EC Welcomes Changes To European Patent Laws On Medicines

by Ulrika Lomas, for LawAndTax-News.com, Brussels

03 May 2006

The European Commission announced last week that it welcomes the adoption by the European Council of a regulation allowing companies to produce copies of patented medicines under license for export to “countries in need” without sufficient capacity to produce them.

The regulation implements within the EU the necessary conditions to meet a WTO Agreement of December 2005, under which national authorities can grant compulsory licences for such production if certain conditions are fulfilled.

Internal Market and Services Commissioner Charlie McCreevy stated that:

"This regulation is a key element in ensuring access to affordable medicines for poor countries. Its rapid adoption highlights the EU's commitment to the implementation of the WTO Decision. Countries in need will acquire affordable medicines which are safe and effective and at the same time the patent system will continue to support investment in the research and development of new medicines”.

Trade Commissioner Peter Mandelson added:

"This is an important EU contribution to the fight against killer diseases in developing countries. It shows that the EU is committed to the WTO process, and to ensuring that the WTO system can respond to the public health concerns of poor countries in need of affordable medicines."

On 6 December 2005, WTO Members agreed to amend the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).

This amendment would make permanent a provisional decision on compulsory licensing originally adopted on 30 August 2003. The WTO General Council has submitted the proposed amendment to the WTO Members for acceptance.

Once accepted and in force, this amendment will complete a process that began in 2001 with the Doha Declaration on the TRIPS Agreement and Public Health.

The existing rules on intellectual property provide that compulsory licences can only be authorised predominantly for the supply of the domestic market. The amendment will allow any WTO Member to export pharmaceutical products made under compulsory licence for the purpose of supplying developing countries with no or insufficient manufacturing capacities in the pharmaceutical sector. The new rules will be formally incorporated into the TRIPS Agreement.

The amendment will take effect for the Members that have accepted it when two thirds of the WTO Members accept the amendment.

WTO Members have set themselves until 1 December 2007 to do this.

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