Notification Detail

The draft Act on the amendment of the Drug Prevention Act and some other Acts

Notification Number: 2014/621/PL (Poland)
Date received: 11/12/2014
End of Standstill: 14/01/2015
Invocation of the Emergency Procedure: Yes

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Message 002

Communication from the Commission - TRIS/(2014) 03672
Directive 98/34/EC
Translation of the message 001
Notification: 2014/0621/PL

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Nao inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 201403672.EN)

1. Structured Information Line
MSG 002 IND 2014 0621 PL EN 11-12-2014 PL NOTIF



2. Member State
PL


3. Department Responsible
Departament Regulacji Gospodarczych, Ministerstwo Gospodarki,
Plac Trzech Krzyży 3/5, 00-507 Warszawa,
tel. +48-22/693-5407, fax: +48-22/693-4025, e-mail: notyfikacja@mg.gov.pl


3. Originating Department
Ministerstwo Zdrowia - Zastępca Dyrektora Departamentu Zdrowia Publicznego - Justyna Mieszalska, tel. +48-22/53 00 318, j.mieszalska@mz.gov.pl; dep-zp@mz.gov.pl


4. Notification Number
2014/0621/PL - C00P


5. Title
The draft Act on the amendment of the Drug Prevention Act and some other Acts


6. Products Concerned
Designer drugs and new psychoactive substances, so-called ‘legal highs’, medicinal products which contain in their composition psychoactive substances.


7. Notification Under Another Act
-


8. Main Content
The draft Act places under statutory control 114 new substances containing psychoactive effect i.e. affecting the central nervous system, by supplementing the list of Schedule I-N Narcotic Drugs and groups I-P, II-P, IV-P psychotropic substances, constituting Annexes 1 and 2 of the Drug Prevention Act of 29 July 2005 (Journal of Laws of 2012(124)). These are as follows:
1. synthetic cannabinoids: JWH–015, JWH–098, JWH–251, JWH–307, JWH-166, JWH-201, JWH-208, JWH-302, JWH-368, AM–2201, 3–(4–hydroxymethyl benzoilo)–1–pentyloindo, 5-FUR-144, A-834,735, AM-2233, AM-1248, APICA, APINACA, MAM-2201, RCS-2, UR-144, AB-001, EAM-2201 (5-fluoro JWH-210), 5F-AKB-48, 5F-PB-22, AM-1220, AB-FUBINACA, STS-135, QUCHIC, QUPIC, THJ-018;
2. cathinone derivatives: 3–FMC, 3,4–DMMC, pentedrone, buphedrone, ethcathinone, pentylone, MPBP, pMPPP, brephedrone, 4-methyl buphedrone (methylbuphedrone), dibutylone, α-PPP, ethyone, 3-MMC, iso-pentedrone, α-PVP, αPBP (1–phenyl–2–(pirrolidine–1–yl)butane–1–on), MDPBP (3,4 methylenedioxy pyrrolidine butyrophenone), NEB, 4-BEC, 4-Cl-α-PPP, α-PHP, hexadrone, Eutylone, MDPPP;
3. phenylethylamine derivatives: 2C-G, 2C-N, 25C-NBOMe (2C-C-NBOMe), 25D-NBOMe, 25E-NBOMe, 25G-NBOMe, 25N-NBOMe, 2C-D, 2C-P, 2C-C, 25H-NBOMe, 25I-NBOMe, 25B-NBOMe, 4-MA, TMA-6, proscaline, MMDPEA (3-metox-4,5-methylenedioxy phenethylamine), 25i-NBMD;
4. piperazine derivatives: DBZP, MeOPP, mCPP;
5. piperidine derivative: 2-DPMP;
6. tryptamine derivatives: 4-AcO-DiPT, 4-AcO-DMT, 5-MeO-DALT, 5-MeO-DMT, 4-HO-MET, 4-AcO-MET, 4-HO-DiPT, 5MeO-MiPT;
7. other chemical substances: D2PM, 2–AT (2-aminotetraline), 2–AI (2-aminoindane) ethylphenidate, methoxetamine MXE, 3-MeO-PCE, 5-IT 5- (2-aminopropyl) indole, dimethocaine, fluorotropacocaine (p-FBT, p-fluorobenzoiloxytropane), zaleplon, zopiclone, tapentadol, RH-34, 6-APDB, 5-APB, 5-MAPB, MPA, 6-APB, Butyrfentanyl, synthacaine, camfetamine, 4-fluoro-butyr-fentanyl, 3-MeO-PCP, mitragynine, Salvinorin A 3F MA-AH-7921, MT-45, nalbuphine.
The project also introduces the definition of new psychoactive substance.
The amendments in points 22 and 23 of the draft, which provide new wording to Article 44b and add Article 44d to the Drug Prevention Act, prohibit the production and the placing on the market in the Republic of Poland of new psychoactive substances and prohibit the importation of designer drugs (currently, only production and placing on the market are prohibited).
Furthermore, the draft anticipates amendment of the Pharmaceutical Act of 6 September 2001 (Journal of Laws of 2008, No 45(271), as amended) by implementing regulations which limit the possibility of dispensing “OTC” medicinal products whose composition contains psychoactive substances, thus establishing the maximum content of the above substances, which is required for the purpose of performing effective therapy, over a given period of time for safe treatment of one person, and limiting the quantity which may be purchased at any one time. The exception are medicinal products whose composition contains psychoactive substances that are available over-the-counter, and for which the maximum content of psychoactive substances prescribed by doctors has been determined. The dispensing of medicinal products without limit when the maximum levels of psychoactive substances have been determined shall be subject to a financial penalty of up to PLN 50 000. It is proposed to approve the following limits: 720 mg for pseudoephedrine, 150 mg for codeine, 200 mg for dextromethorphan dispensed in packaging which may be purchased at any one time.


