Commission staff working document - Progress Report on the European and Developing Countries Clinical Trials Partnership (EDCTP) {COM(2008)688} {SEC(2008)2724}
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) 2723 

COMMISSION STAFF WORKING DOCUMENT 

Progress Report on the European and Developing Countries Clinical Trials Partnership 

(EDCTP) 

{COM(2008)688} 
{SEC(2008)2724} 

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TABLE OF CONTENTS 

Executive Summary ................................................................................................................. 4 

I. 

A. 

B. 

1. 

2. 

3. 

4. 

5. 

6. 

II. 

A. 

III. 

IV. 

A. 

B. 

V. 

Introduction ................................................................................................................ 7 

Establishment of the EDCTP Programme ................................................................... 7 

Governance .................................................................................................................. 8 

EEIG General Assembly ............................................................................................ 10 

Executive Secretariat.................................................................................................. 10 

Partnership Board....................................................................................................... 11 

European Network of National Programmes ............................................................. 11 

Developing Countries Coordinating Committee........................................................ 11 

High Representative ................................................................................................... 12 

The early years: 2003-2006...................................................................................... 13 

Projects financed from 2003 to 2006 ......................................................................... 14 

EDCTP Independent External Review .................................................................. 20 

A new start: 2007-2008 ............................................................................................ 21 

Follow-up of the Van Velzen report .......................................................................... 21 

Operations, calls and grants ....................................................................................... 22 

EDCTP funding / Member States co-funding overview ....................................... 31 

VI. 

Key Performance Indicators ................................................................................... 39 

A. 

B. 

Synergy of research and development funding.......................................................... 46 

Third-party collaboration and funding ....................................................................... 46 

VII. 

The EDCTP medium- and long-term strategy and activities .............................. 47 

VIII.  EDCTP Forum ......................................................................................................... 48 

IX. 

X. 

XI. 

Recent press releases and publications .................................................................. 48 

Commissioner Potočnik's letter to the EDCTP Member States .......................... 49 

Joint DG Research / DG Development platform................................................... 49 

XII.  Health research strategy on the three main poverty-related diseases................. 50 

XIII. 

Involvement of African Governments.................................................................... 50 

XIV.  Other Article 169 initiatives .................................................................................... 51 

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Annexes ................................................................................................................................... 52 

Annex 1: Independent External Review of EDCTP - Key Recommendations ..................... 52 

1. To the EDCTP:..................................................................................................................... 52 

2. To the EDCTP Member States:............................................................................................ 52 

3. To the European Commission, in relation to future EDCTP activities:............................... 53 

4. To the European Commission, in relation to new Article 169 initiatives:........................... 53 

Annex 2: Members of the different EDCTP constituencies .................................................. 54 

Annex 3: Recent EDCTP press releases................................................................................. 59 

Start of Phase II trial of intravenous artesunate for children with severe malaria ................... 59 

HIV/AIDS infected children can now benefit from a European and Developing Countries 
Clinical Trials Partnership (EDCTP) funded trial.................................................................... 60 

ITM starts 4ABC trial to compare four new antimalarial treatments for African children ..... 61 

EDCTP approves € 80 M of funding to boost HIV/AIDS, TB and malaria research.............. 62 

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EXECUTIVE SUMMARY 

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.  

1 

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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 as 
the development of HIV treatment for children. 

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I. 

INTRODUCTION 

The European Commission has financed research on HIV/AIDS, malaria, and tuberculosis for 
many  years.  The  projects  supported  until  year  2002  involved  mainly  basic  and  preclinical 
research, and early clinical trials.  

The  prioritisation  of  the  three  main  poverty-related  diseases  during  the  Fifth  Framework 
Programme  for  research,  technological  development  and  demonstration  activities  (1998-
2002)5  led  to  the  development  of  vaccines  and  drug  candidates  against  these  three  diseases, 
and  the  testing  of  these  up  to  early  clinical  trials  in  Europe  and  Africa.  When  the  Sixth 
Framework  Programme  (2002-2006)6  started,  further  development  of  these  EU-financed 
products into advanced clinical trials (phases II and III) in Africa was very difficult: neither 
the European Union nor the African scientific community had the capacity to prepare for and 
perform large scale clinical trials in Africa.  

At  that  time,  Member  States  were  undertaking  individual  research  and  development 
programmes  or  activities  to  address  HIV/AIDS,  malaria  and  tuberculosis  without  sufficient 
coordination  at  European  level  to  allow  a  coherent  approach  for  a  fully  effective  research 
programme.  Moreover,  the  enabling  environment  to  conduct  these  clinical  trials  in  Africa 
following  the  best  practices  in  accordance  with  good  clinical  practice  (GCP),  good  clinical 
laboratory  practice  (GCLP),  sound  ethical  review  and  competent  regulatory  oversight  was 
limited.  

A. 

Establishment of the EDCTP Programme 

The  European  and  Developing  Countries  Clinical  Trials  Partnership  (EDCTP)  was 
established7 in September 2003 by 15 European countries8 with the aim to develop capacity 
building for clinical trials and new clinical interventions to address the needs of sub-Saharan 
Africa in the fields of HIV/AIDS, malaria and tuberculosis.  

Created under the umbrella of Article 169 of the Treaty, the EDCTP aims at better integrating 
existing  research  from  different  European  Member  States  in  the  field  of  poverty-related 
diseases. As such, one of the first EDCTP tasks was to identify these activities, so as to create 
a map of European research on HIV/AIDS, malaria and tuberculosis.  

The EDCTP Programme was created to address three main strategic objectives:  

1) 

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

Decision No 1513/2002/EC of the European Parliament and of the Council of 27 June 2002 
Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 
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, plus Norway 

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2) 

3) 

Sustainable  capacity  building  in  Africa.  Public  health  and  research  activities  in 
Africa  should  be  sustainable,  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.  

Coordination  of  European  Member  States  research  policies.  Although  the  research 
activities of some European Union Member States in Africa have been remarkable, 
these could profit from a better collaboration and coordination. The coordination of 
European national research programmes and policies on poverty-related diseases for 
Africa, in line with Article 169 of the Treaty, will increase the efficacy of European 
interventions against these diseases.  

The  EDCTP  is  mainly  funded  through  a  €  200  million  grant  under  the  Sixth  Framework 
Programme.  The  grant  agreement  (between  EDCTP  and  the  Commission)  requires  an 
equivalent amount of co-funding from Member States, increasing the total EDCTP budget to 
€ 400 million. Therefore, Member States contribute to this co-funding budget both in cash and 
in  kind.  Additional  funding  from  Third  Parties  (foundations,  public-private  partnerships, 
industry and other stakeholders) is envisaged for later clinical phases, especially in the case of 
industry, which could become involved in the EDCTP activities when a product moves closer 
to marketing authorisation. 

The EDCTP was launched for an initial period of 5 years. In July 2007, after the publication 
of the Van Velzen report9, the grant agreement was extended for two additional years, until 
2010, without additional budget.  

The EDCTP's own website, which includes details of calls for proposals and a wide variety of 
other information, is at http://www.edctp.org. 

B. 

Governance 

The EDCTP European Economic Interest Group (EDCTP-EEIG) is the legal form chosen for 
implementing the Programme and managing the funding. The EEIG consists of: 

•  A  governing  body,  the  General  Assembly,  in  which  all  participating  European  Member 

States are represented  

•  An executive body, the Secretariat, which assures the day-to-day management. 

•  Partnership structures external to the EEIG, which comprise: 

–  The  Partnership  Board  (PB),  a  scientifically  independent  expert  panel  that 

develops the strategic planning of the EDCTP  

–  The  Developing  Countries  Coordinating  Committee  (DCCC),  which  consists 
of representative African scientists and ensures the input and commitment of the 
African countries and researchers  

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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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–  The  European  Network  of  National  Programmes  (ENNP),  which  consists  of 
representatives  of  the  European  national  programmes  and  develops  proposals  to 
coordinate and joint national activities and funding. 

The Partnership structures and the European Commission hold permanent seats as observers 
in the EEIG Assembly.  

The  EDCTP,  created  under  the  structure  of  a  European  Economic  Interest  Group  (EEIG) 
where  all  participating  Member  States  are  represented  in  the  General  Assembly  (GA),  is  at 
present  (2007-2009)  chaired  by  UK,  and  co-chaired  by  Denmark,  France  and  Spain.  The 
Assembly meets twice a year, although some decisions are taken by written procedure.  

Recently,  and  following  the  recommendations  of  the  Van  Velzen  report,  a  Steering 
Committee comprising the GA Chairperson, the three Vice-Chairs and the Executive Director 
has  been  established  to  take  decisions  under  the  mandate  of  the  General  Assembly.  The 
Steering Committee also has the High Representative and the Chairpersons of the Partnership 
Board,  Developing  Countries  Coordinating  Committee  and  European  Network  of  National 
Programmes as observers. 

The EDCTP Secretariat is based in The Hague (The Netherlands) and is composed of 24 staff 
under the Executive Director, Dr. Charles Mgone (Tanzania), in office since February 2007. 
The Africa office is based in Cape Town (South Africa), where the High Representative (Dr. 
Pascoal Mocumbi, from Mozambique) is based. This office ensures an adequate commitment, 
ownership and stewardship of African governments, as well as the South-South coordination 
and networking among African researchers.  

The EDCTP Programme receives input from different advisory boards: the Partnership Board, 
in  charge  of  scientific  advice,  is  currently  chaired  by  Dr.  Sodiomon  Sirima  (Burkina  Faso); 
the Developing Countries Coordinating Committee, chaired by Dr. Andrew Kitua (Tanzania) 
is in charge of South-South networking; and the European Network of National Programmes, 
chaired by Laura Brum (Portugal), in charge of the North-North networking.  

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Although  the  EDCTP  Programme  was  created  as  a  true  partnership  between  Africa  and 
Europe, in the early period African representation was weak. However, in the last 2 years, this 
partnership has become more visible, since a higher African representation has been sought in 
all EDCTP constituencies (General Assembly and Partnership structures).  

During  the  last  year,  the  chairmanship  of  both  the  Developing  Countries  Coordinating 
Committee and the Partnership Board have changed, and are both now Africans, for the first 
time since the creation of the EDCTP Programme. This, together with an African Executive 
Director, and an African High Representative, facilitates the interaction North-South, since all 
constituencies work closely with the EDCTP Secretariat, advising the Executive Director, and 
they all participate in the General Assembly meetings.  

1. 

EEIG General Assembly 

The General Assembly is the ultimate and exclusive decision making body of the European 
Economic Interest Group,  the  legal  structure of the  EDCTP.  It acts collectively  and the full 
members  are  jointly  and  severally  liable  for  the  actions  of  the  EEIG.  The  principal 
responsibility  of  the  Assembly  is  to  ensure  that  all  necessary  activities  are  undertaken  to 
achieve the statutory objectives of EDCTP, and that its resources are properly and efficiently 
managed. It has the final and exclusive decision power concerning: 

•  General strategies and plans of action for EDCTP  
•  Annual action plans, including calls for proposals  
•  Annual budgets and accounts  
•  Appointment  and  dismissal  of  the  Executive  Director  (ED),  the  Director  of  Finance  and 
Administration  (DFA),  the  High  Representative  (HR)  and  senior  staff  members  of  the 
Secretariat  

•  Selection of the location(s) of the Secretariat  
•  Commitments for collaboration, agreements and partnerships with third parties  
•  Public release of information on initiatives, achievements and results of EDCTP  
•  The  appointment  of  the  advisory  bodies  (Partnership  Board,  Developing  Countries 

Coordinating Committee, European Network of National Programmes).  

2. 

Executive Secretariat 

The Executive Secretariat assures the day-to day activities of the EEIG, runs independent peer 
review  systems,  supports  the  Partnership  Board's  policy  development  and  networking, 
supports  the  work  of  the  EEIG  Assembly,  Developing  Countries  Coordinating  Committee 
(DCCC), and European networking; handles liaisons and negotiations with partners, oversees 
funded programmes, and maintains operational and financial control systems. 

The Main Office of the EEIG Executive Secretariat is situated in The Hague, the Netherlands. 
The  Secretariat  established  a  second  office  in  Cape  Town,  South  Africa,  which  represents 
EDCTP  in  Africa,  and  promotes  the  participation  of  developing  countries  in  EDCTP.  It 
provides support to activities of EDCTP constituencies in Africa, in particular the DCCC and 
the High Representative. 

All financial data presented in this report has been kindly provided by the EDCTP Secretariat.  

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3. 

Partnership Board 

The Partnership Board (PB) is a scientifically independent panel of experts as full members 
with voting rights. The EEIG-Assembly appoints its members, seeking a balance of African 
and European experts. 

The PB designs the strategic framework of the EDCTP and advises the Assembly on technical 
and  scientific  matters  relating  to  the  EDCTP  programme.  The PB  prepares  proposals  and 
recommendations to be submitted via the Secretariat to the Assembly, specifically with regard 
to: 

•  Strategic needs and priorities for new clinical interventions, training and capacity building  
•  Calls for project proposals and other procedures for implementing plans of action  
•  Criteria and procedures for peer reviews  
•  Annual action plans, including the calls foreseen for the year  
•  Results of evaluation sessions and priority lists of projects. 

4. 

European Network of National Programmes 

The European Network of National Programmes (ENNP) is an advisory body to the EDCTP-
EEIG Assembly as well as to EDCTP's other constituencies on the integration of the National 
Programmes  of  the  EDCTP  member  states  into  a  joint  programme.  The ENNP  consists  of 
representatives  of  the  European  national  programmes  and  develops  proposals  to  coordinate 
and  join  national  activities  and  funding.  These representatives  are  called  European 
Networking Officers (ENOs). 

The tasks of the ENNP can be divided into external and internal tasks. The external tasks are: 

•  Analyse and compare national funding mechanisms  
•  Identify gaps, overlaps and potential synergies between national programmes  
•  Develop strategies and proposals for harmonisation and European networking  
•  Advise on mechanisms for cofunding  
•  Help implement these strategies  
•  Coordinate networking activities on behalf of member states. 

Internal tasks: 

•  Promote the goals of EDCTP within the member states  
•  Assist in the allocation of funding for EDCTP-related activities  
•  Network  with  each  other  and  if  possible  network  the  scientific  communities  in  each 

country  

•  Foster links between scientists from their own and other countries  
•  Advise on how to promote broad participation of EDCTP member states in joint activities. 

5. 

Developing Countries Coordinating Committee 

The Developing Countries Coordinating Committee (DCCC) is an independent advisory body 
of prominent African scientists and health professionals appointed by the General Assembly 
and representing different regions/countries in Africa. The goal of the DCCC is to strengthen 
policy  debate  and  input  to  strategy  from  African  experts  and  countries.  It  ensures  the  input 
and  commitment  of  African  countries  and  researchers.  The  DCCC  provides  input  to  the 
strategy  of  EDCTP  by  aggregating  and  transmitting  advice  from  scientists  of  developing 
countries to the Partnership Board, the Secretariat and the Assembly. 

