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European & Developing Countries Trials Partnership (EDCTP)

• http://www.edctp.org website

Background

The EDCTP is a partnership between the European Union, Norway, developing countries and other donors, as well as the pharmaceutical industry, to enable clinical trials and the development of new medicines and vaccines against HIV/AIDS, tuberculosis, and malaria.[2] The need for global action against these diseases in order to promote poverty reduction has been recognised by the United Nations, the G8, and the African Union, and the program envisioned the provision of €600 million for the period 2003-2007 in order to translate medical research results into clinical applications relevant to the needs of developing countries.

The European Council adopted the Programme for Action: Accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction (COM (2001)96, [3]) on 15 May 2001, following its launch by the European Commission. The Commission proposal was adopted on 16 June 2003 by the Council and the European Parliament.[4] The Programme was to be based on three central pillars: "...the impact of existing interventions, the affordability of key pharmaceuticals and trade, and the research and development of specific global public goods."[5] These aims relate specifically with the EU stance on access to essential medicines. [6]

The first EDCTP Annual Forum was held in Rome, Italy, on 28 - 29 September 2004.

Projects and activities

A number of different partnership activities have been proposed:

• North/North networking and co-ordination

Partnerships among the EU and associated countries, allowing focused collaboration of national and European efforts that were not previously coordinated.

• North/South networking and co-ordination

Partnerships among EU and developing countries that focuses specifically on developing countries' needs, who are jointly involved in setting the research priorities.

• South/South networking and co-ordination

Efforts aimed at creating lasting long-term partnerships between African scientists and research institutions in Africa.

• Public/private partnerships

Designed to create opportunities for the active involvement of industry in the clinical development of promising drug candidates in Africa, with the EDCTP taking a share of the risk.

• Global partnerships

Effective cooperation and coordination with other international organisations (see Member states and participants section, below).

• Capacity building

Manifested as a general strengthening of clinical research capacity in Africa, including training activities, workshops and meetings, and the upgrading of clinical trial sites in Africa.

Funding

Proposed EDCTP expenditure for the first 5 years of the Programme (2003-2007)[1]

The total budget of the EDCTP is €600 million for the period 2003-2007, of which one third (€200 million) is to be provided by the EU budget, an equivalent amounts from Member States' activities, and the remaining €200 million from industry, charities, and private organisations. The Partnership is intended to be a long-term initiative (10-20 years) and a separate legal entity has been created to maintain its independence and flexibility.

Taken together, clinical trials based in developing countries where the diseases are endemic, capacity building, and South-South networking are expected to make up over 90% of the overall budget. (figure).

Member states and participants[7]

• Europe

EU member states, plus Norway.

• Developing countries

All sub-Saharan African countries.

• Industry

Industry interest has been expressed by (amongst others) GSK, Chiron, Aventis Pasteur, and Sanofi-Synthélabo.

• International initiatives (prospective)

The World Health Organisation (WHO-TDR) (http://www.who.int/tdr/)

The Global Fund to fight HIV/AIDS, Tuberculosis and Malaria (GFATM) (http://www.theglobalfund.org/)

The Global Alliance for Vaccines and Immunization (GAVI) (http://www.vaccinealliance.org/)

The International Aids Vaccine Initiative (IAVI) (http://www.iavi.org/)

The European Malaria Vaccine Initiative (EMVI) (http://www.emvi.org/)

The Malaria Vaccine Initiative (MVI) (http://www.malariavaccine.org/)

Stop TB Partnership (Stop TB) (http://www.stoptb.org/)

The National Institutes of Health (NIH) (http://www.nih.gov/)

• Private non-profit organisations (prospective)

The Wellcome Trust

The Bill and Melinda Gates Foundation

Representatives

High representative - Pascoal Mocumbi Executive director - Odile Leroy