European Commission - Directorate-General for Research 1 Implementing FP 6 priority themes: EDCTP EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP

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Implementing FP 6 priority

themes: EDCTP

EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP

Proposal adopted by the European Commission 28 August 2002COM (2002) 474 Final

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EDCTP

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themes: EDCTP

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

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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

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themes: EDCTP

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

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themes: EDCTP

Global features

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€

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themes: EDCTP

Scope

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

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themes: EDCTP

Schematic diagram of the EDCTP structure

European National

ProgrammesSouth-South Network

EDCTP

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themes: EDCTP

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)

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themes: EDCTP

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

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themes: EDCTP


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

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themes: EDCTP


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

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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:

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

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themes: EDCTP

EDCTP: Overview of structures

Partnership Board

European

Networking

Dev. Countries

Coordinating Cttee

EEIGAssembly

Secretariat

The Partnership

European Economic Interest Group

(Legal structure)

EDCTP Forum

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themes: EDCTP

EDCTP: Overview of Structure

Secretariat

EEIG Assembly

Partnership Board

EDCTP GovernanceDC committees

European Networks

Scientific and strategic

Legal and liableentity

Executive tasks

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themes: EDCTP

The Partnership Board

Role: Strategic vision for clinical trials (and upstream links)Capacity development strategyStrategy for partnerships with research organisations and donorsReceive advice form Developing Countries Coordinating Committee (DCCC)

Composition: 14 members, 4 chosen each by Developing Countries andEuropean states Joint Selection of 4 independent members by their scientific expertise (including industry)2 ex officio members from European Commission

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themes: EDCTP

EEIG Assembly

Composition: 1 representative from each EU and EEFA member state participating in the initiative1 European Commission Representative2 DC representatives Executive Director and deputy

Role: Reflects EU member states broad financial, governance and legal responsibilities for EDCTPFinal approval for strategic, operational and financial plansmanagement of EEIGEmployer of secretariat staff

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themes: EDCTP

The Secretariat

Composition:Led by Executive Director and a Deputy, employed by the EEIGThe 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 AfricaRole: Executes the work approved by the EEIG Assembly and thePartnership Board and selects the clinical trialsRuns independent peer review systemHandles liaison and negotiations with external partners, maintains operational and financial control systemExecutes tasks in accordance with ethical principles

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themes: EDCTP

0 50 100 150 200 250 300 350 400 450

Euros Euros (million)

600 Million €

Clinical Trials

CapacityStrenghthening

Fundraising

South-SouthNetwork

Secretariat

Informationmanagment

EuropeanNetworking

Proposed EDCTP expenditures in million € during the first 5 years

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themes: EDCTP

EDCTPFunding pathways and benefits to donors

Funds Funds

ActivitiesActivities

IndustryInternational

Initiatives DG Research

DG Development

Joint

Programme

Networking Capacity building

Community

Clinical trials

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themes: EDCTP

Road Map of the EDCTP

National Programmes

Joint Programme

CapacityStrenghth.

ClinicalTrials

FundRaisingand GlobalAdvocacy

Information Management

Implementation

Co-

Networking ofEU NationalProgrammes

Time (Years)1 2 3 4 5

NeedsAssessment

Action Plan

Trial 1

Trial 2

Trial 3

Trials 4-n

Policy

South-SouthNetwork

sponsorships

Documents

European Commission - Directorate-General for Research 1 Implementing FP 6 priority themes: EDCTP EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP