7.6.2014   

EN

Official Journal of the European Union

L 169/1

(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,

(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:

(1)

promote research activities that comply with the following conditions:

(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.

(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.

(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.

(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).

(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.

7.6.2014   

EN

Official Journal of the European Union

L 169/14

(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 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)

Decision No 742/2008/EC of the European Parliament and of the Council (4) provides for a Community financial contribution to the Ambient Assisted Living Joint Research and Development Programme ("AAL JP") matching that of the Member States but not exceeding EUR 150 000 000 for the duration of the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) established by Decision No 1982/2006/EC of the European Parliament and of the Council (5).

(5)

In December 2012, the Commission communicated to the European Parliament and the Council a report on the interim evaluation of the AAL JP. That evaluation was carried out by an expert panel. The overall opinion of that expert panel was that the AAL JP had achieved good progress towards its objectives and remarkable results and that it should be continued beyond the current funding period. The expert panel noted however a few shortcomings, in particular the need for stronger user involvement in projects from the earliest possible stage and further improvements of the operational performance in terms of time-to-contract and time to payment.

(6)

The interim evaluation of 2010 and the consultation process of 2012 highlighted the diversity of financial instruments, eligibility rules and reimbursement systems. Participating States, through the Ambient Assisted Living General Assembly, could reflect on this and promote the exchange of good practices.

(7)

In its communication of 12 October 2006 entitled 'The demographic future of Europe — from challenge to opportunity', the Commission underlined the fact that demographic ageing is one of the main challenges facing all the Member States and that increased use of new technologies could help to control costs, improve well-being and promote the active participation in society of elderly people, as well as improving the competitiveness of Union economy.

(8)

Under the flagship initiative 'Innovation Union' of the Europe 2020 strategy, the Commission indicated the ageing of the population as one of the societal challenges where innovation breakthroughs can play an important role and boost competitiveness, enable European companies to lead in the development of new technologies, to grow and assume global leadership in new growth markets, improve the quality and efficiency of public services and so contribute to creating large numbers of new quality jobs.

(9)

About 20 million people across the Union are employed in "white-coat" jobs in the health sector and social services sector, a figure which is expected to increase in the coming years due to the aging population. Training and life-long learning in this sensitive sector should be a key priority. Therefore, the need for white coat jobs and for investments in modern skills, such as using information technologies, should be assessed more precisely.

(10)

In its communication of 19 May 2010 entitled 'A Digital Agenda for Europe', the Commission proposed to reinforce the AAL JP in order to help address the challenges of the ageing population.

(11)

In its communication of 29 February 2012 entitled 'Taking forward the Strategic Implementation Plan of the European Innovation Partnership on Active and Healthy Ageing', the Commission proposed to take account of relevant priorities of the Strategic Implementation Plan for future research and innovation work programmes and instruments which are part of Horizon 2020. The Commission also proposed to take into account the contributions that can be made by the AAL JP to the European Innovation Partnership on Active and Healthy Ageing.

(12)

Under the European Innovation Partnership on Active and Healthy Ageing established under the Innovation Union, innovative information and communication technologies (ICT) based solutions are expected to play an important role in meeting its goals of two additional healthy life years by 2020 as well as improving quality of life for citizens and improving efficiency of care systems in the Union. Its Strategic Implementation Plan sets out priorities for accelerating and scaling up innovation in active and healthy ageing across the Union, in three domains: prevention and health promotion, care and cure, and independent living and social inclusion.

(13)

Since ICT systems handle a large amount of personal data and profiles, and operate in real-time communication, thus bringing with them a high risk of data security breaches, data protection aspects should be taken into account. Moreover, the right to privacy should be respected.

(14)

The Active and Assisted Living Research and Development Programme ('the AAL Programme') should build on the achievements of the previous programme and address its shortcomings by encouraging sufficient user participation in projects from the initial stage, in order to ensure that solutions developed are acceptable and respond to specific user needs, and by ensuring better AAL Programme implementation.

(15)

The implementation of the AAL Programme should take into account a broad definition of innovation including organisational, business, technological, societal and environmental aspects. It should ensure a multidisciplinary approach and the integration of social sciences and humanities within the AAL Programme.

(16)

Activities of the AAL Programme 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.

(17)

A ceiling should be established for the Union's financial participation in the AAL Programme for the duration of Horizon 2020. The Union's financial participation in the AAL Programme should not exceed the financial contribution of the Participating States for the duration of Horizon 2020 in order to achieve a high leverage effect and ensure an active involvement of the Participating States in achieving the AAL Programme objectives.

(18)

In order to take into account the duration of Horizon 2020, calls for proposals under the AAL 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.

(19)

In line 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 the AAL Programme at any appropriate time.

(20)

In order to ensure that a financial commitment by the Union will be matched by the Participating States, the financial contribution by the Union should be subject to formal commitments from the Participating States before the launch of the AAL Programme and their fulfilment. The Participating States' contribution to the AAL Programme should include the administrative costs incurred at national level for the effective operation of the AAL Programme.

(21)

The joint implementation of the AAL Programme requires an implementation structure. The Participating States have agreed on the implementation structure for the AAL Programme and set up in 2007 the "Ambient Assisted Living" aisbl, an international non-profit association with legal personality established under Belgian law ('AALA'). Given that, according to the report on the interim evaluation, the existing governance structure of AAL JP has proven to be efficient and of good quality, the AALA should be used as the implementation structure and should take the role as allocation and monitoring body of the AAL Programme. The AALA should manage the Union's financial contribution and should ensure an efficient implementation of the AAL Programme.

