Besluit 2014/556 - Deelname van de Unie aan een tweede, door verscheidene lidstaten gezamenlijk opgezet partnerschapsprogramma voor klinische proeven tussen Europese en ontwikkelingslanden (EDCTP2) - Hoofdinhoud

EU fighting poverty-related diseases in developing countries: EDCTP2

EDCTP2 is a joint programme designed to help organisations from developing countries and the EU working together on clinical trials. It aims to support the clinical development of new or improved diagnostics, drugs, vaccines and microbicides against diseases which burden sub-Saharan Africa.

ACT

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.

SUMMARY

EDCTP2, which follows up on EDCTP1, is co-funded by the European Union’s (EU) Horizon 2020 Programme and some participating states. Article 185 of the Treaty on the Functioning of the European Union enables the EU to participate in research programmes undertaken jointly by several EU countries (Public-Public Partnerships).

The objective of EDCTP2 is to contribute to reducing the social and economic burden of poverty-related diseases in developing countries, in particular in sub-Saharan Africa. It aims to accelerate the clinical development of effective, safe, accessible, suitable and affordable medical interventions for poverty-related diseases.

Focus

EDCTP2’s work covers:

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  HIV/AIDS,
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  malaria,
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  tuberculosis,
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  a series of neglected tropical diseases (except Chagas),
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  diarrhoeal, and
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  lower respiratory infections.

Participation and funding

Participation in EDCTP2 projects takes place in line with Horizon 2020 rules for participation and dissemination (Regulation 1290/2013) and the specific conditions contained in the EDCTP2 Decision:

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  the minimum number of participants in an action is two bodies established in two participating states and a third body in a sub-Saharan country;
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  legal entities established in a sub-Saharan country listed in the EDCTP2 annual work plan are eligible for funding;
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  joint calls with non-EU countries or their scientific/technological agencies, with international organisations or with other third parties may be launched by the implementation structure.

Further rules on eligibility for participation and funding are found in EDCTP2 annual work plans.

Project implementation

EDCTP2 projects include:

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  promoting networking, coordination, alignment, collaboration and integration of national research programmes and activities on the diseases (listed above) at scientific, management and financial level;
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  supporting clinical trial research and related activities;
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  capacity development for clinical trials and clinical research, in particular in sub-Saharan Africa;
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  establishing cooperation and launching joint actions with other public and private funders;
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  assuring awareness, support and acknowledgement of the EDCTP2 programme and its activities through advocacy and communication.

Implementation structure

The EDCTP Association implements EDCTP2. The structure provides financial support to participants in actions that it selects through calls for proposals under its responsibility.

Budget

The EU’s financial contribution, including EFTA contributions, amounts to €683 million which equals that of the participating European countries. This covers the period 2014-24.

For further information: presentation by EDCTP

REFERENCES

RELATED ACTS

Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-20) and repealing Decision No 1982/2006/EC (Official Journal L 347 of 20.12.2013, pp. 104-173).

Council Decision 2013/743/EU of 3 December 2013 establishing the specific programme implementing Horizon 2020 - the Framework Programme for Research and Innovation (2014-20) and repealing Decisions 2006/971/EC, 2006/972/EC, 2006/973/EC, 2006/974/EC and 2006/975/EC (Official Journal L 347 of 20.12.2013, pp. 965-1041).

Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in Horizon 2020 - the Framework Programme for Research and Innovation (2014 -20) and repealing Regulation (EC) No 1906/2006 (Official Journal L 347, 20.12.2013, pp. 81-103).

10.08.2014

Deze samenvatting is overgenomen van EUR-Lex.