EN    EN EN 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 30.10.2008 
SEC(2008) 2723 
  
COMMISSION STAFF WORKING DOCUMENT 
Progress Report on the European and Developi ng Countries Clinical Trials Partnership 
(EDCTP) 
 
{COM(2008)688} 
{SEC(2008)2724} 
EN 2   EN TABLE OF CONTENTS 
Executive Summary .............................................................................................................. ... 4 
I. Introduction................................................................................................................ 7 
A. Establishment of the EDCTP Programme ................................................................... 7 
B. Governance .................................................................................................................. 8 
1. EEIG General Assembly............................................................................................ 10 2. Executive Secretariat.................................................................................................. 10 3. Partnership Board....................................................................................................... 11 4. European Network of National Programmes ............................................................. 11 5. Developing Countries C oordinating Committee........................................................ 11 
6. High Representative................................................................................................... 12 
II. The early years: 2003-2006...................................................................................... 13 
A. Projects financed from 2003 to 2006 ......................................................................... 14 
III. EDCTP Independent External Review .................................................................. 20 
IV. A new start: 2007-2008 ............................................................................................ 21 
A. Follow-up of the Van Velzen report .......................................................................... 21 
B. Operations, calls and grants ....................................................................................... 22 
V. EDCTP funding / Member States co-funding overview....................................... 31 
VI. Key Performance Indicators ................................................................................... 39 
A. Synergy of research and development funding.......................................................... 46 
B. Third-party collaboration and funding....................................................................... 46 
VII. The EDCTP medium- and long-te rm strategy and activities .............................. 47 
VIII. EDCTP Forum ......................................................................................................... 48 IX. Recent press releases and publications .................................................................. 48 X. Commissioner Poto čnik's letter to the E DCTP Member States .......................... 49 
XI. 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 
EN 3   EN 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 artes unate for children with severe malaria ................... 59 
HIV/AIDS infected children can now benefit from a European and Developing Countries 
Clinical Trials Partnershi p (EDCTP) funded trial.................................................................... 60 
ITM starts 4ABC trial to compare four new anti malarial treatments for African children ..... 61 
EDCTP approves € 80 M of funding to boost HIV/AIDS, TB and malaria research.............. 62 
EN 4   EN EXECUTIVE SUMMARY  
The European and Developing Countries Clinical Tr ials Partnership (herei nafter referred to as 
"the EDCTP Programme") was established in 2003 by Decision of the European Parliament 
and of the Council1 by 14 Member States2 and Norway (Switzerland joined the EDCTP in 
2005). The objectives were to acc elerate the development of ne w clinical interventions to 
fight HIV/AIDS, malaria and tube rculosis in the developing c ountries, particularly in sub-
Saharan Africa, and to improve the quality of re search in relation to these diseases. Created 
under the umbrella of the Article 169 of the Treaty3, the EDCTP Programme aims at 
coordinating and jointly implementing activities at Member State level.  
EDCTP is managed through a General Assembly  where Member States are represented, a 
Secretariat under the Executive Director, and a High Representative. A dvisory bodies include 
the Partnership Board (the scie ntific advisory boar d), the Developing Count ries Coordinating 
Committee, and the European Network of National Programmes.  
The Community has made a contribution to  the EDCTP through a €200 million financial 
contribution under the 6th Framework Progr amme for Research and Technological 
Development (2002-2006) – FP6. The participat ing Member States provide 50% co-funding, 
both in cash and in kind, increasing the to tal EDCTP budget to €400 million. An additional 
€200 million funding from third parties is also envisaged.  
The EDCTP Programme had an initial implem enting phase (from 2003 to 2006) slower than 
initially foreseen. Over that period budget sp ending was abnormally low, calls for proposals 
were cancelled, and a 2004 report from the Eu ropean Court of Auditors (PF-1828 (6046)) 
revealed several deficiencies. During the same  period, the Secretariat was under four different 
Executive Directors, two of them being ad interim . As a consequence, in 2006 Commissioner 
Janez Poto čnik requested a panel of high level expert s to prepare an Independent External 
Review (IER) report on the European and Devel oping Countries Clinical  Trials Partnership, 
the so called van Velzen report, which was published in July 20074.  
The present progress report, published as a Co mmission Staff Working Document, is intended 
to inform on the achievements and current stat us of the first five years of the EDCTP 
Programme, from 2003 to 2008, following the reco mmendations of the Van Velzen report. 
The time elapsed since its publication in July 20 07 has allowed the implementation of most of 
its recommendations to the EDCTP Secret ariat, Member States and Commission.  
                                                 
1 DECISION No 1209/2003/EC of the European Parliament and of the Council of 16 June 2003 on 
Community participation in a research and development programme aimed at developing new clinical 
interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partnership between Europe and developing countries, undertaken by several Member States. OJCE Nº L 169/1 of 8.7.2003.  
2 Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, 
Portugal, Spain, Sweden, and the United Kingdom. 
3 Article 169: "In implementing the multiannual framework programme the Community may make 
provision, in agreement with the Member States  concerned, for participation in research and 
development programmes undertaken by several Member States, including participation in the structures created for the ex ecution of those programmes." 
4 Independent External Review Report: European and Developing Countries Clinical Trials Partnership 
(July 2007); also known as the Van Velzen Repo rt; see http://ec.europa.eu/ research/health/poverty-
diseases/doc/final_ier_report_12july2007_en.pdf 
EN 5   EN Since 2007, the EDCTP Secretariat has redefined its  scientific strategy,  through stakeholder's 
meetings held on the different diseases and products, increased colla boration with Public-
Private Partnerships, renewed calls for proposals, and simplified the co-funding.  
Participating Member States have created a General Assembly Steering Committee, renewed 
their commitment to the EDCTP, reinforced Af rican 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 Af rica including EDCTP, and sett ing pre-conditions for future 
Article 169 initiatives, such as the necessity  to ensure the pre-existence of national 
programmes and commitment to funding.  
On the operational side, from September 2003 to May 2008, the EDCTP Programme has 
launched 33 calls and financed about 145 projec ts. Among these, 32 are clinical trials; 55 are 
training (MSc, PhDs and post do ctoral) awards; 11 are suppor ting network activities; 14 are 
capacity building in ethics; 16 are Senior Fellowships; one project on strengthening the 
regulatory framework in Africa through co llaboration with WHO; and one for the 
establishment and maintenance of a clinical trials registry. The projects are based in 26 different countries in sub-Saharan Africa, i nvolving 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 Memb er States). In May 2008, and as partial 
outcome of these calls, the EDCTP General Assembly approved the financing of 8 new 
projects on malaria treatment, malaria vacci ne, malaria in pregnancy, and tuberculosis 
vaccine; 8 new projects on capacity building for African ethical committees; 3 trans-disease 
regional networks of excellence (E ast, 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 vaccine s. In 2008, the EDCTP expects to increase 
this figure to over € 279 million.  
However, since most projects are 3-year contracts,  and some of them are just starting, the total 
EDCTP expenditure on research grants has been so far of €15.7 million. Out of the total 
commitment, 63% is going to African resear chers. In 2007, 88% of the EDCTP budget was 
devoted to grants.  
Member States co-funding has increased from less than €1 million in 2005, to €6 million in 
2006, and up to €21 million in 2007. Data from  January to April 2008 already show €67 
million Member States' committed or pledged from Member States.  
Third party contribution contributed or committed from different foundations, product-
development public private partnerships and industries accounts so far for €34.1 million.  
In the almost five years si nce its creation, the EDCTP ha s achieved several important 
landmarks:  
EN 6   EN Enhanced coordination of research activ ities 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 estab lish national research budgets and to further 
contribute to the establis hment of an African Fund for Health Research 
EDCTP funding gives African re searchers more ownership, provides better fora for 
discussion and knowledge exchange 
Capacities and sites developed are fully owne d by the institutions and countries, avoiding 
scientific colonization 
Grantees have developed new research si tes by accessing funding from other sources 
EDCTP funding is instrumental in  the approval of some major h ealth policy changes, such as 
the development of HIV treatment for children. 
EN 7   EN I. I NTRODUCTION  
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, tec hnological development and de monstration activities (1998-
2002)5 led to the development of vaccines and dr ug 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 clini cal trials in Africa.  
At that time, Member States were undert aking individual research and development 
programmes or activities to a ddress HIV/AIDS, malaria and t uberculosis without sufficient 
coordination at European level to allow a cohe rent approach for a fu lly 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 competen t regulatory oversight was 
limited.  
A. Establishment of the EDCTP Programme 
The European and Developing  Countries Clinical Trials  Partnership (EDCTP) was 
established
7 in September 2003 by 15 European countries8 with the aim to develop capacity 
building for clinical trials and new clinical in terventions to address the needs of sub-Saharan 
Africa in the fields of HIV/AI DS, malaria and tuberculosis.  
Created under the umbrella of Article 169 of th e Treaty, the EDCTP aims at better integrating 
existing research from different European Me mber States in the field of poverty-related 
diseases. As such, one of the firs t EDCTP tasks was to identify thes e activities, so as to create 
a map of European research on HIV/ AIDS, malaria and tuberculosis.  
The EDCTP Programme was created to addr ess three main strategic objectives:  
1) Development of new inte rventions and products agains t poverty-related diseases. 
The fight against HIV/AIDS, malaria a nd tuberculosis needs both prophylactic 
(vaccine and microbicides) and therapeutic (drugs) tools to pr event infection and 
control disease progression.  
                                                 
