Council of Europe Aims to Hold Medical Device Companies Accountable for Counterfeit Products

January 12, 2011

In a move designed to address the public health threat posed by increased distribution of counterfeit medical device products, the Council of Europe Committee of Ministers (Council) has drafted a binding international instrument that, if ratified, will impose criminal liability on the medical device counterfeiters operating in any of Europe’s 47 member states.

For years, the Council has been concerned about the secondary channels that create pathways for the distribution of counterfeit products, especially those created by the Internet, the ineffectiveness of proposed deterrents and the criminal element that has penetrated the marketplace throughout Europe. As the Council sees it, counterfeiting medical products and similar crimes threaten the right to life protected by the European Convention on Human Rights and Fundamental Freedoms.

The Council’s move, known as the MEDICRIME Convention, is the first international criminal law measure that proposes to obligate member states to criminalize activity such as the manufacturing of counterfeit medical products; supplying, offering to supply and/or trafficking in counterfeit medical products; falsifying documents in sales of medical device products; and the unauthorized manufacturing or supplying of products and marketing of non-conforming medical device products.

The MEDICRIME Convention provides for national and international cooperation and coordination across public administration sectors, and for preventive measures as well as protective measures for alleged victims and witnesses. It also anticipates the creation of a monitoring body composed of members from each member country, to oversee the MEDICRIME Convention by the member states.

Consistent with the Convention’s concerns about the global threat presented by counterfeiting of medical products and other related crimes, MEDICRIME applies to the 47 member countries of the Council, but can also be recognized and ratified by non-Council countries around the world. The Convention will be opened for signature in 2011, at a date to be set by the Council.

Countries and organizations in other parts of the world are also considering similar action such as the World Health Organization’s anti-counterfeiting proposal and the Anti-Counterfeiting Trade Agreement to which the United States and nine other nations, as well as the European Union, are expected to be signatories.

In the absence of a clear mandate with enforceable sanctions, counterfeiting will continue to pose a global threat to patients’ well-being and safety. Whether the Convention will provide the protection sought can be judged only after it has been enacted and in force for some reasonable time, but it seems clear that the public health risk justifies the attempt.