midwifery to regulate
the practice of midwifery.
N.Y. Education Law, Title VIII, Article 141: Podiatry. Defines the practice of podiatry, establishes
the requirements for a professional license, and establishes the Board of Podiatry to regulate the
practice of podiatric medicine.
N.Y. Education Law, Title VIII, Article 143: Optometry. Defines the practice of optometry,
establishes the requirements for a professional license, and establishes the Board of Optometry to
regulate the practice of optometry.
N.Y. Insurance Law, Article 43: Non-Profit Medical and Dental Indemnity. Regulates the
organization and conduct of corporations under the Not-for-Profit Corporation Law for the purpose
of providing medical expense indemnity, dental expense indemnity, hospital services, or health
services.
N.Y. Insurance Law, Article 48: Managed Care Health Insurance Contracts. Regulates managed
care health insurance products delivered and issued for delivery in the State of New York by
insurers licensed in the State.
N.Y. Not-for-Profit Law, Article 14, Section 1406: Medical Societies. Establishes requirements for
incorporation and permissible corporate purposes of medical societies.
N.Y. Public Health Law, Article 2: Department of Health. Establishes the Department of Health of
the State of New York and outlines the organizational structure and authority of the Department.
N.Y. Public Health Law, Article 2-A: Prescription Drugs. Regulates the provision of prescription
drugs in the State of New York, creates education programs for prescribers to receive objective
information in connection with pharmaceutical products, and establishes mandatory State
prescription forms.
N.Y. Public Health Law, Article 24-A: Protection of Human Subjects. Regulates the use of human
subjects in medical and psychological research projects by requiring the informed consent of all
human research volunteers prior to conducting medical or psychological research.
N.Y. Public Health Law, Article 28: Hospitals. Regulates the establishment and operation of
hospitals (the definition of which includes ambulatory surgery centers, diagnostic and treatment
centers and other licensed facilities) in the State of New York under the supervision and regulation
of the Department of Health.
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N.Y. Public Health Law, Article 28-A: Nursing Home Companies. Establishes requirements for the
organization and operation of nursing homes companies in the State of New York, including
obtaining approval from the Commissioner of the Department of Health in connection with
enumerated organizational activities and transactions.
N.Y. Public Health Law, Article 28-B: Hospital Mortgage Loan Construction. Provides hospitals
and other health care facilities access to financial assistance to encourage the timely construction
and modernization of health care facilities to improve the delivery of health care.
N.Y. Public Health Law, Article 28-D: Practice of Nursing Home Administration. Regulates nursing
home administration by establishing educational, training, and experience standards, licensure
requirements, and registration requirements for all nursing home administrators.
N.Y. Public Health Law, Article 29-E: Accountable Care Organizations. Establishes regulations for
the formation and operation of accountable care organizations in the State of New York to protect
the interests of patients and health care providers.
N.Y. Public Health Law, Article 33: Controlled Substances. Establishes requirements governing
and controlling the possession, manufacture, dispensing, administration, and distribution of
controlled substances, which include pharmaceutical products.
N.Y. Public Health Law, Article 40: Hospice. Regulates the establishment and operation of
hospices in the State of New York, including obtaining approval from the Commissioner of the
Department of Health for the establishment of hospices in the State.
N.Y. Public Health Law, Article 44: Health Maintenance Organizations.
Establishes a
comprehensive system, administered by the Commissioner of the Department of Health, for the
authorization and regulation of health maintenance organizations in the State of New York to assure
the quality of health services provided in the State.
N.Y. Public Health Law, Article 45: Medical Referral Services. Prohibits any person or entity from
engaging in any business or service for profit that includes the referral or recommendation of a
person to any health care provider or health care facility for the treatment of any condition, and
prohibits health care providers and health care facilities from entering into agreements with such
medical referral services.
New York Compilation of Codes, Rules and Regulations
Title 10, Ch. II, Subchapter E: Food and Drug Products; Research. Rules and regulations
promulgated by the Department of Health regulating drug substitution and certain diabetes
equipment and related supplies in the State.
Title 10, Ch. II, Subchapter L: Hospitals and Related Facilities. Rules and regulations promulgated
by the Department of Health requiring notification of patient abuse, establishing uniform accounting
and financial requirements for health care facilities, and regulating the organization and operation
of nursing home companies in the State.
Title 10, Ch. II, Subchapter N: Professional Medical and Dental Services. Rules and regulations
promulgated by the Department of Health requiring physicians and dentists to obtain excess
malpractice insurance.
Title 10, Ch. II, Subchapter O: Physician Assistants; Prohibited Discrimination in Hospital Staff
Appointments and Privileges. Rules and regulations promulgated by the Department of Health
establishing education and certification requirements for Physician Assistants and regulating the
practice in the State, regulating hospital staff appointment practices, and establishing a system to
investigate discrimination in physician staff appointments and privileges in the State.
Title 10, Ch. II, Subchapter P: Licensure and Practice of Nursing Home Administration. Rules and
regulations promulgated by the Department of Health establishing a board of examiners to regulate
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nursing home administrators in the State and implementing licensure requirements for nursing
home administrators.
Title 10, Ch. II, Subchapter R: Health Maintenance Organizations. Rules and regulations
promulgated by the Department of Health regulating the organization and operation of managed
care organizations.
Title 10, Ch. V, Subchapter A: Medical Facilities—Minimum Standards. Rules and regulations
promulgated by the Department of Health establishing minimum standards with which all medical
facilities in the State must comply.
Title 10, Ch. V, Subchapter B: Hospital Establishment. Rules and regulations promulgated by the
Department of Health establishing requirements for the organization and operation of hospitals.
Title 10, Ch. V, Subchapter C: State Hospital Code. Rules and regulations promulgated by the
Department of Health establishing general standards for outpatient ambulatory facilities,
establishing a process to apply to the Department of Health for assistance to innovate and update
health care facilities, and establishing hospital and health care facility accreditation requirements.
Title 10, Ch. IX: Physician Profiling. Requirement that the Department of Health collect and make
publicly available information regarding criminal convictions for any and all offenses and any
malpractice or other judgments awarded against physicians who are licensed in the State of New
York.
Title 10, Ch. X: Assisted Living Residences. Rules and regulations promulgated by the Department
of Health regulating the organization and operation of assisted living residences.
3. Provide any special issues which arise in your jurisdiction.
N.Y. Education Law, Title VIII, Article 130, Section 6509-a: Additional Definition of Professional
Misconduct; Limited Application. Permits professionals licensed to practice in the State of New
York to practice in partnerships, groups or professional corporations, and as a university faculty
practice corporation, and permits pooling and sharing of fees and money received for professional
services by one professional member with the other members of the professional partnership,
group or professional corporation, or university faculty practice corporation.
N.Y. Compilation of Codes, Title 8, Ch. 1, Part 29: Rules of the Board of Regents; Unprofessional
Conduct. Prohibits and defines unprofessional conduct of any professional licensed, certified to
practice in the State of New York, including, among other things, willful and gross negligence in
complying with laws, rules and regulations governing the practice of the profession; giving and
receiving a fee or other consideration for the referral of a patient; fee-sharing; and providing
professional services not duly authorized by the patient or their legal representative.
N.Y. Education Law, Title VIII, Article 131-A, Section 6530(18): Definitions of Professional
Misconduct Applicable to Physicians, Physician’s Assistants, and Specialist’s Assistants.
Professional misconduct includes offering, soliciting, receiving, or providing fees in consideration
for the referral of patients.
N.Y. Education Law, Title VIII, Article 131-A, Section 6530(19): Definitions of Professional
Misconduct Applicable to Physicians, Physician’s Assistants, and Specialist’s Assistants.
Professional misconduct includes sharing in the fees for professional services (“fee-splitting”)
received by physicians, physician’s assistants, or specialist’s assistants with any person, unless
such person is a partner, employee, associate in a professional firm or corporation, professional
subcontractor, consultant authorized to practice medicine, or a legally authorized trainee.
N.Y. Public Health Law, Article 45: Medical Referral Services. Prohibits any person or entity from
engaging in any business or service for profit that includes the referral or recommendation of a
person to any health care provider or health care facility for the treatment of any condition, and
prohibits health care providers and health care facilities from entering into agreements with such
medical referral services.
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N.Y. State Finance Law, Article XIII: New York False Claims Act. Creates civil liability for the
submission of false or fraudulent claims to the government of the State of New York by any person
or entity and permits any person to bring a qui tam civil action on behalf of any other person or the
State of New York.
New York Compilation of Codes, Rules and Regulations, Title 13, Ch. IX: False or Fraudulent
Claims Involving Government Funds or Property. Provides civil enforcement authority for the New
York False Claims Act to the Attorney General of the State of New York and establishes guidelines
for qui tam actions.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Mobile health applications are not currently regulated under the laws of New York. However, the
Food and Drug Administration (the “FDA”) has issued a guidance document that explains its
position on mobile medical applications and how it intends to regulate certain mobile medical
applications. The FDA guidance document on mobile medical applications can be located at:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocume
nts/UCM263366.pdf.
Contact Information
Lori Braender, Partner
[email protected]
Day Pitney LLP
7 Times Square
New York, New York 10036
Tel 212.297.5800 Fax 212.966.2940
www.daypitney.com
.
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, North Carolina
Prepared by Lex Mundi member firm Womble Carlyle Sandridge & Rice, LLP
1. Provide an introduction on health law in your jurisdiction.
North Carolina regulates health care through a combination of statutes, regulations, state agencies, and
licensing boards. North Carolina’s Department of Health and Human Services regulates much of the health
care industry in the state through its various offices and divisions: http://www.ncdhhs.gov/index.htm
North Carolina’s Department of Insurance regulates continuing care retirement communities
(http://www.ncdoi.com/SE/Default.aspx) and health care insurance (http://www.ncdoi.com/).
The various health care professions are regulated by their respective licensing boards.
2. Provide a check list of laws.
North Carolina’s laws are set forth in the North Carolina General Statutes (“N.C. General Statutes”),
http://www.ncleg.net/gascripts/Statutes/StatutesTOC.pl, and its regulations are set forth in the North
Carolina Administrative Code (“N.C.A.C.”), http://reports.oah.state.nc.us/ncac.asp.