5 Decision No 1513/2002/EC of the European Parliament and of the Council of 27 June 2002 
6 Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 
7 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  
8 Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, 
Portugal, Spain, Sweden, and the United Kingdom, plus Norway 
EN 8   EN 2) Sustainable capacity building in Africa. Public health and research activities in 
Africa should be sustainable, so local popul ations can better c ontrol the pandemic. 
The coordination of development aid polic y and research polic y should aim at a 
better implementation of these separate polic ies into a long term strategy against the 
three diseases.  
3) Coordination of European Member Stat es research policies. Although the research 
activities of some European Union Member States in Africa have been remarkable, 
these could profit from a better collabor ation and coordination. The coordination of 
European national research programmes a nd policies on poverty-related diseases for 
Africa, in line with Article 169 of the Treat y, will increase the efficacy of European 
interventions against these diseases.  
The EDCTP is mainly funded through a € 2 00 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 contribu te to this co-funding budget both in cash and 
in kind. Additional funding from Third Part ies (foundations, public-private partnerships, 
industry and other stakeholders) is envisaged for la ter clinical phases, esp ecially 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 in cludes details of calls for pr oposals and a wide variety of 
other information, is at http://www.edctp.org . 
B. Governance 
The EDCTP European Economic Interest Group (E DCTP-EEIG) is the legal form chosen for 
implementing the Programme and managi ng 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 indepe ndent expert panel that 
develops the strategic planning of the EDCTP  
– The Developing Countries C oordinating Committee (DCCC) , which consists 
of representative African scientists and ensures the input and commitment of the 
African countries and researchers  
                                                 
9 Independent External Review Report: European and Developing Countries Clinical Trials Partnership 
(July 2007); also known as the Van Velzen Repo rt; see http://ec.europa.eu/ research/health/poverty-
diseases/doc/final_ier_report_12july2007_en.pdf 
EN 9   EN – The European Network of Na tional Programmes (ENNP) , which consists of 
representatives of the European nationa l programmes and deve lops 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 repr esented in the General Assembly (GA), is at 
present (2007-2009) chaired by UK, and co-c haired by Denmark, France and Spain. The 
Assembly meets twice a year, although some decisions are ta ken by written procedure.  
Recently, and following the recommendations of the Van Velzen report, a Steering 
Committee comprising the GA Chairperson, the th ree Vice-Chairs and the Executive Director 
has been established to take decisions unde r the mandate of the General Assembly. The 
Steering Committee also has the High Representati ve and the Chairpersons of the Partnership 
Board, Developing Countries Coordinating Co mmittee and European Network of National 
Programmes as observers. 
The EDCTP Secretariat is based in The Hague (T he 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 (Sout h 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 Si rima (Burkina Faso); 
the Developing Countries Coordinating Committ ee, 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 ch arge of the North-North networking.  
EN 10   EN 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 visi ble, since a higher African re presentation has been sought in 
all EDCTP constituencies (General Asse mbly and Partnership structures).  
During the last year, the chairmanship of  both the Developing Countries Coordinating 
Committee and the Partnership Board have cha nged, 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, faci litates the interaction North-South, since all 
constituencies work closely w ith the EDCTP Secretariat, advi sing the Executive Director, and 
they all participate in the General Assembly meetings.  
1. EEIG General Assembly 
The General Assembly is the ultimate and ex clusive 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 fo r the actions of the EEIG. The principal 
responsibility of the Assembly is to ensure that all necessary activ ities are undertaken to 
achieve the statutory objectives of EDCTP, and that its resour ces are properly and efficiently 
managed. It has the final and excl usive decision power concerning: 
• General strategies and pl ans of action for EDCTP  
• Annual action plans, incl uding calls for proposals  
• Annual budgets and accounts  
• Appointment and dismissal of the Executive Di rector (ED), the Dir ector 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 initiativ es, achievements and results of EDCTP  
• The appointment of the advisory bodies (Partnership Board, Developing Countries 
Coordinating Committee, European Ne twork of National Programmes).  
2. Executive Secretariat 
The Executive Secretariat assures the day-to day activities of the EEIG, runs independent peer 
review systems, supports th e Partnership Board's policy development and networking, 
supports the work of the EEIG Assembly, Developing Countries Coordinating Committee 
(DCCC), and European networking; handles liais ons and negotiations with partners, oversees 
funded programmes, and maintains operat ional 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 participa tion 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.  
EN 11   EN 3. Partnership Board 
The Partnership Board (PB) is a scientifically independent panel of experts as full members 
with voting rights. The EEIG-A ssembly appoints its members, seeking a balance of African 
and European experts. 
The PB designs the strategic framework of th e EDCTP and advises the Assembly on technical 
and scientific matters relating to the EDCT P programme. The PB prepares proposals and 
recommendations to be submitted via the Secretar iat to the Assembly, specifically with regard 
to: 
• Strategic needs and priorities for new clinical  interventions, training and capacity building  
• Calls for project proposals a nd 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 a nd priority lists of projects. 
4. European Network of National Programmes 
The European Network of National Programme s (ENNP) is an adviso ry body to the EDCTP-
EEIG Assembly as well as to EDCTP's other c onstituencies 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 deve lops proposals to coordinate 
and join national activities and funding. Th ese representatives are called European 
Networking Officers (ENOs). 
The tasks of the ENNP can be divided into extern al and internal tasks. The external tasks are: 
• Analyse and compare national funding mechanisms  
• Identify gaps, overlaps and potential s ynergies between national programmes  
• Develop strategies and proposals for ha rmonisation 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 fundi ng for EDCTP-related activities  
• Network with each other and if possible ne twork the scientific communities in each 
country  
• Foster links between scientists fr om 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 Committ ee (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 re searchers. The DCCC provides input to the 
strategy of EDCTP by aggregatin g and transmitting advice from scientists of developing 
countries to the Partnership Board, the Secretariat and the Assembly. 
EN 12   EN The DCCC develops strategies and actions to improve coordination between its members, and 
with other partners participating in EDCT P, including governments and international 
organisations. Such actions can include: 
• Promoting the creation and networking of na tional 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 authorit ies and relevant Developing Co untries national programmes  
• Collecting opinions from and disseminating info rmation to Developing Countries scientists  
• Interacting with WHO and othe r regional organizations by mu tually 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 kno wn, credited and respect ed person for his/her 
public service record. The HR is committed a nd 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 th e EDCTP, particularly in Africa  
• Contribute to the EDCTP´s fund raising activities  
• Represent the EDCTP in th e above listed functions. 
The HR has no executive functions, and cannot fina ncially 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 re presentatives of the PB, ENNP and DCCC.  
EN 13   EN II. T HE EARLY YEARS : 2003-2006 
The EDCTP Programme is the first implementation of Article 169 ever. As such, it 
encountered difficulties in its in itial operational work, since new st ructures 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 Pr ogrammes, the very nature of the Article 169, 
is an ambitious task. Consequently, the ED CTP Programme had a sl ow starting phase.  
Since the establishment of the EDCTP Programme in Sept ember 2003 up to now, the EDCTP 
Secretariat had three different executive direct ors, 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 advi sory boards, Partnership Board, Developing 
Countries Coordinating Committee and, later in 2005, the European Network of National 
Programmes was a major achievement of the fi rst phase of the EDCT P Programme. Defining 
the roles of each of these was not an easy ta sk, and several conflicts arose between the 
Partnership Board (the scientific  advisory board) and the Gene ral Assembly, where scientists 
were also present.  
In 2004, a report from the European Court of Auditors expressed co ncern with the EDCTP 
Programme management. Many aspects of th e Programme were evaluated, and specific 
recommendations were put forward, concerning the evaluation procedure, administrative 
procedures, and co-funding. The repo rt pointed out that a co-fundi ng level of at least 50% was 
expected from participating Member States and further recommended that the Commission 
should limit its contribution to the EDCTP Pr ogramme to the same level attained by 
participating Member States (with a maxi mum Community contribution of € 200 million). 
The 2007-2010 Roadmap, agreed between the EDCTP and the Commission in 2006, indicates the relative Commission and Memb er States yearly contributions needed to meet the overall 
funding goal for the lifetime of the programme. 
In fact, before the report from the C ourt of Auditors (2003-2004), the only budgetary 
contribution to the EDCTP Programme came fr om the Community funding. The participating 
Member States contribution, th e so-called co-funding, was very low in the initial years of 
EDCTP, reaching significant le vels only during 2007. In the fo llowing years, this MS co-
funding still has to increa se further to match the Community contribution. 
The cancelling of the first two calls for proposals led to a cl ear budgetary anomaly. Although 
the grant agreement signed with the Eu ropean Commission specified a maximum 
management budget of 7.5% of the Community c ontribution, in the earl y years most of the 
EDCTP programme funding was dedicated to su staining the Secretaria t, with little funding 
going to research-related activities. However, it is notable that subsequently, - with the 
publication of new calls for proposals, the pr oportion of budget committed to management 
has decreased and is currently between 5 and 6%, while budget devoted to financing research 
projects has increased.  
EN 14   EN During this initial pe riod of the EDCTP, achieving the original goal of Article 169, the 
coordination of National Programme s, has been a difficult task for two main reasons. First, 
and most important, some participating Memb er 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 activiti es in the field had to achieve an internal 
coordination that required re-a djusting their national activities. Full co-ordination is a very 
ambitious goal that will ta ke 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 15   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 ma rkers to predict the 
outcome of anti-tuberculosis therapy. €973,033 N/A TBD South Africa
United Kingdom Second annual and financial reports were received and 
approved and payments made in January 2007. Third annual 
and financial report was recei ved in December 2007. Third 
payment was made in February 2008. 
  Gillespie Rapid Evaluation of Moxifloxacin 
in the treatment of sputum smear 
positive tuberculosis: REMoxTB. €3,157,240 N/A €8,750,000 South Africa, Tanzania, 
Zambia Revised clinical protocol wa s received and approved and a 
payment was made in June 2007. 
  Jindani A controlled clinical trial to 
evaluate high dose rifapentine and 
moxifloxacin in the treatment of pulmonary tuberculosis. €4,251,991 €273,143 
 €257,000 Mozambique, Zambia, 
Zimbabwe, South Africa Clinical protocol was approve d and payment made in June 
2007. 
  Merry Determining the optimal doses of 
antiretroviral and anti-tuberculous 
medications when used in 
combination for the treatment of HIV/TB in co infected patients. €1,026,952 N/A TBD South Africa
United Kingdom 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.  
Malaria D´Alessandro Evaluation of 4 artemisinin-based 
combinations for treating 
uncomplicated malaria in African 
children €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, Kenya, United 
Kingdom, Austria, Germany Clinical protocol was recei ved 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 of Simple 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 an nual technical and financial 
reports are now due in February 2008. 
 
