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European Law Monitor NewsExpert group on research programme for clinical trials in Africa calls for greater Member State commitment to coordinating research

An expert group, asked by the Commission to review the only research programme so far established to combine EU and national funds, has said that any future programmes need a much stronger up-front commitment from Member States. The group, chaired by former MEP Wim Van Velzen, was asked to look at the European and Developing Countries Clinical Trials Partnership (EDCTP), a common research programme designed to pool resources from the EU research budget and national research programmes for clinical trials in the area of HIV/AIDS, malaria and tuberculosis, and to make recommendations for improving EDCTP and for future programmes. A number of recommendations are addressed to the management of the EDCTP programme and its "owners" among the Member States. Further recommendations are addressed to the Commission, to be borne in mind when future such "Article 169" proposals for the coordination of national and European research programmes are prepared.

Welcoming the report, European Science and Research Commissioner Janez Potočnik said: "This report is an honest and constructive assessment of the EDCTP experience so far. My wish is to improve the chances of success of this programme because the issues here are too important to leave to chance. I will carefully examine each recommendation. In any case, making EDCTP, and other such programmes that may follow, successful requires political commitment at high level from the Member States. This report will certainly help us in bringing this issue to the attention of ministers."

The European and Developing Countries Clinical Trials Partnership was established in 2003 by 15 European countries to develop new clinical interventions and adapt existing treatments to address the needs of sub-Saharan Africa in the field of poverty-related diseases, specifically HIV/AIDS, tuberculosis and malaria. A grant of €200m was allocated from the 6th Research Framework Programme, which was to be matched by €200m from the Member States. However a number of administrative and management problems mean that to date €40m has been allocated from the EU budget with €37m coming from Member States, as of 30 June. Among other points, the report's authors criticised the lack of follow-through of commitments made when the EDCTP was created and the fact that money that was pledged by Member States came with national strings attached.

Regarding future initiatives to pool EU and national research money, as allowed for in Article 169 of the treaty, the group recommends that new proposals should only be made when certain pre-conditions are fulfilled:

       * Well-identified, existing national programmes in that field;
      * Strong commitments from Member States to making the necessary budget available;
   * Irreversible political commitments from the Member States involved, if necessary with sanctions
       * Rules in place to create a "common pot" with no national ear-marking of funds.

The group also makes suggestions about how to improve the implementation and governance of EDCTP and proposes certain conditions for any future financing under FP7 including:

       * Better coordination between Commission services on health research policy
       * Better consultation and collaboration with African research and policy-makers
       * Clearer up-front commitments from Member States

The group was composed of:

       * Dr Adetokunbo O. Lucas • former Director of WHO Tropical diseases research programme
       * Wim Van Velzen (Chair) • former MEP, involved in various research organisations
     * Allyson Pollock • director of the Centre for International Public Health Policy, University of Edinburgh
     * Jean Stéphenne • President and General Manager of GlaxoSmithKline Biologicals
     * Fernand Sauer (Rapporteur) • former Executive Director of the European Medicines Agency.

A minority dissenting opinion was presented by one of the members of the expert group, suggesting discontinuing the current EDCTP funding programme for HIV/AIDS, malaria and tuberculosis. All other four experts disagreed with this recommendation.
The full report is available from:  

Reproduced with the permission of the European Commission IP/07/1104