Abortion
N.C. General Statutes, Chapter 90, Articles 1I, 1K
10A N.C.A.C. 14E, 43A, 71G
Acupuncture
N.C. General Statutes, Chapter 90, Article 30
21 N.C.A.C. 1
Adult Care Homes
N.C. General Statutes, Chapter 131D, Articles 1, 3- 5; Chapter 131E, Article 13
10A N.C.A.C. 13F-13G
Advance Directives; Health Care Powers of Attorney; Living Wills; Natural Death
N.C. General Statutes, Chapter 32A, Articles 3-4; Chapter 90, Article 23; Chapter 130A, Article 21
10A N.C.A.C. 28E
Aging Provisions and Program Operations
N.C. General Statutes, Chapter 143, Article 29; Chapter 143B, Article 3 (Parts 14-14F)
10A N.C.A.C. 5-6
Ambulatory Surgery Centers
N.C. General Statutes, Chapter 131E, Article 6 (Part 4)
10A N.C.A.C 13C
Assisted Living Administrators
N.C. General Statutes, Chapter 90, Article 20A
10A N.C.A.C. 13F
Athletic Trainers
N.C. General Statutes, Chapter 90, Article 34
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21 N.C.A.C. 3
Blind, Services for
N.C. General Statutes, Chapter 111, Articles 1-2
10A N.C.A.C. 63
Blood Banks
N.C. General Statutes, Chapter 90, Article 15B
10A N.C.A.C. 13B
Cardiac Rehabilitation Certification
N.C. General Statutes, Chapter 131E, Article 8
10A N.C.A.C. 14F
Certificate of Need
N.C. General Statutes, Chapter 131E, Article 9
10A N.C.A.C. 14C
Certificate of Public Advantage
N.C. General Statutes, Chapter 90, Article 1E; Chapter 131E, Article 9A
10A N.C.A.C. 14I
Children’s Services
N.C. General Statutes, Chapter 7B, Articles 3, 5, 11-14, 37-40
10A N.C.A.C. 70
Chiropractic
N.C. General Statutes, Chapter 90, Article 8
21 N.C.A.C. 10
Continuing Care Retirement Communities
N.C. General Statutes, Chapter 58, Article 64
11 N.C.A.C. 11H
County Departments of Health and Social Services
N.C. General Statutes, Chapter 153A, Article 13
10A N.C.A.C. 67-68
Deaf and Hard of Hearing, Services for
N.C. General Statutes, Chapter 143B, Article 3 (Part 29)
10A N.C.A.C. 17
Dentistry and Dental Professionals
N.C. General Statutes, Chapter 90, Articles 2-2A, 16
21 N.C.A.C. 16
Dieticians
N.C. General Statutes, Chapter 90, Article 25
21 N.C.A.C. 17
Emergency Medical Services
N.C. General Statutes, Chapter 131E, Article 7
10A N.C.A.C. 13P
Employee Assistance Professionals
N.C. General Statutes, Chapter 90, Article 32
21 N.C.A.C. 11
False Claims
N.C. General Statutes, Chapter 1, Article 51
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Fee-Based Pastoral Counselors
N.C. General Statutes, Chapter 90, Article 26
21 N.C.A.C. 45
Free Clinics
N.C. General Statutes, Chapter 90, Article 1J
Health Care Facilities Financing/Medical Care Commission
N.C. General Statutes, Chapter 131A
10A N.C.A.C. 13
Health Care Personnel Registry; Medication Aides
N.C. General Statutes, Chapter 131E, Article 15
10A N.C.A.C. 13O
Health Insurance and Related Topics
N.C. General Statutes, Chapter 58, Articles 50-56, 62, 65-68
11 N.C.A.C. 12
Home Care and Home Health Agencies
N.C. General Statutes, Chapter 131E, Articles 6 (Parts 3-3A), 16 (Section 131E-265)
10A N.C.A.C. 13J
Hospice Agencies
N.C. General Statutes, Chapter 131E, Article 10
10A N.C.A.C. 13K
Hospitals
N.C. General Statutes, Chapter 131E, Articles 2, 5, 15A
10A N.C.A.C. 13B
Incompetence and Adult Protective Services
N.C. General Statutes, Chapter 35A, Article 1; Chapter 108A, Articles 6-6A
10A N.C.A.C. 71A
Industrial Hygienists
N.C. General Statutes, Chapter 90, Article 33
10A N.C.A.C. 41C
Intermediate Care Facilities for Individuals with Intellectual Disabilities
N.C. General Statutes, Chapter 143B, Article 3 (Part 13)
10A N.C.A.C. 27G
Jails, Local Confinement Facilities
N.C. General Statutes, Chapter 153A, Article 10 (Part 2)
10A N.C.A.C. 14J
Laboratories (including Pap Smears, HIV Testing, and Mammograms)
10A N.C.A.C. 13M, 42
Marriage and Family Counselors
N.C. General Statutes, Chapter 90, Article 18C
10A N.C.A.C. 71; 21 N.C.A.C. 31, 53
Massage Therapists
N.C. General Statutes, Chapter 90, Article 36
21 N.C.A.C. 30
Maternity Homes
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N.C. General Statutes, Chapter 131D, Article 1B
10A N.C.A.C. 70K, 71L
Medical Records; Medical Communications and Related Matters; Health Information Exchange
N.C. General Statutes, Chapter 8, Article 7; Chapter 90, Articles 1C, 29, 29A; Chapter 131E, Article 5
(Part 7)
10A N.C.A.C. 69
Medicaid
N.C. General Statutes, Chapter 108A, Articles 2 (Parts 6-8), 7; Chapter 108C; Chapter 108D
10A N.C.A.C. 21-23, 25
Medical Malpractice, Informed Consent and Related Topics
N.C. General Statutes, Chapter 90, Articles 1B, 1F-1H
Mental Health
N.C. General Statutes, Chapter 122C
10A N.C.A.C. 26-29
Midwives
N.C. General Statutes, Chapter 90, Article 10A
21 N.C.A.C. 33
Minors, Treatment of
N.C. General Statutes, Chapter 90, Article 1A
N.C. Department of Health and Human Services
N.C. General Statutes, Chapter 143B, Article 3
Title 10A of the N.C.A.C.
Nurse Practitioners
N.C. General Statutes, Chapter 90, Articles 1, 1D
21 N.C.A.C. 32M, 36
Nursing (including Nurse Aides)
N.C. General Statutes, Chapter 90, Articles 9A- 9C, 9F-9G; Ch. 131E, Article 6 (Part 5)
21 N.C.A.C. 36
Nursing Home Administrators
N.C. General Statutes, Chapter 90, Article 20
21 N.C.A.C. 37
Nursing Homes
N.C. General Statutes, Chapter 131E, Articles 6 (Parts 1-2), 13, 16 (Section 131E-265)
10A N.C.A.C. 13D
Occupational Health
N.C. General Statutes, Chapter 130A, Article 20
13 N.C.A.C. 7
Occupational Therapists
N.C. General Statutes, Chapter 90, Article 18D
21 N.C.A.C. 38
Opticians
N.C. General Statutes, Chapter 90, Article 17
21 N.C.A.C. 40
Optometry
N.C. General Statutes, Chapter 90, Articles 6-6A
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21 N.C.A.C. 42
Perfusionists
N.C. General Statutes, Chapter 90, Article 40
21 N.C.A.C. 32V
Pharmacy
N.C. General Statutes, Chapter 90, Articles 4A-4C, 5E
21 N.C.A.C. 46
Physical Therapists
N.C. General Statutes, Chapter 90, Article 18B
21 N.C.A.C. 48
Physicians
N.C. General Statutes, Chapter 90, Articles 1, 1D
21 N.C.A.C. 32
Physician Assistants
N.C. General Statutes, Chapter 90, Articles 1, 1D
21 N.C.A.C. 32O, 32S
Podiatrists
N.C. General Statutes, Chapter 90, Article 12A
21 N.C.A.C. 52
Polysomnography
N.C. General Statutes, Chapter 90, Article 42
Professional Counselors
N.C. General Statutes, Chapter 90, Article 24
21 N.C.A.C. 53
Provider Sponsored Organizations
N.C. General Statutes, Chapter 131E, Article 17
Psychologists
N.C. General Statutes, Chapter 90, Article 18A
21 N.C.A.C. 54
Public Health (including communicable diseases, immunizations, and anatomical gifts)
N.C. General Statutes, Chapter 130A
10A N.C.A.C. 41, 45
Radiation Protection
N.C. General Statutes, Chapter 104E
15A N.C.A.C. 11
Referral Fees; Self-Referrals; Billing for Anatomic Pathology Services
N.C. General Statutes, Chapter 90, Articles 27-28, 41
Respiratory Therapists
N.C. General Statutes, Chapter 90, Article 38
21 N.C.A.C. 61
Social Workers
N.C. General Statutes, Chapter 90B
21 N.C.A.C. 63
Speech/Language Pathologists and Audiologists (including Hearing Aid Specialists)
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N.C. General Statutes, Chapter 90, Article 22; Chapter 93D
21 N.C.A.C. 64
Sterilization
N.C. General Statutes, Chapter 90, Article 19
10A N.C.A.C. 43A
Substance Abuse Professionals
N.C. General Statutes, Chapter 90, Article 5C
10A N.C.A.C. 25C, 27G
3. Provide any special issues which arise in your jurisdiction.
a. North Carolina’s Response to the Patient Protection and Affordable Care Act
North Carolina did not expand its Medicaid program in response to the Patient Protection and
Affordable Care Act (“ACA”). North Carolina also did not create a state insurance exchange, but instead
chose to let the federal government provide the exchange for the ACA insurance policies which were offered
in 2014 by two insurance companies (Blue Cross/Blue Shield of North Carolina throughout the state and a
subsidiary of Aetna Insurance in certain portions of the state). United HealthCare Insurance Company has
announced plans to offer ACA insurance policies in North Carolina in 2015.
b. Certificate of Need
North Carolina is among the states that has a certificate of need program, and North Carolina’s program is
applicable to a broader range of activities than is the case in many of the other states that have certificate
of need programs. In order to achieve the goal of preventing excess capacity in health care facilities
producing wasteful costs while meeting health care needs in all geographic areas, North Carolina prepares
an annual State Medical Facilities Plan which identifies those additional health care services that will be
permitted; for these identified opportunities to expand services, potential providers can compete to obtain
authorization to provide those services. In addition, subject to various exemptions, certain existing and/or
new activities which are not limited by the State Medical Facilities Plan require certificate of need approval,
including, but not limited to, changes in inpatient beds, certain specified services, expenditures exceeding
$2,000,000, acquisition of major medical equipment (exceeding an expenditure threshold of $750,000), and
establishment of a diagnostic center (exceeding an expenditure threshold of $500,000 for the total cost of
all items of equipment which cost more than $10,000).
c. Medicaid Managed-Care
The North Carolina General Assembly recently devoted substantial energy considering alternative methods
for “reforming” the State’s Medicaid program through the use of managed-care contractors which would
receive capitated and/or risk-based payments for arranging and/or providing services for Medicaid
enrollees. However, the North Carolina House and Senate have not agreed upon the approach to be used.
The House and the Governor favor an approach principally relying upon accountable care organizations
(“ACOs”) controlled by physicians and hospitals; the Senate’s approach would not exclude ACOs from
participation, but would rely more on contractors, including for-profit ones, to administer the Medicaid
program. Given that the House, Senate, and the Governor all favor some version of converting Medicaid
to a managed-care program, a change from the current fee-for-service program is likely to be adopted;
however, the specifics are yet to be determined.
d. Local Management Entities for Medicaid Mental Health Services
In 2011, the North Carolina General Assembly passed legislation to establish local management entities
(“LMEs”) under the authority of the Social Security Act’s 1915(b)/(c) Medicaid Waiver. Through Chapter
122C of the North Carolina General Statutes, LMEs became responsible for managing state and Medicaid
funds for beneficiaries in need of health care services related to mental illness, intellectual and
developmental disabilities, and substance abuse. In addition to serving a management function, LMEs
have become the liaison between Medicaid beneficiaries or consumers of mental health care services and
providers of such services covered by the Medicaid Waiver. In 2012, a network of twenty-three (23) LMEs
managed Medicaid funds across North Carolina. However, as of April 2014, this network was reduced to
nine (9) LMEs through a consolidation effort. Lawmakers in North Carolina are watching this model of
mental health care management closely to see if it is successful and applicable to other areas of medicine.
e. Stand-Alone Community Hospitals
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Stand-alone community hospitals in North Carolina have struggled to survive in recent years because they
rely heavily on declining Medicare and Medicaid reimbursement rates and have relatively little power to
negotiate favorable reimbursement rates with private insurers. The future of reimbursement in North
Carolina appears to be unfavorable in light of the General Assembly’s decision to decline the expansion of
Medicaid. Confronted with these revenue-related challenges, community hospitals have explored
affiliations with larger health systems. In some cases, hospitals decided to affiliate with health systems in
change-of-control transactions, with or without consideration, in an effort to improve their branding and
access to clinical resources. In other cases, hospitals entered into management agreements with larger
health systems in order to share clinical services and cut costs. Some larger health systems even formed
joint ventures with hospitals and agreed to invest funds in them over the next decade. Some of these
transactions were further complicated by state statutes requiring review by the Attorney General of North
Carolina in order to transfer ownership of a nonprofit hospital to a for-profit company, public bid statutes for
the sale or lease of hospitals owned by units of local government, or state and federal antitrust statutes that
protect competition in the regional health care market. Community hospitals that have completed affiliations
with larger health systems explain that such transactions provide the opportunities to leverage clinical
resources, make improvements to outdated infrastructure, make investments in technology and ensure
continued access to health care in communities across North Carolina for years to come.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
North Carolina does not regulate mobile health applications.
Contact Information
Anthony H. Brett
[email protected]
Thomas S. Stukes
[email protected]
Womble Carlyle Sandridge & Rice, LLP
One West Fourth Street, Suite 1200
Winston-Salem, NC 27101
Tel 336.721.3620
Fax 1.336.733.8331
Firm Website http://www.wcsr.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, Puerto Rico
Prepared by Lex Mundi member firm McConnell Valdés
A.
Introduction:
According to the Puerto Rico Department of Economic Development and Commerce, in Puerto Rico there
currently are 66 hospitals which are managed by the private and public sectors, with a total of 11,887
authorized beds, all of which are required to meet U.S. standards.
