Download 3.6. Ensuring transparency in the area of drugs circulation and

Draft, 8 October , 2013
STATE DRUG POLICY
(2014-2020)
1
Draft, 8 October , 2013
Structure
Introduction .....................................................................................................................................5
I.
Situation Analysis ...................................................................................................................6
II.
Principles, Goal and Objectives of State Drug Policy .....................................................9
III.
Strategic Areas of Activity ............................................................................................... 10
1.
1.1.
Ensuring affordability of drugs and medical items ..........................................................10
System of drugs selection .................................................................................................11
1.2. Public procurements ...............................................................................................................12
1.2.1. State Benefits Program, Health Insurance Additional Drug Package –regulation of demand
through reimbursement mechanisms ............................................................................................. 13
1.2.2. Procurement of drugs and medical items for public health sector ......................................14
1.3. Regulation of Drug Pricing ....................................................................................................15
1.3.1. Reinforcing requirements for drugs and medical items wholesalers to reduce the supply
chain ..............................................................................................................................................16
1.3.2 Mechanisms of price regulation ...........................................................................................16
1.4. Rational Use of Drugs ............................................................................................................17
1.4.1. Introduction of Clinical Guidelines and Protocols and improvement of education system at
all levels on the issues of Rational Use of Drugs ..........................................................................18
1.4.2. Prescription Sale of Drugs ...................................................................................................19
1.4.3. Formation of adherence towards Rational Use of Drugs to fight against unethical
marketing of drugs in health care system workers and population of Kyrgyz Republic...............19
2. System of Drugs Circulation .....................................................................................................20
2.1. Improvement of ensuring of quality, safety and efficacy of drugs and medical items ...........20
2.1.1. Improvement of drugs regulation system to ensureequal therapeutic efficacy of
genericdrugs...................................................................................................................................21
2.1.2.Introduction of Good pharmaceutical practice standards (GPhP) ........................................22
2.1.3. Enforcement of Surveillance of pharmaceutical market .....................................................23
2.2. Improvement of the system of drugs and medical items supply ............................................24
2.2.1. Supply of narcotics and psychotropic drugs ........................................................................24
2.2.2. Supply of essential drugs with limited physical accessibility .............................................25
2.2.3. Disposal of unusable drugs ..................................................................................................26
2.3. Measures on elimination of Illicit drug sale and enforcement of sanctions for violation of
norms and rules.............................................................................................................................. 26
3. Improvement of management of drug circulation .....................................................................27
3.1. Formation of state policy in the area of drug circulation, based on clear vision, continuity
and feedback ..................................................................................................................................27
3.2. Removal of contradictions and gaps in the legislation ...........................................................27
2
Draft, 8 October , 2013
3.3. Institutional Strengthening .....................................................................................................29
3.4. Improvement of Human Resources ........................................................................................30
3.5. Development and implementation of the "Code of ethical conduct in the area of drug
circulation ......................................................................................................................................31
3.6. Ensuring transparency in the area of drugs circulation and introduction of monitoring of
pharmaceutical sector and drugs prices .........................................................................................32
3.7. Monitoring and Evaluation System of the State Drug Policy implementation ...............33
3
Draft, 8 October , 2013
List of Acronyms
ADP
Additional Drug Package
CPs
Clinical Protocols
DDS&ME
Department of Drug Supply & Medical
Equipment
EDL
Essential Drug List
GoKR
Government of the Kyrgyz Republic
HCO
Health Care Organization
HIF
Health Insurance Fund
HPAC
Health Policy Analysis Center
KR
Kyrgyz Republic
MHIF
Mandatory Health Insurance Fund
MIA
Ministry of Internal Affairs
MOH
Ministry of Health
OOPs
Out of Pocket payments/expenditures
RDU
Rational Drug Use
RMIC
Republican Medical Information Center
SBP
State Benefits Program
SDP
State Drug Policy
SSNC
State Service of Narcotics Control
4
Draft, 8 October , 2013
Introduction
The Constitution of the Kyrgyz Republic declares the right of every citizen to health
protection. Ensuring access to drugs as an integral part of public health protection is one of the
most important tasks of the State. Harmonious development of pharmaceutical sector is of great
social and economic importance for Kyrgyzstan.
The State Drug Policy (SDP) is an integral part of health policy on population health
protection and is being developed in the framework of systemic reforms of health care system of
the Kyrgyz Republic. This is a strategic document that defines principles, goals, objectives and
priorities, set by the Government in the area of drug circulation; it outlines the framework within
which the activities of public and private sectors, as well as all major participants of
pharmaceutical industry shall be coordinated.
The first SDP (1998) was adopted under the crisis in pharmaceutical sector, when the
centralized system of supply, public/state regulation and quality assurance of drugs has fallen
apart, resulting in severe shortage of drugs and import of substandard drugs into the country,
development of drugs black market, and collapse of drug prescription dispensing system. The
1998 SDP stipulated immediate measures to establish national system of regulation of drugs
circulation under the country's financial constraints and emerging private wholesale and retail
network of pharmaceutical sector. Subsequent SDPs of 2002 and 2007 were aimed at
implementation of next measures to ensure access to safe, effective and quality drugs and their
rational use.
This document is the fourth strategic document in the field of drugs circulation. It is a
product of development of the Interagency Working Group, established by the Ministry of
Health, with representatives of all relevant government agencies, civil society and experts,
pharmaceutical business as members to this Working Group, with the technical support provided
by World Health Organization. The fourth SDP was developed in the environment of the
growing interest on the part of civil society, Parliament, executive structures in the area of drugs
circulation. The development process was distinguished by transparency and was accompanied
by extensive consultations; the document has primarily taken into consideration the interests,
needs and expectations of citizens, balanced with the wishes of Health Care Organizations,
pharmaceutical services providers and other stakeholders.
Proper and full implementation of this SDP and the Plan of Actions will contribute to
implementing the objectives of the National health reform program "Den - Sooluk " for 20122016 on improvement of population health outcomes by selected priorities and significant
improvement of the key individual services quality.
5
Draft, 8 October , 2013
I.
Situation Analysis
In 1998 the Government of the Kyrgyz Republic (hereinafter KR) approved the first State
Drug Policy (hereinafter SDP), aimed at improvement of public health by improving access to
safe, effective and quality drugs. The SDP has already been revised twice to meet changing
priorities and health policy of the KR (2002, 2007). Due to completion of the latest SDP
implementation, it was evaluated, and the results of this evaluation enabled to identify areas for
further development of drug supply system, and formed the basic principles for the new SDP for
2014 - 2020.
Implementation of three SDPs is marked by substantial progress in the area of drug
circulation. The first State Drug Policy has established the framework for managing drugs and
medical items circulation, including both creation of the regulatory authority/body and
establishment of procedures and mechanisms (registration, certification, licensing, control and
analytical service, inspection). Under the SDP implementation, serious work has been done on
development and revision of the legislation, regulating relations in the area of drugs and medical
items circulation.
As part of the SDP implementation, and to reduce population’s expenditures, special
measures have been introduced, envisaging reimbursable (exempt) drug supply and promotion of
good practice of drugs prescription and their rational use: supply of drugs at ambulatory level
under the State Benefits Program (hereinafter SBP) and Additional Drugs Package of Mandatory
Health Insurance (ADP HIF), selection of drugs for the List of Essential Drugs List (hereinafter
EDL), development of clinical guidelines and clinical protocols (hereinafter CG/CP). Within the
framework of drug supply programs, prescription dispensing and administration of drugs under
generic names have been introduced.
Besides, foundations for geographical and physical availability of drugs have been laid;
the network of pharmacies has been significantly expanded, in rural areas included.
Principles of evidence based medicine (hereinafter EBM) and rational use of drugs
(hereinafter RDU) have been integrated into the curricula of medical education. Introduction of
information technologies (hereinafter IT) has been started at the level of the Department of Drug
Supply and Medical Equipment (hereinafter DDS&ME) (website, registers, etc.).
However, despite these accomplishments, topical problems still remain, especially as far
as affordability of drugs is concerned. Expenditures for drugs in the form of household general
out of pockets payments (hereinafter OOPs) per capita are the highest among all health
expenditures (Fig. 1).
6
Draft, 8 October , 2013
Fig.1.Per capita expenditures as OOPs by the levels of health services delivery (in Som)1
Ambulatory services, Drugs and Hospital services
800
700
667
2000
2003
600
2006
2009
470
500
400
335
300
247
172
200
100
42
51
168
164
94
81
112
0
Амбулаторные
услуги
Лекарственные
средства
Госпитальные
услуги
Source: CHS, 2011
Thus, during 2000-2009, inflation adjusted household expenditures on drugs have
increased by
almost 2 times. This increase was accounted for by high prices for drugs and excessive
consumption of drugs by population, associated with both improper drug prescription practice of
doctors, and increased scale of self-medication of the population. The situation is aggravated by
the lack of information on rational drugs use in population, OTC drugs sale, when virtually all
drugs can be freely purchased over the counter without prescriptions, with exception of narcotic
and psychotropic drugs, which are subject to national control.
The fact that medical professionals have low adherence towards Clinical
Guidelines/Clinical Protocols (CP) is obvious. There are issues on insufficiently clear
understanding related to general coordination, delineation of duties and responsibilities between
organizations, involved in development, evaluation and introduction of CG/CPs upon
administration of drugs for treatment. Health care organizations (hereinafter HCOs) do not
adequately introduce CG/CPs, promote RDU concept among physicians, that creates “no
alternative” information environment for unethical marketing of pharmaceutical companies;
availability of incentives/financial rewards for doctors, paid by pharmaceutical companies,
exacerbates the situation even further.
Introduction of drug cost reimbursement programs (State Benefits Program and
Additional Drug Package) is intended to reduce the financial burden of population related to
expenditures on drugs through reimbursement of part of the drug’s cost and observance of proper
drugs prescription practice, as well to reduce the number of hospital admissions by providing
drugs for treatment of conditions, effectively managed at primary health care level (PHC).