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The DCCC develops strategies and actions to improve coordination between its members, and 
with  other  partners  participating  in  EDCTP,  including  governments  and  international 
organisations. Such actions can include: 

•  Promoting  the  creation  and  networking  of  national  programmes  for  clinical  trials  for 

HIV/AIDS, malaria and TB in Africa  

•  Creating and promoting an African Forum of concerned scientists and experts  
•  Liaising with health authorities and relevant Developing Countries national programmes  
•  Collecting opinions from and disseminating information to Developing Countries scientists  
•  Interacting  with  WHO  and  other  regional  organizations  by  mutually  attending  relevant 

meetings  

•  Interacting with the High Representative, the Secretariat, the PB, the ENNP and European 

national programmes. 

6. 

High Representative 

The  EEIG-EDCTP  Assembly  may  appoint  one  or  more  High  Representatives.  The  High 
Representative  (HR)  is  an  internationally  known,  credited  and  respected  person  for  his/her 
public  service  record.  The  HR  is  committed  and  devoted  to  the  stated  objectives  and  the 
modus operandi of the EDCTP Programme. 

The High Representative is working closely with the Executive Director and the Secretariat in 
order to: 

•  Raise the visibility of the EDCTP  
•  Advocate and gain political support for the EDCTP, particularly in Africa  
•  Contribute to the EDCTP´s fund raising activities  
•  Represent the EDCTP in the above listed functions. 

The HR has no executive functions, and cannot financially or legally commit to the EEIG or 
EDCTP.  He  is  supported  in  his/her  activities  by  the  Secretariat,  and  he/she  works  in  close 
cooperation with the Executive Director. 

The EDCTP High Representative is Dr Pascoal Mocumbi. 

Annex  2  lists  the  different  representatives  of  the  16  EDCTP  participating  countries,  the 
personnel of the EDCTP Secretariat, and the representatives of the PB, ENNP and DCCC.  

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II. 

THE EARLY YEARS: 2003-2006 

The  EDCTP  Programme  is  the  first  implementation  of  Article  169  ever.  As  such,  it 
encountered difficulties in its initial operational work, since new structures had to be created, 
and  new  ways  of  work  had  to  be  found.  In  addition,  the  original  EDCTP  goal,  the 
coordination of European National Research Programmes, the very nature of the Article 169, 
is an ambitious task. Consequently, the EDCTP Programme had a slow starting phase.  

Since the establishment of the EDCTP Programme in September 2003 up to now, the EDCTP 
Secretariat had three different executive directors, and two interim executive directors.  

The  inexperience  of  the  Secretariat  was  apparent  in  the  early  period.  The  two  first  calls  for 
proposals published by the EDCTP in 2004 and 2005 were cancelled partially or totally, since 
the  procedure  for  evaluating  proposals  was  considered  flawed.  As  a  consequence,  the  first 
EDCTP Executive Director stepped down.  

The  creation  from  scratch  of  the  EDCTP  advisory  boards,  Partnership  Board,  Developing 
Countries  Coordinating  Committee  and,  later  in  2005,  the  European  Network  of  National 
Programmes was a major achievement of the first phase of the EDCTP Programme. Defining 
the  roles  of  each  of  these  was  not  an  easy  task,  and  several  conflicts  arose  between  the 
Partnership Board (the scientific advisory board) and the General Assembly, where scientists 
were also present.  

In  2004,  a  report  from  the  European  Court  of  Auditors  expressed  concern  with  the  EDCTP 
Programme  management.  Many  aspects  of  the  Programme  were  evaluated,  and  specific 
recommendations  were  put  forward,  concerning  the  evaluation  procedure,  administrative 
procedures, and co-funding. The report pointed out that a co-funding level of at least 50% was 
expected  from  participating  Member  States  and  further  recommended  that  the  Commission 
should  limit  its  contribution  to  the  EDCTP  Programme  to  the  same  level  attained  by 
participating  Member  States  (with  a  maximum  Community  contribution  of  €  200  million). 
The 2007-2010 Roadmap, agreed between the EDCTP and the Commission in 2006, indicates 
the relative Commission and Member States yearly contributions needed to meet the overall 
funding goal for the lifetime of the programme. 

In  fact,  before  the  report  from  the  Court  of  Auditors  (2003-2004),  the  only  budgetary 
contribution to the EDCTP Programme came from the Community funding. The participating 
Member  States  contribution,  the  so-called  co-funding,  was  very  low  in  the  initial  years  of 
EDCTP,  reaching  significant  levels  only  during  2007.  In  the  following  years,  this  MS  co-
funding still has to increase further to match the Community contribution. 

The cancelling of the first two calls for proposals led to a clear budgetary anomaly. Although 
the  grant  agreement  signed  with  the  European  Commission  specified  a  maximum 
management  budget  of  7.5%  of  the  Community  contribution,  in  the  early  years  most  of  the 
EDCTP  programme  funding  was  dedicated  to  sustaining  the  Secretariat,  with  little  funding 
going  to  research-related  activities.  However,  it  is  notable  that  subsequently,  -  with  the 
publication  of  new  calls  for  proposals,  the  proportion  of  budget  committed  to  management 
has decreased and is currently between 5 and 6%, while budget devoted to financing research 
projects has increased.  

EN 

13 

   EN 

During  this  initial  period  of  the  EDCTP,  achieving  the  original  goal  of  Article  169,  the 
coordination  of  National  Programmes,  has  been  a  difficult  task  for  two  main  reasons.  First, 
and  most  important,  some  participating  Member  States  lacked  a  national  programme  on 
HIV/AIDS,  malaria  and  tuberculosis,  so  this  had  to  be  created.  In  the  second  place, 
participating  Member  States  with  ongoing  activities  in  the  field  had  to  achieve  an  internal 
coordination  that  required  re-adjusting  their  national  activities.  Full  co-ordination  is  a  very 
ambitious goal that will take several more years.  

A. 

Projects financed from 2003 to 2006 

From September to December 2003, no calls were launched.  

In 2004 the following calls were launched: 

•  Five clinical trial calls:  

–  Trials  assessing  the  effectiveness  and  safety  of  simplified  anti-retroviral  drug 

regimens and monitoring in HIV;  

–  Trials  of  studies  of  surrogate  markers  of  drug  efficacy  emphasising  non-clinical 

predictors and relapse following anti-tuberculosis therapy;  

–  Phase II-III of drug regimens that shorten or simplify current treatment options in 

tuberculosis;  

–  Phase  II-III  drug  trials  for  the  treatment  of  severe  malaria  using  artemisinin 

compounds;  

–  Phase  II-III  drug  trials  for  the  treatment  of  uncomplicated  malaria  using 

artemisinin compounds 

•  One call for senior fellowships. 

EN 

14 

   EN 

Summary update of clinical trial projects from 2004 calls: 

Programme 
Area 

Grantee 

Title 

EC 
Funding 

Member 
State 
funding 

Reported 
3rd party 
funding 

African and 
European 
Collaborator 
Countries 

Update 

TB 

van Helden 

Surrogate  markers  to  predict  the 
outcome 
anti-tuberculosis 
therapy. 

of 

€973,033 

N/A 

TBD 

South 
United Kingdom 

Africa

Second  annual  and  financial  reports  were  received  and 
approved  and payments  made in  January  2007.  Third  annual 
and  financial  report  was  received  in  December  2007.  Third 
payment was made in February 2008. 

Gillespie 

Jindani 

Merry 

Malaria 

D´Alessandro 

Rapid  Evaluation  of  Moxifloxacin 
in  the  treatment  of  sputum  smear 
positive tuberculosis: REMoxTB. 

A  controlled  clinical 
to 
evaluate  high  dose  rifapentine  and 
moxifloxacin  in  the  treatment  of 
pulmonary tuberculosis. 

trial 

Determining  the  optimal  doses  of 
antiretroviral  and  anti-tuberculous 
medications  when 
in 
combination  for  the  treatment  of 
HIV/TB in co infected patients. 

used 

Evaluation  of  4  artemisinin-based 
combinations 
treating 
uncomplicated  malaria  in  African 
children 

for 

€3,157,240 

N/A 

€8,750,000 

South  Africa, 
Zambia 

Tanzania, 

Revised  clinical  protocol  was  received  and  approved  and  a 
payment was made in June 2007. 

€4,251,991 

€273,143 

€257,000 

Mozambique, 
Zimbabwe, South Africa 

Zambia, 

Clinical  protocol  was  approved  and  payment  made  in  June 
2007. 

€1,026,952 

N/A 

TBD 

South 
United Kingdom 

Africa

Amendment to grant agreement (paid for mass spectrometer) 
in  the  amount  of  218,000.00  Euros  in  January  2007.  In  July 
2007  clinical  protocol  and  ethical  clearances  were  received 
and the second payment was made.  

€2,111,714 

€3,599,110 

TBD 

Uganda,  Nigeria,  Gambia, 
Mozambique,  Burkina  Faso, 
Zambia,  Rwanda,  United 
Kingdom,  Spain,  Belgium, 
France, Denmark 

Technical  progress  report  was  approved  in  March  2007  and 
Ethical clearances were received in May 2007. Submission of 
financial report was delayed until 2008. 

Kremsner 

Artusenate  for  severe  malaria  in 
African children 

€5,365,420 

€1,371,200 

10,740 

Gambia,  Malawi,  Ghana, 
Gabon, 
United 
Kenya, 
Kingdom, Austria, Germany 

Clinical  protocol  was  received  in  August  2007,  ethical 
clearances  in  September  2007,  and  the  second  payment  was 
made in October 2007. 

HIV 

Chintu 

CHAPAS  Trials:  Children  with 
HIV  in  Africa:  Pharmacokinetics 
and  Adherence 
Simple 
of 
Antiretroviral Regimens 

€1,280,333 

N/A 

TBD 

Zambia,  Netherlands,  United 
Kingdom and Italy 

The second annual technical and financial report was received 
in  March  2007  and  payments  were  made  in  May  2007.  A 
contract  amendment  occurred  in  June  2007  altering  the 
payment  scheme.  The  third  annual  technical  and  financial 
reports are now due in February 2008. 

EN 

15 

EN 

 
  
  
  
 
  
  
In 2005, the following calls were launched: 

•  Four clinical trial calls:  

–  Capacity  building  for  the  conduct  of  phase  I/II  and  Phase  III  trials  of  vaginal 

microbicides against sexual transmission of HIV;  

–  Identification of safe and efficacious ARV in combination with tuberculosis drugs 

in tuberculosis patients with HIV infection;  

–  Capacity building and site development for the conduct of phase III trials of TB 

vaccines in children under 1 year of age  

–  Capacity building and site development for the conduct of phase III trials of TB 

vaccines in high risk populations (these last two were merged)  

•  Three ethics calls:  

–  Support of an African coordinating office for ethics;  
–  Support for Courses and Seminars on Ethics;  
–  Support  for  the  establishment  and  the  strengthening  of  African  National  Ethics 

Committees or Institutional Review Boards  

•  Four Training Award calls:  

–  MSc Studentships,  
–  PhD scholarships,  
–  Career development fellowships  
–  Senior Fellowships. 

•  Four Networking calls:  

–  Providing incentives for joint capacity building programmes in Africa with two or 

more European institutions;  

–  Sponsorship  of  meetings  or  workshops  of  sustainable  networks  on  an  EDCTP 

relevant subject;  

–  Coordination and networking of research activities in Africa;  
–  Support  to  national  networking  of  African  scientists  working  on  HIV/AIDS, 

Malaria and Tuberculosis in Africa 

EN 

16 

   EN 

 
Summary update of clinical trial projects from 2005 calls: 

Programme 
Area 

Grantee 

Title of Project 

EC 
Funding 

Member 
State 
funding  

Reported 
3rd  Party 
funding 

African and 
European 
Collaborator 
Countries 

Update  

TB 

Bertilsson 

Optimisation of tuberculosis and HIV co-
treatment  in  Africa:  Pharmacokinetic  and 
pharmacogenetic  aspects  on  drug-drug 
interactions  between 
and 
efavirenz. 

rifampicin 

€907,052 

€1,179,000 

TBD 

Ethiopia, 
Sweden, Germany 

Tanzania, 

This  grant  was  signed  and  the  first  payment  was  made  in 
January 2007. The clinical protocol was finalised and ethical 
clearances were received in January 2008. 

van ‘t Hoog 

Prospective epidemiological studies of TB 
in  neonates  and  adolescents  in  Karemo 
Division,  Siaya  District,  Western  Kenya, 
in preparation for future vaccine trials. 

€1,678,216 

€1,949,904 

TBD 

Kenya, Austria, Netherlands  This  grant  arose  from  two  projects  that  were  merged.  The 
projects are on TB vaccine development in babies and high-
risk populations. This grant was signed and the first payment 
made in June 2007.  

Musoke 

Engers 

Towards  conducting  phase  III  trials  of 
novel TB vaccines in Ugandan infants and 
adolescents. 

€1,850,000 

€1,849,287 

€1,9M 
(Aeras US) 

Uganda, Sweden, Belgium 

This  grant  arose  from  two  projects  that  were  merged.  The 
projects are on TB vaccine development in babies and high-
risk populations. The grant was signed and the first payment 
was made in August 2007.  

Capacity building for the conduct of ICH-
GCP  level  TB  vaccine  trials  in  high  risk 
populations in Ethiopia and East Africa. 

€988,856 

€2,000,825 

TBD 

Ethiopia, 
Madagascar, 
Netherlands, Belgium 

Zambia, 
Denmark, 

This  grant  arose  from  two  projects  that  were  merged.  The 
projects are on TB vaccine development in babies and high-
risk populations. This grant was signed and the first payment 
was made in August 2007. Clinical protocol was received in 
December 2007.  

HIV 

Van 
Wijgert 

de 

Hayes 

McCormack 

Preparing for Phase II vaginal microbicide 
trials in Rwanda and Kenya: Preparedness 
studies, 
and 
strengthening of medical referral systems. 

building 

capacity 

Site 
strengthening 
microbicides in Tanzania and Uganda. 

capacity 
trials  of  vaginal 

preparation 
for 

and 

Establishing  HIV  microbicides  clinical 
trial 
and 
expanding an existing site in South Africa. 

in  Mozambique 

capacity 

€2,000,000 

€2,178,443 

None 

Rwanda,  Kenya,  Belgium, 
Italy, Netherlands 

This  grant  was  signed  and  the  first  payment  was  made  in 
April 2007. Ethical clearances were received and the second 
payment was made in June 2007. 

€2,435,071 

€1,850,189 

853,274 

Tanzania, 
Netherlands, 
Kingdom 

Uganda, 
United 

This  grant  was  signed  and  the  first  payment  was  made  in 
May 2007.  

€2,436,622 

€1,115,707 

3,164,481 

Mozambique,  South  Africa, 
United Kingdom, Spain 

This grant was signed and the fist payment was made in May 
2007.  Ethical  clearances  and  the  research  protocol  were 
received and the second payment was made in May 2007. 

