Improve EDCTP governance and funding, says expert group
'For an Article 169 Programme to become and remain successful, there must be pre-existing national programmes, strong commitment by Member States to provide funding and irreversible national support,' according to an independent review of the European and Developing Countries Clinical Trials Partnership (EDCTP). The EDCTP was established in 2003 by 15 European countries to develop new clinical interventions for HIV/AIDS, tuberculosis and malaria, and to adapt existing treatments for these diseases to address the needs of sub-Saharan Africa. It was set up using Article 169 of the Treaty, which provides a legal basis for the European Community to support the integration of national research programmes by means of participation in programmes undertaken by several EU Member States. The EDCTP was the first programme to use this instrument. The report, compiled by a five-member expert group at the request of EU Science and Research Commissioner Janez Potocnik, looks at some of the difficulties experienced by the EDCTP, and recommends that more funding is provided under the Seventh Framework Programme (FP7) for research, but only if certain conditions are met first. One panel member dissented however, believing that the programme should be discontinued. 'This report is an honest and constructive assessment of the EDCTP experience so far,' said Mr Potocnik. 'My wish is to improve the chances of success of this programme because the issues here are too important to leave to chance.' The Commissioner promised to examine each recommendation, and added that the success of a programme such as the EDCTP is dependent upon political commitment at a high level from the Member States. 'This report will certainly help us in bringing this issue to the attention of ministers,' he said. Under FP6, the European Commission originally allocated €200 for the EDCTP. This was meant to be matched with €200 from national budgets and €200 from the private sector. However, a number of administrative and management problems mean that, to date, only €40 has been allocated from the EU budget, and only €37 from the Member States. 'The difficulty for the EDCTP Programme in combining two major tasks should not be underestimated: integrating national clinical trials programmes and working with scientists and clinicians in Africa,' states the expert report. 'This is a very long-term ambition, which can only produce progressive results if all interested partners understand their responsibilities and respect their commitments, which must be renewed from time to time.' The majority of expert group members recommended that the EDCTP should continue. It must comply strictly with its mandate, and the Member States that created and own the EDCTP must take all necessary measures to provide the promised levels of funding, and to drastically improve EDCTP governance and performance. The funding period was recently extended to 2010, with a number of conditions attached. A further grant under FP7 is possible in the future. However, 'if by the end of 2008 the EDCTP [does] not improve significantly in terms of visible and tangible outputs and results, in line with key recommendations [...] the panel does not recommend the renewal of the financing decision under FP7, based on Article 169 of the Treaty,' writes the expert group. The group's recommendations to the EDCTP encompass the need to: define a clear, convincing and realistic EDCTP strategy and shared vision; to create a more political General Assembly; to increase links with other partnerships in order to avoid duplication; renew calls for projects; and simplify and streamline funding. For their part, the Member States are asked to 'renew their EDCTP vows'. Within the General Assembly, decision-making should also be restricted to Member States that provide funding, and to African representatives (who should have a stronger presence in the General Assembly). The recommendations also call upon the Member States to refrain from imposing national criteria on the programme, and to instead accept one integrated scientific and ethical evaluation carried out by a pool of national experts. A number of recommendations also address the European Commission. The EU executive body should report to the Council and Parliament on the current status of the EDCTP, create a joint DG Research/DG Development platform for dialogue with the EDCTP; and reformulate health research strategy prior to taking a decision on whether or not to finance the platform under FP7. More African involvement is also a priority. The report calls on the Commission to involve African governments at an early stage in order to link the EDCTP's capacity strengthening efforts to those of individual countries, and to consult African governments on the future of the EDCTP and international health research under FP7. Provided that budgetary, administrative and governance commitments are met, the Commission should then submit a new funding proposal to the Council before the FP7 mid-term review. When future Article 169 initiatives are designed, their architects should remember the following, the expert group suggests: 'Before EU money becomes available, there must be: a common work-plan; sound governance structure; fixed national financial contributions; clear evaluation criteria and procedures; clear deliverables; solutions for the liability issue.' The expert group was composed of: - Adetokunbo Lucas, former director of the World Health Organisation (WHO) tropical diseases research programme; - Wim Van Velzen, former MEP; - 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, former executive director of the European Medicines Agency. Dr Pollock explains in a separate chapter in the report why she believes that the EDCTP should be discontinued. 'On the basis of the evidence received EDCTP has not met and is unlikely to meet the objectives laid out for it, unless it is substantially reformed with respect to political accountability and its own internal strategy. As documented in [...] the majority report, the complex governance arrangements and cofunding requirements have resulted in a major underspend,' writes Dr Pollock. 'It is my view that the majority report recommendations which are intended to strengthen governance will not resolve the continuing ambiguity with respect to political control and accountability,' she adds.