Brussels, 28/08/2002 (Agence Europe) - The European Commission adopted on Wednesday a proposal for a decision concerning the Community's participation in the developing countries clinical trials programme on medicines or vaccines used to combat transmissible diseases linked to poverty (AIDS, malaria and tuberculosis). Presented at an inaugural conference in Barcelona on 19 and 20 April last (see EUROPE of 20 and 22 April), the European-Developing Countries Clinical Trials Programme (EDCTP) is based on a long-term partnership between the developing African countries and 15 European states: Norway and the EU Member States, with the exception of Luxembourg. The initiative marks the first use of Article 169 of the Treaty, which enables the Community to participate in research and development programmes undertaken by several Member States. The decision will be submitted to the European Parliament for approval under the codecision procedure.
The Commission proposes a Community contribution of € 200 million to the programme for the duration of the sixth research framework programme (2002-2006), taken from the budget reserved for the priority area of Genomics and Biotechnology for Health. It would be transferred into the "common structure" responsible for management of the programme. The practical arrangements for the Community's financial participation as well as rules on intellectual property rights would have to be adopted jointly through a convention concluded by the Commission and the common structure. The participating states would remain jointly liable for implementation of the programme. Provisions are foreseen to guarantee the protection of the Community's financial interests. An annex describes the different activities eligible for financing under the Community funds: (1) networking and coordination of European national programmes and activities in the developing countries; (2) support for clinical trials and strengthening of capacities in the developing countries; (3) activities to ensure the development, visibility and sustainability of the EDCTP; (4) secretariat and management of information on the clinical trials.
The participating states have estimated the total cost of the EDCTP at € 600 million for five years. They thus intend to adopt a coherent approach at the European level to fight more effectively the global problem caused by AIDS, malaria and tuberculosis. In addition to their considerable impact on the economic and social development of the countries concerned, these three diseases kill some 6 million people a year. In some African countries, 40% of the population is infected with HIV. As the Barcelona conference demonstrated, the countries concerned expect a great deal from this programme in terms of development of their own research and clinical trials structures, but also in terms of more effective therapies and/or better adapted to their specific needs. Several African ministers nonetheless insisted in Barcelona on the need to respect ethical rules and to place the programme at the service of the local communities.