Communication from the Commission to the European Parliament and the Council on the progress report on the ‘european and developing countries clinical trials partnership’ programme {SEC(2008)2723} {SEC(2008)2724}
Date: 2008-10-30
Institutions: European Commission
Subjects: code of conduct, developing countries, experiment on humans, medicinal product

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 30.10.2008 
COM(2008) 688 final 

Communication from the Commission to the European Parliament and the Council 

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

{SEC(2008)2723} 
{SEC(2008)2724} 

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Communication from the Commission to the European Parliament and the Council 

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

BACKGROUND 

The European Commission communication of September 2000 Accelerated Action targeted at 
major  communicable  diseases  within  the  context  of  poverty  reduction1  set  out  a  broad  and 
coherent Community response, for the period 2001-2006, to the global emergency caused by 
the  three  major  infectious  diseases  that  affect  the  world’s  poorest  populations,  undermining 
global health: HIV/AIDS, malaria and tuberculosis. 
In the same spirit, the Millennium Development Goals (MDGs) developed out of the United 
Nations’ Millennium Declaration2 that same month (September 2000) aim at halving extreme 
poverty, halting the spread of HIV/AIDS, and providing universal primary education by 2015. 
Goal Number 6 aims at combating HIV/AIDS, malaria and other diseases with two specific 
targets: Target 7, to have halted and begun to reverse the spread of HIV/AIDS by 2015; and 
Target  8,  to  have  halted  and  begun  to  reverse  the  incidence  of  malaria  and  other  major 
diseases  by  2015  (tuberculosis,  which  kills  some  2  million  people  a  year,  being  the  third 
major poverty-related disease).  
The Commission communication to the Council and the European Parliament Programme for 
action: Accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty 
reduction3, presented in February 2001 and updated in 20054, set out the specific mechanisms 
of  the  EU’s  response  to  this  global  emergency,  which  include  strengthening  and  increasing 
support for research and development, capacity building in developing countries, and creating 
incentives for the development of specific global public goods. Among these, the creation of a 
European  Clinical  Trials  Platform  [later  renamed  the  European  and  Developing  Countries 
Clinical  Trials  Partnership]  designed  to  remove  important  scientific,  technological  and 
operational hurdles to product development in developing countries. 

The European and Developing Countries Clinical Trials Partnership (hereinafter referred to as 
"the EDCTP Programme") was established in September 2003 by Decision of the European 
Parliament and of the Council5,6 to accelerate the development of new clinical interventions to 
fight  HIV/AIDS,  malaria  and  tuberculosis  in  the  developing  countries,  particularly  in  sub-
Saharan Africa, and to improve generally the quality of research in relation to these diseases. 
Created  as  the  first  application  ever  of  Article  169  of  the  Treaty7,  the  EDCTP  Programme 

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COM(2000) 585 of 20.9.2000. 
United Nations General Assembly Resolution 55/2 (8 September 2000). 
COM(2001) 96 final. 
COM(2005) 179 final. 
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 (OJ L 169, 8.7.2003). 
The founder members of the EDCTP were Austria, Belgium, Denmark, France, Germany, Greece, 
Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, the United Kingdom, and 
Norway. Switzerland joined in 2005. 
Article 169 states: ‘In implementing the multiannual framework programme the Community may make 
provision, in agreement with the Member States concerned, for participation in research and 
development programmes undertaken by several Member States, including participation in the 
structures created for the execution of those programmes.’. 

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aims  at  coordinating  and  jointly  implementing  activities  run  by  the  Member  States  in 
partnership with developing countries.  

RATIONALE 

This  Communication  follows  a  recommendation  in  the  Independent  External  Review  (IER) 
report8, also known as the Van Velzen report, that the Commission should inform the Council 
and the European Parliament about the current status of the EDCTP Programme, in advance 
of the 2008 evaluation (required by the original EDCTP Decision) due at the end of the first 
five years of the EDCTP.  