Puerto Rico is home to respected medical research centers.
Health facilities in Puerto Rico, including pharmacies, home health care agencies, and clinical laboratories,
are regulated and licensed by the Secretary of Health of Puerto Rico. Health professionals, in turn, are
regulated and licensed by their respective Examining Boards. The Puerto Rico Health Insurance
Administration, a government entity, provides health care to Medicaid qualified beneficiaries. United States
federal health care laws, such as Medicare, the Anti-kickback statute, and the self-referral laws apply in
Puerto Rico. Health plans and health services organizations (also known as “health maintenance
organizations”) are regulated and licensed by the Commissioner of Insurance.
Health professionals are regulated by various laws.
B.
List of Selected Laws:
1.
Health Facilities Act of Puerto Rico, Law Number 101 of June 26, 1965, 24 LPRA 331 et seq.
Act 101 entrusts the Health Department with the responsibility of regulating and licensing most health
facilities in Puerto Rico.
2.
Act Number 97 of June 25, 1962, regulates the operation and licensing of clinical laboratories. 24
LPRA '91 et seq.
3.
The Pharmacy Act of Puerto Rico, Act number 247 of September 3, 2004, entrusts the Secretary
of Health with the responsibility of licensing and regulating the operation of pharmacies, drug distributors,
drug manufacturers, and distributors of over-the-counter products, among others. 20 LPRA '407 et seq.
4.
Patient=s Bill of Rights and Responsibility Act, Act Number 194 of August 25, 2000, sets forth the
rights of a patient before a healthcare provider and a health plan. The law lists several specific actions by
a provider or a health plan that constitute violations. The law provides for a grievance procedure.
Obligations on the part of a patient, such as providing accurate information on his health to a provider, are
also listed.
5.
Controlled Substances Act of Puerto Rico, Act Number 4 of June 23, 1971, governs the
manufacture, distribution, prescribing and dispensing of controlled substances, including the issuance of
certificates of registration. 24 LPRA ' 2101 et seq.
6.
Act Number 65 of June 19, 1964 establishes a procedure for physicians and other providers to
notify the Secretary of Health of any abortion performed in Puerto Rico. 24 LPRA' 231 et seq.
7.
Act Number 28 of March 20, 1951 requires a physician treating a cancer patient to notify the Cancer
Control Program of the Health Department of said case using those forms provided by the latter. Such
notification requirement is imposed on other healthcare providers such as clinical laboratories. 24 LPRA '
381 et seq.
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8.
Certificates of Need (CON) Law, Act Number 2 of November 7, 1975. This statute requires the
obtainment of a certificate of need prior to the establishment of a health facility, the addition of hospital
beds, the conversion of hospital beds from one category to another, for example, conversion of an acute
care bed to an intensive care bed. Similar health facilities in the same service area are deemed to be
affected persons and as such may oppose a CON application, conduct discovery and participate in the
hearing process. A change in ownership and the expansion of a health facility also require the prior
obtainment of a CON but in these cases no hearings are required. 24 LPRA '334 et seq.
9.
Health Insurance Code of Puerto Rico, Act Number 194 of August 29, 2011. This Code sets forth
uniform norms for the health insurance industry including, among others, norms for the management of
prescribed drugs’ benefits, for the protection of health information, for verifying the credentials of
professionals or entities, for audits and quality control programs. It also regulates those entities the offer
health insurance for groups and individuals, as applicable under the Patient Protection and Affordable Care
Act, and the Health Care and Education Reconciliation Act. 26 LPRA § 9001, et seq.
9.
Health Services Organizations Act, Number 113 of June 2, 1976. This statute sets forth the
requirements for the licensing and operation of health services organizations. 26 LPRA § 1901, et seq.
10.
Non-Occupational Disability Insurance. Puerto Rico Act No. 139 of June 26, 1968 establishes a
mandatory government insurance plan that provides benefits for employees who are dis¬abled because of
a non-occupational illness or injury, including maternity.
11.
Compensation System for Work-Related Accidents. Act No. 45 of April 18, 1935 provides that the
Puerto Rico State Insurance Fund Corporation will collect premiums from employers based on the total
amount of salaries paid. The government system is exclusive and mandatory, and may not be substituted
by private coverage. The coverage begins upon payment of a premium.
12.
Unemployment Compensation. The Puerto Rico Employment Security Act, Act No. 74 of June 21,
1956 requires payment by the employer of a payroll tax, including wages paid for services rendered outside
Puerto Rico, but within the United States, the U.S. Virgin Islands and Canada, if: the employees are not
covered by the unemployment compensation statute of any other State, the U.S. Virgin Islands, or Canada,
and said services are controlled or directed from Puerto Rico.
13.
Chauffeur’s Insurance. This is a mandatory government insurance plan, which applies to non
exempt (hourly) employees; employers are required to insure any person whose work requires the
employee to drive a “motor vehicle” as part of that employee’s regular duties. This requirement has been
interpreted to include finger-lifts operating in a warehouse.
14.
Wages and Special Provisions Applicable to Nurses. Puerto Rico Act No. 27 of 2005, and
Regulation Number 7095 of the Puerto Rico Department of Labor and Human Resources on February 28,
2006, grant nurses a minimum wage that is higher than the current federal minimum wage. This does not
apply to employers who have one (1) nurse.
15.
Payroll Deduction Authorization. Puerto Rico Act No. 17 of April 17, 1931, prohibits deductions
from a non-exempt employee's wages unless they are covered by one or more exceptions contained in this
law or are otherwise authorized by other laws.
16.
Child support. The Child Support Administration Organic Act, employers to furnish the Child
Support Administration of the Department of the Family of the Commonwealth of Puerto Rico, usually
referred to by the acronym “ASUME”, the following information with regards to each person it employs or
re-employs: The name, address and social security number of the employee; and the name, address and
federal employment identification number, or if the local or federal law does not require a federal
employment identification number, the employment identification number of the Government of Puerto Rico.
17.
Mandatory Decree 41 applies with regards to overtime, vacation and sick leave with regards to
employees hired before August 1, 1995. It covers hospitals, clinics and similar health industry businesses.
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18.
Mandatory Decree 70 applies with regards to overtime, vacation and sick leave with regards to
employees hired before August 1, 1995 and covers some specialty care businesses.
19.
Act Number 168 of June 30, 1968, 13 LPRA '371 et seq tax incentives to any natural or juridical
person engaged in the operation of a hospital unit, for a period of 10 years,
In order to enjoy the tax incentives provided under Act 168, an entity must apply for and obtain a tax
concession from the Puerto Rico Department of the Treasury (Treasury).
Act 168 defines a “hospital unit“ as any natural or juridical person, or combination thereof that commenced
operations or was constructed after December 31, 1968, including:
General, tuberculosis and mental disease hospitals or any other kind of hospital engaged in the treatment
of diseases of human beings, as well as the facilities directly related to its normal operation;
Expansions to existing facilities within the premises of the hospital that involves a substantial investment
for the improvement of medical-hospital services;
Nurse or medical, residents and interns homes located within the premises of the hospital;
Clinics and convalescent homes; and
High-technology medical services subcontractors of hospital units that make a substantial investment that
is necessary and convenient for the hospital unit to increase its medical services.
Generally, under Act 168, an eligible hospital unit may enjoy the following:
a)
Tax credit of up to 15% of eligible payroll expenses;
b)
100% personal and real property tax exemption;
c)
100% excise tax exemption on equipment, machinery and devices (excluding spare parts
and accessories thereof);
d)
100% sales and use tax exemption on certain machinery and equipment and other items;
e)
100% municipal tax exemption; and
f)
100% exemption on the income generated from certain obligations and up to 50% on the
interest related to such obligations.
Act 168 provides for the transfer of the benefits conferred therein to a third party as long as the acquirer of
the hospital unit continues to render the services under the tax concession. Such transfer is subject to the
approval of Treasury. Treasury must be notified within 30 days after the transfer.
20.
The Export Services Act was signed by the Governor in 2012 to establish and develop international
export services in Puerto Rico. May services are eligible, including research and development. One of the
intentions behind this law is to stimulate inbound transfer of foreign services providers to Puerto Rico. The
Export Services Act was signed by the Governor in 2012 to establish and develop international export
services in Puerto Rico. May services are eligible, including research and development. One of the
intentions behind this law is to stimulate inbound transfer of foreign services providers to Puerto Rico. This
law provides of a 4% corporate tax rate, which may be reduced to 3%, 100% tax exemption on dividends
or profit distribution and on property taxes for certain export businesses for 20 years and this may be
renewed for 10 years.
List of Examining Boards
1.
Medical Discipline and Licensure Board, 20 LPRA § 131, et seq.
2.
Board of Nurse Examiners, 20 LPRA § 203, et seq.
3.
Board of Dental Examiners, 20 LPRA § 81, et seq.
4.
Board of Examiners of Health Service Administrators, 20 LPRA § 2351
5.
Board of Examiners of Medical Technologists, 20 LPRA § 281, et seq.
6.
Board of Examiners of Emergency Medical Technicians,
20 LPRA §3451, et seq.
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7.
C.
Board of Examiners of Psychologists, 20 LPRA § 3201, et seq.
Mobile applications
Mobile applications are subject to U.S. federal law.
D.
Special Issues
In Lozada Tirado v. Testigos Jehová, 177 DPR 89 (2010), the Supreme Court of Puerto Rico declared
unconstitutional Article 6 of the Advanced Statement of Will Regarding Treatment in the Event of a Terminal
Health Condition or Persistent Vegetative State Act@. The Court ruled that limiting the right of a person to
decide to withhold medical treatment to two conditions (terminal health condition and persistent vegetative
state) violated the right to privacy of that person to reject medical treatment regardless the type of medical
condition. In Lozada Tirado the patient refused to receive blood transfusions under any circumstances.
The Fair Labor Standards Act (“FLSA”) applies to every employer with an annual business volume in excess
of five hundred thousand dollars ($500,000). It also applies to those employees of an employer who does
not meet the stated annual volume but whose employees are engaged directly in interstate commerce or
in the production of goods for interstate commerce. Normally daily overtime is paid at two times the regular
rate for employers who do not fall under the FLSA. Persons who were working for these employers in
Puerto Rico on August 1, 1995 in an industry which provided a higher overtime rate than time and a half
for hours worked in excess of eight (8) during the workday under the applicable mandatory decree continue
to receive the higher benefit.; and if the mandatory decree provides for vacation and/or sick leave benefits
which are below or above the statutory limits will continue to receive the benefits provided by the specific
decree covering the employer's operation One must look to see what Mandatory Decree applies if you are
buying a business which was operating in Puerto Rico before August 1, 1995. If you are starting a new
business, then the general law covers the employer and there is no need to check what decree applies.
For persons hired before August 1, 1995, then Man¬datory Decrees Nos. 41 and 4 of the Puerto Rico
Minimum Wage Board are applicable to the Hospitals, Clinics and Related Services Industry ("MD 41 and
4"). MD41 and 4 do not require that hours worked in ex¬cess of eight (8) daily be paid at twice the regular
wage rate the employee is then drawing. As a general rule, the accrual of vacation is at the rate of one and
one-fourth day per month and for the accrual of sick leave at the rate of one day per month, provided that
the employee works at least 115 hours during the month, but MD 41 and 4 provide a higher monthly accrual
of 1½ day and 1¼ day, respectively, for vacation and sick leave.
Contact Information
Mario L. Paniagua
[email protected]
James D. Noel III
[email protected]
McConnell Valdés LLC
270 Muñoz Rivera Avenue
San Juan, Puerto Rico, USA 00918
Tel 1.202.857.5382 Fax 1.787.759.9225
Firm Website http://www.mcvpr.com
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International Guide on Health Industry Laws
USA, Rhode Island
Prepared by Lex Mundi member firm Adler Pollock & Sheehan P.C.
1. Provide an introduction on health law in your jurisdiction.
Rhode Island’s healthcare sector is constantly growing, resulting in numerous developments in
health care laws. Recently, two national for-profit healthcare systems acquired local community
hospitals, thereby testing Rhode Island’s Hospital Commission Act (“HCA”). The HCA requires
approval from both the Rhode Island Attorney General and the Rhode Island Department of
Health before a hospital may convert from a non-profit to a for-profit. When evaluating
transactions resulting in such a change, the agencies will consider the following factors:
1.
