This programme aims to contribute to the reduction of the social and economic burden of poverty-related diseases in developing countries and in particular in sub-Saharan Africa by accelerating the clinical development of effective, safe and affordable medical interventions for poverty-related diseases.
Budget of €683 million from the EU (Horizon 2020) and €683 from the Member States.
The EU contribution will be made from the 'health, demographic change and wellbeing' challenge as part of the implementation of Horizon 2020.
Contributions from the participating states will consist of financial contributions and 'in kind' contributions towards the costs of implementing activities.
Poverty-related diseases represent a major obstacle to the sustainable development of developing countries, especially in sub-Saharan Africa. Effective, safe and affordable medical treatments still do not exist for most poverty related diseases and investment in clinical research remains inadequate as conducting clinical trials is costly and the return on investment is limited due to market failure.
The second European and Developing Countries Clinical Trials Partnership (EDCTP2) will address this by investing in the research and development of new or improved medical interventions against poverty-related diseases with the aim of benefiting developing countries, particularly sub-Saharan African countries.
The specific objectives of the programme are:
- An increased number of new or improved medical interventions for HIV/AIDS, tuberculosis, malaria and other poverty-related diseases, and by the end of the programme to have delivered at least one new medical intervention, such as a new drug or a new vaccine against TB or any other poverty-related disease; to have issued at least 30 guidelines for improved or extended use of existing medical interventions; and to have progressed the clinical development of at least 20 candidate medical interventions.
- Strengthened cooperation with sub-Saharan African countries, in particular on building their capacity for conducting clinical trials in full compliance with fundamental ethical principles and relevant national, EU and international legislation, including the EU’s Charter of Fundamental Rights, the European Convention on Human Rights and its Supplementary Protocols, the 2008 version of the World Medical Association’s Declaration of Helsinki and the standards on good clinical practice of the International Conference on Harmonisation.
- Better coordination, alignment and integration of relevant national programmes to increase the cost-effectiveness of European public investments.
- Extended international cooperation with other public and private funders.
- An increased impact due to effective cooperation with relevant EU initiatives, including EU development assistance.
Consortia consisting of a minimum of two legal entities established in two different participating states, and third entity in a sub-Saharan African country listed in the current work plan may apply.
The participating states are: Belgium, Denmark, Germany, Ireland, Greece, Spain, France, Italy, Luxembourg, the Netherlands, Austria, Portugal, Sweden, and the United Kingdom as well as Switzerland and Norway.
However, any Member State and any country associated to the Horizon 2020 Framework Programme may participate in the programme.
The rules for participation and dissemination in Horizon 2020 apply, with some derogations.
Any activities funded will be considered as indirect actions under the rules for participation and dissemination in Horizon 2020.
The following activities will be supported:
- Promoting networking, coordination, alignment, cooperation and integration of national research programmes and activities on poverty-related infectious diseases at scientific, management and financial level.
- Supporting clinical trial research and related activities on poverty-related diseases, in particular HIV/AIDS, malaria, tuberculosis and neglected infectious diseases.
- Fostering capacity development for clinical trials and related research in developing countries through grants for:
- Career development of junior/senior fellows
- Promoting mobility
- Staff exchange grants
- Research training networks
- Strengthening ethics and regulatory bodies
- Mentoring and partnerships at individual or institutional level
- Establishing cooperation and launching joint actions with other public and private funders.
- Assuring awareness, endorsement and acknowledgment of the EDCTP2 Programme and its activities through advocacy and communication.
TYPES OF GRANTS
Research & Innovation Actions (RIAs)
Actions primarily consisting of clinical research activities and clinical trials in partnership with sub-Saharan Africa aiming at increasing the number of new or improved medical interventions for HIV/AIDS, tuberculosis, malaria and other poverty-related diseases, including neglected ones, in particular in sub-Saharan Africa.
Actions may normally include one or more clinical trials (phase I to IV) conducted in sub-Saharan Africa, in particular phase II and/or III trials. Actions involving the conduct of phase II and III trials of drugs and vaccines will normally include a regulatory strategy. Whilst clinical trial(s) represent the main activity, the action may involve additional relevant research studies such as nested sub-studies or epidemiological studies. These actions may also involve supporting activities fostering networking (within Africa and within Europe, as well as between Africa and Europe) or capacity development of researchers, institutions and sites in sub-Saharan Africa to conduct clinical trials and related research, including observational studies.
Coordination & Support Actions (CSAs)
Actions primarily consisting of accompanying measures, such as activities to:
- Develop, strengthen and extend clinical research capacities in sub-Saharan Africa.
- Promote networking and collaboration both between European and African researchers and among African researchers, clinical research institutions and sites.
- Foster coordination and cooperation between public and private funders.
Actions may involve activities of standardisation, dissemination, awareness-raising and communication, conduct of preparatory and accompanying studies, networking, coordination or support services, policy dialogues and mutual learning exercises and studies.
Actions may also include complementary activities of strategic planning, networking and coordination between regional and national programmes and targeted measures to maximise the public health impact of research results stemming from EDCTP-funded activities in sub-Saharan Africa.
In particular, CSAs will support sub-Saharan African countries in developing a robust ethical and regulatory framework for conducting clinical trials, targeting both national ethics committees (NECs) and national regulatory authorities (NRAs) as well as supporting regional clinical research networks in sub-Saharan Africa (“EDCTP Regional Networks”) in order to build and strengthen regional, national, institutional and individual capacities to conduct clinical trials according to ICH-GCP standards.
Training & Mobility Actions (TMAs)
Actions primarily consisting of activities fostering career development of individual junior and senior fellows from sub-Saharan Africa, supporting training and mentorship of researchers, and promoting mobility of individual researchers and research staff.
Applications are made in response to Calls for Proposals.
Application is made online - a link is provided alongside the Call for Proposals.
Annual work plans will identify topics and activities to be implemented, and Calls for Proposals will be launched.
Thes first workplan will cover the initial two years of the second EDCTP programme (2014-2015), in order to align with the EC work programmes for Horizon 2020. In subsequent years the workplan will be published annually, covering one-year periods.