The Council of Europe has been paying great attention to the issue of counterfeiting. A number of seminars and high level conferences1 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 organisations, such as the WHO, was considered advisable.

The Survey Report on Counterfeit medicines (also known as the “Harper Report”)2 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.

An important political backing to the Council of Europe’s work against counterfeiting was provided by the Parliamentary Assembly of the Council of Europe (PACE), which adopted a number of Recommendations3 on this subject. One of the main messages that could be drawn is “the rapidly rising incidence of counterfeit goods in Europe – a phenomenon which places customers’ health and well-being at risk, erodes the markets for legitimate producers, damages the reputation of brand names, distorts competition, undermines employment and reduces tax income.”

In 2007, the Parliamentary Assembly submitted a Report on the need for a Council of Europe convention on the suppression of counterfeiting and trafficking in counterfeit goods, underlining that “traffic in counterfeit goods is a scourge that is growing to epidemic proportions across the wider Europe in both the range and volume of goods involved. All member states of the Council of Europe are concerned as countries of origin, transit or destination for counterfeit goods.” The Assembly highlighted that there is a legal vacuum at international level and that appropriate national authorities are either inexistent or weak and therefore underlined the need to make provision for an international legal instrument establishing specific offences relating to counterfeiting medicines so that counterfeiters can be arrested and criminally prosecuted.

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.