Analysis of these programs’ implementation indicated that there are barriers to their effective
implementation. Implementation of these programs indicates inadequate or insufficient use of
cheaper generic drugs. Use of cheaper generic drugs often faces resistance, as doctors and
patients believe that expensive drugs under trade names are more efficient and qualitative2. At
HPAC, Research Paper Document № 76, «Access to health services and patient’s Out of Pocket Expenditures in Kyrgyzstan:
Survey of Households for 2001-2010 », www.hpac.kg
2
HPAC, Research Paper Document №67, «Research of Factors, influencing on use of generics», 2009, www.hpac.kg
1
7
Draft, 8 October , 2013
the same time, high price of drugs is not a guarantee of the quality, but this belief helps
promoting expensive generic drugs under the trade names. The Mandatory Health Insurance
Fund (MHIF) data analysis indicated that only 30% of funds, allocated for reimbursement of
patients’ expenditures for drugs under the ADP HIF, actually are used for reimbursement of
drugs under generic names, and70% - for reimbursement of more expensive generics under the
trade names.
It should be noted that at present, prices for generic drugs under the trade names are not
much cheaper than the original drugs, and sometimes they are even higher, as the prices are
influenced by aggressive promotion of drugs by pharmaceutical companies.
Proper quality assurance/control of therapeutic efficacy of drugs remains as the matter of
utmost importance, as there is a probability of having generics with low efficacy at the market.
According to the findings of the survey/study of factors of generics use, about 60% of the
interviewed physicians believe based on the their experience, that the efficacy of cheaper
generics under INN is much lower compared to the one of expensive drugs under trade names.
Currently, over 5500 drugs have market authorization in the country, and the number of
registered drugs increases every year. Unfortunately, this factor is not indicating that all EDs are
accessible for population, as same/one group reproduced generics are mostly registered. As for
example, Diclofenac from 41 manufacturers and Ceftriaxone from 29 manufacturers are
authorized in our country. It was assumed, that such a large number of produced analogues will
promote reduction of prices, however, it did not happen due to aggressive promotion of drugs; on
the other hand, this fact hinders the choice of drugs both among physicians and patients. The
situation is aggravated by the lack of quite a number of necessary drugs at pharmaceutical
market; moreover, some efficient and cheaper drugs are washed out from the market due to
unjustified change of drugs prescription practice. Thus, review of the current EDL indicates, that
the List contains 51 names of drugs, which are nor registered in the KR (16%), and hence, can’t
be used on the country’s territory. In 2011, 63 names of drugs (15%) from the 2009 EDL were
not imported into the country3. According to experts, this situation reflects weak mechanisms of
drugs circulation and lack of active monitoring of registered drugs. It should be noted, that the
list of market authorized drugs in a number of developed European countries does not exceed
1000-2500 names.
The issues of quality of imported drugs remain topical, as according to the study on the
quality of drugs in pharmaceutical sector4, only 30% of the products were from the
manufacturers, which were audited by the World Health Organization (WHO) and EU for GMP
standards compliance, or were imported from countries with stringent regulatory authorities. The
study included 300 drugs from 33 INN (8.7% of the total number of drugs registered in 2008),
used for treatment of most common diseases, such as cardiovascular, communicable, ulcerative
diseases of gastrointestinal tract, i.e., representing more than 50% of the causes of morbidity and
mortality in the Kyrgyz Republic. No subsequent studies that would indicate improvement were
undertaken.
Besides, there are challenges related to the presence of forged and substandard drugs at
the market and their illegal sale, as surveillance system functions, stipulated by the current
legislation, do not permit conducting special professional inspections to the full extent.
3Research
4
Paper № 77 « Assessment of implementation & efficiency of the State Drug Policy of the KR for 2007-2010»
Quality of drugs in the sector of public procurements of the KR, WHO. 2008
8
Draft, 8 October , 2013
According to the findings of the independent study on the quality of drugs5 in pharmacies of
different regions of the country, 18% of drug samples on average, purchased in pharmacies for
testing/trials, did not have authorizations/certificates of the State regulatory body, i.e. most likely
were imported illegally into the KR.
With adoption of the Law "On the Fundamentals for Technical Regulation in the Kyrgyz
Republic" and the policy of the Government aimed at improvement of investment environment
and business support, a number of contradictions have emerged, hindering implementation of
supervisory functions over drugs circulation. If, in case of consumer goods, their efficacy and
quality are evaluated by the consumer, then drugs represent a special commodity, and the state
must ensure and guarantee not only safety of drugs, but such characteristics as efficacy and
quality, since health and life of the consumer depend on them.
Thus, there are a number of outstanding topical issues in the area of drugs circulation of
the KR. The most severe of them is the growing financial burden of population, directly related
to the expenditures on drugs and limiting their accessibility. Unethical marketing of
pharmaceutical companies, including active advertisement of drugs in mass media, contributes to
further rise in prices for drugs, excessive consumption of drugs among population, both
administered by doctors, and as a result of self-medication. Needs for further improvement of
registration process in relation to safety, efficacy and quality of drugs remain in the area.
Problems also persist in promoting principles of rational use of drugs in health care. Weakness of
institutional capacity of management bodies in the sphere of drug circulation compounded by
unceasing revisions of regulatory body, which is time and effort consuming, results in inadequate
coordination and transparency in this area, poor interagency cooperation and contradictions in
the current legislation.
II.
Principles, Goal and Objectives of State Drug Policy
Principles:
• Continuity of health care reforms policy;
• Focus on ensuring equity in access to essential drugs for population, especially for vulnerable
populations;
• Recognition of drugs as special type of products, influencing on people’s health, the quality and
efficacy of which can’t be objectively assessed either by the patient or by the doctor, prescribing
drugs;
•Continuous support of the Policy of generics use;
• SDP with focus on ethical standards;
• Transparency at all stages of drug circulation;
• Wide involvement of all stakeholders into the process of formation, implementation, and
evaluation of policy and feedback in the field of drugs supply.
5
Quality of drugs in the KR, Report on the Study of Pharmaceutical Market of the KR for presence of counterfeit and substandard drugs using
Minilab, 2010
9
Draft, 8 October , 2013
Goal:
Ensure accessibility of essential, safe, effective and quality drugs for the citizens of the
Kyrgyz Republic and their rational use.
Objectives:
•












III.
Ensuring affordability of essential drugs and medical items;
Ensuring presence on the market of safe, effective and high-quality generic drugs of
clinical efficacy, equal to that one of original drugs;
Enforcement of responsibility and role of MOH in coordination of the SDP and
optimization of the structure for dug circulation management;
Ensuring efficiency and transparency of drug procurements at all levels of health care;
Development of efficient pricing policy;
Development of response measures to aggressive and unethical promotion of drugs and
medical devices;
Prescription dispensing of limited list of drugs;
Ensuring physical accessibility of all drugs , included into the EDL;
Promotion and introduction of the rules of good pharmaceutical practices (GLP, GCP,
GMP, GDP, GPP);
Ensuring efficient and timely post-marketing control of safety, efficacy and quality of
drugs;
Ensuring coordination of activities of interested government agencies in the area of fight
against illicit market of drugs and medical items (MI);
Ensuring transparency of drugs and MI circulation through building of single
information system;
Strengthening of cadre capacity in drugs circulation area.
Strategic Areas of Activity
1. Ensuring affordability of drugs and medical items
The key objective of this SBP is improvement of economic affordability of drugs through
refining existing procurement procedures and practices to implement internal economy reserves
and rationalize expenditures, impacting on demand for drugs, as well as supply of drugs through
introduction of new approaches of state influence on prices.
It is proposed to regulate the demand for drugs through:
-
implementation of efficient strategy for selection of essential drugs and increase of
demand for cheaper generics, under the condition of equal clinical efficacy;
rationalization of practices of drugs use;
improvement of drugs benefits program;
optimization of the system of public procurements of drugs.
10
Draft, 8 October , 2013
The system of state influence on prices will be determined by the presence of weighted
pricing policy regarding pharmaceutical industry to provide affordable prices for drugs,
especially for the ones, included into the EDL.
1.1. System of drugs selection
Under the conditions of low-budget and financial burden of the citizens in drug supply, in
1996 Kyrgyzstan has recognized the Concept of essential drugs, formulated by the WHO in
1975. To reduce expenditures on inefficient types of medical care and focus on providing equal
access to the most effective and safest science-evidence-based drugs within the existing
resources, the Essential Drugs List (EDL) was developed, which is updated and approved by the
Government of the Kyrgyz Republic on a regular basis.
Systematic update of the EDL by eliminating obsolete, irrelevant, unnecessary, less
efficient and less safer drugs and by including cost-effective products with the best proven
therapeutic effect and safety profile, enables to organize supply of drugs from the perspective of
the patient and the real status of economy of the Kyrgyz Republic.
Unfortunately, there is the probability of including unproven and ineffective drugs into
the EDL due to imperfect processes of drugs selection for the EDL. Poor adherence and
inadequate knowledge of professionals, involved into selection of drugs, decrease quality of the
EDL.
Since the state policy implies supply of the citizens with drugs primarily from the EDL,
which is the basis for all drugs programs to be implemented in KR, as well as for public
procurements, it becomes important to ensure high quality of the EDL. Inclusion of drugs into
the EDL should be the result of competitive selection with the main criteria of safety, proven
clinical efficacy and cost-effectiveness. At that, epidemiological situation in the country and
health care priorities should be taken into account.
Hospital lists of procured drugs are formed independently by hospitals but are based on
the EDL. To improve access to drugs given the local and specific needs, it is allowed to include
up to 20% of drugs on the hospital list, which are not included into the EDL. At that, the amount
of funds, allocated for procurement of these additional drugs, is not regulated currently. This can
lead to unjustified and irrational use of resources.
Under this SBP, it is proposed to form the drugs selection system and form the EDL
based on the following principles:
• Social equity, equal access to basic health care. Drugs, used for treatment of socially significant
diseases, should be primarily included into the EDL, as they impose the highest burden on the
state, society and individual.
• Selection, based on proven clinical value and safety, taking into account cost-effectiveness.
Evidence-based drugs and effective drugs, selected according to the established objective
medical standards, shall be included into the EDL and other drug lists. These are the drugs for
treatment and prevention of diseases, which are really safe and beneficial, as confirmed by
credible scientific evidence and international medical practice.
