EN Official Journal of the European Union L 127/32

COUNCIL DECISION 2005/387/JHA

of 10 May 2005

on the information exchange, risk-assessment and control of new psychoactive substances

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Articles 29, 31(1)(e) and 34 (2)(c) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament (1),

Whereas:

(1) The particular dangers inherent in the development of psychoactive substances require rapid action by the Member States.

(2) When new psychoactive substances are not brought within the scope of criminal law in all Member States, problems may arise in cooperation between the judicial authorities and law enforcement agencies of Member States owing to the fact that the offence or offences in question are not punishable under the laws of both the requesting and the requested State.

(3) The European Union Action Plan on Drugs 2000-2004 provided for the Commission to organise an appropriate assessment of the Joint Action of 16 June 1997 concerning the information exchange, risk assessment and the control of new synthetic drugs (2) (herineafter ‘the Joint Action’) taking into account the external evaluation commissioned by the European Monitoring Centre on Drugs and Drug Addiction (hereinafter ‘the EMCDDA’) of the early warning system. The assessment showed that the Joint Action had fulfilled its expectations. Nevertheless, the outcome of the assessment made it clear that the Joint Action was in need of reinforcement and reorientation. In particular, its main objective, the clarity of its procedures and definitions, the transparency of its operation, and the relevance of its scope had to be redefined. The Communication from the Commission to the European Parliament and the Council on the mid-term evaluation of the EU Action Plan on Drugs (2000-2004) indicated that changes to the legislation would be introduced in order to enhance action against synthetic drugs. The mechanism as established by the Joint Action should therefore be adapted.

(4) New psychoactive substances can be harmful to health.

(5) The new psychoactive substances covered by this Decision may include medicinal products as defined in Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to veterinary medicinal products (3) and in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use (4).

(6) The information exchange under the early warning system, established under the Joint Action, has proved to be a valuable asset to the Member States.

(7) Nothing in this Decision should prevent Member States from exchanging information, within the European Information Network on Drugs and Drug Addiction (hereinafter ‘the Reitox network’), on emerging trends in new uses of existing psychoactive substances which may pose a potential risk to public health, as well as information on possible public health related measures, in accordance with the mandate and procedures of the EMCDDA.

(8) No deterioration of either human or veterinary health care as a result of this Decision will be permitted. Substances of established and acknowledged medical value are therefore excluded from control measures based on this Decision. Suitable regulatory and public health related measures should be taken for substances of established and acknowledged medical value that are being misused.

(9) In addition to what is provided for under the pharmacovigilance systems as defined in Directive 2001/82/EC and in Directive 2001/83/EC, the exchange of information on abused or misused psychoactive substances needs to be reinforced and appropriate cooperation with the European Medicines Agency (hereinafter ‘EMEA’) ensured. The United Nations Commission on Narcotic Drugs (hereinafter ‘CND’) Resolution 46/7 ‘Measures to promote the exchange of information on new patterns of drug use and on psychoactive substances consumed’, provides a useful framework for action by the Member States.

(10) The introduction of deadlines into every phase of the procedure established by this Decision should guarantee that the instrument can react swiftly and enhances its ability to provide a quick-response mechanism.

(11) The Scientific Committee of the EMCDDA has a central role in the assessment of the risks associated with a new psychoactive substance, it will for the purpose of this Decision be extended to include experts from the Commission, Europol and the EMEA, and experts from scientific fields not represented, or not sufficiently represented, in the Scientific Committee of the EMCDDA.

(12) The extended Scientific Committee that assesses the risks associated with new psychoactive substances should remain a concise technical body of experts, capable of assessing effectively all risks associated with a new psychoactive substance. Therefore the extended Scientific Committee should be kept to a manageable size.

(13) Since the objectives of the proposed action, namely to bring about an exchange of information, a risk-assessment by a scientific committee and an EU-level procedure for bringing notified substances under control, cannot be sufficiently achieved by the Member States and can therefore, by reason of the effects of the envisaged action, be better achieved at European Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Decision does not go what is beyond what is necessary in order to achieve those objectives

(14) In conformity with Article 34(2)(c) of the Treaty, measures based upon this Decision can be taken by qualified majority as these measures are necessary to implement this Decision.

