Brussels, 06/06/2007 (Agence Europe) - As part of the preparations for the report by Italian MEP Margherita Gianluca Susta (ALDE) on ratification by the European Community of the amendment to the trade-related aspects of intellectual property rights agreement (TRIPS) to ensure continuation of the compulsory license system to guarantee access to medicinal drugs, the European Parliament's international trade committee organised, in Brussels on Tuesday 5 June, a hearing to allow MEPs to take stock of the effectiveness of the system.
Presenting the results of a study conducted by them for the European Parliament after a call for tenders, Professors Frederick M. Abbott (Florida State University College of Law) and Jerome H. Reichman (Duke University School of Law) recognised that the effectiveness of the compulsory licensing system is very relative, mainly due to the dimension of the markets concerned. They call for regional pharmaceutical supply centres to be set up. Such centres would bring together the compulsory licenses issued by several countries and negotiate on their behalf either with the patent holder or with the generic medicines manufacturers. The centres would thus have the critical mass needed for real power of negotiation, offering a more attractive market to drug producers at the same time. They consider it is preferable to ratify the system as it is, as the opening of further negotiations seems too risky at the present time. Both experts pressed for ratification of the TRIPS amendment, which requires European Parliament assent. They also said they wanted the EU to step up its support for research and innovation, through public-private partnerships. The EU should also promote the transfer of technologies and the installation of production sites in developing countries (they cited the example of a German project in Bangladesh), although they acknowledge the fact that India, which has become the pharmacy of the poor in recent years, is unable to ensure that its whole population has access to medicinal products. Pointing out that access to medicines is not only a question of patents but also of public funding, political resolve and an effective healthcare system, Jon Pender (GSK) said the pharmaceuticals industry is in favour of ratifying the protocol allowing an interim waiver to be transformed into a permanent mechanism. The representative for the generics industry (EGA), Greg Perry, was interested in the idea of grouping several licenses in order to overcome the problem of market size. Paul Cawthorne felt the agreement on compulsory licenses had had a real impact on access to medicines in some countries, but that most of the developing countries have not yet applied it as they come under enormous pressure mainly from the United States. He called on the Union to ratify the agreement but also to help developing countries to apply it. Speaking on behalf of the Commission, Ms Gumaelius called for the TRIPS amendment to be approved. She stressed the need to develop access to medicines, underlining the fact that the poor countries are also those that are the most exposed to counterfeit medicines.
In August 2003, the WTO had authorised, in the form of an interim waiver, the issue, for public health needs, of compulsory licenses allowing a derogation to the rules on the protection of intellectual property rights for medicines. With its decision of December 2005, the WTO transformed this interim waiver into a TRIPS provision. A limited number of countries or organisations, including Canada, China, India, Norway and the EU, have for now adopted texts to ensure this system is implemented, especially the possibility that their laboratories may provide generic medicines to countries issuing compulsory licenses. Only seven countries (out of 150) have so far ratified the 2005 decision, namely: South Korea, the United States, India, Norway, Philippines, Salvador and Switzerland. (oj)