(22)

In order to achieve the objectives of the AAL Programme, the AALA should provide financial support mainly through grants to participants in actions selected by the AALA. Those actions should be selected following calls for proposals under the responsibility of the AALA, which should be assisted by independent external experts. The ranking list should be binding as regards the selection of proposals and the allocation of funding from the Union's financial contribution and from the national budgets for AAL Programme projects.

(23)

The Union's financial contribution should be managed in accordance with the principle of sound financial management and with the rules on indirect management laid down in Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (6) and Commission Delegated Regulation (EU) No 1268/2012 (7).

(24)

In order to protect the financial interests of the Union, the Commission should, through proportionate measures, have the right to reduce, withhold or terminate the Union's financial contribution where the AAL Programme is implemented inadequately, partially or late, or the Participating States do not contribute, or contribute partially or late, to the financing of the AAL Programme. Those rights should be provided for in the delegation agreement to be concluded between the Union and the AALA.

(25)

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.

(26)

Participation in indirect actions funded by the AAL Programme is subject to Regulation (EU) No 1290/2013 of the European Parliament and of the Council (8). However, due to specific operating needs of the AAL Programme it is necessary to provide for derogations from that Regulation in accordance with Article 1(3) of that Regulation.

(27)

Calls for proposals by AALA 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.

(28)

Specific derogations from Regulation (EU) No 1290/2013 are necessary, as the AAL Programme is intended as a market-oriented research and innovation programme in which many different national funding streams are joined up (such as research innovation, health and industry funding programmes). By their nature, those national programmes have different participation rules and cannot be expected to fully align with Regulation (EU) No 1290/2013. In addition, the AAL Programme is targeting in particular small and medium-sized enterprises and user organisations not usually participating in Union research and innovation activities. In order to facilitate the participation of those enterprises and organisations, the Union's financial contribution is provided in accordance with the well-known rules of their national funding programmes and implemented through a single grant combining Union funding with the corresponding national funding.

(29)

The financial interests of the Union should be protected through 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.

(30)

The Commission should conduct, with the assistance of independent experts, an interim evaluation assessing in particular the quality and efficiency of the AAL Programme and progress towards the objectives set, as well as a final evaluation, and prepare a report on those evaluations.

(31)

The evaluation should be based on precise and up-to-date information. Upon request from the Commission, the AALA and the Participating States should therefore submit any information which the Commission needs to include in the reports on the evaluation of the AAL Programme.

(32)

The actions envisaged in the AAL Programme should help underpin European public health and care systems, since they are an essential means of sustaining social welfare and reducing the welfare gap between regions and population sectors that is widening alarmingly owing to the current economic and social crisis.

(33)

The AAL Programme should ensure the effective promotion of gender equality as set out in Horizon 2020. The AAL Programme should promote gender equality and the gender dimension in research and innovation content. Particular attention should be paid to gender balance, subject to the situation in the field, in evaluation panels and in bodies such as advisory groups and expert groups. The gender dimension should be adequately integrated in research and innovation content in strategies, programmes and projects and followed through at all stages of the research cycle.

(34)

The AAL Programme should comply with ethical principles as set out in Horizon 2020. Particular attention should be paid to the principle of proportionality, the right to privacy, the right to the protection of personal data, the right to the physical and mental integrity, the right to non-discrimination and the need to ensure high levels of human health protection.

(35)

Since Participating States have decided to continue the AAL Programme and since the objectives of this Decision, namely to directly support and complement the Union policies in the field of active and healthy ageing, cannot be sufficiently achieved by the Member States but can rather, 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 in order to achieve those objectives,

(a)

the demonstration by the Participating States that the AAL Programme is set up in accordance with Annexes I and II;

(b)

the designation by the Participating States or by organisations designated by the Participating States, of the AALA, as the structure responsible for the implementation of the AAL Programme and for allocating and monitoring the Union's financial contribution;

(c)

a commitment by each Participating State to contribute to the financing of the AAL Programme;

(d)

demonstration by the AALA of its capacity to implement the AAL Programme, including allocating and monitoring the Union 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 the AAL Programme in accordance with Annex III.

(a)

the implementation by the AALA of the AAL Programme objectives as set out in Annex I and activities set out in Annex II to this Decision in accordance with Regulation (EU) No 1290/2013, subject to Article 5 of this Decision;

(b)

the maintenance of an appropriate and efficient governance model in accordance with Annex III;

(c)

compliance by the AALA with the reporting requirements set out in Article 60 (5) of Regulation (EU, Euratom) No 966/2012; and

(d)

fulfilment of the commitments by each Participating State referred to in point (c) of paragraph 1 and fulfilment of the annual commitments to contribute to the financing of the AAL Programme.

(a)

financial contributions to the indirect actions supported under the AAL Programme in accordance with Annex II;

(b)

in-kind contributions corresponding to the administrative costs incurred by the national administrations for the effective implementation of the AAL Programme in accordance with Annex II.

(a)

the requirements concerning the AALA's contribution regarding relevant indicators from among the performance indicators set out in Annex II to Decision 2013/743/EU;

(b)

the requirements concerning the AALA's contribution to the monitoring referred to in Decision 2013/743/EU;

(c)

the specific performance indicators necessary for monitoring the functioning of the AALA in accordance with Article 3(2);

(d)

the arrangements regarding the provision of data and information necessary to ensure that the Commission is able to meet its dissemination and reporting obligations.