(15) This Decision respects fundamental rights and observes the principles recognised by Article 6 of the Treaty and reflected in the Charter of Fundamental Rights of the European Union,

HAS DECIDED AS FOLLOWS:

Article 1

Subject matter

This Decision establishes a mechanism for a rapid exchange of information on new psychoactive substances. It takes note of information on suspected adverse reactions to be reported under the pharmacovigilance system as established by Title IX of Directive 2001/83/EC.

This Decision also provides for an assessment of the risks associated with these new psychoactive substances in order to permit the measures applicable in the Member States for control of narcotic and psychotropic substances to be applied also to new psychoactive substances.

Article 2

Scope

This Decision applies to substances not currently listed in any of the schedules to:

(a) the 1961 United Nations Single Convention on Narcotic Drugs, that may pose a comparable threat to public health as the substances listed in Schedule I or II or IV thereof, and

(b) the 1971 United Nations Convention on Psychotropic Substances, that may pose a comparable threat to public health as the substances listed in Schedule I or II or III or IV thereof.

This Decision relates to end-products, as distinct from precursors in respect of which Council Regulation (EEC) No 3677/90 of 13 December 1990 laying down measures to be taken to discourage the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic substances (5), and Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (6) provide for a Community regime.

Article 3

Definitions

For the purpose of this Decision the following definitions shall apply:

(a) ‘new psychoactive substance’ means a new narcotic drug or a new psychotropic drug in pure form or in a preparation;

(b) ‘new narcotic drug’ means a substance in pure form or in a preparation, that has not been scheduled under the 1961 United Nations Single Convention on Narcotic Drugs, and that may pose a threat to public health comparable to the substances listed in Schedule I, II or IV;

(c) ‘new psychotropic drug’ means a substance in pure form or in a preparation that has not been scheduled under the 1971 United Nations Convention on Psychotropic Substances, and that may pose a threat to public health comparable to the substances listed in Schedule I, II, III or IV;

(d) ‘marketing authorisation’ means a permission to place a medicinal product on the market, granted by the competent authority of a Member State, as required by Title III of Directive 2001/83/EC (in the case of medicinal products for human use) or Title III of Directive 2001/82/EC (in the case of veterinary medicinal products) or a marketing authorisation granted by the European Commission under Article 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (7);

(e) ‘United Nations system’ means the World Health Organisation (WHO), the Commission on Narcotic Drugs (CND) and/or the Economic and Social Committee acting in accordance with their respective responsibilities as described in Article 3 of the 1961 United Nations Single Convention on Narcotic Drugs or in Article 2 of the 1971 United Nations Convention on Psychotropic Substances;

(f) ‘preparation’ means a mixture containing a new psychoactive substance;

(g) ‘Reporting Form’ means a structured form for notification of a new psychoactive substance and/or of a preparation containing a new psychoactive substance agreed between the EMCDDA/Europol and their respective networks in the Member States’ Reitox and the Europol National Units.

Article 4

Exchange of information

1. Each Member State shall ensure that its Europol National Unit and its representative in the Reitox network provide information on the manufacture, traffic and use, including supplementary information on possible medical use, of new psychoactive substances and of preparations containing new psychoactive substances, to Europol and the EMCDDA, taking into account the respective mandates of these two bodies.

Europol and the EMCDDA shall collect the information received from Member States through a Reporting Form and communicate this information immediately to each other and to the Europol National Units and the representatives of the Reitox network of the Member States, the Commission, and to the EMEA.

2. Should Europol and the EMCDDA consider that the information provided by a Member State on a new psychoactive substance does not merit the communication of information as described in paragraph 1, they shall inform the notifying Member State immediately thereof. Europol and the EMCDDA shall justify their decision to the Council within six weeks.

Article 5

Joint Report

1. Where Europol and the EMCDDA, or the Council, acting by a majority of its members, consider that the information provided by the Member State on a new psychoactive substance merits the collection of further information, this information shall be collated and presented by Europol and the EMCDDA in the form of a Joint Report (hereinafter the ‘Joint Report’). The Joint Report shall be submitted to the Council, the EMEA and the Commission.

