The Council of Europe drafted a convention which constitutes, for the first time, a binding international instrument in the criminal law field on counterfeiting of medical products and similar crimes involving threats to public health (MEDICRIME Convention)

The Council of Europe has long been concerned about the absence of harmonised international legislation, non-deterrent sanctions that were not proportionate to the harm caused to patients, and the involvement of criminal organisations which operate across borders.

Counterfeiting medical products and similar crimes threaten the right to life enshrined in the European Convention on the Protection of Human Rights and Fundamental Freedoms (ECHR). Incidences of counterfeit medical products and similar crimes undermine public trust in healthcare systems and authorities' surveillance thereof.

Counterfeiting of medical products and similar crimes have a global spread, no country is spared.

The Council of Europe sees it as a common responsibility for the global community to eradicate this phenomenon, and hence accession to the Medicrime Convention is open for all states interested in working with the Council of Europe on this important goal.

Safeguarding of public health through penal measures against criminal behaviors, protection of victims, promotion of cooperation at national and international levels, and preventive measures are the overarching aims of the above convention.

The core values of the Council of Europe, a pan-European political organisation comprising 46 member states in Europe, are the protection of human rights and essential freedoms, the promotion of the rule of law and of pluralist democracies. The Organisation aims at identifying solutions for challenges faced by today's societies.

Preparatory work

The Council of Europe has been paying great attention to the issue of counterfeiting. A number of seminars and high level conferences were dedicated to discussing this problem, the threats it poses and possible solutions to it. Throughout these events it was stressed that the Council of Europe should approach the problem of counterfeit pharmaceutical products from a public health perspective and see it as a threat to public health (and safety), thus undermining the right to life enshrined in Article 2 of the European Convention on the Protection of Human Rights and Fundamental Freedoms. To this end the elaboration of an international legal instrument, possibly a convention within the Council of Europe, in co-operation with other relevant international organizations, such as the WHO, was considered advisable. 

The Survey Report on Counterfeit medicines (also known as the “Harper Report”) provided a comprehensive overview of the current situation of counterfeit medicines in the territory of the Council of Europe member states to the Partial Agreement in the Social and Public Health Field and identified existing gaps in legislation and administrative procedures.

At the inter-governmental level, the Committee of Experts on Pharmaceutical Questions “Ad-hoc group on counterfeit medicines” (P-SP-PH/CMED), under the Public Health Committee (CD-P-SP) of the Partial Agreement in the Social and Public Health Field, set up the Ad hoc Group on Counterfeit Medicines in 2003 with the task of focusing on public health protection and possibilities for improved co-operation of member states and other stakeholders as regards counterfeit medicines and other forms of pharmaceutical crime.