9. Brief Statement of Grounds
The draft Act on the Amendment of the Drug Prevention Act and certain other Acts were drawn up because of the need to place under statutory control psychoactive substances which have been detected in samples seized from shops offering ‘legal highs’. The Annexes to the Drug Prevention Act, which contain lists of narcotic drugs and psychotropic substances, have been expanded by 114 new substances, whose use not only endanger the health and life of individuals, but also entail a risk to public health. Bearing in mind the increasing number of suspected cases of poisoning with the abovementioned substances and the confirmed deaths having a causal link with the use of ‘legal highs’, it appears that the statutory control proposed in the abovementioned draft Act is the most effective and proportionate means of controlling this threat to public health.
Inclusion in the draft Act of the definition of a new psychoactive substance is justified under Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances and takes into account changes in the actual state of affairs, which took place in 2010. The market for ‘legal highs’, which previously occurred in various forms, has changed and now these drugs are advertised and promoted in terms of their content of substances which act on the central nervous system.
The draft also introduces a ban on the manufacture, import and marketing in the Republic of Poland of new psychoactive substances and prohibits the import of designer drugs (currently, only production and placing on the market are prohibited). The lack of regulations on the import of the above substances leads to their influx in wholesale quantities, following by their marketing in Poland. Provisions that prohibit importing the above are intended to send a clear message that designer drugs and new psychoactive substances are harmful substances. The proposed regulations may lead to an unquestionable reduction in the influx on the Polish market of products that are dangerous to life and health and eliminate their inflow from third countries.
Amendments to the Pharmaceutical Act have been introduced due to the need to reduce the availability of OTC medicinal products whose composition contains psychoactive substances used for non-medical purposes and the manufacture of drugs. Given the scale of the non-medical use of medicinal products which contain psychoactive substances, mainly used by children and adolescents for intoxication purposes, and the use of pseudoephedrine by organized crime in the production of methamphetamine, it is necessary to take immediate action in order to limit the sale of these products. Despite the fact that large numbers of poisonings have not been noted with the use of these medicinal products, in many cases their use can lead to addiction and serious problems with health. Under the draft Act the proposed solutions anticipate that the retail trade in medicinal products which contain in their composition psychoactive substances with ‘over the counter (OTC)’ availability category in the form of single sales transactions, are subject to limitation because of the maximum content of psychoactive substances required for the purpose of performing effective therapy over a given period of time for the safe treatment of one person, with the exception of medicinal products prescribed by a doctor. The maximum level of the abovementioned substances in the form of unit packaging of the medicinal product shall be determined by the Minister of Health by way of regulation. It is planned that regulations limiting the dispensing of OTC medicinal products in terms of their maximum level of psychoactive substances will come into force on 1 January 2017; this approach will furnish those entities that place medicinal products on the market with a transition period and permit them to adapt any marketing permits and registration documents. Up to the time that the new regulations come into force it is planned to implement provisions that limit sales to one item of packaging per transaction for medicinal products which contain pseudoephedrine, dextromethorphan or codeine, in other words those substances that are currently most frequently used for non-medical purposes and the manufacture of methamphetamine.
In addition, bearing in mind the safety of patients in the so-called ‘self-healing’ process, the draft assumes an obligation on the part of pharmacists and pharmaceutical technicians to provide information on how to dose and the possible risks and side effects associated with the use of dispensed medicinal products which contain psychoactive substances.


