10th November 2004
EU PROPOSES RULES ON GENERIC DRUGS FOR DEVELOPING COUNTRIES
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On 29 October, the European Commission proposed new regulations to implement the WTO decision of 30 August 2003 allowing manufacturers of generic pharmaceuticals to produce patented medicines for export to developing countries to combat the spread of diseases such as HIV-AIDS, malaria and tuberculosis. The regulations, which must be approved by the bloc’s 25 national governments and by the European Parliament, would enable generic medicine companies to apply to national authorities for the grant of a compulsory license from a patent holder who has exclusive rights over the manufacture and sale of the products concerned, thus enabling essential medicines to be exported to developing countries in need. “The WTO decision and the new regulation will help save lives by helping countries in need to acquire affordable medicines without undermining the patent system which is one of the main incentives for the research and development of new medicines,” said Internal Market Commissioner Frits Bolkestein. Most national laws in Europe at present do not allow compulsory licences for export because until recently the WTO TRIPS Agreement provided for compulsory licences only “predominantly for the supply of the domestic market”. The Doha Declaration on trade and health adopted in November 2001 agreed to address the difficulties raised by this restriction, and in their 30 August 2003 decision WTO Members agreed on a waiver giving these countries access to generics by allowing compulsory licensing for export. Canada was the first country to pass a law implementing the WTO decision in May of this year (see BRIDGES Weekly, BRIDGES Weekly13 October 2004).
“Access to essential medicines,” EC, 29 October 2004; “EC Offers Rules to Allow Generic Versions of Patented Drugs to Battle Disease in LDCs,” WTO REPORTER, 2 November 2004.
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