THE NATURE OF THE CHALLENGE  

The  three  main  poverty-related  diseases,  HIV/AIDS,  malaria  and  tuberculosis  kill  about  six 
million  people  a  year,  mostly  in  sub-Saharan  Africa.  The  lack  of  adequate  preventive  and 
therapeutic tools results in an increased prevalence year after year.  

In  addition,  the  most  vulnerable  populations  lack  the  capacity  to  fight  against  these  three 
infections.  Research  on  these  diseases  is  particularly  difficult,  due  to  a  lack  of  trained 
personnel  and  of  infrastructure,  especially  in  sub-Saharan  Africa.  Without  such  capacity, 
researchers  cannot  properly  contribute  to  fighting  these  diseases  and  support  the  local 
population.  

While  many  European  countries  do  have  relevant  research  programmes  for  sub-Saharan 
Africa  on  the  three  diseases,  they  do  so  in  bilateral  North-South  collaborations,  and  lack 
proper  coordination  with  other  European  partners.  This  fragmentation  hampers  the 
development  of  an  appropriate  approach  to  helping  African  researchers  and  populations  to 
combat these diseases.  

Finally,  European  research  activities  in  sub-Saharan  Africa  are  conducted  with  no  clear 
synergy with development aid and cooperation programmes, which invest considerable funds 
in public health capacity.  

OBJECTIVES 

The  EDCTP  Programme  was  created  to  tackle  these  challenges  and,  ultimately,  to  help 
alleviate poverty in Africa. The strategic objectives of EU intervention were to:  

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

(2) Build sustainable public health and research capacity in Africa, so local populations can 
better control the pandemic. The coordination of development aid policy and research policy 

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Independent External Review Report: European and Developing Countries Clinical  Trials 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. 

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should  aim  at  a  better  implementation  of  these  separate  policies  into  a  long  term  strategy 
against the three diseases.  

(3)  Coordinate  European  Member  States’  research  policies.  While  the  research  activities  of 
some European Union Member States in Africa have been remarkable, they could profit from 
better  collaboration  and  coordination.  Coordinating  European  national  research  programmes 
and policies on poverty-related diseases for Africa in line with Article 169 of the Treaty will 
increase the impact of European interventions against these diseases.  

THE EARLY YEARS: THE EDCTP 2003–2006 

The  European  and  Developing  Countries  Clinical  Trials  Partnership  was  created  as  an 
independent  organisation  under  the  legal  form  of  a  European  Economic  Interest  Group 
(EEIG), based in The Hague, The Netherlands.  

The EDCTP Programme is financed with €200 million from the Sixth Framework Programme 
for Research and Development (2002-2006)9 – (FP6). Moreover, participating Member States 
are  co-funding  the  Programme  with  another  €200  million.  In  addition,  the  original  EDCTP 
Decision  provided  for  the  possibility  of  attracting  the  private  sector  and  mobilising  €200 
million  more  from  other  stakeholders,  including  industry,  foundations,  public-private 
partnerships and other like-minded organisations.  

The EDCTP initiative is unique in many ways. Firstly, it is the first use of Article 169, under 
which  European  Member  States  agree  to  coordinate  their  national  research  programmes. 
Secondly,  it  addresses  poverty-related  diseases  in  sub-Saharan  Africa,  where  lack  of  local 
capacity is an integral part of the problem. And thirdly, it involves Member State co-funding 
from  both  development  aid  and  research  agencies,  precisely  to  tackle  the  capacity-building 
and public health aspects of this research.  

Because  of  this  unique  combination  of  challenges,  the  EDCTP  Programme  had  a  very 
difficult initial period. In the first  three years performance  was lower than expected,  budget 
spending was abnormally low, calls for proposals were cancelled, and a 2004 report from the 
European Court of Auditors (PF-1828 (6046)) revealed some shortcomings. In addition, from 
2003 to 2006, the EDCTP was managed by four different Executive Directors (two of them 
ad interim).  