EN 16   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 fo r the conduct of phase III trials of TB 
vaccines in children under 1 year of age  
– Capacity building and site development fo r 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 coordi nating office for ethics;  
– Support for Courses and Seminars on Ethics;  
– Support for the establishment and the st rengthening of African National Ethics 
Committees or Institutio nal Review Boards  
• Four Training Award calls:  
– MSc Studentships,  
– PhD scholarships,  
– Career development fellowships  
– Senior Fellowships. 
• Four Networking calls:  
– Providing incentives for joint capacity build ing 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 re search activities in Africa;  
– Support to national networking of Afri can scientists working on HIV/AIDS, 
Malaria and Tuberculosis in Africa 
 
EN 17   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 rifampicin and 
efavirenz. €907,052 €1,179,000 TBD Ethiopia, Tanzania, 
Sweden, Germany This grant was signed and the first payment was made in 
January 2007. The clinical protoc ol 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 deve lopment in babies and high-
risk populations. This grant was signed and the first payment made in June 2007.  
  Musoke 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 fr om two projects that were merged. The 
projects are on TB vaccine deve lopment in babies and high-
risk populations. The grant was signed and the first payment was made in August 2007.  
  Engers 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, Zambia, 
Madagascar, Denmark, Netherlands, Belgium This grant arose from two proj ects that were merged. The 
projects are on TB vaccine deve lopment in babies and high-
risk populations. This grant was signed and the first payment was made in August 2007. Clin ical protocol was received in 
December 2007.  
HIV Van de 
Wijgert Preparing for Phase II vaginal microbicide 
trials in Rwanda and Kenya: Preparedness 
studies, capacity building and 
strengthening of medical  referral systems. €2,000,000 €2,178,443 None Rw anda, 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. 
  Hayes Site preparation and capacity 
strengthening for trials of vaginal microbicides in Tanzania and Uganda. €2,435,071 €1,850,189 853,274 Tanzania, Uganda, 
Netherlands, United Kingdom This grant was signed and the first payment was made in 
May 2007.  
  McCormack Establishing HIV microbicides clinical 
trial capacity in Mozambique and 
expanding an existing site in South Africa. €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 paym ent was made in May 2007. 
 
 
EN 18   EN In 2006 the following calls were launched: 
• Two clinical trial calls:  
– Joint call with BMGF: Capacity build ing in preparation for the conduct of  preventive HIV vaccine trials  
– Support of studies for the Preven tion of Mother to Child Transm ission (PMTCT) of HIV, including prevention of transmission duri ng 
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 Back-up with AZT/3TC or single dose 
FTC/TDF in order to avoid NNRTI resistance after single dose NVP for 
PMTCT. €418,624 €745,232 €107,108 Tanzania, Denmark, 
Sweden This grant was signed and first payment made in 
October 2007.  
  Kisanga Improving the balance between efficacy 
and development of resistance in women 
receiving single dose nevirapine. €507,732 €999,803 TBD 
 Tanzania, Zambia, United 
Kingdom, Netherlands This grant was signed and first payment made in 
October 2007.  
  Newell Impact of HAART during pregnancy and 
breastfeeding on MTCT and Mothers 
Health: The Kesho Bora Study. €1,303,062 €1,408,316 TBD Kenya, South Africa, 
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. 
  Van de Perre A phase III double blind 
placebo/controlled trial of the efficacy 
and safety of infant periexposure 
prophylaxis with lamivudine to prevent HIV-1 transmission by breastfeeding 
(PROMISE-PEP trial). €2,000,000 €10,199,421 €600,000 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 contract negotiations due to 
recommendations to reduce budget and grantee concerns with contractual language. This grant was 
signed in March 2008. 
 
EN 19   EN Programme 
Area Grantee Project Title EC 
Funding Member 
State 
funding  Reported 
Third 
party 
funding African and 
European 
Collaborator 
Countries Update 
  Bekker Feasibility of an d capacity building for 
adolescent HIV vaccine trials in South Africa. €2,001,835 €1,048,000 €1,640 
 South Africa, Switzerland, 
France This grant was approved by the GA in June 2007. 
Prolonged contract negotiations due to recommendations to reduce budget. This grant was 
signed in December 2007.  
  Hanke Building Capacity of Infant HIV-1 
Vaccine CT centres in Nairobi, Kenya 
and the Gambia.  €2,269,648 €996,397 €188,000 
 Kenya, Gambia, United 
Kingdom, Sweden, Spain This grant was approved by the GA in June 2007. 
Prolonged contract negotiations due to 
recommendations to reduce budget and grantee concerns with contractual language. Signing expected in early 2008. 
  Kaleebu 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, Mozambique, 
Netherlands, United 
Kingdom This grant was approved by the GA in June 2007. 
Prolonged contract negotiations due to 
recommendations to reduce budget and grantee 
concerns with contractual language. This grant was signed and first payment was made in November 2007.  
  Kapiga Capacity devel opment and strengthening 
in preparation for HIV vaccine trials in 
Tanzania and Burkina Faso.  €1,797,798 €1,284,098 €47,869 Tanzania, Burkina Faso, 
United Kingdom, Italy, 
France This grant was approved by the GA in June 2007. 
Prolonged contract negotiations due to 
recommendations to reduce budget and grantee 
concerns with contractual language. This grant was signed in February 2008.  
  Weber African European HIV Vaccine 
Development Network. €2,281,445 €1,428,100 €2,800,000 South Africa, Tanzania, 
Mozambique, United 
Kingdom, Spain, 
Switzerland, Germany, Netherlands This grant was approved by the GA in June 2007. 
Prolonged contract negotiations due to 
recommendations to reduce budget and grantee 
concerns with contractual language. This grant was signed in February 2008. 
 