• Transparency and involvement of general public into drugs selection process. The developed
evaluations and justifications for decisions/conclusions on selection of drugs should be open and
11
Draft, 8 October , 2013
widely available for public review, discussion, criticism and administrative appealing.
Improvement of the procedures for selecting drugs should be carried out through development of
necessary regulatory and comprehensive regulatory and logistics documents in the framework of
legislation. While developing restrictive drugs lists or formularies, it is necessary to minimize the
possibility of abuse and reinforce responsibility for decision-making. To eliminate distortions in
evaluations and opinions/conclusions, organizations and professionals, performing evaluation,
selection and procurement of essential drugs(ED), should make decisions without involving
people with potential conflict of interests, for example, specialists, associated with drug
manufacturers and distributors.
• Drug programs, envisaging partial reimbursed of the drugs cost, shall be based on the EDL.
• Procurements of drugs from the state budget shall be made on the basis of the EDL. It is
allowed to include up to 20% off the EDL drugs to the hospital lists; however, these drugs
should have evidence of clinical efficacy, safety, cost-effectiveness and documented
confirmation/justification of the necessity to be included into the list of procured drugs due to the
local or specific characteristics of health care organization. In addition, the amount of funds to be
allocated for procurement of drugs off the EDL, should be regulated.
Concept of essential drugs selection will be developed, which will outline comprehensive
and coherent system of drugs selection in the KR for all health care levels, as well as define the
place and role of all participants, involved in the selection process, taking into account the
potential conflict of interests, criteria for inclusion/exclusion of drugs and the procedures for the
EDL compilation and revision/updating in compliance with WHO expert committee
recommendations, and given the KR health care system priorities, pharmacovigilance and postmarketing control data. The process of formation of hospitals lists of drugs, lists of drugs for
drug exemption programs, and other drugs lists will also be regulated.
It would be necessary to train professionals, participating in drug selection (members of
the National Drug Committee, Committees on Quality and Safety of health care in HCOs) in the
principles and methods of essential drugs selection and critical evaluation of medical
information, search for evidence and making calculations of cost-efficiency of drugs.
1.2. Public procurements
The KR Government is the largest purchaser of drugs and medical items in the
pharmaceutical sector, as it procures drugs and medical items in Health Care Organizations
(HCO) and reimburses expenditures for drugs under the ADP HIF and SBP programs. It is
estimated, that the share of public drug procurements makes about 30% of the total volume of
retail sales of pharmaceutical market. In its search for ways to improve economic affordability of
essential drugs for the public, the state might influence on the prices of drugs in exchange for
guaranteed sales, i.e. offering win-win conditions for all market participants. Also, one of the
most efficient ways to reduce prices for drugs and MI is ensuring transparency of procurements
process, including data on prices and amounts of procured drugs and MI. In general,
implementation of the principles of transparency, accountability and integrity in public
procurements will lead to reduction of health expenditures and improvement of affordability of
essential drugs. Under these conditions, the choice of interventions for implementing the
capacity of the largest purchaser in the sector should be based on a balanced, well-thought, fair
and responsible approach, without detriment to scrupulous market participants.
12
Draft, 8 October , 2013
1.2.1. State Benefits Program, Health Insurance Additional Drug Package –regulation of
demand through reimbursement mechanisms
Introduction of the system of reimbursed drugs supply of the KR citizens on outpatient
basis under compulsory health insurance has become the key element in solving the issues of
poor access of citizens to treatment with modern effective drugs. The main tool in drug supply
system is reimbursement of a significant part of drug’s cost by the Government.
The country has the experience in implementing program of drug cost reimbursement
supply - Additional Drugs Package and drugs supply under the SBP, where the function of the
primary payer and purchaser is played by the MHIF under the KR Government. Selection of
drugs, sold under the drug reimbursement supply programs, is made from the drugs, included
into the EDL and is based on the MOH strategy on identification of priority diseases, including
monitored diseases in the country, clinical protocols on case management and price factor. But
methodology and criteria for selection of drugs in the framework of reimbursement programs are
not developed.
Contractual process between the insurer and suppliers/providers of pharmaceutical
services does not cover the issues of drugs pricing. Lack of transparent information system of
monitoring over prices does not enable doctors and patients to know prices for drugs.
Meanwhile, the exempt drug programs, if properly regulated, might have a great impact on
curbing population’s expenditures on purchasing of drugs and improving affordability of drugs
for people, especially for socially vulnerable groups. Unfortunately, funds, annually allocated for
these programs, are not fully used for various objective and subjective reasons. Besides,
population is either poorly informed or does not always have access to the drugs reimbursement
programs. Local governance bodies are weakly involved into the issues of pharmaceutical
network development and implementation of these programs. The current programs of target
social assistance in Bishkek city to supply socially vulnerable population groups and chronic
patients with drugs require coordination with state programs of drugs exempt programs as far as
approaches and mechanisms of implementation are concerned.
To strengthen the role of state drug supply programs on outpatient basis, as one of the
factors, containing population expenditures, the principles and mechanisms of drugs exempt
programs will be revised, including criteria for definition of the population exempt groups.
Contract relations with pharmaceutical services providers will be improved with clear
delineation of rights and duties of both parties, development of financial incentives for pharmacy
facilities to contain prices for drugs.
Drugs exempt programs should be developed under the conditions of transparency and
accountability, wide information of patients and physicians through involvement of mass media,
radio and TV, public awareness campaigns and creation of information platforms on drugs’
prices.
13
Draft, 8 October , 2013
1.2.2. Procurement of drugs and medical items for public health sector
Public procurement system has all the health problems, identified in the Government's
strategic document6 on improvement of public procurement system, namely, imperfect legal and
regulatory framework, regulating all stages of public procurements process, low capacity of
forecasting/planning the range of products of procuring entities, the volume of goods, volumes of
works and services, and procurement methods, insufficient qualifications of members of tender
committees, responsible persons in purchasing organizations, as well as existing cases of
corruption offenses in the public procurement process, lack of awareness of potential suppliers
about the ongoing public procurement and increase of their access to them, lack of an automated
monitoring system and analysis of the use of budget funds, allocated for public procurements.
The above problems are compounded by the fact that the pharmaceutical product, having s its
own specific features due to the property, affects the health of people. Health care organizations
should be able to select the most effective drugs, taking into account clinical experience,
information about side effects and cost of treatment that requires special approaches.
To select priority drugs and reduce the amount of procured drugs with lower economic
efficiency, it is necessary to use such techniques, as «VEN / ABC-analysis."
It is a common practice in line with international standards to conduct a preliminary
selection of reliable suppliers of high quality products in order to prevent supply of sub-standard
and counterfeit drugs and medical items.
Drugs and medical devices have a limited shelf life, specific requirements for transport
and storage, which determines the need for a coherent system of inventory management and
supply of drugs and medical devices to ensure uninterrupted supply without accumulation of
excess stocks.
Kyrgyzstan lacks the system of control and monitoring of drug procurements for the
entire supply chain in health care organizations. The lack of transparency in the conduct of
procurement procedures is a serious threat to the system of supply of drugs and medical devices,
as it increases the risk of purchasing drugs and medical items of low quality at high prices due to
the impact on the procurement processes of various interest groups.
In most health care organizations, the process of formation of bids and bid evaluation
involves experts who do not have the appropriate competence. It is necessary to engage
professionally trained staff for preparing specifications for tender documents and procurements.
The documents related to procurements or tenders should indicate INN or other common names
of drugs and medical devices.
Health sector reforms aimed at giving greater autonomy to health care organizations,
require application of different approaches and their combination for procurement of drugs and
medical devices, such as:
• Independent procurements of health care organizations that shall cover most of their
needs for drugs and medical items
6
Resolution of the Kyrgyz Republic Government «On Approval of the Strategy for development of public procurements in the Kyrgyz Republic
for 2012-2014» №661 as of 27 September 2012, Bishkek
14
Draft, 8 October , 2013
• Group procurements of health care organizations, united by territory principle or by
levels of health care organizations (commonly used by all health care organizations to procure
drugs in large quantities)
• Centralized procurements at the national level (following the List, defined by the KR
MOH)
• Procurements through framework agreement procedures, which shall be applied at the
central level by the Ministry of Health in cooperation with MHIF towards limited, coherent set
of drugs and medical items. The framework agreement is declaration of intent to purchase
specific goods from the group of purchasers, the estimated value of the summarized needs with
no obligation to purchase them. The supplier shall offer products at the specified prices
depending on individual needs, terms of payment, terms of delivery, delivery point. Health care
organizations conclude individual contract with supplier without additional rechecking and
modifications based on the framework agreement terms.
• Procurements through UN agencies and other international organizations that specialize
on procurement of specific goods (vaccines, drugs for treatment of tuberculosis, HIV/AIDS,
malaria)
Under this SDP and Strategy for development of public procurements for 2012-2014,
comprehensive measures will be taken to improve the system of public procurements; a package
of regulatory and legal documents has been developed to regulate public procurements, taking
into account specific characteristics of pharmaceutical products and peculiarities of organization
of procurements by HCOs, based on the principles of transparency and accountability.
Planning/forecasting of drugs and medical items should be based on the VEN / ABC-analysis;
management of all stages of the procurement cycle should be automated and integrated with the
accounting 1C program in health care organizations and the system of electronic public
procurements. Introduction of monitoring of drug and medical device procurements is an
important mechanism of influence on procurement practices and improvement of efficiency of
limited public funds distribution. Special attention should be given to development of human
resources on procurements management at all levels, including the issues of development and
evaluation of technical specifications.
Actions will be taken to ensure strict compliance with all procurement procedures.
Strengthening of public control is an important condition for rationalization of public funds
spending, reduction of corruption risks and ensuring openness and transparency of public
procurements. For this purpose it is necessary to ensure participation of representatives of civil
society and NGOs in the procedures of procurements and access to detailed information on the
tender procurements on the websites of MHIF, MOH, Ministry of Finance, which will enable to
track the volumes of procurements and the prices for drugs.
1.3. Regulation of Drug Pricing
The Kyrgyz Government policy focuses on formation of market economy and
competitive environment, that’s why pharmaceutical market sets prices independently,
proceeding from the population demand and purchasing power. The specificity of
pharmaceutical market is its limited capacity, making it nonresistant to violent price fluctuations,
implying supply interruptions resulting either in deficit or overstock of drugs and medical items.
15
Draft, 8 October , 2013
Low level of IT development and lack of continuous monitoring of prices for drugs in
pharmacies does not enable to aggregate and analyze prices at the pharmaceutical market.
Population "out of pocket" expenditures for health has increased by 3.5 times over the
last 10 years, from 1.5 billion Soms in 2000 up to 5.6 billion Soms in 2009; in the structure of
expenditures, 60% fall on drugs7. In the expenditures structure of people over 50 years of age,
expenditures for drugs make about 1/3 of their income, which largely affects the socio-economic
and psychological situation of low income groups of the population8.
This situation in the pharmaceutical market indicates that there is a long-felt need to
introduce mechanisms of the state influence on pricing processes through: a) reduction of
suppliers’ chain, b) mechanisms of pricing for drugs and medical items from the EDL.
1.3.1. Reinforcing requirements for drugs and medical items wholesalers to reduce the
supply chain
Currently, there are about 300 pharmaceutical suppliers on the local pharmaceutical
market.
Abundance of drug wholesalers leads to the fact that the total volume of trade
markups/margins (wholesale or retail) from the moment of the drug enters the country to the
stage it is sold to the main consumer, varies widely compared to the purchased price.
To address this issue, regulations or standards have to be improved, as well as licensing
requirements, aimed at reducing the number of wholesale firms to the optimum level, given the
limited capacity of the pharmaceutical market in the KR. Bona fide or conscientiously operating
wholesalers should stay on the market, the ones, who observe the appropriate rules and maintain
high professional standards of safety, quality and high level of competence of pharmaceutical
sector workers - pharmacists. All stages of drugs delivery to the consumer require observance of
strict professional standards. At the same time, the rules of wholesale should be enforced,
monitoring of activity of wholesale pharmaceutical suppliers should be developed as well.
1.3.2 Mechanisms of price regulation
Selection of pricing policy should be based on continuous monitoring of prices for drugs
and medical items. The main directions of the pricing policy should be based on internationally
recognized and most effective ways of regulating prices for drugs and medical items and should
be pursued through: (a) government control of taxes, duties and other markups on drugs and (b)
establishment of mechanisms for price regulation.
Drugs and medical items under the Lists, defined by the Government (EDL and other
lists of medical equipment, including supplies and commodities, reagents and pharmaceutical
substances) should not be subject to value added tax (VAT) and other taxes and duties that affect
the increase of their cost.
Price regulation in pharmaceutical sector should be done through:
HPAC: CHS, NHA – 2009.
Policy Research Paper No 77 “Evaluation of implementation and efficiency if the SDP for 2007-2010”, HPAC.
7
8
16
Draft, 8 October , 2013



Regulation of trade margins/markups (wholesale and retail) for drugs, taking into account
geographical and socio-economic criteria,
Development and introduction of mechanisms of internal reference prices for drugs,
included into the EDL. Reference pricing is part of a comprehensive national system of
reimbursement of expenditures of citizens for purchasing drugs. It is inextricably linked
to the implemented programs on drug exempt supply of citizens on ambulatory level,
introduction of GMP international standards, development of regulatory tools,
mechanisms and culture of rational drug use, sustainable market infrastructure, adequate
funding. The system of internal reference pricing envisages establishment of the limit
state reimbursement rate for drugs.
Regulation of prices for drugs, included into the EDL through contracts between
MOH/MHIF or group of health care organizations on the one hand and pharmaceutical
suppliers on the other -through setting the limit prices for drugs for a certain period of
time. The amount of procurements and payment terms shall be determined independently
by each health care organization, based on its needs and financial capacities.
Development of information technologies and continuous monitoring of prices for drugs and
medical devices at all levels is a prerequisite for introduction of the state regulation of prices.
Under the state reimbursement programs, it is necessary to further improve information systems
on recording of drugs and medical items, dispensed through pharmacies network and subject to
reimbursement. This includes creation of single information network between the MHIF and
pharmaceutical institutions to ensure transparency and improve mutual accountability of all the
structures, formation of a sustainable system of monitoring of drugs prices by specific groups,
sold under these programs, as well as ensuring free access to the database on drugs retail price
for public.
1.4. Rational Use of Drugs
Administration of unjustified large number of drugs while ignoring their interaction
(polypragmasy), as well as population behavioral stereotype to take drugs without prescriptions,
have become a topical issue in the KR.
According to the studies, conducted in the KR’s hospitals in 2009, patients receive 7-8
drugs per treatment course on average, and the maximum number reach up to 29 drugs per
patient’s treatment course. According to the studies, simultaneous consumption/use of 2 drugs
leads to adverse drug interactions in 6% of patients, 5 drugs - increases their incidence up to
50%, and taking of 10 drugs increases the risk of side effects or adverse reactions up to 100%. It
should be noted that consumption/use of several drugs makes prediction of their pharmacological
and adverse effects more difficult. Besides, polypragmasy leads to unjustified expenditures of
patients, which have negative effect on the families’ budget.
Irrational use of drugs is caused by inadequate level of knowledge of physicians in the
area of RDU, inadequate introduction or lack of implementation of CG/CPs, aggressive
marketing by pharmaceutical companies, administration of drugs, particularly injectable, at the
patients’ request/demand, poor public awareness about drug safety, free sale of drugs subject to
prescription sale only.
17
Draft, 8 October , 2013
The latest studies, carried out in Kyrgyzstan, indicate that 100% administration of
injectables to children was observed in hospitals of the country, as well as irrational use of
antibiotics, implying incorrect selection of drugs, duration of treatment course and unjustified
administrations of drugs9; while at ambulatory health care level, every fourth patient purchases
drugs in pharmacy without physicians’ prescription10.
To address problems of irrational use of drugs, under this SDP it is proposed to create
sustainable system of development and implementation of CG/CPs, providing sale of drugs by
prescription from prescription list, improvement of pre-and post-diploma education in RDU
issues and continuous training on RDU, ensuring prescription dispensing of prescription drugs,
measures to change people's attitude to irresponsible use of drugs through mass media.
1.4.1. Introduction of Clinical Guidelines and Protocols and improvement of education
system at all levels on the issues of Rational Use of Drugs
Up to date, the following measures have been implemented: "Methodology for
development of evidence based clinical guidelines" was approved; process of review and
approval of CG/CPs have been improved. However, the activity on development of CG/CPs is
limited, mechanisms for their introduction have not been worked out, i.e. the Coordinating body,
procedures, instructions for CG/CPs development have not been approved yet; the capacity of
expert bodies is not adequate; timely publication, dissemination and training in CG/CPs have not
been worked out yet; there is no proper monitoring of introduction of CG/CPs and financial
support of the entire process of their development and introduction. Ignoring any of these stages
undermines the entire previous process. Each stage should follow a strict methodology.
Introduction of CG/CP into clinical practice should be accompanied by the most efficient
scientifically-justified methods of introduction taking into account the needs of the target
audience and local conditions.
The most important factor in the success of introducing CG /CP is training of health
workers at all levels – pre-in- and post-diploma – continuous skills upgrading – in RDU
principles and clinical protocols. By now, principles of evidence based medicine (EBM) and
rational use of drugs (RDU) have been integrated into the curricula of medical education; a new
specialty "Clinical Pharmacologist" has been introduced into higher medical education. Problems
like lack of effective integration of the revised CPs into the educational process at pre-and postdiploma levels, including skills upgrading persist; not all practitioners are trained in current CPs;
the activity of Quality Committees under HCOs is still inadequate.
The necessity has emerged to create a sustainable system for development,
implementation and monitoring of CG/CPs and their further promotion in health and education
systems of the Kyrgyz Republic. Educational standards in the field of professional and postdiploma training to train medical and pharmaceutical professionals will include the issues of
rational use of drugs, pharmaco-economic analysis, further strengthening of generics conception
and ethical promotion of drugs. The activity of Quality Committees in HCOs is the key
component and shall be activated in the area of RDU, pharmacovigilance, substitution of drugs
and critical evaluation of information, received from pharmaceutical companies.
9
Policy Research Paper №68 «Situation Analysisof justification of hospitalization of children under 5 and pregnant women», HPAC, Bishkek
2009
10
Policy Research Paper №67, «Study of factors, influencing on use of generics», HPAC,2009
18
Draft, 8 October , 2013
1.4.2. Prescription Sale of Drugs
Prescription sale of drugs is aimed at limiting uncontrolled use of drugs by population,
especially antimicrobial drugs. To date, despite the relevant legal documents, drugs sale only by
prescription does not work in full degree. Today any drug can be freely purchased in the KR
pharmacies without prescription, with the exception of narcotic and psychotropic drugs, and
potent drugs subject to the national control. Failure to comply with the rules of prescription sale
of a number of drugs, especially anti-microbial ones, potentially endangers the health of every
citizen and society in general. According to the analysis of data on the total consumption of
antibiotics for the 2011, Kyrgyz Republic takes the seventh place among 33 Eurasian region
countries, which participated in the global survey. At that, 46.8% of the country’s population
take antibiotics on their own, without any prescription11., while in countries with a strong
regulatory system of drugs circulation, antibiotics can’t be purchased without prescription. This
results in leads to the situation when uncontrolled use of antibiotics leads to drug-resistant forms
of microorganisms (not only bacterial, but viral, and fungal); in addition, it increases the number
of complications from improper therapy, improper self-medication and non-adherence to dosage.
The studies, conducted in the KR, have shown 100% resistance of typhoid fever germ and 93%
of resistance of Salmonella germs to Ampicillin, which indicates the growth of microbial
resistance to antibiotics12. The society may go back to the era when there antibiotics were not
available, and when even a simple infection could mean a death sentence to the patient.
Within the framework of this document, it is proposed to restore the prescription sale of
drugs. In this case, it is proposed to change approaches through development of a limited list
drugs to be sold through prescription. Introduction of this list should be accompanied by
reinforcing of measures of administrative influence, necessary trainings of specialists, wide
general activity on notification of population.
Introduction of mandatory prescription sale of drugs from the specific drugs list may
result in increased pressure on reimbursement programs, so it would be necessary to evaluate this
intervention and take appropriate actions, for example, exclusion of antibiotics from the list of
drugs under the HIF Additional Drug package Program, except for children under 5.
1.4.3. Formation of adherence towards Rational Use of Drugs to fight against unethical
marketing of drugs in health care system workers and population of Kyrgyz Republic
Improper unethical promotion of drugs by pharmaceutical companies leads to excessive
use of drugs. In Kyrgyzstan most of physicians receive information about drugs, primarily from
pharmaceutical companies, and not from independent sources. According to the results of the
research, despite the a number of steps taken by the Ministry of Health to restrict the activities of
pharmaceutical companies in health care organizations, 90% of the interviewed doctors reported
that they met with representatives of private pharmaceutical companies during the last year, and
42% say that the frequency of contacts is at least 1 time a month13.
As in many countries, excessive administration of expensive drugs is observed in the KR,
caused by an extremely aggressive marketing. Expensive drugs are the ones which are primarily
promoted to the market, promotion cost of which is already included into the price of drugs,
11
Momunova. А. Peculiarities of use anitmicrobal drugs for respiratory organs diseases. Central Asian-Medical Magazine 2003; 9: 208-210
Program for containment of resistance to anti-microbal drugs in the Kyrgyz Republic for 2009-2012, Decree №660 as of 22.09.2009
12
13
Policy Research paper № 77 « Evaluation of implementation and efficiency of the State Drug Policy of the Kyrgyz republic for 2007-2010»,
HPAC, Bishkek, 2012
19
Draft, 8 October , 2013
making them unreasonably expensive. Pharmaceutical companies are engaged in all kinds of
activities to promote their products, including all marketing tools, such as: dissemination of
information materials and organization of presentations, distribution of free samples of drugs and
accruing bonuses, as well as uncontrollable drug advertising in mass media.
RDU is the most important mechanism of counteraction against unethical marketing.
Therefore, measures will be taken under this policy aimed at further introduction of RDU,
building of single information –reference system on reliable methods of treatment and
characteristics of drugs for health and pharmaceutical workers, enforcement of requirements
towards knowledge of RDU during attestation of health and pharmaceutical workers,
development of indicators on performance and activity of HCOs.
One of efficient tools of countering aggressive marketing is provision of objective
systematized information on drugs in the format of the national formulary of the main drugs. It is
necessary to determine the status of the national formulary, institutionalize the process of its
development and implementation in practice, with identifying sources of funding.
Implementation of programs to counter unethical marketing through provision of independent,
reliable information on drugs for health professionals and population requires cooperation with
local administrations and self-governance bodies, development of measures to strengthen the
responsibility of advertisers, advertisements disseminators for placing/publishing information
about drugs without proper authorizations and permits.
2. System of Drugs Circulation
2.1. Improvement of ensuring of quality, safety and efficacy of drugs and medical items
In the framework of the KR Law "On drugs”, the state system for ensuring safety and
quality of drugs has been formed, which includes the following stages:
- State registration;
- Licensing of pharmaceutical activities of pharmacies;
- Evaluation and attestation/confirmation of conformity of drugs and medical devices;
- Pharmaceutical inspection (supervision);
- Pharmacovigilance.
The above procedures are designed to ensure quality, efficacy and safety of drugs and
medical items through the entire chain of their circulation: manufacturer - wholesale - retail link /
health care organization - consumer/patient. During the last few years, efforts were invested into
comprehensive improvement of the system of state control of drugs and medical items quality
and its institutional reinforcement. Thus, due to the entry of the Law "On regulatory legal acts of
the Kyrgyz Republic" into force, the legislation related to regulation of drugs circulation has
been fully updated. Within the framework of technical regulations, regulations have been
introduced on safety of drugs and medical devices, national standards of best pharmaceutical
practices have been approved. New laboratory facility has been introduced, and in this
connection, the scope of the DDS&ME as the certification body has been expanded.
20
Draft, 8 October , 2013
There is a strong need for further improvement of registration system to ensure essential
drugs presence at the market.
Post-marketing control of the market of drugs and medical devices requires improvement
as well. Unexpected control of pharmaceutical market is missing. Health professionals distrust
some drugs and medical devices, and at that, there is no documented evidence of side effects or
other claims about the quality of drugs and medical devices, which requires strengthening of
pharmacovigilance system. Continuous improvement of regulatory activity requires allocation of
state co-financing and improvement of material-technical base of the regulatory body and
improvement of human resources capacity.
All above problems in the area of regulation of drugs and medical items shall be
addressed through introduction of good practices rules of pharmaceutical activity
2.1.1. Improvement of drugs regulation system to ensure equal therapeutic efficacy of
generic drugs
Original drugs comprise not more than 3% of the pharmaceutical market of KR. The
market is primarily represented by generic drugs.
From the legal perspectives, generic drugs, authorized to the country's pharmaceutical
market have equal quality and efficacy. However, there is evidence of in equivalence of
therapeutic efficacy of generics and distrust of doctors and patients to cheap generics14.
Lack of information for physicians in public domain related to study of therapeutic
equivalence of drugs, registered in the Kyrgyz Republic, also hinders proper therapeutic
selection of drugs.
Following WHO recommendations, procedure for registration of generic drugs in the
Kyrgyz Republic is simplified compared to the registration procedure of original drugs. The Law
on drugs in the KR stipulates an additional clause for the simplified registration of generics. In
addition, the registration waver is applied to importing of drugs, approved by the KR MOH. The
Law "On Drugs" stipulates the clause for importing drugs and medical devices under registration
wavier rule in case of epidemics and emergencies. But there are no clearly defined criteria for
applying the above clauses for authorizing drugs and medical devices to the market.
The current simplified procedure for the state registration of generics should be applied
only for drugs that are registered in the countries that are members of the International
Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals
for Human Use (ICH), or in countries that are members to the International System of the
Pharmaceutical Inspection Cooperation (PIC/S). After creation of national GMP inspectorate the
procedure of simplified registration can be extended to drugs approved by the national GMP
inspectors.
This list should be complied and approved by the Government of the Kyrgyz Republic on
a periodic basis. It would make sense of this List should also include the countries, with which
the KR has inter-governmental agreements, in the area of drug supply in particular. It is also
necessary to develop and adopt procedures to verify the origin of the drugs (supporting
14
Research Paper №67, «Study of factors, influencing on use of generic drugs», HPAC, Bishkek, 2009.
21
Draft, 8 October , 2013
documents from the regulatory authority, inspection of production, etc.). The process of drugs
registration will be brought into compliance with the Good Regulatory Practice standards (GRP).
The legal procedure for registration of biological products (biosimilars) analogues should be also
defined. To increase credibility and confidence in the registration system, it is necessary to
ensure the provision of publicly available relevant information about registered products, with
the exception of the confidential part of the registration dossier. In order to ensure the rights of
patients and physicians to obtain reliable information about drugs, the criteria for classifying
information as confidential should be reconsidered. The process of decision making on
registration of drugs and medical devices should be transparent and followed by mandatory
publication of publicly available summary report of the registration / refusal of drugs and
medical devices. To improve the efficiency of registration process it is necessary to continuously
improve the competence of experts, including skills in interpretation of bioequivalence studies,
as well as increase personal responsibility of experts in decision-making process.
2.1.2. Introduction of Good pharmaceutical practice standards (GPhP)
Introduction of good pharmaceutical practice standards will result in significant
improvement of the system of drugs and medical items circulation at all stages, ensure quality of
drugs and medical items in the republic and will restore prescription sale of drugs.
GPhP in the KR are based on international guidelines and should be widely expanded.
The process of implementation and compliance with good pharmaceutical practice
standards requires involvement of professional pharmaceutical associations.
The entities of pharmaceutical activity (pharmacies, drugstores, pharmacy kiosks,
wholesale warehouses, optics shops and medical equipment shops, manufacturing enterprises)
should organize their activities in accordance with standards, approved by the good practice
standards.
Introduction of GPhP rules should be done gradually, allocating sufficient time needed by
the entities of pharmaceutical activities to bring logistics, personnel qualification/competence
and quality management system in compliance with the new adopted rules and standards.
The period of transition of pharmaceutical activities entities towards introduction of
GPhP standards should not exceed one term of licensed activity, but not later than 5 years from
the date of publication of the GPhP Rules. Upon expiration of five years term since the date of
GPhP rules publication, the licensing terms of pharmaceutical activity should strictly comply
with the requirements of the adopted GPhP standards.
The pharmaceutical activity entities, that have implemented the requirements of the
adopted GPhP standards within the first 3 years after publication of the said standards, should be
given preferences during public tenders on procurements of drugs and medical items.
GPh practice rules, adopted in the KR, should be harmonized with international
guidelines on good practices (GMP, GDP, GCP, GLP, GSP) and should be updated and
improved continuously given the changes entered into international guidelines.
The system should be created to assess the pharmaceutical activity entities for their
compliance with the GPhP, with issuance of certificate. To this effect, it is necessary to set the
22
Draft, 8 October , 2013
system of continuous training of pharmaceutical inspection specialists in skills of GPHP
compliance evaluation.
2.1.3. Enforcement of Surveillance of pharmaceutical market
Due to the fact that drugs can cause irreparable damage to health if used incorrectly, they
can lose their therapeutic properties during not improper management of drugs transportation
and storage, so the extensive network of wholesale and retail pharmaceutical organizations of the
country should be constantly controlled.
In addition, there is an illegal drug market in the KR, as evidenced by a wide range of
drugs in pharmacies compared to the official imports, which also carries potential risks for the
health of people15. However, the current system of surveillance (pharmaceutical inspections)
does not allow ensuring presence of only legal drugs in the sales network because of the
requirement to notify the pharmacies and economic entities about the upcoming inspection ten
days prior to the inspection. As a result, the pharmaceutical inspection can’t fully perform its
functions, as for example, the element of suddenness of inspections is missing. The activity of
pharmaceutical inspection should ensure that there are no unregistered, expired, poor quality and
counterfeit drugs on the market of the country. Frequency of inspections should be based on the
principles of risk assessment and management and should be regulated by the legislation on state
control and surveillance.
