The European and Developing Countries Clinical Trials Partnership (EDCTP Programme) was established in September 2003 by Decision of the European Parliament and of the Council5,6 to accelerate the development of new clinical interventions to fight HIV/AIDS, malaria and tuberculosis in the developing countries, particularly in sub-Saharan Africa, and to improve generally the quality of research in relation to these diseases.

Created as the first application ever of Article 169 of the Treaty, the EDCTP Programme aims at coordinating and jointly implementing activities run by the Member States in partnership with developing countries.

This Communication follows a recommendation in the Independent External Review (IER) report, also known as the Van Velzen report, that the Commission should inform the Council and the European Parliament about the current status of the EDCTP Programme, in advance of the 2008 evaluation (required by the original EDCTP Decision) due at the end of the first five years of the EDCTP.

The main conclusions are as follows:

The main challenges of the Programme : f or the first time, 14 European Member States, together with Norway and Switzerland, are building a new structure to coordinate their clinical research activities on HIV/AIDS, malaria and tuberculosis in sub-Saharan Africa. The research financed will have a direct impact on the hardest-hit populations, in terms of new drugs, vaccines and public health interventions.

To recall, the main objectives of the programme were to:

1) Develop new interventions and products against poverty-related diseases. The fight against HIV/AIDS, malaria and tuberculosis needs both prophylactic (vaccines and microbicides) and therapeutic (drugs) tools to prevent infection and control disease progression.

2) Build sustainable public health and research capacity in Africa, so local populations can better control the pandemic. The coordination of development aid policy and research policy should aim at a better implementation of these separate policies into a long term strategy against the three diseases.

3) Coordinate European Member States’ research policies. While the research activities of some European Union Member States in Africa have been remarkable, they could profit from better collaboration and coordination. Coordinating European national research programmes and policies on poverty-related diseases for Africa in line with Article 169 of the Treaty will increase the impact of European interventions against these diseases.

As part of the European contribution to the UN’s Millennium Development Goals, the EDCTP is an important instrument in the fight against HIV/AIDS, malaria and tuberculosis. Better vaccines and treatments would help dramatically reduce the incidence of such diseases, and research is essential to developing these tools. The special nature of EDCTP activities — financing capacity building and research activities in developing countries — calls for collaboration on the part of development aid and research agencies.

Main achievement and lessons to be experience gained : the Commission considers Article 169 to be a powerful, ambitious instrument for coordinating national programmes and building the European Research Area. Activities conducted under this Article have a longer than average implementation phase, but come with greater potential and are able to deliver results not achievable with other instruments. As such, they should be considered long-term activities.

In this context, the EDCTP has made its mark in a number of important ways, starting to fulfil the original objectives of the Programme: i) to encourage African countries to establish national research budgets and to further contribute to the establishment of an African Fund for Health Research; ii) to facilitate funding to give African researchers more ownership, and provide better fora for discussion and knowledge exchange; iii) to enable capacity and sites developed to be fully owned by the institutions and countries, avoiding ‘scientific colonisation’; iv) that grantees have developed new research sites by accessing funding from other sources; v) the development of HIV treatment in children .

Despite some serious initial difficulties, the performance of the EDCTP Programme has improved in the last two years, with specific achievements in line with the original goals of the Programme and with the recommendations of the Van Velzen report. The remaining two years of the EDCTP contract until 2010 will be crucial to determining the extent of Member States’ financial and political commitment and the Secretariat’s capacity to negotiate and follow up research contracts.

As learnt from the EDCTP, two of the main pre-conditions for new Article 169 initiatives are pre-existing national research programmes and a full funding commitment, in advance, from Member States. From the outset, the EDCTP Programme was set up as a long-term initiative which could only achieve its goals of research capacity-building in Africa, halting disease progression and integrating European research in the long term. Nevertheless, progress in the medium term should be objective and measurable.

Follow-up : as requested by Council and Parliament in the 2003 EDCTP Decision, following the publication of this progress report the Commission will begin a five-year evaluation of the Programme . The results obtained will be taken into account when considering a decision on renewing the EDCTP Programme for the period 2010-2015.

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This report outlines the state of progress on the European and Developing Countries Clinical Trials Partnership (the EDCTP Programme) which was established, in 2003, by Decision of the European Parliament and of the Council by 14 Member States (all the then Member States except Finland) and Norway (Switzerland joined the EDCTP in 2005). The objectives were to accelerate the development of new clinical interventions to fight HIV/AIDS, malaria and tuberculosis in the developing countries, particularly in sub-Saharan Africa, and to improve the quality of research in relation to these diseases. Created under the umbrella of the Article 169 of the Treaty, the EDCTP Programme aims at coordinating and jointly implementing activities at Member State level.

EDCTP is managed through a General Assembly where Member States are represented, a Secretariat under the Executive Director, and a High Representative. Advisory bodies include the Partnership Board (the scientific advisory board), the Developing Countries Coordinating Committee, and the European Network of National Programmes.

