P9_TA(2021)0434

Joint Undertakings under Horizon Europe *

European Parliament legislative resolution of 21 October 2021 on the proposal for a Council regulation establishing the Joint Undertakings under Horizon Europe (COM(2021)0087 — C9-0166/2021 — 2021/0048(NLE))

(Consultation)

(2022/C 184/19)

The European Parliament,

— having regard to the Commission proposal to the Council (COM(2021)0087),

— having regard to Article 187 and the first subparagraph of Article 188 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C9-0166/2021),

— having regard to Rule 82 of its Rules of Procedure,

— having regard to the letter from the Committee on Transport and Tourism,

— having regard to the report of the Committee on Industry, Research and Energy (A9-0246/2021),

1. Approves the Commission proposal as amended;

2. Calls on the Commission to alter its proposal accordingly, in accordance with Article 293(2) of the Treaty on the Functioning of the European Union;

3. Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

4. Asks the Council to consult Parliament again if it intends to substantially amend the Commission proposal;

5. Instructs its President to forward its position to the Council and the Commission.

Amendment 1

Proposal for a regulation

Recital 1

Text proposed by the Commission Amendment (1) In order to achieve the greatest possible impact of Union funding and the most effective contribution to the Union's policy objectives, Regulation [XXXX] of the European Parliament and of the Council (10) (the ‘Horizon Europe Regulation’)] established the policy and legal framework for European partnerships with private and/or public sector partners. European partnerships are a key element of the policy approach of Horizon Europe. They are set up to deliver on Union priorities targeted by Horizon Europe and ensure clear impact for the EU and its people, which can be achieved more effectively in partnership, through a strategic vision that is shared and committed to by partners, rather than by the Union alone. (1) In order to achieve the greatest possible impact of Union funding and the most effective contribution to the Union's policy objectives, Regulation [XXXX] of the European Parliament and of the Council (10) (the ‘Horizon Europe Regulation’)] established the policy and legal framework for European partnerships with private and/or public sector partners. European partnerships are a key element of the policy approach of Horizon Europe. They are set up to deliver on Union commitments and priorities targeted by Horizon Europe and ensure clear impact for the EU and its people and the environment , which can be achieved more effectively in partnership, through a strategic vision that is shared and committed to by partners, rather than by the Union alone.

Amendment 2

Proposal for a regulation

Recital 2

Text proposed by the Commission Amendment (2) In particular, European partnerships in the ‘Global Challenges and European Industrial Competitiveness’ pillar of Horizon Europe play an important role in achieving the strategic objectives such as accelerating the transitions towards sustainable development goals and a green and digital Europe and should contribute to recovery from the unprecedented COVID-related crisis. European partnerships address complex cross-border challenges that require an integrated approach. They make it possible to address the transformational, systemic and market failures described in the impact assessments accompanying this Regulation by bringing together a broad range of players across the value chains and ecosystems to work towards a common vision and translating it into concrete roadmaps and coordinated implementation of activities. Furthermore, they allow concentrating efforts and resources on common priorities to solve the complex challenges. (2) In particular, European partnerships in the ‘Global Challenges and European Industrial Competitiveness’ pillar of Horizon Europe play an important role in achieving the strategic objectives such as accelerating the achievement of the United Nations (UN) sustainable development goals (SDGs), the Union’s commitments under the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (1a) (the ‘Paris Agreement’) and the transition towards a green and digital Europe and should contribute to a socially, economically and environmentally resilient recovery from the unprecedented COVID-related crisis while enhancing European industrial leadership . European partnerships address complex cross-border challenges that require an integrated approach. They make it possible to address the transformational, systemic and market failures described in the impact assessments accompanying this Regulation by bringing together a broad range of players across the value chains and ecosystems to work towards a common vision and translating it into concrete roadmaps and coordinated implementation of activities. Furthermore, they allow concentrating efforts and resources on common priorities to solve the complex challenges to the benefit of society .

Amendment 3

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission Amendment (2a) In order to ensure scientific excellence, and in accordance with Article 13 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), freedom of scientific research should be ensured and the highest standards of scientific integrity should be promoted.

Amendment 4

Proposal for a regulation

Recital 2 b (new)

Text proposed by the Commission Amendment (2b) It is important that all European partnerships respect the ethical practices and fundamental ethical principles while adhering to the ethical standards set out in the different national, sectoral or institutional codes of ethics. Their research activities should always apply the principles laid down in Article 19 of the Horizon Europe Regulation and in the Commission statement on ethics and stem cell research concerning that Article.

Amendment 5

Proposal for a regulation

Recital 3

Text proposed by the Commission Amendment (3) To deliver on priorities and impact, European partnerships should be developed through a broad involvement of relevant stakeholders across Europe including industry, research organisations, bodies with a public service mission at local, regional, national or international level, and civil society organisations such as foundations that support and/or carry out research and innovation. They should also be one of the measures to strengthen cooperation between private and/or public sector partners at the international level including by joining up research and innovation programmes and cross-border investment in research and innovation bringing mutual benefits to people and businesses while ensuring that the Union can uphold its interests in strategic areas . (3) To deliver on priorities and impact, European partnerships should be developed through a broad involvement of all relevant stakeholders across Europe including industry , small and medium-sized enterprises (SMEs) and start-ups, universities , research organisations, bodies with a public service mission at local, regional, national or international level, civil society organisations , including non-governmental organisations (NGOs), and foundations that support and/or carry out research and innovation. They should also be one of the measures to strengthen cooperation between private and/or public sector partners at the international level including by joining up research and innovation programmes and cross-border investment in research and innovation bringing mutual benefits to people and businesses while ensuring that the Union can develop its strategic autonomy alongside an open economy .

Amendment 6

Proposal for a regulation

Recital 6

Text proposed by the Commission Amendment (6) Regulation (EU) 2020/852 (11) establishes the general framework for determining whether an economic activity qualifies as environmentally sustainable for the purposes of defining sustainable investments. It creates a common reference that investors, banks, industry and researchers can use when investing in projects and economic activities that have a substantial positive impact on climate and environment and no significant harm on any of them. It is the reference for green investments in the Union. (6) Regulation (EU) 2020/852 (11) establishes the general framework for determining whether an economic activity qualifies as environmentally sustainable for the purposes of defining sustainable investments. It creates a common reference that investors, banks, industry and researchers can use when investing in projects and activities which fall within its scope and that have a substantial positive impact on climate and environment and no significant harm on any of them. It is the reference for green investments in the Union.

