Decision 2014/556 - Decision 556/2014/EU on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States - Main contents
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official title
Decision No 556/2014/EU of the European Parliament and of the Council of 15 May 2014 on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States| Legal instrument | Decision |
|---|---|
| Number legal act | Decision 2014/556 |
| Original proposal | COM(2013)498  |
| CELEX number i | 32014D0556 |
| Document | 15-05-2014 |
|---|---|
| Publication in Official Journal | 07-06-2014; OJ L 169 p. 38-53 |
| Effect | 27-06-2014; Entry into force Date pub. +20 See Art 13 |
| Deadline | 30-06-2017; Review |
| End of validity | 31-12-9999 |
7.6.2014 |
EN |
Official Journal of the European Union |
L 169/38 |
DECISION No 556/2014/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 15 May 2014
on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 185, and the second paragraph of Article 188, thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(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 (3) 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 (4), 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 (5). 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 (6). |
(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... |
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