Europe’s ability to rapidly respond to public health and security
threats caused by new psychoactive substances (NPS) will be
significantly strengthened, thanks to new legislation published
today by the European Union (1).
The legislation includes a stronger EU Early Warning
System (EWS) and a faster risk-assessment process.
The developments are in response to the recent growth in the
market in NPS and follow a proposal from
the European Commission (EC)
comprising:
- a Regulation regarding
information exchange on, and an early-warning system and
risk-assessment procedure for, new psychoactive
substances (amending the EMCDDA founding
regulation); and
- a Directive including
new psychoactive substances in the definition of ‘drug’.
The new legislation retains the current three-step approach to
responding to NPS — early warning, risk assessment and control
measures — while significantly strengthening existing processes
by streamlining and accelerating data-collection and assessment
procedures. Throughout the new procedure, shorter deadlines are
introduced.
The EMCDDA will continue to play a
leading role in monitoring NPS reported by EU Member
States and will initiate an in-depth scientific
investigation into any new substance causing concern. Following
the submission by the agency of its initial report,
the European Commission will have two
weeks to request it to assess the potential risks posed by the
substance, to be delivered within six weeks.
Based on the risk assessment report, the
Commission may propose whether or not to
control the substance through a formal decision.
The Council of the EU and
the European Parliament will then have
two months to agree or not. National
authorities will have six months (instead of 12) to
place the substance under control on their territory once the
decision enters into force.
In 2016, 66 NPS were detected for the first time via
the EU Early Warning System (EWS) — a
rate of over one per week.
The EWS currently monitors over 620
new psychoactive substances compared with around 350 in 2013.
This total included 24 new fentanils, highly potent opioids
detected on Europe’s drug market in the past few years. Exposure
to very small amounts of fentanils can cause life-threatening
poisoning, reflected in the substantial increase in the number of
reported fatalities involving their use.
Over the last year, for example, more than 60 deaths in Europe
involved carfentanil.
The EMCDDA and Europol — with the support of
the EU Member
States, the European Medicines
Agency (EMA) and the European Commission
— have been working together since 1997 to
monitor the appearance of new drugs and the extent of their
diffusion on the European drug scene. The first legislative
frameworks (1997 and 2005)(2) have allowed the
partners to develop an advanced early-warning system for
monitoring new drugs and a structure for performing scientific
risk assessments.
Commenting today, EMCDDA Director Alexis Goosdeel
said: ‘The EMCDDA welcomes this new legislation to
strengthen the EU’s response to new psychoactive substances. The
unprecedented rise in the availability of new drugs in recent
years clearly requires us to strengthen our early-warning and
response capacity. This faster legal mechanism will help us keep
pace with the NPS phenomenon and ensure that prompt action is
taken to protect public health’.
Notes
(1) Official Journal of the
European Union. The legislation will come into
force tomorrow and will become applicable 12 months after that
date.
(2) Joint action on new synthetic drugs (16 June
1997); Council Decision
(2005/387/JHA)(10 May 2005).
