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.