EN 

17 

EN 

 
  
  
  
  
  
  
 
In 2006 the following calls were launched: 

•  Two clinical trial calls:  

–  Joint call with BMGF: Capacity building in preparation for the conduct of preventive HIV vaccine trials  
–  Support  of  studies  for  the  Prevention  of  Mother  to  Child  Transmission  (PMTCT)  of  HIV,  including  prevention  of  transmission  during 

breast feeding. 

Summary update of clinical trial projects from 2006 calls: 

Programme 
Area 

Grantee 

Project Title 

EC 
Funding 

Member 
State 
funding  

Reported 
Third 
party 
funding 

African and 
European 
Collaborator 
Countries 

Update 

HIV/PMTCT  Katzenstein 

Kisanga 

Newell 

Van de Perre 

Back-up  with  AZT/3TC  or  single  dose 
FTC/TDF 
to  avoid  NNRTI 
resistance  after  single  dose  NVP  for 
PMTCT. 

in  order 

Improving  the  balance  between  efficacy 
and  development  of  resistance  in  women 
receiving single dose nevirapine. 

Impact of HAART during pregnancy and 
breastfeeding  on  MTCT  and  Mothers 
Health: The Kesho Bora Study. 

III 

phase 

double 

safety  of 

A 
blind 
placebo/controlled  trial  of  the  efficacy 
and 
infant  periexposure 
prophylaxis  with  lamivudine  to  prevent 
transmission  by  breastfeeding 
HIV-1 
(PROMISE-PEP trial). 

€418,624 

€745,232 

€107,108 

Tanzania, 
Sweden 

Denmark, 

This  grant  was  signed  and  first  payment  made  in 
October 2007.  

€507,732 

€999,803 

TBD 

Tanzania,  Zambia,  United 
Kingdom, Netherlands 

This  grant  was  signed  and  first  payment  made  in 
October 2007.  

€1,303,062 

€1,408,316 

TBD 

€2,000,000 

€10,199,421 

€600,000 

South  Africa, 
Kenya, 
Burkina 
Faso,  United 
Kingdom, France, Sweden 

This grant was signed and first payment  made in June 
2007 Clinical protocol approved and ethical clearances 
received in December 2007. Second payment was made 
then. 

South  Africa,  Burkina 
Faso,  Uganda,  Zambia, 
France, Norway, Sweden  

This grant was approved by the GA in 2006. Prolonged 
contract  negotiations  ensued  as  grantee  needed  to 
secure  additional  funding.  Signing  was  done  in  April 
2008  after  putting  the  grant  on  hold  to  enable  raise 
around €10,100,000 co-funding from Member States. 

HIV 
Vaccines 

Bakari 

HIV  Vaccine  trial  capacity  building  in 
Tanzania  and  Mozambique  by  continued 
exploration  of  optimal  DNA  priming  and 
MVA boosting strategies 

€2,590,191 

€1,147,645 

€377,927 

Tanzania,  Mozambique, 
Sweden,  Demark,  United 
Kingdom 

This  grant  was  approved  by  the  GA  in  June  2007. 
Prolonged 
to 
reduce  budget  and  grantee 
recommendations 
concerns  with  contractual  language.  This  grant  was 
signed in March 2008. 

contract 
to 

negotiations 

due 

EN 

18 

EN 

 
  
  
 
  
  
 
Programme 
Area 

Grantee 

Project Title 

EC 
Funding 

Member 
State 
funding  

Reported 
Third 
party 
funding 

African and 
European 
Collaborator 
Countries 

Update 

Bekker 

Hanke 

Kaleebu 

Feasibility  of  and  capacity  building  for 
adolescent  HIV  vaccine  trials  in  South 
Africa. 

€2,001,835 

€1,048,000 

€1,640 

South  Africa,  Switzerland, 
France 

Infant  HIV-1 
Building  Capacity  of 
Vaccine  CT  centres  in  Nairobi,  Kenya 
and the Gambia.  

€2,269,648 

€996,397 

€188,000 

Kenya,  Gambia,  United 
Kingdom, Sweden, Spain 

Strengthening  long  term  clinical  and  lab 
research  capacity,  cohort  development 
and collection of baseline data in Uganda 
and Mozambique for future vaccine trials 

€2,217,715 

€817,817 

€1,277,282  Uganda, 

Netherlands, 
Kingdom 

Mozambique, 
United 

Kapiga 

Capacity  development  and  strengthening 
in  preparation  for  HIV  vaccine  trials  in 
Tanzania and Burkina Faso.  

€1,797,798 

€1,284,098 

€47,869 

Weber 

African 
Development Network. 

European  HIV  Vaccine 

€2,281,445 

€1,428,100 

€2,800,000 

Tanzania,  Burkina  Faso, 
United  Kingdom, 
Italy, 
France 

South  Africa,  Tanzania, 
United 
Mozambique, 
Spain, 
Kingdom, 
Switzerland, 
Germany, 
Netherlands 

*Half of this budget was provided by the Bill and Melinda Gates Foundation, so it could be considered as Third Party Funding.  
** In addition to the BMGF budget.  

This  grant  was  approved  by  the  GA  in  June  2007. 
Prolonged 
to 
recommendations  to  reduce  budget.  This  grant  was 
signed in December 2007.  

negotiations 

contract 

due 

This  grant  was  approved  by  the  GA  in  June  2007. 
Prolonged 
to 
recommendations 
reduce  budget  and  grantee 
concerns  with  contractual  language.  Signing  expected 
in early 2008. 

contract 
to 

negotiations 

due 

This  grant  was  approved  by  the  GA  in  June  2007. 
Prolonged 
to 
recommendations 
reduce  budget  and  grantee 
concerns  with  contractual  language.  This  grant  was 
signed and first payment was made in November 2007.  

contract 
to 

negotiations 

due 

This  grant  was  approved  by  the  GA  in  June  2007. 
Prolonged 
to 
recommendations 
reduce  budget  and  grantee 
concerns  with  contractual  language.  This  grant  was 
signed in February 2008.  

contract 
to 

negotiations 

due 

This  grant  was  approved  by  the  GA  in  June  2007. 
Prolonged 
to 
reduce  budget  and  grantee 
recommendations 
concerns  with  contractual  language.  This  grant  was 
signed in February 2008. 

contract 
to 

negotiations 

due 

EN 

19 

EN 

 
  
  
 
  
 
  
  
  
 
III. 

EDCTP INDEPENDENT EXTERNAL REVIEW 

As  stated  above,  the  EDCTP  Programme  had  an  initial  implementing  phase  (from  2003  to 
2006)  slower  than  foreseen.  Over  that  period  budget  spending  was  abnormally  low,  and  a 
2004  report  from  the  European  Court  of  Auditors  revealed  some  deficiencies.  During  the 
same  period,  the  Secretariat  had  four  different  Executive  Directors,  two  of  them  during  an 
interim period.  

As  a  result,  and  at  the  request  of  Commissioner  Janez  Potočnik,  an  Independent  External 
Review (IER) was conducted between January and July 2007 to provide recommendations on 
how  the  EDCTP  could  better  integrate  Member  States'  national  programmes  and  increase 
clinical trial and capacity building activities through a stronger partnership with Africa. 

The review group was composed of: 

–  Adetokunbo O. Lucas, former Director of WHO Tropical diseases research programme 

–  Wim Van Velzen (Chair), MEP (1989-1999) 

–  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  (Rapporteur),  former  Executive  Director  of  the  European  Medicines 

Agency.  

The  full  IER  report10,  also  know  as 
is  available  at 
http://ec.europa.eu/research/health/poverty-diseases/doc/final_ier_report_12july2007_en.pdf, 
and presents a list of Key Recommendations to the EDCTP Secretariat, Member States, and to 
the Commission, as included in the Annex 1 to the present evaluation report. 

the  Van  Velzen  report, 

The present progress report, published as a Commission Staff Working Document, follows a 
recommendation  from  the  Van  Velzen  report,  where  the  Commission  should  report  to  the 
European  Council  and  Parliament  about  the  current  status  of  the  EDCTP  Programme,  in 
anticipation of the 2008 evaluation (requested by the original co-decision) due at the end of 
the first five years of the EDCTP.  

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

10 

EN 

Independent  External  Review  Report:  European  and  Developing  Countries  Clinical  Trials  Partnership  (July  2007),  also  named 
after 
report;  see  http://ec.europa.eu/research/health/poverty-
the  expert  group  as 
diseases/doc/final_ier_report_12july2007_en.pdf 

the  Van  Velzen 

the  Chair  of 

20 

   EN 

 
                                                 
IV. 

A NEW START: 2007-2008 

The  year  2007  showed  several  breakthroughs  for  the  EDCTP,  including  the  2007-2010 
Roadmap, the new EDCTP administrative structure, and the new calls for integrated grants:  

The agreement with the Commission in late 2006 on the 2007-2010 Roadmap paved the way 
for  a  new  co-funding  per-programme  mechanism,  replacing  the  previous  per-project  co-
funding.  Indeed,  in  the  years  2003-2006  the  EDCTP  had  to  find  50%  co-funding  for  each 
project  signed.  This  limited  considerably  the  ability  of  researchers,  Member  States  and 
EDCTP Secretariat to co-finance and sign contracts. The 2007-2010 roadmap allowed a so-
called per-programme co-funding: from now on, individual contracts did not necessarily had 
to be co-financed at 50%. Yearly co-funding milestones were agreed, with the ultimate goal 
of  achieving  50%  MS  co-funding  at  the  end  of  the  EDCTP  Programme.  This  has  greatly 
facilitated  MS  co-funding,  proposal  submission  to  researchers,  and  contract  signature  to  the 
EDCTP.  

In order to facilitate fulfilment of its function as the first implementation of the Article 169 of 
the European Treaty, the EDCTP Programme had to put in place various measures to ensure a 
sound and transparent funding mechanism as well as a robust administrative structure to serve 
all  stakeholders.  These  included  establishing  a  firm  platform  and  instruments  for  delivering 
the  programmes  such  as  setting  up  of  rules  and  regulations,  standard  operating  procedures, 
quality  control  and  quality  assurance,  and  good  governance.  The  establishment  of  these 
instruments has now been completed and was followed by the securing of African ownership, 
commitment  and  leadership  with  the  goal  of  having  a  mutual  partnership  and  a  sustainable 
programme.  

At first, the EDCTP Programme provided individual grants for various activities such as for 
the  conduct  of  clinical  trials,  the  support  of  networks  and  capacity  building  for  personnel 
training and infrastructure improvements. Although such grants were very useful for ensuring 
a  wide  distribution  of  EDCTP  activities  and  enhancing  the  profile  and  visibility  of  the 
partnership in Africa, they were extremely labour intensive for a small secretariat. Currently, 
the  EDCTP  Programme  is  consolidating activities by rolling out projects through integrated 
grants that have clinical trials as the core activity, with capacity development and networking 
as  means  of  guaranteeing  quality  trials  under  best  practices  while  ensuring  utilisation  and 
sustainability  of  the  developed  capacity.  These  activities  are  augmented  by  assisting  the 
creation  of  an  enabling  environment  through  the  establishment  and  support  of  an  ethics 
review mechanism and regulatory framework. Many projects have been funded in this regard.  

A. 

Follow-up of the Van Velzen report 

Since  early  2007,  and  following  the  recommendations  from  the  Van  Velzen  report,  the 
EDCTP  Secretariat  has  redefined  its  scientific  strategy,  through  stakeholder's  meetings  on 
HIV/AIDS  drugs,  microbicides  and  vaccines,  malaria  drugs,  vaccines  and  malaria  in 
pregnancy,  tuberculosis  drugs  and  vaccines  as  well  as  African  networks  of  excellence. 
Moreover, the EDCTP has increased collaboration with Public-Private Partnerships which are 
now more involved in funded projects.  

Participating Member States have created a General Assembly Steering Committee (GASC), 
where  GA  Chair  and  co-chairs  are  represented.  The  GASC,  where  the  EDCTP  Executive 
Director is also present, takes decisions on behalf of the General Assembly on current issues, 

EN 

21 

   EN 

 
as approval of project to be funded. In an answer to a letter from the Commission, the EDCTP 
Member  States  have  renewed  their  commitment  to  the  Programme,  both  politically  and,  in 
some  cases,  financially.  The  African  participation  into  the  General  Assembly  has  being 
reinforced,  though  the  attendance  of  chairs  of  all  committees;  and  Member  States  are  more 
and more accepting a unique central EDCTP scientific and ethics evaluation.  

The Commission is joining efforts of its services in relation to EDCTP, working on a strategic 
research policy for Africa including EDCTP, and setting pre-conditions for future Article 169 
initiatives, as pre-existence of national programmes and funding. The EDCTP has contributed 
to  the  European  Programme  for  Action  "to  confront  HIV/AIDS,  malaria  and  tuberculosis 
through external action"11 in close collaboration with DG DEV and AIDCO. Through EDCTP 
efforts,  there  is  a  continuous  support  for  the  technical  and  political  dialogue  on  human 
resources  necessary  for  effective  advocacy  and  action  in  this  Programme  for  Action.  This 
includes support for research capacity building and support to explore the potential for use of 
information  technology  for  training,  capacity  building  and  service  delivery  in  health.  In 
addition  these  actions  give  support  to  country  preparedness  and  capacity  building  for 
adaptation and large scale introduction of new pharmaceutical products and commodities. The 
collaboration  among  these  different  DGs  in  synergy  with  EDCTP  is  becoming  an  essential 
"research for development" tool.  

B. 

Operations, calls and grants  

In  addition  to  the  ongoing  projects,  EDCTP  launched  11  new  calls  in  2007.  The  estimated 
EDCTP contribution to all calls in 2007 is approximately 90 million Euros with matching co-
funding expected from Member States. 

