Brussels, 17/07/2007 (Agence Europe) - Born of real need - to develop medicines tailored for poor countries - and institutional concern - the first use of Article 169 of the Treaty - the European and Developing Countries Trials Partnership (EDCTP) has been far from delivering the expected results. That was what a panel of five independent experts found, and their recommendation is for significant amendments to the management structure of the programme. There was one dissenting voice from among the experts: Allyson Pollock believes that it will not be possible to get out of the current situation unless the European Commission takes over direct administration of the programme and a more rigorous comprehensive strategy is adopted. A few days before the publication of this expert report, in June, the EDCTP's initial five-year period was extended until the end of 2010, with no additional funding.
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. One theme is present throughout the report: African scientists and leaders were not sufficiently involved in this partnership, in which the main players are EU member states which did not even make a financial contribution. Reading the report, there is a feeling that there was only real partnership during the launch meetings, which African ministers attended in Barcelona (see EUROPE 8197) and Brussels. Not only were decisions taken without the involvement of the African partners, they were taken on the basis of guidelines provided by contributing states. There was no real overall reflection either on African facilities and needs, or on possible coordination with other initiatives. Article 169 of the Treaty (coordination of national research programmes) had to be tried, and the Commission made a proposal without making the necessary commitment to the initiative. The result was that member states' representatives made it a sort of regulation committee. Of the €600 million promised in 2003 to fund the programme, barely €60 million have hitherto been committed and only €16 million really spent (and 30% of this went on administrative costs). The 15 member states which promised €200 million have put €37 on the table. The Commission is hoping, by the end of the year, to reach the sum of €40 million (also out of a target of €200 million) under the 6th Framework Programme. The private sector was also supposed to provide €200 million: hitherto only the Bill and Melinda Gates Foundation have contributed €7 million.
Among other points, the report criticises the procedures and the time delays (between six and nine months to obtain funding), the lack of monitoring of commitments made when the EDCTP was set up, and the fact that the provision of the funds promised by member states was accompanied by national conditions as to how the funding was to be used.
For the future, the expert 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 the 7th Framework Programme 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 the 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; and Fernand Sauer (Rapporteur), former executive director of the European Medicines Agency. (oj)
The full report is available from:
http: //ec.europa.eu/research/health/poverty-diseases/doc/final_ier_report_12july2007_en.pdf