Amendment 7

Proposal for a regulation

Recital 7

Text proposed by the Commission Amendment (7) Where relevant, partnerships should consider Technical Screening Criteria as of Art. 3 and the ‘Do No Significant Harm’ principle as of Art. 17 of the Regulation (EU) 2020/852 as an instrument to improve their projects readiness and access to green financing that will be crucial for market uptake and wider deployment of the innovative technologies and solutions they will deliver. Scientific evidence is at the core of the Technical Screening Criteria. Research and innovation, pursued by Partnerships, should play an important role to help economic operators reach or go beyond the standards and thresholds set up in the Regulation and to keep the Technical Screening Criteria up-to-date and consistent with the European Green Deal objectives. (7) Where relevant, partnerships should consider Technical Screening Criteria as of Art. 3 and the ‘Do No Significant Harm’ principle as of Art. 17 of the Regulation (EU) 2020/852 where the activity of the Joint Undertaking falls within the scope of that Regulation as an instrument to improve their projects readiness and access to green financing that will be crucial for market uptake and wider deployment of the innovative technologies and solutions they will deliver. Scientific evidence is at the core of the Technical Screening Criteria. Research and innovation, pursued by Partnerships, should play an important role to help economic operators reach or go beyond the standards and thresholds set up in the Regulation and to keep the Technical Screening Criteria up-to-date and consistent with the European Green Deal objectives.

Amendment 8

Proposal for a regulation

Recital 10

Text proposed by the Commission Amendment (10) The research and innovation activities undertaken by the joint undertakings should be funded from Horizon Europe. To achieve maximum impact, the joint undertakings should develop close synergies with other Union programmes and funding instruments, particularly with those supporting the deployment of innovative solutions, education and regional development, in order to increase economic and social cohesion and reduce imbalances. (10) The research and innovation activities undertaken by the joint undertakings should be funded from Horizon Europe. To achieve maximum impact, the joint undertakings should develop close synergies with other Union programmes and funding instruments, particularly with those supporting the deployment of innovative sustainable solutions, education and regional development, in order to respond to global challenges and increase economic and social cohesion and reduce imbalances and mitigate environmental impacts .

Amendment 9

Proposal for a regulation

Recital 11

Text proposed by the Commission Amendment (11) The new policy approach for European Partnerships, and in particular institutionalised European partnerships, calls for a novel way of establishing the legal framework under which they would operate. While the setting up of joint undertakings on the basis of Article 187 TFEU for the purpose of Horizon 2020 has proven to be effective as far as the implementation is concerned, it is necessary to step it up. Therefore, this Regulation aims at increasing the coherence, efficiency, effectiveness and impact-orientation of implementation through translating the Horizon Europe provisions, and the experience gained from programme implementation under Horizon 2020 into common provisions across the joint undertakings in a harmonised way. It aims at facilitating the creation of collaboration and synergies between European partnerships, thereby making full use of their interconnections at the organisational level. Joint undertakings should seek opportunities to involve representatives of other European partnerships in discussions during the drafting of their work programmes, identify the areas in which complementary or joint activities would address the challenges more effectively and efficiently, avoid overlaps, align timing of their activities and ensure access to results and other relevant means of knowledge exchange. (11) The new policy approach for European Partnerships, and in particular institutionalised European partnerships, calls for a novel way of establishing the legal framework under which they would operate. While the setting up of joint undertakings on the basis of Article 187 TFEU for the purpose of Horizon 2020 has proven to be effective as far as the implementation is concerned, it is necessary to step it up. Therefore, this Regulation aims at increasing the coherence, efficiency, effectiveness and impact-orientation and societal added value of implementation through translating the Horizon Europe provisions, and the experience gained from programme implementation under Horizon 2020 into common provisions across the joint undertakings in a harmonised way. It aims at facilitating the creation of collaboration and synergies between European partnerships, thereby making full use of their interconnections at the organisational level. Joint undertakings should seek opportunities to involve representatives of other European partnerships in discussions during the drafting of their work programmes, identify the areas in which complementary or joint activities would address the challenges more effectively and efficiently, avoid overlaps, align timing of their activities and ensure access to results and other relevant means of knowledge exchange.

Amendment 10

Proposal for a regulation

Recital 12

Text proposed by the Commission Amendment (12) Following the identification of synergies between them, joint undertakings should aim to determine budget shares which should be used for complementary or joint activities between joint undertakings. Moreover, this Regulation aims at achieving improved efficiencies and harmonisation of the rules through intensified operational collaboration and by exploring economies of scale, including the establishment of a common back office, which should provide horizontal support functions to the joint undertakings. The common back office should make it easier to achieve greater impact and harmonisation on common points while retaining a certain degree of flexibility to meet the specific needs of each joint undertaking. The structure should be established using service level agreements to be concluded jointly by the joint undertakings. The common back office functions should cover coordination and administrative support functions in areas where its screening has proved efficient and cost-effective and should take into account the compliance with the requirement of accountability of each individual authorising officer. The legal setup should be designed to best serve the common needs of the joint undertakings, to ensure their close collaboration and to explore all possible synergies among the European partnerships and, as a consequence, between the various parts of the Horizon Europe programme as well as between the other programmes managed by the joint undertakings. (12) Following the identification of synergies between them, joint undertakings should aim to determine budget shares which should be used for complementary or joint activities between joint undertakings. Moreover, this Regulation aims at achieving improved efficiencies and harmonisation of the rules through intensified operational collaboration and by exploring economies of scale, including , where applicable, the possibility of establishing common back office functions , which should provide horizontal support to the joint undertakings. Increasing the number of functions that the joint undertakings operate in common makes it easier to achieve greater impact and harmonisation on common points while retaining a certain degree of flexibility to meet the specific needs of each joint undertaking. The common back office functions may cover coordination and administrative support functions, in areas where its screening has proved efficient and cost-effective and should take into account the compliance with the requirement of accountability of each individual authorising officer. The joint undertakings should be able to conclude jointly service-level agreements , to ensure their close collaboration and to explore all possible synergies among the European partnerships and, as a consequence, between the various parts of the Horizon Europe programme as well as between the other programmes managed by the joint undertakings.

Amendment 11

Proposal for a regulation

Recital 13 a (new)

Text proposed by the Commission Amendment (13a) The joint undertakings should increase their insight and have a more integrated and systemic approach to managing the activities in their research areas. Complementarity and synergy with collaborative research work programmes and with the European Research Council would nurture the bottom-up inspired innovation pipeline. It would create opportunities for research in areas that are not currently addressed and also promote applications in other sectors, both up and downstream of the pipeline.

Amendment 12

Proposal for a regulation

Recital 14

Text proposed by the Commission Amendment (14) Horizon Europe introduces a more strategic, coherent and impact-driven approach to European partnerships, building on the lessons learned from the Horizon 2020 interim evaluation. In line with the new ambition, this Regulation aims at a more effective use of institutionalised European partnerships notably by focusing on clear objectives, outcomes and impact that can be achieved by 2030, and by ensuring a clear contribution to the related Union policy priorities and policies. Close collaboration and synergies with other relevant initiatives at Union, national and regional level, in particular with other European partnerships, are key in achieving greater impact and ensuring take up of results. In assessing the overall impact, broader investments beyond the contributions from partners and triggered by the joint undertakings that contribute to achieving their objectives should be taken into account. (14) Horizon Europe introduces a more strategic, coherent and impact-driven approach to European partnerships, building on the lessons learned from the Horizon 2020 interim evaluation. In line with the new ambition, this Regulation aims at a more effective use of institutionalised European partnerships notably by focusing on clear objectives, outcomes and impact that can be achieved by 2030, and by ensuring a clear contribution to the related Union policy priorities and policies. Close collaboration and synergies with other relevant initiatives at Union, national and regional level, in particular with other European partnerships, are key in achieving greater scientific, socio-economic and environmental impact and ensuring take up of results. The Commission should develop clear, simple and concrete guidelines to enable the different types of synergies, such as transfer of resources, alternative funding, cumulative funding and integrated funding. It is of particular importance for the Member States and the regions to maximise the alignment of their smart specialisation strategies and operational programmes with work programmes of the joint undertakings to enable the possible 5 % transfer mechanism from European structural and investments funds to the joint undertakings, as provided for in Article 15(5) of the Horizon Europe Regulation and subject to the conditions set out in the relevant provisions of the Regulation (EU) 2021/1060 of the European Parliament and of the Council (1a) (the Common Provisions Regulation). Synergies and complementarities with the European financial institutions, such as European Bank for Reconstruction and Development and the European Investment Bank, as well as between joint undertakings themselves and with other Union funding programmes and relevant industrial alliances with charitable foundations and trusts, should also be explored. In assessing the overall impact, broader investments beyond the contributions from partners and triggered by the joint undertakings that contribute to achieving their objectives should be taken into account to facilitate the acceleration of market uptake of innovative solutions.

Amendment 13

Proposal for a regulation

Recital 15

Text proposed by the Commission Amendment (15) This Regulation is based on the principles and criteria set out in the Horizon Europe Regulation, including openness and transparency, a strong leverage effect and long-term commitments of all the involved parties. One of the objectives of this Regulation is to ensure the openness of the initiatives to a broad range of entities, including newcomers. The partnerships should be open to any entity that is willing and capable to work towards the common goal, and promote broad and active participation of stakeholders in their activities, membership and governance, and to ensure that the results would be for the benefit of all Europeans, notably through a broad dissemination of results and pre-deployment activities across the Union. (15) This Regulation is based on the principles and criteria set out in the Horizon Europe Regulation, including openness and transparency, a strong leverage effect and long-term commitments of all the involved parties. One of the objectives of this Regulation is to ensure the openness of the initiatives to a broad range of entities, including newcomers. The partnerships should be open to any entity that is willing and capable to work towards the common goal, and promote broad and active participation of stakeholders in their activities, membership and governance, and to ensure that the results would be for the benefit of all Europeans while contributing to the global sustainable development, notably through a broad dissemination of results and pre-deployment activities as widely as possible across the Union.

Amendment 14

Proposal for a regulation

Recital 17 a (new)

Text proposed by the Commission Amendment (17a) A share of the EUR 5,4 billion allocated to Horizon Europe from Next Generation EU under the inter-institutional agreement on the multiannual financial framework for the years 2021-2027 (the ‘MFF’), may contribute to increase the funds of the joint undertakings. That contribution may also be supplemented by decommitments, as provided for in Article 15(3) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (1a) (the ‘Financial Regulation’), and adjusted to reflect contributions from associated countries. Additional contributions from the Union pursuant to Article 13 of Horizon Europe Regulation, Article 5 of the Council Regulation (EU, Euratom) 2020/2093 (the ‘MFF Regulation’) (1b) and Article 15(3) of the Financial Regulation, are to be distributed within clusters of Pillar 2 of Horizon Europe in a fair way, taking into account the research priorities of the Union as well as its policy goals. Any additional Union contribution should be matched by contributions from Members other than the Union.

Amendment 15

Proposal for a regulation

Recital 18

Text proposed by the Commission Amendment (18) In line with the ambitions set out in the Horizon Europe Regulation, one of the preconditions of setting up institutionalised partnerships is ensuring partner’s contributions throughout the lifetime of the initiatives. In this context, private partners should deliver a significant part of their contributions in the form of in-kind contributions to operational costs of the joint undertaking. Joint undertakings should be able to seek measures to facilitate these contributions through their work programmes , notably by reducing funding rates . These measures should be based on the specific needs of a joint undertaking and the underlying activities. In justified cases, it should be possible to introduce additional conditions that require the participation of a member of the joint undertaking or their constituent or affiliated entities, targeting activities where the industrial partners of the joint undertaking can play a key role , such as large-scale demonstrations and flagship projects, and contribute more via lower funding rates . The level of participation of members should be monitored by the executive director in order to empower the governing board to take appropriate actions, ensuring a balance between commitment from partners and openness. In duly justified cases, the capital expenditure for, e.g., large scale demonstrators or flagship projects, may be considered as an eligible cost in line with the applicable legal framework. (18) In line with the ambitions set out in the Horizon Europe Regulation, one of the preconditions of setting up institutionalised partnerships is ensuring partner’s contributions throughout the lifetime of the initiatives. In this context, private partners should deliver a significant part of their contributions in the form of in-kind contributions to operational costs of the joint undertaking. Joint undertakings should be able to seek measures to facilitate these contributions through their work programmes. These measures should be based on the specific needs of a joint undertaking and the underlying activities. In justified cases, it should be possible to introduce additional conditions that require the participation of a member of the joint undertaking or their constituent or affiliated entities, targeting activities where the industrial partners of the joint undertaking can play a key role or to achieve an integrated system programme . The level of participation of members should be monitored by the executive director in order to empower the governing board to take appropriate actions, ensuring a balance between commitment from partners and openness. In duly justified cases, the capital expenditure for, e.g., large scale demonstrators or flagship projects, may be considered as an eligible cost in line with the applicable legal framework.

