EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP Proposal adopted by the European Commission 28 August 2002 COM (2002) 474 Final

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EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS
PARTNERSHIP Proposal adopted by the European
Commission 28 August 2002COM (2002) 474 Final
riedere
EDCTP

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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

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riedere

• 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/conference
  s/edctp/edctp_en.html

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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

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Global features
riedere

• 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

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Scope
riedere

• 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

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Schematic diagram of the EDCTP structure
Community Joint Programme
European National
South-South
Programmes
Network
EDCTP
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• 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)

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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

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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

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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

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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

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EDCTP Overview of structures
Partnership
EEIG
Board
Assembly
Dev.
Secretariat
Countries
European

Coordinating
Networking
Cttee
European Economic
EDCTP Forum
Interest Group
The Partnership
(Legal structure)
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EDCTP Overview of Structure
EDCTP Governance
Scientific and strategic
DC committees
Partnership Board
Legal and liable entity
EEIG Assembly
European Networks
Secretariat
Executive tasks
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The Partnership Board

• Composition
• 14 members, 4 chosen each by Developing Countries
  and
• European states
• Joint Selection of 4 independent members by
  their scientific
• expertise (including industry)
• 2 ex officio members from European Commission

• Role
• Strategic vision for clinical trials (and
  upstream links)
• Capacity development strategy
• Strategy for partnerships with research
  organisations
• and donors
• Receive advice form Developing Countries
  Coordinating Committee (DCCC)

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EEIG Assembly

• Composition
• 1 representative from each EU and EEFA member
  state
• participating in the initiative
• 1 European Commission Representative
• 2 DC representatives
• Executive Director and deputy

• Role
• Reflects EU member states broad financial,
  governance and
• legal responsibilities for EDCTP
• Final approval for strategic, operational and
  financial plans
• management of EEIG
• Employer of secretariat staff

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The Secretariat

• Composition
• Led by Executive Director and a Deputy, employed
  by the EEIG
• The 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 Africa

• Role
• Executes the work approved by the EEIG Assembly
  and the
• Partnership Board and selects the clinical trials
• Runs independent peer review system
• Handles liaison and negotiations with external
  partners, maintains operational and financial
  control system
• Executes tasks in accordance with ethical
  principles

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Proposed EDCTP expenditures in million during
the first 5 years
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EDCTP

• Funding pathways and benefits to donors

Community
International Initiatives
Industry
DG Research
DG Development
Funds
Funds
Joint
Programme
Activities
Activities
Networking
Capacity building
Clinical trials
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Road Map of the EDCTP
Information
Management
Networking of
EU National
Programmes
Needs
Capacity
Assessment
Strenghth.
Action Plan
South-South
Implementation
Network
Trial 1
Clinical
Trial 2
Trials
Trial 3
Trials 4-n
Fund
Co-
Raising
sponsorships
and Global
Policy
Advocacy
1
2
3
4
5
National Programmes
Time (Years)
Joint Programme