Europe has responded to rising concerns over the use of two new drugs by subjecting them to ‘control measures and criminal penalties’ throughout the Union. The implementing decision of the Council of the EU (1), published in the Official Journal of the European Union today, was adopted in the final stage of the three-step legal procedure designed to respond to potentially threatening new psychoactive substances (NPS) available on the market (2). The two new substances — 4,4'-DMAR and MT-45 — have been raising health concerns in Europe after harmful effects related to them were reported by the Member States through the EU Early Warning System (EWS).
The decision is based on the findings of formal risk assessments on the two substances, conducted by the extended EMCDDA Scientific Committee, with participation of additional experts from the EU Member States, European Commission, Europol and the European Medicines Agency. The risk assessment reports assessed the health and social risks of the drugs, as well as international trafficking and the involvement of organised crime (3).
4,4'-DMAR is a derivative of aminorex, has psychostimulant properties, and is reported to have been available on the drug market since at least December 2012. MT-45, a synthetic opioid investigated in the 1970s for its analgesic properties, was detected for the first time on the European drug market in October 2013. At the time of the risk assessments, a total of 31 and 28 deaths had been associated with these drugs respectively, and, in all cases, the presence of the substance in biological samples was analytically confirmed.
The Council implementing decision states that the evidence available for each substance provides ‘sufficient grounds’ for subjecting it to control measures across the Union. Reasons for the conclusion include: the health risks posed by use of the drugs and their lack of medical value.
At the time of the risk assessments, three Member States (DK, FI, SI) and one Member State (SE) had controlled 4,4'-DMAR and MT-45 respectively under national drug control legislation. As a result of today’s decision, all EU Member States are called upon to introduce control measures and criminal penalties within one year. This will facilitate cross-border law enforcement and judicial cooperation and protect from the risks posed by the availability and use of these substances.
EMCDDA Director Wolfgang Götz welcomed the news: ‘Today’s decision to introduce controls on 4,4’-DMAR and MT-45 is another positive example of the EU’s ability to respond to harms posed by new psychoactive substances. Both substances had been available for only short period of time before the EWS undertook the first action to respond to emerging health concerns posed by them. The EMCDDA is a world leader in the collection, exchange and analysis of information on new drugs, but more investment is needed to develop greater capacity to assess the health implications of the wide variety of new substances now becoming available.’