In  order  to  perform  a  full  analysis  of  the  Programme,  in  December  2006  the  Commission 
requested  an  Independent  Expert  Review  of  the  EDCTP,  which  resulted  in  the  Van  Velzen 
report8, delivered in July 2007. 

FOLLOW-UP OF THE VAN VELZEN REPORT (EDCTP ACTIVITIES 2007-2008) 

The Independent Expert Review report presented in July 2007 provided recommendations: (1) 
to  the  EDCTP  Secretariat;  (2)  to  the  participating  Member  States;  (3)  to  the  European 
Commission,  on  future  EDCTP  activities;  and  (4)  to  the  European  Commission,  on  new 
Article  169  initiatives.  The  full  text  of  the  recommendations  is  attached  as  Annex  1  to  the 
Progress Report. 

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Decision No 1513/2002/EC of the European Parliament and of the Council of 27 June 2002. 

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1. Recommendations to the EDCTP 

Since early 2007, and following the recommendations in the Van Velzen report, the EDCTP 
has redefined its scientific strategy (recommendation 1.1), through stakeholders’ meetings on 
HIV/AIDS  drugs,  microbicides  and  vaccines,  malaria  drugs,  vaccines  and  malaria  in 
pregnancy, tuberculosis drugs and vaccines, and African networks of excellence.  

Participating Member States have set up an executive Steering Committee (1.2), in which the 
Chair  and  Co-chairs  of  the  General  Assembly  and  the  EDCTP  Executive  Director  are 
represented.  The  General  Assembly  Steering  Committee  takes  decisions  on  behalf  of  the 
General Assembly on current issues, such as approval of projects to be funded.  

Moreover, the EDCTP has introduced collaboration with public-private partnerships such as 
the  Medicines  for  Malaria  Venture  and  the  Global  TB  Alliance,  which  are  increasingly 
involved in funded projects (1.3).  

The EDCTP has also published new calls for proposals (1.4) as a direct result of the different 
stakeholders’  meetings.  In  2007,  11  calls  were  published,  totalling  approximately  €180 
million  (€90  million  from  the  Commission  and  €90  million  in  co-funding  from  EDCTP 
participating countries).  

Finally,  the  EDCTP  has  also  simplified  the  co-funding  procedure  (1.5)  to  allow  increased 
participation  by  African  researchers  as  Principal  Investigators  in  EDCTP-funded  projects. 
However,  the  creation  of  a  true  common  pot  of  national  funds  is  a  long-term  goal  that  has 
only just started to be implemented by EDCTP and other joint programming initiatives under 
the Sixth Framework Programme (FP6). 

2. Recommendations to the EDCTP Member States  

At the Commission’s request10, the EDCTP Member States have renewed their commitment 
to the Programme (2.1), both politically, indicating their ongoing support for the Programme, 
and — in some cases — financially, with specific funding contributions. A common funding 
pot of national development aid agency funds from some Member States is now in place. The 
common  pot  for  research  financing  has  proven  more  difficult,  since  many  countries  claim 
they cannot finance foreign researchers.  

Representation in the General Assembly of the chairs of all EDCTP committees has boosted 
African  participation  (2.2).  In  addition,  the  Developing  Countries  Coordinating  Committee 
has new African regional representatives. On the other hand, since all Member States provide 
funding,  however  small  it  may  be,  restricting  the  decision  making  to  ‘Member  States  that 
provide financial contributions’, as recommended in the report, is not relevant.  

Recommendation  2.3,  giving  decision-making  status  to  representatives  from  African 
countries,  cannot  be  legally  implemented,  since  the  European  Economic  Interest  Grouping, 
the legal structure of the EDCTP, does not allow non-European representation. Nevertheless, 
as  stated,  African  consultative  participation  in  the  General  Assembly  has  been  significantly 
reinforced, involving African representatives in the decision-making process.  

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Letters  from  Commissioner  Potočnik  to  16  Ministers  of  Research  from  EDCTP  countries  sent  in 
autumn 2007. 

