7.6.2014 EN Official Journal of the European Union L 169/1 DECISION No 553/2014/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 on the participation of the Union in a Research and Development Programme jointly undertaken by several Member States aimed at supporting research and development performing small and medium-sized enterprises (Text with EEA relevance) 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. Both the European Parliament and the Council have endorsed this 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 with respect to 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 743/2008/EC of the European Parliament and of the Council (4), the Community decided to make a financial contribution to Eurostars, a joint research and development programme undertaken by all Member States and five participating countries in the framework of Eureka, an intergovernmental initiative established in 1985 with the objective of promoting cooperation in industrial research (‘Eurostars’). (5) In April 2012, the Commission communicated to the European Parliament and the Council a report on the interim evaluation of Eurostars carried out by a Group of Independent Experts two years after the beginning of the programme. The overall opinion of the experts was that Eurostars meets its objectives, adds value to European research and development performing small and medium-sized enterprises (‘SMEs’) and should be continued after 2013. Eurostars is also considered to meet a number of genuine needs of SMEs engaged in research and development; it has attracted a large number of applications, with the budget for projects eligible for funding exceeding the initial budget. A number of recommendations for improvement were made, mainly addressing the need of further integration of national programmes and improvements in the operational performance in order to reach shorter time-to-contract and more transparency in the procedures. (6) The definition of SME provided for in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (5) should apply. (7) In accordance with Council Decision 2013/743/EU (6), support may be provided to an action building on Eurostars and reorienting it along the lines stated in its interim evaluation. (8) The second Research and Development Programme jointly undertaken by several Member States aimed at supporting research and development performing small and medium-sized enterprises (‘Eurostars-2’), aligned with the Europe 2020 strategy, its flagship initiative ‘Innovation Union’ and the Commission Communication of 17 July 2012 entitled ‘A Reinforced European Research Area Partnership for Excellence and Growth’, will aim to supporting research and development performing SMEs by co-financing their market oriented research projects in any field. As such, and in combination with the activities under the ‘Leadership in Enabling and Industrial Technologies’ objective set out in Horizon 2020, it will contribute to the goals of the Industrial Leadership part of that programme to speed-up development of the technologies and innovations that will underpin tomorrow’s businesses and help innovative European SMEs to grow into world-leading companies. As part of the improvements from the previous Eurostars programme, Eurostars-2 should head towards shorter time-to-grant, stronger integration and lean, transparent and more efficient administration to the ultimate benefit of research and development performing SMEs. To keep the bottom-up nature and the business-driven agenda with its main focus on market potential from the previous Eurostars programme is key to the success of Eurostars-2. (9) In order to take into account the duration of Horizon 2020, calls for proposals under Eurostars-2 should be launched at the latest by 31 December 2020. In duly justified cases calls for proposals may be launched by 31 December 2021. (10) The Eureka Ministerial Conference on 22 June 2012 in Budapest endorsed a strategic vision for Eurostars-2 (‘Budapest Document’). The ministers committed to support the continuation of Eurostars after its termination in 2013 for the period covered by Horizon 2020. This will consist of a reinforced partnership addressing the recommendations of the interim evaluation of Eurostars. The Budapest Document sets out two main objectives for Eurostars-2. Firstly, a structural-oriented objective to deepen the synchronisation and alignment of the national research programmes in the field of funding, which is a central element towards the realisation of the European Research Area by the member countries. Secondly a content-related objective to support research and development performing SMEs engaging in transnational research and innovation projects. The Budapest Document invites the Union to participate in Eurostars-2. (11) For the purpose of simplification, administrative burdens should be reduced for all parties. Double audits and disproportionate documentation and reporting should be avoided. When audits are conducted, the specificities of the national programmes should be taken into account, as appropriate. (12) Audits of recipients of Union funds provided under Eurostars-2 should be carried out in accordance with Regulation (EU) No 1291/2013. (13) The Participating States intend to contribute to the implementation of Eurostars-2 during the period covered by Eurostars-2 (2014-2024). (14) Eurostars-2 activities should be in line with the objectives and bottom-up principles of Horizon 2020 and with the general principles and conditions laid down in Article 26 of Regulation (EU) No 1291/2013. (15) A ceiling should be established for the Union’s financial contribution to Eurostars-2 for the duration of the Horizon 2020. Within the limits of that ceiling, there should be flexibility regarding the Union’s contribution, which should be at least one third but no more than half of the contribution of the Participating States in order to ensure a critical mass necessary to satisfy the demand from projects eligible for financial support, to achieve a high leverage effect and ensure stronger integration of national research programmes of the Participating States. (16) In accordance with the objectives of Regulation (EU) No 1291/2013, any Member State and any country associated to Horizon 2020 should be entitled to participate in Eurostars-2. (17) Any Eureka Member or country associated to Eureka that is not a Member State or a country associated to Horizon 2020 may become a Eurostars-2 partner country. (18) The Union’s financial contribution should be subject to formal commitments from the Participating States to contribute to the implementation of Eurostars-2 and to the fulfilment of those commitments. Financial support under Eurostars-2 should mainly take the form of grants to projects selected following calls for proposals launched under Eurostars-2. In order to meet the objectives of Eurostars-2, the Participating States shall ensure sufficient financial contributions to fund a reasonable number of proposals selected through each call. (19) The joint implementation of Eurostars-2 requires an implementation structure. The Participating States have agreed on designating the Eureka Secretariat (‘ESE’) as the implementation structure for Eurostars-2. ESE is an international non-profit association established under Belgian law in 1997 by the Eureka countries and, since 2008, is responsible for the implementation of Eurostars. ESE’s role goes beyond the implementation of Eurostars, being at the same time the secretariat of the Eureka initiative, with its own governance linked to the management of Eureka projects outside of Eurostars. The Union, represented by the Commission, is a founding member of the Eureka initiative and full member of the Eureka Secretariat association. (20) In order to achieve the objectives of Eurostars-2, ESE should be in charge of the organisation of the calls for proposals, the verification of the eligibility criteria, the peer-review evaluation and the selection and the monitoring of projects, as well as the allocation of the Union contribution. The evaluation of proposals should be performed centrally by independent external experts under the responsibility of ESE following calls for proposals. The projects’ ranking list should be binding for the Participating States as regards the allocation of funding from the Union’s financial contribution and from contribution from Participating States. (21) Overall, Eurostars-2should demonstrate clear progress towards further alignment and synchronisation of the national research and innovation programmes as a truly joint programme featuring stronger scientific, management and financial synchronisation. Stronger scientific integration should be achieved through the common definition and implementation of activities and should ensure the excellence and