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EDCTPEUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS

PARTNERSHIP

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Member States Workshop, 27th-28th September, 2010Brussels

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An innovative EU model of partnership An innovative EU model of partnership for health researchfor health research

Dr. Ruxandra Draghia-Akli Director for Health ResearchEuropean Commission

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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.

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Art. 169/185 initiativesImplementing Legal Body

Co-funding

EDCTP EEIG-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-ASBLLegal structure based on national law

100 % Virtual Common Pot

EUROSTARS Eureka Association is an international not-for-profit association according to Belgium law-ASBLLegal structure based on national law

100 % Virtual Common Pot

ERMP ( Metrology) Non profit association under German law-e.VLegal structure based on national law

90 % Virtual Common Pot+10% Real Common Pot (for researcher excellence and mobility grants)

BONUS EEIG-European Economic Interest Group.European Community Body

Mix of Virtual/Common pot

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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 mio Est. >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

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The partnership

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

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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.

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EDCTP - achievements

● Number of projects 155● Sub-Saharan countries involved 28● Participating African institutions 125● 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.

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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.

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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, December Start of an Impact Assessment for a new EDCTP proposal

2010, July Approval of a no-cost extension of EDCTP until 2015

8th April-22nd June Public Consultation of stakeholders

30th August Report of Impact analysis by independent expert group

27th-28th September Consultation with Member States: Consensus Workshop

2010, December Presentation of Impact Assessment Report

to IA Board

EDCTP - Milestones

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EDCTP

Final Results of the Public Consultation

The questionnaire was open from 8th April 22nd June 2010

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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 ProfileB. Activities, Scientific Strategy and

Management C. FundingD. Policy Options E. Third PartiesF. Ethics and Intellectual Property Rights PolicyG. Social and Economic Impact H. Governance Structure I. General Remarks

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A. RESPONDENT PROFILE

My answers to this questionnaire represent:

20%

5%

75%

0%

10%

20%

30%

40%

50%

60%

70%

80%

My personalopinion

The view of anorganisationor company

The view of apublic

authority

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RESPONDENT PROFILEFor Individuals

4%

5%

2%

5%

7%

11%

11%

55%

0% 10% 20% 30% 40% 50% 60%

Other

Employee of a private-for profit org

EDCTP constituent member

Employee of a public authority

Employee of a private-non profit org

Employee of a public organisation

Interested citizen

A researcher

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RESPONDENT PROFILEFor

organisations/companies

31%

25%

19%

13%

8%

4%

0%

5%

10%

15%

20%

25%

30%

35%

Private non-profit

organisation

Publicorganisation

Private for-profitorganisation

Otherorg./ company

Higher EducationEstablishment

EDCTPconstituency

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RESPONDENT PROFILEFor Public Authorities

92%

8%0%

0%

20%

40%

60%

80%

100%

Centralised authority(Governmental body)

Other authority Decentralised, regionalauthority

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RESPONDENT PROFILEGeographical distribution

17%

8%

58%

30%

12%

56%

21%

75%

23%

0%

10%

20%

30%

40%

50%

60%

70%

80%

EU 27 Africa Other geographic areas

Public Authority

Personal Opinion

Organisation/ Company

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EDCTP future – Policy optionsResults Public Consultation

10%

3%

17%

63%

76%

50%

12%

11%

17%

15%

7%

16%

3%

0%

0%

0% 10% 20% 30% 40% 50% 60% 70% 80%

Personal opinion

Organisation/ company

Public authority

Option A: No European Union policy

Option B: Programme based

Option C: Business as usual

Option D: Expanded scope

A different option

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EDCTP future – under discussionResults Public Consultation

4

4

3

31

17

40

65

79

57

0 20 40 60 80

Broaden research, Neglecteddiseases, health services

Phase 1-4

Geographical expansion

%

Agree

Disagree

Don't Know

Remain focused or widen scope?

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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

100%

94%

90%

0%

4%

5%

0%

2%

5%

0% 20% 40% 60% 80% 100%

Personal opinion

Organisation/ company

Public authority

Don't know

Disagree

Agree

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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

92%

90%

84%

8%

8%

9%

0%

2%

7%

0% 20% 40% 60% 80% 100%

Personal opinion

Organisation/ company

Public authority

Don't know

Disagree

Agree

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

FUNDING

50%

83%

82%

42%

11%

10%

8%

6%

8%

0% 20% 40% 60% 80% 100%

Personal opinion

Organisation/ company

Public authority

Don't know

Disagree

Agree

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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

83,4%

11,9%

3,8%0,9%

57,4%

23,4%

17,4%

1,7%

54,9%

23,8%

18,3%

3,0%

0,0%

10,0%

20,0%

30,0%

40,0%

50,0%

60,0%

70,0%

80,0%

90,0%

International fundingbodies

Largepharma/ biotech/ industries

SMEs

High level of engagement

Medium level of engagement

Low level of engagement

Don't know

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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.

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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 €.