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Member  States  are  increasingly  accepting  a  single  central  EDCTP  scientific  and  ethics 
evaluation (2.4) drawing on a pool of the best experts.  

Member States are indeed enforcing the Article 169 concepts on an increasingly sustainable 
basis  (2.5),  both  in  terms  of  the  integration  of  national  research  programmes  and  in  yearly 
financial contributions to the EDCTP, and report back each year to the EDCTP, which in turn 
reports to the Commission on Member States’ commitments.  

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

This  report  is  designed  to  comply  with  the  first  of  the  group’s  recommendations  (3.1),  i.e. 
reporting to the Council and Parliament about the current status of the programme in advance 
of the 2008 evaluation.  

Commission  services  have  engaged  in  a  dialogue  on  the  EDCTP  (3.2)  and  have  agreed  to 
participate  actively  in  its  Partnership  Board  and  General  Assembly.  Complementing  this 
effort, the Commission is using the existing ‘Inter-service Group on Communicable Diseases 
for  Poverty  Reduction’  to  strengthen  dialogue  at  all  levels.  The  latter  group  follows  up  EU 
policy  and  progress  in  confronting  HIV/AIDS,  malaria  and  tuberculosis  through  external 
action,  while  the  EDCTP  establishes  synergies  between  research  capacity  building  and 
training of health care workers. 

The new health research strategy agreed in the Seventh Framework Programme (2007-2013) 
— FP7 — focuses on translational health research on the three diseases (3.3). Although the 
specific  programme  in  the  FP7  refers  to  possible  further  support  for  the  EDCTP,  subject  to 
certain  achievements,  this  strategy  may  have  to  be  reformulated  depending  on  the  final 
evaluation  of  the  EDCTP  and  the  impact  assessment  studies  planned  for  2009  before  any 
proposal for a Decision to renew the EDCTP.  

The  EDCTP  High  Representative  began  consultations  and  exchanges  on  its  future  with  all 
stakeholders  (including  African  governments)  in  2007.  The  Commission  is  constantly 
working  to  strengthen  the  EDCTP’s  participation  in  relevant  international  fora  such  as  the 
Global  Ministerial  Forum  on  Research  for  Health  in  Bamako,  Mali,  on  17-19  November 
2008. The involvement of African partners in the EDCTP Partnership Board has helped put 
the three diseases on national health research agendas. Although capacity in human resources 
and laboratories is being built (3.4, 3.5), more efforts are needed to ensure sustainability. 

Recommendation 3.6, that a proposal for a new Decision for the continuation of the EDCTP 
Programme be made, will be considered in due time.  

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

The  new  Article  169  initiatives  in  preparation  or  already  submitted  to  the  Council  and  the 
European  Parliament  (AAL11,  BONUS-Art  16912,  EMRP13,  EUROSTARS14)  closely  follow 
the recommendations of the Van Velzen report, and include a specific set of preconditions to 
be met (4.1) before any Member State can take part in a new Article 169 initiative. 

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Joint research programme on technologies for ‘Ambient Assisted Living’. 
Joint research programme on ‘Baltic Sea’ research. 
‘European Metrology Research Programme’. 
Joint research programme on ‘research-performing SMEs’. 

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The need to ensure the pre-existence of national research programmes and that Member States 
are fully committed to funding (4.2) is one of the main pre-conditions set by the Commission 
for new Article 169 initiatives.  

A  common  work-plan,  sound  governance  structure,  fixed  national  financial  contributions, 
clear  evaluation  criteria  and  procedures,  clear  deliverables  and  solutions  in  case  of  liability 
(4.3) are also required for new Programmes based on Article 169.  

Following  the  positive  developments  in  late  2006  and  early  2007,  and  in  line  with  the 
recommendations  of  the  Van  Velzen  report,  in  July  2007  the  Commission  extended  the 
original five-year EDCTP contract by two years, i.e. up to September 2010, without additional 
funding.  The  forthcoming  evaluation  of  the  EDCTP  will  cover  the  first  five  years  of  the 
Programme, from September 2003 to September 2008, as required by Article 8 of the EDCTP 
Decision.  

