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}
Date: 2008-10-30
Institutions: European Commission
Subjects: code of conduct, developing countries, experiment on humans, medicinal product

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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  Council1  by  14  Member  States2  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  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 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 20074.  

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.  

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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.  
Austria,  Belgium,  Denmark,  France,  Germany,  Greece,  Ireland,  Italy,  Luxembourg,  the  Netherlands, 
Portugal, Spain, Sweden, and the United Kingdom. 
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." 
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/poverty-
diseases/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  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 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,  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:  

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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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