2. The Joint Report shall contain:

(a) a chemical and physical description, including the name under which the new psychoactive substance is known, including, if available, the scientific name (International Non-proprietary Name);

(b) information on the frequency, circumstances and/or quantities in which a new psychoactive substance is encountered, and information on the means and methods of manufacture of the new psychoactive substance;

(c) information on the involvement of organised crime in the manufacture or trafficking of the new psychoactive substance;

(d) a first indication of the risks associated with the new psychoactive substance, including the health and social risks, and the characteristics of users;

(e) information on whether or not the new substance is currently under assessment, or has been under assessment, by the UN system;

(f) the date of notification on the Reporting Form of the new psychoactive substance to the EMCDDA or to Europol;

(g) information on whether or not the new psychoactive substance is already subject to control measures at national level in a Member State;

(h) as far as possible, information will be made available on: (i) the chemical precursors that are known to have been used for the manufacture of the substance, (ii) the mode and scope of the established or expected use of the new substance, (iii) any other use of the new psychoactive substance and the extent of such use, the risks associated with this use of the new psychoactive substance, including the health and social risks.

3. The EMEA shall submit to Europol and the EMCDDA the following information on whether in the European Union or in any Member State:

(a) the new psychoactive substance has obtained a marketing authorisation;

(b) the new psychoactive substance is the subject of an application for a marketing authorisation;

(c) a marketing authorisation that had been granted in respect of the new psychoactive substance has been suspended.

Where this information relates to marketing authorisations granted by Member States, these Member States shall provide the EMEA with this information if so requested by it.

4. Member States shall provide the details referred to under paragraph 2 within six weeks from the date of notification on the Reporting Form as set out in Article 4(1).

5. The Joint Report shall be submitted no more than four weeks after the date of receipt of the information from Member States and the EMEA. The Report shall be submitted by Europol or the EMCDDA, as appropriate, in accordance with Article 5(1) and (2).

Article 6

Risk assessment

1. The Council, taking into account the advice of Europol and the EMCDDA, and acting by a majority of its members, may request that the risks, including the health and social risks, caused by the use of, the manufacture of, and traffic in, a new psychoactive substance, the involvement of organised crime and possible consequences of control measures, be assessed in accordance with the procedure set out in paragraphs 2 to 4, provided that at least a quarter of its members or the Commission have informed the Council in writing that they are in favour of such an assessment. The Member States or the Commission shall inform the Council thereof as soon as possible, but in any case within four weeks of receipt of the Joint Report. The General Secretariat of the Council shall notify this information to the EMCDDA without delay.

2. In order to carry out the assessment, the EMCDDA shall convene a special meeting under the auspices of its Scientific Committee. In addition, for the purpose of this meeting the Scientific Committee may be extended by a further five experts at most, to be designated by the Director of the EMCDDA, acting on the advice of the Chairperson of the Scientific Committee, chosen from a panel of experts proposed by Member States and approved every three years by the Management Board of the EMCDDA. Such experts will be from scientific fields that are not represented, or not sufficiently represented, in the Scientific Committee, but whose contribution is necessary for the balanced and adequate assessment of the possible risks, including health and social risks. Furthermore, the Commission, Europol and the EMEA shall each be invited to send a maximum of two experts.

3. The risk assessment shall be carried out on the basis of information to be provided to the scientific Committee by the Member States, the EMCDDA, Europol, the EMEA, taking into account all factors which, according to the 1961 United Nations Single Convention on Narcotic Drugs or the 1971 United Nations Convention on Psychotropic Substances, would warrant the placing of a substance under international control.

4. On completion of the risk assessment, a report (hereinafter the ‘Risk Assessment Report’) shall be drawn up by the Scientific Committee. The Risk Assessment Report shall consist of an analysis of the scientific and law enforcement information available, and shall reflect all opinions held by the members of the Committee. The Risk Assessment Report shall be submitted to the Commission and Council by the chairperson of the Committee, on its behalf, within a period of twelve weeks from the date of the notification by the General Secretariat of the Council to the EMCDDA referred to in paragraph 1.

The Risk Assessment Report shall include:

(a) the physical and chemical description of the new psychoactive substance and its mechanisms of action, including its medical value;

(b) the health risks associated with the new psychoactive substance;

(c) the social risks associated with the new psychoactive substance;

(d) information on the level of involvement of organised crime and information on seizures and/or detections by the authorities, and the manufacture of the new psychoactive substance;

(e) information on any assessment of the new psychoactive substance in the United Nations system;

(f) where appropriate, a description of the control measures that are applicable to the new psychoactive substance in the Member States;

(g) options for control and the possible consequences of the control measures, and

(h) the chemical precursors that are used for the manufacture of the substance.

