Brussels, 05/12/2005 (Agence Europe) - In Brussels on 1 December, World AIDS Day, the European Parliament approved by 543 votes to 21, with 35 abstentions, the report from Belgian Liberal, Johan Van Hecke, on the proposal for a regulation putting in place a system of compulsory licences for the export of generic medicines to poor countries in order to improve disadvantaged people's access to available treatment for AIDS and other serious illnesses . The amendments adopted bring legal clarification to the text proposed by the European Commission and extend the benefits of this scheme to all developing countries (the original proposal being only for WTO member countries). Before obtaining a compulsory licence, a licence must be sought from the patent holder, who is required to respond within 30 days (and not “within a reasonable time scale” as in the original text). Remuneration of the licence has a maximum upper limit of 4%. The appearance of the generic medicine must be distinct (in colour or shape) in order to avoid reimportation. These amendments were agreed with the Council. The text of the Regulation will be adopted shortly after finalisation by legal and linguistic experts and enters into force on the 20th day after publication in the Official journal.
Commissioners Charlie McCreevy (Internal Market) and Peter Mandelson (Trade) expressed the Commission's welcome for the Parliament vote in favour of the Regulation proposal “allowing companies to produce, under licence, copies of patented medicines for their export to developing countries”. The Commission recognises that the Council and the Parliament have worked very hard to reach this agreement on the first reading. The Regulation is particularly important for the EU's relationship with developing countries, and represents a key political signal for negotiations at the forthcoming WTO Ministerial Conference in Hong Kong. The Commission had presented its Regulation following a decision by the WTO General Council in August 2003, allowing the part regulation of the problem of access to medicines in poor countries within the framework of the process started by the Doha Declaration of 14 November 2001.