Amendment 16

Proposal for a regulation

Recital 19

Text proposed by the Commission Amendment (19) In line with the principle of fair sharing of contributions among the members of joint undertakings, financial contributions to the administrative costs of the joint undertakings should be divided equally between the Union and the members other than the Union. Deviations from that principle should only be considered in exceptional and duly justified cases such as where the size or the membership structure of a member of the joint undertaking other than the Union would result in contributions per constituent or affiliated entity, in particular small and medium-sized enterprises ( SMEs), of such a high level that they would seriously jeopardise the incentive to become or remain a constituent or affiliated entity of the member of the joint undertaking. In such cases, the minimum percentage of annual financial contribution to the administrative costs of the joint undertaking from members other than the Union should be 20 % of the total annual administrative costs and the contributions from SMEs should be significantly lower than those from larger constituent or affiliated entities. Once a critical mass of membership that allows for a contribution higher than 20 % of the total annual administrative costs is reached, annual contributions per constituent or affiliated entity should be maintained or increased with the aim to gradually increase the share of the members other than Union in the overall contribution to the annual administrative costs of the joint undertaking. The members of the joint undertaking other than the Union should endeavour to increase the number of constituent or affiliated entities in order to maximise the contribution to 50 % of the administrative costs of the joint undertaking over its lifetime. (19) The ratio of administrative costs to the total budget should be of a comparable value across the joint undertakings and should not exceed 5 % of their budget. Furthermore, in line with the principle of fair sharing of contributions among the members of joint undertakings, financial contributions to the administrative costs of the joint undertakings should be divided equally between the Union and the members other than the Union. Members other than the Union should agree among themselves on the fair distribution of their part of the administrative expenses of their joint undertakings. Deviations from that principle should only be considered in exceptional and duly justified cases such as where the size or the membership structure of a member of the joint undertaking other than the Union would result in contributions per constituent or affiliated entity, in particular SMEs, research organisations or universities , of such a high level that they would seriously jeopardise the incentive to become or remain a constituent or affiliated entity of the member of the joint undertaking. In such cases, the minimum percentage of annual financial contribution to the administrative costs of the joint undertaking from members other than the Union should be 20 % of the total annual administrative costs and the contributions from SMEs , research organisations and universities should be significantly lower than those from larger constituent or affiliated entities. Once a critical mass of membership that allows for a contribution higher than 20 % of the total annual administrative costs is reached, annual contributions per constituent or affiliated entity should be maintained or increased with the aim to gradually increase the share of the members other than Union in the overall contribution to the annual administrative costs of the joint undertaking. The members of the joint undertaking other than the Union should endeavour to increase the number of constituent or affiliated entities in order to maximise the contribution to 50 % of the administrative costs of the joint undertaking over its lifetime.

Amendment 17

Proposal for a regulation

Recital 20

Text proposed by the Commission Amendment (20) The Horizon Europe Regulation requires the partners to show their long term commitment, including a minimum share of public and/or private investments. Consequently, it is necessary for the Union to identify in this Regulation founding members established in member states, countries associated to the Horizon Europe Programme or international organisations. However, where necessary, it should be possible to expand the membership base of joint undertakings after they are established with associated members selected following open and transparent procedures, taking into account in particular the new technological developments or the association of additional countries to the Horizon Europe Programme. Legal entities interested in supporting the joint undertakings’ objectives in their specific areas of research, without becoming a member, should also be offered the possibility to become contributing partners of these joint undertakings. (20) The Horizon Europe Regulation requires the partners to show their long term commitment, including a minimum share of public and/or private investments. Consequently, it is necessary for the Union to identify in this Regulation founding members established in member states, countries associated to the Horizon Europe Programme or international organisations. However, where necessary, it should be possible to expand the membership base of joint undertakings after they are established with associated members selected following regular, open, fair and transparent calls for interests and subsequent selection procedures, taking into account the opinion of the scientific advisory body as well as the new technological developments and innovative approaches or the association of additional countries to the Horizon Europe Programme. Legal entities interested in supporting the joint undertakings’ objectives in their specific areas of research, without becoming a member, should also be offered the possibility to become contributing partners of these joint undertakings.

Amendment 18

Proposal for a regulation

Recital 21

Text proposed by the Commission Amendment (21) The establishment of a joint undertaking ensures a mutually beneficial public-private partnership for the members involved, including by promoting certainty on major budget allocations for the relevant industries over a period of seven years . Becoming a founding member or associated member, or one of their constituent or affiliated entities, allows gaining influence, either directly or through the industry representatives, in the governing board of the joint undertaking . The governing board is the decision-making body of the joint undertaking that decides on the long-term strategic orientation of the partnership, as well as its annual priorities. Founding members and associated members and if applicable representing their constituent entities, should therefore be able to contribute to the joint undertaking's agenda and priority setting through the adoption and possible amendment of the Strategic Research and Innovation Agenda, as well as the adoption of the annual work programme, including the content of the calls for proposals, the applicable funding rate per call topic, and the related rules for submission, evaluation, selection, award and review procedures. (21) The establishment of a joint undertaking ensures a mutually beneficial public-private partnership for the members involved, including by promoting certainty on major budget allocations for the relevant industries over a period of seven years , and by providing political signalling, enhanced planning and investor certainty . The governing board is the decision-making body of the joint undertaking that decides on the long-term strategic orientation of the partnership, as well as its annual priorities based on the input of partners, including the private sector, the scientific community, Member States representatives and not-for-profit civil society organisations active in the field of the relevant joint undertaking . Founding members and associated members and if applicable representing their constituent entities together with all other relevant stakeholders , should therefore be able to contribute to the joint undertaking's agenda and priority setting through the adoption and possible revision of the Strategic Research and Innovation Agenda, as well as the adoption of the annual work programme, including the content of the calls for proposals, the applicable funding rate per call topic, and the related rules for submission, evaluation, selection, award and review procedures.

Amendment 19

Proposal for a regulation

Recital 22

Text proposed by the Commission Amendment (22) It is appropriate that the members other than the Union commit to the implementation of this Regulation by means of a letter of commitment. Those letters of commitment should be legally valid throughout the lifetime of the initiative and closely monitored by the joint undertaking and the Commission. Joint undertakings should create a legal and organisational environment that enables members to deliver on their commitments while ensuring continuous openness of the initiative and transparency during their implementation, notably for priority setting and for participation in calls for proposals. (22) The joint undertakings should be able to work in an agile, simple and flexible manner and have in place a set of clear rules, thereby enhancing attractiveness for all stakeholders in particular for industry, SMEs, research organisations and participating states. It is appropriate that the members other than the Union commit to the implementation of this Regulation by means of a letter of commitment. Those letters of commitment should be published in a timely manner on the website of the relevant joint undertaking while ensuring that confidentiality rules are respected, and should be legally valid throughout the lifetime of the initiative and closely monitored by the joint undertaking and the Commission. Joint undertakings should create a legal and organisational environment that enables members to deliver on their commitments while ensuring continuous openness of the initiative, transparency and the respect of rules on conflicts of interest, during their implementation, notably for priority setting and for participation in calls for proposals promoting participation that is gender balanced and geographically diverse . Joint undertakings should, where appropriate, identify calls for proposal where a coordinating role for SME participants is promoted.