the high impact of the projects selected. Management integration should ensure further improvement of operational excellence and accountability for the programme. Stronger financial integration should be based on overall and yearly adequate financial contribution by the States participating in Eurostars-2 and a high degree of national synchronisation. This should be achieved through a progressive harmonisation of national funding rules. (22) The Union’s financial contribution should be managed in accordance with the principle of sound financial management and with the rules on indirect management set out in Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (7) and Commission Delegated Regulation (EU) No 1268/2012 (8). (23) In order to protect the Union’s financial interests, the Commission should have the right to reduce, suspend or terminate the Union’s financial contribution if Eurostars-2 is implemented inadequately, partially or late, or if the Participating States do not contribute, or contribute partially or late, to the financing of Eurostars-2. Those rights should be provided for in the delegation agreement to be concluded between the Union and the ESE. (24) Participation in indirect actions funded by Eurostars-2 is subject to Regulation (EU) No 1290/2013 of the European Parliament and of the Council (9). However, due to the specific operating needs of Eurostars-2, it is necessary to provide for derogations from that Regulation in accordance with Article 1(3) of that Regulation. (25) In order to facilitate the participation of SMEs which are more used to national channels and which would otherwise carry out research activities only within their national boundaries, the Eurostars-2 financial contribution should be provided in accordance with the well-known rules of their national programmes and implemented through a funding agreement directly administered by the national authorities, combining Union funding with the corresponding national funding. A derogation should therefore be made from Article 15(9), Articles 18(1), 23(1), (5) to (7), 28 to 34 of Regulation (EU) No 1290/2013. (26) Calls for proposals by Eurostars-2 should also be published on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission. (27) The Union’s financial interests should be protected by means of proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties in accordance with Regulation (EU, Euratom) No 966/2012. (28) The Commission, in cooperation with the Participating States, should conduct an interim evaluation assessing in particular the quality and efficiency of Eurostars-2 and progress towards the objectives set, as well as a final evaluation and prepare a report on those evaluations. (29) Upon request from the Commission, ESE and the Participating States should submit any information which the Commission needs to include in the reports on the evaluation of Eurostars-2. (30) Since the objectives of this Decision, namely to support transnational research activities performed by research-intensive SMEs and to contribute to the integration, alignment and synchronisation of national research funding programmes cannot be sufficiently achieved by the Member States due to lack of transnational dimension and of complementarity and interoperability of national programmes but can rather, by reason of the scale and impact of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS DECISION: Article 1 Subject matter This Decision lays down rules on the participation of the Union in the second Research and Development Programme jointly undertaken by several Member States aimed at supporting research and development performing small and medium-sized enterprises (‘Eurostars-2’) and the conditions for its participation. Article 2 Definitions For the purpose of this Decision the following definitions apply: (1) ‘SME’ means a micro-, small- and medium-sized enterprises, as defined in Recommendation 2003/361/EC; (2) ‘research and development performing SME’ means an SME which meets at least one of the following conditions: (a) reinvests at least 10 % of its turnover to research and development activities; (b) dedicates at least 10 % of its full-time equivalents to research and development activities; (c) has at least five full-time equivalents (for SME with no more than 100 full-time equivalents) for research and development activities; or (d) has 10 full-time equivalents (for SME with over 100 full-time equivalents) for research and development activities. Article 3 Objectives Eurostars-2 shall pursue the following objectives: (1) promote research activities that comply with the following conditions: (a) the activities are carried out by transnational collaboration of research- and development performing SMEs among themselves or including other actors of the innovation chain (e.g. universities, research organisations); (b) results of activities are expected to be introduced into the market within two years of the completion of an activity; (2) increase the accessibility, efficiency and efficacy of public funding for SMEs in Europe by aligning, harmonising and synchronising the national funding mechanisms of Participating States; (3) promote and increase the participation of SMEs without previous experience in transnational research. Article 4 Participation in and partnership with Eurostars-2 1. The Union shall participate in Eurostars-2 jointly undertaken by Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom, (the "Participating States"), in accordance with the conditions laid down in this Decision. 2. Any Member State other than those listed in paragraph 1 and any other country associated to Horizon 2020 may participate in Eurostars-2 provided it fulfils the condition laid down in point (c) of Article 6(1) of this Decision. If it fulfils the condition laid down in point (c) of Article 6(1), it shall be regarded as a Participating State for the purposes of this Decision. 3. Any Eureka Member or country associated to Eureka that is not a Member State or a country associated to Horizon 2020 may become a Eurostars-2 partner country provided it fulfils the condition set out in point (c) of Article 6(1). Those Eureka Members or countries associated to Eureka that fulfil the condition laid down in point (c) of Article 6(1), shall be regarded as partner countries for the purposes of this Decision. Legal entities from those partner countries shall not be eligible for the Union’s financial contribution under Eurostars-2. Article 5 Union’s financial contribution 1. The Union financial contribution, including EFTA appropriations, to Eurostars-2 shall be up to EUR 287 000 000. The Union’s financial contribution shall be paid from the appropriations in the general budget of the Union allocated to the relevant parts of the Specific Programme, implementing Horizon 2020, established by Decision 2013/743/EU, in accordance with point (c)(vi) of Article 58(1), and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012, and in particular from appropriations under the heading "Innovation in SMEs" under Part II. 2. Without exceeding the amount laid down in paragraph 1, the Union’s contribution shall be at least one third of the contributions of the Participating States referred to in point (a) of Article 7(1). It shall cover operational costs, including the costs of the evaluation of proposals, and administrative costs. Where during the lifetime of Eurostars-2 the rate of the Union’s contribution needs to be adapted, the Union’s contribution may go up to a maximum of half of the contributions of the Participating States referred to in point (a) of Article 7(1). 