WRITTEN QUESTION E-3089/01

by Erik Meijer (GUE/NGL) to the Commission

(13 November 2001)

Subject: Equating the fight against HIV/Aids and tropical diseases with measures to tackle anthrax by ensuring access to medicines for all

1. Is the Commission aware of the report in the Dutch newspaper Trouw of 20 October 2001 under the headline Anthrax forces US to infringe patent that there are calls in both the United States and Canada for infringement of Bayer's patent rights on the anti-anthrax drug ciproflaxin?

2. Can the Commission confirm that the aim of the policy change referred to above is in fact to authorise the production of a drug similar to ciproflaxin by for example Ranbaxy in India or by a Canadian company, from which the Canadian government has apparently already ordered 900 000 tablets of a cheaper version of the drug?

3. Does the Commission share my view that this is a welcome development in that the health interests of the American and Canadian populations are overriding the economic interests of the pharmaceutical industry and that the Trips Agreement, which protects the intellectual property of the pharmaceutical industry, can therefore now be set aside because of what the US and Canadian governments claim is a national emergency?

4. Does the Commission agree with me that this legitimate infringement of patent law would smack of cynicism unless, at the same time, the developing countries are also generously authorised to set aside the patent legislation of the Trips Agreement on the grounds of the permanent state of emergency in their countries caused by the HIV/Aids epidemic and the massive spread of life-threatening tropical diseases that has existed for years, to enable them to provide their populations with affordable medicines as soon as possible?

5. Is the Commission prepared, following on from the Khanbhai report on poverty reduction adopted by Parliament on 4 October 2001, to ensure that its delegation vigorously supports the right of people in the developing countries to health, health care and access to medicines at the upcoming fourth WTO ministerial conference in Qatar?

Answer given by Mr Lamy on behalf of the Commission

(7 January 2002)

The Commission is aware of the discussion that has taken place between the United States and Canada and the patent owner Bayer regarding sales of Ciproflaxin. The Commission understands that the matter has been settled in both cases between the patent holder and the respective buyers without setting aside patent rights, but it is not aware of any purchases of similar drugs from generic producers whether from India or elsewhere.

To the knowledge of the Commission, no infringement of intellectual property rights has taken place in the anthrax case, and neither the United States nor Canada have resorted to compulsory licences.

The Commission would point out that the trade-related intellectual property rights (TRIPs) Agreement provides for the possibility to grant compulsory licences. As confirmed in the Declaration on the TRIPs Agreement and Public Health adopted at the fourth World Trade Organisation (WTO) Ministerial meeting at Doha, each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. Also, each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency. The latter point is important, as Members are allowed to grant compulsory licences using a fast-track procedure when facing a situation of national emergency or extreme urgency.

The Declaration on the TRIPs Agreement and Public Health referred to above, and which is in line with the position adopted by the Community before the Conference, represents a significant step forward in the debate on access to medicines. It brings clarification with regard to the link between the TRIPs Agreement and WTO Members' right to adopt public health measures. In addition, it reflects the consensus reached on the definition of the flexibility inherent in several relevant TRIPs provisions.