Strategy of the European Commission for Research on Povertyrelated Diseases

1

• Strategy of the European Commission for Research
  on Poverty-related Diseases
• February 2004
• Research Directorate General
• European Commission- Health Research
• Arnd Hoeveler

2
Political Context
Programme for Action

• Trade Make pharmaceuticals more affordable for
  Developing Countries (TRIPS, Doha, etc.)

• Development
• Existing health-related interventions (Global
  Health Funds)

• Research
• New interventions against the three diseases

3
European Commissions Research Policy on PRD

• Research Programme (FP6) Priority for HIV/AIDS,
  Malaria, Tuberculosis 400 million for 4 years
• Two main pillars
• Large consortia (project funding)
• Basic and preclinical research up to early human
  testing (10-25 M - 15-50 partners 4-7 years)
• Small-scale, high risk projects (max. 1 M, 2
  years, young researchers)
• EDCTP (Programme Funding)
• Product development focusing on phase II-III
  clinical trials
• Separate legal entity, external from the
  Commission with own implementation structures

4

EDCTP Art. 169
Clinical Trials (Phase II/III)
HIV/AIDS
Malaria
TB
Early clinical testing
NEW INSTRUMENTS IP, NoE
Pre-clinical

• Vaccines
• Drugs

• Vaccines
• Drugs

• Vaccines
• Microbicides

Discovery

TRADITIONAL INSTRUMENTS STREP, CA, SSA
Genomics
Research Strategy of the EC to confront HIV/AIDS,
Malaria and Tuberculosis
5
FP5 funding on HIV/AIDS, Malaria and TB
6
EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS
PARTNERSHIP
EDCTP
7
EDCTP

• Long-term partnership between Europe and
  Developing Countries to fight HIV/AIDS,
  Tuberculosis and Malaria through new clinical
  interventions

8
The Legal Framework

• Co-decision of 16 June 2003
• EU Council
• European Parliament

Structure private legal entity EEIG (European
Economic Interest Grouping)
9
European-Developing Countries Clinical Trials
Partnership (EDCTP)

• Objective accelerate clinical development
  of new interventions for HIV/AIDS,
  Malaria and TB
• Activities
• Phase II/III clinical trials in sub-Saharan
  Africa (SSA)
• Research capacity building in SSA
• Networking and coordination of activities in DC
• Networking and coordination of European National
  programmes

10
Funding

• EU countries
• European Commission
• Private sector foundations, industry

600 M
11

Proposed EDCTP expenditures during the first 5
years
12
EDCTP political aims

• Develop a genuine  Partnership Model  where DCs
  are equal partners
• 85 of the budget will go to DCs
• Strong focus on the research capacity-building in
  DCs
• Networking and coordination of European Member
  States activities

13
EDCTP political aims

• Brokerage concept to allow deals with industry
  and other international organizations
• Clear IPR policy ensuring availability and easy
  access to affordable products for DCs
• Linking research to health care

14
EDCTP overview of structures

• Advocacy, High visibility, Fund raising
• Scientific Strategy
• Legal and financial structure
• Management

Haut Représentant
Partnership
Partnership Board DCCC EC network
EDCTP forum
EEIG-Assembly
EEIG
Executive Director Secretariat
15
Partnership Board
Malaria Pedro Alonso Fred Binka Thomas Egwang
TB Bernard Fourie Alwyn Mwinga
Clinical Trials Peter Smith
Industry Michel Klein Margaret Liu
HIV/AIDS Patrice Debré Souleymane Mboup Stefano
Vella Britta Wahren
Non-voting Members Arnd Hoeveler (DG RTD) Lieve
Fransen (DG DEV) Rob Ridley (WHO)
16
EDCTP Secretariat

• Executive Director
• Piero OLLIARO
• c/o NWO
• Laan van Nieuw Oost Indië 334
• NL-2593 Den Haag
• The Netherlands
• E-mail secretary_at_edctp.org
• Web page www.edctp.org

17
EDCTP Conclusion and challenges

• Establish ownership of the EDCTP by African
  countries on all levels (political, scientific
  and institutional)
• Create an efficient infrastructure and a career
  system for African researchers
• Link up EDCTP activities with local/regional/Nepad
  health systems
• Establish new public-private partnerships to
  share the risk of investment together with
  industry

18

EDCTP Art. 169
Clinical Trials (Phase II/III)
HIV/AIDS
Malaria
TB
Early clinical testing
NEW INSTRUMENTS IP, NoE
Pre-clinical

• Vaccines
• Drugs

• Vaccines
• Drugs

• Vaccines
• Microbicides

Discovery

TRADITIONAL INSTRUMENTS STREP, CA, SSA
Genomics
Research Strategy of the EC to confront HIV/AIDS,
Malaria and Tuberculosis