The market control system will be brought into compliance with Good Regulatory
Practice (GRP), with organization of comprehensive system of market control. At that, access to
information on the results of pharmaceutical inspections should be made available for public.
Continuous professional training for pharmaceutical inspection specialists will be
introduced. Mechanisms providing increase of responsibility and transparency of pharmaceutical
inspectors activity will also be introduced.
The system of getting feedback will be developed and implemented in the form of
spontaneous reports from pharmaceutical and health care organizations, as well as from public to
help to reduce the amount of substandard and counterfeit products on the market of drugs and
medical devices.
2.1.4. Enforcement of Pharmacovigilance
Health care workers and people often make claims to the quality of drugs and medical
items, however, this information is not collected and analyzed, respectively, adequate measures
are not taken.
The system of pharmacovigilance is regulated by the Technical Regulations "On safety of
drugs for medical use" through introduction of spontaneous reports on detected drug side-effects
using “yellow cards”. Although ‘yellow cards” are continuously distributed among physicians
with explanation of the procedure for filling them out, very few cases of side effects to drugs are
reported by doctors, indicating that the level of adherence of physicians and efficiency of
communication on pharmacovigilance issues is quite low. This is evidenced by reduction of the
15
Quality of drugs in the sector of public procurements of the KR, WHO. 2008
23
Draft, 8 October , 2013
number of spontaneous reports from doctors –from 57 reports in 2007 down to 17 reports in
2012 (DDS&ME website as of March 26, 2013).
According to the research, 70% of the interviewed doctors responded that they had side
effects to drugs in their practice, the most common manifestations of side effects being allergic
reactions (55%) and intolerance of drugs (35%). However, only 6% of them indicated that they
filled out "yellow" cards. The main reasons for non-use of "yellow card" is almost complete lack
of awareness among physicians about the procedures to work with these cards. Thus, 65% of
doctors responded that they did not have these forms; during discussions of this issue, the
respondents often admitted that they had not even seen the "yellow cards" and have not heard of
their existence16.
For early detection of risks, associated with the use of drugs under normal use, it is
necessary to improve the system of pharmacovigilance through introduction of Good
pharmacovigilance practice (GPhP). Mechanisms for transfer of information of drug side-effects
(“yellow cards”) from HCOs to the DDS&ME and feedback on each reported case will be
developed. Development and introduction of automated database on drug side effects will imply
the mechanisms for transfer of reports/messages both electronically and in hard copies. Special
attention will be given to improvement of the capacity of HCOs in drugs safety issues
2.2. Improvement of the system of drugs and medical items supply
2.2.1. Supply of narcotics and psychotropic drugs
Currently, physical accessibility of narcotic drugs in the country is limited for various
reasons, including inadequate regulatory norms, wrong interpretation of legislative norms by
HCOs, lack of knowledge in health care workers and legislators on treatment of pain and use of
narcotic drugs, which all create excessive administrative barriers for issuance of prescriptions for
narcotic drugs.
Another reason is low accessibility of narcotic and psychotropic drugs in pharmacies,
when patients with prescriptions can’t buy these drugs. The issue of access to these drugs is even
more topical in remote regions. Inadequately rigid control and frequent inspections by the
Ministry of the Internal Affairs, often without prescriptions, lead to the reluctance of retail
pharmacies to have a range of narcotic and psychotropic substances, and reluctance of physicians
to prescribe psychotropic drugs.
Since a number of departments are engaged in regulation of this sphere, the problem of
improving access to narcotic and psychotropic drugs should be addressed comprehensively and
jointly with all the stakeholders in the interests of patients in the need of care. To decrease
unnecessary sufferings of patients in need of narcotic drugs for painkilling purposes, it is
necessary to adopt the strategies, aimed at removal of political, regulatory legal and
administrative barriers for provision of palliative care.
Strategy will be develop on improvement of narcotic and psychotropic drugs supply to
patients for shorter and middle terms, and measures will be taken to train all stakeholders.
16
Policy Research Document № 77 « Evaluation of implementation and efficiency of the SDP of the KR for 2007-2010 .», HPAC, Bishkek, 2012
24
Draft, 8 October , 2013
2.2.2. Supply of essential drugs with limited physical accessibility
The government policy in drug circulation area should be aimed at availability of
essential drugs on the country market. However, some essential drugs are not available in the
Kyrgyz Republic due to a number of reasons: 1) limited demand of drugs, used for treatment of
rare diseases (orphan drugs); 2) limited purchasing power of the majority of population due the
high cost of drugs, needed for treatment of severe diseases. So treatment of these diseases either
lies as a hard burden on the shoulders of the patients and their families or makes treatment
impossible altogether. Physical absence of these drugs on the local market forces patients to
purchase them in other countries; 3) absence of demand for some affordable and efficient
essential drugs due to the change of drugs administration practice by doctors for various reasons,
including aggressive pressure of pharmaceutical firms. About 10 names of these drugs were not
included in into the current EDL due to absence of their registration in the KR, and physical
availability on the market respectively.
With respect to high-cost essential drugs (including orphan drugs), the state should set
itself the task of expanding access to these drugs through development of integrated strategies
and technologies in line with the available resources, which should include measures to optimize
the prices for new patented drugs and generics and improve procurement practices. It is
necessary to incorporate the definition of rare diseases and orphan drugs into the KR legislation
in order to provide access to the really necessary drugs and limit speculation of the concept of
rare diseases. To reduce the cost of high cot drugs, mechanisms will be developed to ensure
transparent information on prices and suppliers, proper planning and forecasting of demand,
supply management. In order to reduce prices for generic drugs, the government will use
negotiations and promotion competition between manufacturers. To reduce prices of the patented
drugs, the government will hold active negotiations with their vendors to obtain the best
achievable lower prices, provide donor supported programs, that provide free delivery and apply
voluntary and compulsory licensing under the rules, described in the TRIPS Agreement. Patent
laws of the Kyrgyz Republic should not contain the rules that limit access of drugs for the
population.
The issues will be addressed related to getting affordable and effective drugs to the KR
pharmaceutical market, which are the drugs of choice in the national CG / CPs. Comprehensive
measures should be planned, including, on the one hand, negotiations with pharmaceutical
suppliers to bring these products to the market of the Kyrgyz Republic in line with the List, and
work with physicians to change clinical practice under the CG/CPs on the other hand.
Since many vital essential drugs are not registered in the country, the Ministry of Health
should develop a strategy to provide the most favorable regime for all the above drugs, while
ensuring their high safety, efficacy and quality. To this effect criteria for formation of the List of
essential drugs will be developed, which are authorized for import into the KR without
registration for a specified period of time, with their subsequent registration in the Kyrgyz
Republic.
The system for monitoring of availability of the above drugs will be created, which will
include presence/availability of drugs in CG/CPs, Registers of patients in need, prices both in the
country and outside, forecasts of consumption rates, regulatory status of drugs, etc.
25
Draft, 8 October , 2013
2.2.3. Disposal of unusable drugs
Drug supply system faces the challenge of disposal of drugs, which have become
unusable at various stages of supply. Accordingly, system of measures should be developed to
prevent possibilities of using these drugs (timely withdrawal from the market, collection, storage
and disposal).
The general procedure for disposal of unusable drugs, described in the Technical
Regulations "On safety of drugs for medical use", is triggered to this or that degree only in case
unsuitable drugs emerge in the wholesale supply chain or at the fault of wholesale suppliers /
manufacturers.
But there are a number of circumstances in which there is uncertainty about application
of the procedure of unsuitable drugs disposal: retail pharmacies periodically accumulate expired
drugs in small quantities; application of the procedures for disposal of these drugs in accordance
with the Technical Regulations is economically unjustified. There is no procedure for collecting,
storing and disposing unusable drugs in health care organizations. Disposal of drugs involves
additional expenditures.
To facilitate the process of drugs disposal due to the necessity to prepare a number of
authorization documents and other bureaucratic barriers, centralized procedures will be
developed for disposal of unusable drugs depending on the location and conditions of their
formation (wholesale warehouses, retail network, places of illicit sale of drugs).
2.3. Measures on elimination of Illicit drug sale and enforcement of sanctions for violation
of norms and rules
Illicit sale of drugs, when they are sold illegally among other goods typical for street sale,
presents a serious threat to life and health of the population. Moreover, in contrast to consumer
goods, negligence of the conditions of drugs storage and sale might result in serious
consequences of consumer’s health. Along with this problem, there are issues of drugs
counterfeit and sale of expired drugs in the sphere of legal drug circulation. r and quality remain
unattended. Illegal sale occurs due to high incomes, concealment of revenues from taxation and
minor penalties for this offense, which is equated to illegal trade of conventional consumer
goods.
Suppression of illicit trade of drugs and, consequently, reduction of poisoning risks for
the population or other side effects, are possible, if the penalty for such offense is severe to the
degree necessary to make it overweigh the possible benefit from illegal sale of drugs. All this is
attributed to high revenues on the one hand and relatively low penalties for this offense on the
other hand, i.e. punishment for this type of offense does not correspond to the severity of the
caused damage, and the profit from this activity is significant.
Suppression of illicit sale, fight against counterfeit and sale of counterfeit drugs and
expired drugs and, therefore, mitigation of risks of poisoning or other adverse effects for the
population are possible – conditioned that the punishment for such offenses are so serious, that
will override potential profit from illegal drugs sale. To this effect the measures of administrative
and criminal liability for illegal sale of drugs will be reinforced. It is also necessary to expand the
powers, functions, rights and responsibilities of local governments and self-governance bodies to
counter the illegal sale of drugs and medical devices.
26
Draft, 8 October , 2013
Punishment for counterfeiting of drugs and sale of expired drugs will also be reinforced.
It is therefore proposed to amend the Administrative Code of the Kyrgyz Republic in a stepwise
way.