*Half of this budget was provided by the B ill and Melinda Gates Foundation, so it could be considered as Third Party Funding.  
** In addition to the BMGF budget.  
 
EN 20   EN III. EDCTP  INDEPENDENT EXTERNAL REVIEW  
As stated above, the EDCTP Programme had an initial implementi ng 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 Audito rs 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 reque st of Commissioner Janez Poto čnik, an Independent External 
Review (IER) was conducted between January a nd July 2007 to provide recommendations on 
how the EDCTP could better integrate Member States' national programmes and increase 
clinical trial and capac ity building activities through a stronger partnership with Africa. 
The review group was composed of: – Adetokunbo O. Lucas, former Director of W HO 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 Ma nager of GlaxoSmith Kline Biologicals 
– Fernand Sauer (Rapporteur), former Executi ve Director of the European Medicines 
Agency.  
The full IER report
10, also know as the Van Velzen report, is available at 
http://ec.europa.eu/research /health/poverty-diseases/doc/f inal_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 Anne x 1 to the present evaluation report. 
The present progress report, published as a Co mmission Staff Working Document, follows a 
recommendation from the Van Velzen report, where the Commission should report to the 
European Council and Parliament about the cu rrent status of the EDCTP Programme, in 
anticipation of the 2008 ev aluation (requested by the original  co-decision) due at the end of 
the first five years of the EDCTP.  
The time elapsed since its publi cation, in July 2007, has allowed the impl ementation of many 
of its recommendations to the EDCTP Secr etariat, Member States and Commission.  
                                                 
10 Independent External Review Report: Europ ean and Developing Countries Clinical Tr ials Partnership (July 2007), also named 
after the Chair of the expert group as the Van Velzen report; see http://ec.europa.eu/research/health/poverty-
diseases/doc/final_ier_report_12july2007_en.pdf  
 
EN 21   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 c ontracts. The 2007-2010 roadmap allowed a so-
called per-programme co-funding: from now on, individual contracts di d 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 fulfilmen t 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 mechan ism as well as a robust admini strative struct ure 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 fo llowed by the securing of African ownership, 
commitment and leadership with the goal of having a mutual partners hip and a sustainable 
programme.  
At first, the EDCTP Programme provided indivi dual grants for various activities such as for 
the conduct of clinical tria ls, the support of networks an d capacity building for personnel 
training and infrastructure improvements. Althou gh such grants were very useful for ensuring 
a wide distribution of EDCTP activities and enhancing the pr ofile and visibility of the 
partnership in Africa, they were extremely labour  intensive for a small secretariat. Currently, 
the EDCTP Programme is consol idating 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 u tilisation and 
sustainability of the developed capacity. Thes e activities are augmented by assisting the 
creation of an enabling envir onment through the establishmen t and support of an ethics 
review mechanism and regulatory framework. Many pr ojects 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 redefine d its scientific strategy, thr ough stakeholder's meetings on 
HIV/AIDS drugs, microbicides and vaccines, malaria drugs, vaccines and malaria in 
pregnancy, tuberculosis drugs and vaccines as well as Afri can networks of excellence. 
Moreover, the EDCTP has increased collaboration with Public-Private Pa rtnerships 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 represen ted. The GASC, where the EDCTP Executive 
Director is also present, take s decisions on behalf of the General Assembly on current issues, 
 
EN 22   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 EDCT P scientific and ethics evaluation.  
The Commission is joining efforts of its services  in relation to EDCTP,  working on a strategic 
research policy for Africa incl uding EDCTP, and setting pre-c onditions for future Article 169 
initiatives, as pre-ex istence of national programmes and funding. The EDCTP has contributed 
to the European Programme for Action "to co nfront HIV/AIDS, mala ria and tuberculosis 
through external action"
11 in close collaboration with DG DEV and AIDCO. Through EDCTP 
efforts, there is a continuous support for th e technical and politic al dialogue on human 
resources necessary for effective advocacy an d action in this Programme for Action. This 
includes support for research cap acity building and suppor t to explore the potential for use of 
information technology for training, capacity building and service delivery in health. In 
addition these actions give s upport to country preparedne ss and capacity building for 
adaptation and large scale intr oduction of new pharmaceutical products and commodities. The 
collaboration among these different DGs in sy nergy 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 ap proximately 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  Allocated funds  Launch Date  Deadline  
TB Vaccine  11,236,020  05 July 2007  05 November 2007  
Ethics  450,000  01 August 2007  05 November 2007  
Senior Fellowships  1,200,000  05 July 2007  12 November 2007  
Malaria Vaccine  14,405, 263  05 July 2007  19 November 2007  
Malaria Treatment  9,143,337  01 August 2007  26 November 2007  
Networks of Excellence  10,000,000  01 August 2007  03 December 2007  
Malaria in Pregnancy  9,143,337  01 August 2007  26 November 2007  
TB Treatment  14,286,674  22 November 2007  15 February 2008  
HIV Treatment  6,500,000  1 December 2007  01 April 2008  
HIV Microbicides  6,100,000  1 December 2007  01 May 2008  
HIV Vaccine  7,000,000  5 December 2007  30 May 2008  
Total  89,464,631      
 A total of 56 applications were received. Amo ng these, 27 projects have been approved and 
others are undergoing different stages of peer-reviewed evalua tion and approval. These latter 
include 5 on HIV treatment (of which 3 ha ve been recommended for funding); two on 
                                                
 
11 Doc.8689/05-COM(2005) 179 final 
 
EN 23   EN microbicides, still under evaluation, and 5 on HI V 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:  
 
EN 24   EN Support of clinical trials, capacity build ing 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, Uga nda, Burkina Faso, 
AMANET, EMVI Fostering research capacity, networking and 
project management thr ough 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 €6,338,582 €2,999,953 €3,338,629 - 
IP.07.31080.003  
F. ter Kuile Austria, Denmark, UK, BMGF, 
Zimbabwe, Burkina Faso, Ghana, 
Malawi, Mali, Mozam bique 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 €6,262,785 €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 
 
 
EN 25   EN Support of clinical trials, capacity build ing 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 la bel expansion studies 
with the fixed dose combinations artemether-
lumefantrine, amodia quine-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 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 - 
IP.07.32080.003 
G. Hussey Sweden, Spain, Switzerland, Belgium, 
Austria, Ireland. Netherlands, KNCV, 
Aeras, South Africa , Kenya, Uganda, 
Mozambique and the USA   €8,116,029 €3,174,142 €4,941,888   
 
 
EN 26   EN  
Call for Support of clinical trials, capacity buildin g 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 To be invited to submit full 
proposal 
IP.07.33112.001 
L. Lyamuya HIV vaccine trial capacity building in Tanzania and 
Mozambique by continued expl oration of optimal DNA and 
MVA boosting strategies; TaMoVac II €3,500,000 €3,500,000 - To be invited to submit full 
proposal 
IP.07.33112.004 
B Ensoli A Platform for AIDS Vaccine in Southern Africa (PAVSA) €3,500,000 €3,500,000 €500,000 To be invited to submit full 
proposal 
 
As of June 2008, the calls on HIV/AIDS re search are undergoing evalua tion and final decision by th e EDCTP General Assembly. 
 
EN 27   EN 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 Counc il for Science and 
Technology Strengthening the Na tional Scientific and Ethical Review 
System and Process in Uganda €49,140 €49,140 
CB.07.41302.008 – BRTI -  
Dr Peter Robert Mason 
Biomedical Research & Training Institute Establishing an Ethics Research Unit €49,273 €49,273 
CB.07.41302.012 – MOH Benin -  
Dr Roch Appolinaire Houngnihin 
Ministry of Health -Benin 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 Strengthening the National Ethi cs 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 
CB.07.41302.013 - RNEC -  
Dr Kayitesi Kayitenkore 
Rwandan National Ethics Committee Strengthening of the Na tional Ethics Committee €47,516 €47,516 
CB.07.41302.001 – WABTP -  
Prof. Dr Clement Adebamowo 
West African Bioethics Training Program (WAB) Strengthening the Na tional Health Research Ethics Committee €62,000 
(€12,000 will be secured from the West African 
Bioethics Training Programme). €50,000 
CB.07.41302.005 – TANHER -  
Dr Yohanna Mashalla 
Tanzania Health Re search Forum (TANHER-
Forum) Strengthening ethical standards and practices in  the protection 
of participants in health research in Tanzania €50,000 €50,000 
 