(e)

provision for the publication of calls for proposals by the AALA in particular on the single portal for participants, as well as through other Horizon 2020 electronic means of dissemination managed by the Commission.

7.6.2014   

EN

Official Journal of the European Union

L 169/27

(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 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 912/2009/EC of the European Parliament and of the Council (4), the Community decided to make a financial contribution to the European Metrology Research Programme (the "EMRP") matching that of the Participating States but not exceeding EUR 200 000 000, for the duration of the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) established by Decision No 1982/2006/EC of the European Parliament and of the Council (5).

(5)

In April 2012, the Commission communicated to the European Parliament and to the Council a report on Interim Evaluation of the European Metrology Research Programme – EMRP. That interim evaluation had been carried out by an expert panel three years after the beginning of the programme. The overall opinion of the expert panel was that EMRP is a well-managed joint European research programme that has already achieved a relatively high level of scientific, management and financial integration. However, the expert panel noted its limited industrial exploitation, limited opening to excellent science outside the metrology institutes and insufficient capacity building. The expert panel was also of the opinion that a more inclusive European metrology research area could be built by implementing the EMRP.

(6)

Pursuant to Council Decision 2013/743/EU (6) further support may be provided to EMRP.

(7)

The European Metrology Programme for Innovation and Research ("EMPIR"), aligned with the Europe 2020 strategy and its flagship initiatives, in particular ‘Innovation Union’, ‘A Digital Agenda for Europe’, ‘Resource-efficient Europe’ and ‘An Industrial Policy for the Globalisation Era’, will be a more ambitious and inclusive programme, implemented over a period of ten years (2014-2024) by 28 Participating States. As part of the improvement of the previous programme, EMPIR will include activities on innovation and industrial exploitation, on research for norms, standardisation and regulatory purposes and on capacity building.

(8)

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

(9)

EMPIR's 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.

(10)

A ceiling should be established for the Union’s financial participation in EMPIR for the duration of Horizon 2020. Within the limits of that ceiling, the Union contribution should be equal to the contribution of the States participating in EMPIR, in order to achieve a high leverage effect and ensure a stronger integration of Participating States' programmes.

(11)

In line 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 EMPIR.

(12)

The Union’s financial contribution should be subject to formal commitments from the Participating States to contribute to the implementation of EMPIR and to the fulfilment of those commitments. Participating States’ contributions to EMPIR should include a contribution to administrative costs, subject to a ceiling of 5 % of the budget of EMPIR. Participating States should commit to increase, if necessary, their contribution to EMPIR by a reserve funding capability of 50 % of their commitment to ensure that they are able to fund their national entities, National Metrology Institutes ("NMIs") and Designated Institutes ("DIs"), participating in the selected projects.

(13)

The joint implementation of EMPIR requires an implementation structure. The Participating States have agreed upon the implementation structure for EMRP, and in 2007 set up EURAMET e.V. ("EURAMET"), the European Regional Metrology Organisation and a non-profit association under German law. EURAMET also has tasks and obligations related to the wider European and global harmonisation of metrology. Membership of EURAMET is open to all European NMIs, as members, and to DIs, as associates. Membership of EURAMET is not conditional upon the existence of national metrology research programmes. Given that, according to the Report on Interim Evaluation of EMRP, the governance structure of EURAMET has proved to be efficient and of high quality for the implementation of the EMRP, EURAMET should also be used for the implementation of EMPIR. EURAMET should, therefore, be the recipient of the Union’s financial contribution.

(14)

In order to achieve the objectives of EMPIR, EURAMET should provide financial support mainly in the form of grants to participants in actions selected at the level of EURAMET. Those actions should be selected following calls for proposals under the responsibility of EURAMET. The ranking list should be binding as regards the selection of proposals and the allocation of funding from the Union’s financial contribution and from the contributions from Participating States for EMPIR projects.

(15)

The Union’s financial contribution should be managed in accordance with the principle of sound financial management and with the relevant rules on indirect management laid down 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).

(16)

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 EMPIR is implemented inadequately, partially or late, or if the Participating States do not contribute, or contribute partially or late, to the financing of EMPIR. Those rights should be provided for in the delegation agreement to be concluded between the Union and EURAMET.

(17)

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.

(18)

Audits of recipients of Union funds provided in accordance with this Decision should ensure a reduction in the administrative burden, in accordance with Regulation (EU) No 1291/2013.

(19)

Participation in indirect actions funded by EMPIR is subject to Regulation (EU) No 1290/2013 of the European Parliament and of the Council (9). However, due to specific operating needs of EMPIR, it is necessary to provide for derogations from that Regulation in accordance with Article 1(3) of that Regulation.