EDCTP PROJECT FUNDING 

Since  its  inception,  the  EDCTP  Programme  has  financed  around  145  projects,  including  32 
clinical trials, in 122 institutions from 26 different African countries. In addition, 55 training 
awards  and  16  Senior  Fellowships  were  funded,  allowing  a  number  of  African  scientists  to 
return to their countries to do research on poverty-related diseases.  

From 2003 to December 2007, the EDCTP financed grants for €76.2 million (total funding in 
signed  contracts,  including  Commission,  Member  State  and  third-party  financing),  63%  of 
these going to African researchers. Furthermore, in May 2008, partly as a result of the calls 
published in 2007, the EDCTP General Assembly approved the financing of 10 new projects 
on malaria treatment, malaria vaccine, malaria in pregnancy, and tuberculosis vaccine; 8 new 
projects  on  capacity  building  for  African  ethical  committees;  3  trans-disease  regional 
networks of excellence (East, Central and West Africa), and 6 senior fellowships, for a total 
of about €87 million, including 50% in co-funding from Member States and third parties. In 
2008, the EDCTP expects to commit project funding of over €100 million from Community 
financing, as shown in Figure 1 below.  

Member States’ co-funding has increased from less than €1 million in 2005 to €6 million in 
2006 and €21 million in 2007. Data from January to April 2008 shows €67 million committed 
or  pledged  by  Member  States.  Although  EDCTP  Member  State  co-funding  dramatically 
increased in 2007, and pledges for the years 2008-2010 are increasing, so far the level of co-
funding  achieved  is  only  €96  million  out  of  a  total  of  €200  million  required  from  Member 
States  by  the  end  of  2010  (Figure  1).  This  means  that  in  the  next  2.5  years,  participating 
Member  States  have  to  contribute  a  further  €104  million.  Moreover,  since  most  of  the 
Member States’ contributions are for their nationals participating in EDCTP-funded projects, 
the co-funding of African researchers is still an important issue which remains to be solved.  

Since  its  creation,  the  EDCTP  has  also  collaborated  with  major  international  stakeholders, 
foundations, and industries, thereby attracted more funding. Special mention should be made 
of the Bill and Melinda Gates Foundation, which published a joint call for proposals on HIV 
vaccines  with  the  EDCTP  in  December  2006,  and  of  the  London  School  of  Tropical 
Medicine,  which  is  engaged  in  a  Masters  Course  on  Clinical  Trials  with  the  EDCTP.  The 
EDCTP is also working closely with public-private partnerships such as the Malaria Medicine 
Venture on clinical trials for malaria treatment, and with the Global TB Alliance and industry 
in  clinical  trials  for  tuberculosis  treatment.  Although  these  collaborations  have  started  to 

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deliver  results  in  2008,  as  shown  in  Figure  1  (see  third-party  funding),  they  need  to  be 
extended even further, and should ideally reach the €200 million figure set when the EDCTP 
Programme was set up.  

120000000

100000000

80000000

60000000

40000000

20000000

0

2003

2004

2005

2006

2007

2008

MS contribution

Third party contribution EC funding signed grants

MS contribution: Member States’ annual contribution to signed projects. 2008 data include committed 
contribution to signed or approved projects until May 2008. 
Third-party contribution: third-party annual contributions to EDCTP signed projects, if known. 2008 data 
include committed contribution to signed or approved projects up to May 2008. 
EC funding signed grants: value of signed grants. 2008 data include the value of signed grants in the first quarter, 
approved grants and estimate values of future grants for the full year 2008. 

Figure  1.  Overview  of  Member  State,  third-party  and  EC  total  funding  commitments  to 
EDCTP projects. 

