Download 1 - European Commission

1. ------IND- 2014 0621 PL- EN- ------ 20150105 --- --- IMPACT
Project name:
draft Act on the amendment of the Drug Prevention Act and some other
Acts
Lead ministry and cooperating ministries
Ministry of Health, Ministry of Finance
Person responsible for the project: Minister, Secretary of State or
the Undersecretary of State
Igor Radziewicz-Winnicki, Undersecretary of State in the Ministry of
Health
Project supervisor contact person
Aleksandra Umińska, tel. 53 00 393, [email protected]
Date of preparation
3 October 2014
Source:
– Drug Prevention Act of 29 July 2005
(Journal of Laws of 2012(124))
– Council Regulation (EC) No 1234/2007 of
22 October 2007 establishing a common
organisation of agricultural markets and on
specific provisions for certain agricultural
products (“Single CMO Regulation”) (OJ L
299 of 16 November 2007, p. 1, as amended),
– Council Decision 2005/387/JHA of
10 May 2005 on the information exchange,
risk assessment and control of new
psychoactive substances (OJ L 127 of
20 May 2005, p. 32),
– Regulation (EC) No 273/2004 of the
European Parliament and of the Council of
11 February 2004 on drug precursors (OJ L
47 of 18 February 2004, p. 1, as amended),
– Council Regulation (EC) No 111/2005 of
22 December 2004 laying down rules for the
monitoring of trade between the Community
and third countries in drug precursors (OJ L
22 of 26 January 2005, p. 1, as amended).
Number on the List of legislative and
programme works of the Council of
Ministers:
UD 13
REGULATORY IMPACT ASSESSMENT
1. Which problem is being addressed?
The Act on the amendment of the Drug Prevention Act and some other Acts was drawn up as a requirement to extend
statutory control to cover chemical substances, which in 2010 were traded as so-called legal stimulants in shops, and
recently also online, and to adapt the provisions of the Drug Prevention Act of 29 July 2005 (Journal of Laws of
2012(124)) to the Medical Activities Act of 15 April 2011 (Journal of Laws of 2013(217)).
Under this draft Act, the amendments also adapt procedure related to preventive medicine and the prohibition of
manufacturing and marketing psychoactive substances to provisions that are binding and practised in most countries of
the European Union. The proposed amendments provide, amongst others, a concept and definition of the new
psychoactive substance, as an approximation to the nomenclature used in other countries of the European Union. The
above matter stems from Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk assessment
and control of new psychoactive substances (OJ L 127 of 20 May 2005, p. 32).
Furthermore, the draft, in addition to the activities performed on the single market by State Sanitary Inspection,
anticipates tasks for the Customs Service relating to the control of the import of designer drugs and new psychoactive
substances from third countries.
The Freedom of Economic Activities Act of 2 July 2004 (Journal of Laws of 2013(672), as amended) also implements
the appropriate amendments; this is because State Sanitary Inspection supervision of compliance by undertakings with
the provisions of the Drug Prevention Act of 29 July 2005 has shown that some legal regulations which concern the
rights of undertakings prevent sanitary inspectors from performing their duties effectively. This primarily concerns the
possibility of objecting to the performance of an audit. This right, in relation to the prosecution of rogue undertakings
who supply young people with designer drugs, not only hinders, but often renders it impossible to act effectively.The
right to object does not apply when the undertaking is suspected of committing a crime or offence, or crime or tax
offence, but when the undertaking organises a wholesale network or a network of shops which offer designer drugs,
commonly referred to as legal stimulants.The draft Act also amends Article 46 and Article 47 of the Drug Prevention Act
of 29 July 2005. These amendments were proposed in connection with the need to implement the European Union
provisions on the organisation of the market for hemp for fibre, which came into force on 1 July 2012. The abovementioned European Union provisions were implemented by Article 91(1)(1) of Council Regulation (EC) No 1234/2007
of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain
agricultural products (“Single CMO Regulation”) (OJ L 299 of 16 November 2007, p. 1, as amended).
The proposed amendments also stem from the need to adapt national legislation to the amendment of Regulation (EC)
No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (OJ L 47 of
18 February 2004, p.1, as amended) and Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules
for the monitoring of trade between the Community and third countries in drug precursors (OJ L 22 of 26 January 2005,
p. 1, as amended), amendments which came into force on 30 December 2013, and the resulting need for the Chief
Pharmaceutical Inspector to also supervise category 4 precursors.
Article 71a was also implemented into the Pharmaceutical Act of 6 September 2001 (Journal of Laws of 2008,
No 45(271), as amended) because of the urgent need to limit access to OTC medicinal products whose composition
contains psychoactive substances used for non-medical purposes and the manufacture of drugs.