Calls for proposals published by the EDCTP in 2007:  

THE 2007 EDCTP CALLS 

Calls  
TB Vaccine  
Ethics  
Senior Fellowships  
Malaria Vaccine  
Malaria Treatment  
Networks of Excellence  
Malaria in Pregnancy  
TB Treatment  
HIV Treatment  
HIV Microbicides  
HIV Vaccine  
Total  

Allocated funds  
11,236,020  
450,000  
1,200,000  
14,405, 263  
9,143,337  
10,000,000  
9,143,337  
14,286,674  
6,500,000  
6,100,000  
7,000,000  
89,464,631 

Launch Date  
05 July 2007  
01 August 2007  
05 July 2007  
05 July 2007  
01 August 2007  
01 August 2007  
01 August 2007  
22 November 2007  
1 December 2007  
1 December 2007  
5 December 2007  

Deadline  
05 November 2007  
05 November 2007  
12 November 2007  
19 November 2007  
26 November 2007  
03 December 2007  
26 November 2007  
15 February 2008  
01 April 2008  
01 May 2008  
30 May 2008  

A total of 56 applications were received. Among these, 27 projects have been approved and 
others are undergoing different stages of peer-reviewed evaluation and approval. These latter 
include  5  on  HIV  treatment  (of  which  3  have  been  recommended  for  funding);  two  on 

11 

Doc.8689/05-COM(2005) 179 final 

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microbicides, still under evaluation, and 5 on HIV vaccines (of which 3 have been positively 
reviewed  on  the  basis  of  letters  of  intent  and  are  to  submit  full  proposals).  The  approved 
projects include the following:  

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Support of clinical trials, capacity building and networking in malaria vaccines: 

Project code and 
coordinator 

Participating countries and third 
parties 

Project title 

Budget 
requested 

EC 

MS 

Third party 

IP.07.31100.001 

R. Chilengi 

Denmark, UK, Germany, Tanzania, The 
Gambia, Gabon, Uganda, Burkina Faso, 
AMANET, EMVI 

Fostering research capacity, networking and 
project management through phase I-IIB clinical 
trials of candidate malaria vaccine GMZ2 

€10,000,000 

€4,999,720 

€2,052,500 

€3,144,796 

Support of clinical trials, capacity building and networking in malaria in pregnancy: 

Project code and 
coordinator 

Participating countries and third 
parties 

Project title 

Budget 
requested 

EC 

MS 

Third party 

IP.07.31080.002 
C. Menéndez 

Austria, Germany, Spain, France, Benin, 
Gabon, Kenya, Mozambique and 
Tanzania 

Evaluation of alternative antimalarial drugs to 
sulfadoxine-pyrimethamine for intermittent 
preventive treatment in pregnancy (IPTp) in the 
context of insecticide treated nets 

IP.07.31080.003  
F. ter Kuile 

Austria, Denmark, UK, BMGF, 
Zimbabwe, Burkina Faso, Ghana, 
Malawi, Mali, Mozambique and Gambia 

Optimization of the existing dose and regimen of 
intermittent preventive treatment with 
sulfadoxinepyrimethamine for the prevention of 
malaria in pregnancy in the context of high coverage 
of insecticide treated nets and highly seasonal malaria 
transmission 

€6,338,582 

€2,999,953 

€3,338,629 

- 

€6,262,785 

€2,999,798 

€2,122,078 

€1,140,909 

IP.07.31080.001 
U. D’Alessandro 

Austria, Belgium, Netherland, UK, 
DNDi, MMV, Burkina Faso, Ghana, 
Malawi, Rwanda, Tanzania and Zambia  

Safe and efficacious artemisinin-based combination 
treatments for African pregnant women with malaria 

€6,140,259 

€2,988,993  

€2,371,266 

€780,000 

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Support of clinical trials, capacity building and networking in malaria treatment: 

Project code and 
coordinator 

Participating countries and third 
parties 

Project title 

Budget 
requested 

EC 

MS 

Third party 

IP.07.31060.003 
V Mwapasa 

Austria, Belgium, Spain, Netherlands, 
UK, Zambia, Malawi, Mozambique, 
DNDi and MMV. 

Special populations and label expansion studies 
with the fixed dose combinations artemether-
lumefantrine, amodiaquine-artesunate, and 
dihydroartemisinin-piperaquine in Zambia, Malawi 
and Mozambique. 

€7,457,044 

€2,226,582 

€2,259,192 

€2,201,270 

IP.07.31060.002 
A.Djimde 

France, Sweden, MMV, Sima-Tau, 
Mali, Senegal, Republic of Guinea and 
Burkina Faso. 

An integrated approach to clinical trials, capacity 
building and networking in West Africa. 

 €5,992,206 

€2,996,103 

Cofunding 
confirmed but 
amount not 
decided yet 

Third party 
contribution 
confirmed but 
amount not 
decided yet 

Support of clinical trials, capacity building and networking in tuberculosis vaccines development: 

Project code and 
coordinator 

Participating countries and third 
parties 

Project title 

Budget 
requested 

EC 

MS 

Third party 

IP.07. 2080.001 
T M Doherty 

Denmark, Netherlands, Ethiopia (AHRI) 
and Guinea-Bissau. 

Conduct of ICH-GCP level Phase II TB vaccine 
trials in high-risk populations in Africa. 

€11,920,070 

€4,778,034 

€6,774,922 

€367,114 

IP.07.32080.002 
M. Ota 

Belgium, UK, South Africa, Senegal and 
Gambia 

IP.07.32080.003 
G. Hussey 

Sweden, Spain, Switzerland, Belgium, 
Austria, Ireland. Netherlands, KNCV, 
Aeras, South Africa, Kenya, Uganda, 
Mozambique and the USA 

A proof-of-concept Phase IIb clinical trial to 
evaluate the protective efficacy of a booster 
MVA85A vaccination administered to healthy, 
HIV-infected adults in South Africa, Senegal and 
The Gambia. 

€9,999,550 

€4,974,200 

€5,025,350 

- 

€8,116,029 

€3,174,142 

€4,941,888 

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Call for Support of clinical trials, capacity building and networking in HIV/AIDS vaccines development: 

Project code and 
coordinator 

Project title 

 Budget requested : EC 

 Budget requested: 
MS 

 Budget 
requested : Third 
party 

PB Recommendation 

IP.07.33112.003 
G. Pantaleo 

AfrEVacc II - African-European HIV Vaccine 
Development Network II. 

€3,500,000 

€3,500,000 

€3,000,000 

IP.07.33112.001 
L. Lyamuya 

IP.07.33112.004 
B Ensoli 

HIV vaccine trial capacity building in Tanzania and 
Mozambique by continued exploration of optimal DNA and 
MVA boosting strategies; TaMoVac II 

€3,500,000 

€3,500,000 

- 

A Platform for AIDS Vaccine in Southern Africa (PAVSA) 

€3,500,000 

€3,500,000 

€500,000 

To be invited to submit full 
proposal 

To be invited to submit full 
proposal 

To be invited to submit full 
proposal 

As of June 2008, the calls on HIV/AIDS research are undergoing evaluation and final decision by the EDCTP General Assembly. 

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Support for the establishment and the strengthening of African National Ethics Committees or Institutional Review Boards: 

Project code and coordinator 

Project title 

 Budget requested : TOTAL 

 Budget requested : 
EC contribution 

CB.07.41302.007 - UNCST -  
Dr Maxwell Otim Onapa 
Uganda National Council for Science and 
Technology 

CB.07.41302.008 – BRTI -  
Dr Peter Robert Mason 
Biomedical Research & Training Institute 

CB.07.41302.012 – MOH Benin -  
Dr Roch Appolinaire Houngnihin 
Ministry of Health -Benin 

Strengthening the National Scientific and Ethical Review 
System and Process in Uganda 

€49,140 

€49,140 

Establishing an Ethics Research Unit 

€49,273 

€49,273 

Support project for the establishment and the strengthening of 
the Benin National Ethic Committee 

€48,000 

€48,000 

CB.07.41302.018 - NIMR2 -  
Mr John Changalucha 
National Institute forMedical Research 

Establishment of a local Institutional Review Board (IRB) in 
Mwanza, Tanzania and strengthen collaboration between 
thelocal and national IRBs. 

€49,966 

€49,966 

CB.07.41302.017 – ETBIN -  
Prof. Dr Beyene Petros 
Ethiopian Bioethics Initiative 

CB.07.41302.013 - RNEC -  
Dr Kayitesi Kayitenkore 
Rwandan National Ethics Committee 

CB.07.41302.001 – WABTP -  
Prof. Dr Clement Adebamowo 
West African Bioethics Training Program (WAB) 

CB.07.41302.005 – TANHER -  
Dr Yohanna Mashalla 
Tanzania Health Research Forum (TANHER-
Forum) 

Strengthening the National Ethics and Health Research in 
Ethiopia 

€59,000 
(€9,000 will be secured from the matching fund 
from the Armauer Hansen Research Institute 
which hosts ETBIN). 

€50,000 

Strengthening of the National Ethics Committee 

€47,516 

€47,516 

Strengthening the National Health Research Ethics Committee 

€62,000 
(€12,000 will be secured from the West African 
Bioethics Training Programme). 

€50,000 

Strengthening ethical standards and practices in the protection 
of participants in health research in Tanzania 

€50,000 

€50,000 

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Senior Fellowships: 

Project code and 
coordinator 

Participating 
countries and 
third parties 

Project title 

Budget 
requested 

Confunding / third 
party contribution (not 
a requirement for this 
call  

Recommendation 

TA.2007.40200.001 
Harr Freeya Njai 

Uganda, Gambia, UK 

Characterization of neutralizing antibody responses in 
Chronic Clades A and D Human Immunodeficiency Virus 
Type 1 (HIV-1) infections and the relationship with 
established markers of disease progression – A 
longitudinal study in Rural Uganda 

TA.2007.40200.011 
Nicaise Ndembi 

Uganda, Cameroon, 
UK 

Frequency and determinants of dual infection with 
different strains of HIV-1 in low and high risk populations 
in Uganda 

TA.2007.40200.012 
Daniel Dodoo 

Ghana, Tanzania, 
AMANET-EMVDA 

Assessment of functionality of antibodies that associate 
with antibodies that associate with protection from clinical 
malaria using the in vitro P. falciparum growth inhibition 
assay 

€199,998 

MRC/UVRI: €71,349 

Approved for funding 

€194,269.68 

MRC/UVRI: €23,800 

Approved for funding 

€192,500 

AMANET-EMVDA: 
€50,000 

Approved for funding 

TA.2007.40200.005 
Pauline Byakika-Kibwika  

Uganda, Netherlands 
(NACCAP) 

Effectiveness and pharmacokinetics of intravenous 
artesunate versus quinine for treatment of severe malaria 
in adults admitted to Mulago hospital, Kampala, Uganda 

€196,800 

TA.2007.40200.016 
Christian Happi Tientcha 

Nigeria, Cameroon 

Validation of New Biomarkers for Monitoring 
Plasmodium falciparum Reduced susceptibility /Tolerance 
or Resistance to Artemisinin Derivatives and Partner 
Drugs in Nigeria 

€200,000 

TA.2007.40200.010 
Keertan Dheda 

South Africa  

Human lung innate immune pathways regulating the stasis 
and killing of M. tuberculosis in a high burden setting. 

€199,870 

NACCAP: €40,700 
SEWANKAMBO FUND 
UGANDA: €46,200 
IRISH AID: €38,500 
HRB IRELAND: €17,600 

Approved for funding on 
condition that GMP 
investigational product is 
available 

Standby project in case GMP 
investigational product is not 
available for Byakika-Kibwika  

Approved for funding 

TA.2007.40200.009 
Mark Patrick Nicol 

South Africa  

The impact of rapid genotypic detection of multi-drug 
resistant tuberculosis on treatment outcome in a semi-rural 
region of South Africa. 

€200,000 

Approved for funding 

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Networks of Excellence: 

Project code and 
coordinator 

Requested from 
EC 

Eastern Africa  

IP.07.41700.001 Kaleebu 

€2,499,200 

Requested from Member States 

Total 
requested 

Recommendation 

€3,223,348.7 
UK, Denmark, Switzerland, Norway and Netherlands 

€2,499,970 

Netherlands  

€5,722,549 

€2,499,970 

Approved for funding and 
encouraged to merge with Kibiki 

Encouraged to merge with 
Kaleebu 

€2,468,400 (100%) 

Germany  

€2,468,400  

Approved for funding 

€2,499,920.5  

€737,741.4 (23%) UK 

€3,237,662 

Approved for funding 

€2,500,000  

€1,200,000 (32%) UK and Germany 

€3,700,000  

€2,500,035.8 

€2,499,970  

€54,364.2 Switzerland 

€2,554,400 

€2,499,970 

Not approved for funding, but 
encouraged to merge and 
resubmit 

IP.07.41700.005 
Kibiki 

Central Africa  

IP.07.41700.006 
Ntoumi 

West Africa  

IP.07.41700.007 
Mboup 

Southern Africa  

IP.07.41700.003  
Walzl 

IP.07.41700.004 
Rustomjee 

IP.07.41700.008 
Mulenga 

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Graphical distribution of African partnerships in EDCTP-funded projects

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V. 

EDCTP FUNDING / MEMBER STATES CO-FUNDING OVERVIEW 

EDCTP receives its funding from both the European Commission and the participating Member 
States,  in  a  50%/50%  co-funding  mechanism.  The  co-funding  mechanism  agreed  in  the  2007-
2010  Roadmap  allows  the  Commission  to  fund  a  higher  than  50%  contribution  in  the  initial 
phases of the EDCTP Programme, but will force participating Member States to compensate with 
a higher than 50% co-funding at the end of the programme towards 2010.  

Over the period from 2003 to 2007 the EDCTP has signed grants for a total of €76.2 million (EC, 
MS and third party funding contribution), including the contracts for the joint call with the Bill & 
Melinda Gates Foundation.  

Over the same period, the EDCTP Member States have contributed to EDCTP €20.4 million in 
cash, and about €7 million in kind and direct payments to researchers for EDCTP projects, and 
pledged  an  additional  21,192,000  Euro.  This  includes  the  6.7m  Euro  which  the  participating 
Member States provided to the joint call on HIV capacity building that was equally co-funded by 
Member States, EDCTP EC funds and funds from the BMGF. 

YEAR  MS contribution 

Third 
contribution 

party 

EC  funding  to 
signed grants 

EDCTP  expenditure 
until May 2008 

2003 

2004 

2005 

2006 

2007 

0 

0 

824.546 

0

0

0

0

211.059 

45.000

3.150.553 

8.276.000

4.304.858 

5.774.373 

2.107.718

14.680.000

8.401.962 

20.833.809 

1.807.653

21.921.000

13.040.518 

67.286.956 

30.179.604

2008 

(committed until May) 

(up to May)

101.617.000 
(foreseen)

8.313.672  

(up to May) 

TOTAL 

94.719.684 

34.094.975

146.539.000

37.422.622 

To date the EDCTP Programme has launched 33 calls and committed to fund 145 projects that 
include  clinical  trials,  capacity  development  and  support  of  scientific  networks.  With  the 
exception of the 2007 calls, EDCTP has now completed contract negotiations and signing for all 
of these projects.  

Among these 145 projects, 32 are clinical trials on HIV/AIDS, malaria and tuberculosis; 55 are 
training  awards  (MSc,  PhDs  and  post  doctoral  awards);  16  are  Senior  Fellowships;  11  are  for 
supporting networking activities; 14 are on capacity building in ethics; one on strengthening the 

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regulatory framework in Africa through collaboration with WHO; and one for the establishment 
and  maintenance  of  a  clinical  trials  registry  on  HIV/AIDS,  malaria  and  tuberculosis.  These 
projects are based in 123 institutions and 26 different countries in sub-Saharan Africa (as shown 
in the accompanying graphic) and reflect the involvement of practically all participating Member 
States.  

