Barcelona, 19/04/2002 (Agence Europe) - The European Commission and Spanish Presidency organised a conference in Barcelona on Friday and Saturday, for the launch of the preparatory phase of a new clinical trials programme: Europe - Developing Countries (EDCTP).
This programme the preparation of which is being co-ordinated by the Hospital Clinic Barcelona, will concern three major diseases (malaria, AIDS, tuberculosis) which are the major scourges in poor countries. Due to the close ties of co-operation that exist between the European Union and the ACP countries and bilateral collaboration between EU Member States and African countries, it will devote itself to Africa as a priority. The Commission's main aim is to allow for research to be undertaken that has so far not been pursued as it was not regarded as being sufficiently profitable by the pharmaceutical industry. In some cases, work is well under way, but clinical trials have not yet been undertaken due to cost and, most often, research has not progressed because the victims of certain diseases are essentially African and do not have the means to pay for the medicines. This is the case, notably for malaria that kills at least 1 million people a year, 90% of whom in Africa. For other pathologies, like AIDS (2 million deaths a year in Africa, according to estimates) or tuberculosis (2 million victims in developing countries, each year), it is also medicines or vaccines adapted to the local use and specific strains that are said to be required. This programme does, however, raise major ethical issues, that several African speakers did not fail to bring up at the opening of the conference, even though they do see in the programme the possibility of developing research and contributing to possibilities of treatment. For its part, the Commission says that the programme will strictly respect ethical codes and international standards of good clinical practice. The preparatory phase is currently financed by a subsidy of 1.2 million euro, granted by the Commission, and should end in June 2003. The sixth Research Framework-Programme (RFP), the examination of which is not yet complete, should then take over: 200 million euro would be released over the five years of the programme, or some 40 million a year. Another contribution could come from the European Development Fund, as long as the ACP countries mention the EDCTP among the priorities of their national indicative programmes. National contributions will also be added: 14 EU Member States (Luxembourg, that has no research is the exception) and Norway, associated in Community research, should participate. This programme could be the first opportunity of using Article 169 of the Treaty that enables the EU to contribute to specific co-operation regarding research between several Member States. The use of this instrument is provided for in the context of the 6th RFP, but passes through a co-decision procedure that can take up to 18 months. The Commission, which, for now, has to wait for the adoption of the framework-programme, has not yet presented a formal proposal, and some are already worried by a delay in the implementation of the programme if it had to wait for the completion of the co-decision procedure.
In Barcelona, Commissioner Philippe Busquin said that "Europe can contribute significantly to resolving the global problem of diseases linked to poverty on condition that it gathers together its disparate efforts". "It is important that the public authorities engage in the process as it seems clear that industry will not necessarily benefit from it", he added. He recalled that he had proposed the opening of the PCRD to teams of researchers in developing countries and that the European Ethical Group should be issuing an opinion in the coming months on the conduct of clinical trials in developing countries.