Together with increased liability for the illegal sale of medicines it is necessary to reduce
the demand of the population for the products of the "black market" of drugs, including
smuggling, counterfeit drugs and expired drugs. To reduce the demand for "black market"
products, it is necessary to inform population on a regular basis about the dangers of purchasing
drugs from illegal sellers and purchasing expired drugs. Population should also be informed
about how to define legally operating pharmacies and pharmacies points, how to find out about
the registered drugs, how to understand their shelf life.
3. Improvement of management of drug circulation
Efficient management of drugs circulation sphere implies availability of capacity and
mechanisms for formation of the state policy, adequate legislation, regulations, as well as
availability of effective mechanisms to regulate processes and tools of control over the activity
of drug circulation entities and ensuring transparency and accountability.
3.1. Formation of state policy in the area of drug circulation, based on clear vision,
continuity and feedback
Formation of state policy in health care, including drug circulation is the direct function
of the KR MOH. Given the fact that drug circulation is the area of overlapping of interests,
requirements and expectations of citizens, HCOs, suppliers of pharmaceutical services and other
interested parties, inevitably implying conflict of interests, the process of development of state
policy should envisage extensive consultations with all stakeholders. Despite the fact that the
Law "On normative legal acts" requires mandatory public discussion of draft regulations, this
process is not regulated at all and is limited to placing drafts of legal acts on the official website.
That’s why, the normative legal act will stipulate the regulations for drafting of strategic/policy
and regulatory documents with mandatory involvement of all stakeholders.
Besides, the SDP implementation requires efficient inter-agency coordination and wide
support of public.
Regular monitoring of the SDP implementation with involvement of all stakeholders will
be organized. Periodical reports on the SDP implementation will be published.
3.2. Removal of contradictions and gaps in the legislation
The legislation, regulating business activity, as well as administrative responsibility,
should be harmonized with the legal acts on drugs circulation of the KR.
To develop business in the Kyrgyz Republic, the following measures were taken:
conditions/terms for the start of business conduct have been simplified, mandatory state
standards have become voluntary, the number of licenses has been significantly reduced, and
licensing requirements for most of the activities have been simplified; the authorities of public
27
Draft, 8 October , 2013
bodies in regards to control-enforcement activities have been limited. These measures had a
positive impact on development of “shuttle” and wholesale- retail trade, public catering and
services. Possibilities of conducting illegal inspections of entrepreneurs and, therefore
opportunities for corruption, have been reduced.
The areas of business that require strict measures to ensure safety of life and health of
citizens, special rules, procedures and regulations are implemented. E.g., the operation of the
Law No 67 as of May 22, 2004 "On the basis of technical regulation in the Kyrgyz Republic"
(Law of the Kyrgyz Republic No 299 dated 16 November 2009, No 171 dated October 14, 2011)
does not cover application of measures to prevent occurrence and spread of mass communicable
human diseases, prevention of human diseases, delivery of health care. But drugs, medical
devices and medical equipment present part of measures for delivery of health care to the
citizens of the country.
However, drugs, medical devices and medical equipment fall within the scope of the Law
"On the basis of technical regulation in the Kyrgyz Republic", contradicting the principles of
rulemaking, stipulated by Law “On Regulatory Legal Acts of the KR”.
For this reason, amendments will be entered into the legislation on technical regulation to
introduce the concept of drugs as a special kind of product and their accompanying medical
services as a special kind of service, which should be handled under special rules.
Changes should, first of all, define mandatory observance of quality standards in the field
of drug circulation; and secondly, should determine that the entrepreneurs, engaged in
pharmaceutical business, should be controlled more strictly compared to those who do business
with conventional products. For example, inspections of drugs without prior notice should be
used, as well as selected inspections of drugs batches in pharmacies and stores, and other control
and surveillance measures to detect smuggled drugs, counterfeited drugs, expired drugs and
drugs of inadequate quality.
Treating drugs and medical devices as conventional goods also impedes the efficient
procurements of drugs and medical devices under the conditions of dynamic changes of modern
pharmaceutical market, due to the fact that the main criterion in the legislation on procurements
is the price, not the quality, safety and efficacy of drugs and medical devices. However, health
care organizations should be able to select the most effective drugs based on clinical experience
of drugs use and post-marketing surveillance data. In future, definition of drugs and medical
devices as a special type of products will be stipulated in the Law on Public Procurements. Also,
the legislation will entrench specific methods of organization of drugs procurements to achieve
the most competitive prices for high-quality pharmaceutical products from the leading
manufacturers in the global market.
As drugs are treated in the Kyrgyz Republic as consumer goods, violations in the field of
drugs circulation are also reviewed according to the standard procedures. However, unlike
consumer goods, failure to follow the rules of storage, sale of drugs can lead to serious
consequences for the health of the consumer. In this connection, will be substantially
strengthened accountability for violations of rules for handling drugs. Will also be strengthened
by the punishment of counterfeiting of drugs and sale of drugs with expired shelf life. It is
therefore proposed to amend the Administrative Code of the Kyrgyz Republic.
The definition of "drug” also requires legislative adjustment, as it has been repeatedly
amended to address urgent political and regulatory challenges. This has resulted in the situation,
when the term "drugs" includes unreasonably large number of different names of products,
28
Draft, 8 October , 2013
representing separate groups of products (medical devices, dietary supplements, pharmaceutical
substances and materials, chemicals, reagents, test kits). Such a wide scope of products under the
term "drugs" is accepted neither in any CIS or in the western countries. This leads to the fact that
many goods groups that are not drugs by nature, are subject to the drugs requirements. So
artificial barriers are created in circulation of these products on the market. The situation is
particularly difficult for domestic drug manufacturers, as they have to go through the process of
double registration - at the level of imports of pharmaceutical substance, and then - when
registering the drug, produced from this drug substance. The Ministry of Health solves this
current problem by including pharmaceutical substances into the list of unregistered drugs, but
allowed for import and use on the territory of the Kyrgyz Republic, which generates significant
bureaucratic barriers. Clear legal definition of drugs and medical devices, introduction of the
concept of medical- pharmaceutical products in accordance with internationally accepted norms
with subsequent changes to be entered into the Technical Regulations "On safety of drugs"
would solve many issues of the pharmaceutical market. It is also necessary to remove
contradictions and inconsistencies in interpretation of the Law "On Drugs", stipulating import of
drugs and medical devices that are exempt from state registration.
In addition, there is an urgent need for harmonization of the existing legal framework
regulating the sphere of drugs circulation with the principles of the law on normative legal acts
of the Kyrgyz Republic.
3.3. Institutional Strengthening
The Government of the KR ensures pursuing single state policy in health care. The MOH
is the authorized state body in the sphere of health protection in the Kyrgyz Republic. According
to the functional classification, the Ministry’s system, as the central governance body, should
delineate functions on development of sector policy (drafting legal acts, standards, rules,
regulations) and functions to implement the sectoral policy (practical application of the
legislation) in order to avoid conflict of interests and apply objective approach to development of
certain norms.
State management of drug circulation system should meet the following management
principles, providing efficient and non-corrupt governance:
• Clear separation of functions of policy development from the functions on
implementation of the policy;
• Public control over transparency of procedures on decision making and implementing
decisions;
• Strengthening of accountability of the DDSS&ME, creation of tools to measure
efficiency of the regulatory authority;
• Co-financing of regulatory bodies mainly from the state budget;
• Establishment of internal system of performance assurance of the DDS&ME’s activity;
• Availability of capacity at the Ministry of Health with appropriate resourcing
Currently, in the central office of the Ministry of Health there is no institutional structure
to ensure a full cycle of development of drug policy, including setting the problems, organization
of consultations on their discussion, proposal of ways to address them, control of policy
implementation, monitoring and evaluation. Efforts to create this organization structure are
limited by financial resources. However, it has become topical to establish a department
29
Draft, 8 October , 2013
responsible for developing national drug policy, monitoring and evaluation of its implementation
in the central office of the KR MOH, and to lay regulatory functions, coordination, surveillance
and control exclusively upon the DDS&ME.
So that the structure in the MOH Central Office responsible for drug policy performs its
functions to full extend, its status should be not lower than the level of a separate unit; funding of
the unit in charge of drug policy is envisaged from the national budget and grant funds in the
amount, sufficient to carry out all functions of the unit, including computer hardware and
software, office equipment, travel expenses, monitoring activities, evaluation of the SDP.
Retraining and skills upgrading of skills and knowledge on the SDP issues of the SDP
department/unit staff should be provided, as well as education and study tours in the countries,
whose experience is most useful for implementation of the SDP in Kyrgyzstan
It will be in the scope of work of the DDS&ME to coordinate the activities of state and
local government agencies in the area of drugs circulation and control and surveillance of
implementation of regulations, procedures and standards in the area of drugs circulation in all
institutions, regardless of ownership forms and departmental affiliation.
Based on the analysis of regulatory system compliance with good regulatory practice
(GRP) with involvement of WHO and independent operational regulators of other countries,
internal system of quality assurance of the DDS&ME activity will be organized, and all business
processes will be developed and approved. The DDS&ME performance reviews will take place
following the current KR legislation. The Public Steering Committee under the KR MOH will
enforce control over transparency of procedures of DDS&ME and effectiveness of its
performance, but unjustified revisions of regulatory agency diverting tremendous human and
technical resources of DDS&ME must be stopped. Information on the decisions of the
DDS&ME for wide public will be provided in a timely manner, including negative decisions,
decisions on the budget of the Department indicating the sources of financing, the results of
internal audit.
Besides, the DDS&ME is currently financed only against the extra-budgetary resources.
As the stability of the republican budget revenues increases, it would be necessary to shift to
financing of the DDS&ME mainly to the national budget. The services have to be entered in the
Register of public services accordingly.
The cost of the license for pharmaceutical activity and registration of drugs will be
estimated on the basis the market value, which should be the price for entry of drugs to the drugs
market. However, the price of the market authorization should not be too high, given the
constraints of sale of drugs in the rural areas.
The cost of expert evaluation and tests on registration and certification will be estimated
on the basis of the actual cost of the work and services for formation of incentives for
development of scientific-intellectual capacity of expert bodies.