2. Recommended solutions, including planned intervention tools and expected effect
The principle objective of the draft Act is to protect the health of citizens against dangerous products or substances.
Owing to the rapid growth in the number of shops that offer substances in their pure form or in the form of mixtures,
under the draft, the proposed amendments to the wording of Annexes to the Drug Prevention Act of 29 July 2005 stem
from the need to place under statutory control new psychoactive substances which have been detected in samples seized
from shops offering legal stimulants. All of the narcotic drugs proposed to be subjected to statutory control produce
psychoactive effects and affect the central nervous system. The ban on importing designer drugs and new psychoactive
substances into Poland will allow the Customs Services to effectively eliminate these products before they are marketed;
this includes inspection of products which are sent to individual buyers in packages.
Furthermore, the draft Act assumes the appointing of a Risk Assessment Team, comprising experts specialising in new
psychoactive substances and with appropriate experience and scientific achievement. The main task of the abovementioned Team is to draw up an expert opinion on the potential threat connected with the use of given substances and to
recommend to the Minister of Health the inclusion of those substances which are the most dangerous to human health
and life on lists of narcotic drugs, psychotropic substances and new psychoactive substances. Thanks to work performed
by this Team, the Minister of Health will be able to take decisions on the implementation of legislative procedure with
the purpose of including given substances in the Annexes of the Drug Prevention Act of 29 July 2005 or on the list of
new psychoactive substances. Thanks to the Team, the assessments of the risks associated with the consumption of new
psychoactive substances will be made primarily in terms of the impact on health, on the basis of rational, scientific
evidence and interdisciplinary expert evaluation.
The introduction into the Drug Prevention Act of 29 July 2005 of the concept of new psychoactive substances has made
it possible to define these substances as being similar to narcotic drugs and psychotropic substances which affect the
central nervous system. Their characteristic feature will be primarily the fact that they will be included in the Regulation,
issued by the Minister of Health. New psychoactive substances shall be classified for inclusion in the list, following
assessment of their physicochemical properties, their addictive potential, toxicity, their related threat to human life and
health and their social harm. Concerning the creation of a list of new psychoactive substances with known composition
and properties, it is necessary to preserve the concept of a designer drug, which defines new substances with more or less
known properties and effects on health, including the more dangerous effects on health. It is these products in particular
which constitute the object of the administrative procedure initiated by the State Sanitary Inspection authorities.
State Sanitary Inspection supervision of compliance by undertakings with the provisions of the Drug Prevention Act of
29 July 2005 has shown that that part of legal regulations which concern the rights of undertakings prevent sanitary
inspectors from performing their duties effectively. This primarily concerns the possibility of objecting to the
performance of an audit. This right, in relation to the prosecution of rogue undertakings who supply young people with
substitutes, not only hinders, but often even renders it impossible to act effectively. The right to object does not apply
when the undertaking is suspected of committing a crime or offence, or crime or tax offence, but when the undertaking
organises a wholesale network and a network of shops which offer designer drugs, commonly referred to as legal
stimulants. It does not appear that this was the intention of the legislator, who wanted to defend undertakings against the
discretion of officials. This kind of activity, though not prosecuted under criminal law, is clearly highly reprehensible and
cannot be protected by the State. For these reasons it was proposed to change the provisions on controlling undertakings.
This is why the Freedom of Economic Activities Act of 2 July 2004 (Journal of Laws of 2013(672), as amended)
implements the appropriate amendments. In keeping with Article 79(1) of this Act, the inspection authorities notify
undertakings of the intention to initiate an inspection. At the same time, this Article provides for exceptions. It is
proposed to add a new point to the existing catalogue of exemptions under Article 79(2). The proposed amendment will
unequivocally indicate that notifications on the intention to carry out an inspection shall not take place when the
performance of an inspection is necessary in order to counter violation of the prohibition, referred to in Article 44b(1) of
the Drug Prevention Act of 29 July 2005.
The proposed amendments under Article 46(2) of the Drug Prevention Act of 29 July 2005 adapt national legislation on
the market for hemp to changes in binding European Union regulations by removing references to the provisions under
Article 91 of Council Regulation (EC) No 1234/2007, binding for the last time in the marketing year for 2011/2012, and
to the mechanism for authorising primary processors. The amendment to Article 46(5)(2) adapts the requirements
relating to entities applying for permission to purchase hemp for fibre so that entities from other states may also perform
the above-mentioned activities. The amendment to Article 46(6)(2) repeals (in keeping with EU legislation) the
obligation for the main processor to obtain authorisation and to submit it together with an application requesting
permission to engage in business activities involving the purchase of hemp for fibre. Under Article 47(2) the repealed
point (3) is the result of amendments to Article 46(2) of the Drug Prevention Act of 29 July 2005. Article 47(3a) and (3b)
introduces the possibility of replacing the obligation to sign the cultivation contract in the form of a written obligation to
process hemp on one’s own, which at the same time will permit the same entity to cultivate and process hemp. Until now
this was possible under the provisions of Article 91 of Council Regulation (EC) No 1234/2007. Implementation of the
above-mentioned entry will permit, amongst others, the Institute of Natural Fibres and Medicinal Plants in Poznan – the
leading cultivator of hemp varieties in Poland and at the same time a processor of hemp – to continue its business
activities.