(20)

The contribution from Participating States mainly represents institutional funding of the NMIs and DIs participating in the selected projects. The contribution from Participating States should also include a cash contribution to the administrative costs of EMPIR. A proportion of the Union’s contribution should be allocated to entities other than NMIs and DIs participating in the selected projects. The calculation of the Union’s financial contribution for NMIs and DIs participating in EMPIR projects should ensure that the Union’s contribution to EMPIR does not exceed the contribution of the Participating States. Considering that the institutional funding of the NMIs and DIs by Participating States corresponds to the overheads allocated to the EMPIR projects not reimbursed by the Union’s contribution, the flat rate for the financing of the eligible indirect costs of the NMIs and DIs should be adapted, compared to the flat rate laid down in Regulation (EU) No 1290/2013. The flat rate for the financing of the eligible indirect costs of the NMIs and DIs should be determined on the basis of the full indirect costs declared as eligible by NMIs and DIs participating in EMRP projects, which are stable and constitute a reliable approximation of the indirect costs to be incurred by NMIs and DIs participating in EMPIR projects. Since those indirect costs amount to 140 % of the total direct eligible costs of the NMIs and DIs, excluding direct eligible costs for subcontracting and in-kind contributions free of charge not used on the premises of the beneficiaries, the flat rate for the financing of indirect costs of the NMIs and DIs should be lowered from 25 %, as laid down in Regulation (EU) No 1290/2013, to 5 %. It is therefore appropriate to provide for a derogation from Article 29 of that Regulation for the NMIs and DIs. Other entities participating in EMPIR projects should be funded in accordance with that Regulation.

(21)

Calls for proposals by EMPIR 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.

(22)

The appropriateness of the funding model with regard to the matching principle between Union and non-Union funds should be re-assessed at the time of the interim evaluation of EMPIR.

(23)

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.

(24)

The Commission should conduct an interim evaluation assessing in particular the quality and efficiency of EMPIR, the progress made towards the objectives set and a final evaluation, and should prepare a report on those evaluations.

(25)

Upon request from the Commission, EURAMET and the Participating States should submit any information the Commission needs to include in the reports on the evaluation of EMPIR.

(26)

The objective of this Decision is the Union's participation in EMPIR, namely to support the provision of appropriate, integrated and fit-for-purpose metrology solutions and the creation of an integrated European Metrology Research system with critical mass and active engagement at regional, national, European and international level that cannot be sufficiently achieved by the Member States alone. The scale and complexity of metrology requirements calls for investments that go beyond the core research budgets of the NMIs and their DIs. The excellence required for research and the development of cutting-edge metrology solutions is spread across national borders and hence cannot be brought together at national level only. Since the objective can therefore be better achieved at Union level by integrating national efforts into a consistent European approach, by bringing together compartmentalised national research programmes, by helping design common research and funding strategies across national borders, and by achieving the critical mass of actors and investments required, 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 that objective,

(a)

the demonstration by the Participating States that EMPIR is set up in accordance with Annexes I and II;

(b)

the designation by the Participating States, or NMIs designated by Participating States, of EURAMET e.V. ("EURAMET") as the structure responsible for implementing EMPIR and for receiving, allocating and monitoring the Union’s financial contribution;

(c)

the commitment by each Participating State to contribute to the financing of EMPIR and to establish a reserve funding capability of 50 % of the amount of the commitment;

(d)

the demonstration by EURAMET of its capacity to implement EMPIR, 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 EMPIR in accordance with Annex III.

(a)

the implementation by EURAMET of EMPIR's objectives set out in Annex I and activities set out in Annex II, in accordance with the rules for participation and dissemination referred to in Article 5;

(b)

the maintenance of an appropriate and efficient governance model in accordance with Annex III;

(c)

the compliance by EURAMET 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 (c) of paragraph 1 of this Article.

(a)

contributions through institutional funding of the NMIs and the DIs participating in EMPIR projects;

(b)

financial contributions to the administrative costs of EMPIR.

(a)

the requirements for EURAMET’s contribution regarding the performance indicators set out in Annex II to Decision 2013/743/EU;

(b)

the requirements for EURAMET’s contribution to the monitoring referred to in Annex III to Decision 2013/743/EU;

(c)

the specific performance indicators related to the functioning of EURAMET;

(d)

the requirements for EURAMET regarding the provision of information on administrative costs and on detailed figures concerning the implementation of EMPIR;

(e)

the arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations;

(f)

provisions for the publication of calls for proposals by EMPIR, in particular on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission.

7.6.2014   

EN

Official Journal of the European Union

L 169/38

(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,

(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.

(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.

(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.

(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.

7.6.2014   

EN

Official Journal of the European Union

L 169/54

(1)

Public-private partnerships in the form of Joint Technology Initiatives were initially provided for in Decision No 1982/2006/EC of the European Parliament and of the Council (1).

(2)

Council Decision 2006/971/EC (2) identified specific public-private partnerships to be supported, including a public-private partnership on Innovative Medicines Joint Technology Initiative between the Union and the European Federation of Pharmaceutical Industries and Associations (‘EFPIA’).

(3)

Commission Communication entitled ‘Europe 2020 A Strategy for smart, sustainable and inclusive growth’ (the ‘Europe 2020 Strategy’), endorsed by the European Parliament and the Council, emphasises the need to develop favourable conditions for investment in knowledge and innovation so as to achieve smart, sustainable and inclusive growth in the Union.

(4)

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 to achieve a greater impact with respect to research and innovation by combining Horizon 2020 and private sector funds in public-private partnerships in key areas where research and innovation can contribute to the Union’s wider competitiveness goals, leverage private investment and help tackle societal challenges. Those partnerships should be based on a long-term commitment, including a balanced contribution from all partners, be accountable for the achievement of their objectives and be aligned with the Union’s strategic goals relating to research, development and innovation. The governance and functioning of those partnerships should be open, transparent, effective and efficient and give the opportunity to a wide range of stakeholders active in their specific areas to participate. In accordance with Regulation (EU) No 1291/2013, Union involvement in those partnerships may take the form of financial contributions to joint undertakings established on the basis of Article 187 of the Treaty on the Functioning of the European Union under Decision No 1982/2006/EC.