3.4. Improvement of Human Resources
One of the main preconditions of sustainable development of the pharmaceutical industry
is availability of highly professional pharmaceutical staff. The issue of planning of training of
staff for public health sector under the conditions of market economy is very topical. It is
30
Draft, 8 October , 2013
necessary to develop the methodic for determining the needs for these professionals to place the
budgetary quotas in higher and secondary educational institutions.
Specialists with higher pharmaceutical education are trained in the KR by the KSMA. In
almost all regions of the country, medical schools annually produce pharmacists with specialized
secondary education on a contractual basis. At the same time, the quality of training in
educational institutions in "pharmacy" does not meet modern requirements.
As part of the reforming higher education, the specialty "pharmacist" has been renamed
into "pharmacist". It was assumed that the specialty of "pharmacist", obtained upon graduation
from a medical school, will be renamed as "pharmacist’s assistant," but it was not implemented.
Thus, nowadays both higher educational and secondary special institutions issue diplomas in the
specialty "pharmacist". The situation is aggravated by the fact that the regulations don’t stipulate
mandatory requirements for qualification and experience of pharmaceutical workers; specialists
with secondary education may hold positions requiring compulsory higher education, which is
contrary to the requirements of international standards of good pharmacy practice. All this leads
to significant problems in management of pharmaceutical personnel and pharmaceutical
industry.
In accordance with WHO criteria, Single Register of pharmaceutical workers is the
efficient tool for monitoring of qualification of pharmacists in the system of continuous
education and licensing of pharmaceutical activities. The information about the certified
professionals and graduates should be available in public domain.
It is planned to develop Strategy for human resources development in the pharmaceutical
sector in view of the priority health care needs. Jointly with the Ministry of Education audits will
be organized of all the institutions involved in training of pharmaceutical personnel in the
specialty "pharmacy", to check their compliance with the requirements of educational standards;
the issue of renaming qualification of specialists with secondary specialized pharmaceutical
education will be addressed, and for this purpose consultations will professional communities
will be held.
The Nomenclature of pharmaceutical positions and job descriptions will be revised;
incentives will be developed to attract specialists to work in hospital pharmacies; mechanisms
will be created to retain graduates of regional educational institutions in rural pharmacies.
3.5. Development and implementation of the "Code of ethical conduct in the area of drug
circulation
Unethical promotion of drugs by pharmaceutical companies results in excessive use of
drugs. Most of people, prescribing drugs, receive information primarily from pharmaceutical
companies and not from independent, objective sources. As in many countries, excessive
administration of expensive drugs is practiced in KR, caused by extremely aggressive marketing
of pharmaceutical companies. The activity of pharmaceutical companies includes all marketing
tools, ranging from dissemination of information materials and organization of presentations to
distribution of free technical means, payment of costs of trips to different conferences and
bonuses for sold drugs.
According to the "WHO Ethical Criteria" scientific and educational/training activities
should not be used for promoting drugs to the market, advertising drugs, prescribed or used for
31
Draft, 8 October , 2013
treatment of patients with severe medical conditions, which might be prescribed only by a
qualified doctor. Medical representatives should not offer "incentives" to the people, prescribing
drugs and pharmacists. In turn, people, prescribing drugs, and pharmacists, should not seek these
"incentives." With that, the newest, and therefore the most expensive, but least-studied drugs are
promoted to the market.
Availability of sanctions for violations in the area of drugs circulation does not guarantee
implementation of the legislation unless there is the system of ethical conduct. Since the majority
of professionals, working in the area of drug circulation, are not civil servants, and employees of
pharmaceutical industry – are individuals, the code of ethics of public servants and civil service
legislation does not apply to them.
That’s why to develop the Ethical Code will be developed, which will define conduct in
this area. This Code will include the following aspects of behavior in handling drugs:
• Identification of conflicts of interests;
• Honesty in reporting, statement of facts, management of resources;
• Making decisions based only on the facts;
• Equity in application of rewards and punishments;
• Transparency and openness in decision-making;
• Protection of informants of unethical conduct;
• Recruitment of staff only on the basis of competence, exclusion of nepotism, tribalism
and fraternities;
• Implementation of the legislation, banning inaccurate, misleading or unethical
promotion of drugs;
• Control of information, provided by pharmaceutical companies to medical personnel.
The Code of Ethics will include the system of implementation, including organizational
structure (for example, advice on ethics), measures of punishment and disclosure of violations of
ethics in the area of drugs handling.
3.6. Ensuring transparency in the area of drugs circulation and introduction of monitoring
of pharmaceutical sector and drugs prices
Transparency of processes in the area of drug circulation is ensured primarily by
automated processes of collection, processing, transfer of information and open access to it.
Information systems of the DDS&ME are used to facilitate implementation of regulatory
activities within the institution and to work with suppliers in the Single Window system.
Availability/presence of databases in the DDS&ME promotes rapid display of regulatory
decisions, guidelines, procedures and other documents on the website of the regulator and
improvement of transparency of drugs circulation area. However, fragmentation of the
DDS&ME information systems does not allow to improve business processes in the authorized
agency itself and does not provide the health system with tools of informational support of public
drug procurements and tasks related to automation of recording of drugs in HCOs. Information
on the process of registration of drugs remains to be hard-to-reach.
32
Draft, 8 October , 2013
To improve access to information in this area, as well to improve transparency and
openness, it is proposed to create Single information system of drug supply, which will cover all
aspects of drugs circulation, starting with the date of registration and ending with their sale and
disposal. Single information system will be built to provide access in two modes: for the
authorized users and for common users. For authorized users with appropriate access, the system
should enable them to track each batch of drugs arrived into the country or produced locally, so
it would be possible to learn online where this or that batch of drugs or drugs in a given batch are
that at any time.
Temporary (until the registration procedure is over) online access to information on
stages of proceeding of submitted documents will be provided. During the procedure of
registration, licensing or certification, pharmaceutical companies should obtain all necessary
information on the stages of the process.
Health care providers and pharmacists will be continuously provided with permanent
authorized access to all information, necessary for their work with drugs, including information
on their efficacy, side effects, etc.
It is planned to develop tool for building of automated system for collection and analysis
of the information on the drugs, procured by HCOs, including codifiers of drugs and medical
devices, which will be also used for the public electronic procurement system and other
purposes, and VEN ABC analysis for improving drug supply management.
Information on different aspects of pharmaceutical sector activity is collected by many
agencies and departments (Ministry of Health, DDS&ME, RMIC, MHIF, etc.). However, the
situation analysis indicates that the existing data is fragmented and does not enable to regularly
assess the pharmaceutical sector status in the country . In addition, access to some types of
information is limited or its collection is not carried out in the country altogether (for example,
some parameters according to the international tool to assess pharmaceutical sector). Work will
be carried out to form an integral M&E system to implement regular evaluation of the
pharmaceutical sector activity by the key areas of activity and prices for drugs.
3.7. Monitoring and Evaluation System of the State Drug Policy implementation
Monitoring and evaluation system shall take into account the structure of the new State
Drug Policy and shall be based on the sequential approach, when getting results at one level
leads to results at next level, thus ultimately ensuring achievement of the common goal. In
practice, the following sequence of monitoring and evaluation has been set: contribution/input process - result - consequence - impact. Data collection will be carried out by selected indicators
and markers, reflecting the progress on each of the above levels. The Marker, unlike the
indicator, is the measure of tracking implementation of one- off, but key activity. This SDP
focuses on new strategic interventions such as regulation of prices for drugs and medical devices,
removal of accumulated contradictions in the existing legislation, development of missing
practice guidelines, regulatory documents, including the "Code of Ethical Conduct in the sphere
of drugs circulation". In this connection, the SDP Plan of Work shall include a large number of
measures, which will be implemented once, but are necessary for next steps implementation.
The markers are usually monitored/traced down only until the achievement of results.
Collection of data on indicators will be based on two types of data sources: (i) routine
sources when indicators are collected regularly and in accordance with the approved statistical
33
Draft, 8 October , 2013
forms , and (ii) assessment studies, which are necessary to evaluate the impact of the
implemented SDP on drugs circulation. Some studies/surveys have already been conducted
under the implementation of National health care reforms programs (e.g., CHS within the
framework of "Den Sooluk " is carried out jointly with the National Statistical Committee every
two years). Topics for other studies and surveys will be determined by the Ministry of Health
annually subject to the needs assessment.
The developed Package of indicators consists of the "Control Panel " and three sections
linked to three priority areas of activity: "Ensuring affordability of drugs", "Drugs circulation
system" and "Improvement of drugs circulation system management".
The "Control Panel" is a set of the most important indicators related mainly to indicators
of consequences / impact and enable decision-makers to quickly assess the changing situation in
the field of drugs circulation and take necessary decisions. Indicators of the "Control Panel" will
reflect implementation of the main objectives of the new SDP. They will enable to track down
the process of the EDL formation in order to ensure inclusion of drugs with proven efficacy only
, will provide information on changes of the situation with regard to ensuring affordability of
essential drugs and medical devices for the population of the Kyrgyz Republic, will help to
guarantee availability of safe, effective and quality drugs on the market through proper
compliance with key procedures and will indicate strengthening of strategic
management/stewardship in the sphere of drugs circulation.
The basic Package of indicators includes indicators and markers, which were distributed
by priority areas of the SDP.
Benchmarks (based on 2012 data) and targets by years till 2020 have been identified for
each indicator. It is assumed that the Package of indicators will be reviewed periodically (for
example, during the mid-term evaluation of the SDP progress).
Analysis and evaluation of the Indicators Package will be conducted at the level of the
Ministry of Health. Summarized data on the previous year will be presented to the Government
of the Kyrgyz Republic and the Parliament of the Kyrgyz Republic, as well as Development
Partners and other stakeholders on an annual basis.
Monitoring and evaluation of the SDP also envisage improvement of capacity in M&E
area. To this end, regular trainings are scheduled for the professionals to be involved in M&E of
drug circulation area, as well as decision-makers. It is assumed that wide access will be
available to the results of the SDP M & E results, key areas of the pharmaceutical sector activity
in general and prices for drugs and medical devices in particular. This will increase transparency
and efficiency of management decisions in the field of drugs circulation of the KR.
34