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EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP Proposal adopted by the European Commission 28 August 2002 COM (2002) 474 Final. riedere:. EDCTP. The Global Crisis. Growing number of infections of HIV, Malaria and Tuberculosis in developing countries and its

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  1. EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIPProposal adopted by the European Commission 28 August 2002COM (2002) 474 Final riedere: EDCTP

  2. 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

  3. 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/conferences/edctp/edctp_en.html

  4. 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

  5. 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€

  6. 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

  7. Schematic diagram of the EDCTP structure Community Joint Programme European National South-South Programmes Network EDCTP

  8. 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)

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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)

  14. EDCTP: Overview of Structure EDCTP Governance Scientific and strategic DC committees Partnership Board Legal and liable entity European Networks EEIG Assembly Secretariat Executive tasks

  15. 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)

  16. 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

  17. 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

  18. Proposed EDCTP expenditures in million € during the first 5 years

  19. EDCTP Funding pathways and benefits to donors Community International Initiatives Industry DG Research DG Development Funds Funds Joint Programme Activities Activities Networking Clinical trials Capacity building

  20. 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

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