The main funding problem in the current EDCTP Programme has proved to be the inability of 
some  countries  to  contribute  to  a  common  co-funding  pot.  In  fact,  many  participating 
countries only agree to fund their own national researchers, while others also finance African 
researchers,  and  some  may  even  co-fund  other  European  researchers.  One  of  the  main 
recommendations of the Van Velzen report, the achievement of a common funding pot, seems 
difficult to achieve if we consider only research funding from participating Member States, as 
most  of  them  do  not  allow  contributions  to  external  scientists.  Nevertheless,  in  the  last  few 
months, in addition to the contribution from national research agencies, the EDCTP has seen 
increasing  financial  contributions  from  Member  States’  development  aid  agencies,  naturally 
focused on activities in developing countries (where most of the EDCTP funding goes). This 
innovative  solution  greatly  improves  the  ability  of  Member  States  to  co-finance  EDCTP 
projects.  

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EDCTP PERFORMANCE AND ACHIEVEMENTS 

EDCTP implementation is tracked by means of performance indicators. In 2007, the EDCTP 
secretariat  introduced  key  performance  indicators  on  grants,  partnerships,  co-funding  and 
governance  to  monitor  the  main  activities  of  the  Programme.  These  indicators,  updated 
monthly  and  published  on  the  EDCTP  website  (www.edctp.org)  allow  achievements  in 
reaching EDCTP objectives to be measured.  

The  Secretariat  in  charge  of  day-to-day  management  of  the  EDCTP  Programme  has 
introduced  new  measures  to  ensure  adequate  administrative  follow-up  of  EDCTP  activities, 
and  participating  Member  States  are  achieving  a  level  of  commitment  and  coordination  not 
seen before.  

In  addition  to  ongoing,  internal  monitoring  by  the  EDCTP’s  executive  management,  the 
European  Commission  reports  annually  to  the  European  Parliament  and  the  Council  on  the 
EDCTP  when  it  reports  on  the  Framework  Programme.  The  Commission  also  receives  full 
annual  reports  on  the  EDCTP’s  financial  and  scientific  activities,  and  reserves  the  right  to 
conduct  mid-term  reviews  of  the  Programme,  such  as  that  carried  out  by  the  Van  Velzen 
group.  

Moreover, the Commission will conduct a five-year evaluation, as required in Article 8 of the 
original  EDCTP  Decision.  The  report  on  this  evaluation,  to  be  launched  in  2008,  will  be 
forwarded to both the Council and Parliament and will be made public. The evaluation could 
be followed by an impact assessment.  

Although  the  serious  difficulties  encountered  between  2003  and  2006  must  not  be 
underestimated,  in  just  under  five  years  of  existence,  as  noted  in  the  June  2008  meeting  of 
African  researchers  in  the  EDCTP  Developing  Countries  Clinical  Trials  Partnership,  the 
EDCTP  has  made  its  mark  in  a  number  of  important  ways,  starting  to  fulfil  the  original 
objectives of the Programme:  

the  EDCTP’s  ownership  of  the  research  agenda  and  its  active  participation  in  identifying 
priorities and gaps are unique; 
there is an enhanced coordination of research activities and demonstrable capacity building; 
African  researchers  have  the  same  opportunities  as  their  northern  colleagues  to  develop 
proposals and become Principal Investigators; 
the concept of networks of excellence developed by the EDCTP is increasingly attracting the 
attention of other funding agencies; 
the  EDCTP  is  stimulating  African  countries  to  establish  national  research  budgets  and  to 
further contribute to the establishment of an African Fund for Health Research; 
EDCTP  funding  gives  African  researchers  more  ownership,  and  provides  better  fora  for 
discussion and knowledge exchange; 
capacity  and  sites  developed  are  fully  owned  by  the  institutions  and  countries,  avoiding 
‘scientific colonisation’; 
publications stemming from EDCTP-funded projects are on the increase; 
EDCTP grantees have developed new research sites by accessing funding from other sources; 
EDCTP funding has been instrumental in the approval of some major policy changes, such as 
the development of HIV treatment in children. 

Further details on the EDCTP’s performance are available in the accompanying Commission 
Staff  Working  Paper,  Progress  Report  on  the  European  and  Developing  Countries  Clinical 
Trials Partnership (EDCTP).  