The need to adapt national legislation to the amended Regulation (EC) No 273/2004 of the European Parliament and of
the Council of 11 February 2004 on drug precursors (OJ L 47 of 18 February 2004, p. 1, as amended) and Council
Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the
Community and third countries in drug precursors (OJ L 22 of 26 January 2005, p. 1, as amended), amendments which
came into force on 30 December 2013, will lead to the Chief Pharmaceutical Inspector supervising category 4 precursors,
thus expanding the tasks of Pharmaceutical Inspection in terms of controlling category 4 precursors, covering medicinal
products which contain ephedrine, pseudoephedrine or the salts of these substances.
Furthermore, amendment of the Drug Prevention Act of 29 July 2005 includes amendment to Article 39, whose purpose
is to specify the administrative procedures in terms of issuing permits and permissions defined under the Act, as well as
to regulate under the Act the fees for issuing these.
The provisions on limiting the dispensing of OTC medicinal products (Article 71a of the Pharmaceutical Act of
6 September 2001), in terms of their maximum level of psychoactive substances, shall come into force on
1 January 2017, thus guaranteeing the parties which market medicinal products a transition period to adapt any marketing
permits and registration documents. In order to avoid the withdrawal from the market of medicinal products which
exceed the specified level of psychoactive substances, medicinal products placed on the market before the entry into
force of the new Regulation, may be retailed up to their expiry date.
3. How was this problem solved in other countries, in particular OECD/EU Member States?
The main purpose of the amendment is to improve the efficiency of combating threats to public health caused by new
psychoactive substances. The concept of the proposed changes was based largely on an analysis of legal solutions
currently used in European countries as well as at the level of the European Union.
The proposed amendments to the Drug Prevention Act of 29 July 2005 implement an additional definition of new
psychoactive substances as well as the Regulations of the Minister of Health, which contain a list of new psychoactive
substances or their groups. At the same time, the amendments permit definition of the controlled substances based not
on individual lists of substances, but on groups with a defined chemical structure. The experience of at least a handful of
European countries has shown that this approach permits more effective control and eliminates the need to constantly
modify the lists. Furthermore, the sanctions imposed for violating these provisions are of an administrative nature. The
group method of defining substances has for many years been used successfully in Great Britain and Ireland.
In recent times, in connection with the considerable increase in the number of new drugs on the European market, many
countries have opted for a similar solution, such as: Bulgaria, Latvia, Malta, Luxembourg, Italy, Cyprus, Lithuania,
Denmark, France and Norway [EMCDDA, 2013].
The solutions proposed under this amendment, which assume a diverse approach to given substances because of their
level of harm, assessed on the basis of scientific risk assessment, is consistent with the solutions contained in the
proposal from the European Commission concerning a Directive of the European Parliament and of the Council
amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the
constituent elements of criminal acts and penalties in the field of illicit drug trafficking, as regards the definition of drugs
[COM/2013/0618] and the Regulation of the European Parliament and of the Council on new psychoactive substances
[COM(2013) 619]. The Commission proposes to introduce different reactions depending on the risk to public health
caused by a particular substance. And so, according to the above-mentioned draft documents, medium-hazard substances
are subject to restrictions on the consumer market, whilst substances causing a threat to public health shall, to a large
extent, be subject to criminal penalties. In the present amendment to the Act, designer drugs and new psychoactive
substances correspond to the first of the cited groups, whilst narcotic drugs and psychotropic substances correspond to
the second of the cited groups. As part of the proposed solutions contained in the processed amendment to the Act,
designer drugs and new psychoactive substances are banned for sale on the consumer market, with penalties of an
administrative nature. On the other hand, narcotic drugs and psychotropic substances are controlled on the basis of penal
legislation under the Drug Prevention Act of 29 July 2005.
Furthermore, the referred to Act implements a risk assessment system that relates to new psychoactive substances. This is
part of a rational and evidence based policy towards new psychoactive substances; this policy has been employed for
many years by most European countries. According to data published in the European Monitoring Centre for Drugs and
Drug Addiction [EMCDDA 2009, p. 26] which is dedicated to making new psychoactive substances subject to legal
control, in Europe a total of 20 countries hold risk assessment procedures. Of these 20 countries, 6 countries have
implemented risk assessment regulations into their national drug legislation [Denmark, Germany, Estonia, France,
Holland and Great Britain]. In the remaining cases, the conduct of risk assessment stems from different legal acts or is
not regulated, but applied in the preparation of legal changes in relation to substance control.