3. An amount not exceeding 4 % of the Union’s financial contribution referred to in paragraph 1 may be used to contribute to the administrative costs of Eurostars-2. Participating States shall cover the national administrative costs necessary for the implementation of Eurostars-2. Article 6 Conditions for the Union’s financial contribution 1. The Union’s financial contribution shall be conditional upon the following: (a) the demonstration by the Participating States that they have set up Eurostars-2 in accordance with the objectives laid down in Article 3; (b) the designation by the Participating States or organisations designated by Participating States, of the ESE, as the structure responsible for implementing Eurostars-2 and for receiving, allocating and monitoring the Union’s financial contribution; (c) the commitment by each Participating State to contribute to the financing of Eurostars-2; (d) the demonstration by ESE of its capacity to implement Eurostars-2, including receiving, allocating and monitoring the Union’s financial contribution, in the framework of indirect management of the Union budget in accordance with Articles 58, 60 and 61 of Regulation (EU, Euratom) No 966/2012; and (e) the establishment of a governance model for Eurostars-2 in accordance with Annex II. 2. During the implementation of Eurostars-2, the Union’s financial contribution shall also be conditional upon: (a) the implementation by the ESE of Eurostars-2’s objectives set out in Article 3 and activities set out in Annex I, in accordance with the rules for participation and dissemination referred to in Article 8; (b) the maintenance of an appropriate and efficient governance model in accordance with Annex II; (c) compliance by ESE with the reporting requirements set out in Article 60(5) of Regulation (EU, Euratom) No 966/2012; (d) the effective payment by the Participating States of the financial contribution to all participants in Eurostars-2 projects selected for funding following the calls for proposals launched under Eurostars-2, fulfilling the commitments referred to in point (c) of paragraph 1 of this Article; (e) allocation of the funding from the national budgets for Eurostars-2 projects and the Union’s financial contribution in accordance with the ranking lists of the projects; and (f) the demonstration of clear progress in the scientific, managerial and financial cooperation by the establishment of minimum operational performance targets and milestones for the implementation of Eurostars-2. Article 7 Contribution from Participating States 1. Contribution from the Participating States shall consist of the following financial contributions: (a) co-financing of the selected Eurostars-2 projects through relevant national forms of funding, mainly through grants. The Commission may use the established grant equivalence rules for the valuation of the contributions from the Participating States in forms other than grants; (b) financial contribution to the administrative costs of Eurostars-2 not covered by the Union contribution as set out in Article 5(3). 2. Each Participating State shall designate a National Funding Body (NFB) to administer financial support to the national participants in Eurostars-2 in accordance with Article 8. Article 8 Rules for participation and dissemination 1. For the purposes of Regulation (EU) No 1290/2013, the ESE shall be considered to be a funding body. 2. By way of derogation from Article 15(9) of Regulation (EU) No 1290/2013, the NFBs, under the coordination of the ESE, shall verify the financial capacity of all applicants for funding under Eurostars-2. 3. By way of derogation from Article 18(2) of Regulation (EU) No 1290/2013, grant agreements with beneficiaries of indirect actions under Eurostars-2 shall be signed by the NFBs concerned. 4. By way of derogation from Article 23(1), (5), (6) and (7) and Articles 28 to 34 of Regulation (EU) No 1290/2013, the funding rules of the participating national programmes shall apply to Eurostars-2 grants administered by the NFBs. Article 9 Implementation of Eurostars-2 1. Eurostars-2 shall be implemented on the basis of annual work plans. 2. Eurostars-2 shall provide financial support mainly in the form of grants to participants following calls for proposals. Article 10 Agreements between the Union and the ESE 1. Subject to a positive ex-ante assessment of the ESE in accordance with Article 61(1) of Regulation (EU, Euratom) No 966/2012, the Commission, on behalf of the Union, shall conclude a delegation agreement and annual transfer of funds agreements with the ESE. 2. The delegation agreement referred to in paragraph 1 shall be concluded in accordance with Article 58(3) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012, and in accordance with Article 40 of Delegated Regulation (EU) No 1268/2012. It shall also set out the following: (a) the requirements for the ESE regarding the performance indicators set out in Annex II to Decision 2013/743/EU; (b) the requirements for the ESE’s contribution to the monitoring referred to in Annex III to Decision 2013/743/EU; (c) specific performance indicators for the functioning of the ESE in respect of Eurostars-2; (d) requirements for the ESE regarding the provision of information on administrative costs and of detailed figures concerning the implementation of Eurostars-2; (e) arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations; (f) an obligation for the ESE to sign bilateral agreements with the NFBs before any transfers of the Union’s financial contribution take place, such bilateral agreements laying down the minimum operational performance targets and milestones for the implementation of Eurostars-2; (g) provisions for the publication of calls for proposals by Eurostars-2, in particular on the single portal for participants, as well as through other Horizon 2020 electronic means of dissemination managed by the Commission. Article 11 Termination, reduction or suspension of the Union’s financial contribution 1. If Eurostars-2 is not implemented or is implemented inadequately, partially or late, the Commission may terminate, proportionately reduce, or suspend the Union’s financial contribution in line with the actual implementation of Eurostars-2. 2. If the Participating States do not contribute, contribute partially or late to the financing of Eurostars-2, the Commission may terminate, proportionately reduce, or suspend the Union’s financial contribution, taking into account the amount of funding allocated by the Participating States to implement Eurostars-2. Article 12 Ex-post audits 1. ESE shall ensure that ex-post audits of expenditure on indirect actions are carried out by the respective NFBs in accordance with Article 29 of Regulation (EU) No 1291/2013. 2. The Commission may decide to carry out itself the audits referred to in paragraph 1. In such cases, it shall do so in accordance with the applicable rules, in particular the provisions of Regulations (EU, Euratom) No 966/2012, (EU) No 1290/2013 and (EU) No 1291/2013. Article 13 Protection of the financial interests of the Union 1. The Commission shall take appropriate measures ensuring that, when actions financed under this Decision are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties. 2. The ESE shall grant Commission staff and other persons authorised by it, as well as the Court of Auditors, access to its sites and premises and to all the information, including information in electronic format, needed in order to conduct their audits. 3. The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Council Regulation (Euratom, EC) No 2185/96 (10) and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (11), with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with an agreement or decision or a contract funded under this Decision. 4. Contracts, grant agreements and grant decisions resulting from the implementation of this Decision shall contain provisions expressly empowering the Commission, the Court of Auditors, OLAF and the ESE to conduct such audits and investigations, in accordance with their respective competences. 5. In implementing Eurostars-2, the Participating States shall take the legislative, regulatory, administrative or other measures necessary to protect the Union’s financial interests, in particular to ensure full recovery of any amounts due to the Union in accordance with Regulation (EU, Euratom) No 966/2012 and Delegated Regulation (EU) No 1268/2012. Article 14 Communication of information 1. At the request of the Commission, the ESE shall send any information necessary for the preparation of the reports referred to in Article 15. 2. The Participating States shall submit to the Commission, through the ESE, any information requested by the European Parliament, the Council or the Court of Auditors concerning the financial management of Eurostars-2. 3. The Commission shall include the information referred to in paragraph 2 of this Article in the reports referred to in Article 15. Article 15 Evaluation 1. By 30 June 2017, the Commission shall carry out, in close cooperation with the Participating States and with the assistance of independent experts, an interim evaluation of Eurostars-2. The Commission shall prepare a report on that evaluation which includes the conclusions of the evaluation and observations by the Commission. The Commission shall send that report to the European Parliament and to the Council by 31 December 2017. The result of the interim evaluation of Eurostars-2 shall be taken into account in the interim evaluation of Horizon 2020. 