Assessment of the Proposed eu Regulation on the Compulsory Licensing of Generic drugs for export to developing countries

The study examines the the draft Regulation establishing a compulsory licensing system for the export of patented drugs to developing countries. The Regulation aims at uniformly implementing, within the European Union, the Decision of the WTO of 30 August 2003 on the TRIPS Agreement and Public Health. Following the presentation of the core aspects of the draft Regulation, the paper outlines the possible impacts of the Regulation, including the difficulties faced by importing countries. The paper also highlights the differences compared to similar regulations in Canada, Norway and Netherlands and then proposes an extensive list of possible improvements in light of the findings of the analysis. The paper concludes that the draft Regulation does not fully take advantage of the flexibility that is open to the EU to encourage prospective European suppliers to provide pharmaceutical products at affordable prices and improve access to medicines in developing countries and LDCs. The draft regulation also includes a number of unnecessary conditions not stipulated in the WTO Decision