Source:
1) EMCDDA Legal Responses to New Psychoactive Substances in Europe, European Monitoring Centre for Drug
Addiction, 2009 Lisbon,
2) EMCDDA Perspectives on drugs: legal approaches to controlling new psychoactive substances. 2014. EMCDDA
| Perspectives on drugs: legal approaches to controlling new psychoactive substances. [ONLINE] Available at:
http://www.emcdda.europa.eu/topics/pods/controlling-new-psychoactive-substances. [10.01.2014].
4. Entities impacted by the draft
Group
Organisational
units
reporting to the Minister of
Internal
Affairs,
performing operational and
exploratory activities in the
fight against crimes related
to illegal trafficking in
narcotic
drugs,
psychotropic
substances
and designer drugs.
State Sanitary Inspection
authorities,
supervising
compliance
with
the
prohibition
on
the
manufacture and marketing
of designer drugs and new
psychoactive substances.
Size
21
State Sanitary Inspection at
the Ministry of Internal
Affairs.
16
Organisational units of the
Customs
Service
supervising foreign trade.
154
Undertakings
exempted
from Article 84c(5) of the
Freedom of Economic
Activities
Act
of
2 July 2004 concerning the
supervision of prohibitions
defined
under
Article 44b(1) of the Drug
Prevention
Act
of
29 July 2005.
All undertakings
344
Source of data
Ministry of Internal Affairs
data
Impact
Effective struggle in combating
crimes related to illegal
trafficking in narcotic drugs,
psychotropic substances and
designer drugs.
Chief Sanitary Inspectorate data Increasing the effectiveness of
sanitary inspectors. Regulation
includes the application of
administrative law as an
effective instrument in the
opinion of international experts
who recommend a wider range
of legal solutions in the field of
drug addiction prevention.
Ministry of Internal Affairs
Increasing the effectiveness of
and Chief Sanitary Inspectorate sanitary inspectors. Regulation
data
includes the application of
administrative law as an
effective instrument in the
opinion of international experts
who recommend a wider range
of legal solutions in the field of
drug addiction prevention.
Ministry of Finance data
Preventing the importation into
the Republic of Poland of
designer drugs and new
psychoactive substances.
Ministry of Health data
The effectiveness of tasks
performed by sanitary
inspectors.
Growers and processors of
hemp.
The
manufacturers
of
medicinal products and
entities
operating
pharmaceutical
wholesalers,
pharmacies
and para pharmacies. The
draft Regulation will also
impact those persons that
purchase
medicinal
products
containing
pseudoephedrine,
by
limiting the possibility of
dispensing
“OTC”
medicinal products whose
composition
contains
psychoactive substances,
thus establishing maximum
content in the medicinal
product required for the
purpose of performing
effective therapy over a
given period of time for the
safe treatment of one
person, constituting a limit
in the dispensing of
medicinal products sold at
any one time.
National Office for the
Prevention
of
Drug
Addiction
25 (cultivation surface,
134 ha)
Ministry of Agriculture and
Rural Development data
pharmacies and para
pharmacies – total of
14 789
Health Protection Information
Systems Centre data
wholesalers – 608
Health Protection Information
Systems Centre data
producers – 250
Chief Pharmaceutical
Inspectorate data
1
National Office for the
Prevention of Drug Addiction
Allowing domestic and foreign
entities to continue conducting
business activities involving
the processing and cultivation
of hemp for fibre in Poland.
Facilitating
the
business
activities of entities wishing to
simultaneously pursue the
cultivation and processing of
hemp, by restoring under
national law the option,
previously regulated by the
EU, involving a mechanism of
subsidies for the processing of
straw into fibre.
The amount and type of duties
imposed on hemp for fibre
growers will not change;
however, in the case of
processors, it will be adapted
by the need to obtain
authorisation
from
the
Agricultural Market Agency
and
to
present
such
authorisation at the appropriate
Marshal's Office.
The Regulation will impact
pharmacies
and
para
pharmacies which, in the event
of failure to comply with the
standard under Article 71a(2),
will have to pay an
administrative penalty of up to
PLN 50 000, imposed by the
Regional
Pharmaceutical
Inspector, as proposed under
the added Article 129c of the
Pharmaceutical Act.
The proposed amendments
will not impact in any
significant
manner
the
functioning of the Office for
the Prevention of Drug
Addiction.
