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EDCTP

Transnational Cooperation

European and Developing Countries Clinical Trials Partnership

Introduction

Based in the Hague, Netherlands, the European and Developing Countries Clinical Trials Partnership (EDCTP) was established in 2003 as an European response to the crisis provoked by the three main poverty-related diseases (HIV/Aids, tuberculosis and malaria), which altogether constrain prospects of human and social development. EDCTP emanates from Article 185 of the Lisbon Treaty, and aims at promoting an integrated approach to clinical research towards prevention and treatment of those diseases, particularly in Sub-Saharan Africa, the worst affected region in the world. Its first programme took place between 2003 and 2013. Portuguese is one of its working languages, together with English and French.

The ongoing programme was approved by European co-decision on 6 May 2014, stretches from 2014 thru 2024, and is equally funded by H2020 and EDCTP participating states, i.e. 1.366 million euros altogether. Apart from HIV/Aids, tuberculosis and malaria, the grouping of infectious neglected diseases affecting Sub-Saharan Africa are included as well.

Portugal is a founding member of this partnership, and is represented by the Foundation for Science and Technology with the following delegates to the General Assembly: Ricardo Pereira and Ana Quartin, from the Department of International Relations. The Portuguese representation seeks, on the one hand, to build on the ongoing work by the Portuguese scientific community operating in the area of EDCTP. On the other hand, it aims at consolidating goals of scientific diplomacy through the reinforcement of cooperation with strategic countries in Sub-Saharan Africa (namely Portuguese-speaking ones), envisaging articulation with other national, European and African public and private organisations that promote health and development in Sub-Saharan Africa.

Governance

EDCTP has originally been constituted as a European grouping of economic interest. However, considering the need to increase representativeness of involved countries, namely African ones; to adjust liabilities of participating states; and enhance sustainability, the Association EDCTP has been established on 10 April 2014. The association is composed of the following bodies: General Assembly (supreme body), Board and Executive Secretariat, apart from a Strategic Advisory Committee.

For the time being, the following countries have joined the Association EDCTP (designated ‘participating states’): Angola, Austria, Burkina Faso, Cameroon, Denmark, Ethiopia, Finland, France, Gabon, The Gambia, Germany, Ghana, Ireland, Italy, Luxembourg, Mali, Mozambique, Netherlands, Niger, Nigeria, Norway, Portugal, Republic of Congo (Brazzaville), Senegal, South Africa, Spain, Sweden, Tanzania, Uganda, United Kingdom and Zambia.

Regardless of this list of members, it should be noted that EDCTP-2 activities may be implemented in all Sub-Saharan Africa countries, and, in some calls, by any country affiliated with H2020. Calls are timely announced.

Sub-Saharan African countries

Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Republic of Congo, Ivory Coast, Equatorial Guinea, Eritrea, Ethiopia, Gabon, the Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

EDCTP Main Outcomes (2003-2015)

  • Approval of 207 projects in the area of clinical trials, capacity development and network support in 30 countries in Sub-Saharan Africa and with involvement of 351 institutions (2012) (see portfolio of projects);
  • Launch of 4 networks of excellence promoting South-South cooperation, which trained 400 African researchers;
  • Establishment of the Pan African Clinical Trials Registry and the African Vaccine Regulatory Forum.

EDCTP-2 Goals (2014-2024)

Main goal: Acceleration of the development of new or improved tools (drugs, microbicides, diagnostics and vaccines) against poverty-related diseases (HIV/AIDS, tuberculosis, malaria and neglected infectious diseases) in partnership with sub-Saharan Africa, by provision of a critical mass of resources to support clinical trials.

Other goals:

  • To coordinate the European national programmes to effectively work in synergy and in mutual partnership with sub-Saharan African stakeholders in conducting relevant clinical trials for the development of the tools to fight HIV/AIDS, TB, malaria and NIDs;
  • To develop and strengthen the capacities in sub-Saharan Africa to ensure that the relevant clinical trials are conducted using best practice;
  • To develop closer partnerships with the pharmaceutical industry and other third parties, such as private foundations, to more effectively deliver the objectives of the programme.

EDCTP-2 Activity Areas

Disease-specific priorities for clinical trials and health services/optimisation research:

  • Treatment (evaluation of novel drugs and drug combinations in advanced clinical stages);
  • Diagnostics (evaluation of diagnostic products);
  • Prevention (candidate vaccines testing);
  • Implementation research.
  • Capacity Building
  • Networking of European and African Programmes
  • Advocacy and Resource Mobilisation

Portuguese Contribution to EDCTP between 2014 and 2016

EDCTP goals are accomplished through manifold means. The major one is through the development of research projects and other activities that emanate from the calls for proposals launched by the EDCTP secretariat, mostly in linkage with other funders. However, they are also achieved through projects and activities implemented under the auspices of other funding schemes, including national calls. In 2014 and 2015 Portuguese contribution to the EDCTP goals comprised two research projects; four doctoral grants; and ten postdoctoral grants funded under various FCT national calls, found here. Consisting of 317.632 € in 2014 and 286.616 € in 2015, they however account up to cc. 1,5 million euros for all their duration. In Sub-Saharan Africa research was done in such countries as Angola, Cape Verde, Democratic Republic of Congo and Mozambique.

In 2016 FCT has contributed 200.000 € in cash to the cofunding of WANETAM (West African Network for TB Aids and malaria), in which Henrique Silveira (Institute of Hygiene and Tropical Medicina, UNL) participates, under the coordination of Souleymane Mboup (Cheikh Anta Diop University, Senegal).

Public Presentations since 2013

Apoio à Investigação Clínica nos PALOP: O papel da FCT e perspetivas futuras, Seminário: Comissões de ética – uma ferramenta para o desenvolvimento da investigação clínica em África, 9 March 2015, Calouste Gulbenkian Foundation, Lisbon

Reforço das Capacidades de Investigação Clínica em Angola através do Programa EDCTP-2: Contributos para os Objetivos do «Plano de Desenvolvimento Sanitário da República de Angola (2012-2015), Workshop Horizon 2020 (organised by the Ministry of Science and Education of the Republic of Angola and the Delegation of the European Commission in Angola, 14 October 2014, Luanda

The role of Portuguese research in the European & Developing Countries Clinical Trials Partnership (EDCTP2), 21 February 2014, Instituto de Higiene e Medicina Tropical, Universidade Nova de Lisboa

International Scientific Cooperation in Neglected Tropical Diseases: Portuguese Participation in EDCTP-2, 31 October 2013, Fundação Calouste Gulbenkian, Lisboa

For more information and funding opportunities

Please visit: www.edctp.org

Contact

Ricardo Pereira
FCT – Fundação para a Ciência e a Tecnologia
DRI – Departamento de Relações Internacionais
Av. D. Carlos I, 126
1249 – 074 LISBOA
Portugal

ricardo.pereira@fct.pt
Tel: (351) 21 392 44 79

Ana Quartin
FCT – Fundação para a Ciência e a Tecnologia
DRI – Departamento de Relações Internacionais
Av. D. Carlos I, 126
1249 – 074 LISBOA
Portugal

ana.quartin@fct.pt
Tel: (351) 21 391 15 42