 
EN 28   EN 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 Hu man Immunodeficiency Virus 
Type 1 (HIV-1) infections and the relationship with 
established markers of disease progression – A 
longitudinal study in Rural Uganda €199,998 MRC/UVRI: €71,349 Approved for funding 
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 €194,269.68 MRC/UVRI: €23,800 Approved for funding 
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 €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 Mula go hospital, Kampala, Uganda €196,800 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 
TA.2007.40200.016 
Christian Happi Tientcha Nigeria, Cameroon Validation of New Biomarkers for Monitoring 
Plasmodium falciparum Reduced susceptibility /Tolerance 
or Resistance to Artemisi nin Derivatives and Partner 
Drugs in Nigeria €200,000   Standby project in case GMP 
investigational product is not 
available for Byakika-Kibwika  
TA.2007.40200.010 
Keertan Dheda South Africa  Human lung innate immune path ways regulating the stasis 
and killing of M. tuberculosis in a high burden setting. €199,870   Approved for funding 
TA.2007.40200.009 
Mark Patrick Nicol South Africa  The impact of rapid genotypic detection of multi-drug 
resistant tuberculosis on treat ment outcome in a semi-rural 
region of South Africa. €200,000   Approved for funding 
 
 
EN 29   EN  
Networks of Excellence: 
Project code and 
coordinator Requested from 
EC Requested from Member States Total 
requested Recommendation 
Eastern Africa          
IP.07.41700.001 Kaleebu €2,499,200 €3,223,348.7 
UK, Denmark, Switzerland, Norway and Netherlands €5,722,549 Approved for funding and 
encouraged to merge with Kibiki 
IP.07.41700.005 
Kibiki €2,499,970 Netherlands   €2,499,970 Encouraged to merge with 
Kaleebu 
Central Africa          
IP.07.41700.006 
Ntoumi €2,468,400 (100%) Germany  €2,468,400  Approved for funding 
West Africa          
IP.07.41700.007 
Mboup €2,499,920.5  €737,741.4 (23%) UK €3,237,662 Approved for funding 
Southern Africa          
IP.07.41700.003  
Walzl €2,500,000  €1,200,000 (32%) UK and Germany €3,700,000  Not approved for funding, but 
encouraged to merge and 
resubmit 
IP.07.41700.004 
Rustomjee €2,500,035.8 €54,364.2 Switzerland €2,554,400   
IP.07.41700.008 
Mulenga €2,499,970    €2,499,970   
 
 
EN 30   EN 
Graphical distribution of  African partnerships in EDCTP-funded projects
 
EN 31   EN V. EDCTP  FUNDING / MEMBER STATES CO -FUNDING OVERVIEW  
EDCTP receives its funding from both the Eur opean 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 hi gher than 50% contribu tion in the initial 
phases of the EDCTP Programme, but will force part icipating 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 contribu tion), 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 incl udes the 6.7m Euro which the participating 
Member States provided to the joint call on HI V capacity building that was equally co-funded by 
Member States, EDCTP EC funds  and funds from the BMGF. 
YEAR MS contribution Third party 
contribution EC funding to 
signed grants EDCTP expenditure 
until May 2008 
2003 0 0 0 211.059 
2004 0 0 45.000 3.150.553 
2005 824.546 0 8.276.000 4.304.858 
2006 5.774.373 2.107.718 14.680.000 8.401.962 
2007 20.833.809 1.807.653 21.921.000 13.040.518 
2008 67.286.956 
(committed until May) 30.179.604
(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 netw orks. With the 
exception of the 2007 calls, EDCT P has now completed contract negotiations and signing for all 
of these projects.  
Among these 145 projects, 32 are clinical trials on HIV/AIDS, malaria a nd tuberculosis; 55 are 
training awards (MSc, PhDs and post doctoral awards);  16 are Senior Fe llowships; 11 are for 
supporting networking activities; 14  are on capacity build ing in ethics; one on strengthening the 
 
EN 32   EN regulatory framework in Africa th rough 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 institu tions and 26 different countries in  sub-Saharan Africa (as shown 
in the accompanying graphic) and reflect the involve ment of practically a ll participating Member 
States.  
 
EN 33   EN Co-funding in relation to the Roadmap projections. The figures, expressed in thousands  of euros, compare the actual 
performance of EDCTP with respect to th e projections made in the EDCTP Roadmap 2007 to 2010. The first part of the table 
shows all participating MS activities (incl uding those not related to EDCTP, such as  basic and preclinical research) on HIV/AID S, 
malaria and tuberculosis. (Data from 2007 is still not available. ) The second half of the table shows the activities of MS dire ctly 
linked to EDCTP (clinical trials on the three diseases in sub- Saharan Africa where coordinati on 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)  46,386  51,239  57,108  89 ,421 82,674 80,876 75,645 483,351 
MS integrated 
activities (Up to 2007)  46,386  35,821 60,037  66,737        
                 
Roadmap estimate of 
MS funds committed 
to EDCTP initiatives  309  975  5,088  9,916  10,420  10,760  8,948  46,419  
MS Funds committed 
to EDCTP initiatives: 
(Actuals to 2007)  0  778  7,519  20,833,808 67,286,956*       
 
Funds committed specificall y to EDCTP activities as a proportion of 
all MS integrated activities
0102030405060708090
2004 2005 2006 2007 2008
YearPercentage
Actual Predicted
 
 
EN 34   EN *Includes cash till end of April actually received  and invoices to the Memb er State which will be 
received, plus additional committed MS funds to curre nt 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 additi onal 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 afte r closure of the call for propos als 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, al though this depends very much on the grantees’ 
response time, which is now the main limiting factor.  
It is encouraging that the par ticipating 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 particip ating Member States have allocated more of 
their national budget for the three poverty-rela ted diseases to EDCTP initiatives. The 
participating Member States are currently on cour se to exceed the levels  of co-funding of EDCTP 
activities anticipated in  the 2007-2010 Roadmap.  
It is anticipated that under the current EDCTP c ontract Member States will continue to set aside 
funding for the EDCTP Programme on an annual basis up to and incl uding 2010. This funding 
will continue to be used together with any re maining EDCTP funds to launch further strategic 
joint calls. In addition EDCTP has allocated €5 million to integrating existing initiatives from 
individual Member States nationa l programmes in order to devel op Joint Programme activities.  
Although the level of contri butions varies among par ticipating Member States and there is a need 
to encourage more participation from some of th em, the overall performance is very encouraging. 
Table 3 below shows year by year co-funding cont ributions of participating Member Sates on 
EDCTP projects whereas table 4 sh ows the overall Member State funding in diseas es of poverty 
(HIV/AIDS, malaria and tuberculosis) w ithin 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, t uberculosis and malaria. Moreover,  it must also be remembered 
that many participating Member States do not ev en have national programmes as such for these 
poverty-related diseases. Such nati onal programmes as they exis t are normally shared between 
the budgets of the Development Aid, H ealth, and Research ministries.  
To streamline its activities, the EDCTP Progr amme is working towa rds 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. Spai n on the other hand has a two-track system 
which provides a significant amount of funding through a comm on basket, alongside further 
funding of Spanish researchers in EDCTP projects  for which they require their own scientific 
 
EN 35   EN review. The remaining countries employ other m echanisms for funding EDCTP initiatives, some 
with and some without common re view of proposals and grant ad ministration through EDCTP.  
Although EDCTP Member State co-funding has dram atically 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 co ntribute € 104 million. Moreover, since most of the 
MS contributions are for their nationals participating in EDCT P-funded projects, the co-funding 
of African researchers is s till 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 strate gy of EDCTP and follow-up on the letter that was 
sent to them by the EC Research Commission er encouraging the renewal of member state 
political and financial commitment to EDCTP. EDCT P is taking this opport unity to also explore 
how they might develop a mechanism of instituti ng political representation of European Member 
states and their African partne rs at the General Assembly. 
 