2. At the end of the Union’s participation in Eurostars-2, but no later than 31 December 2022, the Commission shall conduct a final evaluation of Eurostars-2. The Commission shall prepare a report on that evaluation which is to include results of that evaluation. The Commission shall send that report to the European Parliament and to the Council. Article 16 Entry into force This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 17 Addressees This Decision is addressed to the Member States. Done at Brussels, 15 May 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) Opinion of 10 December 2013 (not yet published in the Official Journal). (2) Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal) and decision of the Council of 6 May 2014. (3) 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 (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104). (4) Decision No 743/2008/EC of the European Parliament and of the Council of 9 July 2008 on the Community’s participation in a research and development programme undertaken by several Member States aimed at supporting research and development performing small and medium-sized enterprises (OJ L 201, 30.7.2008, p. 58). (5) OJ L 124, 20.5.2003, p. 36. (6) Council Decision 2013/743/EU of 3 December 2013 establishing the specific programme implementing Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020) and repealing Decisions 2006/971/EC, 2006/972/EC, 2006/973/EC, 2006/974/EC and 2006/975/EC (OJ L 347, 20.12.2013, p. 965). (7) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (8) Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 (OJ L 362, 31.12.2012, p. 1). (9) 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 (2014-2020)’ and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, p. 81). (10) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (11) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). ANNEX I Implementation of Eurostars-2 1. The ESE shall organise continuously open calls for proposals, with cut-off dates for the award of financial support to indirect actions. 2. Applicants shall submit project proposals to the ESE as a single entry point. 3. After the closure of a call for proposals, a central eligibility check shall be carried out by the ESE on the basis of the eligibility criteria set out in the annual work plan. No different or further eligibility criteria may be added by the Participating States. 4. The NFBs, under the coordination of the ESE, shall verify the financial capacity of the participants according to common, clear and transparent rules. 5. Eligible proposals shall be evaluated centrally and ranked by a group of external independent experts in accordance with the criteria set out in Article 15(1) of Regulation (EU) No 1290/2013, on the basis of transparent procedures. 6. The ESE shall provide an evaluation review procedure in accordance with Article 16 of Regulation (EU) No 1290/2013. 7. The ranking list, approved as a whole by the Eurostars-2 high-level group referred to in Annex II, shall be binding for the allocation of funding from the national budgets for Eurostars-2 projects. 8. Once the ranking list is approved, each Participating State shall finance its national participants in those projects selected for funding through the designated NFB, making all possible efforts to ensure that the top-50 ranked projects and at least 50 % to 75 % of the projects above thresholds are funded. The financial contribution to the participants shall be calculated according to the funding rules of the national programme of the relevant Eurostars-2 Participating State. The Union’s financial contribution shall be transferred by the ESE to the NFBs provided that the NFBs have paid their financial contribution to the projects. 9. All eligible participants in projects selected centrally shall be funded. The granting of financial support by the NFBs to project participants selected centrally shall be subject to the principles of equal treatment, transparency and co-funding. 10. The ESE shall be responsible for evaluating proposals, informing NFBs, coordinating the synchronisation process, monitoring projects through project reporting and audits carried out by NFBs, and reporting to the Commission ensuring a short time-to-grant. It shall also take appropriate measures to encourage recognition of the Union’s contribution to Eurostars-2, both to the programme itself and to individual projects. It shall promote appropriate visibility for the Union’s contribution through the use of the Horizon 2020 logo in all published material, including printed and electronic publications, related to Eurostars-2. 11. ESE shall conclude Eurostars-2 bilateral agreements with the NFBs of Participating States. Those Eurostars-2 bilateral agreements shall set out the responsibilities of the contracting parties in accordance with the Eurostars-2 rules, objectives and implementation modalities. The Eurostars-2 bilateral agreements shall include the rules governing the transfer of the Union’s contribution and the minimum operational targets and national progressive milestones for further integration and synchronisation of national programmes, including a shorter time-to-grant in accordance with Regulation (EU, Euratom) No 966/2012 and Regulation (EU) No 1290/2013. Those targets and milestones shall be agreed by the Eurostars-2 high-level group in consultation with the Commission. The signature of the Eurostars-2 bilateral agreement and compliance with the operational targets and milestones shall be a pre-condition for NFBs to receive the Union’s contribution. 12. The ESE may conclude Eurostars-2 bilateral agreements with the NFBs of partner countries. Those Eurostars-2 bilateral agreements shall set out the responsibilities of the contracting parties in accordance with the Eurostars-2 rules, objectives and implementation modalities, specify the conditions under which partnership with Eurostars-2 shall take place, and include the minimum operational targets, including a short time-to-grant. 13. Networking activities and exchange of best practices shall also be organised amongst the Participating States in order to promote stronger integration at scientific, managerial and financial level. 14. Other activities shall also include brokerage, programme promotion and networking activities with other stakeholders (investors, research and innovation providers, intermediaries) mainly to widen participation from beneficiaries in all Participating States and to involve SMEs with no prior experience in transnational research projects. ANNEX II Governance of Eurostars-2 1. The ESE shall manage Eurostars-2. The Head of the ESE, as the legal representative of the ESE, shall be in charge of implementing Eurostars-2 by: (a) preparing the annual budget for the calls, central organisation of joint calls for proposals and reception of the proposals as single entry point; the central organisation of the eligibility and evaluation of proposals, according to common eligibility and evaluation criteria, central organisation of the ranking and selection of proposals for funding, and project monitoring and follow-up; the receipt, allocation and monitoring of the Union contribution; (b) collecting the necessary information from the NFBs for the transfer the Union contribution; (c) promoting Eurostars-2; (d) reporting to the Eurostars-2 high-level group and the Commission on the Eurostars-2 programme; (e) informing the Eureka network about the activities of Eurostars-2; (f) signing the delegation agreement with the Commission, the bilateral agreements with the NFBs and the contracts with the experts assessing Eurostars-2 applications; (g) adopting the Eurostars-2 annual work plan following the prior agreement of the Eurostars-2 high-level group and of the Commission. 2. The Eurostars-2 high-level group, composed of the national representatives in the Eureka High Level Group of the Eurostars-2 Participating States, shall supervise the operations of the ESE on Eurostars-2 by: (a) supervising the implementation of Eurostars-2; (b) appointing the members of the Eurostars-2 Advisory Group (‘EAG’); (c) approving the annual work plan; (d) approving the ranking list of Eurostars-2 projects to be funded and taking the award decision. The Union, represented by the Commission, shall have the status of observer in the Eurostars-2 high-level group. The Commission shall be invited to participate at the meetings, shall receive all meeting documents and may take part in the discussion. Any partner country shall have the right to send representatives to meetings of the Eurostars-2 high-level group as observers. 3. The EAG shall be composed of Eureka National Project Coordinators (persons in the national government or agency dealing with the operational level of the management of Eureka/Eurostars programme and in charge of the promotion of Eurostars-2 in the Participating States) from the Participating States. The Commission and partner countries shall have the right to send representatives to the EAG meetings as observers. The EAG meetings shall be chaired by the ESE. The EAG shall advise the ESE and the Eurostars-2 high-level group on the arrangements for the implementation of Eurostars-2. 4. The NFB shall be in charge of the administration of financial support to the national participants.

