1. European Commission - Directorate-General for Research 1 Implementing FP 6 priority themes: EDCTP EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP Proposal adopted by the European Commission 28 August 2002 COM (2002) 474 Final riedere: EDCTP

2. European Commission - Directorate-General for Research 2 Implementing FP 6 priority themes: EDCTP The Global Crisis UGrowing number of infections of HIV, Malaria and Tuberculosis in developing countries and its disastrous consequences for the population UCases of infection mainly among the poorest groups of society in DCs ULack of affordable drugs and vaccines UVicious cycle for the economy of the DCs

3. European Commission - Directorate-General for Research 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:

4. European Commission - Directorate-General for Research 4 Implementing FP 6 priority themes: EDCTP The Legal Framework UReferring to Article 169 of the Treaty of Amsterdam the Community may make provisions for participation in research programmes undertaken by several Member States UThe EDCTP respects principles of human rights and of fundamental freedom reflected in Article 6 of the Treaty of the EU

5. European Commission - Directorate-General for Research 5 Implementing FP 6 priority themes: EDCTP Global features ULong-term sustainable initiative (10-20 years) UShared ownership of European and Developing Countries UDynamic structure with balanced involvement of different stakeholders (DC, MS, Commission, WHO, Industry, International Organisations) UIntegration of European National Programmes UNetworking between North-South and South-South USignificant Community contribution during the next 4 years: 200 M€ riedere:

6. European Commission - Directorate-General for Research 6 Implementing FP 6 priority themes: EDCTP Scope UNetwork of European National Programmes UClinical trials (drugs, vaccines, and new interventions) conducted mainly in Africa UCapacity building in developing countries - Research Facilities - Human resources USouth-South Network riedere:

7. European Commission - Directorate-General for Research 7 Implementing FP 6 priority themes: EDCTP Schematic diagram of the EDCTP structure European National Programmes South-South Network EDCTP

8. European Commission - Directorate-General for Research 8 Implementing FP 6 priority themes: EDCTP Components of the EDCTP UIntegration of European National Programmes UJoint Programme to accelerate the development of new interventions by supporting and/or funding of clinical trials UIntegration of DC networks  Development and co-ordination of Southern networks  Capacity building in developing countries (facilities and human resources)

9. European Commission - Directorate-General for Research 9 Implementing FP 6 priority themes: EDCTP Objectives of the Joint Programme (1) 1. Improve networking and co-operation between National Programmes: Uimprove information exchange and networking Usupport joint projects with National Programmes, Commission and other partners Udevelop coherent capacity strengthening and training programmes with DCs

10. European Commission - Directorate-General for Research 1010 Implementing FP 6 priority themes: EDCTP Objectives of the Joint Programme (2) 2. Supporting and funding clinical trials: UClinical trials from public and private sectors UFocus on large scale clinical trials mostly undertaken in DCs UBased on the principle of fair competition and peer review UFacilitate access to Good Manufacturing Practice (GMP) UShare data management structures

11. European Commission - Directorate-General for Research 1 Implementing FP 6 priority themes: EDCTP Objectives of the Joint Programme (3) 3. Sustained partnership between DCs and Europe: Udevelopment of logistics, clinical and laboratory infrastructures in DCs UProfessional training ULong-term assistance for participants on safety and ethical issues UShared ownership of developed and developing countries

12. European Commission - Directorate-General for Research 1212 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: UPartnership Board with a central role UEEIG Assembly which forms the legal structure to fund the management USecretariat with an active role in the execution of tasks

13. European Commission - Directorate-General for Research 1313 Implementing FP 6 priority themes: EDCTP EDCTP: Overview of structures Partnership Board European Networking Dev. Countries Coordinating Cttee EEIG Assembly Secretariat The Partnership European Economic Interest Group (Legal structure) EDCTP Forum

14. European Commission - Directorate-General for Research 1414 Implementing FP 6 priority themes: EDCTP EDCTP: Overview of Structure Secretariat EEIG Assembly Partnership Board EDCTP Governance DC committees European Networks Scientific and strategic Legal and liable entity Executive tasks

15. European Commission - Directorate-General for Research 1515 Implementing FP 6 priority themes: EDCTP The Partnership Board Role: U Strategic vision for clinical trials (and upstream links) UCapacity development strategy UStrategy for partnerships with research organisations and donors UReceive advice form Developing Countries Coordinating Committee (DCCC) Composition: U14 members, 4 chosen each by Developing Countries and European states UJoint Selection of 4 independent members by their scientific expertise (including industry) U2 ex officio members from European Commission

16. European Commission - Directorate-General for Research 1616 Implementing FP 6 priority themes: EDCTP EEIG Assembly Composition: U1 representative from each EU and EEFA member state participating in the initiative U1 European Commission Representative U2 DC representatives UExecutive Director and deputy Role: UReflects EU member states broad financial, governance and legal responsibilities for EDCTP UFinal approval for strategic, operational and financial plans management of EEIG UEmployer of secretariat staff

17. European Commission - Directorate-General for Research 1717 Implementing FP 6 priority themes: EDCTP The Secretariat Composition: ULed by Executive Director and a Deputy, employed by the EEIG UThe appointment and performance management will be organised by the EEIG Assembly UThe EEIG must be located in an EEFA state, one office of the Secretariat will be located in Africa Role: UExecutes the work approved by the EEIG Assembly and the Partnership Board and selects the clinical trials URuns independent peer review system UHandles liaison and negotiations with external partners, maintains operational and financial control system UExecutes tasks in accordance with ethical principles

18. European Commission - Directorate-General for Research 1818 Implementing FP 6 priority themes: EDCTP Proposed EDCTP expenditures in million € during the first 5 years

19. European Commission - Directorate-General for Research 1919 Implementing FP 6 priority themes: EDCTP EDCTP Funding pathways and benefits to donors Funds Activities Industry International Initiatives DG Research DG Development Joint Programme Networking Capacity building Community Clinical trials

20. European Commission - Directorate-General for Research 2020 Implementing FP 6 priority themes: EDCTP Road Map of the EDCTP National Programmes Joint Programme Capacity Strenghth. Clinical Trials Fund Raising and Global Advocacy Information Management Implementation Co- Networking of EU National Programmes Time (Years) 12345 Needs Assessment Action Plan Trial 1 Trial 2 Trial 3 Trials 4-n Policy South-South Network sponsorships