European Union approves second EDCTP programme

Published on 6 May 2014

Today, the Council of the European Union in its meeting on Economic and Financial Affairs (ECOFIN) has approved the participation of the European Union in the second programme of the European & Developing Countries Clinical Trials Partnership (EDCTP) in accordance with the proposal approved by the European Parliament on 15 April 2014. With a budget of € 683 million for the programme period, the second programme will support all stages of clinical trials, from phase I to IV, on HIV/AIDS, tuberculosis, malaria and neglected infectious diseases. With this approval, the implementation phase of the second programme will start after the signing of the delegation agreement between the European Commission and the new EDCTP implementing structure. Publication of the first workplan is expected in the second half of 2014.

Dr Mark Palmer, Chairperson of the EDCTP General Assembly: “The approval by the European Union of the second EDCTP programme is very welcomed. We are excited as this will create new opportunities for research to tackle a number of diseases which all put a very significant health burden on sub-Saharan Africa”.

Prof. Charles Mgone, EDCTP Executive Director: “The European Union Council’s approval of EDCTP2 underpins the EU’s commitment to fight diseases of the poverty in partnership with sub-Saharan African countries. Furthermore, the expanded scope of the new programme is an endorsement of the partnership as the best way forward to reduce the burden of these diseases and to improve health of the people in endemic countries”.

Scope of EDCTP2
The second EDCTP programme will strongly contribute to the overall European-African partnership. EDCTP2 will continue to support the clinical development of new or improved diagnostics, drugs, vaccines and microbicides against HIV/AIDS, tuberculosis and malaria. Importantly, EDCTP2 will also support studies on neglected infectious diseases (NIDs).

EDCTP’s funding strategy will remain unchanged. EDCTP will continue to promote:

  • Multicentre projects that combine clinical trials, capacity building and networking
  • Capacity development for clinical trials and clinical research in sub-Saharan countries
  • Closer collaboration with industry, like-minded organisations, product development partners, research funders and development cooperation agencies.

All stages of clinical trials will be supported, from phase I to IV, though the main focus will be on phase II and III clinical trials. The geographical focus of EDCTP2 will remain on sub-Saharan Africa, although collaborative research with other developing countries outside sub-Saharan Africa could be envisioned when possible and desirable.

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