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THE FUTURE OF THE EDCTP PROGRAMME 

The  present  EDCTP  contract  will  end  in  2010.  The  EDCTP  Programme  was  created  as  a 
‘long-term  partnership  between  Europe  and  developing  countries’;  its  objectives  cannot 
reasonably be achieved in seven years. The development of new drugs and vaccines can easily 
take 10 or more years; sustainable capacity building  is, by  definition, a long-term goal; and 
integration  of  European  national  programmes,  the  ultimate  goal  of  Article  169,  is  an 
ambitious, long-term target. To progress towards these objectives, additional funding for the 
continuation of the EDCTP Programme beyond 2010 would be needed.  

Provided that the original goals of the Programme are met, that the recommendations of the 
Van Velzen report are followed, and that the results of the five-year evaluation and the impact 
assessment are positive, the continuation of the EDCTP (2010-2015) might be envisaged, and 
the European Commission might duly consider a new proposal for continuation of the EDCTP 
Programme.  

The Commission, Parliament and Council will need to reflect carefully on the legal, financial 
and  scientific  decisions  entailed  in  renewing  the  EDCTP  Programme.  For  example,  they 
should consider the changes in EU membership that have occurred since 2004, and the  fact 
that funding  will  have  to be commensurate with the scientific goals and scope of the future 
Programme.  

CONCLUSION 

The EDCTP Programme was launched in September 2003 as the first application of Article 
169 of the EC Treaty. For the first time, 14 European Member States, together with Norway 
and Switzerland, are building a new structure to coordinate their clinical research activities on 
HIV/AIDS, malaria and tuberculosis in sub-Saharan Africa. The research financed will have a 
direct impact on the hardest-hit populations, in terms of new drugs, vaccines and public health 
interventions.  

As  part  of  the  European  contribution  to  the  UN’s  Millennium  Development  Goals,  the 
EDCTP is an important instrument in the fight against HIV/AIDS, malaria and tuberculosis. 
Better vaccines and treatments would help dramatically reduce the incidence of such diseases, 
and research is essential to developing these tools.  

Despite  some  serious  initial  difficulties,  the  performance  of  the  EDCTP  Programme  has 
improved in the last two years, with specific achievements in line with the original goals of 
the Programme and with the recommendations of the Van Velzen report. The remaining two 
years of the EDCTP contract until 2010 will be crucial to determining the extent of Member 
States’  financial  and  political  commitment  and  the  Secretariat’s  capacity  to  negotiate  and 
follow up research contracts.  

The special nature of EDCTP activities — financing capacity building and research activities 
in developing countries — calls for collaboration on the part of development aid and research 
agencies.  Better  coordination  of  these  funding  sources  will  contribute  to  increasing  the 
performance of both financing bodies in developing countries.  

Article  169  is  a  powerful,  ambitious  instrument  for  coordinating  national  programmes  and 
building the European Research Area. Activities conducted under this Article  have a longer 
than  average  implementation  phase,  but  come  with  greater  potential  and  are  able  to  deliver 

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results not achievable with other instruments. As such, they should be considered long-term 
activities.  

As learnt from the EDCTP, two of the main pre-conditions for new Article 169 initiatives are 
pre-existing national research programmes and a full funding commitment, in advance, from 
Member States. 

From the outset, the EDCTP Programme was set up as a long-term initiative which could only 
achieve  its  goals  of  research  capacity-building  in  Africa,  halting  disease  progression  and 
integrating  European  research  in  the  long  term.  Nevertheless,  progress  in  the  medium  term 
should be objective and measurable.  

As  requested  by  Council  and  Parliament  in  the  2003  EDCTP  Decision,  following  the 
publication  of  this  progress  report  the  Commission  will  begin  a  five-year  evaluation  of  the 
EDCTP  Programme.  The  results  obtained  will  be  taken  into  account  when  considering  a 
decision on renewing the EDCTP Programme for the period 2010-2015.  

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