Parliament approves clinical trials proposal

March 31, 2003

Brussels, 28 Mar 2003

The European Parliament has adopted a report on the Commission's proposal for Community participation in a research programme aimed at developing affordable drugs to treat AIDS, malaria and tuberculosis, through a partnership between Europe and developing countries. A number of amendments were adopted, the majority seeking to widen the scope of the research.

The proposed programme, 'The European and developing countries clinical trials programme' (EDCTP) will run under the umbrella of the Sixth Framework Programme (FP6). It will bring together all of the EU's Member States along with Norway and scientists from numerous developing countries, to develop new drugs and carry out clinical trials.

In justifying the amendments, Parliament rapporteur Gérard Caudron claims that while the programme should focus on the three diseases outlined in the proposal (AIDS, malaria and tuberculosis), 'it would appear inadvisable to circumscribe such research too narrowly.' He therefore argues that co-existing infections that play a role in the development of these diseases should also be the subject of research.

Other amendments emphasise the fact that the products resulting from the envisaged clinical trials must be easily accessible to developing countries. The programme should also take account of existing interventions regarded as promising and invest in improving them at the same time as developing new products, says Mr Caudron.

The five year budget for the programme is 600 million euro, with 200 million coming from the EU, 200 million from national research programmes and 200 million from the private sector. Funding of this amount from the private sector has, however, still to be found.

The EDCTP represents a new form of cooperation, as described by Article 169, which has never before been implemented. Under Article 169, the Community may participate in research programmes undertaken by several Member States. To see the Parliament's amendments, please click here

CORDIS RTD-NEWS / © European Communities

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