The EU, The Developing World, and Data Exclusivity; Effects of Current Policies on Access to Medicines

Mihir Mankad and  Daniel Rosenholtz
December 4, 2009

Compulsory licenses are an important mechanism for developing countries needing to access medicines when drug supply does not meet drug demand, or to serve important public interests.  Data exclusivity has the potential to erode this important pathway to greater access to medicines.  The ability to issue a compulsory license for a medicine patent means little if the licensee must conduct expensive, time-consuming, and duplicative clinical trials.  Although the European Union has recognized the importance of a substantive right to compulsory licenses with regard to production for export, they have not recognized how data exclusivity can make compulsory licenses a nullity.  The EU directive granting a waiver of data exclusivity for production for export to non-EU countries is a good idea, but means little in light of the increasing frequency of data exclusivity provisions in free trade agreements between the EU and non-EU countries. Finally, because the EU is now pushing such protections in their bilateral agreements, all of the resulting problems will be exported to the developing world. In that case, the issues are even more acute as there is even less access to medicines.

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