Amendment 20

Proposal for a regulation

Recital 23

Text proposed by the Commission Amendment (23) Further simplification is a cornerstone of the Horizon Europe Framework Programme. In that context, there should be a simplified reporting mechanism for partners, who are no longer required to report on non-eligible costs. In-kind contributions to operational activities should be accounted solely on the basis of eligible costs. That allows for the automated calculation of in-kind contributions to operational activities via the Horizon Europe IT tools, lowers the administrative burden for partners and makes the reporting mechanism for contributions more effective. In-kind contributions to operational activities should be closely monitored by the joint undertakings and regular reports should be prepared by the executive director of the governing board in order to establish whether the progress towards reaching the in-kind contributions targets is satisfactory enough. The governing board should assess both the efforts made and the results achieved by the members contributing to operational activities, as well as other factors, such as the level of participation of SMEs and attractiveness of the initiative to newcomers. When necessary, it should take appropriate remedial and corrective measures taking into account the principles of openness and transparency. (23) Further simplification is a cornerstone of the Horizon Europe Framework Programme. In that context, there should be a simplified reporting mechanism for partners, who are no longer required to report on non-eligible costs. In-kind contributions to operational activities should be accounted solely on the basis of eligible costs. That allows for the automated calculation of in-kind contributions to operational activities via the Horizon Europe IT tools, lowers the administrative burden for partners and makes the reporting mechanism for contributions more effective. In-kind contributions to operational activities should be closely monitored by the joint undertakings and regular reports should be prepared by the executive director of the governing board and made public in a timely manner on the website of the relevant joint undertaking in order to establish whether the progress towards reaching the in-kind contributions targets is satisfactory enough. The governing board should assess both the efforts made and the results achieved by the members contributing to operational activities, as well as other factors, such as the level of participation of SMEs, attractiveness of the initiative to newcomers and geographical diversity . When necessary, it should take appropriate remedial and corrective measures taking into account the principles of openness and transparency.

Amendment 21

Proposal for a regulation

Recital 24

Text proposed by the Commission Amendment (24) The joint undertakings should provide a systematic opportunity and incentive for members other than the Union to combine their research and innovation activities with those of the joint undertaking. Additional activities should not receive financial support from the joint undertaking. However, they can be accounted as members’ in-kind contributions when contributing to the objectives of the joint undertaking and directly linked to its activities. That link can be established through the uptake of results from indirect actions funded by the joint undertaking or its preceding initiatives, or by demonstrating a significant Union added-value. This Regulation should lay down more specific provisions concerning the scope of additional activities for each joint undertaking, to the extent that it is necessary to achieve the desired directionality and impact. It should be further decided by joint undertakings’ governing boards whether, for valuing the contributions, the use of simplifying methods such as lump-sums or unit costs is necessary to achieve simplification, cost effectiveness and appropriate level of protection of confidential commercial data. (24) The joint undertakings should provide a systematic opportunity and incentive for members other than the Union to combine their research and innovation activities with those of the joint undertaking. Additional activities should not receive financial support from the joint undertaking. However, they can be accounted as members’ in-kind contributions when contributing to the objectives of the joint undertaking and directly linked to its activities. That link can be established through the uptake of results from indirect actions funded by the joint undertaking or its preceding initiatives, or by demonstrating a significant Union added-value. This Regulation should lay down more specific provisions on identifying the scope of additional activities in the most transparent way for each joint undertaking, to the extent that it is necessary to achieve the desired directionality and impact. It should be further decided by joint undertakings’ governing boards whether, for valuing the contributions, the use of simplifying methods such as lump-sums or unit costs is necessary to achieve simplification, cost effectiveness and appropriate level of protection of confidential commercial data.

Amendment 22

Proposal for a regulation

Recital 24 a (new)

Text proposed by the Commission Amendment (24a) In order to support the careers of young researchers and foster excellence in research and innovation, the joint undertakings should provide up to date information and regular open calls to PhD and postdoctoral students in the remit of the relevant joint undertaking fostering, where relevant, complementarities and synergies with the Marie Skłodowska-Curie Actions.

Amendment 23

Proposal for a regulation

Recital 25

Text proposed by the Commission Amendment (25) The governance of joint undertakings should ensure that their decision-making processes are fit to keep pace with fast-changing socio-economic and technological environment and global challenges. Joint undertakings should benefit from the expertise, advice and support from all relevant stakeholders, in order to effectively implement their tasks and ensure synergies at Union and national level. Therefore, joint undertakings should be empowered to set up advisory bodies with a view to providing them with expert advice and carrying out any other task of an advisory nature that is necessary for the achievement of the joint undertakings' objectives. In setting up the advisory bodies, joint undertakings should ensure a balanced representation of experts within the scope of the activities of the joint undertaking , including with respect to gender balance . The advice provided by these bodies should bring in scientific perspectives as well as those of national and regional authorities and of other stakeholders of joint undertakings. (25) The governance of joint undertakings should ensure that their decision-making processes are transparent and fit to keep pace with fast-changing socio-economic and technological environment and global challenges. The governing bodies of joint undertakings should take into account the principle of gender balance and geographical diversity. Joint undertakings should benefit from the expertise, advice and support from all relevant stakeholders, including but not limited to universities and other research organisations, representatives of industry and SMEs in order to effectively implement their tasks and ensure synergies at Union, national and regional level. Therefore, joint undertakings should be empowered to set up advisory bodies with a view to providing them with expert advice and carrying out any other task of an advisory nature that is necessary for the achievement of the joint undertakings' objectives. In setting up the advisory bodies, joint undertakings should ensure a balanced representation of experts within the scope of the activities of the joint undertaking. The advice provided by these bodies should bring in scientific perspectives as well as those of national and regional authorities, of other stakeholders of joint undertakings and of civil society organisations .

Amendment 24

Proposal for a regulation

Recital 26

Text proposed by the Commission Amendment (26) Joint undertakings should be able to set up an advisory body with a scientific advisory function. That body or its members should be in a position to provide independent scientific advice and support to the respective joint undertaking. The scientific advice should concern, in particular, annual work plans, additional activities as well as any other aspect of the joint undertakings’ tasks, as necessary. (26) Joint undertakings should set up an advisory body with a scientific advisory function. That body or its members should provide independent scientific advice and support to the relevant joint undertaking independently from members of other governing bodies of the joint undertaking . The scientific advice should concern, in particular, the strategic research and innovation agenda, the annual work plans, additional activities , socio-economic, environmental and climate impacts, potential new members as well as any other aspect of the joint undertakings’ tasks, as necessary.