Furthermore,
implementation of a definition
of
new
psychoactive
Council for the Prevention
of Drug Addiction
Medical entities
Organisational
units
supporting the family and
foster care system, family
assistants, foster families
and persons running family
orphanages
1
National Office for the
Prevention of Drug Addiction
300 (estimated value)
National Office for the
Prevention of Drug Addiction
Daily support facilities
– 1 602
Ministry of Labour and Social
Policy
Fostering, related, nonprofessional,
professional families
and family orphanages
– 40 260
Care and educations
sites – 918
Family assistants –
3 012
substances
specifies
the
currently binding provisions
and helps to apply them in
practice.
The proposed amendments
will not impact in any
significant
manner
the
functioning of the Council for
the Prevention of Drug
Addiction.
Furthermore,
implementation of a definition
of
new
psychoactive
substances
specifies
the
currently binding provisions
and helps to apply them in
practice.
The proposed amendments
will not impact in any
significant
manner
the
functioning of medical entities.
The currently functioning
provisions under Article 24b of
the Drug Prevention Act and
the Regulation of the Minister
of Health of 17 October 2013
on the scope and manner of
cooperation of medical entities
providing
treatment
or
rehabilitation to persons using
narcotic drugs or psychotropic
substances and the Office for
the Prevention of Drug
Addiction assume that data on
non-classified substances will
also be collected. In practical
terms, this means that the
scope of work and burdens
placed on medical entities will
not change.
The Regulation expands the
catalogue
of
entities
performing tasks on the
prevention of drug addiction to
include organisational units
that support families, the foster
care system, family assistants,
foster families and persons
running family orphanages, in
consideration of the fact that
the prevention of drug
addiction
is
particularly
important amongst persons at
risk of becoming socially
excluded, and who find
support primarily in family
care and foster family units.
Children who are covered by
the present system usually
come
from dysfunctional
families, and thus the level of
risk of addiction to both
alcohol and narcotic drugs or
designer drugs is very high.
5. Information on the scope, duration and summary of results of the consultation
Concerning the above-mentioned draft Act, so-called pre-consultations took place with the Chief Sanitary Inspector, the
National Office for the Prevention of Drug Addiction, the Supreme Chamber of Medicine, the Institute of Forensic
Research in Krakow and the Medical University of Warsaw.
The term of planned consultation was set at 30 days.
The draft Act on the amendment of the Drug Prevention Act and some other Acts, which was developed at the consensus
conference on 11 June 2014, was sent back for public consideration and consultation with a three-day deadline for the
submission of comments.
The draft Act was submitted for public consultation to the following entities:
1. Prezes Prokuratorii Generalnej Skarbu Państwa (The Attorney General of the State Treasury);
2.
Naczelna Rada Lekarska (The Supreme Medical Council);
3.
Naczelna Rada Pielęgniarek i Położnych (The Supreme Council of Nurses and Midwives),
4.
Naczelna Izba Aptekarska (The Polish Pharmaceutical Chamber);
5.
Krajowa Izba Diagnostów Laboratoryjnych (The National Chamber of Laboratory Diagnosticians);
6.
Instytut Psychiatrii i Neurologii w Warszawie (The Institute for Psychiatry and Neurology in Warsaw),
7.
Krajowe Biuro do Spraw Przeciwdziałania Narkomanii (The National Office for the Prevention of Drug Addiction);
8.
Główny Inspektorat Sanitarny (The Chief Sanitary Inspectorate);
9.
