Explanatory Memorandum to COM(2003)560 - Information exchange, risk-assessment and the control on new narcotic drugs and new synthetic drugs - Main contents
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| dossier | COM(2003)560 - Information exchange, risk-assessment and the control on new narcotic drugs and new synthetic drugs. |
|---|---|
| source | COM(2003)560  |
| date | 03-10-2003 |
This Council Decision aims at updating, re-enforcing and extending the Joint Action on New Synthetic Drugs of June 16th 1997 concerning the information exchange, risk assessment and the control of new synthetic drugs. i
Since 1997 five synthetic drugs i have been examined using the provisions of the Joint Action on New Synthetic Drugs. Two of them (4-MTA and PMMA) have been made subject to control measures in the European Union. Council conclusions in relation to GHB and ketamine were also adopted, recommending that the European Police Office (Europol) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) closely monitor the misuse of both substances over a period of one year.
The European Union Action Plan on Drugs 2000-2004 asks the Commission to: organise an assessment of the Joint Action on New Synthetic Drugs of June 1997 taking into account the evaluation by the EMCDDA of the early warning system. i In order to execute this task an external evaluator was selected to carry out the evaluation. Based upon a series of interviews with stakeholders, the replies to an extensive questionnaire sent to the parties involved (Member States, Europol, the European Commission, the European Agency for the Evaluation of Medicinal Products (EMEA), and the EMCDDA) and desk research, a report has been produced, which was made available in November 2002. i
Contents
The assessment of the external evaluator indicated that the Joint Action on New Synthetic Drugs plays a significant role in the combat against drugs. Nevertheless, the evaluation concluded that the Joint Action on New Synthetic Drugs is in need of a re-orientation with respect to its objective and scope. Furthermore, the evaluation made clear that clarification of the applicable procedures and enhancement of the transparency of its operation in practise is necessary.
By means of this Council Decision the mechanism as created by the Joint Action on New Synthetic Drugs is being adapted significantly, but incrementally, as its established basic structure remains unaffected. This Council Decision consists of the three consecutive but independent phases created by the Joint Action on New Synthetic Drugs:
* an early warning system (EWS) to exchange rapidly all information available on substances notified to Europol and the EMCDDA;
* a risk-assessment by a scientific committee in order to assess the social, health and other risks associated with a notified substance;
* an EU-level procedure for bringing notified substances under control in the Member States.
The changes to the Joint Action are directly related to the outcome of the external evaluation. Besides the redrafting of those definitions and procedures that have proven to be unclear, the most important innovation is that this Council Decision includes under its scope all new synthetic drugs and all new narcotic drugs alike, including those drugs that could be defined as medicinal products.
This extended scope, which will permit the notification of a wider range of substances than under the former Joint Action on New Synthetic Drugs, will not lead to an enhanced use of the risk-assessment and the control-measures (the second and third phase). The phases of risk-assessment and control are restricted to a small number of the substances that come within the scope of the Council Decision. Most notably, medicinal products and substances already under assessment by the United Nations are excluded from these phases. Thus, a sharper separation between the early warning system and the procedures of risk-assessment and control will be created. With these proposals the relevance of the instrument for the Member States will be enhanced, taking into account its use in practice.
Other changes are the result of a more fundamental re-orientation of the established Joint Action's mode of operation. Originally, the Joint Action had been designed to operate as a quick response mechanism aimed at achieving a rapid exchange of information on a new synthetic substance and the quick synchronisation of its legal status in the Member States, in case of a sudden surge in the presence of this substance within the European Union. In practise, another important task has been added over time. Nowadays, the long term monitoring of a synthetic substance by a continuous exchange of information between Member States and Europol/ EMCDDA, possibly followed by a procedure aimed at controlling the substance, could be considered as prominent a function as its quick response-task. However, the fusion of both objectives in one instrument is not self-evident and might lead to confusion and to questions of legitimisation and legitimacy in case information collected for one goal would be used to support another. Therefore, in this Council Decision a choice between both uses had to be made. This Council Decision has been drafted from the perspective of a quick response mechanism, which indicates a return to the original intentions of the Joint Action as set out in its preamble. Even so a continuous flow of information on new drugs amongst the Member States is valuable and must not be hampered by unnecessary formalities. In order to reconcile both practises the Council Decision makes a distinction between notified substances that demand prompt measures at European Union level, and substances that do not demand prompt measures. This distinction has been made operational by the inclusion of two specific provisions:
- the inclusion of a deadline by which the Joint Report by Europol and the EMCDDA must be submitted to the Member States, the EMEA and the Commission. In case no Joint Report by Europol/EMCDDA has been submitted by this deadline the phases of risk-assessment and control remain closed.