EN 36   EN Member State co-funding of EDCTP activities. Indicates Member State co-funding already contribu ted or committed to signed project grants or to 
the common funding pot. It does not include  pledged money not yet committed to unsi gned or future projects. Until April 2008, p articipating MS have 
contributed €40 million to the EDCTP budget, and have committe d 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 
MEMBER STATE CASH DIRECT IN KIND CASH DIRECT IN  KIND CASH DIRECT IN KIND CASH DIRECT IN KIND CASH DIRECT IN KIND  GRAND 
TOTALS 
Austria 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 
Belgium 9,712 35,000 0 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 
Denmark 0 0 0 1,395 0 0 671 113,052 910,929 277 0 1,707,456 2,343 113,052 2,618,385 2,733,780 
France 0 0 0 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 
Germany 1,107 0 0 4,650 0 830,306 2,782 0 605,577 1,146 539,015 336,308 9,685 539,015 1,772,191 2,320,891 
Greece 0 0 0 2,325 0 1,766 0 0 919 1,625 0 0 3,950 0 2,685 6,635 
Ireland 1,395 0 0 1,395 2,650 2,650 551,292 0 3,866 754,540 0 0 1,308,622 2,650 6,516 1,317,788 
Italy 0 0 0 4,650 0 0 14,782 0 4,534 1,146 115,620 230,731 20,578 115,620 235,265 371,463 
Luxembourg 930 0 0 0 0 0 384 0 2,531 159 0 0 1,473 0 2,531 4,004 
Netherlands 0 0 0 186,487 0 725,178 1,181,883 0 990,538 651,509 0 1,192,629 2,019,879 0 2,908,345 4,928,224 
Norway 0 0 0 1,395 0 1,236 671 0 6,381 277 3,302,000 774,000 2,343 3,302,000 781,617 4,085,960 
Portugal 2,324 0 0 2,325 0 0 1,151 0 0 0 0 0 5,800 0 0 5,800 
Spain 0 0 0 1,034,077 33,000 810 1,078,362 476,308 178,288 1,078,363 0 314,421 3,190,802 509,308 493,519 4,193,629 
 
EN 37   EN COFUNDING OF EDCTP PROJECTS BY THE PARTICIPATING MEMBER STATES 
2005 2006 2007 2008/2009/2010 TOTALS FROM THE INCEPTION 
MEMBER STATE CASH DIRECT IN KIND CASH DIRECT IN  KIND CASH DIRECT IN KIND CASH DIRECT IN KIND CASH DIRECT IN KIND  GRAND 
TOTALS 
Sweden 1,860 0 0 1,090,738 0 3,410 2,702,318 0 225,069 37,204 0 1,174,510 3,832,120 0 1,402,989 5,235,109 
Switzerland 0 0 0 0 65,500 6,626 0 79,470 29,038 198,000 0 0 198,000 144,970 35,664 378,634 
United Kingdom 777,797 0 0 891,919 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 
Total (Euro) 795,125 35,000 0 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 ta ble summarises all 
European activities in the field, both related (clinical trials with ongoing coordination of MS National Research Programmes) o r not (basic and 
preclinical research) with the EDCTP. Exact figures up to 2007, but estimates from 2008.For 2003-2005 definitions of valid acti vities may have 
differed from one MS to another. Repor ting criteria were standardised in 2006. 
OVERALL CONTRIBUTIONS OF PARTICIPATIN G 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 38   EN OVERALL CONTRIBUTIONS OF PARTICIPATIN G 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 16,990,6 00 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 39   EN VI. K EY PERFORMANCE INDICATORS  
In early 2007, the EDCTP Secretariat agreed wi th 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 divi ded in four categories: Grants (grants signed, 
clinical trials, capacity building a nd time to contract), Partne rship (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 approve d projects that are under negotiation. 
 
EN 40   EN 2. Clinical trials approved 
 
Number of clinical trials a pproved 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 author ities (NRA's) included in EDCTP-WHO collaboration 
capacity strengthening activities 
• Ethics: number of projects for stre ngthening ethics framework activities 
*Cumulative data until end of May 2008 
 
EN 41   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 approve d projects are under negotiation. 
5. Number of African countries invol ved 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 42   EN 6. Number of African institutions in volved in EDCTP ongoing projects 
 
*Cumulative data until end of May 2008 in cluding signed and approved projects. 
7. Number of African project coordinators per disease 
 
Number of African Project Coordinators i nvolved 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 43   EN The table shows the number of approved clin ical 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 proj ects 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 44   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, sup port 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 45   EN 13. Overview of Member State, Third part y and EC funding commitment to 
EDCTP projects 
020000000400000006000000080000000100000000120000000
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 da ta include committed contribution to signed or approved 
projects until May 2008. 
Third party contribution : third party annual contribution to ED CTP signed projects, if known. 2008 da ta 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 46   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, ca lls for the collaborati on of Development and 
Research Agencies. From the research point of  view, it is not possibl e 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 Ag encies are getting involved in the EDCTP 
Programme, and the Directorates General for Development (DEV) and Aid and Cooperation 
(AIDCO) of the European Commission have al so contributed ca. € 14 million to capacity 
building and health-related activities in research  projects originally fi nanced 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 effort s to work with industry and like-minded 
organisations. Recent activ ities include exploring buy-ins and pa rticipation 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 Health care AG, Sanofi-Aventis, Seque lla Inc, IDT (Integrated 
DNA Technologies), the International AIDS V accine Initiative (IAVI),  the International 
Partnership for Microbicides (IPM), the Europ ean Malaria Vaccine Initiative (EMVI), the 
African Malaria Network (AMANET) and Archiv el Farma SL, to name some. Up to date, 
total Third-Party funding amounts about € 34 million.  
The EDCTP Programme is also supporting streng thening of National Re gulatory Authorities. 
One of the projects funded has an initial grant of 250,000 Euros to  the World Health 
Organisation (WHO) and co-funding from Th e Netherlands by the Netherlands-African 
Partnership for Capacity Development and Clin ical 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 str eamlining and harmonising the 
vaccine regulatory process in Africa. There ar e plans to use this platform and Article 58 
(authorisation of pharmaceutical  compounds for developing countries) of the European 
Medicines Agency (EMEA) to review and regist er in several African countries the malaria 
vaccine RTS,S being developed by GlaxoSm ithKline (GSK) and the Bill & Melinda Gates 
Foundation (BMGF). 
EDCTP plans to follow up these activities with  further funding as we ll as to map all ongoing 
capacity building activities on ethics  and competent authority activit ies. To meet this goal, the 
EDCTP General Assembly approved in May 2008 financing for 568,744 Euros to continue with this work and further e xpand the project to in clude monitoring of regulatory functioning 
and progress in Africa.  
 
EN 47   EN EDCTP’s endeavour to work with like minded-or ganisation has led to the launch of a joint 
call with the BMGF in December 2006. This ca ll 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 coll aborative efforts of 8 Member States.  
Among ongoing clinical trials, th ird-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. Contri butions to intravenous artesuna te 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-fu nd the current calls on 
malaria treatment and pregnancy associated mala ria. 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 exce llence call, and the US Center for Disease 
Control and Prevention (CDC) in po ssibly a new TB treatment call.  
VII. T
HE EDCTP  MEDIUM - AND LONG -TERM STRATEGY AND ACTIVITIES  
The EDCTP has been created a nd is owned by European Union Member States. These MS 
provide the funds to the EDCTP initiativ e both directly, through the 50% co-funding 
mechanism, or indirectly, through the Commu nity 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 initia tive, and make sure the EDCTP 
fits in their product development strategy, from ba sic research to advanced  clinical trials in 
and for developing countries.  
From its inception EDCTP had developed a st rategy described in the so-called Joint 
Programme of Activities (JPA) wh ich is annually revised to fo rm 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 Eur opean Commission to guid e 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, Europ ean 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 curr ent funding period. These will include working 
effectively with other players in all phases of clinical tria ls 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. Part ners that are currently working with EDCTP include the Bill & 
Belinda Gates Foundation and International AI DS Vaccine Initiative (joint call on HIV 
preventive vaccines), TB Alliance, Sanofi- Aventis, Bayer and Sequella (TB treatment), 
Malaria Medicines Venture (Treatment of seve re malaria in children). Additionally, several 
companies such as Bayer and Glaxo-Smith-K line are either supplying drugs for conducting 
clinical trials or act as clinical trials sponsors in various EDCTP funded studies.  
 
EN 48   EN VIII. EDCTP  FORUM  
Every year since the implementation of the ED CTP Programme, the Secretariat is organising 
the EDCTP Forum, a meeting of all EDCTP stak eholders, from the different Constituencies 
(General Assembly, Partnership Board, Deve loping 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 resear chers 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-re lated diseases.  
IX. R ECENT PRESS RELEASES AND PUBLICATIONS  
In the last few months of 2007 and early 20 08, several press releas es on success stories 
deriving from EDCTP-funded resear ch projects were released (s ee annex 3). This includes the 
start of a phase II trial of intravenous artesuna te for the treatment of children with severe 
malaria, the start of a clinical trial to comp are four new antimalarial treatments for African 
children, and the results of an ongo ing 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 Administratio n (FDA) gave a tentative approval to a fixed-dose anti-HIV 
drug specifically formulated for paedia tric use in developing countries.  
All EDCTP press releases are publ ished though the EDCTP website ( www.edctp.org ), as are 
all news, calls for proposals, results of eval uations, 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, part nership, 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 partnershi ps between Northern 
and Southern researchers are addressing questions  relevant to both. Fostering new models of 
science development and collaboration. Current  Opinion in HIV & AI DS. 3(4):521-525, July 
2008. Mgone, Charles ( http://www.co-hivandaids.com/ pt/re/cohiv/abstract.01222929-200807000-
00018.htm;jsessionid=LFhQHtKPh2 QLFnFZBbKRxLzjpmhtz1SzGqJwcTjS21DF3J3yjrFj!1
629792715!181195629!8091!-1 ). 
Collaborative approach to clinical trials (M ay 2008). Charles Mgone and Pascoal Mocumbi. 
Health Partnerships Review 2008 (G lobal Forum for Health Research) . 
Additional EDCTP-related articles are ava ilable from the following EDCTP webpage: 
http://www.edctp.org/Articles.253.0.html .  
 