Główny Inspektorat Farmaceutyczny (The Chief Pharmaceutical Inspectorate);
10. Państwowa Agencja Rozwiązywania Problemów Alkoholowych (The State Agency for Prevention of Alcohol
Related Problems);
11. Helsińska Fundacja Praw Człowieka (The Helsinki Foundation for Human Rights);
12. Fundacja Batorego (The Stefan Batory Foundation);
13. Stowarzyszenie Monar (The “Monar” Association);
14. Polska Sieć Polityki Narkotykowej (The Polish Drug Policy Network);
15. Polskie Towarzystwo Zapobiegania Narkomanii (The Polish Society for the Prevention of Drug Abuse);
16. Krajowy Konsultant w dziedzinie psychiatrii (The National Consultant for Psychiatry);
17. Krajowemu Konsultantowi w dziedzinie toksykologii klinicznej (The National Consultant for Clinica Toxicology);
18. Gdański Uniwersytet Medyczny (The Medical University of Gdańsk);
19. Polska Izba Przemysłu Chemicznego (The Polish Chamber of the Chemical Industry);
20. Polskie Stowarzyszenie Producentów Kosmetyków i Środków Czystości (The Polish Association of Producers of
Cosmetics and Cleaning Agents);
21. Stowarzyszenie Inżynierów i Techników Przemysłu Chemicznego (The Polish Association of Chemical Engineers);
22. Polskie Stowarzyszenie Przetwórców Tworzyw Sztucznych (The Polish Association of Plastic Manufacturers);
23. Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (The Office for the
Registration of Medicinal Products, Medical Devices and Biocidal Products);
24. Instytut Chemii Przemysłowej (The Institute of Industrial Chemistry);
25. Instytut Przemysłu Organicznego (The Organic Industry Institute);
26. Federacji Związków Pracodawców Ochrony Zdrowia “Porozumienie Zielonogórskie” (The Federation of Health
Protection Employer Unions);
27. Ogólnopolski Związek Zawodowy Lekarzy (The National Trade Union of Doctors);
28. Ogólnopolski Związek Zawodowy Pielęgniarek i Położnych (The National Trade Union of Nurses and Midwives);
29. Krajowy Sekretariat Ochrony Zdrowia NSZZ “Solidarność” (The “Solidarity” National Secretariat for Health
Protection);
30. Instytut Włókien Naturalnych i Roślin Zielarskich (The Institute of Natural Fibres and Medicinal Plants);
31. Polska Izba Lnu i Konopi (The Polish Chamber of Flax and Hemp);
32. Biuro do spraw Substancji Chemicznych (The Bureau For Chemical Substances);
33. Narodowy Instytut Leków (The National Medicines Institute);
34. Instytut Ekspertyz Sądowych w Krakowie (The Institute of Forensic Research in Krakow);
35. Warszawski Uniwersytet Medyczny (The Medical University of Warsaw);
36. Federacja Związków Zawodowych Pracowników Ochrony Zdrowia i Pomocy Społecznej (The Health Care and
Social Welfare Federation of Trade Unions);
37. The Business Centre Club;
38. Izba Gospodarcza “Apteka Polska” (The “Polish Pharmacy” Chamber of Commerce);
39. Izbie Gospodarczej Właścicieli Punktów Aptecznych i Aptek (The Chamber of Commerce of Proprietors of
Pharmacies and Para Pharmacies);
40. Izba Gospodarcza “Farmacja Polska” (The “Polish Pharmacy” Chamber of Commerce);
41. Konfederacja Pracodawców Polskich (The Federation of Polish Employers);
42. Ogólnopolskie Porozumienie Związków Zawodowych (The All-Poland Alliance of Trade Unions);
43. Polska Izba Zielarsko-Medyczna i Drogeryjna (The Polish Chamber of Herbal-Medical and Drugs);
44. Polska Konfederacja Pracodawców Prywatnych The “Lewiatan” Polish Federation of Private Employers);
45. Polski Związek Pracodawców Przemysłu Farmaceutycznego (The Polish Union of Pharmaceutical Industry
Employers);
46. Polski Związek Producentów Leków bez Recepty PASMI (The Polish Association of Producers on Non-prescription
Medicines);
47. Stowarzyszenie Farmaceutów Szpitalnych (The Association of Hospital Pharmacists);
48. Stowarzyszenie Importerów Równoległych Produktów Leczniczych (The Association of Importers of Parallel
Medicinal Products);
49. Związek Pracodawców Innowacyjnych Firm Farmaceutycznych “INFARMA” (The Employers’ Association of
Innovative Pharmaceutical Companies INFARMA);
50. Narodowy Fundusz Zdrowia (The National Health Fund);
51. Centralne Laboratorium Kryminalistyczne Komendy Głównej Policji (The Central Forensic Laboratory of the
Police);
52. Komenda Główna Policji (Polish General Police Headquarters);
53. Mr Patryk Pankowski, professional lobbyist;
54. Mr Jędrzej Sadowski, professional lobbyist;
55. Prezes Urzędu Ochrony Konkurencji i Konsumentów (President of the Office of Competition and Consumer
Protection);
56. Rada Działalności Pożytku Publicznego (The Public Benefit Council).
Consultation findings were presented in the consultation report.
6. Impact on the public finances sector
(fixed prices for …… (year))
Total revenue
State budget
JST (local government unit)
remaining units (treated
separately)
Total expenditure
State budget
Impact over 10 years from the entry into force of the amendments [PLN thousands]
0
1
2
3
4
5
6
7
8
9
10
Total (0-10)
243
243
0
243
243
0
243
243
0
243
243
0
243
243
0
243
243
0
243
243
0
243
243
0
243
243
0
243
243
0
2 430
2 430
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
JST (local government unit)
remaining units (treated
separately)
Total balance
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
243
243
243
243
243
243
243
243
243
243
2 430
State budget
243
243
243
243
243
243
243
243
243
243
2 430
0
0
0
0
0
0
0
0
0
0
0
JST (local government unit)
remaining units (treated
0
0
0
0
0
0
0
0
0
0
0
separately)
Implementation of the Act on the amendment of the Drug Prevention Act and some other Acts
does not have any additional impact on the State budget. The employment of one employee at
the Chief Pharmaceutical Inspectorate will be covered under budget part 46 – Health, section
851 – Health Protection, chapter 85133 – Pharmaceutical Inspection.