(5)

In accordance with Regulation (EU) No 1291/2013 and Council Decision 2013/743/EU (4), further support should be provided to joint undertakings established under Decision No 1982/2006/EC under the conditions specified in Decision 2013/743/EU.

(6)

The Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines (‘IMI Joint undertaking’) set up by Council Regulation (EC) No 73/2008 (5) has demonstrated the effective mobilisation of resources by bringing together several partners from the pharmaceutical industry, academia, small and medium-sized enterprises (‘SMEs’), patient organisations and regulators.

(7)

The IMI Joint Undertaking has also stepped up cooperation between stakeholders in the health research and innovation field by allowing access to other partners’ expertise and increasing the collaboration between the pharmaceutical industry and other stakeholders in the Union by developing comprehensive research agendas and horizontal policy coordination. No other European or national programme has enabled cross-company collaboration within the pharmaceutical sector on the scale that has been achieved by the Joint Technology Initiative on Innovative Medicines. The interim evaluation of the IMI Joint Undertaking underlined that it enables mutual learning and provides an opportunity to improve the reciprocal understanding of the stakeholders, thus benefiting all parties, and that it has significantly contributed to the transition towards an open innovation model in biopharmaceutical research.

(8)

Research related to the future of medicine should be undertaken in areas where combination of societal, public health and biomedical industry competitiveness goals requires the pooling of resources and fostering collaboration between the public and private sectors, with the involvement of SMEs. The scope of the initiative should be expanded to cover all areas of life science research and innovation of public health interest, as identified by the World Health Organisation report on priority medicines for Europe and the World, which has been updated in 2013. The initiative should consequently seek to involve a broader range of partners, including mid-caps, from different sectors, such as biomedical imaging, medical information technology, diagnostic and animal health industries. A wider participation would help to advance the development of new approaches and technologies for the prevention, diagnosis and treatment of diseases with high impact on public health.

(9)

A new joint undertaking should be established for the implementation of the Joint Technology Initiative on Innovative Medicines (‘IMI2 Joint Undertaking’) and should replace and succeed the IMI Joint Undertaking. The IMI2 Joint Undertaking should seek to foster the capacity of smaller actors such as research organisations, universities and SMEs for participating in open innovation models and to promote the involvement of SMEs in its activities, in line with its objectives.

(10)

The continuation of this initiative should also take into account the experience acquired from the operations of the IMI Joint Undertaking including the results of its interim evaluation and stakeholders’ recommendations and should be implemented using a structure and rules that are more fit for its purpose in order to enhance efficiency and ensure simplification at operational level. To that effect, the IMI2 Joint Undertaking should adopt financial rules specific to its needs in accordance with Article 209 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (6).

(11)

The Members other than the Union of the IMI2 Joint Undertaking have agreed to pursue the research activities in the area of activities of the IMI2 Joint Undertaking within a structure better adapted to the nature of a public-private partnership. It is appropriate that the Members other than the Union of the IMI2 Joint Undertaking accept the Statutes contained in the Annex to this Regulation by means of a letter of endorsement.

(12)

As a means to further develop the IMI2 Joint Undertaking’s objectives, membership should also be open to other legal entities. Moreover, legal entities interested in supporting the IMI2 Joint Undertaking’s objectives in their specific areas of research should be offered the possibility to become Associated Partners of the IMI2 Joint Undertaking.

(13)

It should be possible for any eligible institution to become a participant or a coordinator in the selected projects.

(14)

To achieve its objectives, the IMI2 Joint Undertaking should provide financial support to participants mainly in the form of grants following open and competitive calls for proposals.

(15)

The participants should be fully informed about applicable legal and procedural conditions, including those laid down on the basis of Article 1(3) of Regulation (EU) No 1290/2013 of the European Parliament and of the Council (7), especially regarding eligibility for funding and the exploitation and dissemination of results. Those conditions should be consistent and reasonable and should ensure equitable and fair treatment of participants regarding ownership of and access to the results generated within the IMI2 Joint Undertaking’s projects.

(16)

The contributions from the Members other than the Union should relate to the administrative costs of the IMI2 Joint Undertaking and, together with the contributions from the Associated Partners for their specific area of research, to the co-financing required to carry out research and innovation actions supported by the IMI2 Joint Undertaking.

(17)

Participation in indirect actions funded by the IMI2 Joint Undertaking should comply with Regulation (EU) No 1290/2013. The IMI2 Joint Undertaking should, moreover, ensure consistent application of those rules based on relevant measures adopted by the Commission.

(18)

The IMI2 Joint Undertaking should also use electronic means managed by the Commission to ensure openness and transparency and facilitate participation. Therefore, the calls for proposals launched by the IMI2 Joint Undertaking 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. Moreover, relevant data on, inter alia, proposals, applicants, grants and participants should be made available by the IMI2 Joint Undertaking for inclusion in Horizon 2020 reporting and dissemination electronic systems managed by the Commission, in an appropriate format and with the periodicity corresponding to the Commission’s reporting obligations.

(19)

The Union financial contribution should be managed in accordance with the principle of sound financial management and with the relevant rules on indirect management set out in Regulation (EU, Euratom) No 966/2012 and Commission Delegated Regulation (EU) No 1268/2012 (8).

(20)

For the purpose of simplification, the administrative burden should be reduced for all parties. Double audits and disproportionate amounts of documentation and reporting should be avoided. Audits of recipients of Union funds under this Regulation should be carried out in compliance with Regulation (EU) No 1291/2013.