EN 49   EN X. C OMMISSIONER POTOČNIK'S LETTER TO THE EDCTP  MEMBER STATES  
Following the publication of the Va n Velzen report, Commissioner Poto čnik wrote in 
September 2007 to the EDCTP Member States in forming 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 st rong support of the European Commission to the EDCTP, 
Commissioner Poto čnik 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 Commissione r also met in his office with Dr Diana 
Dunstan the EDCTP-EEIG Chairperson, Pr of. Charles Mgone, The EDCTP Executive 
Director, Dr Pascoal Mocumbi and Senior EC o fficials 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 IE R report, the creation of a joint platform DG 
DEV/DG RTD.  
XI. J
OINT DG  RESEARCH / DG  DEVELOPMENT PLATFORM  
Following the recommendation made in the Van Velzen report, DG Research and DG 
Development have accepted to establish a platfo rm to reinforce dialogue with EDCTP. After 
an exchange of letters between Commissioners Michel and Poto čnik 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 a nd DG Research participated in the Member 
States Experts meeting on HIV/AIDS, Mala ria and Tuberculosis (30-31 October 2007), 
hosted by DG Development, which dealt with pr eparations for monitoring and reporting on 
the EU Programme for Action on HIV/AIDS, malaria and incl uded 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 Res earch responsible for managing research on HIV/AIDS, 
malaria and tuberculosis regularly attends EDCT P stakeholder meetings for planning strategy 
and content of future EDCTP calls for propos als. In addition, the Commission services 
participate as observers in meetings of the EDCTP govern ance 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).  
 
EN 50   EN XII. H EALTH 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 ot her relevant policy discus sions in the field (e.g. 
European Parliament, WHO, OECD etc). For ex ample, the European parliament report on 
Major and Neglected Diseases in Developing Countries13, called for "the activities of EDCTP 
to be expanded to include othe r neglected diseases as well as other phases of clinical 
development". In formulating future calls for pr oposals under the Health  research theme 
(Cooperation Specific Programme) of the 7th Framework Programme such policy discussions 
will be taken closely into acc ount. The future financing of the EDCTP Programme will be 
considered in this wider EU policy context.  
XIII. I NVOLVEMENT OF AFRICAN GOVERNMENTS  
Extensive discussions between the Comm ission (DG Development) with African 
governments concerning national health strategi es capacity building and sustainability will 
continue in the context of the Programme for Ac tion: 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 th e EDCTP Programme are curren tly being strengthened to 
improve consultation with African governments.  The advocacy of the High Representative, 
Dr Pascoal Mocumbi, must be specia lly acknowledged in this regard.  
Furthermore, DG Research will work with EDCTP to ensure that EU delegations in African 
countries are properly informed about the ED CTP 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 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).  
13 2005/2047 (INI) 
14 COM(2004) 726 
 
EN 51   EN XIV. Other Article 169 initiatives 
One of the aims of the 2007 IE R 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. 1 69 initiatives identified in the FP7 specific 
programme adopted on 19 December 2006, be ing 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 "E uropean Metrology Research Programme" 
• EUROSTARS, joint research progra mme on "research-performing SMEs" 
Together with the discussions which took pl ace previously between  the Commission and 
representatives of the Member States, in pa rticular with CREST, a number of essential 
prerequisites have been drawn up by the Comm ission 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 ar e in process of establishing new frameworks 
for this area. This will form the basis for th eir participation in the AAL Joint Programme. 
EUROSTARS will integrate existing research  national Programmes supporting SMEs. 
Clear and irrevocable political commitme nts from MS to the Joint Programme:  For the 
AAL, Community support will be provided through annual fina ncing agreements; only MS 
providing upfront commitments will be eligible  for funding. For EUROSTARS, an agreement 
will be concluded with the Eureka Secretar iat for the whole duration of the Programme. 
Financial integration : For AAL and EUROSTARS, the Ro admap 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 proce dure 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 Pr ogrammes 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 structur e, responsible for the implementation of the 
Joint Programme. The AAL Association will make use of the Eureka Secretariat. 
Principles for protection of In tellectual Property Rights (IPR):  The AAL and the 
European Joint Programmes will entail clear pr inciples on IPR in the agreements to be 
concluded with the AAL associati on and the EUROSTARS Secretariat. 
 
EN 52   EN Annexes  
Annex 1: Independent External Revi ew of EDCTP - Key Recommendations 
1. To the EDCTP: 1.1. Define a clear, convincing and realisti c EDCTP strategy with a common shared 
vision, clearly defined contributions from  each partner and equitable sharing of 
results. 
1.2. Make the General Assembly more polit ical and create an Executive Steering 
Committee. 
1.3. Expand association with major Product Deve lopment 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. 
1.4. 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. 
1.5. 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. Interested Member States should rene w their “EDCTP vows”  in Council; accept 
reforms to EEIG structures, and directly  finance an EDCTP “common funding pot”. 
2.2. In the General Assembly, the decision maki ng should be restricted  to Member States 
who provide financial contributions with representation at the highest appropriate 
national level and to African representati on; other member would become observers, 
starting in 2008. 
2.3. The African presence in the General Asse mbly should be reinforced, with decision-
making status for representatives from Af rican countries or regional organisations. 
2.4. Member States should refrain from imposing national criteria, and accept one 
integrated scientific and ethical evalua tion conducted by EDCTP, utilising a pool of 
the best national experts.  
2.5. Member States should enforce the Article  169 concepts in their own countries on a 
sustainable basis, involving national pa rliaments when required, and report back 
annually to the EDCTP and the Comm ission on progress in implementation. 
 
EN 53   EN 3. To the European Commission, in relation to future EDCTP activities: 
3.1. Report to the Council and Parliament about the current status, in anticipation of the 
2008 review. 
3.2. Create a joint DG Research / DG Development platform to engage in a dialogue with 
the EDCTP. 
3.3. Reformulate health research strategy before any new decision to finance EDCTP 
from FP7, in particular on the three diseases. 
3.4. Consult African Government s on EDCTP future and intern ational health research 
under FP7. 
3.5. Involve African Governments at an early stage to link capacity  strengthening to 
national strategies, in order to ensure sustainability. 
3.6. Submit a new funding proposal to the Counc il and Parliament, before FP 7 mid-term 
review, provided that: 
• Interested Members States political/ budgetary/administrative commitments are 
clear. 
• The EDCTP programme integrates the re levant 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. For an Article 169 Programme to become and remain successful there must be pre-
existing national programmes, strong comm itment by Member States to provide 
funding and irreversible  national support. 
4.3. Before EU money becomes available, there must be: common work-plan; sound 
governance structure; fixed na tional financial contributions ; clear evaluation criteria 
and procedures; clear deliverables; solutions for the liability issue. 
 