Amendment 25

Proposal for a regulation

Recital 26 a (new)

Text proposed by the Commission Amendment (26a) The governing boards should provide the scientific advisory body with timely information on decisions concerning recommendations and opinions proposed by the scientific advisory body. Those decisions should be made publicly available.

Amendment 26

Proposal for a regulation

Recital 28

Text proposed by the Commission Amendment (28) With the view to ensuring that joint undertakings are aware of the positions and views of stakeholders from the entire value chain in their respective fields, joint undertakings should be able to set up their respective advisory stakeholders groups, to be consulted on horizontal issues or specific questions, as per the needs of each joint undertaking. Such groups should be open to all public and private stakeholders, including organised interest groups, and international interest groups from member states, associated countries as well as from other countries, active in the field of the joint undertaking. (28) With the view to ensuring that joint undertakings are aware of the positions and views of stakeholders from the entire value chain in their respective fields, joint undertakings should be able to set up their respective advisory stakeholders groups, to be consulted on horizontal issues or specific questions, as per the needs of each joint undertaking. Such groups should be open to all public and private stakeholders, including organised interest groups, civil society organisations and international interest groups from Member States, associated countries as well as from other countries, active in the field of the joint undertaking.

Amendment 27

Proposal for a regulation

Recital 29

Text proposed by the Commission Amendment (29) The joint undertakings should operate in an open and transparent way, providing all relevant information in a timely manner to their appropriate bodies as well as promoting their activities, including information and dissemination activities, to the wider public. (29) The joint undertakings should operate in a simple, flexible, open , fair and transparent way, providing all relevant information in a timely manner to their appropriate bodies as well as promoting their activities, including information and dissemination activities, to the wider public , engaging in awareness-raising campaigns and promoting educational and dissemination activities, with the involvement of academic, scientific and knowledge networks, social and economic partners, media, organisations representing industry and SMEs and other actors . All joint undertakings should make dedicated efforts to ensure that the public is sufficiently and timely informed of the joint undertakings’ activities and should provide appropriate information on their respective websites, including the publication of relevant documentation such as annual activities, progress reports, agendas and minutes of board meetings in line with confidentiality rules. They should enhance the dialogue with society, increase awareness, favour active participation in all stages of scientific inquiry, thus enabling citizens to co-design solutions, contribute to ideas and create constructive attitudes about the activities and the results of the joint undertakings, thereby increasing trust in technological solutions to current and future challenges.

Amendment 28

Proposal for a regulation

Recital 30

Text proposed by the Commission Amendment (30) The joint undertakings should be implemented using a structure and rules that enhance efficiency and ensure simplification. To that effect, the joint undertakings should adopt financial rules specific to its needs in accordance with Article 71 of Regulation (EU, Euratom) No 2018/1046 of the European Parliament and of the Council (2). (30) The governance structure and the dedicated programme office are unique features of the joint undertakings that should permit a higher level of trust-based operations. The joint undertakings should be implemented using a structure and rules that enhance their impact, efficiency and ensure maximum administrative simplification for the beneficiaries and reduction of their administrative burden . To that effect, the joint undertakings should adopt financial rules specific to its needs in accordance with Article 71 of Regulation (EU, Euratom) No 2018/1046 of the European Parliament and of the Council (2). In order to enable the joint undertakings to perform their tasks and additional activities, adequate staff numbers and grades should be ensured.

Amendment 29

Proposal for a regulation

Recital 32

Text proposed by the Commission Amendment (32) Participation in indirect actions funded by the joint undertakings under Horizon Europe should comply with the rules set out in the Horizon Europe Regulation. The joint undertakings should ensure consistent application of those rules based on relevant measures adopted by the Commission. The joint undertakings should use the corporate model grant agreement prepared by the Commission. In relation to the period to object to transfers of ownership of results referred to in [Article 36(4)] of the Horizon Europe Regulation, the duration of innovation cycles in the areas covered by the respective joint undertakings should be taken into account. (32) Participation in indirect actions funded by the joint undertakings under Horizon Europe should comply with the rules set out in the Horizon Europe Regulation . SMEs in particular may lack the resources to actively engage in European projects and should be supported by all joint undertakings to participate in their activities However, in order to encourage the participation of SMEs, joint undertakings should be able to apply different reimbursement rates for the Union funding within an action depending on the type of participant. The reimbursement rates should be indicated in the work programme . The joint undertakings should ensure consistent application of those rules based on relevant measures adopted by the Commission. The joint undertakings should use the corporate model grant agreement prepared by the Commission. In relation to the period to object to transfers of ownership of results referred to in [Article 36(4)] of the Horizon Europe Regulation, the duration of innovation cycles in the areas covered by the relevant joint undertakings should be taken into account.

Amendment 30

Proposal for a regulation

Recital 32 a (new)

Text proposed by the Commission Amendment (32a) Since the lack of skills is a major obstacle to competitiveness, joint undertakings should actively contribute to reducing the specific skills gap across the Union and to adopting measures to improve the gender balance and address the gender dimension, including in the STEM fields, by assisting in the building of new knowledge and human capital, by engaging in awareness raising campaigns and by promoting educational and dissemination activities, with the involvement of academic, scientific and knowledge networks, social and economic partners, the media, organisations representing industry and SMEs and other players. Joint undertakings should seek for possibilities to inform students who might wish to pursue a career in the science, technology, engineering and mathematics and in other areas related to the operational activities of the joint undertakings. Joint undertakings should be one of the instruments for attracting talents and reducing the problem of brain drain, keeping a balanced circulation of researchers and specialised expertise.

Amendment 31

Proposal for a regulation

Recital 33

Text proposed by the Commission Amendment (33) One of the main purposes of joint undertakings is to foster the Union’s economic capacities and in particular its scientific and technological sovereignty. Moreover, the post pandemic recovery highlights the need to invest in key technologies such as 5G , AI, cloud, cybersecurity and green tech and the valorisation of these technologies in the Union. Results generated by all participants will play an important role in this respect and all participants will benefit from the Union funding through the results generated in the project and access rights thereto, even those participants not having received Union funding. Therefore, to protect the Union interests, the right for joint undertakings to object to transfers of ownership of results or to grants of an exclusive licence regarding results should also apply to participants not having received Union funding. In exercising this right to object the joint undertaking should strike a fair balance between the Union interests and protection of fundamental rights on the results of the participants without funding in accordance with the principle of proportionality, taking into account that these participants did not receive any Union funding for the action from which the results were generated. (33) Among the main purposes of joint undertakings is to foster the Union’s economic capacities and in particular its industrial, scientific and technological sovereignty as well as climate neutrality and to build a more sustainable and competitive economy through scientific, digital and technological innovation . Moreover, the post pandemic recovery highlights the need to invest in necessary infrastructures and key technologies such as new communication technologies, 5G and 6G , AI, cloud, cybersecurity and green tech as well as the valorisation , deployment and commercialisation of these technologies in the Union . The joint undertakings should contribute to fostering open science in accordance with the principles set down in Articles 14 and 39 of the Horizon Europe Regulation, which state that access to research data should be ‘as open as possible, as closed as necessary’, taking into consideration the legitimate interests of the beneficiaries . Results generated by all participants will play an important role in this respect and all participants will benefit from the Union funding through the results generated in the project and access rights thereto, even those participants not having received Union funding. Therefore, to protect the Union interests, the right for joint undertakings to object to transfers of ownership of results or to grants of an exclusive licence regarding results should also apply to participants not having received Union funding. In exercising this right to object the joint undertaking should strike a fair balance between the Union interests and protection of fundamental rights on the results of the participants without funding in accordance with the principle of proportionality, taking into account that these participants did not receive any Union funding for the action from which the results were generated.