(21)

The financial interests of the Union and of the other Members of the IMI2 Joint Undertaking should be protected through 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.

(22)

The Commission’s internal auditor should exercise the same powers over the IMI2 Joint Undertaking as those exercised in respect of the Commission.

(23)

In view of the specific nature and the current status of the joint undertakings, and to ensure continuity with the Seventh Framework Programme, the joint undertakings should continue to be subject to a separate discharge. By way of derogation from Articles 60(7) and 209 of Regulation (EU, Euratom) No 966/2012, discharge for the implementation of the budget of the IMI2 Joint Undertaking should therefore be given by the European Parliament on the recommendation of the Council. Hence, the reporting requirements set out in Article 60(5) of Regulation (EU, Euratom) No 966/2012 should not apply to the Union financial contribution to the IMI2 Joint Undertaking but they should be aligned to the extent possible to the ones foreseen for bodies under Article 208 of Regulation (EU, Euratom) No 966/2012. The auditing of accounts and of the legality and regularity of the underlying transactions should be undertaken by the Court of Auditors.

(24)

The IMI2 Joint Undertaking should operate in an open and transparent way providing all relevant information in a timely manner to its appropriate bodies as well as promoting its activities, including information and dissemination activities to the wider public. The rules of procedure of the bodies of the IMI2 Joint Undertaking should be made publicly available.

(25)

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. The IMI2 Joint Undertaking should, therefore, collaborate and exchange information with the Scientific Panel for Health, where appropriate.

(26)

Horizon 2020 should contribute to the closing of the research and innovation divide within the Union by promoting synergies with the European Structural and Investment Funds (ESIF). Therefore the IMI2 Joint Undertaking should seek to develop close interactions with the ESIF, which can specifically help to strengthen local, regional and national research and innovation capabilities in the area of the IMI2 Joint Undertaking and underpin smart specialisation efforts.

(27)

The IMI Joint Undertaking was set up for a period up to 31 December 2017. The IMI2 Joint Undertaking should provide continued support to the Innovative Medicines research programme by implementing the remaining actions initiated under Regulation (EC) No 73/2008 in accordance with that Regulation. The transition from the IMI Joint Undertaking to the IMI2 Joint Undertaking should be aligned and synchronised with the transition from the Seventh Framework programme to Horizon 2020 to ensure optimal use of the funding available for research. In the interest of legal certainty and clarity, Regulation (EC) No 73/2008 should therefore be repealed and transitional provisions should be set out.

(28)

Given the aim of Horizon 2020 to achieve greater simplification and coherence, all calls for proposals by the IMI2 Joint Undertaking should take into account the duration of Horizon 2020.

(29)

Since the objective of this Regulation, namely establishment of the IMI2 Joint Undertaking in order to strengthen industrial research and innovation across the Union cannot be sufficiently achieved by the Member States but can rather, by reason of avoiding duplication, retaining critical mass and ensuring that public financing is used in an optimal way, 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 Regulation does not go beyond what is necessary in order to achieve that objective,

(a)

to support, in accordance with Article 25 of Regulation (EU) No 1291/2013, the development and implementation of pre-competitive research and of innovation activities of strategic importance to the Union’s competitiveness and industrial leadership or to address specific societal challenges in particular as described in parts II and III of Annex I to Decision 2013/743/EU, and in particular the challenge to improve European citizens’ health and well-being;

(b)

to contribute to the objectives of the Joint Technology Initiative on Innovative Medicines, in particular to:

(a)

up to EUR 1 425 000 000 to match the contribution of European Federation of Pharmaceutical Industries and Associations (‘EFPIA’), or its constituent entities or their affiliated entities;

(b)

up to EUR 213 000 000 to match additional contributions from other Members, Associated Partners, or from their constituent entities or their affiliated entities.

(a)

the requirements for the IMI2 Joint Undertaking’s contribution regarding the relevant performance indicators referred to in Annex II to Decision 2013/743/EU;

(b)

the requirements for the IMI2 Joint Undertaking’s contribution in view of the monitoring referred to in Annex III to Decision 2013/743/EU;

(c)

the specific performance indicators related to the functioning of the IMI2 Joint Undertaking;

(d)

the arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations including on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission;

(e)

provisions for the publication of calls for proposals of the IMI2 Joint Undertaking also on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission;

(f)

the use of and changes to human resources, in particular the recruitment by function group, grade and category, the reclassification exercise and any changes to the number of staff members.

(a)

pursuant to any arbitration clause contained in agreements or contracts concluded by the IMI2 Joint Undertaking or in its decisions;

(b)

in disputes relating to compensation for damage caused by the staff of the IMI2 Joint Undertaking in the performance of their duties;

(c)

in any dispute between the IMI2 Joint Undertaking and its staff within the limits and under the conditions laid down in the Staff Regulations and the Conditions of Employment.

(a)

the IMI2 Joint Undertaking and OLAF to conduct audits and investigations, for the purposes described in paragraphs 1 and 2, in accordance with their respective competences; and

(b)

the Commission and the Court of Auditors to conduct audits, for the purposes described in paragraphs 1 and 2, of the recipients of funding from the IMI2 Joint Undertaking, in accordance with their respective competences.

7.6.2014   

EN

Official Journal of the European Union

L 169/77

(1)

Public-private partnerships in the form of Joint Technology Initiatives were initially provided for in Decision No 1982/2006/EC of the European Parliament and of the Council (2).