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Co-funding  in  relation  to  the  Roadmap  projections.  The  figures,  expressed  in  thousands  of  euros,  compare  the  actual 
performance of EDCTP with respect to the projections made in the EDCTP Roadmap 2007 to 2010. The first part of the table 
shows all participating MS activities (including those not related to EDCTP, such as basic and preclinical research) on HIV/AIDS, 
malaria and tuberculosis. (Data from 2007 is still not available.) The second half of the table shows the activities of MS directly 
linked to EDCTP (clinical trials on the three diseases in sub-Saharan Africa where coordination of MS National Programmes do 
exist.)  

MS financial contribution (thousands of Euros) 

Year  

2004  

2005  

2006  

2007  

2008  

2009  

2010  

TOTAL  

MS integrated 
activities Roadmap 
projections 
(estimates)  
MS integrated 
activities (Up to 2007)  

Roadmap estimate of 
MS funds committed 
to EDCTP initiatives  
MS Funds committed 
to EDCTP initiatives: 
(Actuals to 2007)  

46,386  

51,239  

57,108  

89,421 

82,674 

80,876 

75,645 

483,351 

46,386  

35,821 

60,037  

66,737 

309  

975  

5,088  

9,916  

10,420  

10,760  

8,948  

46,419  

0  

778  

7,519  

20,833,808 

67,286,956* 

Funds committed specifically to EDCTP activities as a proportion of 
all MS integrated activities

e
g
a
t
n
e
c
r
e
P

90

80

70

60

50

40

30

20

10

0

2004

2005

2007

2008

2006

Year

Actual

Predicted

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*Includes cash till end of April actually received and invoices to the Member State which will be 
received, plus additional committed MS funds to current and future projects (in cash, in kind and 
contributed directly to the grantees).  

For  the  11  calls  that  were  launched  in  2007,  EDCTP  has  committed  90m  Euro  and  to  date 
EDCTP member states have given or pledged an additional 35.8m Euro towards these calls. It is 
expected  that  more  funds  will  be  realised  from  both  Member  States  and  third  parties  as  the 
proposals come to the selection.  

The average time-to-contract after closure of the call for proposals has been around 5 months in 
2007,  a  sharp  decrease  from  the  previous  years.  EDCTP  aims  at  bringing  this  time  down  to  3 
months  for  future  contract  negotiations,  although  this  depends  very  much  on  the  grantees’ 
response time, which is now the main limiting factor.  

It is encouraging that the participating Member State co-funding to EDCTP projects to date has 
far  exceeded  the  co-funding  as  anticipated  and  projected  in  the  EDCTP  2007-2010  Roadmap 
shown in table below.  

The  figures  demonstrate  that  a  number  of  participating  Member  States  have  allocated  more  of 
their  national  budget  for  the  three  poverty-related  diseases  to  EDCTP  initiatives.  The 
participating Member States are currently on course to exceed the levels of co-funding of EDCTP 
activities anticipated in the 2007-2010 Roadmap.  

It is anticipated that under the current EDCTP contract Member States will continue to set aside 
funding for the EDCTP Programme on an annual basis up to and including 2010. This funding 
will  continue  to  be  used  together  with  any  remaining  EDCTP  funds  to  launch  further  strategic 
joint  calls.  In  addition  EDCTP  has  allocated  €5  million  to  integrating  existing  initiatives  from 
individual Member States national programmes in order to develop Joint Programme activities.  

Although the level of contributions varies among participating Member States and there is a need 
to encourage more participation from some of them, the overall performance is very encouraging. 
Table  3  below  shows  year  by  year  co-funding  contributions  of  participating  Member  Sates  on 
EDCTP projects whereas table 4 shows the overall Member State funding in diseases of poverty 
(HIV/AIDS, malaria and tuberculosis) within the scope of EDCTP activities.  

Some Member States do not have a significant research community working on the three poverty 
related diseases of HIV/AIDS, tuberculosis and malaria. Moreover, it must also be remembered 
that many participating Member States do not even have national programmes as such for these 
poverty-related  diseases.  Such  national  programmes  as  they  exist  are  normally  shared  between 
the budgets of the Development Aid, Health, and Research ministries.  

To  streamline  its  activities,  the  EDCTP  Programme  is  working  towards  a  common  funding 
mechanism, scientific review and administration of proposals. Currently Sweden and Ireland are 
contributing  directly  to  an  EDCTP  common  funding  basket  and  allow  review  of  proposals  and 
grant  administration  to  be  done  by  EDCTP.  Spain  on  the  other  hand  has  a  two-track  system 
which  provides  a  significant  amount  of  funding  through  a  common  basket,  alongside  further 
funding  of  Spanish  researchers  in  EDCTP  projects  for  which  they  require  their  own  scientific 

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review. The remaining countries employ other mechanisms for funding EDCTP initiatives, some 
with and some without common review of proposals and grant administration through EDCTP.  

Although EDCTP Member State co-funding has dramatically increased in 2007, and pledges for 
years 2008-2010 are increasing, so far the level of co-funding achieved is only € 96 million out of 
the total € 200 million to be achieved by the end of 2010. This means that in the next 2.5 years, 
participating Member States still have to contribute € 104 million. Moreover, since most of the 
MS contributions are for their nationals participating in EDCTP-funded projects, the co-funding 
of African researchers is still an important issue to be solved in the future.  

To  help  promote  a  common  European  approach  to  solve  the  co-funding  issue,  the  General 
Assembly  Chair  and  Vice-Chairs,  the  Executive  Director  and  the  Joint  Programme  Manager 
accompanied by Member States’ representatives are visiting the relevant Member State ministers 
and senior officials to discuss the future strategy of EDCTP and follow-up on the letter that was 
sent  to  them  by  the  EC  Research  Commissioner  encouraging  the  renewal  of  member  state 
political and financial commitment to EDCTP. EDCTP is taking this opportunity to also explore 
how they might develop a mechanism of instituting political representation of European Member 
states and their African partners at the General Assembly. 

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Member State co-funding of EDCTP activities. Indicates Member State co-funding already contributed or committed to signed project grants or to 
the common funding pot. It does not include pledged money not yet committed to unsigned or future projects. Until April 2008, participating MS have 
contributed  €40  million  to  the  EDCTP  budget,  and  have  committed  and  pledged  €70  million  more  for  2008  to  2010,  totalling  €  110  million.  This 
contribution has dramatically increased in year 2007 and in the first quarter of 2008.  

COFUNDING OF EDCTP PROJECTS BY THE PARTICIPATING MEMBER STATES 

2005 

2006 

2007 

2008/2009/2010 

TOTALS FROM THE INCEPTION 

 GRAND 
TOTALS 

MEMBER STATE 

CASH  DIRECT 

IN KIND 

CASH 

DIRECT 

IN KIND 

CASH 

DIRECT 

IN KIND 

CASH 

DIRECT 

IN KIND 

CASH 

DIRECT IN KIND 

Austria 

0 

0 

Belgium 

9,712 

35,000 

Denmark 

France 

0 

0 

Germany 

1,107 

Greece 

0 

Ireland 

1,395 

Italy 

0 

Luxembourg 

930 

Netherlands 

Norway 

0 

0 

Portugal 

2,324 

Spain 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1,860 

0 

0 

4,959 

125,000 

57,452 

395 

14,900 

0 

7,214 

139,900 

57,452 

204,566 

2,325 

632,700 

39,000 

41,151 

460,026 

583,851 

0 

872,651 

1,712,554 

53,188 

2,000,377

2,335,405  4,388,970 

1,395 

0 

0 

671 

113,052 

910,929 

277 

0 

1,707,456 

2,343 

113,052 

2,618,385  2,733,780 

4,650 

82,000 

2,000 

2,783 

361,824 

142,812 

1,146 

4,849,965 

530,357 

8,579 

5,293,789

675,169 

5,977,537 

4,650 

2,325 

0 

0 

830,306 

2,782 

1,766 

0 

1,395 

2,650 

2,650 

551,292 

4,650 

0 

186,487 

1,395 

2,325 

0 

0 

0 

0 

0 

0 

0 

14,782 

384 

725,178 

1,181,883 

1,236 

671 

0 

1,151 

0 

0 

0 

0 

0 

0 

0 

0 

605,577 

1,146 

539,015 

336,308 

9,685 

539,015 

1,772,191  2,320,891 

919 

1,625 

3,866 

754,540 

0 

0 

0 

0 

3,950 

0 

2,685 

6,635 

1,308,622 

2,650 

6,516 

1,317,788 

4,534 

1,146 

115,620 

230,731 

20,578 

115,620 

235,265 

371,463 

2,531 

159 

990,538 

651,509 

0 

0 

0 

1,473 

1,192,629 

2,019,879 

0 

0 

2,531 

4,004 

2,908,345  4,928,224 

6,381 

277 

3,302,000 

774,000 

2,343 

3,302,000

781,617 

4,085,960 

1,034,077 

33,000 

810 

1,078,362 

476,308 

178,288 

1,078,363 

0 

0 

0 

0 

0 

5,800 

0 

0 

5,800 

314,421 

3,190,802 

509,308 

493,519 

4,193,629 

EN 

36 

EN 

 
  
COFUNDING OF EDCTP PROJECTS BY THE PARTICIPATING MEMBER STATES 

2005 

2006 

2007 

2008/2009/2010 

TOTALS FROM THE INCEPTION 

 GRAND 
TOTALS 

MEMBER STATE 

CASH  DIRECT 

IN KIND 

CASH 

DIRECT 

IN KIND 

CASH 

DIRECT 

IN KIND 

CASH 

DIRECT 

IN KIND 

CASH 

DIRECT IN KIND 

Sweden 

1,860 

Switzerland 

0 

United Kingdom 

777,797 

0 

0 

0 

Total (Euro) 

795,125 

35,000 

0 

0 

0 

0 

1,090,738 

0 

3,410 

2,702,318 

0 

225,069 

37,204 

0 

65,500 

6,626 

0 

79,470 

29,038 

198,000 

0 

0 

1,174,510 

3,832,120 

0 

1,402,989  5,235,109 

0 

198,000 

144,970 

35,664 

378,634 

891,919 

0 

118,000 

9,736,308 

0 

178,070 

10,764,247 

813,868 

2,711,497 

22,170,271 

813,868 

3,007,567  25,991,706 

3,230,191 

815,850 

1,730,982 

15,319,497 

1,615,680 

3,919,855 

13,490,034 

10,508,019 

10,684,463 

32,834,847 

12,974,549 16,335,300 62,144,696 

Total EDCTP Member State expenditure on HIV/AIDS, malaria and tuberculosis. One of the original goals of the EDCTP was to create a map of 
current  research  on  poverty-related  diseases  in  Europe  (inside  the  North-North  partnership  component  of  the  initiative).  The  table  summarises  all 
European  activities  in  the  field,  both  related  (clinical  trials  with  ongoing  coordination  of  MS  National  Research  Programmes)  or  not  (basic  and 
preclinical  research)  with  the  EDCTP.  Exact  figures  up  to  2007,  but  estimates  from  2008.For  2003-2005  definitions  of  valid  activities  may  have 
differed from one MS to another. Reporting criteria were standardised in 2006. 

OVERALL CONTRIBUTIONS OF PARTICIPATING STATES ON RESEARCH AND DEVELOPMENT  
OF POVERTY-RELATED DISEASES 

STATE 

2003 

2004 

2005 

2006 

2007 

2008 

2009 

2010 

TOTAL 

AUSTRIA  

45,900 

502,813 

96,900 

43,700 

233,466 

No data 

No data 

No data 

922,779 

BELGIUM  

4,995,500 

4,919,000 

12,346,022 

4,523,100 

4,691,028 

3,389,725 

3,389,725 

2,561,200 

40,815,300 

DENMARK  

6,700,000 

7,345,000 

8,140,000 

4,915,000 

4,774,652 

7,887,062 

7,887,062 

7,000,000 

54,648,776 

FRANCE  

4,058,559 

5,119,725 

18,735,954 

3,382,237 

3,052,166 

3,431,946 

3,431,946 

3,073,672 

44,286,205 

EN 

37 

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OVERALL CONTRIBUTIONS OF PARTICIPATING STATES ON RESEARCH AND DEVELOPMENT  
OF POVERTY-RELATED DISEASES 

STATE 

2003 

2004 

2005 

2006 

2007 

2008 

2009 

2010 

TOTAL 

GERMANY  

16,488,004 

15,190,097

18,769,417 

2,878,306 

1,988,759 

2,541,841 

2,541,841 

2,234,754 

62,633,019 

GREECE  

0 

0 

3,447,635 

1,766 

919 

No data 

No data 

No data 

3,450,320 

IRELAND  

5,501,000 

5,398,000 

6,251,614 

879,119 

555,158 

17,321,000

17,285,000

17,125,000

70,315,891 

ITALY  

19,927,023 

6,233,302 

6,798,000 

11,279,168

7,228,402 

90,815 

90,815 

73,905 

51,721,430 

LUXEMBOURG  

290,320 

58,068 

449,163 

382,028 

488,451 

No data 

No data 

No data 

1,668,030 

NETHERLANDS   21,041,312 

19,880,348

21,053,000 

4,111,523 

3,108,421 

2,613,633 

2,613,633 

2,087,500 

76,509,370 

PORTUGAL  

1,518,359 

1,207,186 

1,951,719 

454,251 

1,151 

No data 

No data 

No data 

5,132,666 

SPAIN  

1,200,000 

1,200,000 

7,200,000 

2,633,191 

2,962,858 

157,210 

157,210 

No data 

15,510,469 

SWEDEN  

7,953,919 

8,827,902 

13,620,620 

3,329,289 

5,756,904 

5,637,634 

5,637,634 

5,184,000 

55,947,902 

UNITED 
KINGDOM  

18,934,000 

19,947,000

24,887,000 

16,990,600

26,653,994  16,737,309

14,975,309

6,896,474 

146,021,686 

NORWAY  

1,032,250 

1,750,000 

1,964,187 

1,200,788 

289,052 

8,900,000 

8,900,000 

8,900,000 

32,936,277 

SWITZERLAND  

- 

- 

- 

3,033,626 

4,952,031 

850,000 

850,000 

37,500 

8,874,007 

TOTAL (Euro) 

109,686,146

97,578,441

145,711,231

60,037,692

66,737,412  69,558,175

67,796,175

55,174,005

670,618,277 

EN 

38 

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VI. 

KEY PERFORMANCE INDICATORS 

In early 2007, the EDCTP Secretariat agreed with the European Commission and the General 
Assembly in defining Key Performance Indicators that could be used to assess progress in the 
different EDCTP activities. Indicators were divided in four categories: Grants (grants signed, 
clinical  trials,  capacity  building  and  time  to  contract),  Partnership  (African  countries, 
institutes  and  project  coordinators),  Co-funding,  and  Governance  (percentage  of  budget 
devoted to administrative issues vs. research, and to African vs. European researchers).  

KPI are updated monthly and published in the EDCTP website.  

1. 

Value of grants signed 

Funds  committed  or  spend  against  time  (EDCTP  funds  only,  not  including  MS  and  Third 
party  funding).  2008  data  include  values  of  grants  signed  in  the  first  quarter  of  2008. 
Estimated data refers to approved projects that are under negotiation. 

