Action on new drugs
The EMCDDA has been assigned a key role in the detection and assessment of new drugs in the European Union under the terms of a Council Decision on the information exchange, risk-assessment and control of new psychoactive substances.
The new legal instrument was formally adopted by the Council of the European Union under the Luxembourg Presidency on10 May2005. It establishes a mechanism fora rapid exchange of information on new psychoactive substances and takes note of information on suspected adverse reactions to be reported under the pharmacovigilance system.
The Decision also provides for an assessment of the risks associated with 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.
This Decision applies to substances not currently listed in any of the schedules to the 1961 United Nations Single Convention on Narcotic Drugs, that may pose a comparable threat as the substances listed in Schedules I or II or IV thereof; and the 1971 UN Convention on Psychotropic Substances, that may pose a comparable threat to public health as the substances listed in Schedule I or II or IV thereof.
Between 1997 and 2005 the EMCDDA has played a leading role in the implementation of the Joint action concerning the information exchange, risk assessment and control of new synthetic drugs. The Council Decision on the information exchange, risk-assessment and control of new psychoactive substances repealed the Joint Action while building on its achievements and maintaining the three-step approach:
- an 'early-warning system' to identify new drugs as they appear on the European market;
- a mechanism for assessing the risks of these drugs; and
- a decision-making process (control measures) through which these products may be placed under control in the EU Member States
To ensure greater transparency in the implementation of the Decision, Article 10 stipulates that ‘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.’
Head of sector: Roumen Sedefov
Senior scientific analyst: Ulrik Solberg
Scientific analyst: Ana Gallegos
Project assistant: Anabela Almeida
EDND login area — Entry to the European Information system and database on new drugs
On 3 March 2008, the Council adopted a Decision defining BZP as a new psychoactive substance which is to be made subject to control measures and criminal provisions. The Member States have one year to take the necessary measures, in accordance with their national law, to submit BZP to control measures, proportionate to the risks of the substance, and criminal penalties, as provided for under their legislation complying with their obligations under the 1971 United Nations Convention on Psychotropic Substances.
EMCDDA, Lisbon, February 2009