Parliament committee backs Commission proposal on EU-developing countries clinical trials

January 27, 2003

Brussels, 24 Jan 2003

The new European Commission proposal, aimed at finding affordable drugs for HIV/AIDS, malaria and tuberculosis in developing countries, was strongly backed on 22 January by the European Parliament's Committee on industry and research.

The proposal focuses on the European-Developing Countries Clinical Trials Programme (EDCTP). This would see a partnership between European and developing countries for the development of new clinical interventions to fight HIV/AIDS, malaria and tuberculosis in the developing countries, particularly in Sub Saharan Africa.

The European Commission proposes that under the Sixth Framework Programme (FP6), Article 169 is employed for the first time. This would see the Commission supporting a programme undertaken by several Member States. In this case, the Commission proposes providing 200 million euro for the EDCTP, to be matched by 200 million euro from the Member States involved and 200 million euro from the private sector. The total investment called for in the proposal contrasts greatly with the 100 million euro that was allocated for this field under the Fifth Framework Programme.

However, to ensure easy and affordable access to any new medicines developed by the programme, MEPs at the meeting insisted on amending the rules laid out in the proposal regarding the intellectual property rights. 'A transparent approach to intellectual property rights, in the public interest, must be one of the principles underlying any of the EDCTP's activities.'

The amended proposal insists that products should be effective, simple to use and suited to the conditions for developing countries.

Adopting a report by French MEP Gérard Caudron, the committee also emphasised the need to accelerate the clinical trials of new drugs and vaccines to combat the three major diseases, but that 'neglected' diseases must not be excluded and must in the longer term be able to be incorporated in the EDCTP.'

MEPs also called for improved training and the strengthening capacities of developing countries as well as 'stepping up the transfer of technologies to the developing countries and mobilising additional funds to fight these diseases.'

The new proposal comes under the co-decision procedure and will be included on the plenary session agenda in February in Strasbourg.

For further information, please refer to the following web address: ittees/itre/20030122/485749en.pdf

CORDIS RTD-NEWS / © European Communities

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