10. Reference Documents - Basic Texts
References to basic texts: The Drug Prevention Act of 29 July 2005 (Journal of Laws of 2012(124)), the Pharmaceutical Act of 6 September 2001 (Journal of Laws of 2008, No 45(271), as amended)
The basic texts were submitted under an earlier notification: 2011/007/PL


11. Invocation of the Emergency Procedure
Yes


12. Grounds for the Emergency
The proceeded regulations have been drawn up because of the urgent need to limit the placing on the market of psychoactive substances that are dangerous to life and health i.e. substances that affect the central nervous system, and the use for non-medical purposes, primarily by children and adolescents, of psychoactive substances contained in medicinal products.
The dynamic development of this phenomenon and the fact that there is no real State control in the current binding law regarding the marketing of the abovementioned substances or products which contain these substances, leads to a serious threat to the lives and health of citizens, especially minors.
In recent times the observable sharp increase in the number of cases of poisoning with ‘legal highs’ (in 2012 a total of 279 cases of poisoning was reported, in 2013 there were 1079, whilst in the period January-September 2014 there were 1645) and the cases of death which could have had a causal connection with the use of the abovementioned substances, are an indication of the urgent need to implement and notify the proposed regulations. The dramatic growth in the number of cases of poisoning in the last few months and the escalation of the problem constitute unforeseeable circumstances. Bearing in mind the above, the main purpose of the draft is to place State control over substances whose presence has been found in shops offering ‘legal highs’; this constitutes the most effective and proportional means of controlling the threat to public health.
Furthermore, bearing in mind the fact that adolescents take medicines in the ‘over the counter (OTC)’ availability category with the purpose of intoxicating themselves, which in turn may lead to addiction and serious health problems, the draft contains regulations that limit the possibility of purchasing the abovementioned products. Additionally, medicinal products whose composition contains pseudoephedrine, are purchased from pharmacies in ‘wholesale’ quantities and used for the production of methamphetamine, which constitutes a huge problem throughout Europe.
All of the above circumstances connected with the uncontrolled use of dangerous substances, because of the rapid growth of the problem, currently constitute a real threat to public health, primarily to the life and health of consumers.


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
Yes


16. TBT and SPS aspects
TBT aspects

NO – the draft shall have no significant impact on international trade.

SPS aspects

NO – the draft shall have no significant impact on international trade.




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European Commission

Contact point Directive 98/34
Fax: +32 229 98043
email: dir83-189-central@ec.europa.eu

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