(2)

Council Decision 2006/971/EC (3) identified specific public-private partnerships to be supported, including a public-private partnership in the specific area of the Clean Sky Joint Technology Initiative.

(3)

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

(4)

Regulation (EU) No 1291/2013 of the European Parliament and of the Council (4) established Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020) (‘Horizon 2020’). Horizon 2020 aims to achieve a greater impact with respect to research and innovation by combining Horizon 2020 and private sector funds in public-private partnerships in key areas where research and innovation can contribute to the Union’s wider competitiveness goals, leverage private investment and help tackle societal challenges. Those partnerships should be based on a long-term commitment, including a balanced contribution from all partners, be accountable for the achievement of their objectives and be aligned with the Union’s strategic goals relating to research, development and innovation. The governance and functioning of those partnerships should be open, transparent, effective and efficient and give the opportunity to a wide range of stakeholders active in their specific areas to participate. In accordance with Regulation (EU) No 1291/2013, Union involvement in those partnerships may take the form of financial contributions to joint undertakings established on the basis of Article 187 of the Treaty on the Functioning of the European Union under Decision No 1982/2006/EC.

(5)

In accordance with Regulation (EU) No 1291/2013 and Council Decision 2013/743/EU (5), further support should be provided to joint undertakings established under Decision No 1982/2006/EC under the conditions specified in Decision 2013/743/EU.

(6)

The Clean Sky Joint Undertaking set up by Council Regulation (EC) No 71/2008 (6) is achieving its objectives of stimulating new research within the framework of a public-private partnership which enables long-term cooperation to take place among European aeronautical stakeholders. Small and medium-sized enterprises (SMEs) have participated very extensively in Clean Sky, with approximately 40 % of the budget for calls for proposals allocated to them. The interim evaluation of the Clean Sky Joint Undertaking has shown that the Joint Undertaking is successfully stimulating developments towards environmental targets. In addition, it has been highly successful in attracting extensive and wide-ranging participation by all Union key industries and a large number of SMEs. It has led to new collaborations and to the participation of new organisations. Its research area should therefore continue to be supported in order to achieve its objectives as set out in this Regulation.

(7)

Continued support for the Clean Sky research programme should also take into account the experience acquired from the operations of the Clean Sky Joint Undertaking, including the results of its interim evaluation and the stakeholders’ recommendations, and should be implemented using a structure and rules that are more fit for its purpose in order to enhance efficiency and to ensure simplification. To that effect, the Clean Sky 2 Joint Undertaking should adopt financial rules specific to its needs in accordance with Article 209 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (7).

(8)

The private members of the Clean Sky Joint Undertaking have agreed for the research activities in the area of the Clean Sky Joint Undertaking to be pursued within a structure better adapted to the nature of a public-private partnership. It is appropriate that the private members of the Clean Sky 2 Joint Undertaking accept the Statutes annexed to this Regulation by means of a letter of endorsement.

(9)

To achieve its objectives, the Clean Sky 2 Joint Undertaking should provide financial support to participants and members, mainly in the form of grants following open and competitive calls for proposals.

(10)

The Clean Sky 2 Joint Undertaking should operate in an open and transparent way providing all relevant information in a timely manner to its appropriate bodies as well as promoting its activities, including information and dissemination activities to the wider public. The rules of procedure of the bodies of the Clean Sky 2 Joint Undertaking should be made publicly available.

(11)

The contributions from the private members should not be limited only to the administrative costs of the Clean Sky 2 Joint Undertaking and to the co-financing required to carry out research and innovation actions supported by the Clean Sky 2 Joint Undertaking, but should also cover additional activities previously declared and to be undertaken by the private members, as specified in an additional activities plan. In order to get a proper overview of the leverage effect of those additional activities, they should represent contributions to the broader Clean Sky Joint Technology Initiative.

(12)

Participation in indirect actions funded by the Clean Sky 2 Joint Undertaking should comply with Regulation (EU) No 1290/2013 of the European Parliament and of the Council (8). The Clean Sky 2 Joint Undertaking should, moreover, ensure consistent application of those rules based on relevant measures adopted by the Commission.

(13)

The Clean Sky 2 Joint Undertaking should also use electronic means managed by the Commission to ensure openness and transparency and to facilitate participation. Therefore, the calls for proposals launched by the Clean Sky 2 Joint Undertaking 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. Moreover, relevant data on, inter alia, proposals, applicants, grants and participants should be made available by the Clean Sky 2 Joint Undertaking for inclusion in the Horizon 2020 reporting and dissemination electronic systems managed by the Commission, in an appropriate format and with the periodicity corresponding to the Commission’s reporting obligations.

(14)

The Clean Sky 2 Joint Undertaking should take into account the OECD definitions regarding Technological Readiness Level in the classification of technological research, product development and demonstration activities.

(15)

The Union 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 and Commission Delegated Regulation (EU) No 1268/2012 (9).

(16)

For the purpose of simplification, the administrative burden should be reduced for all parties. Double audits and disproportionate amounts of documentation and reporting should be avoided. Audits of recipients of Union funds under this Regulation should be carried out in compliance with Regulation (EU) No 1291/2013.

(17)

The financial interests of the Union and of the other members of the Clean Sky 2 Joint Undertaking should be protected through 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.

(18)

The Commission’s internal auditor should exercise the same powers over the Clean Sky 2 Joint Undertaking as those exercised in respect of the Commission.