EN 

39 

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2. 

Clinical trials approved 

Number of clinical trials approved from 2004 until May 2008 further projects of the current 
calls will be approved later in 2008.  

3. 

Capacity building activities 

EDCTP supported capacity development activities in Africa: 

•  SF: Senior Fellowships projects 
•  TA:  Training  Awards  projects,  including  Masters  studentships,  PhD  scholarships  and  Career  Development 

Fellowships 

•  Regulatory:  Number  of  national  regulatory  authorities  (NRA's)  included  in  EDCTP-WHO  collaboration 

capacity strengthening activities 

•  Ethics: number of projects for strengthening ethics framework activities 
*Cumulative data until end of May 2008 

EN 

40 

   EN 

 
 
 
4. 

Contract negotiation period for new projects 

The period from the General Assembly approval of a proposal until the signing of the contract 
by the project coordinator. This time period includes actions by both EDCTP secretariat and 
the potential grantee. 2008 approved projects are under negotiation. 

5. 

Number of African countries involved in EDCTP ongoing projects 

Number of African countries involved in EDCTP activities. 

*Cumulative data until end of May 2008 including signed and approved projects  

EN 

41 

   EN 

 
 
 
6. 

Number of African institutions involved in EDCTP ongoing projects 

*Cumulative data until end of May 2008 including signed and approved projects. 

7. 

Number of African project coordinators per disease 

Number  of  African  Project  Coordinators  involved  in  EDCTP  projects  including  Clinical 
Trials, Senior Fellowships and Career Development fellowships until May 2008. 

8. 

Number of countries collaborating in EDCTP clinical trials 

EN 

42 

   EN 

 
 
 
 
The  table  shows  the  number  of  approved  clinical  trials  projects  involving  different 
proportions of African and European countries until May 2008. 

9. 

Annual MS co-funding of EDCTP activities (€) 

Composition and level of Member State (MS) co funding of EDCTP activities. 2008 data of 
contribution for direct to projects and in kind are estimated. 

10. 

EDCTP cash expenditure between grants and other costs 

Split of EDCTP cash expenditure between grants and other costs (governance, support costs 
and programme activities). Data until end of March 2008. 

EN 

43 

   EN 

 
 
 
11. 

EDCTP costs split by area of cash expenditure in 2007 

Breakdown of total EDCTP budget: 

•  Support costs: those incurred with the hosting institutions (NWO, MRC) 
•  Governance costs: costs of holding constituency meetings plus audit fees 
•  Programme costs: all other costs excluding grants, support costs and the governance costs. Including running 

of the secretary, the Forum and evaluations. 
•  Grants: funding allocated to awarded proposals. 

12. 

EDCTP expenditure divided between African and European countries 

EDCTP total and committed expenditure from 2003 divided between African and European 
institutions and nationals. Data until end of March 2008. 

EN 

44 

   EN 

 
 
 
13. 

Overview  of  Member  State,  Third  party  and  EC  funding  commitment  to 
EDCTP projects 

120000000

100000000

80000000

60000000

40000000

20000000

0

2003

2004

2005

2006

2007

2008

MS contribution

Third party contribution EC funding signed grants

MS  contribution:  Member  States  annual  contribution  to  signed  projects.  2008  data  include  committed  contribution  to  signed  or  approved 
projects until May 2008. 

Third party contribution: third party annual contribution to EDCTP signed projects, if known. 2008 data include committed contribution to 
signed or approved projects until May 2008. 

EC funding: values of signed grants (EC funds only). 2008 data include the value of signed grants in first quarter 2008, approved grants and 
estimate values of future grants for the full year 2008. 

EN 

45 

   EN 

 
 
A. 

Synergy of research and development funding 

The very nature of the diseases the EDCTP Programme is fighting, with the ultimate goal of 
poverty-alleviation in Developing Countries, calls for the collaboration of Development and 
Research  Agencies.  From  the  research  point  of  view,  it  is  not  possible  to  start  advanced 
clinical  trials  in  sub-Saharan  Africa  without  a  preliminary  and  sustained  capacity  building 
effort.  That  is  the  reason  why  the  EDCTP  Programme  was  designed  to  rely  on  the  support 
from both development and research stakeholders.  

In  this  regard,  European  Development  Agencies  are  getting  involved  in  the  EDCTP 
Programme, and the Directorates General for Development (DEV) and Aid and Cooperation 
(AIDCO)  of  the  European  Commission  have  also  contributed  ca.  €  14  million  to  capacity 
building and health-related activities in research projects originally financed by the European 
Commission under the International Cooperation programme, and that now are being further 
developed under the umbrella of the EDCTP. 

B. 

Third-party collaboration and funding 

The  EDCTP  Programme  has  stepped  up  its  efforts  to  work  with  industry  and  like-minded 
organisations. Recent activities include exploring buy-ins and participation of third parties in 
EDCTP  calls  and  projects.  Proposals  that  have  been  recently  submitted  in  response  to  the 
current  EDCTP  calls  include  participation  from  different  public-private  partnerships  or 
pharmaceutical  companies,  like  the  AERAS  Global  Tuberculosis  Vaccine  Foundation, 
Crucell, the Global Alliance for Tuberculosis Drug Development, the Bill & Melinda Gates 
Foundation  (BMGF),  Bayer  Healthcare  AG,  Sanofi-Aventis,  Sequella  Inc,  IDT  (Integrated 
DNA  Technologies),  the  International  AIDS  Vaccine  Initiative  (IAVI),  the  International 
Partnership  for  Microbicides  (IPM),  the  European  Malaria  Vaccine  Initiative  (EMVI),  the 
African  Malaria  Network  (AMANET)  and  Archivel  Farma  SL,  to  name  some.  Up  to  date, 
total Third-Party funding amounts about € 34 million.  

The EDCTP Programme is also supporting strengthening of National Regulatory Authorities. 
One  of  the  projects  funded  has  an  initial  grant  of  250,000  Euros  to  the  World  Health 
Organisation  (WHO)  and  co-funding  from  The  Netherlands  by  the  Netherlands-African 
Partnership  for  Capacity  Development  and  Clinical  Trials  Intervention  (NACCAP).  This  is 
being  conducted  through  joint  clinical  trials  evaluation  and  monitoring,  training  (Global 
Training Network) and establishment of the African Vaccines Regulators’ Forum (AVAREF). 
The  establishment  of  AVAREF  will  contribute  towards  streamlining  and  harmonising  the 
vaccine  regulatory  process  in  Africa.  There  are  plans  to  use  this  platform  and  Article  58 
(authorisation  of  pharmaceutical  compounds  for  developing  countries)  of  the  European 
Medicines  Agency  (EMEA)  to  review  and  register  in  several  African  countries  the  malaria 
vaccine  RTS,S  being  developed  by  GlaxoSmithKline  (GSK)  and  the  Bill  &  Melinda  Gates 
Foundation (BMGF). 

EDCTP plans to follow up these activities with further funding as well as to map all ongoing 
capacity building activities on ethics and competent authority activities. To meet this goal, the 
EDCTP  General  Assembly  approved  in  May  2008  financing  for  568,744  Euros  to  continue 
with this work and further expand the project to include monitoring of regulatory functioning 
and progress in Africa.  

EN 

46 

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EDCTP’s  endeavour  to  work  with  like  minded-organisation  has  led  to  the  launch  of  a  joint 
call  with  the  BMGF  in  December  2006.  This  call  for  capacity  building  for  HIV  vaccines 
yielded  6  projects  in  8  African  countries.  In  these  projects,  four  out  of  six  have  African 
coordinators, and partnership includes collaborative efforts of 8 Member States.  

Among  ongoing  clinical  trials,  third-party  contribution  to  the  phase  II/III  moxifloxacin  TB 
trial amount to over € 8 million. This came from Global Alliance for TB Drug Development, 
Bayer AG and Sanofi-Aventis. Contributions to intravenous artesunate trials from the Malaria 
Medicine  Venture  (MMV)  currently  add  to  over  €  1  million  and  will  go  up  to  €  3  million 
when the trials enter phase III.  

Furthermore, negotiations are underway to see how the MMV can co-fund the current calls on 
malaria  treatment  and  pregnancy  associated  malaria.  EDCTP  is  also  exploring  into  ways  of 
working  together  with  the  Wellcome-Trust  and  the  Canadian  International  Development 
Research  Centre  (IDRC)  in  the  nodes  of  excellence  call,  and  the  US  Center  for  Disease 
Control and Prevention (CDC) in possibly a new TB treatment call.  

VII. 

THE EDCTP MEDIUM- AND LONG-TERM STRATEGY AND ACTIVITIES  

The  EDCTP  has  been  created  and  is  owned  by  European  Union  Member  States.  These  MS 
provide  the  funds  to  the  EDCTP  initiative  both  directly,  through  the  50%  co-funding 
mechanism,  or  indirectly,  through  the  Community  budget.  The  future  of  the  EDCTP  goes 
through  the  development  of  a  stronger  sense  of  ownership  from  the  Member  States,  who 
should stress their political and financial support to this initiative, and make sure the EDCTP 
fits  in  their  product  development  strategy,  from  basic  research  to  advanced  clinical  trials  in 
and for developing countries.  

From  its  inception  EDCTP  had  developed  a  strategy  described  in  the  so-called  Joint 
Programme of Activities (JPA) which is annually revised to form annual work-plans through 
the Joint Programme B (JPB). In 2007 this has been supplemented with the Roadmap, a plan 
of action that has been agreed with the European Commission to guide activities through the 
no-cost extension period of 2008-2010. To fine-tune this strategy EDCTP with the help of a 
consultant  has  identified  12  key  performance  indicators  that  will  be  used  to  evaluate  and 
monitor  EDCTP  activities  as  well  as  inform  the  stakeholders  including  European  Members 
states, African partners, European Commission, the scientific communities, private sector and 
all  other  relevant  parties.  These  will  be  reviewed  monthly  and  published  on  the  EDCTP 
website on a quarterly basis.  

EDCTP  is  also  in  the  process  of  developing  a  long-term  strategy  that  will  encompass 
activities  to  be  undertaken  beyond  the  current  funding  period.  These  will  include  working 
effectively  with  other  players  in  all  phases  of  clinical  trials  and  possibly  involving  other 
diseases of poverty in addition to the current three. EDCTP is currently working with other 
like-minded  organisations  and  private  industry  and  anticipate  expanding  this  in  the  current 
calls that it has launched. Partners that are currently working with EDCTP include the Bill & 
Belinda  Gates  Foundation  and  International  AIDS  Vaccine  Initiative  (joint  call  on  HIV 
preventive  vaccines),  TB  Alliance,  Sanofi-Aventis,  Bayer  and  Sequella  (TB  treatment), 
Malaria  Medicines  Venture  (Treatment  of  severe  malaria  in  children).  Additionally,  several 
companies  such  as  Bayer  and  Glaxo-Smith-Kline  are  either  supplying  drugs  for  conducting 
clinical trials or act as clinical trials sponsors in various EDCTP funded studies.  

EN 

47 

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VIII.  EDCTP FORUM  

Every year since the implementation of the EDCTP Programme, the Secretariat is organising 
the EDCTP Forum, a meeting of all EDCTP stakeholders, from the different Constituencies 
(General  Assembly,  Partnership  Board,  Developing  Countries  Coordinating  Committee,  and 
European  Network  of  National  Programmes)  to  researchers  involved  in  EDCTP  projects  or 
interested in the EDCTP objectives.  

Last  EDCTP  Forum  was  held  in  Ouagadougou,  Burkina  Faso,  from  22nd  to  24th  October 
2007.  During  three  days  about  200  African  researchers  in  the  fields  of  HIV/AIDS,  malaria 
and tuberculosis presented their latest results and prepared the future of the African research 
in  this  domain.  Little  by  little,  the  EDCTP  Forum  is  becoming  the  African  meeting  on  the 
three major poverty-related diseases.  

IX. 

RECENT PRESS RELEASES AND PUBLICATIONS 

In  the  last  few  months  of  2007  and  early  2008,  several  press  releases  on  success  stories 
deriving from EDCTP-funded research projects were released (see annex 3). This includes the 
start  of  a  phase  II  trial  of  intravenous  artesunate  for  the  treatment  of  children  with  severe 
malaria,  the  start  of  a  clinical  trial  to  compare  four  new  antimalarial  treatments  for  African 
children,  and  the  results  of  an  ongoing  EDCTP  project  that  shows  that  HIV/AIDS  infected 
children can now benefit from a new treatment. As a consequence of these latest results, the 
US Food and Drug Administration (FDA) gave a tentative approval to a fixed-dose anti-HIV 
drug specifically formulated for paediatric use in developing countries.  

All EDCTP press releases are published though the EDCTP website (www.edctp.org), as are 
all news, calls for proposals, results of evaluations, annual reports, meetings, composition of 
the EDCTP governing and advisory boards, etc.).  

The EDCTP recently participated in the Geneva Health Forum 2008 Towards global access to 
Health (25-28 May 2008). The forum brought together on an equal basis all actors involved in 
access to health. Under the flags of equity, partnership, and capacity building, it links policies 
and guidelines to actual practice in the field. 

Recently published articles include:  

The  emerging  shape  of  a  global  HIV  research  agenda:  how  partnerships  between  Northern 
and Southern researchers are addressing questions relevant to both. Fostering new models of 
science development and collaboration. Current Opinion in HIV & AIDS. 3(4):521-525, July 
2008. 
Mgone,  Charles  (http://www.co-hivandaids.com/pt/re/cohiv/abstract.01222929-200807000-
00018.htm;jsessionid=LFhQHtKPh2QLFnFZBbKRxLzjpmhtz1SzGqJwcTjS21DF3J3yjrFj!1
629792715!181195629!8091!-1). 

Collaborative approach to clinical trials (May 2008). Charles Mgone and Pascoal Mocumbi. 
Health Partnerships Review 2008 (Global Forum for Health Research). 

Additional  EDCTP-related  articles  are  available  from  the  following  EDCTP  webpage: 
http://www.edctp.org/Articles.253.0.html.  

EN 

48 

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X. 

COMMISSIONER POTOČNIK'S LETTER TO THE EDCTP MEMBER STATES 

Following  the  publication  of  the  Van  Velzen  report,  Commissioner  Potočnik  wrote  in 
September 2007 to the EDCTP Member States informing them. Furthermore, he emphasised 
the  importance  of  the  political  involvement  and  financial  support  of  Member  States,  as 
owners of the programme, for the future of EDCTP. 

Many  responses  have  been  received  so  far.  Out  of  these,  especial  mention  to  the  strong 
support  to  the  EDCTP  concept  as  stressed  by  Germany,  Spain,  Switzerland  and  United 
Kingdom.  

