Council of Europe anti-counterfeiting convention draws near

More than 140 senior officials from health, law enforcement and judicial authorities from around the world came together last week to discuss the practical implementation of the Council of Europe's Medicrime convention.

Medicrime aims to become the first international instrument providing for the criminalisation of counterfeiting of medical products and similar crimes in order to protect the public health.

Commenting on the development earlier this year, Henk de Jong, who is chair of the European Pharmacopoeia Commission (until June 2010 when he is replaced by Dr. Marianne Ek) and sits on the CoE committee tasked with developing the convention, said that the aim is to make counterfeiting of both medicines and their individual components a criminal act.

"The current situation is that counterfeiting of medicines is handled differently across all the countries in Europe and the penalties levied are often not a sufficient deterrent," he said.  "The CoE convention is trying to lay down sanctions that are proportionate to the potential harm caused to patients."

The convention has enormous reach, added Prof. De Jong, because it applies not only to the 47 member countries of the CoE, but can also be recognised and ratified by non-CoE countries around the world.

Medicrime is the first international convention of its type and covers the manufacture of counterfeits (including medicines, active ingredients and excipients and medical devices), supplying, offering to supply and trafficking in fakes and the falsification of documents.

The convention also envisages preventive measures including the introduction of quality and safety requirements for medical products and measures ensuring their safe distribution. That could include adequate traceability systems of a medical product to its source and risk management and prevention strategies like enforcement agency training.

Preventive measures also comprise awareness-raising campaigns, supervision of the distribution chain, and agreements with Internet service Providers and Domain Registrars to help tackle distribution of counterfeit medicines online. The convention invites Parties to take measures to protect the rights of victims, including their right to compensation from the perpetrators.  

The convention also establishes a framework for international co-operation on criminal law, with single points of contact (SPOCs) appointed to promote and ease contact between authorities around Europe, according to Prof de Jong.

"It is a truly multisectoral and multinational effort," he said.

In a keynote at the Basle meeting, Dr. Jan Kleijssen, head of the CoE's Directorate of Standard-Setting, said that "in many countries the manufacture and trading in counterfeit medical products still carry only light sanctions, such as fines."

"Today, it is estimated to be a multi-billion euro industry and even more profitable than trafficking in narcotic drugs," added Kleijssen. The CoE estimates that in some parts of Europe counterfeits represent between 6 and 20 per cent of the overall drugs market.

The CoE has for a long time been involved in finding appropriate answers to the serious problems posed by counterfeiting of medical products and other threats to public health. The convention on counterfeit medicines follows similar work by the CoE on issues such as cybercrime, trafficking in human beings, and sexual abuse of children.

The Committee of Ministers of the CoE will be invited to adopt the Convention on 12 May. It will then be opened for signature and ratification by member states at the Conference of Ministers of Justice in Istanbul, Turkey, on 25-26 November.

The Basle event was organised under the aegis of the Swiss Chairmanship of the Council of Europe Committee of Ministers by Swissmedic, the Swiss Agency for Therapeutic Products, and the CoE.