Amendment 32

Proposal for a regulation

Recital 38

Text proposed by the Commission Amendment (38) In accordance with [Article 8(2)(c)] of the Horizon Europe Regulation, joint undertakings should have a clear life cycle approach. In order to adequately protect the financial interests of the Union, joint undertakings should be set up for a period ending 31 December 2031 to allow them to exercise their responsibilities with regard to grant implementation until the last indirect actions launched have been completed. (38) The joint undertakings should be financed by the Union programmes under the MFF and, where applicable, by Next Generation EU. In accordance with [Article 8(2)(c)] of the Horizon Europe Regulation, joint undertakings should have a clear life cycle approach. In order to adequately protect the financial interests of the Union, joint undertakings should be set up for a period ending 31 December 2031 to allow them to exercise their responsibilities with regard to grant implementation until the last indirect actions launched have been completed.

Amendment 33

Proposal for a regulation

Recital 38 a (new)

Text proposed by the Commission Amendment (38a) The joint undertaking, its bodies and staff should avoid any conflict of interest in the implementation of their activities. The governing board and the Executive Directors should adopt rules for the prevention, avoidance and management of conflicts of interest. Members of the Scientific Committee should make publicly available and keep updated a declaration of full professional activities, of financial interests and of conflicts of interest.

Amendment 34

Proposal for a regulation

Recital 39

Text proposed by the Commission Amendment (39) In the context of the European Commission’s priority of ‘A European Green Deal’ (3) supported by the revised Union Bioeconomy Strategy (4), the EU Biodiversity Strategy (5), the Clean Planet for All Communication (6), the Circular Economy Action Plan (7) and the new Farm to Fork communication (8), the European bio-based sector, including SMEs, regions and primary producers should become climate neutral, more circular and more sustainable while remaining competitive on the global scale. A strong, resource efficient and competitive bio-based innovation ecosystem can decrease dependency on and accelerate the substitution of non-renewable fossil raw materials and mineral resources. It can develop renewable bio-based products, materials, processes and nutrients from waste and biomass through sustainability and circularity-driven innovation. Such ecosystem can also create value from local feedstock — including waste, residues and side-streams — to deliver jobs, economic growth and development throughout the Union not only in urban areas but also in rural and coastal territories where biomass is produced and that are often peripheral regions that rarely benefit from industrial development. (39) In the context of the Commission’s priority of ‘A European Green Deal’ (3) supported by the revised Union Bioeconomy Strategy (4), the EU Biodiversity Strategy (5), the Clean Planet for All Communication (6), the Circular Economy Action Plan (7), the new Farm to Fork communication (8) and the UN SDGs, the European bio-based sector, including SMEs and start-ups , regions and primary producers should become climate neutral, more circular and more sustainable while remaining competitive on the global scale. A strong, resource efficient and competitive bio-based innovation ecosystem can decrease dependency on and accelerate the substitution of non-renewable fossil raw materials and mineral resources. It can develop renewable bio-based products, materials, processes and nutrients from waste and biomass through sustainability and circularity-driven innovation. Such ecosystem can also create value from local feedstock — including waste, residues and side-streams — to deliver jobs, economic , social growth and development throughout the Union not only in urban areas but also in rural and coastal territories where biomass is produced and that are often peripheral regions that rarely benefit from industrial , economic and social development. It can also contribute to the identification of solutions using negative emissions technologies and approaches.

Amendment 35

Proposal for a regulation

Recital 40

Text proposed by the Commission Amendment (40) The Bio-Based Industry Joint Undertaking established under Horizon 2020 has focused on sustainable resource use, especially in resource-intensive and high-impact sectors, such as agriculture, textiles manufacturing and construction, in particular also aiming at local operators, manufacturers, plants and factories. Its interim evaluation published in October 2017 included a strong set of 34 recommendations that are reflected in the design of the Circular Bio-based Europe Joint Undertaking established by this Regulation. The Circular Bio-based Europe Joint Undertaking is not a direct continuation of the Bio-Based Industry Joint Undertaking but rather a programme that builds on the achievements of the predecessor and addresses its shortcomings. In line with the recommendations, the Circular Bio-based Europe Joint Undertaking should involve a wider range of stakeholders including the primary sector (agriculture, aquaculture, fisheries and forestry) as well as providers of waste, residues and side streams, regional authorities and investors to prevent market failures and unsustainable bio-based processes. To deliver on its objectives, it should only fund projects that are respecting principles of circularity, sustainability and planetary boundaries. (40) The Bio-Based Industry Joint Undertaking established under Horizon 2020 has focused on sustainable resource use, especially in resource-intensive and high-impact sectors, such as agriculture, textiles manufacturing and construction, in particular also aiming at local operators, manufacturers, plants and factories. Its interim evaluation published in October 2017 included a strong set of 34 recommendations that are reflected in the design of the Circular Bio-based Europe Joint Undertaking established by this Regulation. The Circular Bio-based Europe Joint Undertaking is not a direct continuation of the Bio-Based Industry Joint Undertaking but rather a programme that builds on the achievements of the predecessor and addresses its shortcomings. In line with the recommendations, the Circular Bio-based Europe Joint Undertaking should involve a wider range of stakeholders including the primary sector ( across technologies, agriculture, aquaculture, fisheries and forestry) as well as providers of waste, residues and side streams, regional authorities and investors to prevent market failures and unsustainable bio-based processes as well as representatives from civil society organisations. In particular it should ensure openness to smaller actors . To deliver on its objectives, it should only fund projects that are respecting principles of circularity, sustainability, planetary boundaries and mitigate their potential social, and environmental impacts .