- the provision of some discretion to Europol and the EMCDDA whether or not to draw up a Joint Report. Though in principle a notification of a new narcotic drug or a new synthetic drug under this Council Decision should be followed up by a Joint Report, it can be assumed that not all notifications would merit such a follow-up. As not all cases in which a deviation from the principle that a notification should be followed by a Joint report can be foreseen in advance, a certain flexibility is necessary. Therefore no explicit criteria have been included in this Council Decision. First and foremost, a prudent judgement is required to be exercised by both bodies, but Europol and the EMCDDA are also invited to develop policy guidelines which could be used to select those notifications that would demand a risk-assessment. The choices made by Europol and the EMCDDA in this respect should be explained in the annual report on the operation of the Council Decision. This report is to be prepared annually by Europol and the EMCDDA in order to provide adequate feedback to those Member States that have notified substances to the early warning system, and insight into the working of the instrument in general.
The early warning system may therefore be used for the exchange of information on, and thus the monitoring of, new narcotic drugs and new synthetic drugs alike, including medicinal products. However, under this Council Decision a risk-assessment will only be allowed when specific conditions are fulfilled.
Another fundamental change will be the re-emphasis on the principle of subsidiarity with respect to the use of control measures. The Council Decision should address these issues, which cannot be effectively dealt with by Member States individually. In this Council Decision the necessary presence of such an overall interest is expressed by the introduction of a majority threshold with respect to the start of a risk-assessment on a notified substance. Only where more than half of the Member States of the European Union have indicated to be in favour of a risk-assessment on a notified new narcotic or new synthetic substance the risk-assessment will be carried out.
A final change concerns the EMCDDA-Scientific Committee, which, extended with experts from the Member States and representatives of the Commission, the EMEA and Europol, is responsible for the carrying out of the risk-assessment. At present, all Member States may, in addition to their representative on the EMCDDA-Scientific Committee, nominate an expert for the implementation of the risk-assessment. The Council Decision proposed here deviates from this policy line. After the completion of the enlargement process of the European Union the extended Scientific Committee might be of a size which would make it unmanageable. Instead, as a consequence of this Council Decision, the extended Scientific Committee will be composed of the members of the EMCDDA Scientific Committee and representatives from the Commission, the EMEA, and Europol. To this body will be added at most five experts from scientific fields not (sufficiently) represented in the Scientific Committee, but whose contribution is necessary for the balanced and adequate assessment of the risks associated with the assessed substance, including health and social risks. The reference to experts from scientific fields not currently represented, or currently not sufficiently represented, on the Scientific Committee relates to the circumstance that a balanced risk-assessment, which takes into account different types of risks, demands the presence of experts in all relevant fields.
Since the entering into force of the Amsterdam Treaty and the subsequent amendment of the Treaty on European Union the Joint Action is no longer available as a legal instrument, which made it necessary to choose a new legal instrument. The adaptation of the Joint Action has not lead to a significantly different approach than taken before as this Council Decision continues to ask from Member States to put control-measures on specific substances which have passed through the stages of notification and risk-assessment. These control-measures were not defined in detail in the 1997 Joint Action on New Synthetic Drugs, nor are they defined in detail in this Council Decision. As these are left to the discretion of the national legislator, the Member States are not asked to adapt their legislation, but to make effective use of the existing provisions in their legislation. These circumstances make a Council Decision the most appropriate legal instrument available to succeed the Joint Action.