Summary: Support for research-performing SMEs (Eurostars-2) Support for research-performing SMEs (Eurostars-2) SUMMARY OF: Decision No 553/2014/EU – EU participation in a research and development programme aimed at supporting research and development performing small and medium-sized enterprises WHAT IS THE AIM OF THE DECISION? It sets up Eurostars-2, a joint programme designed for supporting small and medium-sized enterprises (SMEs) performing research and development (R & D) and wishing to work together transnationally. KEY POINTS Eurostars-2, which follows up on Eurostars-1, is co-funded by the European Union’s Horizon 2020 programme and the national budgets of more than 30 participating and partner countries of Eurostars-2. The partner countries are EUREKA members or countries associated with Eureka. The EU participates in this joint programme on the basis of Article 185 of the Treaty on the Functioning of the European Union (public-public partnership). Objectives Eurostars-2 aims to contribute to the further alignment and synchronisation of national R & D programmes. This is in order to achieve stronger scientific, management and financial integration of R & D across Europe. It seeks to support research-performing SMEs (see below) to increase their knowledge and research intensity — and thus their innovative capacity — so as to expand their business activities into larger, often international, markets. This contributes to competitiveness, growth and job creation. Definition A ‘research and development-performing SME’ is defined as an SME which meets at least one of the following conditions: it reinvests at least 10 % of its turnover in R & D activities; it dedicates at least 10 % of its full-time equivalents (or the same number of hours worked by part-time staff) to R & D activities; it has at least 5 full-time equivalents (for SMEs with fewer than 100 full-time equivalents) or 10 full-time equivalents (for SMEs with over 100 full-time equivalents) for R & D activities. Participation and funding Participation of legal entities under Eurostars-2 projects takes place in line with Horizon 2020 rules for participation and dissemination (Regulation (EU) No 1290/2013) and the specific derogations contained in this Eurostars-2 decision. Other legal entities, such as universities and research institutes, may also participate in Eurostars-2 projects. Legal entities from Eurostars-2 partner countries are not eligible for an EU financial contribution. The funding rules of the participating national programmes apply to Eurostars-2 grants which are channelled through National Funding Bodies (NFBs) to final beneficiaries. Further rules on eligibility for participation and funding are detailed in Eurostars-2 annual work plans. Projects Eurostars-2 projects are ‘bottom up’, transnational and focus on results that have market potential, i.e. within 2 years of the completion of an activity, the results of the projects are expected to be introduced on the market. Implementation ESE, the Eureka Secretariat, has been designated by the participating countries to implement Eurostars-2. ESE concludes bilateral agreements with NFBs which set out the responsibilities of the parties in relation to Eurostars-2 rules, objectives and implementation arrangements. ESE organises the calls for proposals, the peer review (evaluation of work by one or more people of similar competence to the producers of the work (peers)), the selection and the monitoring of projects, as well as the allocation of the EU contribution. Budget The EU is contributing € 287 million to Eurostars-2 projects over the 2014–2024 period. This contribution is equivalent to at least one-third of the contribution provided by the national budgets of participating countries. Some funding also comes from participating organisations. The EU’s financial contribution is subject to formal commitments from the participating states. Financial support mainly takes the form of grants to selected projects. FROM WHEN DOES THE REGULATION APPLY? It has applied since 27 June 2014. BACKGROUND For more information, see: ‘What is Eurostars’ on the Eureka website. MAIN DOCUMENT Decision No 553/2014/EU of the European Parliament and of the Council of 15 May 2014 on the participation of the Union in a research and development programme jointly undertaken by several Member States aimed at supporting research and development performing small and medium-sized enterprises (OJ L 169, 7.6.2014, pp. 1–13) 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 (OJ L 347, 20.12.2013, pp. 104–173) Successive amendments and corrections to Regulation (Euratom) No 1291/2013 have been incorporated in to the original document. This consolidated version is of documentary value only. 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 (2014–2020)’ and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, pp. 81–103) last update 03.08.2016


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 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 (7), 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. (22) The Union’s financial contribution should be subject to formal commitments from the Participating States to contribute to implementing the EDCTP2 Programme and to the fulfilment of those commitments. (23) The joint implementation of the EDCTP2 Programme requires an implementation structure. The Participating States have agreed on the implementation structure for EDCTP2 Programme and have set up the EDCTP2-Implementation Structure (‘EDCTP2-IS’). The EDCTP2-IS should be the recipient of the Union’s financial contribution and should ensure the efficient implementation of the EDCTP2 Programme. (24) EDCTP2 activities should be in line with the objectives and research and innovation priorities of Horizon 2020 and with the general principles and conditions laid down in Article 26 of Regulation (EU) No 1291/2013. (25) Calls for proposals by EDCTP2-IS should also be published on the single portal for participants, as well as through other Horizon 2020 electronic means of dissemination managed by the Commission. (26) The Union’s financial contribution should be managed in compliance with the principle of sound financial management and in accordance with the relevant rules on indirect management laid down in Regulation (EU, Euratom) No 966/2012 of the European Parliament and the Council (8) and Commission Delegated Regulation (EU) No 1268/2012 (9). (27) In order to protect the Union’s financial interests, the Commission should have the right to reduce, suspend or terminate the Union’s financial contribution if the EDCTP2 Programme is implemented inadequately, partially or late, or if the Participating States do not contribute, or contribute partially or late, to the financing of the EDCTP2 Programme. Those rights should be provided for in the delegation agreement to be concluded between the Union and the EDCTP2-IS. (28) In order to implement the EDCTP2 Programme efficiently, financial support should be provided by the EDCTP2-IS mainly in the form of grants to participants in actions selected at the level of the EDCTP2-IS. The selection of those actions should be made following open and competitive calls for proposals under the responsibility of the EDCTP2-IS. (29) Participation in indirect actions under the EDCTP2 Programme is subject to Regulation (EU) No 1290/2013 of the European Parliament and of the Council (10). However, due to the specific operating needs of the EDCTP2 Programme, it is necessary to provide for derogations from that Regulation in accordance with Article 1(3) of that Regulation. (30) Derogations from point (b) of Article 9(1), point (c) of Article 10(1) and Article 12 of Regulation (EU) No 1290/2013 are necessary in order to require participation and allow funding of African entities, and allow cooperation through joint calls between the EDCTP2 Programme and any other legal entity. (31) For the purpose of simplification, administrative burdens should be reduced for all parties. Double audits and disproportionate documentation and reporting should be avoided. When audits are conducted, the specificities of the national programmes should be taken into account, as appropriate. (32) Audits of recipients of Union funds provided in accordance with this Decision should ensure a reduction of the administrative burden, in compliance with Horizon 2020. (33) The Union’s financial interests should be protected by means of proportionate measures throughout the expenditure life-cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties in accordance with Regulation (EU, Euratom) No 966/2012. (34) The Commission should conduct interim evaluations, assessing in particular the quality and efficiency of the EDCTP2 Programme, the progress made towards the objectives set and a final evaluation, and should prepare reports on those evaluations. (35) Upon request from the Commission, the EDCTP2-IS and the Participating States should submit any information the Commission needs to include in the