Satisfactory character, commitment, competence, and standing in the community;
2.
Sufficient safeguards to assure the affected community continued access to affordable
care;
3.
Clear and convincing evidence to provide health care and access for traditionally
underserved populations in the affected community;
4.
Procedures or safeguards to insure that ownership interests will not be used as
incentives for hospital employees or physicians to refer patients to the hospital;
5.
Commitment to assure the continuation of collective bargaining rights and workplace
retention;
6.
Estimated future employment needs under the conversion, and retraining of employees
who may be impacted by the proposed restructuring;
7.
Demonstration that public interest will be served, including access to essential medical
services needed to provide safe and adequate treatment, and assurance of a balanced
health care delivery system;
8.
Issues of market share, especially as they affect quality, access, and affordability of
services; and
9.
Applicants must meet the Conditions of Approval for any previous Conversion under the
Act.
In 2013, Prime Healthcare Services completed its acquisition of the community hospitals,
Landmark Medical Center and the Rehabilitation Hospital of Rhode Island pursuant to the HCA.
At the time of its acquisition, Prime became Rhode Island’s first for-profit hospital corporation. In
addition, Prime acquired Landmark out of a five-year special mastership and, therefore, was
required to seek the approval of the Rhode Island Superior Court. In 2014, Prospect Medical
Holdings acquired CharterCare Health Partners – becoming the second for-profit acquisition of a
non profit medical system in Rhode Island
In addition to these recent acquisitions, there are two major healthcare groups in Rhode Island:
Lifespan and Care New England. Lifespan, Rhode Island’s first health system, currently owns
and operates Rhode Island Hospital, Miriam Hospital, Hasbro Children’s Hospital, Bradley
Hospital, and Newport Hospital. Care New England owns and operates Butler Hospital, Kent
Hospital, and Women & Infants Hospital of Rhode Island.
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Rhode Island’s Insurance market is also an active area of regulatory and legislative
developments. Rhode Island’s health exchange is successful as implemented through
HealthSource RI. That exchange, however, may face financial hurdles in fiscal year 2016 when
federal funding ends. Per-member fees are likely not a viable option in the State due to Rhode
Island’s small population. As a result, the General Assembly is considering other options for
funding the exchange, including the possibility of switching to a federally facilitated marketplace.
A bipartisan bill introduced in 2014 would have terminated the state-run exchange and switched
operations to Healthcare.gov instead. A committee recommended that the bill be held for study,
but may take it up again in 2015. If that bill passed, Rhode Island would have been the first state
to forego a successful exchange for a federally funded marketplace.
Rhode Island’s regulatory agencies are also very active. The disciplinary boards for practitioners
initiate numerous investigations, complaints, and disciplinary proceedings each year.
2. Provide a check list of laws with a short summary of the general requirements of each.
Rhode Island Statutes
R.I. Gen. Laws § 5-31.1-1 et seq.:
Dentists and Dental Hygienists
R.I. Gen. Laws § 5-34-1 et seq.:
Nurses
R.I. Gen. Laws § 5-37.3-1 et seq:
Confidentiality of Health Care Communications and
Information Act
R.I. Gen. Laws § 23-1-1 et seq.:
Department of Health
R.I. Gen. Laws § 23-15-1 et seq.:
Determination of Need for New Health Care Equipment
and New Institutional Health Services
R.I. Gen. Laws § 23-16-1 et seq.:
Health Facilities Construction
R.I. Gen. Laws § 23-17.8-1 et seq.:
Abuse in Health Care Facilities
R.I. Gen. Laws § 23-17.12-1 et seq.:
Health Care Services – Utilization Review Act
R.I. Gen. Laws § 23-17.13-1 et seq.:
Health Care Accessibility and Quality Assurance Act
R.I. Gen. Laws § 23-17.14-1 et seq.:
The Hospital Conversions Act
R.I. Gen. Laws § 23-17.15-1 et seq.:
Long-Term Health Care Goals and Values
R.I. Gen. Laws § 40-5-1 et seq.:
Mental Health Law
R.I. Gen. Laws § 27-18-1 et seq.:
Accident and Sickness Insurance Policies
R.I. Gen. Laws § 27-18.7-1 et seq.:
Extended Medical Leave
R.I. Gen. Laws § 27-20.9-1 et seq.:
Contract with Health Care Providers
Rhode Island Regulations
Rhode Island agencies issue regulations to accompany the statutory provisions. Those
regulations include:
R5-37-MD/DO:
Rules and Regulations for the Licensure and Discipline of Physicians
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R42-35-PP:
Rules and Regulations Pertaining to Practices and Procedures Before
the Rhode Island Department of Health. These Rules and Regulations
provide the procedures for all administrative actions within the
Department of Health. They include the procedure for contested
hearings, decisions, and rule making.
R23-15-CON:
Rules and Regulations for Determination of Need for New Health Care
Equipment and New Institutional Health Services. These Rules and
Regulations establish the procedure and standards regarding the
determination of need for the development of new health care equipment
and new institutional health services.
EEOHS Policy 0300:
Rhode Island Medicaid Rules and Procedures. These Rules and
Procedures govern the implementation of the Rhode Island Medicaid
system for both providers and Medicaid recipients and applicants.
3. Provide any special issues which arise in your jurisdiction.
Medical Records: R.I. Gen. Laws § 5-37.3-1 et seq. creates a qualified privilege for patients’
health care information. The purpose of that Act is to establish safeguards for maintaining the
integrity of confidential health care information. Thus, under that Act, health care information may
be disclosed with the written consent of the patient or his authorized representative or if it is
relevant to a civil action brought by the patient. A court will determine that the information is
relevant to a civil action when the requesting party can demonstrate that there is reasonable
ground to believe that the information begin sought is relevant to the proceedings, and the need
for the information clearly outweighs the privacy interest of the individual. Under that balancing
test, the Court will specifically examine: (1) the particular purpose for which the information was
collected; (2) the individual’s reasonable expectation of privacy in the information; (3) the degree
to which disclosure of the information would embarrass, injure, or invade the privacy of the
individual; (4) the importance of the information to the lawsuit or proceeding; and (6) whether the
information is available for some other source.
New Institutional Health Services or Equipment: Pursuant to R.I. Gen. Laws § 23-15-3 et seq., in
order to offer new institutional health services or use new health care equipment, a practice,
provider, or corporation must obtain a Certificate of Need (“CON”) from the Department of Health
(“DOH”). The CON process requires the provider to show an adequate demonstration of need
and affordability. Obtaining a CON requires a number of steps within DOH. The process begins
when an application for a CON is filed with the Department of Health. The applicant and other
parties may present evidence, and DOH may hold hearings on the matter. Then, the hearing
officer, acting purely in a ministerial capacity, compiles a record of the proceedings, along with all
of the exhibits and forwards the record to the Health Services Council (“HSC”). Often, the Health
Services Counsel delegates the initial review to a Project Review Committee, who would then
consider the record and make a recommendation to the HSC. Next, the HSC examines the
materials and provides DOH with a written report containing its findings and recommendations.
DOH then reviews the record and the HSC’s recommendations and renders its decision. If
DOH’s decision is contrary to the HSC’s recommendation, DOH must afford written justification
for its variance therefrom.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Mobile Health applications are not yet regulated in Rhode Island. As providers have started
researching their utility, regulations may begin to arise within the next year.
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Contact Information
Richard R. Beretta, Jr., Shareholder
[email protected]
Leslie D. Parker, Associate
[email protected]
Adler Pollock & Sheehan, P.C.
One Citizens Plaza, 8th Floor
Providence, Rhode Island 02903
Tel 401.274.7200 Fax 401.351.4607
www.apslaw.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, South Carolina
Prepared by Lex Mundi member firm Wyche, P.A.
1. Provide an introduction on health law in your jurisdiction.
Health Care Reform
Under the Patient Protection and Affordable Care Act (“PPACA”), states have the option to
establish their own health insurance exchange for individuals to purchase health insurance or to
rely on a federally-operated exchange. South Carolina elected not to establish its own exchange.
Currently, individuals who purchase insurance from a private insurer through either a stateoperated or federal exchange are eligible for substantial subsidies from the federal government.
However, a recent D.C. Circuit decision held that the payment of subsidies to individuals purchasing
insurance in a state without a state-operated exchange is contrary to the language of PPACA. 96
Because the Fourth Circuit, of which South Carolina is a part, reached the opposite conclusion, the
subsidies paid to the 120,000 individuals in South Carolina who have used the exchange are still
valid. 97 Should the issue reach the United States Supreme Court and the United States Supreme
Court agrees with the D.C. Circuit’s ruling, South Carolina’s federally-operated exchange will
essentially be shuttered, unless South Carolina creates its own exchange or PPACA is amended.
South Carolina has opted out of the Medicaid expansion offered under PPACA.
Regulation of Health Care in South Carolina
The South Carolina Department of Health and Environmental Control (“DHEC”) is responsible for
regulating the state’s health care providers and facilities. Other departments regulate discrete
aspects of health care in South Carolina, including the Department of Health and Human Services,
the Department of Mental Health, the Department of Insurance, the Department of Disabilities and
Special Needs Family Support Services and numerous professional licensing boards. The South
Carolina Attorney General is responsible for enforcing these laws and policing Medicaid and other
health care fraud.
South Carolina is a certificate of need (“CON”) state. As such, establishing a new health care
facility, incurring large capital expenditures by existing health care facilities and offering new
services by existing health care providers each require approval from DHEC. Currently, certain
capital expenditures of greater than $2,000,000 or the purchase of certain medical equipment with
a total cost of greater than $600,000 requires obtaining a CON from DHEC.
In 2013, Governor Haley used a line-item veto to eliminate funding for the state’s CON program in
an attempt to end the program. Until April 2014, the program’s status was uncertain, however, the
South Carolina Supreme Court has recently held that DHEC has a statutory responsibility to
enforce South Carolina’s CON laws. 98 As of the date of this publication, South Carolina’s CON
program remains in place, though how it will be funded is uncertain and remains to be seen.
Health Care Market Conditions
96
Halbig v. Burwell, No. 14–5018, 2014 WL 3579745, at *16–17 (D.C. Cir. July 22, 2014)
King v. Burwell, No. 14–1158, 2014 WL 3582800, at *16 (4th Cir. July 22, 2014)
98 Amisub of South Carolina, Inc. et al. v. South Carolina Department of Health and Environmental
Control, Op. No. 27382 (S.C. Sup. Ct. April 14, 2014)
97
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South Carolina’s insurance and health coverage market is heavily consolidated. Despite South
Carolina opting out of Medicaid expansion, almost a quarter of South Carolina’s population –
approximately 1.1 million people – are enrolled in South Carolina Medicaid. 99 Eighteen percent of
South Carolina’s population is enrolled in Medicare. Of those individuals with private insurance,
over sixty percent are enrolled in a BlueCross BlueShield of South Carolina plan.
Approximately seventeen percent of South Carolina’s population is uninsured. South Carolina
expects that even without the Medicaid expansion, the uninsured rate will continue to drop as more
individuals obtain health insurance through an exchange or through South Carolina’s increased
efforts to enroll Medicaid-eligible individuals in the program. 100
South Carolina has a comparably high Medicaid reimbursement rate, and therefore a high
percentage of South Carolina physicians are willing to participate in its Medicaid program
(approximately 84%). 101
2. Provide a check list of laws with a short summary of the general requirements of each.
South Carolina Laws
SC Code of Laws, Title 44 – Health
Chapter 1 – Establishes the Department of Health and Environmental Control
Chapter 6 – Establishes the Department of Health and Human Services to administer the
South Carolina Medicaid program
Chapter 7 – Regulation of hospitals, municipal hospitals and tuberculosis camps, including
South Carolina’s Certificate of Public Need Program
Chapter 9 – Establishes the State Department of Mental Health to improve mental health
care in South Carolina
Chapter 29 – Contagious and infectious disease reporting requirements and fines for
noncompliance with laboratory standards
Chapter 30 – Implements a program to comply with federal Centers for Disease Control
policies regarding HIV and Hepatitis B
Chapter 53 – Regulates and provides registration requirements for dispensers,
manufacturers and distributors of poisons, drugs and other controlled substances,
including prescription drugs
Chapters 69-75, 89 – Provides licensure of home health agencies, in-home care providers,
hospices, radiologic technicians, athletic trainers and birthing centers
Chapter 113 – Establishes provider self-referral law which bans certain health care
providers from referring patients to entities in which the provider has an investment interest
Chapter 115 – Establishes patients’ right to receive their medical records; requires
physicians to transfer documents under certain conditions but makes a patient’s records
the property of the treating physician
99 Keck, Anthony, “South Carolina’s View: The Affordable Care Act’s Medicaid Expansion Is the Wrong
Approach,” Health Affairs Blog. Sep. 6, 2012.