Article 7

Circumstances where no risk assessment is carried out

1. No risk assessment shall be carried out in the absence of a Europol/EMCDDA Joint Report. Nor shall a risk assessment be carried out where the new psychoactive substance concerned is at an advanced stage of assessment within the United Nations system, namely once the WHO expert committee on drug dependence has published its critical review together with a written recommendation, except where there is significant new information that is relevant in the framework of this Decision.

2. Where the new psychoactive substance has been assessed within the United Nations system, but it has been decided not to schedule the new psychoactive substance under the 1961 Single Convention on Narcotic Drugs or the 1971 Convention on Psychotropic Substances, a risk assessment shall be carried out only if there is significant new information that is relevant in the framework of this Decision.

3. No risk assessment shall be carried out on a new psychoactive substance if:

(a) the new psychoactive substance is used to manufacture a medicinal product which has been granted a marketing authorisation; or,

(b) the new psychoactive substance is used to manufacture a medicinal product for which an application has been made for a marketing authorisation or,

(c) the new psychoactive substance is used to manufacture a medicinal product for which a marketing authorisation has been suspended by a competent authority. Where the new psychoactive substance falls into one of the categories listed under the first subparagraph, the Commission, on the basis of data collected by EMCDDA and Europol, shall assess with the EMEA the need for further action, in close cooperation with the EMCDDA and in accordance with the mandate and procedures of the EMEA. The Commission shall report to the Council on the outcome.

Article 8

Procedure for bringing specific new psychoactive substances under control

1. Within six weeks from the date on which it received the Risk Assessment Report, the Commission shall present to the Council an initiative to have the new psychoactive substance subjected to control measures. If the Commission deems it is not necessary to present an initiative on submitting the new psychoactive substance to control measures, within six weeks from the date on which it received the Risk Assessment Report, the Commission shall present a report to the Council explaining its views.

2. Should the Commission deem it not necessary to present an initiative on submitting the new psychoactive substance to control measures, such an initiative may be presented to the Council by one or more Member States, preferably not later than six weeks from the date on which the Commission presented its report to the Council.

3. The Council shall decide, by qualified majority and acting on an initiative presented pursuant to paragraph 1 or 2, on the basis of Article 34(2) (c) of the Treaty, whether to submit the new psychoactive substance to control measures.

Article 9

Control measures taken by Member States

1. If the Council decides to submit a new psychoactive substance to control measures, Member States shall endeavour to take, as soon as possible, but no later than one year from the date of that decision, the necessary measures in accordance with their national law to submit:

(a) the new psychotropic drug to control measures and criminal penalties as provided under their legislation by virtue of their obligations under the 1971 United Nations Convention on Psychotropic Substances;

(b) the new narcotic drug to control measures and criminal penalties as provided under their legislation by virtue of their obligations under the 1961 United Nations Single Convention on Narcotic Drugs.

2. Member States shall report the measures taken to both the Council and the Commission as soon as possible after the relevant decision has been taken. Thereafter this information shall be communicated to the EMCDDA, Europol, the EMEA, and the European Parliament.

3. Nothing in this Decision shall prevent a Member State from maintaining or introducing on its territory any national control measure it deems appropriate once a new psychoactive substance has been identified by a Member State.

Article 10

Annual report

The EMCDDA and Europol shall report annually to the European Parliament, the Council and the Commission on the implementation of this Decision. The report will take into account all aspects required for an assessment of the efficacy and achievements of the system created by this Decision. The Report shall, in particular, include experience relating to coordination between the system set out in this Decision and the pharmacovigilance system.

Article 11

Pharmacovigilance system

Member States and the EMEA shall ensure an appropriate exchange of information between the mechanism set up by means of this Decision and the pharmacovigilance systems as defined and established under Title VII of Directive 2001/82/EC and Title IX of Directive 2001/83/EC.

Article 12

Repeal

The Joint Action on New Synthetic Drugs of 16 June 1997 is hereby repealed. Decisions taken by the Council based on Article 5 of that Joint Action shall continue to be legally valid.

Article 13

Publication and taking effect

This Decision shall take effect on the day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 10 May 2005. For the Council The President J. KRECKÉ

(1) Opinion delivered on 13 January 2004 (not yet published in the Official Journal).

(2) OJ L 167, 25.6.1997, p. 1.

(3) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).

(4) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).

(5) OJ L 357, 20.12.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1232/2002 (OJ L 180, 10.7.2002, p. 5).

(6) OJ L 47, 18.2.2004, p. 1.

(7) OJ L 136, 30.4.2004, p. 1.