This Council Decision consists of 13 Articles. Some of the Articles describe the procedure from notification to control-measures, while others are related to the scope of this instrument or contain definitions.
Article 1 describes the purpose of the Council Decision. It emphasises that the Council Decision does not envisage a duplication of the pharmacovigilance system as established by Directive 2001/83/EC of the European Parliament and of the Council, which has been created to report suspected adverse reactions to a medicinal product. As it might not be clear from the outset whether or not an incident involving a new narcotic drug or a new synthetic drug would fulfil the reporting criteria under the pharmacovigilance system, Article 11 of this Council Decision asks Member States to maintain a close link between the mechanism created by this Council Decision and the pharmacovigilance system.
Article 2 is concerned with the scope of the Council Decision. The Article defines under the scope of this legal instrument all substances, which have not been listed under either the 1961 United Nations Single Convention on Narcotic Drugs or the 1971 United Nations Convention on Psychotropic Substances.
Therefore substances listed under either the 1961 United Nations Single Convention on Narcotic Drugs or the 1971 United Nations Convention on Psychotropic Substances do not come within the scope of this Council Decision.
Article 3 contains the definitions used throughout the Council Decision.
Article 4 describes the notification procedure a Member State should follow after the discovery of a new narcotic drug or a new synthetic drug on its territory. Article 4 also sets out the work to be undertaken jointly by the EMCDDA and Europol as a follow-up to a notification by a Member State: the EMCDDA and Europol are asked to collect the information available on the notified substance. The Article contains a list of issues on which information should be collected. However, at the same time, Article 4 attributes a certain discretion to Europol and the EMCDDA to judge whether or not prompt measures, and thus the collection of information, would be desirable.
By means of Article 5 the EMCDDA and Europol are asked to collate a Joint Report from the information gathered under the provisions of Article 4.
Article 6 describes the procedure relevant to the assessment of risks associated with a notified substance. In order to fulfil the criterion of subsidiarity, more than half of the Member States of the European Union should agree on the risk-assessment by the extended EMCDDA Scientific Committee. During the period of thirty working days which is given to the Member States in order to come to a decision, they will have sufficient time to consult their experts and to assess their national situation with respect to the notified substance. Also, Article 6 contains a list of issues, which should be included in the risk-assessment report.
Article 7 lists the circumstances, which would disqualify a notified substance from being assessed on its risks as indicated in Article 6. Most importantly, Article 7 states that substances that would qualify as medicinal products as categorised under this Article, will not be assessed on their risks under this Council Decision. Measures to be taken to diminish the abuse of these medicinal products could be considered by the EMEA and the Council. The EMEA could, based upon a scientific assessment of the risks associated with a medicinal product, submit advice on the classification of the medicinal product involved, while the Public Health Group of the Council could decide on proper public health related measures with respect to the substance.
Article 8 describes the procedure for applying control-measures to a new narcotic drug or a new synthetic drug.
Article 9 describes the responsibility of the Member States with respect to the substances that are placed under control as described in Article 8.
Article 10 demands that the EMCDDA and Europol prepare a report on the operation of the Council Decision. The main aim is to increase the transparency of the instrument.
Article 11 relates to the pharmacovigilance system, which has been established EU-wide as a post-marketing surveillance system for authorised medicinal products. Member States, health care practitioners and the pharmaceutical industry are permanently assessing the safety of marketed medicinal products by reporting the suspected adverse reaction to medicinal products they have encountered, or that were reported to them, to the pharmacovigilance system. The major public health interests concerned here are such that there should be no loss of time caused by an accidental reporting of information relevant for the pharmacovigilance system to the Early Warning System only. Therefore Member States and the EMEA are asked to link the Early Warning System closely with the pharmacovigilance system.
Article 12 deals with the repeal of the predecessor of this Council Decision, the Joint Action on New Synthetic Drugs of June 16th 1997.
Article 13 contains the provisions on publication and entry into force of the Council Decision.
This Council Decision does not have financial implications.