100 Statistics from the Kaiser Foundation. http://kff.org/statedata/.
101 Galewitz, Phil. “Study: Nearly A Third of Doctors Won’t see New Medicaid Patients,” Kaiser Health
News. Aug. 6, 2012. http://www.kaiserhealthnews.org/stories/2012/august/06/third-of-medicaid-doctorssay-no-new-patients.aspx
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Chapter 117 – Provides prescription drug information privacy and electronic prescription
processing; requires written consent for transfers of prescription drug information, except
when pursuant to one of a number of statutory exceptions
SC Code of Laws, Title 38 – Insurance
Chapter 3 – Establishes the Department of Insurance to regulate insurance rates and
standards.
Chapter 33 – Regulatory standards for health maintenance organizations
Chapter 71 – Health insurance contract required provisions and coverage requirements
Chapter 72 – Provides requirements and required coverage for long term health care
insurance
Chapter 74 – Establishes a high-risk pool for South Carolina residents paid for by an
assessment of insurers.
Chapter 93 – Regulates privacy of genetic information; insurers may not make decisions
based on genetic information or require covered persons to undergo genetic tests
SC Code of Laws, Title 40 – Professions and Occupations
Except as otherwise specified, each Chapter below provides licensing requirements, disciplinary
measures and licensing board composition:
Chapter 9 – Chiropractors
Chapter 15 – Dentists, Dental Hygienists and Dental Technicians
Chapter 20 – Dietetics Licensure
Chapter 30 – Massage/Bodywork
Chapter 31 – Naturopathy [Unlawful to practice in South Carolina; no licensing
requirements]
Chapter 33 – Nurses
Chapter 35 – Long Term Health Care Administrators
Unlawful to operate nursing homes or community residential facilities or certain other
facilities without the supervision of a long term health care administrator
Chapter 37 – Optometrists
Chapter 38 – Opticians
Chapter 43 – Pharmacies and Pharmacists
I
Includes drug preparation standards and wholesale distributor permits
Chapter 45 – Physical Therapists
Chapter 47 – Physicians, Respiratory Therapists, Acupuncturists, Physician Assistants,
Anesthesiologist Assistants, Cardiovascular Invasive Specialists
Chapter 51 – Podiatrists
Chapter 55 – Psychologists
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Chapter 63 – Social Workers
Chapter 67 – Speech Pathologists and Audiologists
Chapter 75 – Professional Counselors, Therapists and Licensed Psycho-educational
specialists
Regulatory Bodies and Regulations
Except as otherwise specified, each Chapter below provides licensing requirements, disciplinary
measures and licensing board composition:
Chapter 25 – South Carolina Board of Chiropractic Examiners
Chapter 36 – Board of Examiners for the Licensure of Professional Counselors, Marriage
and Family Therapists, and Psycho-educational specialists
Chapter 39 – State Board of Dentistry
Chapter 40 – Department of Labor Licensing and Regulation Panel for Dietetics
Chapter 51 – Department of Health and Environmental Control
Chapter 69 – Department of Insurance
Chapter 77 – Massage/Bodywork Therapy
Chapter 81 – State Board of Medical Examiners
Chapter 87 – Department of Mental Health
Chapter 88 – Department of Disabilities and Special Needs
Chapter 91 – State Board of Nursing
Chapter 93 – South Carolina Board of Long Term Health Administrators
Chapter 94 – State Board of Occupational Therapy
Chapter 95 – Board of Examiners in Optometry
Chapter 96 – South Carolina Board of Examiners in Opticianry
Chapter 99 – State Board of Pharmacy
Chapter 100 – State Board of Examiners in Psychology
Chapter 101 – State Board of Physical Therapy Examiners
Chapter 110 – State Board of Social Work Examiners
Chapter 114 – Department of Social Services
Chapter 115 – Board of Examiners in Speech/Language Pathology and Audiology
Chapter 126 – Department of Health and Human Services
Chapter 134 – Board of Podiatry Examiners
3. Provide any special issues which arise in your jurisdiction.
Physician Self-Referral Law
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The South Carolina Self-Referral law is analogous to both the United States Federal Stark law, 42
U.S.C. 1395nn(h)(5), and the Anti-Kickback Statute, 42 U.S. Code § 1320a-7b. However, because
the definitions and covered conduct for South Carolina’s Self-Referral law are different and in some
cases broader than those of the Federal Stark and Anti-Kickback laws, it is important to ensure
physician referral relationships meet both Federal and state laws.
Physician-Patient Privilege
South Carolina does not recognize physician-patient privilege; however, it does recognize that
physicians owe a duty of confidentiality to their patients. McCormick v. England, 328 S.C. 627,
634, 643–44 (Ct. App 1997).
Abortion Laws
South Carolina heavily regulates the practice of abortion. Women must receive state-directed
counseling and then wait twenty-four hours before obtaining an abortion. Minors must have parental
consent before having an abortion procedure. Certain private health plans offered in the state are
prohibited from covering abortion except when the abortion is to protect the life of the mother or in
the case or rape or incest.
Telemedicine
A bill that would have required insurers to cover telemedicine passed the South Carolina Senate
but failed in the South Carolina House. However, some private insurers, such as BlueCross
BlueShield of South Carolina, have begun covering telemedicine in some cases.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide
a brief summary as to how they are regulated.
Although Federal laws such as the Health Insurance Portability and Accountability Act may apply
to certain health applications, there are no South Carolina-specific state laws which regulate mobile
health applications.
Contact Information
This guide is intended to provide a brief summary and is and shall not constitute legal advice. For
legal advice with respect to a specific matter, please consult one of the South Carolina attorneys
listed below.
Henry L. Parr, Jr., Member
[email protected]
Wyche, P.A.
44 East Camperdown Way
Greenville, South Carolina, USA 29601
Tel 864.242.8209 Fax 864.298.3999
wyche.com
Terrell W. Mills, Member
[email protected]
Wyche, P.A.
44 East Camperdown Way
Greenville, South Carolina, USA 29601
Tel 864.242.8382 Fax 864.298.3999
wyche.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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© 2016 Lex Mundi
International Guide on Health Industry Laws
USA, Tennessee
Prepared by Lex Mundi member firm Bass, Berry & Sims PLC
1. Provide an introduction on health law in your jurisdiction.
While initially rejecting the concept of Medicaid expansion for Tennessee, Governor Bill Haslam’s
office announced in August of 2014 that his administration will submit a plan in the fall of 2014 to the U.S.
Department of Health and Human Services (HHS) to address the expansion of health insurance coverage
for low-income people. If approved by HHS, Tennessee’s plan will represent one of a number of “custombuilt” plans that states who have not adopted wholesale Medicaid expansion under the Affordable Care Act
have negotiated with HHS.
In January 2014, the Tennessee legislature introduced a bill that would bar state and local
governments as well as educational institutions from buying coverage for their employees through the
federal health insurance exchanges on Healthcare.gov. However, this bill never passed.
Historically, Tennessee has had four primary programs – CoverTN, CoverKids, CoverRx, and
AccessTN – operating under the “Cover Tennessee” umbrella to provide health care coverage to many
Tennesseans who had difficulties accessing health insurance. As a result of the Affordable Care Act, the
state has significantly limited or terminated these programs as of January 1, 2014, and has directed these
individuals to apply for alternative coverage, such as through the federal marketplace.
Although there have been recent minor gains in broad population health measures like life
expectancy and infant mortality, Tennessee still ranks worse than the national average in both categories.
Per capita health expenditures in the state are also significantly higher than the US average.
In December 2013, TennCare awarded managed care contracts to the following Managed Care
Organizations (MCOs): AmeriGroup; BlueCare Tennessee; and UnitedHealthcare. The state of Tennessee
has continued to work with MCOs and develop other ideas to improve the coordination of care statewide.
Tennessee has a certificate of need (CON) program, which regulates the ability to establish certain
“health care institutions” and “health care services.” Tennessee has also recently tightened its regulation
of so-called “pain clinics.”
On the enforcement front, in 2012, Tennessee, along with several other states, reached a $43
million settlement with Pfizer Inc. regarding allegedly false and deceptive claims. The state of Tennessee
received $1.1 million from Pfizer for its allegedly unlawful practices in promoting two drugs. In 2012,
Tennessee state attorney general Robert Cooper filed a complaint against HRC Medical Centers Inc. for
allegedly withholding important information about health risks and side effects of a hormone replacement
therapy regimen.
Some of Tennessee’s government agencies and divisions involved in the regulation of health care
include the Department of Finance & Administration (which houses TennCare), the Department of
Commerce & Insurance, the Department of Health (and its Divisions the Health Services and Development
Agency (CONs) and the Board for Licensing Health Care Facilities), Health and Human Services, the Office
of the Attorney General, the Tennessee Board of Medical Examiners, and the Department of Mental Health
and Substance Abuse Services, among others.
2. Provide a check list of laws with a short summary of the general requirements of each.
Tennessee Statutes
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Title 33 – Mental Health and Developmental Disabilities
• Chapter 5 – Intellectual and Developmental Disabilities Services
• Chapter 6 – Mental Health Services
Title 50 – Employer and Employee
• Chapter 3 – Occupational Safety and Health Act of 1972
Title 56 – Insurance
• Chapter 27 – Medical Service Plan Law, 1945
• Chapter 28 – Hospital Service Corporations
• Chapter 29 – Hospital and Medical Service Corporations
• Chapter 30 – Dental Service Plan Law, 1961
• Chapter 31 – Vision Service Plan Law
• Chapter 32 – Health Maintenance Organization Act of 1986
• Chapter 39 – Comprehensive Health Insurance Pool
• Chapter 42 – Long-Term Care Insurance Act
• Chapter 54 – Tennessee Health Care Liability Reporting Act
• Chapter 61 – Tennessee Health Carrier Grievance and External Review Procedure Act
Title 62 – Professions, Businesses and Trades
• Chapter 40 – Industrial Hygienists
Title 63 – Professions of the Healing Arts
• Chapter 1 – Division of Health Related Boards
• Chapter 2 – Medical Records
• Chapter 3 – Podiatrists
• Chapter 4 – Chiropractors
• Chapter 5 – Dentists
• Chapter 6 – Medicine and Surgery
• Chapter 7 – Nursing
• Chapter 8- Optometry Law
• Chapter 9 – Osteopathic Physicians
• Chapter 10 – Pharmacy
• Chapter 11 – Psychologists
• Chapter 13 – Occupational and Physical Therapy Practice Act
• Chapter 14 – Dispensing Opticians
• Chapter 16 – Nursing Home Administrators
• Chapter 18 – Massage Licensure Act of 1995
• Chapter 19 – Physicians Assistants
• Chapter 22 – Professional Counselors, Marital and Family Therapists, and Clinical Pastoral
Therapists
• Chapter 23 – Social Workers
• Chapter 24 – Athletic Trainers
• Chapter 25 – Dietetics / Nutrition Practice Act
• Chapter 26 – Electrologists Practice Act
• Chapter 27 – Respiratory Care Practitioner Act
• Chapter 28 – Clinical Perfusionist Licensure Act
• Chapter 51 – Health Care Consumer Right-to-know Act of 1998
Title 68 – Health, Safety and Environmental Protection
• Chapter 1 – Department of Health
• Chapter 2 – Local Health Services
• Chapter 3 – Vital Records Act of 1977
• Chapter 5 – Prevention of Diseases
• Chapter 6 – Cancer Control
• Chapter 8 – Rabies
• Chapter 9 – Tuberculosis
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•
•
•
•
•
•
•
•
•
•
•
•
•
Chapter 10 – Sexually Transmitted Diseases
Chapter 11 – Health Facilities and Resources
Chapter 12 – Treatment of Disabled Children
Chapter 29 – Tennessee Medical Laboratory Act
Chapter 32 – Blood Donations
Chapter 34 – Family Planning Act of 1971
Chapter 35 – Renal Disease
Chapter 41 – Hemophilia
Chapter 49 – Epilepsy and Seizure Disorders
Chapter 55 – Head and Spinal Cord Injury Information System
Chapter 57 – Surgical Technologists
Chapter 59 – Tennessee Trauma Center Funding Law of 2007
Chapter 60 – Asthma
Tennessee Regulations
Chapter
Agency
0030
0150
0250
0260
0300
0440
0450
0460
0465
0470
0480
0540
0700
0720
0730
0760
0870
0880
0900
0940
1000
1020
1030
1045
1050
1140
1150
1155
1180
1200
1240
1330
1365
Commission on Aging and Disability
Athletic Trainers
Children’s Services
Chiropractic Examiners
Board of Claims
Cosmetology
Counselors Marital / Family Therapists
Dentistry
Intellectual and Developmental Disabilities
Dietitian / Nutritionist Examiners
Dispensing Opticians
Electrolysis Examiners
Healing Arts Licensing Board
Health Services & Development Agency
Health Planning and Resources
Hearing Instruments Specialists
Massage Therapists
Medical Examiners
Medical Malpractice Review
Mental Health & Substance Abuse Services
Nursing
Nursing Home Administrators
Occupational Safety and Health Board
Optometry
Board of Osteopathic Examination
Pharmacy
TN Boards of Occupational & Physical Therapy
Podiatric Medical Examiners
Psychology Examiners
Health, Environment and Conservation
Human Services
Tennessee Board of Respiratory Care
Social Worker Certification
Selected Case Laws
Cookeville Regional Medical Center Authority v. Cardiac Anesthesia Services, PLLC (No. M2007-02561COA-R3-CV November 24, 2009). Contract dispute between a hospital and physician group where the
court ruled that the contract contained a clear violation of the fee-splitting prohibition.
