1. 1 EDCTP EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP _____________________________________ Member States Workshop, 27 th -28 th September, 2010 Brussels ______________________________________ Dr. Ruxandra Draghia-Akli Director for Health Research European Commission

2. 2 European and Developing Countries Clinical Trials Partnership -EDCTP- ● EDCTP was founded in September 2003 in response to the high global burden of three poverty-related diseases namely of HIV/AIDS, tuberculosis and malaria. ● A pioneer European Commission ex-Article 169 initiative  now Article 185 ● The Partnership’s main goal is to accelerate research and development against these three diseases, especially in sub- Saharan Africa.

3. 3 Art. 169/185 initiatives Implementing Legal BodyCo-funding EDCTPEEIG-European Economic Interest Group. European Community Body 100 % Virtual Common Pot. AAL AAL Association is an international not-for-profit association according to Belgium law-ASBL Legal structure based on national law 100 % Virtual Common Pot EUROSTARS Eureka Association is an international not-for-profit association according to Belgium law-ASBL Legal structure based on national law 100 % Virtual Common Pot ERMP ( Metrology)Non profit association under German law-e.V Legal structure based on national law 90 % Virtual Common Pot+10% Real Common Pot (for researcher excellence and mobility grants) BONUSEEIG-European Economic Interest Group. European Community Body Mix of Virtual/Common pot

4. 4 Article 169/185 Initiatives and FP7 (4) Specific Programme: “Article 185 Initiative” [Commission proposal / adoption by European Parliament & Council] EU cont. (€)Ant. total (€) Cooperation: “Ambient Assisted Living (AAL)” [14.06.2007 / 09.07.2008] 150 mio>300 mio Capacities: “Research Performing SMEs (EUROSTARS)” [12.09.2007 / 09.07.2008] 100 mio>400 mio Cooperation: “Metrology (EMRP)” [03.12.2008 / 16.09.2009] 200 mio>400 mio Cooperation: “Baltic Sea research (BONUS)” [29.10.2009 / -] Est. 50 mioEst. >100 mio Virtual Common Pot: The Member States earmark part of their national research budgets for the implementation of the joint programme. Real Common Pot: Community and National partners, would make an upfront cash contribution to a real common pot. EU contribution comes from the corresponding FP7 Specific Programmes

5. 5 The partnership Benin Botswana Burkina Faso Cameroon Congo Cote d’Ivoire Democratic Republic of Congo Ethiopia Gabon Ghana Guinea Guinea-Bissau Guinea-Conakry Kenya Madagascar Malawi Mali Mozambique Nigeria Rwanda Senegal South Africa Sudan Tanzania The Gambia Uganda Zambia Zimbabwe Austria Belgium Denmark France Germany Greece Ireland Italy Luxembourg Netherlands Norway Portugal Spain Sweden Switzerland United Kingdom EDCTP-EEIG member states Sub-Saharan African countries Total BUDGET 2003-2015(includes the no cost extension) 400+ million Euros: EC €200m+ MS €200m + private

6. 6 EDCTP - Independent External Expert Evaluation 1.Acknowledges improvements from 2007 to 2009: A mechanism for cooperation and coordination of participating European member state national programmes. Support to phase II and III clinical trials using best practice. Strengthening of capacity to ensure clinical trials takes place in ethical and sustainable manner. 2.Identifies weaknesses: Lack of integration of national programmes Lack of a real (or virtual) common pot of funding Lack of industry participation Need for better coordination research/development. Create joint DG Research / DG Development platform to engage dialogue with EDCTP.

7. 7 EDCTP - achievements ● Number of projects155 ● Sub-Saharan countries involved 28 ● Participating African institutions125 ● Projects under negotiation 20  The first African Networks of Excellence for clinical trials in central Africa have been established;  There are new national ethics committees in many African countries;  The US Food and Drug Administration (FDA) has approved an anti- retroviral formulation for HIV infected children in Africa, which was tested in a EDCTP project.