The entry into force of the draft Act will lead to an increase in State budget revenue, as
Regulation under Article 39(8) anticipates that fees will be collected for the submission of
applications requesting permission for the manufacturing, processing, treating, using and intraCommunity supply of category 1 and 4 narcotic drugs, psychotropic substances and precursors,
as well as the replacement of these authorisations or permits.
Tests carried out on designer drugs and new psychoactive substances introduced into the
Republic of Poland, disclosed by the Customs Service, will be covered through budget part 19 –
Customs Service, chapter 75013. This Regulation concerns supervision, including the
performance of controls by State Sanitary Inspection and the operation of the Risk Assessment
Team – danger to health and life brought about by new psychoactive substances, will not lead to
an additional burden on regional budgets in terms of financing the Sanitary and Epidemiology
Stations and the Minister of Health Chief Sanitary Inspectorate budget. Team members shall
not be paid for participating in the above-mentioned Team; however, their travel costs will be
returned. Costs connected with the functioning of the Team will be covered from the financial
resources of the Minister of Health, whilst the cost of administrative services will be covered
from Chief Sanitary Inspectorate resources. Costs involving the destruction and performance of
tests on designer drugs and new psychoactive substances will be covered by the party to the
proceedings, and in unjustified cases, through the financial resources of the Chief Sanitary
Source of financing
Inspector. Any potential costs connected with the performance of tests carried out by units with
reporting duties to the Minister of the Interior and which are notified to the Minister of the
Interior State Sanitary Inspection, pursuant to Article 241(1)(2) of this Act, shall be financed by
the State budget as part of planned expenditure under part 42 – Internal Affairs without the need
to increase them, whilst the entry into force of the draft Act will not constitute a basis for
applying for additional resources for this purpose.
The setting up of conditions by the Minister of National Defence for the performance of
scientific research on drug addiction and epidemiological tests, will not lead to greater financial
impact. Furthermore, epidemiological tests may be carried out by research institutes which, as
part of their statutory activities, carry out scientific research and development on an ongoing
basis for the needs of the Armed Forces of the Republic of Poland. Sociological studies in the
field of social service are performed as part of the understanding of social processes and
phenomena taking place in the Armed Forces of the Republic of Poland and, additionally,
significant in terms of national safety and defence provided by the Military Office for Social
Studies at the Military Centre for Civilian Education. The research also covers risks connected
with addiction to psychoactive substances in military surroundings; the costs of this activity are
accounted for in the plans of the Military Centre for Civilian Education.
The proposed amendment, which involves expanding the catalogue of entities performing tasks
on the prevention of drug addiction to include organisational units that support families, the
foster care system, family assistants, foster families and persons running family orphanages,
does not assume the submission of applications requesting additional resources. If a local
government unit decides to train employees belonging to the above-mentioned units, the costs
will be covered with the use of the currently held financial resources.
Additional
Costs connected with the employment of a new employee shall be financed within the limit on
information, including remuneration calculated for the payment of remuneration in budget part 46 – Health.
identification of data
The cost of testing products, for which there is good reason to believe that they are designer
sources and
drugs or new psychoactive substances, confiscated by the Customs Service, will be financed
assumptions made in
through budget part 19 – Customs Service chapter 75013.
the calculation
It is estimated that the Customs Service will perform around 300 tests on these products which,
at an average cost per test of PLN 600, should not exceed PLN 180 000.
New revenue stems from an increase of 25 % (inflation) in the level of fees for:
– the submission of an application requesting the issue of a permit to engage in the wholesale,
manufacture, processing, treatment or use for research purposes of narcotic drugs, psychotropic
substances or precursors belonging to category 1 – (15 000 in revenue for the previous year –
annual increase in revenue of 4 000),
– the submission of an application requesting change of permit, referred to above; (39 000 in
revenue for the previous year – annual increase in revenue of 10 000),
– the submission of an application requesting the issue of a permit to import, export, engage in
the intra-Community acquisition or supply of narcotic drugs or psychotropic substances,
including precursors belonging to category 1 and changes relating to these permits (162 000 in
revenue for the previous year – annual increase in revenue of 40 000).
