Source: EURLEX
Language: en
Format: md

**EN**

# **EN EN**

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 30.10.2008
SEC(2008) 2724

**COMMISSION STAFF WORKING DOCUMENT**

**Accompanying document to the**

**COMMUNICATION OF THE COMMISSION TO THE EUROPEAN PARLIAMENT**

**AND THE COUNCIL**

**on the Progress Report on the ‘European and Developing Countries Clinical Trials**
**Partnership’ Programme**

**EXECUTIVE SUMMARY**

{COM(2008) 688}
{SEC(2008) 2723}

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The European and Developing Countries Clinical Trials Partnership (hereinafter referred to as
"the EDCTP Programme") was established in 2003 by Decision of the European Parliament
and of the Council [1] by 14 Member States [2] 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 subSaharan Africa, and to improve the quality of research in relation to these diseases. Created
under the umbrella of the Article 169 of the Treaty [3], 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) 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 [4] .

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

1 DECISION No 1209/2003/EC of the European Parliament and of the Council of 16 June 2003 on
Community participation in a research and development programme aimed at developing new clinical
interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partnership between
Europe and developing countries, undertaken by several Member States. OJCE Nº L 169/1 of 8.7.2003.
2 Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands,
Portugal, Spain, Sweden, and the United Kingdom.
3 Article 169: "In implementing the multiannual framework programme the Community may make
provision, in agreement with the Member States concerned, for participation in research and
development programmes undertaken by several Member States, including participation in the
structures created for the execution of those programmes."
4 Independent External Review Report: European and Developing Countries Clinical Trials Partnership
(July 2007); also known as the Van Velzen Report; see http://ec.europa.eu/research/health/povertydiseases/doc/final_ier_report_12july2007_en.pdf

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Since 2007, the EDCTP Secretariat has redefined its scientific strategy, through stakeholder's
meetings held on the different diseases and products, increased collaboration with PublicPrivate 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 into the General Assembly,
and are more and more accepting a unique 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 Member States' committed or pledged from Member States.

Third party contribution contributed or committed from different foundations, productdevelopment 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:

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    - 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
asthe development of HIV treatment for children.

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