8. 8 EDCTP - achievements ● A number of recent policy declarations, programmes and reports highlighted the key role of EDCTP, in its own right and as a catalyst model for other programmes aiming at coordinated international collaboration. ● EDCTP is now one of the most visible global health initiatives emanating from Europe, a vital element of its research programme for poverty-related diseases, and one of its strongest instruments for fostering the cooperation with Africa. ● The partnership model of EDCTP could progressively be extended to broader clinical and intervention research against a wider range of poverty-related diseases.

9. 9 2003, September Creation of the EDCTP 2007, July Mid-term review (Van Velzen Report) 2009, December Independent External Expert Evaluation 2003-2009 Forwarded to Council and Parliament on 16 April 2010 2009, DecemberStart of an Impact Assessment for a new EDCTP proposal 2010, JulyApproval of a no-cost extension of EDCTP until 2015 8 th April-22 nd JunePublic Consultation of stakeholders 30 th AugustReport of Impact analysis by independent expert group 27 th -28 th SeptemberConsultation with Member States: Consensus Workshop 2010, December Presentation of Impact Assessment Report to IA Board EDCTP - Milestones

10. 10 EDCTP Final Results of the Public Consultation The questionnaire was open from 8th April 22nd June 2010

11. 11 EDCTP Public Consultation ● The purpose of this consultation was to invite the opinions of EDCTP stakeholders, experts and the public on the need of a new EDCTP initiative. ● The questionnaire consisted of 19 questions in 9 sections: A. Respondent Profile B. Activities, Scientific Strategy and Management C. Funding D. Policy Options E. Third Parties F. Ethics and Intellectual Property Rights Policy G. Social and Economic Impact H. Governance Structure I. General Remarks

12. 12 A. RESPONDENT PROFILE

13. 13 RESPONDENT PROFILE For Individuals

14. 14 RESPONDENT PROFILE For organisations/companies

15. 15 RESPONDENT PROFILE For Public Authorities

16. 16 RESPONDENT PROFILE Geographical distribution

17. 17 EDCTP future – Policy options Results Public Consultation

18. 18 EDCTP future – under discussion Results Public Consultation Remain focused or widen scope?

19. 19 C1. Co-funding arrangements The EDCTP has not yet succeeded in integrating Member State CTs programmes. The EDCTP 2 should better define co-funding arrangements at the start of the programme. FUNDING

20. 20 C2. Member States’ commitments Each Member State should make a formal commitment for a minimum annual payment throughout the life of a new EDCTP initiative. FUNDING

21. 21 C3. A single fund In order to reduce operational complexity, a new EDCTP initiative should create a single fund. FUNDING

22. 22 E1. Partnerships The involvement of third parties such as SMEs, Large pharmaceutical/ biotech/industrial companies, international funding bodies, is important in the development of new products. To what extent should the EDCTP 2 work closely with these third parties? THIRD PARTIES

23. 23 EDCTP - Report of analysis of impact by independent experts’ panel EDCTP should get an expanded mandate (as foreseen under Option 4, Expanded Scope) to maximize the political and socio-economic impact. Expansion to phase 1 and 4 trials is justified. Geographic expansion; the countries involved should primarily be the sub- Saharan countries, but EDCTP2 could be encouraged to engage in alliances with other regions. EDCTP2 should be allowed to work on other neglected infectious diseases as needed by the participating African countries.

24. 24 EDCTP - Report of analysis of impact by independent experts’ panel In addition, The expert panel recommends that any EDCTP2 program should, from the start, outline clear objectives with measurable outcomes both in clinical research as well as in capacity strengthening. It also recommends that the governance structures of EDCTP be modified to include the EC as voting members and eventually to grant full voting rights to the African partners. Monetary funding from the collaborating sub-Saharan African nations would enhance sustainability and lead to true partnership. A time frame for an expanded EDCTP for around 10 years is advisable; considering the time needed for clinical trials phase 2, 3 and/or 4, capacity building including regulatory framework, to allow growth of African leadership and infrastructure. Budget increase required, corresponding to expanded scope. A possible scenario could have an indicative funding of at least 1 billion €.