In  order  to  express  the  strong  support  of  the  European  Commission  to  the  EDCTP, 
Commissioner Potočnik visited the African office of the EDCTP on the 30 November 2007. 
He  met  the  High  Representative  of  the  EDCTP,  Dr.  Pascoal  Mocumbi,  and  the  EDCTP 
personnel  based  in  Cape  Town.  The  Commissioner  also  met  in  his  office  with  Dr  Diana 
Dunstan  the  EDCTP-EEIG  Chairperson,  Prof.  Charles  Mgone,  The  EDCTP  Executive 
Director, Dr Pascoal Mocumbi and Senior EC officials to discuss current developments and 
future plans of EDCTP.  

A parallel letter was also sent to the European Parliament and to Commissioner Louis Michel, 
not  only  informing  them  about  the  Van  Velzen  report,  but  in  the  case  of  Commissioner 
Michel  also  requesting,  in  line  with  the  IER  report,  the  creation  of  a  joint  platform  DG 
DEV/DG RTD.  

XI. 

JOINT DG RESEARCH / DG DEVELOPMENT PLATFORM  

Following  the  recommendation  made  in  the  Van  Velzen  report,  DG  Research  and  DG 
Development have accepted to establish a platform to reinforce dialogue with EDCTP. After 
an exchange of letters between Commissioners Michel and Potočnik to initiate the exercise, 
the  Commission  had  the  first  formal  meeting  of  this  inter-service  platform  in  early  2008. 
Several related meetings have followed.  

In  the  meantime,  the  Commission  services  and  the  EDCTP  constituencies  are  in  regular 
working  contact.  Representatives  of  EDCTP  and  DG  Research  participated  in  the  Member 
States  Experts  meeting  on  HIV/AIDS,  Malaria  and  Tuberculosis  (30-31  October  2007), 
hosted  by  DG  Development,  which  dealt  with  preparations  for  monitoring  and  reporting  on 
the  EU  Programme  for  Action  on  HIV/AIDS,  malaria  and  included  initial  discussions  on 
review of policy directions for the Programme for Action. 

In April 2008 Commission services from DG DEV and DG RTD met to discuss for an update 
on  the  EDCTP  activities  and  future  perspectives.  Both  Directorates  General  agreed  on  the 
importance  of  the  Programme  and  on  the  need  to  better  coordinate  development  aid  and 
research policies for poverty-related diseases in Developing Countries.  

Commission  staff  from  DG  Research  responsible  for  managing  research  on  HIV/AIDS, 
malaria and tuberculosis regularly attends EDCTP stakeholder meetings for planning strategy 
and  content  of  future  EDCTP  calls  for  proposals.  In  addition,  the  Commission  services 
participate  as  observers  in  meetings  of  the  EDCTP  governance  structures,  the  General 
Assembly and Partnership Board and in the annual EDCTP fora (the most recent being held in 
Burkina Faso, 22 to 24 October 2007).  

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XII.  HEALTH RESEARCH STRATEGY ON THE THREE MAIN POVERTY-RELATED DISEASES 

Health  research  strategy  in  relation  to  HIV/AIDS,  malaria  and  tuberculosis  is  under 
continuous  reassessment  as  part  of  the  process of  review  of  the  EU  Programme  for  Action: 
Accelerated  Action  on  HIV/AIDS,  Malaria  and  Tuberculosis  in  the  Context  of  Poverty 
Reduction12,  and  taking  into  account  other  relevant  policy  discussions  in  the  field  (e.g. 
European  Parliament,  WHO,  OECD  etc).  For  example,  the  European  parliament  report  on 
Major and Neglected Diseases in Developing Countries13, called for "the activities of EDCTP 
to  be  expanded  to  include  other  neglected  diseases  as  well  as  other  phases  of  clinical 
development".  In  formulating  future  calls  for  proposals  under  the  Health  research  theme 
(Cooperation Specific Programme) of the 7th Framework Programme such policy discussions 
will  be  taken  closely  into  account.  The  future  financing  of  the  EDCTP  Programme  will  be 
considered in this wider EU policy context.  

XIII. 

INVOLVEMENT OF AFRICAN GOVERNMENTS  

the  Commission 

Extensive  discussions  between 
(DG  Development)  with  African 
governments  concerning  national  health  strategies  capacity  building  and  sustainability  will 
continue in the context of the Programme for Action: research forms a key part of this policy 
framework (see Second Progress report on the EC Programme for Action: accelerated action 
on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction14. Calls under the 
Health research theme in FP7 will take account of such consultations.  

The  governance  structures  of  the  EDCTP  Programme  are  currently  being  strengthened  to 
improve  consultation  with  African  governments.  The  advocacy  of  the  High  Representative, 
Dr Pascoal Mocumbi, must be specially acknowledged in this regard.  

Furthermore, DG Research will work with EDCTP to ensure that EU delegations in African 
countries are  properly informed  about the EDCTP Programme in their country or region. A 
specific report on the EDCTP is being prepared to be forwarded to the African delegations of 
the European Union. 

12 

13 
14 

Decision  2002/36/EC  of  the  European  Parliament  and  of  the  Council  of  19  December  2001,  and 
COM(2005) 179, Communication from the Commission to the Council and the European Parliament: A 
European  Programme  for  Action  to  Confront  HIV/AIDS,  Malaria  and  Tuberculosis  through  External 
Action (2007-2011).  
2005/2047 (INI) 
COM(2004) 726 

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XIV. 

Other Article 169 initiatives 

One  of  the  aims  of  the  2007  IER  of  the  EDCTP  was  to  learn  lessons  for  planning  future 
actions under Article 169 of the Treaty.  

The  Commission  is  working  in  four  new  Art.  169  initiatives  identified  in  the  FP7  specific 
programme  adopted  on  19  December  2006,  being  AAL  and  EUROSTARS  the  most 
advanced:  

•  AAL, joint research programme on technologies for "Ambient Assisted Living"  
•  BONUS-Art 169, joint programme on "Baltic Sea" research 
•  EMRP, joint research initiative on "European Metrology Research Programme" 
•  EUROSTARS, joint research programme on "research-performing SMEs" 

Together  with  the  discussions  which  took  place  previously  between  the  Commission  and 
representatives  of  the  Member  States,  in  particular  with  CREST,  a  number  of  essential 
prerequisites  have  been  drawn  up  by  the  Commission  for  an  efficient  implementation  of 
Article 169 of the Treaty.  

Existence of a "Joint Programme": for the AAL, relevant research activities exist in most 
Member States (MS). A number of countries are in process of establishing new frameworks 
for  this  area.  This  will  form  the  basis  for  their  participation  in  the  AAL  Joint  Programme. 
EUROSTARS will integrate existing research national Programmes supporting SMEs. 

Clear and irrevocable political commitments from MS to the Joint Programme: For the 
AAL,  Community  support  will  be  provided  through  annual  financing  agreements;  only  MS 
providing upfront commitments will be eligible for funding. For EUROSTARS, an agreement 
will be concluded with the Eureka Secretariat for the whole duration of the Programme. 

Financial integration: For AAL and EUROSTARS, the Roadmap presented to Council and 
Parliament in November 2006 encourages MS to consider to create a "common financial pot". 

Scientific integration: For the AAL and EUROSTARS initiatives, the participating MS shall 
ensure  that  the  selection  procedure  to  be  set  up  shall  follow  the  principles  of  scientific 
excellence. 

Management  integration:  The  AAL  Joint  Programme  will  be  implemented  by  a  dedicated 
legal entity which will be governed by a transparent governance structure. 

Mid-term evaluation: The AAL and EUROSTARS Joint Programmes will be subject to an 
evaluation  procedure,  on  the  basis  of  the  main  indicators  defined  in  the  Commission 
proposals.  

Protection  of  the  financial  interests  of  the  Community:  AAL  and  EUROSTARS  have 
identified  a  dedicated  implementation  structure,  responsible  for  the  implementation  of  the 
Joint Programme. The AAL Association will make use of the Eureka Secretariat. 

Principles  for  protection  of  Intellectual  Property  Rights  (IPR):  The  AAL  and  the 
European  Joint  Programmes  will  entail  clear  principles  on  IPR  in  the  agreements  to  be 
concluded with the AAL association and the EUROSTARS Secretariat. 

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Annexes 

Annex 1: Independent External Review of EDCTP - Key Recommendations 

1. To the EDCTP: 

1.1. 

1.2. 

1.3. 

1.4. 

1.5. 

Define  a  clear,  convincing  and  realistic  EDCTP  strategy  with  a  common  shared 
vision,  clearly  defined  contributions  from  each  partner  and  equitable  sharing  of 
results. 

Make  the  General  Assembly  more  political  and  create  an  Executive  Steering 
Committee. 

Expand association with major Product Development Public/ Private Partnerships for 
access to know-how and to provide visibility. Keep an inventory of and contacts with 
other similar programmes, to avoid unnecessary duplication. 

Renew  calls  for  appropriate  projects  to  be  submitted  rapidly  to  attract  the  best 
public/private partnerships and to participate in major R&D initiatives such as MVI, 
IAVI and on TB. 

Simplify  and  streamline  co-funding,  from  a  virtual  to  an  actual  common  pot  (by 
2009),  in  order  to  reduce  operational  complexity  and  allow  African  initiation  of 
EDCTP projects. 

2. To the EDCTP Member States: 

2.1. 

2.2. 

2.3. 

2.4. 

2.5. 

Interested  Member  States  should  renew  their  “EDCTP  vows”  in  Council;  accept 
reforms to EEIG structures, and directly finance an EDCTP “common funding pot”. 

In the General Assembly, the decision making should be restricted to Member States 
who  provide  financial  contributions  with  representation  at  the  highest  appropriate 
national level and to African representation; other member would become observers, 
starting in 2008. 

The African presence in the General Assembly should be reinforced, with decision-
making status for representatives from African countries or regional organisations. 

Member  States  should  refrain  from  imposing  national  criteria,  and  accept  one 
integrated scientific and ethical evaluation conducted by EDCTP, utilising a pool of 
the best national experts.  

Member States should enforce the Article 169 concepts in their own countries on a 
sustainable  basis,  involving  national  parliaments  when  required,  and  report  back 
annually to the EDCTP and the Commission on progress in implementation. 

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3. To the European Commission, in relation to future EDCTP activities: 

3.1. 

3.2. 

3.3. 

3.4. 

3.5. 

3.6. 

Report to the Council and Parliament about the current status, in anticipation of the 
2008 review. 

Create a joint DG Research / DG Development platform to engage in a dialogue with 
the EDCTP. 

Reformulate  health  research  strategy  before  any  new  decision  to  finance  EDCTP 
from FP7, in particular on the three diseases. 

Consult  African  Governments  on  EDCTP  future  and  international  health  research 
under FP7. 

Involve  African  Governments  at  an  early  stage  to  link  capacity  strengthening  to 
national strategies, in order to ensure sustainability. 

Submit a new funding proposal to the Council and Parliament, before FP 7 mid-term 
review, provided that: 

•  Interested  Members  States  political/budgetary/administrative  commitments  are 

clear. 

•  The  EDCTP  programme  integrates  the  relevant  national  ones,  with  a  common 

funding pot. 

•  The EDCTP governance is properly adjusted and more open to African partners. 
•  The EDCTP performance complies with targets from the EDCTP Roadmap. 

4. To the European Commission, in relation to new Article 169 initiatives: 

4.1. 

Set out future Article 169 pre-conditions, preferably in a guidance communication. 

4.2. 

4.3. 

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. 

Before  EU  money  becomes  available,  there  must  be:  common  work-plan;  sound 
governance structure; fixed national financial contributions; clear evaluation criteria 
and procedures; clear deliverables; solutions for the liability issue. 

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Annex 2: Members of the different EDCTP constituencies 

Representatives of the 16 EDCTP participating countries in the General Assembly: 

Chair 

Austria 

Belgium 

Denmark 

France 

Germany 

Greece 

Ireland 

Italy 

Dr Diana Dunstan (Chairperson) 
Medical Research Council UK 
Dr Christiane Druml 
Ethics Committee of the Medical University of Vienna and the Vienna General 
Hospital 
Prof. Bruno Gryseels 
Director, Institute for Tropical Medicine 
Dr Søren Jepsen (Vice-chairperson) 
State Serum Institute 
Prof. Patrice Debre (Vice-chairperson) 
Hôpital Pitié Salpêtrière 
Dr Gabriele Hausdorf 
Bundesministerium für Bildung und Forsching (BMBF) 
Prof. Antonis Antoniadis 
School of Medicine, Aristotle University of Thessaloniki 
Dr Teresa Maguire 
Health Research Board 
Prof. Stefano Vella 
Istituto Superiore di Sanità 

Netherlands  Dr Edvard Beem 

Norway 

ZonMw 
Dr Bjørn Guldvog 
Norwergian Directorate for Health and Social Affairs 

Luxembourg  Carlo Duprel 

Portugal 

Spain 

Sweden 

Switzerland 

United 
Kingdom 

Fonds National de la Recherche 
Ana Maria Faisca 
Ministry of Science, Technology and Higher Education 
Dr Carmen Audera Lopes (Vice-chairperson) 
Director, Oficina de Proyectos Europeus, Instituto de Salud Carlos III 
Dr Hannah Akuffo 
Swedish International Development Agency (SIDA) 
Isabella Beretta 
State Secretariat for Education and Research 
Kevin Moreton  
Medical Research Council  
(Note: Dr Dunstan remains the sole UK representative on the GA but Dr Moreton 
speaks for the UK while Dr Dunstan holds the Chair) 

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EDCTP Secretariat 

1. 

The Hague Office: 

Prof. Charles Mgone 
Executive Director 
Simon Belcher 
Director of Finance and Administration 
David Coles 
Joint Programme Manager 
Dr Waley Salami 
Projects Manager 
Danielle Roordink 
Networking Officer 
Dr Remco de Vrueh 
Networking Officer 
Dr Marjolein Robijn  
Project Officer 
Dr Montserrat Blázquez - Domingo 
Project Officer 
Lara Pandya 
Project Officer 
Ilona van den Brink 
Communications Officer 
Christian Geib  
Project officer 
Lidwien van der Valk 
Legal Adviser 
Chris Bruinings 
Senior Bookkeeper 
Caroline Bijkerk 
Travel Coordinator 
Monique Wolf  
Events Coordinator 
Mary Jane Coloma-Egelink 
Grants Accountant 
Kevin Burke 
Financial Assistant 
Daniela Pereira-Lengkeek  
Administrative Officer 
Patricia Sáez 
Administrative Officer 
Sabina Stanescu 
Administrative Officer 

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2. 

