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(1) In its Communication of 3 March 2010 entitled ‘Europe 2020 A Strategy for smart, sustainable and inclusive growth’ (‘the Europe 2020 strategy’), the Commission emphasised the need to develop favourable conditions for investment in knowledge and innovation so as to achieve smart, sustainable and inclusive growth in the Union. The European Parliament and the Council have endorsed that strategy.

(2) Regulation (EU) No 1291/2013 of the European Parliament and of the Council established Horizon 2020 — The Framework Programme for Research and Innovation (2014-2020) (‘Horizon 2020’). Horizon 2020 aims at achieving a greater impact on research and innovation by contributing to the strengthening of public-public partnerships, including through Union participation in programmes undertaken by several Member States in accordance with Article 185 of the Treaty on the Functioning of the European Union.

(3) Public-public partnerships should aim to develop closer synergies, increase coordination and avoid unnecessary duplication with Union, international, national and regional research programmes, and should fully respect the Horizon 2020 general principles, in particular those relating to openness and transparency. Moreover, open access to scientific publications should be ensured.

(4) By Decision No 1209/2003/EC of the European Parliament and of the Council , the Community decided to make a financial contribution to the European and Developing Countries Clinical Trials Partnership (‘EDCTP1’) matching that of the Participating States but not exceeding EUR 200 000 000, for the duration of the Sixth Framework Programme of the European Community for research, technological development and demonstration activities, contributing to the creation of the European Research Area and to innovation (2002 to 2006) established by Decision No 1513/2002/EC of the European Parliament and of the Council . EDCTP1 was also supported under the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 – 2013) established by Decision No 1982/2006/EC of the European Parliament and of the Council .

(5) In 2009, independent experts adopted the report of the interim evaluation of EDCTP1. The opinion of the expert panel was that EDCTP1 provided a unique platform for a genuine dialogue with African scientists, and that it has started to bridge the gap between North and South in building research capacities and in providing learning and working opportunities for young African researchers. Following that report, there are fundamental issues to be taken into consideration for a second European and Developing Countries Clinical Trials Partnership Programme (‘EDCTP2 Programme’): the current scope of EDCTP1 needs to be amended and extended; the capabilities in developing countries for the sound conduct and management of clinical trials should, where necessary, be further developed and strengthened, in particular the role and development of ethical review committees and the corresponding regulatory environment, the coordination, collaboration and, where appropriate, integration of European national programmes should be further improved; collaboration with other major public and private partners, including the pharmaceutical industry, and public-private partnerships such as the Product Development Partnerships (‘PDPs’), civil society, non-governmental organisations and foundations, need to be strengthened and extended; there should be clear and transparent rules of governance; synergies with European external policy actions should be developed specifically with Union development assistance; co-funding rules should be clarified and simplified; and monitoring tools need to be strengthened.

(6) Pursuant to Council Decision 2013/743/EU , further support may be provided to the EDCTP2 Programme.

(7) The Union is a major funder of research into poverty-related diseases and neglected infectious diseases. The Commission and Member States contribute nearly one quarter (22 %) of the relevant global investment made by governments. The Union is also a major player in global health. For example, the Commission and the Member States provide approximately half the financing of the Global Fund To Fight AIDS, Tuberculosis and Malaria.

(8) EDCTP1 produced major achievements, and developed eight improved medical treatments, in particular for newborns, children and pregnant or breastfeeding women suffering from HIV/AIDS or malaria. It has resulted in the launch of the first four African Regional Networks of Excellence promoting South-South cooperation on clinical research, and more than 400 African researchers have been trained. It has also contributed to establishing the Pan-African Clinical Trials Registry and the African Vaccine Regulators Forum.

(9) Despite the considerable results and achievements of EDCTP1, poverty-related diseases still represent a major obstacle to the sustainable development of developing countries due to their social and economic burden, especially in sub-Saharan Africa. Effective, safe, suitable and affordable medical treatments tailored to the specific circumstances of developing countries 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. It should be underlined that only 10 % of global research funding is allocated to the diseases which account for 90 % of the world’s pathologies. Moreover, European research activities and programmes are still often fragmented and are therefore either subcritical in scale or overlapping, whereas research capacity and investment in developing countries are inadequate.

(10) Supporting the fight against poverty-related diseases would also help to safeguard Europe’s citizens from those diseases as increasing global mobility (including tourism), migratory movements and shifts in the geographic distribution of those diseases mean that Europe may be facing new or returning challenges in connection with those diseases.

(11) On 15 June 2010, the European Parliament adopted a resolution on progress towards achieving the Millennium Development Goals (‘MDG’) in advance of the UN high-level meeting in September 2010, in which it asked the Commission, the Member States and developing countries to address MDG 5 (on improving maternal health), MDG 4 (on child mortality) and MDG 6 (on HIV/AIDS, malaria and tuberculosis) in a coherent and holistic way.

(12) The Union is committed to the 2012 Rio+20 conference conclusions on developing and achieving internationally-agreed Sustainable Development Goals (‘SDG’), following and including the MDG.

(13) In 2000, the Union launched a high-level policy dialogue with Africa leading to the establishment of an Africa-EU Strategic Partnership, following which a Joint Africa-EU Strategy was adopted in 2007 and a high-level policy dialogue on Science, Technology and Innovation was established in 2011.

(14) On 31 March 2010, the Commission presented a communication on the Union’s role in global health, which called for a more coordinated approach among Member States and across relevant policies to identify and jointly address shared global priorities for health research. In that communication, the Commission also restated the need to promote equitable and universal coverage of quality health services, plus effective and fair financing of research that benefits the health of all people.

(15) In the Council Conclusions of 10 May 2010 on the EU role in global health, the Council called on the Union to promote effective and fair financing of research that benefits the health of all and ensures that innovations and interventions lead to affordable and accessible solutions. In particular, models that dissociate the costs of Research and Development (‘R&D’) from the prices of medicines should be explored, including the opportunities for technology transfer to developing countries.

(16) In its Communication of 21 September 2011 on partnering in research and innovation, the Commission put partnerships across institutional, national and continental borders at the centre of the Union’s research policy.

(17) In its Communication of 27 February 2013 entitled ‘A decent life for all: ending poverty and giving the world a sustainable future’, the Commission reaffirmed its commitment to doing its utmost to help achieve the MDG by 2015, and pointed out that EU-funded research under EDCTP1 had contributed to achieving the MDG.

(18) In line with the objectives of Horizon 2020, any Member State and any country associated to Horizon 2020 should be entitled to participate in the EDCTP2 Programme.

(19) Contribution to the exploration of open innovation models for needs-driven research, and available and affordable outcomes in alignment with other Union commitments in health R & D should be considered.

(20) The Participating States intend to contribute to implementing the EDCTP2 Programme during the period covered by it, namely 2014 – 2024. In order to take into account the duration of Horizon 2020, calls for proposals under the EDCTP2 Programme should be launched at the latest by 31 December 2020. In duly justified cases, calls for proposals may be launched by 31 December 2021.

(21) A ceiling should be established for the Union’s financial participation in EDCTP2 Programme for the duration of Horizon 2020. Within the limits of that ceiling, the Union contribution should be equal to the contribution of the states referred to in this Decision in order to achieve a high leverage effect and ensure a stronger integration of those states’ programmes.