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EU regulation to allow greater access to affordable generic medicines

The Council has adopted a regulation which will allow companies in the EU to manufacture generic medicines made under licence for export to developing countries. Intensive cooperation between the Council and the European Parliament has allowed the rapid adoption of this regula...

The Council has adopted a regulation which will allow companies in the EU to manufacture generic medicines made under licence for export to developing countries. Intensive cooperation between the Council and the European Parliament has allowed the rapid adoption of this regulation, which is directly applicable in all Member States at the date of its entry into force, a month from now. The regulation is in keeping with the conditions of a WTO decision in 2005 to amend Article 31(f) of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which says that products made under compulsory licensing must be 'predominantly for the supply of the domestic market', in order to allow any WTO member country to grant licences to export generic pharmaceutical products if certain conditions are met. The decision was made by WTO members in recognition of the fact that the TRIPS agreement, as it stood, was limiting the amount of drugs that countries could manufacture and export when the drug was made under compulsory licence. It was also preventing those countries which were unable to make medicines to import affordable generics. The decision makes permanent a provisional agreement by the WTO on compulsory licensing dating back to August 2003, and completes a process that began in 2001, when ministers stressed the importance of implementing and interpreting the TRIPS Agreement in a way that supports public health - by promoting both access to existing medicines and the creation of new medicines. Welcoming the Council's decision, Internal Market and Services Commissioner Charlie McCreevy said that the regulation's 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,' he said. Trade Commissioner Peter Mandelson also expressed satisfaction with the regulation saying: '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.' The regulation modifies the Commission's initial proposal, namely by widening the eligibility criteria so that more countries, not only members of the WTO but also other least-developed and developing countries, may benefit from the import of licensed products. The text of the regulation makes clear that the compulsory licensing system is intended to address public health problems and therefore it should not be used by countries to pursue 'industrial or commercial policy objectives. Moreover, the regulation prohibits re-importation into the EU and provides for customs authorities to take action against goods re-imported. To safeguard the use against abuse and trade diversion and rules, the regulation imposes clear conditions upon the licensee as regards the acts covered by the licence, the identification of the pharmaceutical products manufacturer under the licence, and the countries to which the products will be exported.