reports on the evaluation of the EDCTP2 Programme. (36) It is essential that the research activities carried out under the EDCTP2 Programme are in full compliance with the Charter of Fundamental Rights of the European Union, the European Convention on Human Rights and its Supplementary Protocols, ethical principles included in the World Medical Association’s Declaration of Helsinki of 2008, the standards of good clinical practice adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, relevant Union legislation and local ethics requirements of the countries where the research activities are to be conducted. (37) It is essential that informed consent for clinical trials conducted in developing countries should always be obtained in a way that is truly informed and voluntary. (38) It is also important that the activities conducted under the EDCTP2 Programme should be coherent with the Union’s development policy actions. In this context, synergies between EDCTP2 and the European Development Fund should be sought. (39) Within the objective of cooperation with international development assistance initiatives, EDCTP2 funded activities should take into account the recommendations proposed by the relevant World Health Organisation (WHO) initiatives where appropriate, including the consultative Expert Working Group on Research and Development (‘CEWG’). (40) The Scientific Panel for Health was set up by Horizon 2020 as a science-led stakeholder platform, in order to elaborate scientific input, to provide a coherent scientific focused analysis of research and innovation bottlenecks and opportunities related to the Horizon 2020 societal challenge on health, demographic change and well-being, to contribute to the definition of its research and innovation priorities and to encourage Union-wide scientific participation. Through active cooperation with stakeholders, it helps to build capabilities and to foster knowledge-sharing and stronger collaboration across the Union in that field. EDCTP2 should, therefore, collaborate and exchange information with the Scientific Panel for Health, where appropriate. (41) Since the objectives of this Decision, namely 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, accessible, suitable and affordable medical interventions for poverty-related diseases, cannot be sufficiently achieved by the Member States due to the lack of necessary critical mass to be achieved, both in human and financial terms, and can therefore, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary for those objectives, HAVE ADOPTED THIS DECISION: Article 1 Participation in the second European and Developing Countries Clinical Trials Partnership Programme 1. The Union shall participate in the second European and Developing Countries Clinical Trials Partnership Programme (the ‘EDCTP2 Programme’), jointly undertaken by Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom (the ‘Participating States’) in accordance with the conditions laid down in this Decision. 2. Any Member State other than those listed in paragraph 1 and any other country associated to Horizon 2020 may participate in the EDCTP2 Programme, provided it fulfils the condition set out in point (e) of Article 3(1) of this Decision. If it fulfils the condition set out in point (e) of Article 3(1), it shall be regarded as a Participating State for the purposes of this Decision. Article 2 Union’s financial contribution 1. The Union’s financial contribution, including EFTA appropriations, to the EDCTP2 Programme shall be up to EUR 683 000 000 to equal the contributions of Participating States. 2. The Union’s financial contribution shall be paid from the appropriations in the general budget of the Union allocated to the relevant parts of the Specific Programme implementing Horizon 2020, established by Decision 2013/743/EU, and in particular from the appropriations under the specific objective ‘Health, demographic change and wellbeing’ in accordance with point (c)(vi) of Article 58(1) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012. 3. Up to 6 % of the Union’s financial contribution referred to in paragraph 1 may be used by the implementing structure of EDCTP2 (the ‘EDCTP2-IS’) to cover its administrative costs. Article 3 Conditions for the Union’s financial contribution 1. The Union’s financial contribution shall be conditional upon the following: (a) the demonstration by the Participating States that the EDCTP2 Programme is set up in accordance with Annexes I, II and III; (b) the designation by the Participating States or organisations designated by the Participating States of the EDCTP2-IS, an entity with legal personality, as the structure responsible for implementing the EDCTP2 Programme and for receiving, allocating and monitoring the Participating States’ contribution, as well as the Union’s financial contribution; (c) the demonstration by the EDCTP2-IS of its capacity to implement the EDCTP2 Programme, including receiving, allocating and monitoring the Union’s contribution in the framework of indirect management of the Union budget in accordance with Articles 58, 60 and 61 of Regulation (EU, Euratom) No 966/2012; (d) the establishment of a governance model for the EDCTP2 Programme in accordance with Annex III; and (e) the commitment by each Participating State to contribute to the financing of the EDCTP2 Programme. 2. During the implementation of the EDCTP2 Programme, the Union’s financial contribution shall be conditional upon the following: (a) the implementation by the EDCTP2-IS of the objectives set out in Annex I, and activities set out in Annex II, to this Decision, in particular the activities and indirect actions that it funds, in compliance with Regulation (EU) No 1290/2013 as referred to in Article 6 of this Decision; (b) the maintenance of an appropriate and efficient governance model for the EDCTP2 Programme in accordance with Annex III; (c) the compliance by the EDCTP2-IS with the reporting requirements set out in Article 60(5) of Regulation (EU, Euratom) No 966/2012; and (d) the fulfilment of the commitments referred to in point (e) of paragraph 1. Article 4 Activities of the EDCTP2 Programme 1. The activities of the EDCTP2 Programme shall meet the objectives described in Annex I and shall comply with Annex II. Activities may include national programme activities of Participating States, including activities undertaken by public or private not-for-profit research organisations, and new activities, including calls for proposals managed by the EDCTP2-IS. Activities shall be included in the work plan of the EDCTP2 Programme adopted annually by the EDCTP2-IS (‘the EDCTP2 annual work plan’), following the positive outcome of their external evaluation by international peer review with regard to the objectives of the EDCTP2 Programme. 2. The EDCTP2 annual work plan shall detail the budgeted value of each activity and shall provide for the allocation of the funding managed by the EDCTP2-IS, including the Union’s financial contribution. The EDCTP2 annual work plan shall differentiate between the activities funded or co-funded by the Union and those funded by Participating States or other revenues. 3. The EDCTP2-IS shall implement the EDCTP2 annual work plan. The EDCTP2-IS shall monitor and report to the Commission on the implementation of all the activities included therein or selected following calls for proposals managed by the EDCTP2-IS. 4. Activities included in the EDCTP2 annual work plan that are not funded by the EDCTP2-IS shall be implemented in compliance with common principles to be agreed by the Participating States and the Commission, taking into account the principles set out in this Decision, in Title VI of Regulation (EU, Euratom) No 966/2012 and in Regulation (EU) No 1290/2013, in particular the principles of equal treatment, transparency, independent peer review evaluation and selection. The Participating States and the Commission shall also agree on the reporting requirements to the EDCTP2-IS, including with regard to indicators inserted into each of those activities. Any activity funded by the EDCTP2-IS in accordance with the EDCTP2 annual work plan, or following calls for proposals managed by the EDCTP2-IS, shall be considered to be an indirect action within the meaning of Regulation (EU) No 1290/2013, and shall be implemented in accordance with Article 6 of this Decision. 