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State ex rel. Landenberger v. Project Return, Inc.(No. M2007-02859, March 11, 2009). Original source
provision of the Tennessee False Claims Act applies where there has been a public disclosure of the alleged
violations.
Knox County ex rel. Environmental & Pest Control, Inc. v. Arrow Exterminators, Inc. (350 S.W.3d 511 Tenn.
2011). The relator qualified as an original source under the Tennessee False Claims Act as a result of the
lengthy independent investigation it conducted and thus was entitled to receive a portion of the settlement
proceeds.
State ex rel. Shriver v. Leech (612 S.W.2d 454 Tenn. 1981). A Civil Investigative Demand (CID) must
identify the parties to the case or investigation and state the case that is pending or the matter under
investigation. Attorney General, himself, or the reporter, has authority under statute to issue CIDs, but the
AG’s deputies and assistants do not have that authority. If the party finds the demands of the CID
unreasonable, the party who issues the CID can wait until the state moves to compel compliance and can
then raise the unreasonableness of the CID as a defense to the action to enforce compliance. The court
has the right to compel testimony.
3. Provide any special issues which arise in your jurisdiction.
Infant mortality
Based on 2010 data from the Centers for Disease Control and Prevention, Tennessee ranked 48rd worst
nationally in infant mortality, with a rate of 7.87 deaths for every 1,000 live births.
Physician Non-Compete
Non-compete provisions that restrict physicians’ ability to practice after termination of an employment or
contract relationship are valid in Tennessee, but must satisfy statutory conditions to be deemed reasonable
and enforceable. The non-compete covenant must be in an employment agreement or other written
document between the provider and the employing or contracting entity, and the duration of the restriction
may be for only up to two years. The maximum geographic restriction is the greater of a ten-mile radius
from the primary practice site or the county in which the primary practice site is located. Alternatively, if
there is no geographic restriction, the provider may be restricted from practicing at any facility at which the
employing or contracting entity provided services while the provider was employed or contracted with the
entity. See Tenn. Code Ann. § 63-1-148(a)(1)(A)-(B).
Certificate of Need
The Tennessee Health Services and Development Agency is responsible for regulating the health care
industry in Tennessee through the Certificate of Need Program. A Certificate of Need (“CON”) is a permit
for the establishment or modification of a health care institution, facility or service at a designated location.
The CON program is designed to assure that health care projects are accomplished in an orderly,
economical manner, consistent with the development of adequate and effective healthcare for the people
of Tennessee. These duties were previously performed by the Health Facilities Commission. See Tenn.
Comp. R. & Regs. 0720-08-.01 to 0720-13-.04.
Corporate Practice of Medicine
Tennessee generally prohibits the corporate practice of medicine, but there are exceptions that allow certain
types of entities to employ physicians. A licensed physician, or group of licensed physicians, including but
not limited to, a medical professional corporation, may employ physicians. In addition, a licensed hospital
or affiliate, a dialysis facility, or a skilled nursing facility may employ physicians (but not radiologists,
anesthesiologists, pathologists or emergency physicians) if the employing entity conforms to specific rules
provided by statute. See Tenn. Code Ann. §§ 68-11-205(b)(4) and 68-11-205(b)(1)(A).
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide a brief
summary as to how they are regulated.
Besides the federal regulation, there do not appear to be any published mobile health application
regulations in Tennessee.
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Contact Information
Daniel R. Kuninsky
Stefanie P. Carter
Bass, Berry & Sims PLC
150 Third Avenue South, Suite 2800
Nashville, TN 37201
Claire F. Miley
Tel 1.615.742.6200 Fax 1.615.742.6293
Firm Website http://www.bassberry.com
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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International Guide on Health Industry Laws
USA, Vermont
Prepared by Lex Mundi member firm Downs Rachlin Martin PLLC
1.
Provide an introduction on health law in your jurisdiction.
In 2011, Governor Peter Shumlin signed Act 48, a comprehensive health care reform law entitled “An Act
Relating to a Universal and Unified Health System.” The law creates Green Mountain Care, the state’s
universal health care system. The goal of the law is to contain costs and to provide, as a public good,
comprehensive, affordable, high-quality, publicly-financed health care coverage for all Vermont residents
in a seamless manner regardless of income, assets, health status, or availability of other health coverage.
For the past half century, the cost of health care has consistently risen at a steeper rate than inflation. This
remains true despite much-publicized reductions in the rate of growth in health spending in recent years.
By 2011, health care spending accounted for 18 cents of every dollar spent in the U.S. and 20 cents of
every dollar spent in Vermont.
The three main elements of the law are:
 The Green Mountain Care Board: The five-member Green Mountain Care Board (“GMCB”)
oversees the state’s entire health care system. The board is responsible for the development,
implementation and evaluation of payment reform pilots. The board reviews and approves health insurance
rates, reimbursement rates for health care professionals, hospital budgets, and certificate of need
applications. It also reviews and approves the benefit package for qualified health plans offered by the
health insurance exchange. In addition, the board will develop and approve the Green Mountain Care
benefit package and recommend a three-year budget.
 The Health Insurance Exchange: The law established the Vermont Health
Benefit Exchange as a division of the Department of Vermont Health Access. The exchange provides
federally-qualified health benefit plans to eligible individuals and small businesses, in a forum in which
Vermonters can compare and purchase health insurance. The Exchange has been plagued with significant
operational issues since the launch, in October of 2013.
 The structure for Green Mountain Care: The law creates a framework to
establish a state universal health care system called Green Mountain Care. Implementation of the program
will occur once the following conditions are met: the state receives the necessary federal waivers, the
legislature enacts a law to finance the program, the Board approves the benefit package, and the Board
makes specific determinations on the impact of implementation of the program on the state’s economy.
Taken together the reforms included in Act 48 are intended to assure that all Vermonters have
health insurance coverage, that health care delivery is efficient and high quality, that costs are
sustainable and that Vermont moves in a deliberate manner toward publicly financing coverage and decoupling health insurance coverage from employment.
In the GMCB’s first two full years of operation, there have been notable achievements, especially in
containing hospital budgets and insurance rates. Perhaps more importantly, the GMCB has established
processes and tools to guide the significant system-building work that will lay the groundwork for
implementing Green Mountain Care. After two cycles of regulating hospital budgets and health insurance
rates, and one cycle of reviewing Certificate of Need applications for major capital spending, the GMCB is
both containing health costs for Vermonters and drawing tighter connections between these previously
separate aspects of health care spending.
The Legislature assigned new responsibilities to the GMCB regarding health insurance rate review and
oversight of health data beginning in 2014. Taken together with the responsibilities previously assigned to
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the GMCB by Act 48, these additions provide the GMCB the perspective, the information, and the leverage
to accelerate progress toward a systematic approach to health care in Vermont. The GMCB has three
fundamental roles in order to achieve the twin goals of improving health and moderating cost: regulation,
innovation, and evaluation.
2.
Provide a check list of laws with a short summary of the general requirements of
each.
Vermont
Statutes
Act No. 48 of 2011: An Act Relating to a Universal and Unified Health System, among other things, created
the Green Mountain Care Board codified in scattered sections of the Vermont Statutes Annotated.
Vt. Stat. Ann. tit. 2, §§ 851 – 853: Health Care Oversight Committee
Vt. Stat. Ann. tit. 2, §§ 901 – 901:
Vt. Stat. Ann. tit. 3, § 2222a:
Joint Legislative Commission on Health Care Reform
Health care system reform; improving quality and affordability
Vt. Stat. Ann. tit. 8, §§ 4061 – 4100k: Health Insurance
Vt. Stat. Ann. tit. 8 §§ 8001 – 9409a:
Retirement Communities and Longterm Care Insurance
Vt. Stat. Ann. tit. 8, §§ 4511 – 4523: Nonprofit Hospital Service Corporations
Vt. Stat. Ann. tit. 8, § 4581 – 4595: Nonprofit Medical Service Corporations
Vt. Stat. Ann. tit. 12 §1042: Certificate of Merit Required in Health Care Negligence Cases
Vt. Stat. Ann. tit. 18, § 5: Duties of Department of Health
Vt. Stat. Ann. tit. 18, §§ 701 – 721: Chronic Care Infrastructure and Prevention Measures
Vt. Stat. Ann. tit. 18, §§ 1001 – 2503: Hospitals, Health Centers, Nursing Homes
Vt. Stat. Ann. tit. 18, §§ 4471 – 4474m: Therapeutic Use of Cannabis
Vt. Stat. Ann. tit. 18, §§ 4631a – 4632: Expenditures by manufacturers of prescribed products,
Disclosure of allowable expenditures and gifts
Vt. Stat. Ann. tit. 18, §§ 5281 – 5292: Patient Choice at End of Life
Vt. Stat. Ann. tit. 18, §§ 7201 – 8205: Mental Health
Vt. Stat. Ann. tit. 18, §§ 9351 – 9607: Unified Health Care System
Vt. Stat. Ann. tit. 18, § 9700 – 9720: Health Care and Decision Making
Vt. Stat. Ann. tit. 21, §§ 2000 – 2028: Health Care Fund Contribution
Vt. Stat. Ann. tit. 26 §§ 1441-1443: Peer Review Privilege
Vt. Stat. Ann. tit. 33, §§ 401 – 402: Department of Vermont Health Access
Vt. Stat. Ann. tit. 33, §§ 1801 – 1812: Vermont Health Benefit Exchange
Vt. Stat. Ann. tit. 33, §§ 1821 – 1900: Green Mountain Care
Vt. Stat. Ann. tit. 33, §§ 1901 – 2018: Medical Assistance (Including Medicaid, Vt. Health Access Plan,
Catamount Health Assistance, etc.)
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Vermont Regulations
Code
Agency
Code Vt. R. 13-010 Division of Rate Setting
Code Vt. R. 13-100 Office of Alcohol and Drug Abuse
Code Vt. R. 13-110 Department of Disabilities, Aging and Independent Living
Code Vt. R. 13-140 Department of Health
Code Vt. R. 13-140-013
Department of Health; Emergency Medical Services Rules
Code Vt. R. 13-140-036
Department of Health; Vermont Occupational Safety and Health
Review Board Rules of Procedure
Code Vt. R. 13-140-073
Department of Health; Maternal Mortality Review Panel Rule
Code Vt. R. 13-141 Department of Health; Board of Medical Practice
Code Vt. R. 13-150 Department of Developmental and Mental Health Services
Code Vt. R. 13-161 Office of Child Support
Code Vt. R. 13-170 Department For Children and Families (DCF)
Code Vt. R. 13-170-530
(VHAP) (5300)
Department of Children and Families (DCF); Vermont Health Access Plan
Code Vt. R. 21-040 Department of Financial Regulation; Division of Health Care Administration
Code Vt. R. 80-280 Administrative and Advisory Agencies; Green Mountain Care Board
Selected Case Law
State v. Rehkop, 180 Vt. 288, 908A.2d 488 (Vt. 2006) outlining procedure for in camera review of
privileged health records where due process requires disclosure.