The Cape Town Office: 

Dr Pascoal Mocumbi 
High Representative 
Dr Thomas Nyirenda 
Networking Manager 
Dr Michael Makanga  
Capacity Development Manager 
Gail Smith  
Administrative Officer 

Members of the Partnership Board:  

Specialist field  Members 
TB 

Dr Richard Adegbola (Vice-chairperson) 
MRC Laboratories, The Gambia 

Clinical trials/GCP  Dr Christian Burri 

Industry 

HIV/AIDS 

Malaria 

HIV/AIDS 

TB 

HIV/AIDS 

Malaria 

Swiss Tropical Institute, Switzerland 
Prof. Juhani Eskola 
National Public Health Institute (KTL), Finland 
Dr Shabbar Jaffar 
London School of Hygiene and Tropical Medicine, United Kingdom 
Prof. Peter Kremsner 
University of Tuebingen, Germany 
Dr Rosemary Musonda 
Botswana Harvard School of Public Health, Botswana 
Prof. Joseph Odihiambo 
Kenya Medical Research Institute, Kenya 
Prof. Eric Sandström (Vice-chairperson) 
Karolinska University Hospital, Sweden 
Dr Sodiomon Sirima (Chairperson) 
Centre National de Recherche et de Formation sur le Paludisme (CNRFP), 
Burkina Faso 

Members of the European Network of National Programmes: 

Austria 

Belgium 

Denmark 

France 

Germany 

Dr Brigitte Bloechl-Daum 
Medical University of Vienna 
Dr Dirk van der Roost (Vice-chairperson) 
Institute for Tropical Medicine 
Klaus Winkel 
Statens Serum Institut 
Dr Bernadette Murgue 
Institut de Recherche pour le Développement 
Dr Claudia Herok (Vice-Chairperson) 
Bundesministerium für Bildung und Forschung 

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Greece 

Ireland 

Italy 

Luxembourg 

Netherlands 

Norway 

Portugal 

Spain 

Sweden 

Switzerland 

United Kingdom 

Dr Anna Papa Konidari 
Aristotle University of Thessaloniki 
Dr Teresa Maguire (acting member) 
St James' Hospital 
Dr Giovanni Guidotti 
National Institute of Health 
Dr Carlo Duprel 
Fonds National de la Recherche 
Dr Judith de Kroon 
NACCAP 
Kårstein Måseide 
The Research Council of Norway 
Prof. Laura Brum (Chairperson) 
Instituto Nacional de Saúde Dr Ricardo Jorge 
Dr Rafael de Andrés Medina 
Instituto de Salud Carlos III 
Prof. Olle Stendahl 
Linköping University 
Isabella Beretta 
State Secretariat for Education and Research 
Dr Claire Newland 
Medical Research Council 

Members of the Developing Countries Coordinating Committee: 

Malaria  Dr Andrew Kitua (Chairperson) 

National Institute for Medical Research (NIMR), Tanzania 

Malaria  Dr Christine Manyando (Vice-chair) 

TB 

HIV 

Tropical Diseases Research Centre, Zambia 
Dr Veronique Nintchom Penlap (Vice-chair) 
University of Yaounde, Cameroon 
Dr Simon Agwale 
Innovative Biotech Limited, Nigeria 

Malaria  Dr Herman Awono Ambene 
OCEAC, Cameroon 
TB/HIV  Dr Tumani Corrah 

HIV 

TB 

Malaria 

TB 

HIV 

MRC Laboratories, The Gambia 
Dr Walter Jaoko 
University of Nairobi, Kenya 
Dr Hulda Swai 
Council of Scientific Industrial Research, South Africa 
Prof. Alioune Dieye 
Institut Pasteur de Dakar, Senegal 
Prof. Mecky Isaac Matee 
Muhimbili University College of Health Science, Tanzania 
Prof. Nkandu P Luo 

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Luo and Associates, Zambia 

Malaria  Dr Mathieu Ndounga 

Centre d'Etudes sur les Ressources Végétales (CERVE), Congo 

The EDCTP High Representative is Dr Pascoal Mocumbi  

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Annex 3: Recent EDCTP press releases 

Press Release 

28 August 2007 

START OF PHASE II TRIAL OF INTRAVENOUS ARTESUNATE FOR CHILDREN WITH 
SEVERE MALARIA 

A  multicentre  Phase  II  trial  of  intravenous  artesunate  will  begin  recruitment  of  patients  in 
September.  The  €5.3  M  trial,  funded  by  the  European  and  Developing  Countries  Clinical 
Trials Partnership (EDCTP), and sponsored by Medicines for Malaria Venture (MMV) will be 
conducted in Gabon and Malawi. It will evaluate the efficacy of two intravenous artesunate 
dosing regimens in clearing Plasmodium falciparum parasites in children with severe malaria. 
The  trial  protocol  has  been  approved  by  the  ethics  committees  and  national  regulatory 
authorities in Malawi and Gabon. 

Severe  malaria  kills  more  than  one  million  African  children  each  year.  Antimalarial 
chemotherapy is the mainstay of treatment. In Africa, intravenous quinine is currently used to 
treat  children  with  severe  malaria  but  it  is  poorly  tolerated  and  has  several  side  effects.  In 
some south-east Asian countries, artemisinin-based treatments are already used in preference 
to quinine. Intravenous artesunate is now recommended by the World Health Organization for 
the  treatment  of  severe  malaria  in  adults  in  low  transmission  areas,  but  there  is  little 
information  on  its  efficacy  in  children  in  high  transmission  regions,  such  as  Africa.  

This phase II randomised, double-blind, dose-finding study of the efficacy, safety, tolerability 
and  pharmacokinetics  of  intravenous  artesunate  in  African  children  with  severe  malaria  has 
two main objectives: 

1. 

To  increase  the  body  of  evidence  for  the  use  of  this  drug  in  children  in  high 
transmission  areas  and  show  that  the  use  of  the  potentially  more  toxic  intravenous 
quinine can be avoided  

2. 

To simplify the dosing regimen of intravenous Artesunate from 5 to 3 injections. 

On occasion  of  the  start of  the trial, Prof. Charles Mgone, EDCTP Executive Director said: 
"The most rational and effective way to combat a serious problem such as malaria in Africa is 
to  combine  all  available  resources.  Working  in  collaboration  with  MMV,  EDCTP  is 
supporting this partnership of European and African scientists to find a safe, affordable and 
accessible treatment for malaria in children". “If we can show superior efficacy and/or safety 
and tolerability of the new artesunate regimen in African children, we are likely to see a major 
policy change in the treatment of severe malaria in African children,” said Dr. J Carl Craft, 
Chief  Scientific  officer  of  MMV.  “I.V.  artesunate  has  the  potential  to  save  countless  young 
lives.” 

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Press Release 

14 September 2007 

HIV/AIDS INFECTED CHILDREN CAN NOW BENEFIT FROM A EUROPEAN AND 
DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP (EDCTP) FUNDED 
TRIAL 

In August, the US Food and Drug Administration (FDA) gave a tentative approval to a fixed-
dose  anti-HIV  drug  specifically  formulated  for  paediatric  use.  The  fixed-dose  combination 
scored tablet of lamivudine 30mg, stavudine 6mg and nevirapine 50mg (Triomune Baby) and 
double  this  strength  (Triomune  Junior)  is  manufactured  by  CIPLA  pharmaceuticals.  It  is 
administered  twice  daily  according  to  a  simple  weight-based  table,  allowing  for  easy 
prescribing.  It  can  also  be  ‘snapped  in  half’  and  dissolved  in  water  for  young  children  who 
cannot swallow tablets. As a result of this tentative approval, this FDC antiretroviral drug will 
be included in the World Health Organization (WHO) Prequalification Programme  and  will 
become  available  for  distribution  under  the  Presidents  Emergency  Plan  for  AIDS  relief 
(PEPFAR)  and  Clinton  Foundation  programmes.  Triomune  Baby  and  Junior  have  already 
been  approved  in  Zambia  and  are  currently  being  used  to  treat  children  there.  The  research 
project leading to this development was financed by the European and Developing Countries 
Clinical Trials Partnership, EDCTP.  

Treatment of HIV/AIDS in children is a great challenge in resource-constrained settings. One 
of the reasons for this is the difficulty and cost of giving paediatric formulations, particularly 
syrups,  of  anti-HIV  drugs  to  children.  The  absence  of  appropriate  paediatric  formulations 
often necessitates administering divided adult tablets to HIV-infected children. This can lead 
to  incorrect  dosing,  especially  under-dosing,  and  increases  the  risk  of  rapid  development  of 
resistance  to  the  drugs.  The  problem  is  compounded  by  underlying  malnutrition  in  these 
children, and the lack of knowledge about how malnutrition affects drug levels in the body.  

The pharmacokinetic study undertaken by Professor Chintu and colleagues (Zambia), together 
with researchers in The Netherlands and UK, is part of a larger ongoing randomised trial that 
is evaluating the necessity of lead-in treatment for one of the anti-HIV drugs (nevirapine) in 
the  triple  combination  pill.  Data  generated  from  the  pharmacokinetic  (dosing)  study  were 
included in the submission for registration and contributed to the US FDA granting tentative 
approval for the registration of this drug for use in children. This will be the first FDC drug 
the  FDA.  
children 
specifically 

registered 

designed 

young 

for 

by 

be 

to 

Triomune Baby  and  Junior tablets  are  scored, crushable and  water soluble for children  who 
cannot  swallow  tablets.  The  fact  that  all  three  drugs  are  combined  in  one  tablet  (which  is 
layered to ensure equal distribution of drugs if snapped in half), and that tablets can be stored, 
distributed,  and  administered  easily  to  children  represents  a  significant  advance  in  HIV 
treatment  for  children  in  resource-limited  settings.  The  tentative  FDA  registration  paves  the 
way  for  the  drug  to  receive  WHO  prequalification  status.  Additionally,  it  will  allow 
programmes  such  as  PEPFAR  and  the  Clinton  Foundation,  which  make  antiretroviral  drugs 
available in many resource-constrained countries, to purchase the drug for widespread use in 
HIV-infected children. 

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Press Release 

19 October 2007 

ITM STARTS 4ABC TRIAL TO COMPARE FOUR NEW ANTIMALARIAL 
TREATMENTS FOR AFRICAN CHILDREN 

In collaboration with several African and European partner institutes, the Antwerp Institute of 
Tropical Medicine will coordinate a multicentre clinical trial to determine the safety and the 
efficacy  of  four  new  antimalarial  treatments,  so  called  Artemisinine-Based  Combination 
Therapies  (ACTs).  The  study,  called  4ABC,  will  be  carried  out  in  seven  African  countries 
(Burkina  Faso,  Gabon,  Mozambique,  Nigeria,  Rwanda,  Uganda  and  Zambia).  Financial 
support  comes  from  the  European  &  Developing  Countries  Clinical  Trial  Partnership 
(EDCTP)  and  the  Belgian,  British  and  German  governments.  Such  a  "head-to-head" 
comparison of ACT's has never been done before and is essential information to help malaria-
endemic countries choosing the most appropriate treatment.  

Every year between 1 to 2 million people, mainly African children, die of malaria. Following 
the spread of resistance of the malaria parasite to chloroquine and other common antimalarial 
drugs, childhood mortality in Africa has been increasing since the 1980’s.  

Artemisinin  derivatives  are  the  most  potent  antimalarials  available  today.  They  can  rapidly 
cure  malaria  but  their  action  is  short  and  therefore  a  combination  with  another  antimalarial 
drug with a longer persistence in the blood is necessary. The use of ACTs should also prevent 
or slow down the emergence of drug-resistant malaria parasites.  

Two of the tested ACTs have already been registered (Coartem, Coarsucam) while others are 
about  to  be  registered  (dihydroartemisin-piperaquine,  chlorproguanil-dapsone+artesunate). 
Previous clinical trials were relatively limited in scale and never tested all these treatments at 
the same time.  

The  trial  will  test  the  safety  and  efficacy  of  these  four  ACTs  in  under-five  children  with 
uncomplicated malaria. This age group is the most vulnerable population segment in African 
endemic countries.  

The data produced by the 4ABC trial will significantly contribute to the proper deployment of 
ACT and consequently to the improvement of health in many African countries. The first trial 
patients have been recently recruited in Mozambique, Burkina Faso and Uganda. Results are 
expected by the second half of 2008.  

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Press Release 

29 May 2008 

EDCTP APPROVES € 80 M OF FUNDING TO BOOST HIV/AIDS, TB AND 
MALARIA RESEARCH 

The  European  &  Developing  Countries  Clinical  Trials  Partnership  (EDCTP)  has  approved 
over  €  80  million  for  research  into  prevention  of  HIV/AIDS,  tuberculosis  and  malaria  in 
Africa.  This  sum  is  the  highest  amount  of  EDCTP  funding  approved  to  date.  The  approval 
marks an increase of European investment in research into the three poverty-related diseases 
and  is  expected  to  significantly  enhance  cooperation  between  European  and  African 
researchers. 

European Science and Research Commissioner Janez Potočnik underlined the integration of 
policies  achieved  by  the  partnership:  "This  decision  from  the  EDCTP  General  Assembly 
shows  the  commitment  of  the  participating  countries  and  the  European  Commission  in  the 
fight  against  the  three  main  poverty-related  diseases  in  and  for  Africa.  We're  confident  that 
our cooperation with African researchers will make a difference". 

Prof.  Charles  Mgone,  EDCTP’s  executive  director  presented  the  latest  developments  of  the 
initiative at the Geneva Health Forum on the 28th of May. He expressed the significance of the 
approval when he said: “This is a very significant milestone for collaboration between north 
and  south  in  the  fight  against  the  three  main  diseases  of  poverty  namely  HIV/AIDS, 
tuberculosis and malaria. It is also very gratifying to note that among the 26 projects approved 
for  funding  22  have  African  scientists  based  in  Africa  as  their  principal  investigators.  This 
underscores  EDCTP’s  objective  of  fostering  a  genuine  partnership  and  enhancing  clinical 
research capacity in Africa.” 

EDCTP is a partnership of 14 European Member States plus Norway, Switzerland and sub-
Saharan countries. The Partnership aims to reduce the global burden  of HIV/AIDS,  TB and 
malaria by pooling resources for conducting clinical trials in sub-Saharan Africa. The current 
approval of funding consists of a contribution from the European Commission of € 40 M, to 
be matched by European Member States and third parties. The projects involve 12 European 
countries  and  22  sub-Saharan  African  countries.  Funding  was  approved  in  the  following 
areas: 

•  Tuberculosis Vaccines 
•  Malaria Treatment 
•  Malaria in Pregnancy 
•  Malaria Vaccines 
•  Ethics review capacity 
•  WHO regulatory affairs 
•  Networks of Excellence 
•  Senior Fellowships 

Additional  funding  in  the  areas  of  HIV  treatment,  vaccines  and  microbicides,  TB  treatment 
and Networks of Excellence is expected to be approved in the second half of 2008. 

The  projects  on  TB  and  malaria  that  will  be  funded  combine  clinical  trials  with  capacity 
building  and  networking  activities.  By  integrating  these  activities  EDCTP  aims  to  enhance 
sustainability of conducting clinical trials on the African continent. Additionally, a number of 

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projects focus on creating and developing capacity for ethics review of clinical trials and of 
enhancing the regulatory framework needed for approval of medicines in Africa. This enables 
African countries to conduct high-quality and ethically sound clinical trials, and to assess the 
safety and efficacy of all medicines that enter the African market. 

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