5. Any communication or publication in the area of the activities of the EDCTP2 Programme, and performed in close collaboration with EDCTP2, whether undertaken by the EDCTP2-IS, a Participating State, or participants to an activity, shall be labelled or co-labelled as ‘[name of the activity] is part of the EDCTP2 programme supported by the European Union’. Article 5 Contributions from Participating States 1. Contributions from the Participating States shall consist of the following: (a) financial contributions to the EDCTP2-IS; (b) in-kind contributions consisting of the costs incurred by the Participating States in implementing activities included and clearly identified in the EDCTP2 annual work plan, or in relation to the administrative budget of the EDCTP2-IS. 2. For the purpose of evaluating the contributions referred to in point (b) of paragraph 1, the costs shall be determined in accordance with the usual accounting practices and accounting standards of the Participating State concerned and to the applicable International Accounting Standards/International Financial Reporting Standards. Article 6 Rules for participation and dissemination 1. Regulation (EU) No 1290/2013 shall apply to indirect actions selected and funded by the EDCTP2-IS on the basis of the EDCTP2 annual work plan or following calls for proposals managed by the EDCTP2-IS. In accordance with that Regulation, the EDCTP2-IS shall be considered to be a funding body and shall provide financial support to indirect actions in accordance with Annex II to this Decision. 2. By way of derogation from point (b) of Article 9(1) of Regulation (EU) No 1290/2013, the minimum number of participants shall be two legal entities established in two different Participating States and a third legal entity in a sub-Saharan African country listed in the EDCTP2 annual work plan. 3. By way of derogation from point (c) of Article 10(1) of Regulation (EU) No 1290/2013, any legal entity established in a sub-Saharan country listed in the EDCTP2 annual work plan shall be eligible for funding. 4. Where such an activity is included in the EDCTP2 annual work plan, the EDCTP2-IS may launch joint calls with third countries or their scientific and technological organisations and agencies, with international organisations or with other third parties, in particular non-governmental organisations, in accordance with the rules developed based on Article 12 of Regulation (EU) No 1290/2013. Article 7 Agreements between the Union and the EDCTP2-IS 1. Subject to a positive ex-ante assessment of the EDCTP2-IS in accordance with Article 61(1) of Regulation (EU, Euratom) No 966/2012, the Commission, on behalf of the Union, shall conclude a delegation agreement and annual transfer of funds agreements with the EDCTP2-IS. 2. The delegation agreement referred to in paragraph 1 shall be concluded in accordance with Article 58(3) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012 and Article 40 of Delegated Regulation (EU) No 1268/2012. It shall also set out, inter alia, the following: (a) the requirements for the EDCTP2-IS contribution regarding the performance indicators set out in Annex II to Decision 2013/743/EU; (b) the requirements for the EDCTP2-IS contribution in relation to the monitoring referred to in Annex III to Decision 2013/743/EU; (c) the specific performance indicators related to the functioning of the EDCTP2-IS; (d) the requirements for the EDCTP2-IS regarding the provision of information on administrative costs and on detailed figures concerning the implementation of the EDCTP2 Programme; (e) the arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations; (f) the arrangements for the approval or rejection by the Commission of the draft EDCTP2 annual work plan, before it is adopted by the EDCTP2-IS; and (g) provisions for the publication of calls for proposals by EDCTP2, in particular on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission. Article 8 Termination, reduction or suspension of the Union’s financial contribution If the EDCTP2 Programme is not implemented or is implemented inadequately, partially or late, the Commission may terminate, proportionately reduce or suspend the Union’s financial contribution in line with the actual implementation of the EDCTP2 Programme. If the Participating States do not contribute, contribute partially or late to the financing of the EDCTP2 Programme, the Commission may terminate, proportionately reduce or suspend the Union’s financial contribution, taking into account the amount of funding allocated by the Participating States to implement the EDCTP2 Programme. Article 9 Ex-post audits 1. Ex-post audits of expenditure on indirect actions shall be carried out by the EDCTP2-IS in accordance with Article 29 of Regulation (EU) No 1291/2013. 2. The Commission may decide to carry out itself the audits referred to in paragraph 1. In such cases, it shall do so in accordance with the applicable rules, in particular the provisions of Regulations (EU, Euratom) No 966/2012, (EU) No 1290/2013 and (EU) No 1291/2013. Article 10 Protection of the financial interests of the Union 1. The Commission shall take appropriate measures ensuring that, when actions financed under this Decision are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties. 2. The EDCTP2-IS shall grant Commission staff and other persons authorised by it, as well as the Court of Auditors, access to its sites and premises and to all the information, including information in electronic format, needed in order to conduct their audits. 3. The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Council Regulation (Euratom, EC) No 2185/96 (11) and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (12) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded in accordance with this Decision. 4. Contracts, grant agreements and grant decisions resulting from the implementation of this Decision shall contain provisions expressly empowering the Commission, the EDCTP2-IS, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their competences. 5. In implementing the EDCTP2 Programme, the Participating States shall take the legislative, regulatory, administrative and other measures necessary to protect the Union’s financial interests, in particular, to ensure full recovery of any amounts due to the Union in accordance with Regulation (EU, Euratom) No 966/2012 and Delegated Regulation (EU) No 1268/2012. Article 11 Communication of information 1. On request, the EDCTP2-IS shall send any information necessary for preparation of the reports referred to in Article 12 to the Commission. 2. The Participating States shall submit to the Commission, through the EDCTP2-IS, any information that is requested by the European Parliament, the Council or the Court of Auditors concerning the financial management of the EDCTP2 Programme. 3. The Commission shall include the information referred to in paragraph 2 of this Article in the reports referred to in Article 12. Article 12 Evaluation 1. By 30 June 2017 the Commission shall carry out, with the assistance of independent experts, an interim evaluation of the EDCTP2 Programme. The Commission shall prepare a report on that evaluation which includes conclusions of the evaluation and observations by the Commission. The Commission shall send that report to the European Parliament and to the Council by 31 December 2017. The result of the interim evaluation of EDCTP2 Programme shall be taken into account in the interim evaluation of Horizon 2020. 2. At the end of the Union participation in EDCTP2 but not later than 31 December 2023, the Commission shall conduct another interim evaluation of the EDCTP2 Programme. The Commission shall prepare a report on that evaluation which is to include the results of that evaluation. The Commission shall send that report to the European Parliament and to the Council. 3. The Commission shall conduct a final evaluation of the EDCTP2 Programme by 31 December 2026. The Commission shall send the results of that evaluation to the European Parliament and to the Council. Article 13 Entry into force This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 14 Addressees This Decision is addressed to the Member States. Done at Brussels, 15 May 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) Opinion of 10 December 2013 (not yet published in the Official Journal). (2) Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal) and decision of the Council of 6 May 2014. (3) 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 (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104). (4) Decision No 1209/2003/EC of the European Parliament and of the Council of 16 June 2003 on Community participation in a research and development programme aimed at developing new clinical interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partnership between Europe and developing countries, undertaken by several Member States (OJ L 169, 8.7.2003, p. 1). (5) Decision No 1513/2002/EC of the European Parliament and of the Council of 27 June 2002 concerning 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) (OJ L 232, 29.8.2002, p. 1). (6) Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) (OJ L 412, 30.12.2006, p. 1). (7) Council Decision 2013/743/EU of 3 December 2013 establishing the specific programme implementing Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020) and repealing Decisions 2006/971/EC, 2006/972/EC, 2006/973/EC, 2006/974/EC and 2006/975/EC (OJ L 347, 20.12.2013, p. 965). (8) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (9) Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 (OJ L 362, 31.12.2012, p. 