Wheeler v. Central Vermont Medical Center, Inc., 155 Vt. 85, 582 A.2d 165 (Vt. 1989) upholding a
court’s refusal to require the disclosure of allegedly peer-review materials.
Robinson v. Springfield Hosp., Docket No. 1:09-CV-75, Ruling On Plaintiff’s Motion to Compel and
Motion to Amend (D. Vt. Feb. 05, 2010), narrowing the scope of the peer review privilege.
3.
Provide any special issues which arise in your jurisdiction.
Therapeutic
Use
of
Cannabis
(Vt.
Stat.
Ann.
tit.
18
§§
4471-4474m)
Vermont law established in the department of health the cannabis therapeutic research program. The
program enables physicians entitled to prescribe regulated drugs under chapter 84 of this title to
prescribe cannabis. The program is used only for treating cancer patients and for such other medical
uses as are prescribed by rule. The commissioner of health has the authority to obtain and be the sole
distributor for Vermont physicians of cannabis administered under this program. Distribution directly to
a patient may take place only pursuant to the instructions of a physician.
Patient Choice at the End of Life (Vt. Stat. Ann. tit. 18 §§ 5281-5292)
Vermont law allows physicians to prescribe lethal doses of medication to terminally ill patients in order
for the patient to end their lives. The legislation largely mirrors a similar law in Oregon for the first three
years and then shifts to a system with less government monitoring. The two key provisions of the bill
are found in section 5283 that establishes the fifteen requirements for legal immunity if a physician
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prescribes lethal doses of medication for a patient to self-administer, and in section 5285 that states a
physician shall not be under any duty, by law or contract, to participate in the provision of a lethal dose
of medication to a patient.
Lyme Disease (Vt. Stat. Ann. tit. 26, ch. 23, 28, 31, 33, 81)
In 2014, a law was passed that will require licensing boards to issue policy statements communicating
to licensees that the boards will not take disciplinary action against a physician, solely for the use of
medical care recognized by the guidelines of the Centers for Disease Control, the Infectious Diseases
Society of America or the International Lyme and Associated Disease Society for treatment of patients
who are clinically diagnosed with Lyme disease or other tick-borne illness. The policy will not preclude
board discipline for other unprofessional conduct that occurs when a practitioner follows the guidelines.
Pretrial Services, Risk Assessments, Medication Assisted Treatment (Vt. Stat. Ann. tit. 13, § 7554d)
The law establishes a process for risk assessments, needs screenings and referrals for substance
abuse treatment to be conducted at all stages of the criminal justice system. The screenings and
referrals are designed to identify and divert individuals from the traditional criminal justice response and
serve them through programs such as recovery support, restorative justice programs, communitybased treatment, rehabilitative services, case management and drug treatment.
4.
Are mobile health applications regulated under the law of your jurisdiction? If so,
provide a brief summary as to how they are regulated.
There are no Vermont-specific laws.
Contact Information
Elizabeth R. Wohl
Director, Health Law Practice Group
[email protected]
Downs Rachlin Martin PLLC
28 Vernon Street
Brattleboro, VT 05301
Tel 1.802.258.3070 Fax 1.802.258.4875
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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© 2016 Lex Mundi
International Guide on Health Industry Laws
Vietnam
Prepared by Lex Mundi member firm Tilleke & Gibbins Consultants Ltd
1. Provide an introduction on health law in your jurisdiction.
The health laws and regulations in Vietnam cover a wide range of areas, including: i) medical
examination and treatment; ii) pharmaceuticals; iii) health insurance; and iv) medical devices. In
addition, the health sector in Vietnam is a conditional business sector, i.e., businesses must meet
specific stipulated conditions before they are allowed to provide health products/services in
Vietnam. However, while businesses operating in medical examination and treatment,
pharmaceuticals, and health insurance require specific operation licenses issued by competent
authorities, businesses trading (selling or/and importing) medical devices can operate without such
licenses (please also see section 2.f below).
The following is a brief overview of the above-mentioned laws and regulations:
(i)
The laws and regulations on medical examination and treatment are designed to ensure that
all patients receive appropriate and equal treatment. They therefore set out many stringent
requirements for medical practitioners and medical examination and treatment establishments
regarding professional qualifications and ethical criteria.
(ii)
The aim of the laws and regulations on pharmaceuticals is to ensure the safety and quality of
drugs provided to users via strict state management of business activities in this area. All
pharmaceuticals circulating in the Vietnam market must be registered with and be approved by
the Ministry of Health (“MOH”).
(iii)
The health insurance laws and regulations regulate two kinds of insurance: social health
insurance and private health insurance. Social health insurance is a non-profit public fund
which is managed by the government, while private health insurance is provided by private
insurance companies. The government’s target is to have all Vietnamese citizens residing in
Vietnam be covered under the government’s social health insurance program. As of 2012, 67%
of the Vietnamese population participated in the program.
(iv)
The laws and regulations on medical devices are designed to ensure the safety and quality of
medical devices provided to users. Domestically manufactured medical devices must be
registered with and approved by the MOH before circulation. Imported medical devices must
be in a list of products permitted for import issued by the MOH and must obtain import permits
before circulation. Second-hand medical devices are prohibited from being imported into
Vietnam.
Relevant authorities:
−
The MOH is responsible for overall state management of the health sector (including all four
above-mentioned areas) in Vietnam.
•
The Drug Administration of Vietnam (“DAV”) under the MOH manages drug registration,
drug quality, business activities relating to drugs, and drug prices.
•
The Department of Medical Equipment and Health Works (“DMEHW”) under the MOH is
in charge of the state management of medical devices.
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−
Provincial People’s Committees are responsible for the state management of health activities
in provinces/cities.
•
−
Provincial/municipal Departments of Health are responsible for supporting provincial
People’s Committees in state management of health activities in provinces/cities, and are
subject to vertical management by the MOH.
Vietnam Social Security, which is an agency under the government, is responsible for the
implementation of health insurance policy and management of health insurance funds.
•
Municipal Social Security Agencies under Vietnam Social Security are responsible for the
implementation of health insurance policies and management of health insurance funds in
provinces/cities.
2. Provide a check list of laws with a short summary of the general requirements of each.
a. Laws and Regulations on Medical Examination and Treatment
Civil Code No. 33/2005/QH11 adopted by the National Assembly of Vietnam on 14 June 2005
(“Civil Code”)
Medical organizations are not allowed to refuse the treatment of people who suffer accidents or
illness. Medical organizations must make use of all available means and capacities to provide
treatment to such people.
Law on Medical Examination and Treatment No. 40/2009/QH12 adopted by the National Assembly
of Vietnam on 23 November 2009 (“Law on Medical Examination and Treatment”)
The Law on Medical Examination and Treatment stipulates the rights and obligations of patients,
medical practitioners and medical examination and treatment establishments. It requires medical
practitioners to have certificates of medical examination and treatment practice, and medical
examination and treatment establishments to have licenses for operation.
Decision No. 2088/BYT-QD of the Ministry of Health dated 11 June 1996 on Regulations on Medical
Ethics
This decision provides criteria for medical practitioners including professional and ethical criteria.
Decrees and circulars detailing and guiding the implementation of the Law on Medical Examination
and Treatment
•
Decree No. 87/2011/ND-CP of the Government dated 27 September 2011 detailing and
guiding a number of articles of the Law on Medical Examination and Treatment.
This decree regulates the organizational forms for medical examination and treatment; the
roadmap for licensing state medical examination and treatment establishments; the roadmap
for granting practice certificates for practitioners of state medical examination and treatment
establishments; and national technical regulations, quality control standards and accreditation
of medical examination and treatment establishments.
•
Circular No. 41/2011/TT-BYT of the Ministry of Health dated 14 November 2011 guiding the
granting of practice certificates to medical examination and treatment practitioners and
operation licenses to medical examination and treatment establishments.
This circular, as the name indicates, stipulates procedures for granting practice certificates and
operation licenses.
•
Circular No. 04/2013/TT-BYT of the Ministry of Health dated 21 January 2013 guiding the
approval and application of prices of medical examination and treatment services to state
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medical examination and treatment establishments managed by other ministries and branches
(i.e., other than the MOH).
The state medical examination and treatment establishments managed by other ministries and
branches include medical examination and treatment establishments of ministries, ministeriallevel agencies, governmental agencies, and state owned groups/enterprises.
•
Circular No. 14/2013/TT-BYT of the Ministry of Health dated 6 May 2013 guiding health checks.
This circular sets out the procedures and content of health checks, and conditions for medical
examination and treatment establishments.
b. Pharmaceutical Laws
Law on Pharmacy No. 34/2005/QH11 adopted by the National Assembly of Vietnam on 14 June
2005 (“Pharmacy Law”)
The Pharmacy Law regulates conditions for trading drugs. It requires that drugs must be registered
with the MOH for circulation in Vietnam. The Pharmacy Law also governs the advertising and
clinical trials of drugs.
Decrees and circulars detailing and guiding the implementation of the Pharmacy Law:
•
Decree No. 79/2006/ND-CP of the Government dated 9 August 2006 detailing the
implementation of a number of articles of the Pharmacy Law, amended and supplemented by
Decree No. 89/2012/ND-CP of the Government dated 24 October 2012.
This decree sets out the state policy on pharmaceuticals, state management of drug prices,
conditions for conducting business activities in pharmaceuticals, the list of drugs subject to the
special control of the state, and drug quality standards. The most important requirement to
conduct business activities in pharmaceuticals is that a person responsible for pharmaceutical
activities must have a “Pharmaceutical Practice Certificate” and a drug trading establishment
must have a “Certificate of Satisfaction of Drug Business Conditions”.
•
Circular No. 09/2010/TT-BYT of the Ministry of Health dated 28 April 2010 guiding the
management of drug quality.
Under this circular, drugs must comply with one of the following quality standards: (i) national
standards which are stated in the Vietnam Pharmacopoeia, or (ii) standards in the
pharmacopoeia of Europe, England, Japan, the U.S., or international pharmacopoeia, or (iii)
manufacturer standards which are equal to or higher than those which are stated in the abovementioned pharmacopoeia.
•
Circular No. 02/2007/TT-BYT of the Ministry of Health dated 24 January 2007 detailing the
implementation of a number of articles of the Pharmacy Law on drug-trading conditions and
Decree No. 79/2006/ND-CP, amended and supplemented by Circular No. 10/2013/TT-BYT
dated 29 March 2013.
This circular stipulates conditions for trading drugs; geographical areas for opening drugretailing establishments; practice certificates or qualification requirements for medical
practitioners; and prescribed forms for practice certificates and certificates of satisfaction of
drug business conditions.
•
Circular No. 47/2010/TT-BYT of the Ministry of Health dated 29 December 2010 guiding the
export and import of drugs and packaging directly in contact with drugs, amended by Circular
No. 45/2011/TT-BYT dated 21 December 2011 and Circular No. 38/2013/TT-BYT dated 15
November 2013.
This circular, as the name indicates, sets out conditions and procedures for export and import
of drugs and packaging in direct contact with drugs. This circular does not regulate
import/export via non-commercial channels for treatment purposes.
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•
Circular No. 19/2014/TT-BYT of the Ministry of Health dated 2 June 2014 guiding the
management of addictive medicines, psychotropic medicines and pre-substances used as
medicines.
•
Circular No. 13/2009/TT-BYT of the Ministry of Health dated 1 September 2009 guiding
activities for drug information provision and advertising, amended by Circular No. 45/2011/TTBYT of the Ministry of Health dated 21 December 2011.
Under this circular, the advertising of prescription drugs, vaccines, and biomedical products is
prohibited.
•
Circular No. 23/2013/TT-BYT of the Ministry of Health dated 13 August 2013 guiding on drug
processing.
This circular, as the name indicates, provides guidance on drug processing; the dossier to
register drug processing; and procedures for registration, suspension and withdrawal of
registration numbers of drug processing.
