New drug 4-MA to be placed under control across the EU

Council decision: ‘Sufficient grounds’ for controlling new drug

Europe has responded today to concerns over the use of the stimulant drug 4-methylamphetamine (4-MA) by subjecting it to ‘control measures and criminal penalties’ throughout the Union. The Decision of the Council of the EU (1) was adopted in the final stage of the three-step legal procedure designed to respond to potentially threatening new psychoactive drugs entering the market (2).

The Council Decision is based on the findings of a formal risk-assessment report on 4-MA produced in 2012 by the extended Scientific Committee of the EU drugs agency (EMCDDA), with participation of additional experts from the EU Member States, European Commission, Europol and the European Medicines Agency (EMA) (3). The report, submitted to the Commission and Council in November 2012, assessed the health and social risks of the drug as well as international trafficking and the involvement of organised crime.

4-MA belongs to the group of synthetic phenethylamines and is closely related to amphetamine. It has no established medical value and has no known legitimate purpose, aside from limited use in scientific research.The drug appears to be sold on the illicit market as amphetamine, being frequently mixed with it. Available information suggests that it is produced and distributed by the same organised crime groups involved in the manufacture and trafficking of amphetamine.

The Council Decision states that the evidence available provides ‘sufficient grounds for subjecting 4-methyl-amphetamine to control measures across the Union’. Reasons for the conclusion include: the drug’s strong similarity to amphetamine and the health risks it poses. The risk-assessment report detailed 21 fatalities (4) in four EU Member States (Belgium, Denmark, Netherlands, UK), where 4-MA was detected in post-mortem samples, either alone or in combination with other substances (particularly amphetamine). The adverse effects of 4-MA include: hyperthermia, hypertension, anorexia, nausea, paranoia and anxiety.

Eight EU Member States (Denmark, Germany, Ireland, France, Cyprus, Lithuania, Netherlands, UK) already control 4-MA under drug control legislation (four doing so via generic legislation on phenethylamines). In addition, two countries (Hungary and Austria) have introduced new legal frameworks to prohibit the unauthorised supply of individual or groups of substances (4-MA is controlled under the generic definition of phenethylamines). One Member State (Finland) controls the drug under medicines legislation.

EMCDDA Director Wolfgang Götz welcomed the news: ‘Today’s decision to introduce controls on 4-methylamphetamine is another positive example of Europe’s ability to respond to new psychoactive substances and demonstrates the strength of the EU early warning system.

As a number of countries already control 4-MA, this decision will help avoid problems in cross-border law enforcement and judicial cooperation. Furthermore, Union-wide measures will also help to prevent some of the harmful health effects caused by the drug.’
EU Member States have one year to take the necessary measures to submit 4-MA to controls in line with their national laws (5).