1). (10) 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 (2014-2020)’ and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, p. 81). (11) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (12) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). ANNEX I 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 (1) 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. (1) For the purpose of this decision, ‘medical interventions’ encompass measures whose purpose is to improve or sustain health or alter the course of a disease, in particular prevention and treatment based on medicinal products such as drugs, microbicides or vaccines, including their delivery modality, follow up of treatment and prevention in the affected population as well as medical diagnostics to detect and monitor disease/health evolution. ANNEX II ACTIVITIES AND IMPLEMENTATION OF THE EDCTP2 PROGRAMME (1) Activities The EDCTP2 Programme shall include the following activities: (a) promoting networking, coordination, alignment, collaboration and integration of national research programmes and activities on poverty-related diseases, including neglected ones, at scientific, management and financial level; (b) supporting clinical trial research and related activities on poverty-related diseases, in particular HIV/AIDS, malaria, tuberculosis and other poverty-related diseases, including neglected ones; (c) fostering capacity development for clinical trials and related research in developing countries, in particular in Sub-Saharan Africa, through grants for: career development of junior and senior fellows, promoting mobility, staff exchange grants, research training networks, strengthening ethics and regulatory bodies, mentoring and partnerships at individual or institutional or regional level; (d) establishing cooperation and launching joint actions with other public and private funders; (e) assuring awareness, endorsement and acknowledgment of the EDCTP2 Programme and its activities through advocacy and communication, not only at Union level and in developing countries, but also at global level. (2) Programme definition and implementation The EDCTP2 Programme shall be implemented by the EDCTP2-IS on the basis of an annual work plan and a multiannual strategic work plan prepared by the EDCTP2-IS, in consultation with the relevant stakeholders, and adopted by the General Assembly of the EDCTP2-IS following international peer-review and subject to the prior approval by the Commission. The annual work plan shall identify topics and activities to be implemented, including calls for proposals to be launched by EDCTP-IS to select and fund indirect actions, as well as the budgets and EDCTP2 funding for those topics and activities. Where appropriate, EDCTP2 may exchange information with other public or private initiatives, including those under Horizon 2020. The annual work plan shall differentiate between the activities funded or co-funded by the Union and those funded by Participating States or other revenues. The multiannual strategic work plan shall set a common strategic research agenda which shall be prepared and updated on an annual basis. EDCTP2-IS shall monitor the implementation of the activities included in the work plan, including indirect actions selected through calls for proposals it manages. It shall allocate and manage funding to those in accordance with this Decision and the effective implementation of activities selected and identified in the previous work plans. (3) Deliverables expected from the implementation of the EDCTP2 Programme An annual report shall be provided by the EDCTP2-IS, which shall give a detailed overview of the implementation of the EDCTP2 Programme. That overview shall provide information on each activity selected in accordance with the work plan, including indirect actions selected through calls for proposals managed by the EDCTP2-IS. Such information shall include a description of each activity, including indirect action, its budget, the value of the funding allocated to it if any, and its status. With regard to calls managed by the EDCTP2-IS, the annual report shall moreover include information on the number of projects submitted and selected for funding, the detailed use of the Union’s financial contribution, the distribution of national and other contributions including specification on the type of in kind contributions, the types of participants, country statistics, brokerage events and dissemination activities. The annual report may also include, when appropriate, information on measures taken to facilitate access to products stemming from EDCTP2. The annual report shall also include information on the progress towards achieving the EDCTP2 Programme objectives set out in Annex I. In addition, the EDCTP2-IS shall provide any report and information foreseen by this Decision and the agreement concluded with the Union. ANNEX III GOVERNANCE OF THE EDCTP2 PROGRAMME The organisational structure of the EDCTP2 Programme shall be as follows: (1) The EDCTP2-IS shall be governed by a general assembly (‘GA’), in which all Participating States are represented. The GA’s principal responsibility shall be to ensure that all necessary activities are undertaken to achieve the objectives of the EDCTP2 Programme, and that its resources are properly and efficiently managed. It shall adopt the annual work plan. The GA shall decide by consensus. Failing consensus, the GA shall take its decisions by a majority of at least 75 % of the votes. The Union, represented by the Commission, shall be invited to all GA meetings as an observer, and shall receive all necessary documents. It may take part in discussions. (2) The GA shall appoint a Management Board that shall supervise the secretariat of the EDCTP2-IS (‘SEC’) established by the GA as the executive body of the EDCTP2 Programme. The Management Board shall consist of such number of Board Members as the GA may determine, but not less than five. SEC shall have at least the following tasks: (a) execute the annual work plan; (b) provide support to the GA; (c) monitor and report on the implementation of the EDCTP2 Programme; (d) manage the financial contributions from the Participating States, the Union and any third party, and report on their use to the GA and the Union; (e) increase the visibility of the EDCTP2 Programme through advocacy and communication; (f) liaise with the Commission in accordance with the delegation agreement referred to in Article 7. (3) A Scientific Advisory Committee (‘SAC’) shall advise the GA on the strategic priorities of the EDCTP2 Programme. The SAC shall be appointed by the GA and consist of European and African independent experts competent in areas relevant to the EDCTP2 Programme, taking into account gender balance. The SAC shall have the following tasks: (a) advise the GA on priorities and strategic needs regarding clinical trials in Africa; (b) advise the GA on the content, scope and dimension of the EDCTP2 draft annual work plan, including diseases covered and approaches to be adopted, from a scientific and technical standpoint; (c) review the scientific and technical aspects of the implementation of the EDCTP2 Programme and deliver an opinion on its annual report. In exercising its tasks, the SAC shall monitor and promote high standards of ethical conduct of clinical trials and engage with vaccine regulatory authorities. The SAC may recommend to the GA the setting up of scientific subcommittees, task forces and working groups. The GA shall establish the number of SAC members, their voting rights and the arrangements for their appointment in accordance with Article 40 of Regulation (EU) No 1290/2013. The GA may set up specialised working groups under the SAC with additional independent experts for specific tasks.

Summary: EU fighting poverty-related diseases in developing countries: EDCTP2 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: HIV/AIDS, malaria, tuberculosis, a series of neglected tropical diseases (except Chagas), diarrhoeal, and 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: 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; legal entities established in a sub-Saharan country listed in the EDCTP2 annual work plan are eligible for funding; 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: promoting networking, coordination, alignment, collaboration and integration of national research programmes and activities on the diseases (listed above) at scientific, management and financial level; supporting clinical trial research and related activities; capacity development for clinical trials and clinical research, in particular in sub-Saharan Africa; establishing cooperation and launching joint actions with other public and private funders; 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 Act Entry into force Deadline for transposition in the Member States Official Journal Decision No 556/2014/EU 27.6.2014 - OJ L 169 of 7.6.2014, pp. 38-53 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