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In the context of the proposed Anti-Counterfeiting Trade Agreement (ACTA), discussions appear to dangerously conflate two distinct issues: medicines suspected of infringing patents and counterfeit medicines. Counterfeit medicines are also mistakenly confused with the term ” counterfeit good”, used vaguely to describe a good that may infringe one or more types of intellectual property rights, in accordance to national intellectual property law. The only internationally-agreed concepts are “counterfeit trademark good” and “pirated copyright good” explicitly defined in the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). 2 The World Health Organization (WHO) has developed a definition for counterfeit medicines that is commonly cited but has not been widely adopted by member count ries in national law.3 According to the WHO definition, what makes a medicine counterfeit is the deliberate or intentional nature of mislabeling a product.
As of 2006 the WHO is sponsoring and acting as Secretariat to a new initiative aimed at combating counterfeit medicines. The International Medical Products Anti- Counterfeiting Taskforce (IMPACT), described as a global multi-stakeholder partnership, has rapidly advanced numerous initiatives, including model “Principles and Elements for National Legislation against Counterfeit Medicines”. It is unclear how the IMPACT taskforce relates to the other work being undertaken by the WHO, including the implementation of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property and the other components of the WHO Medicines Strategy 2008 – 2013.
This Focus Piece analyses the nature, scope and current activities of the IMPACT taskforce, and the link between IMPACT activities and broader trends in the pharmaceutical sector. It highlights the need for the WHO, including its member states, to provide oversight to the work of the IMPACT and its participants.