Brussels, 19/06/2001 (Agence Europe) - On Tuesday, in Brussels, the European Commission published the communication that it is to present on Wednesday to the other WTO members during the meeting of the Council for TRIPS (Trade-Related Aspects of Intellectual Property Rights). The text, which comes within the Commission's strategy for promoting access by developing countries to essential medicines, also aims to keep pressure on the pharmaceuticals industry with a view to obtaining an overall commitment on a mechanism of voluntary licensing associated to differentiated pricing. The communication, presented to the Committee under Article 133 of 8 June, received endorsement from Member States. It does not provide for negotiations on possible modification of the articles in question (the Commission does not have a mandate to do this, stressed the representative of one Member State), but makes a Union contribution to reflection on possible clarification.
The communication proposes to seek a common interpretation of Articles 31 (compulsory licenses), 30 (general exceptions) and 39-3 (protection of clinical data). It stresses the importance of protecting patents and does not envisage amending the article on compulsory licenses (which allows countries, in the case of emergency and for non-commercial use, to make it compulsory for a company to authorise the local production of a product needed in the general interest). Contrary to the appeals made along these lines, the EU and its Member States do not consider it necessary to specify that this should be applied to public health. "The absence of any explicit reference to public health in Article 31 does not prevent the WTO Member States from invoking public health reasons", notes the Commission, which does not see any reason either for reopening discussion on the protection of clinical data to the extent that such data is not directly useful for the manufacture of generic medicines, but solely to meet requirements relating to obtaining marketing authorisation. The document points out, on the other hand, that the European Community and its Member States are willing to discuss the possibility, for a country that does not have its own pharmaceutical industry, to give a compulsory license to a producer from another country and to import medicines produced under that licence.
Commissioner Pascal Lamy declared: "I trust that our proposals will enrich the debate at the WTO, with a view to the Qatar conference, on the way to guarantee that intellectual property rules are applied (…). We must ensure that the poor countries are able to use the flexibility of these rules for access to essential medicines at affordable prices. While taking into account the fact that patents are fundamental for encouraging investment in the development of new medicines, we must interpret and apply the rules in a way that supports developing countries in their fight against fatal diseases. These matters are too important to be left up to the hair-brained ideas of lawyers".
The press release diffused by the Commission stresses that this communication follows up the action plan recently approved to fight against transmissible diseases (AIDS, tuberculosis and malaria), and is an integral part of the communication strategy aimed at encouraging the pharmaceuticals industry to engage in a global system of differentiated prices. To this end, Commissioners Lamy and Poul Nielson had met, on 29 May, the representatives of several laboratories including President de Merck (see also EUROPE of 7 June, p.16). Another meeting between Commissioner Lamy and the presidents of Aventis and GlaxoSmithKline (GSK) was held on 11 June. On that occasion, GSK President Jean-Pierre Garnier had presented the measures taken by his company to "raise the challenge" of access to medicines: - preferential prices for anti-malaria treatments; - extension of this offer to all the less advanced countries and all the countries of sub-Saharan Africa; - development of a pilot programme for managing the use of anti-infection, anti-parasite and anti-diarrhoea medicines; etc. The Commission press release stresses that, over the past six months, a certain number of laboratories have made an effort, but that these individual initiatives have not made it possible to establish an overall scheme for price differences in order to make medicinal products accessible in the long term. EUROPE has reason to believe that the Commission would also like the pharmaceuticals industry to engage in a voluntary licensing system in order to avoid the complex implementation of the compulsory licensing system.