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Europe Daily Bulletin No. 8240
Contents Publication in full By article 12 / 42
GENERAL NEWS / (eu) eu/wto/medicines

Commission to propose, at WTO, a complex mechanism for authorising manufacture and exportation of medicines under compulsory license to poor countries

Brussels, 24/06/2002 (Agence Europe) - The European Commission plans to take advantage of the TRIPS Council meeting at the WTO, from 25 to 27 June in Geneva, to present a concrete proposal for amending the agreement on intellectual property rights in the aim to improve access to essential medicines by poor countries. In order to meet the commitment taken in Doha, the Commission will propose that WTO members complete Article 31 of the TRIPS Agreement with a complex mechanism that would enable a foreign supplier to fill orders of poor countries on the basis of a compulsory licence in specified circumstances, for exclusive distribution to the domestic market of those countries.

The Commission proposes restrictions under Article 31(f) should be maintained but that a new paragraph should be added providing for an exception that will allow the party States, when a compulsory license has been set in place, to produce a medicinal product and to sell it to an entity that will import it into the country covered by the compulsory license. This mechanism must allow the poorest countries that do not have the necessary infrastructure for producing medicines to guarantee their populations access to medicines at affordable prices. The new paragraph, however, should specify a number of conditions: - the medicine should not be marketed in the producer countries but entirely exported towards the country that comes under the compulsory license; - the medicine can only be used on the domestic market of the beneficiary country and cannot be re-exported; - the producer country and the beneficiary country should take all the measures needed to guarantee respect of these two conditions, in order to prevent abuse and deflection towards other markets. The holder of the intellectual property rights and the countries that are party to the Agreement will be kept constantly informed of the various stages in the authorisation procedure. Transparency of this kind should guarantee adequate surveillance to avoid eventual parallel imports, which has so far been the main argument put forward by the pharmaceuticals industry to oppose the possibility of producing a generic medicine intended for developing countries before expiry of the patent. The Commission suggests a three-stage procedure: (1) the State wishing to issue a compulsory license or call on another to do so if the product is not covered by a patent on its own territory, as well as that which is to produce the medicine, should notify it to the rights holder (or to the WTO); (2) the laboratory may propose its own product at a far lower price within a short time; (3) such a commitment should make it possible to avoid the use of a compulsory license, unless the laboratory's offer is considered insufficient by the applicant country. The Commission stresses that this system should apply as a priority to the medicines used to treat AIDS, tuberculosis and malaria and other epidemics, and in the least developed countries.

Oxfam International expresses concern about turn the debate is taking

In a press release on Monday, Oxfam International wonders how determined the rich WTO member countries really are to sticking to the Doha commitments. It recalls that the American administration and the main associations of the pharmaceuticals industry remain fiercely opposed to a truly applicable system. The NGO insists on a system that guarantees access to medicines for all serious illnesses, and recalls that over recent years there have been drug-resistant variants of serious diseases that pose public health threats such as pneumonia, meningitis and diarrhoea, etc. It also regrets that the Commission had deliberately chosen to restrict the solution t hat it proposes to the less developed countries. The fact that the EU "is even considering an amendment of this sort to TRIPS is a big step forward, but in the ruthless and byzantine world of trade rules and disputes, their option has little chance of guaranteeing poor people access to the vital new medicines they need", says Oxfam.

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