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OBJECTIVES OF THE EDCTP2 PROGRAMME EDCTP2 shall contribute to the following objectives:

(1) General Objective EDCTP2 shall contribute to the reduction of the social and economic burden of poverty-related diseases in developing countries, in particular in sub-Saharan Africa, by accelerating the clinical development of effective, safe, accessible, suitable and affordable medical interventions for poverty-related diseases, in partnership with sub-Saharan Africa.

(2) Specific Objectives In order to contribute to the general objective, EDCTP2 shall achieve the following specific objectives:

(a) an increased number of new or improved medical interventions for HIV/AIDS, tuberculosis, malaria and other poverty-related diseases, including neglected ones, and by the end of the programme to have delivered at least one new medical intervention; to have issued approximately 30 guidelines for improved or extended use of existing medical interventions; and to have progressed the clinical development of approximately 20 candidate medical interventions;

(b) strengthened cooperation with sub-Saharan African countries, in particular on building their capacity for conducting clinical trials in compliance with fundamental ethical principles and relevant national, Union and international legislation, including the Charter of Fundamental Rights of the European Union, the European Convention on Human Rights and its Supplementary Protocols, the World Medical Association’s Declaration of Helsinki of 2008 and the standards on good clinical practice adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH);

(c) better coordination, alignment and, where appropriate, integration of relevant national programmes to increase the cost-effectiveness of European public investments. Moreover, the research priorities should be established in an objective-orientated manner in order to accelerate results and contribute to the control and eradication of poverty-related diseases, including neglected ones;

(d) extended international cooperation with other public and private partners to ensure that the impact of all research is maximised and that synergies can be taken into consideration and achieve leveraging of resources and investments;

(e) an increased impact due to effective cooperation with relevant Union initiatives, including its development assistance.

(3) Operational Indicators and Objectives In order to reach the specific objectives set out in point 2, the following indicators shall be monitored during the course of the EDCTP2 programme:

(a) Support clinical trials on new or improved medical interventions for poverty-related diseases, including neglected ones, through partnerships between European and developing countries, in particular sub-Saharan Africa: Indicator: increase the number of supported clinical trials to at least 150, compared to 88 under EDCTP1, that lead to new products, processes, methodologies, diagnostics, treatments or preventions. Indicator: sustain or increase the proportion of clinical trials funded by the EDCTP2-IS with African leadership. Indicator: aim to increase the number of peer-reviewed scientific articles published to three times that of EDCTP1.

(b) Support research capacity-building activities in sub-Saharan Africa enabling clinical trials to be conducted and help to reduce the brain drain: Indicator: aim to sustain or increase the participation of sub-Saharan African countries in the EDCTP2 Programme. Indicator: increase the number of fellowships to sub-Saharan African researchers and MSc/PhD students from 400 under EDCTP1, strongly encouraging and supporting them to continue their research career in sub-Sahara Africa following their fellowship. Indicator: increase the number of capacity-building activities supported for conducting clinical trials in sub-Saharan Africa from 74 under EDCTP1.

(c) Develop a research agenda for EDCTP2 based on common criteria for priority setting and common evaluation, whilst recognising that contributions from national programmes and EDCTP may differ. Target: at least 50 % of the public investment by Participating States are integrated, aligned or coordinated through the EDCTP2 Programme.

(d) Ensure efficiency of the implementation of the EDCTP2 Programme: Target: administrative costs are below 5 % of the EDCTP2-IS budget.

(e) Establish cooperation and launch joint actions with other public and private funders. Target: increase the contributions received from developing countries to at least EUR 30 000 000 compared to EUR 14 000 000 under EDCTP1. Target: obtain additional contributions, either public or private, of at least EUR 500 000 000, compared to EUR 71 000 000 under EDCTP1.

(f) Establish cooperation and launch joint actions with Union, national and international development assistance initiatives, including where appropriate, relevant WHO initiatives, in order to ensure complementarity and increase the impact of the results of EDCTP-funded activities.