Presidency Compromise Proposal for a Regulation on Compulsory Licensing of Patents Relating to the Manufacture of Pharmaceutical Products.
The Luxembourg Presidency has just published Document 7394/05 conveying a Presidency compromise proposal for a Regulation of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems. On 14 November 2001 the Fourth Ministerial Conference of the World Trade Organisation (WTO) adopted the Doha Declaration on the TRIPS Agreement and Public Health. The Declaration recognises that each WTO Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. It also recognises that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing. On 30 August 2003 the General Council of the WTO adopted the Decision on the implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. Subject to conditions, the Decision waives certain obligations concerning the issue of compulsory licences set out in the TRIPS Agreement, to address the needs of WTO Members with insufficient manufacturing capacity.