Additionally, the new revenue stems from the definition of new types of permits: – PLN 750 for
submitting an application requesting the issue of a permit to cultivate poppy and hemp,
performed by research institutions and the Research Centre for Cultivar Testing – it is estimated
that there might be around 10 entities interested in the cultivation of hemp; (revenue for 10
years of PLN 70 000) – PLN 750 for submitting an application requesting the issue of a permit
to collect poppy milk, opium from poppy seed and non-fibrous cannabis herb or resin – it is
estimated that there might be around 10 entities interested in the above-mentioned permits;
currently one entity has come forward; (revenue for 10 years of PLN 70 000); – PLN 100 for
submitting an application requesting the issue of a permit to transport out category 4 precursors;
it is estimated that there might be around 350 entities interested in obtaining a permit; these will
apply for a permit on a multiple basis (around five times a year), each time they engage in
transporting out of the EU (annual revenue of around PLN 175 000 – PLN 1 750,000 for 10
years). In total – new revenue over 10 years of PLN 2 430 000.
7. Impact on competitiveness of the economy and enterprise, including the functioning of enterprises and impact
on families, citizens and households
Time in years since entry into force of
the changes
In monetary
large enterprises
terms
micro-, small and
(in PLN mln,
medium-sized
(fixed prices
enterprises sector
for …… (year)) family, citizens and
households
In nonlarge enterprises
monetary terms
micro-, small and
medium-sized
enterprises sector
family, citizens and
households
Immeasurable
Additional
information, including
identification of data
sources and
assumptions made in
the calculation
0
Effects
1
2
3
5
10
Total (0-10)
The Regulation will improve the functioning of the market in terms of the legal
application of new psychoactive substances, by providing greater legal
certainty for operators. The Regulation will not increase the administrative
burden and disclosure obligations of large enterprises.
The Regulation will not increase the administrative burden and disclosure
obligations of enterprises. The Regulation will improve the functioning of the
market in terms of the legal application of new psychoactive substances, by
providing greater legal stability for operators.
The Regulation protects consumers against new harmful substances; it will
improve safety with respect to public health.
The draft Act shall not impact directly competitiveness of the economy; however, amendment
of the provisions on the cultivation and processing of hemp for fibre may have a positive impact
on enterprise and the functioning of undertakings engaged in processing.
New psychoactive substances that constitute a serious threat to public health may be subject to
limitation, both on the consumer and commercial markets; this means that it will be possible to
apply them for permissible industrial and commercial purposes and for scientific research and
development.
8. Change of regulatory burden (including disclosure obligations) resulting from the draft
not applicable
Burdens are placed outside those strictly required by the
EU (see reverse side of the compatibility table for
details)
reduction in the number of documents
reduction in the number of procedures
shortening the time for settling a case
other:
yes
no
not applicable
increase in the number of documents
increase in the number of procedures
extending the time for settling a case
other:
The implemented burdens are adapted to their
electronisation.
yes
no
not applicable
Comment:
9. Impact on the labour market
Under the draft Act, the proposed amendment to the provisions on the cultivation and processing of hemp for fibre will
have a positive impact on maintaining employment in areas where fibrous hemp is cultivated and processed.
10. Impact on other aspects
environment
regional standing and
development
other:
Discussion of impact
demography
State property
computerisation
health
Under the draft Act, the proposed amendment to the provisions on the cultivation and
processing of hemp for fibre may have a positive impact on regional standing and development
in areas where fibrous hemp is cultivated and processed.
The draft Regulation will contribute to the reduced availability of narcotic drugs, psychotropic
substances, new psychoactive substances and designer drugs and limit damage to human health
caused by the same. However, under the draft Act, the proposed amendment to the provisions
on the cultivation and processing of hemp for fibre will have no impact on the health of the
population.
Furthermore, implementation of the Regulation shall contribute to improving the health security
of citizens. By limiting the wholesale purchase of medicinal products whose composition
contains pseudoephedrine to be used as a psychotropic substance or as a precursor for making
such substances, market demand for these kinds of products will be decreased. The Regulation
shall not limit access to medicinal products and their safe use for medical purposes.
11. Planned performance of the provisions of the act
It is planned that the Act will enter into force on 1 June 2015, with the exception of regulations which refer to the
Pharmaceutical Act of 6 September 2001; it is proposed that these come into force on 1 January 2017 because of the need
to adapt any marketing permits for specific medicinal products.
12. How and when will the impact of the draft be evaluated and what measures will be applied?
The effects of the Drug Prevention Act and some other Acts will be visible once it has come into force. There will be
greater effectiveness of measures aimed at limiting trade in so-called legal stimulants, the procedures connected with
State Sanitary Inspection capacity to control undertakings that place on the market new psychoactive substances will be
facilitated, and citizens will be protected against products and substances that are dangerous for their health. A gauge
which may serve the purpose of assessment will be the number of initiated administrative procedures and the number of
enforced penalties connected with the marketing of designer drugs, as well as the number of hospitalisations connected
with the use of designer drugs and new psychoactive substances.
13. Annexes (important source documents, research, analyses etc.)
None.