EU ratifies amendment to TRIPS on compulsory licences

EU decision to ratify addition of article 31bis

On 24 October 2007, the EU decided to ratify the addition of article 31bis to the TRIPS Agreement.

The amendment was proposed by the decision of the WTO council of 9 December 2005 and is based on the decision of the WTO council of 20 August 2003 that had already been implemented by EU Regulation 816/2006.  Two-thirds of WTO members must ratify the amendment for it to become part of the TRIPS Agreement. 

Article 31bis allows a country to grant compulsory licences to companies to manufacture a patented drug only for export to developing countries that do not themselves have manufacturing capabilities.  The licences are limited to products used for treatment of HIV/AIDS, tuberculosis, malaria and other epidemics.  Only one compulsory licence has so far been granted under these provisions, in Canada to allow Apotex to supply HIV/AIDS drugs to Rwanda. For more information on this issue, see the October 2007 edition of our e-newsletter, InFocus, which you will be able to find on our Newsletters page.

If you would like any more information on this please contact Matthew Royle.