(19)

In view of the specific nature and the current status of the joint undertakings, and to ensure continuity with the Seventh Framework Programme, the joint undertakings should continue to be subject to a separate discharge. By way of derogation from Article 60(7) and Article 209 of Regulation (EU, Euratom) No 966/2012, discharge for the implementation of the budget of the Clean Sky 2 Joint Undertaking should therefore be given by the European Parliament on the recommendation of the Council. Hence, the reporting requirements set out in Article 60(5) of Regulation (EU, Euratom) No 966/2012 should not apply to the Union financial contribution to the Clean Sky 2 Joint Undertaking but they should be aligned, to the extent possible, to the ones foreseen for bodies under Article 208 of Regulation (EU, Euratom) No 966/2012. The auditing of accounts and of the legality and regularity of the underlying transactions should be undertaken by the Court of Auditors.

(20)

To implement the Union financial support for large-scale actions phased over several years, it is advisable to provide for the possibility to split multiannual budgetary commitments by the Union and the Clean Sky 2 Joint Undertaking into annual instalments. Commitments binding on the Union and the Clean Sky 2 Joint Undertaking over the long term should make it possible to reduce the uncertainties connected with the completion of such large-scale actions.

(21)

Horizon 2020 should contribute to the closing of the research and innovation divide within the Union by promoting synergies with the European Structural and Investment Funds (ESIF). Therefore the Clean Sky 2 Joint Undertaking should seek to develop close interactions with the ESIF, which can specifically help to strengthen local, regional and national research and innovation capabilities in the area of the Clean Sky 2 Joint Undertaking and underpin smart specialisation efforts.

(22)

The Clean Sky Joint Undertaking was set up for a period up to 31 December 2017. The Clean Sky 2 Joint Undertaking should provide continued support to the Clean Sky research programme by implementing the remaining actions initiated under Regulation (EC) No 71/2008 in accordance with that Regulation. The transition from the Clean Sky Joint Undertaking to the Clean Sky 2 Joint Undertaking should be aligned and synchronized with the transition from the Seventh Framework Programme to Horizon 2020 to ensure optimal use of the funding available for research. In the interest of legal certainty and clarity, Regulation (EC) No 71/2008 should therefore be repealed and transitional provisions should be set out.

(23)

Given the overall aim of Horizon 2020 to achieve greater simplification and coherence, all calls for proposals by the Clean Sky 2 Joint Undertaking should take into account the duration of Horizon 2020.

(24)

Given the importance of continuous innovation for the competitiveness of the Union’s transport sector and the number of joint undertakings in this field, there should be an analysis in due time, notably in view of the interim evaluation of Horizon 2020, regarding the appropriateness of efforts in collaborative research in the field of transport.

(25)

Since the objectives of this Regulation, namely the establishment of the Clean Sky 2 Joint Undertaking in order to strengthen industrial research and innovation across the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of avoiding duplication, retaining critical mass and ensuring that public financing is used in an optimal way, 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 Regulation does not go beyond what is necessary for that purpose in order to achieve those objectives,

(a)

to contribute to the finalisation of research activities initiated under Regulation (EC) No 71/2008 and to the implementation of Regulation (EU) No 1291/2013, and in particular the Smart, Green and Integrated Transport Challenge under Part III — Societal Challenges of Decision 2013/743/EU;

(b)

to contribute to improving the environmental impact of aeronautical technologies, including those relating to small aviation, as well as to developing a strong and globally competitive aeronautical industry and supply chain in Europe.

This can be realised through speeding up the development of cleaner air transport technologies for earliest possible deployment, and in particular the integration, demonstration and validation of technologies capable of:

(a)

the requirements for the Clean Sky 2 Joint Undertaking’s contribution regarding the relevant performance indicators referred to in Annex II to Decision 2013/743/EU;

(b)

the requirements for the Clean Sky 2 Joint Undertaking’s contribution in view of the monitoring referred to in Annex III to Decision 2013/743/EU;

(c)

the specific performance indicators related to the functioning of the Clean Sky 2 Joint Undertaking;

(d)

the arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations including on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission;

(e)

provisions for the publication of calls for proposals by the Clean Sky 2 Joint Undertaking also on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission;

(f)

the use of and changes to human resources, in particular recruitment by function group, grade and category, the reclassification exercise and any changes to the number of staff members.

(a)

contributions to the Clean Sky 2 Joint Undertaking in accordance with Article 15(2) and point (b) of Article 15(3) of the Statutes;

(b)

in-kind contributions of at least EUR 965 250 000 over the period defined in Article 1 by the Leaders and Core Partners or their affiliated entities, consisting of the costs incurred by them in implementing additional activities outside the work plan of the Clean Sky 2 Joint Undertaking contributing to the objectives of the Clean Sky Joint Technology Initiative. Other Union funding programmes may support those costs in accordance with the applicable rules and procedures. In such cases, the Union financial contribution shall not be a substitute for the in-kind contributions from the Leaders and Core Partners or their affiliated entities.

(a)

pursuant to any arbitration clause contained in agreements or contracts concluded by the Clean Sky 2 Joint Undertaking or in its decisions;

(b)

in disputes relating to compensation for damage caused by the staff of the Clean Sky 2 Joint Undertaking in the performance of their duties;

(c)

in any dispute between the Clean Sky 2 Joint Undertaking and its staff within the limits and under the conditions laid down in the Staff Regulations and the Conditions of Employment.