Early warning system
When a new psychoactive substance is first detected, detailed information on the manufacture, traffic and use, including supplementary information on possible medical use is sent by the EU Member States to the European Police Office (Europol) in the Hague and to the EMCDDA in Lisbon via the Europol National Units and the REITOX national focal points, taking into account the respective mandates of these two bodies. Europol and the EMCDDA collect the information and communicate it immediately to each other and to the Europol National Units and the representatives of the Reitox network of the Member States, the European Commission and to the London-based European Medicines Agency (EMA).
If Europol and EMCDDA consider that the information provided by the Member States on a new psychoactive substance merits further collection and analysis, this information is presented in the form of a Europol-EMCDDA Joint report, which is submitted to the Council, the EMA and the Commission.
The information in the Joint report includes:
- a chemical and physical description, including the name under which the new psychoactive substance is known
- frequency, circumstances and/or quantities in which a new psychoactive substance is encountered
- means and methods of manufacture of the new psychoactive substance and the involvement of organised crime in the manufacture or trafficking
- indications of the health and social risks associated with the new psychoactive substance, including the characteristics of users
- whether or not the new substance is currently under assessment, or has been under assessment, by the UN system
- whether or not the new psychoactive substance is already subject to control measures at national level in a Member
- chemical precursors, mode and scope of the established or expected use of the new substance and any other use of the new
On its part, the EMA submits to Europol and the EMCDDA information whether in the European Union or in any Member State: the new psychoactive substance has obtained a marketing authorisation; is the subject of an application for a marketing authorisation; or a marketing authorisation that had been granted in respect of the new psychoactive substance has been suspended.
Based on the Joint Report the Council (see below), acting by a majority of its members, may request a risk assessment of 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.
A practical guide 'Operating guidelines for the early warning system' has been published to assist the Member States in implementing the EWS and to provide transparency to the entire process. The EWS guidelines have been fully redrafted in order to reflect the scope and deadlines stipulated by Council Decision 2005/387/JHA, thus replacing the earlier guidelines published by the EMCDDA in 2002. The new operating guidelines are the result of cooperation between the two organisations responsible for the EWS – EMCDDA and Europol.
The availability of reference materials (seized substances or reference substances) is of the utmost importance if forensic and toxicology laboratories are to identify new psychoactive substances, especially in the case of a new synthetic drug about which limited scientific literature is available. Council Decision of 28 May 2001on the transmission of samples of controlled substances (2001/419/JHA) sets up a procedure at EU level for the exchange of samples of seized drugs, furthermore the Council Recommendation of 30 March 2004 (2004/C 86/04) provides guidelines for taking samples of seized drugs .
In compliance with the provisions of the Decision, the EMCDDA prepared Joint reports on 1-(3-chlorophenyl)piperazine (mCPP) (October 2005), 1-benzylpiperazine (BZP) (February 2007) and 4-methylmethcathinone (mephedrone) (March 2010).
The Commission proposed that the EMCDDA and Europol ‘carry out further work in accordance with their mandates and the resources available to assess the importance of mCPP in the European Union illicit drugs market’. The two organisations monitored and collected further data on mCPP and the risks it poses through their networks, and informed the Commission of their findings by the end the first quarter of 2007 through the Active monitoring report.