Specialised international organisations already carried out substantial work to combat counterfeiting, with greater emphasis on the protection of intellectual property rights. However, there is a general recognition that, along with the violation of intellectual property rights, counterfeiting of pharmaceutical products and medical devices puts public health and the health of individuals at risk and therefore needs to be addressed as a matter of urgency

Substantial initiatives in the fight against counterfeiting have been taken by the World Health Organisation (WHO). On 18 February 2006, at the Rome International Conference on Combating Counterfeit Medicines, the WHO adopted a declaration stating that “counterfeiting medicines …is a vile and serious criminal offence that puts human lives at risk and undermines the credibility of health systems.” So far, however, it has not been possible to elaborate a binding international instrument on this subject within the WHO.

In response to the threat by counterfeit pharmaceuticals, the WHO officially launched in November 2006 a global task force IMPACT (the International Medical Products Anti-Counterfeiting Taskforce) involving more than 20 international partners. Its terms of reference cover policy proposals and recommendations on legislation and enforcement and include initiatives for the application of new technologies to the detection of counterfeits, and technology transfer to developing countries. The Council of Europe contributes to its work programme.

The European Union has been active in its fight against counterfeiting. Currently, on the basis of a proposal from the European Commission, the Council of the European Union and the European Parliament are examining a set of criminal law measures to supplement civil law and customs action to fight against intellectual property rights violations. The draft directive in preparation addresses issues of intellectual property in general and is not limited to pharmaceutical products or medical devices only.