The Community has made a contribution to the EDCTP through a €200 million financial contribution under the 6th Framework Programme for Research and Technological Development (2002-2006) – FP6. The participating Member States provide 50% co-funding, both in cash and in kind, increasing the total EDCTP budget to €400 million. An additional €200 million funding from third parties is also envisaged.

The EDCTP Programme had an initial implementing phase (from 2003 to 2006) that was slower than initially foreseen. Over that period, budget spending was abnormally low, calls for proposals were cancelled and a 2004 report from the European Court of Auditors (PF-1828 (6046)) revealed several deficiencies. During the same period, the Secretariat was under four different Executive Directors, two of them being ad interim. As a consequence, in 2006 Commissioner Janez Potočnik requested a panel of high level experts to prepare an Independent External Review (IER) report on the European and Developing Countries Clinical Trials Partnership, the so called van Velzen report, which was published in July 2007.

This progress report, published as a Commission Staff Working Document, is intended to inform on the achievements and current status of the first five years of the EDCTP Programme, from 2003 to 2008, following the recommendations of the Van Velzen report.

The time that has elapsed since its publication in July 2007 has allowed the implementation of most of its recommendations to the EDCTP Secretariat, Member States and Commission.

Since 2007, the EDCTP Secretariat has redefined its scientific strategy , through stakeholders’ meetings held on the different diseases and products, increased collaboration with Public-Private Partnerships, renewed calls for proposals and simplified the co-funding.

Participating Member States have created a General Assembly Steering Committee, renewed their commitment to the EDCTP, reinforced African participation in the General Assembly, and are more and more accepting of a single central EDCTP evaluation.

The Commission is joining efforts of its relevant services in relation to EDCTP, working on a strategic research policy for Africa including EDCTP , and setting pre-conditions for future Article 169 initiatives, such as the necessity to ensure the pre-existence of national programmes and commitment to funding.

On the operational side , from September 2003 to May 2008, the EDCTP Programme has launched 33 calls and financed about 145 projects. Among these, 32 are clinical trials; 55 are training (MSc, PhDs and post doctoral) awards; 11 are supporting network activities; 14 are capacity building in ethics; 16 are Senior Fellowships; one project on strengthening the regulatory framework in Africa through collaboration with WHO; and one for the establishment and maintenance of a clinical trials registry. The projects are based in 26 different countries in sub-Saharan Africa, involving 123 institutions, and practically all participating Member States.

In particular, in 2007, the EDCTP launched 11 new calls for a total of €180 million (including €90 million of co-funding expected from Member States). In May 2008, and as partial outcome of these calls, the EDCTP General Assembly approved the financing of 8 new projects on malaria treatment, malaria vaccine, malaria in pregnancy, and tuberculosis vaccine; 8 new projects on capacity building for African ethical committees; 3 trans-disease regional networks of excellence (East, Central and West Africa), and 6 senior fellowships, for a total of about €87 million, including 50% co-funding from MS. The remaining calls are under evaluation.

As a result of all these calls, EDCTP has committed from 2003 to December 2007 €76.2 million (from EC, MS and third party funding) in grants, including a call co-funded by the Bill and Melinda Gates Foundation on HIV vaccines. In 2008, the EDCTP expects to increase this figure to over € 279 million.

However, since most projects are 3-year contracts, and some of them are just starting, the total EDCTP expenditure on research grants has been so far of €15.7 million. Out of the total commitment, 63% is going to African researchers. In 2007, 88% of the EDCTP budget was devoted to grants.

Member States’ co-funding has increased from less than €1 million in 2005, to €6 million in 2006, and up to €21 million in 2007. Data from January to April 2008 already show €67 million committed or pledged from Member States.

Third party contributions contributed or committed from different foundations, product development public private partnerships and industries accounts so far for €34.1 million.

In the almost five years since its creation, the EDCTP has achieved several important landmarks :

enhanced coordination of research activities and demonstrable capacity building; African researchers have an equal opportunity to their northern colleagues to develop proposals and become Principal Investigators; the EDCTP is urging African countries to establish national research budgets and to further contribute to the establishment of an African Fund for Health Research; EDCTP funding gives African researchers more ownership, provides better fora for discussion and knowledge exchange; capacities and sites developed are fully owned by the institutions and countries, avoiding scientific colonization; grantees have developed new research sites by accessing funding from other sources;

EDCTP funding is instrumental in the approval of some major health policy changes, such as the development of HIV treatment for children.

SEC(2008)2723
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SEC(2008)2724
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Decision 2003/1209
OJ L 169 08.07.2003, p. 0001-0005

COM(2003)0223
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COM(2003)0223
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T5-0123/2003
OJ C 062 11.03.2004, p. 0019-0150 E

Debate in Parliament

T5-0123/2003

CES0039/2003
OJ C 133 06.06.2003, p. 0093-0096

CES0414/2003

A5-0027/2003

A5-0027/2003

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COM(2002)0474
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