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.
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)
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.
EDCTP-2 Activity Areas
Disease-specific priorities for clinical trials and health services/optimisation research:
Portuguese Contribution to EDCTP since 2014
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. Between 2014 and 2016 the 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. 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 € to the cofunding of the coordination and support action WANETAM (West African Network for TB Aids and malaria), coordinated by Souleymane Mboup (Cheikh Anta Diop University, Senegal), with participation of Henrique Silveira (Instituto de Higiene e Medicina Tropical da Universidade Nova de Lisboa), supported under the 2015 EDCTP Call for Networks of Excellence. Project's total cost: 3.000.000,00 €.
In 2017 FCT has contributed 200.000 € to the cofunding of the coordination and support action LusoAfro Bio-Ethics (Strenghtening Bioethics Committees in Lusophone African Region), coordinated by João Schwalbach (Bioethics for Health National Committee, Mozambique), with participation of Instituto de Higiene e Medicina Tropical and Faculdade de Direito da Universidade Nova de Lisboa, supported under the 2016 EDCTP Call on Ethics and Regulatory Capacities. Project's total cost: 291.496,26 €.
In 2018 FCT has contributed 125.000 € to the cofunding of the research and innovation action HAT-r-ACC (Towards an arsenic-free oral treatment for human African trypanosomiasis due to Tb rhodesiense as a tool for disease elimination), coordinated by Olaf Valverde Mordt (DNDi, Switzerland), with the participation of Instituto de Higiene e Medicina Tropical da Universidade Nova de Lisboa, supported under the 2017 call targeting control and elimination of NIDs through clinical trials. Project's total cost: 3.769.845,50 €.
On April 20, 2018 FCT supported the session Networking the networks: Maximising impact by strengthening collaboration, capacity and quality of clinical research in sub-Saharan Africa, under the auspices of the Regional Meeting of the World Health Summit in Coimbra, with a 25.000 € contribution. From September 17 to 21 2018, FCT co-hosted 9th EDCTP Forum with the Calouste Gulbenkian Foundation in Lisboa with a 50.000 € contribution.
Other Actions with Portuguese Participation since 2014 (without FCT cofunding)
Coordination and support action TESA II (Trials of Excellence in Southern Africa II), coordinated by Eusébio Macete (Fundação Manhiça, Mozambique), with participation of PT-CRIN (as part of ECRIN), supported under the 2015 EDCTP Call for Networks of Excellence. Project's total cost: 3.000.000,00 €.
Coordination and support action BERC-Luso (Biomedical Ethics and Regulatory Capacity Building Partnership fo Portuguese-Speaking African Countries), coordinated by Maria do Céu Patrão Neves (Ordem dos Farmacêuticos), supported under the 2016 EDCTP Call on Ethics and Regulatory Capacities. Project's total cost: 300.000,00 €.
Research and innovation action Life study (Neonatal HIV early infant diagnosis (EID) versus standard-of-care EID – Impact on infant health: a feasibility study of point-of-care testing at birth versus at 6 weeks of age on the uptake of ART and infant prophylaxis, and on rate of infant survival, morbidity and retention in care), coordinated by Ilesh Jani (National Institute of Health, Mozambique), with participation of Nuno Taveira (Faculdade de Farmácia da Universidade de Lisboa), supported under the 2016 EDCTP Call for Clinical trials to reduce health inequities in pregnant women, newborns and children. Project's total cost: 2.998.498,13 €.
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
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