EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN 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 a nd Developing Countries Clinical Trials 
Partnership’ Programme 
   
EXECUTIVE SUMMARY  
 
{COM(2008) 688} 
{SEC(2008) 2723}  
 
EN 2   EN The European and Developing Countries Clinical Tr ials Partnership (herei nafter referred to as 
"the EDCTP Programme") was established in 2003 by Decision of the European Parliament 
and of the Council1 by 14 Member States2 and Norway (Switzerland joined the EDCTP in 
2005). The objectives were to acc elerate the development of ne w clinical interventions to 
fight HIV/AIDS, malaria and tuberculosis in the developing countries, particularly in sub-
Saharan Africa, and to improve the quality of re search in relation to these diseases. Created 
under the umbrella of the Article 169 of the Treaty3, 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 scie ntific advisory boar d), the Developing Count ries 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 Prog ramme for Research and Technological 
Development (2002-2006) – FP6. The participat ing Member States pr ovide 50% co-funding, 
both in cash and in kind, increasing the to tal EDCTP budget to €400 million. An additional 
€200 million funding from third parties is also envisaged.  
The EDCTP Programme had an initial implem enting phase (from 2003 to 2006) slower than 
initially foreseen. Over that period budget sp ending was abnormally low, calls for proposals 
were cancelled, and a 2004 report from the Eu ropean 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 Poto čnik requested a panel of high level expert s to prepare an Independent External 
Review (IER) report on the European and Deve loping Countries Clinical Trials Partnership, 
the so called van Velzen report, which was published in July 20074.  
The present progress report, published as a Co mmission Staff Working Document, is intended 
to inform on the achievements and current st atus of the first five years of the EDCTP 
Programme, from 2003 to 2008, following the reco mmendations 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 Secret ariat, 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 developm ent 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, Gr eece, 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 th e Member States concerned, for participation in research and 
development programmes undertaken by several Member States, including participation in the 
structures created for the ex ecution of those programmes." 
4 Independent External Review Report: European and Developing Countries Clinical Trials Partnership 
(July 2007); also known as the Van Velzen Repor t; see http://ec.europa.eu/research/health/poverty-
diseases/doc/final_ier_report_12july2007_en.pdf 
 
EN 3   EN Since 2007, the EDCTP Secretariat has redefined its scientific strate gy, through stakeholder's 
meetings held on the different diseases and products, increased colla boration 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 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 projec ts. Among these, 32 are clinical trials; 55 are 
training (MSc, PhDs and post doc toral) awards; 11 are supportin g network activities; 14 are 
capacity building in ethics; 16 are Senior Fellowships; one project on strengthening the 
regulatory framework in Africa through co llaboration with WHO; and one for the 
establishment and maintenance of a clinical tr ials registry. The proj ects are based in 26 
different countries in sub-Saharan Africa, in volving 123 institutions, and practically all 
participating Member States.  
In particular, in 2007 the EDCTP launched 11 ne w calls for a total of €180 million (including 
€90 million of co-funding expected from Memb er 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 vacci ne, 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 a nd 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 thes e 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 vaccine s. 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 resear chers. 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, product-
development public private partnerships and industries accounts so far for €34.1 million.  
In the almost five years since its creati on, the EDCTP has achieved several important 
landmarks:  
 
EN 4   EN • Enhanced coordination of re search 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 nati onal 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 owne d by the institutions a nd countries, avoiding 
scientific colonization 
• Grantees have developed new research si tes 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.