Combatting drugs: information exchange, risk-assessment and control of new psychoactive substances

PURPOSE: to establish a mechanism for a rapid exchange of information on new narcotic drugs and new synthetic drugs that are being used illicitly, and provide for a risk assessment of the drugs.

PROPOSED ACT: Council Decision.

CONTENT: this Council Decision aims at updating and extending the Joint Action on New Synthetic Drugs of 16 June 1997. The mechanism as created by the Joint Action on New Synthetic Drugs is being adapted significantly, but its established basic structure remains unaffected.

The 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 following points must be noted: 

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. 

The proposal also makes a distinction between notified substances that demand prompt measures at EU level, and substances that do not demand prompt measures. This distinction has been made operational by the inclusion of two specific provisions: 1) 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. 2) 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 should be followed up by a Joint Report, it can be assumed that not all notifications would merit such a follow-up. A prudent judgment 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 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 have indicated to be infavour of a risk-assessment on a notified new narcotic or new synthetic substance will the risk assessment will be carried out. Member States have 30 working days to come to a decision. 

A final change concerns the composition of the EMCDDA-Scientific Committee. 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.

This proposal has no financial implications.