•
Decision No. 1570/2000/QD-BYT of the Minister of Health dated 22 May 2000 on the
application of the principles of "good laboratory practice", amended by Circular No. 45/2011/TTBYT of the Ministry of Health dated 21 December 2011.
•
Decision No. 2701/2001/QD-BYT of the Ministry of Health dated 29 June 2001 on the
application of the principles of "good storage practice", amended by Circular No. 45/2011/TTBYT of the Ministry of Health dated 21 December 2011.
•
Decision No. 3886/2004/QD-BYT of the Ministry of Health dated 13 November 2004 on the
application of the principles and standards of "good manufacturing practice" according to
recommendations of the World Health Organization, amended by Circular No. 45/2011/TT-BYT
of the Ministry of Health dated 21 December 2011.
•
Decision No. 799/QD-BYT of the Ministry of Health dated 07 March 2008 on the application of
the principles of “good clinical practice”.
•
Circular No. 03/2012/TT-BYT of the Ministry of Health dated 02 February 2012 on clinical trials.
•
Circular No. 08/2014/TT-BYT of the Ministry of Health dated 26 February 2014 on clinical trial
supporting activities.
This circular regulates, for the first time, activities of Contract Research Organizations (CROs)
and Site Management Organizations (SMOs).
•
Circular No. 22/2009/TT-BYT of the Ministry of Health dated 24 November 2009 regulating
drug registration, amended by Circular No. 45/2011/TT-BYT of the Ministry of Health dated 21
December 2011.
This circular provides for the registration of human-use drugs for circulation in Vietnam. It
requires drug applicant dossiers to be prepared in accordance with ASEAN Common Technical
Documents. This requirement is to implement Vietnam’s commitments of harmonization of drug
specification and quality in ASEAN. .
c. Health Insurance Laws
Law on Health Insurance No. 25/2008/QH12 adopted by the National Assembly of Vietnam on 14
November 2008, amended by Law No. 46/2014/QH13 adopted by the National Assembly of
Vietnam on 13 June 2014 and effective from 01 January 2015 (“Law on Health Insurance”)
The Law on Health Insurance requires compulsory participation in social health insurance by
Vietnamese citizens and stipulates six groups of participants for compulsory social health
insurance. They are: i) participants whose health insurance is partly paid by employers and partly
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paid by themselves; ii) participants whose health insurance is paid by a social security organization;
iii) participants whose health insurance is paid by the state budget; iv) participants whose health
insurance is supported by the state budget; v) participants who are households; and vi) participants
who are not under the previous groups and will be specified by the government.
The payment for medical examination and treatment services using social health insurance is made
by health insurance organizations to health service providers who have health insurance contracts
with the former. Such payment may be made directly to health insurance participants if: i) they use
the services of health service providers who do not have health insurance contracts with health
insurance organizations; or ii) the medical examination and treatment is not in accordance with
provisions under the law; or iii) the medical examination and treatment is overseas.
The social health insurance fund is financed by health insurance premiums, profits from
investments by the fund, financial aid from domestic and foreign organizations, and other lawful
revenues.
Law on Insurance Business No. 24/2000/QH10 adopted by the National Assembly of Vietnam on
9 December 2000, amended by Law No. 61/2010/QH12 adopted by the National Assembly on 24
November 2010 (“Law on Insurance Business”)
Private health insurance is classified as the insurance form for insured people who suffer injuries,
accidents, illness, or disease and whose health care is paid by insurance providers in accordance
with insurance contracts.
The Law on Insurance Business sets out general terms and conditions of insurance contracts
between insurance participants and insurance providers. Moreover, it regulates conditions and
procedures for enterprises to obtain licenses for establishment and operation in the field of
insurance from the Ministry of Finance.
Decrees and circulars detailing and guiding the implementation of the Law on Health Insurance
and the Law on Insurance Business:
•
Decree No. 45/2007/ND-CP of the Government dated 27 March 2007 guiding the
implementation of a number of articles of the Law on Insurance Business, amended and
supplemented by Decree No. 123/2011/ND-CP of the Government dated 28 December 2011
and Decree No. 68/2014/ND-CP of the Government dated 9 July 2014 (“Decree 45”).
This decree regulates insurance business activities, re-insurance business activities, insurance
brokerage activities and insurance agency activities. This decree does not apply to social
insurance, medical insurance, deposit insurance and other types of insurance not of a business
nature which are operated by the state.
•
Decree No. 62/2009/ND-CP of the Government dated 27 July 2009 detailing and guiding a
number of articles of the Law on Health Insurance.
This decree regulates health insurance premium payers; premium and support rates; payment
responsibilities and methods; levels of health insurance benefits; methods of payments for
costs of insured health care; and management and use of the health insurance funds.
•
Circular No. 10/2009/TT-BYT of the Government dated 14 August 2009 guiding the registration
of initial medical examination and treatment and the transferal to higher-level hospitals for
medical examination and treatment.
•
Joint Circular No. 09/2009/TTLT-BYT-BTC of the Ministry of Health and the Ministry of Finance
dated 14 August 2009 guiding the implementation of provisions on health insurance, amended
by Circular No. 24/2014/TTLT-BYT-BTC.
This circular provides more details on payers, rates and responsibilities for paying social health
insurance premiums; payers, rates and methods of paying social health insurance on a
voluntary basis; levels of health insurance benefits; organization of medical care covered by
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health insurance; payment of medical care costs covered by health insurance; and
management and use of health insurance medical care funds.
•
Joint Circular No. 39/2011/TT-BYT-BTC of the Ministry of Health and the Ministry of Finance
dated 11 November 2011 guiding procedures for payment of medical examination and
treatment expenses for health insurance participants with traffic accidents.
•
Circular No. 124/2012/TT-BTC of the Ministry of Finance dated 30 July 2012 guiding the
implementation of a number of articles of Decree No. 45/2007/ND-CP.
This circular guides the establishment and operation of enterprises providing life insurance,
non-life insurance, health insurance, re-insurance, and insurance brokerage, and branches of
foreign non-life insurance enterprises; business activities in life insurance, non-life insurance,
health insurance, re-insurance, insurance brokerage, and insurance agencies; and the
establishment and operation of representative offices of foreign enterprises providing life
insurance, non-life insurance, health insurance, re-insurance, insurance brokerage in Vietnam.
d. Laws on Medical Devices
Circular No. 07/2002/TT-BYT of the Ministry of Health dated 30 May 2002 guiding the registration
for circulation of medical devices (manufactured domestically).
A medical device manufactured in Vietnam must be granted a Circulation Registration Number
(CRN) in a Circulation Registration Certificate by the MOH before it is circulated in the Vietnamese
market.
Decree No. 187/2013/ND-CP of the Government dated 30 November 2013 detailing the
implementation of the Commercial Law regarding activities of international goods sale and
purchase, and sale, purchase, processing and transit of goods with foreign countries.
This decree prohibits importation of second-hand medical devices into Vietnam.
Circular No. 24/2011/TT-BYT of the Ministry of Health dated 21 June 2011 guiding the import of
medical devices.
•
Medical devices are defined as equipment, tools, supplies and chemicals, including necessary
software, used separately or in conjunction with one another by humans for the purpose of:
− preventing, examining, diagnosing, treating or mitigating diseases, or compensating
for injuries;
− examining, replacing, altering, or supporting surgery in the process of, and as a part
of, medical treatment;
− supporting or sustaining life;
− controlling conception;
− sterilization (except for medical and household chemicals, insecticides and antibacterial);
− medical transportation.
Because this definition seems vague, in many cases, manufacturers/traders must consult
with the DMEHW to get confirmation as to whether their products are classified as medical
devices.
•
Under this circular, medical devices may be imported without import licenses if: i) they are not
in the list of medical devices subject to import licenses granted by the MOH, and ii) they are
being imported for the first time but do not use any new diagnosis and treatment methods.
Otherwise, importers must carry out registration procedures for obtaining import licenses from
the competent authority.
Decision No. 36/2006/QD-BYT of the Ministry of Health dated 14 November 2006 on the
promulgation of regulations for clinical trials of medical devices.
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Under this decision, medical devices imported into Vietnam for the first time and using new
methods of diagnosis must undergo clinical trial in Vietnam to evaluate efficacy and safety.
This decision regulates the principles, conditions, dossier requirements, and the process to
conduct a clinical trial. It also provides the rights of sponsors, investigators and patients
involved in clinical trials and other ethical aspects.
e. Laws on handling violations of medical laws
Penal Code No. 15/1999/QH10 passed by the National Assembly of the Socialist Republic of
Vietnam on 21 December 1999 (“Penal Code”), as amended by Law No.37/2009/QH12 dated 19
June 2009.
Under the Penal Code, manufacturing counterfeit drugs or breaching regulations on medical
examination and treatment are violations of a criminal nature.
Decree No. 176/2013/ND-CP of the Government dated 14 November 2013
This decree provides specific provisions on penalties for administrative violations against medical
laws (including all four above-mentioned areas).
f. Commercial Law
Decree No. 59/2006/ND-CP of the Government dated 12 June 2006 on goods and services which
are banned from business, or subject to restrictions or conditions, amended by Decree No.
43/2009/ND-CP dated 7 May 2009
Under this decree, medical examination and treatment, pharmaceuticals, health insurance and
medical devices are conditional business areas. However, while businesses operating in medical
examination and treatment, pharmaceuticals, and health insurance require specific operation
licenses issued by competent authorities, businesses trading (selling or/and importing) medical
devices can operate without such licenses.
Decree No. 185/2013/ND-CP of the Government dated 15 November 2013 providing the penalties
for administrative violations in commercial activities, production of and trading in counterfeit or
banned goods, and protection of consumer rights.
This decree sets out penalties for administrative violations related to counterfeit drugs, and the use
of expired drugs or drugs of unknown origin.
3. Provide any special issues which arise in your jurisdiction.
•
Draft law amending the Pharmacy Law
The National Assembly is working on a new law amending the Pharmacy Law. The draft law
addresses five main issues: i) drug prices, ii) granting licenses for circulation of drugs, iii) clinical
activities related to drugs, iv) quality management of drugs, and v) deploying the project of
“Vietnamese [people] use Vietnamese drugs as a priority”. The draft law aims at facilitating
development of Vietnamese pharmaceutical products. The draft law was read for the first time
by the National Assembly in May 2014 and was planned to be approved by November 2014.
However, the schedule of approval of this new law has been changed and it is uncertain as to
when this new law shall be approved.
•
New draft decree on medical devices
Currently, the regulations on medical devices in Vietnam are incomplete to govern business
activities in this area. Therefore, the MOH has been working with relevant authorities since the
beginning of 2014 to draft a new decree to fill the gaps in legislation on medical devices. The
draft will propose new management methods relating to the registration for circulation of
medical devices and provide stricter conditions for manufacturing and trading medical devices
in Vietnam. The draft decree is scheduled to be approved by the Government in early 2015.
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•
Increasing the coverage of social health insurance
Law No. 46/2014/QH13 amending the Law on Health Insurance will come into effect on 1
January 2015. It will contribute to the increase in a number of participants in social health
insurance. This law specifies more groups of participants who are subject to compulsory
participation in social health insurance. Moreover, it raises the compensation rate for social
health insurance to attract more people to use social health insurance. It also broadens
sanctions on employees who fail to implement their obligations of contribution to the insurance
fund.
4. Are mobile health applications regulated under the law of your jurisdiction? If so, provide a
brief summary as to how they are regulated.
Under the Law on Information Technology No. 67/2006/QH11 adopted by the National Assembly
of Vietnam on 29 June 2006, the application of information technology in the healthcare sector is
encouraged. However, currently, there is no legislation regarding the use of mobile health
applications in Vietnam.
Contact Information
Michael K. Lee
Partner & Head of Corporate/Commercial
[email protected]
Tilleke & Gibbins
Suite 1206, Citilight Tower
45 Vo Thi Sau Street, District 1
Ho Chi Minh City, Vietnam
Tel +84 8 3936 2068 Fax +84 8 3936 2066
Firm Website http://www.tilleke.com/
This guide is part of the Lex Mundi Global Practice Guide Series which features substantive overviews of
laws, practice areas, and legal and business issues in jurisdictions around the globe. View the complete
series of Lex Mundi Global Practice Guides at: www.lexmundi.com/GlobalPracticeGuides
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