EN 54   EN Annex 2: Members of the diffe rent EDCTP constituencies 
Representatives of the 16 ED CTP participating countries in the General Assembly: 
Chair  Dr Diana Dunstan (Chairperson)  
Medical Research Council UK 
Austria Dr Christiane Druml  
Ethics Committee of the Medical Univers ity of Vienna and the Vienna General 
Hospital 
Belgium Prof. Bruno Gryseels  
Director, Institute for Tropical Medicine 
Denmark Dr Søren Jepsen (Vice-chairperson)  
State Serum Institute 
France Prof. Patrice Debre (Vice-chairperson)  
Hôpital Pitié Salpêtrière 
Germany Dr Gabriele Hausdorf  
Bundesministerium für Bildung und Forsching (BMBF) 
Greece Prof. Antonis Antoniadis  
School of Medicine, Aristotle University of Thessaloniki 
Ireland Dr Teresa Maguire  
Health Research Board 
Italy Prof. Stefano Vella  
Istituto Superiore di Sanità 
Netherlands Dr Edvard Beem  
ZonMw 
Norway Dr Bjørn Guldvog  
Norwergian Directorate for Health and Social Affairs 
Luxembourg Carlo Duprel 
Fonds National de la Recherche 
Portugal Ana Maria Faisca  
Ministry of Science, Technology and Higher Education 
Spain Dr Carmen Audera Lopes (Vice-chairperson)  
Director, Oficina de Proyectos Europe us, Instituto de Salud Carlos III 
Sweden Dr Hannah Akuffo  
Swedish International Development Agency (SIDA) 
Switzerland Isabella Beretta  
State Secretariat for Education and Research 
United 
Kingdom 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) 
 
 
EN 55   EN EDCTP Secretariat 
1. The Hague Office: 
Prof. Charles Mgone  
Executive Director 
Simon Belcher  
Director of Finan ce 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  
 
 
EN 56   EN 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  
Swiss Tropical Instit ute, Switzerland 
Industry Prof. Juhani Eskola  
National Public Health Institute (KTL), Finland 
HIV/AIDS Dr Shabbar Jaffar  
London School of Hygiene and Tr opical Medicine, United Kingdom 
Malaria Prof. Peter Kremsner  
University of Tuebingen, Germany 
HIV/AIDS Dr Rosemary Musonda  
Botswana Harvard School of  Public Health, Botswana 
TB Prof. Joseph Odihiambo  
Kenya Medical Research Institute, Kenya 
HIV/AIDS Prof. Eric Sandström (Vice-chairperson)  
Karolinska University Hospital, Sweden 
Malaria 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 Dr Brigitte Bloechl-Daum  
Medical University of Vienna 
Belgium Dr Dirk van der Roost (Vice-chairperson)  
Institute for Tropical Medicine 
Denmark Klaus Winkel  
Statens Serum Institut 
France Dr Bernadette Murgue  
Institut de Recherche pour le Développement 
Germany Dr Claudia Herok (Vice-Chairperson)  
Bundesministerium für Bildung und Forschung 
 
EN 57   EN Greece Dr Anna Papa Konidari  
Aristotle University of Thessaloniki 
Ireland Dr Teresa Maguire (acting member) 
St James' Hospital 
Italy Dr Giovanni Guidotti  
National Institute of Health 
Luxembourg Dr Carlo Duprel  
Fonds National de la Recherche 
Netherlands Dr Judith de Kroon  
NACCAP 
Norway Kårstein Måseide  
The Research Council of Norway 
Portugal Prof. Laura Brum (Chairperson)  
Instituto Nacional de Saúde Dr Ricardo Jorge 
Spain Dr Rafael de Andrés Medina  
Instituto de Salud Carlos III 
Sweden Prof. Olle Stendahl  
Linköping University 
Switzerland Isabella Beretta  
State Secretariat for Education and Research 
United Kingdom Dr Claire Newland  
Medical Research Council 
Members of the Developing Count ries Coordinating Committee: 
Malaria Dr Andrew Kitua (Chairperson)  
National Institute for Medical Research (NIMR), Tanzania 
Malaria Dr Christine Manyando (Vice-chair)  
Tropical Diseases Research Centre, Zambia 
TB Dr Veronique Nintchom Penlap (Vice-chair)  
University of Yaounde, Cameroon 
HIV Dr Simon Agwale  
Innovative Biotech Limited, Nigeria 
Malaria Dr Herman Awono Ambene  
OCEAC, Cameroon 
TB/HIV Dr Tumani Corrah  
MRC Laboratories, The Gambia 
HIV Dr Walter Jaoko  
University of Nairobi, Kenya 
TB Dr Hulda Swai  
Council of Scientific Indust rial Research, South Africa 
Malaria Prof. Alioune Dieye  
Institut Pasteur de Dakar, Senegal 
TB Prof. Mecky Isaac Matee  
Muhimbili University College of Health Science, Tanzania 
HIV Prof. Nkandu P Luo  
 
EN 58   EN 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   
 
EN 59   EN 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 arte sunate will begin recrui tment of patients in 
September. The €5.3 M trial, funded by the Eur opean 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 th e ethics committees a nd 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 Af rica, intravenous quinine is currently used to 
treat children with severe malaria but it is poo rly tolerated and has seve ral side effects. In 
some south-east Asian countries, artemisinin-base d treatments are alread y used in preference 
to quinine. Intravenous artesunate is now r ecommended 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-findi ng 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 potential ly more toxic intravenous 
quinine can be avoided  
2. To simplify the dosing regimen of intrave nous 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. Work ing in collaboration with MMV, EDCTP is 
supporting this partnership of European and Afri can 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 malari a in African children,” said Dr. J Carl Craft, 
Chief Scientific officer of MMV. “I.V. artesuna te has the potential to save countless young 
lives.” 
 
EN 60   EN 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 tentativ e 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 manu factured by CIPLA pharmaceuticals. It is 
administered twice daily according to a simp le 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 te ntative approval, this FD C antiretroviral drug will 
be included in the World Health Organizati on (WHO) Prequalification Programme and will 
become available for distribution under the Pr esidents 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 fina nced by the European a nd Developing Countries 
Clinical Trials Partnership, EDCTP .  
 Treatment of HIV/AIDS in children is a great challenge in resource-c onstrained settings. One 
of the reasons for this is the difficulty and cost  of giving paediatric fo rmulations, particularly 
syrups, of anti-HIV drugs to ch ildren. The absence of appropria te paediatric formulations 
often necessitates administering divided adult tabl ets 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 Professo r 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 specifically designed for young children to be registered by the FDA.   Triomune Baby and Junior tablets are scored, crushable and water soluble for children who 
cannot swallow tablets. The fact that all three drugs are combin ed in one tablet (which is 
layered to ensure equal distributi on of drugs if snapped in half), and that tablets can be stored, 
distributed, and administered easily to childre n 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 prequalifi cation status. Additionally, it will allow 
programmes such as PEPFAR and the Clinton Foundation, which make antiretroviral drugs 
available in many resource-cons trained countries, to purchase the drug for widespread use in 
HIV-infected children.   
 
EN 61   EN Press Release  19 October 2007 
ITM  STARTS 4ABC  TRIAL TO COMPARE FOUR NEW ANTIMALARIAL 
TREATMENTS FOR AFRICAN CHILDREN  
In collaboration with several African and Europe an partner institutes, the Antwerp Institute of 
Tropical Medicine will coordinate  a multicentre clinical trial to determine the safety and the 
efficacy of four new antimalar ial treatments, so called Arte misinine-Based Combination 
Therapies (ACTs). The study, called 4ABC, will be  carried out in seve n African countries 
(Burkina Faso, Gabon, Mozambique, Nigeria, Rwanda, Uganda and Zambia). Financial 
support comes from the European & Developi ng 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 inform ation to help malaria-
endemic countries choosing the most appropriate treatment.  
Every year between 1 to 2 million people, main ly African children, die of malaria. Following 
the spread of resistan ce of the malaria parasite to chlo roquine and other common antimalarial 
drugs, childhood mortality in Africa ha s 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 ther efore 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 dr ug-resistant malaria parasites.  
Two of the tested ACTs have already been re gistered (Coartem, Coarsucam) while others are 
about to be registered (dihydroartemisin-pip eraquine, chlorproguani l-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 th e most vulnerable population segment in African 
endemic countries.  
The data produced by the 4ABC trial will signif icantly contribute to th e proper deployment of 
ACT and consequently to the improvement of h ealth in many African countries. The first trial 
patients have been recently recruited in Mo zambique, Burkina Faso and Uganda. Results are 
expected by the second half of 2008.  
 
EN 62   EN 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 re search into the three poverty-related diseases 
and is expected to significantly enhance cooperation between European and African researchers. 
European Science and Research Commissioner Janez Poto čnik underlined the integration of 
policies achieved by the partne rship: "This decision from the EDCTP General Assembly 
shows the commitment of the participating c ountries and the European Commission in the 
fight against the three main pove rty-related diseases in and fo r Africa. We're confident that 
our cooperation with African resear chers 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 28
th 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 ma in diseases of poverty namely HIV/AIDS, 
tuberculosis and malaria. It is also very gratif ying to note that among the 26 projects approved 
for funding 22 have African scient ists based in Africa as their principal investigators. This 
underscores EDCTP’s objective of fostering a ge nuine partnership and enhancing clinical 
research capacity in Africa.”  
EDCTP is a partnership of 14 European Memb er 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 countri es. 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 th e second half of 2008. 
The projects on TB and malaria that will be funded combine clinical trials with capacity 
building and networking activities. By integr ating these activities EDCTP aims to enhance 
sustainability of conducting clinical trials on th e African continent. A dditionally, a number of 
 
EN 63   EN projects focus on creating and developing capacity fo r ethics review of clinical trials and of 
enhancing the regulatory framework needed for a pproval 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 medicine s that enter the African market.