Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
1
Implementing FP 6 priority
themes: EDCTP
EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP
Proposal adopted by the European Commission 28 August 2002COM (2002) 474 Final
riedere:riedere:
EDCTP
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
2
Implementing FP 6 priority
themes: EDCTP
The Global Crisis
Growing number of infections of HIV, Malaria and
Tuberculosis in developing countries and its
disastrous consequences for the population
Cases of infection mainly among the poorest
groups of society in DCs
Lack of affordable drugs and vaccines
Vicious cycle for the economy of the DCs
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
3
Implementing FP 6 priority
themes: EDCTP
EDCTP:
Overall aim is to develop a long-term partnership
and to encourage networking between Europe and
Developing Countries and to accelerate the
development of effective, affordable and sustainable
products against the poverty related diseases
HIV/AIDS, Tuberculosis and Malaria through
resource building and clinical trials
http://europa.eu.int/comm/research/info/conferences/edctp/edctp_en.html
riedere:riedere:
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
4
Implementing FP 6 priority
themes: EDCTP
The Legal Framework
Referring to Article 169 of the Treaty of
Amsterdam the Community may make provisions
for participation in research programmes
undertaken by several Member States
The EDCTP respects principles of human rights
and of fundamental freedom reflected in Article 6
of the Treaty of the EU
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
5
Implementing FP 6 priority
themes: EDCTP
Global features
Long-term sustainable initiative (10-20 years) Shared ownership of European and Developing
Countries
Dynamic structure with balanced involvement of different stakeholders (DC, MS, Commission, WHO, Industry, International Organisations)
Integration of European National Programmes
Networking between North-South and South-South
Significant Community contribution during the next 4 years: 200 M€
riedere:riedere:
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
6
Implementing FP 6 priority
themes: EDCTP
Scope
Network of European National Programmes
Clinical trials (drugs, vaccines, and new
interventions) conducted mainly in Africa
Capacity building in developing countries - Research Facilities
- Human resources
South-South Network
riedere:riedere:
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
7
Implementing FP 6 priority
themes: EDCTP
Schematic diagram of the EDCTP structure
European National
ProgrammesSouth-South Network
EDCTP
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
8
Implementing FP 6 priority
themes: EDCTP
Components of the EDCTP
Integration of European National Programmes
Joint Programme to accelerate the development of
new interventions by supporting and/or funding of
clinical trials
Integration of DC networks
Development and co-ordination of Southern networks
Capacity building in developing countries (facilities
and human resources)
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
9
Implementing FP 6 priority
themes: EDCTP
Objectives of the Joint Programme (1)
1. Improve networking and co-operation between
National Programmes:
improve information exchange and networking
support joint projects with National Programmes,
Commission and other partners
develop coherent capacity strengthening and
training programmes with DCs
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
10
Implementing FP 6 priority
themes: EDCTP
Objectives of the Joint Programme (2)
2. Supporting and funding clinical trials:
Clinical trials from public and private sectors
Focus on large scale clinical trials mostly
undertaken in DCs
Based on the principle of fair competition and peer
review
Facilitate access to Good Manufacturing Practice
(GMP)
Share data management structures
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
11
Implementing FP 6 priority
themes: EDCTP
Objectives of the Joint Programme (3)
3. Sustained partnership between DCs and Europe:
development of logistics, clinical and laboratory
infrastructures in DCs
Professional training
Long-term assistance for participants on safety and
ethical issues
Shared ownership of developed and developing
countries
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
12
Implementing FP 6 priority
themes: EDCTP
Governance
The governance structure is intended to allow the initiative to
engage with all its stakeholders. The two main parts are “The
Partnership Board”, which draws together the expertise from
developing and European countries, and “The EEIG”, which
provides the legal, financial and operational structures.
The three organs for Governance are:
Partnership Board with a central role
EEIG Assembly which forms the legal structure to fund the
management
Secretariat with an active role in the execution of tasks
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
13
Implementing FP 6 priority
themes: EDCTP
EDCTP: Overview of structures
Partnership Board
European
Networking
Dev. Countries
Coordinating Cttee
EEIGAssembly
Secretariat
The Partnership
European Economic Interest Group
(Legal structure)
EDCTP Forum
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
14
Implementing FP 6 priority
themes: EDCTP
EDCTP: Overview of Structure
Secretariat
EEIG Assembly
Partnership Board
EDCTP GovernanceDC committees
European Networks
Scientific and strategic
Legal and liableentity
Executive tasks
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
15
Implementing FP 6 priority
themes: EDCTP
The Partnership Board
Role: Strategic vision for clinical trials (and upstream links)Capacity development strategyStrategy for partnerships with research organisations and donorsReceive advice form Developing Countries Coordinating Committee (DCCC)
Composition: 14 members, 4 chosen each by Developing Countries andEuropean states Joint Selection of 4 independent members by their scientific expertise (including industry)2 ex officio members from European Commission
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
16
Implementing FP 6 priority
themes: EDCTP
EEIG Assembly
Composition: 1 representative from each EU and EEFA member state participating in the initiative1 European Commission Representative2 DC representatives Executive Director and deputy
Role: Reflects EU member states broad financial, governance and legal responsibilities for EDCTPFinal approval for strategic, operational and financial plansmanagement of EEIGEmployer of secretariat staff
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
17
Implementing FP 6 priority
themes: EDCTP
The Secretariat
Composition:Led by Executive Director and a Deputy, employed by the EEIGThe appointment and performance management will be organised by the EEIG Assembly The EEIG must be located in an EEFA state, one office of the Secretariat will be located in AfricaRole: Executes the work approved by the EEIG Assembly and thePartnership Board and selects the clinical trialsRuns independent peer review systemHandles liaison and negotiations with external partners, maintains operational and financial control systemExecutes tasks in accordance with ethical principles
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
18
Implementing FP 6 priority
themes: EDCTP
0 50 100 150 200 250 300 350 400 450
Euros Euros (million)
600 Million €
Clinical Trials
CapacityStrenghthening
Fundraising
South-SouthNetwork
Secretariat
Informationmanagment
EuropeanNetworking
Proposed EDCTP expenditures in million € during the first 5 years
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
19
Implementing FP 6 priority
themes: EDCTP
EDCTPFunding pathways and benefits to donors
Funds Funds
ActivitiesActivities
IndustryInternational
Initiatives DG Research
DG Development
Joint
Programme
Networking Capacity building
Community
Clinical trials
Eu
rop
ean
Com
mis
sio
n -
Dir
ecto
rate
-Gen
era
l fo
r R
esearc
h
20
Implementing FP 6 priority
themes: EDCTP
Road Map of the EDCTP
National Programmes
Joint Programme
CapacityStrenghth.
ClinicalTrials
FundRaisingand GlobalAdvocacy
Information Management
Implementation
Co-
Networking ofEU NationalProgrammes
Time (Years)1 2 3 4 5
NeedsAssessment
Action Plan
Trial 1
Trial 2
Trial 3
Trials 4-n
Policy
South-SouthNetwork
sponsorships