Amendment 36

Proposal for a regulation

Recital 41

Text proposed by the Commission Amendment (41) The Circular Bio-based Europe Joint Undertaking should establish Deployment Groups that should serve as advisory bodies and should actively participate in the strategic discussions that are setting the agenda for the partnership. It is crucial to include those advisory bodies in the governance structure to ensure wider participation and higher private investment in the circular bio-based sector. The Deployment Groups should in particular provide support to the strategic Governing Board meetings where industrial leaders and the stakeholders’ representatives together with high-level Commission representatives join the permanent Governing Board to discuss and set the strategic direction of the partnership. (41) The Circular Bio-based Europe Joint Undertaking should establish Deployment Groups that should serve as advisory bodies and should actively participate in the strategic discussions that are setting the agenda for the partnership. It is crucial to include those advisory bodies in the governance structure to ensure wider participation and higher private investment in the circular bio-based sector. The Deployment Groups should in particular provide support to the strategic Governing Board meetings where industrial leaders and the stakeholders’ representatives together with high-level Commission representatives join the permanent Governing Board to discuss and set the strategic direction and ensure the environmental and social sustainability of the partnership.

Amendment 37

Proposal for a regulation

Recital 42

Text proposed by the Commission Amendment (42) The main objective of the Clean Aviation Joint Undertaking should be to contribute to reducing the ecological footprint of aviation by accelerating the development of climate neutral aviation technologies for their earliest possible deployment, therefore significantly contributing to the ambitious environment impact mitigation goals of the European Green Deal, that is to say a 55 % emissions reduction by 2030 compared to 1990 levels, and climate neutrality by 2050. This objective can only be achieved through accelerating and optimising the research and innovation processes in aeronautics and by improving the global competitiveness of the Union aviation industry. The Clean Aviation Joint Undertaking should also ensure that cleaner aviation remains safe, secure and efficient for the transportation of passengers and goods by air. (42) The main objective of the Clean Aviation Joint Undertaking should be to contribute to reducing the ecological footprint of aviation by accelerating the development of climate neutral aviation technologies for their earliest possible deployment, therefore significantly contributing to the ambitious environment impact mitigation goals of the European Green Deal, and the Regulation (EU) 2021/1119 of the European Parliament and of the Council (1a) (European Climate Law) that is to say a 55 % emissions reduction by 2030 compared to 1990 levels, and climate neutrality by 2050 at the latest, in line with Paris Agreement . This objective can only be achieved through accelerating and optimising the research and innovation processes in aeronautics and by improving the global competitiveness of the Union aviation industry. The Clean Aviation Joint Undertaking should also ensure that cleaner aviation remains safe, secure and efficient for the transportation of passengers and goods by air.

Amendment 38

Proposal for a regulation

Recital 44 a (new)

Text proposed by the Commission Amendment (44a) Clean and sustainable aviation, which is facing significant challenges due to the COVID-19 pandemic, has been recognised as a vital element for Union’s success in a highly competitive world. The Clean Aviation Joint Undertaking could expand the aeronautics research support base in different ways. It could help import new knowledge, solutions and innovation potential by finding ideas in other sciences and sectors. It could also enable students to contribute in an industrial environment, particularly in SMEs. Successful collaboration between joint undertakings and academic institutions may lead to sponsored research contracts, funded collaborations, student internship programs, shared specialized facilities, industry affiliates programs, grants, awards, prizes that energise the academic community.

Amendment 39

Proposal for a regulation

Recital 47

Text proposed by the Commission Amendment (47) Europe faces the challenge of having to play a leading role in internalising the societal costs of greenhouse gas emissions in the air transport business model while continuing to ensure a ‘level playing field’ for European products in the global market. Therefore, the Clean Aviation Joint Undertaking should support the European representatives in international standardisation and international legislative efforts. (47) Europe faces the challenge of having to play a global leading role in internalising the societal costs of greenhouse gas emissions and environmental impacts in the air transport business model while continuing to ensure a ‘level playing field’ for European products and services in the global market as well as the right to connectivity and the competitiveness of the sector . Therefore, the Clean Aviation Joint Undertaking should support the European representatives in international standardisation and international legislative efforts.

Amendment 40

Proposal for a regulation

Recital 48

Text proposed by the Commission Amendment (48) Interest in Hydrogen has evolved dramatically in the last five years with all member states having signed and ratified the Conference of the Parties (COP21) Paris Agreement. At the end of 2019, the Commission presented the European Green Deal, which aims to transform the Union into a fair and prosperous society, with a modern, resource-efficient and competitive economy, where there are no net emissions of greenhouse gases in 2050. Priority areas include clean hydrogen, fuel cells, other alternative fuels and energy storage. Hydrogen is prominent in the July 2020 ‘Communications on a hydrogen strategy for a climate-neutral Europe and an EU Strategy for Energy System Integration’ as well as for the launch of the European Clean Hydrogen Alliance that brings all stakeholders together to identify technology needs, investment opportunities and regulatory barriers to build a clean hydrogen ecosystem in the Union. (48) Interest in Hydrogen has evolved dramatically in the last five years with all member states having signed and ratified the Conference of the Parties (COP21) Paris Agreement. At the end of 2019, the Commission presented the European Green Deal, which aims to transform the Union into a fair and prosperous society, with a modern, resource-efficient and competitive economy, where there are no net emissions of greenhouse gases in 2050 at latest . Priority areas include clean hydrogen, fuel cells, other alternative fuels, energy storage and negative emissions technologies . Hydrogen is prominent in the July 2020 ‘Communications on a hydrogen strategy for a climate-neutral Europe and an EU Strategy for Energy System Integration’ and the European Parliament's resolution of 19 May 2021 on a European Strategy for Hydrogen (1a) as well as for the launch of the European Clean Hydrogen Alliance that brings all stakeholders together to identify technology research and infrastructure needs, investment opportunities and regulatory as well as economic barriers to build a clean hydrogen ecosystem in the Union.

Amendment 41

Proposal for a regulation

Recital 49

Text proposed by the Commission Amendment (49) Dedicated research and innovation activities related to hydrogen applications have been supported since 2008, mainly through the Fuel Cell and Hydrogen Joint Undertakings (FCH Joint Undertaking and FCH 2 Joint Undertaking) under FP7 and Horizon 2020 as well as by traditional collaborative projects, covering all stages/fields of the hydrogen value chain. The Clean Hydrogen Joint Undertaking should strengthen and integrate Union scientific capacity to accelerate the development and improvement of advanced clean hydrogen applications ready for market, across energy, transport, building and industrial end-uses. This will only be possible if combined with strengthening competitiveness of the Union clean hydrogen value chain, and notably SMEs. (49) Dedicated research and innovation activities related to hydrogen applications have been supported since 2008, mainly through the Fuel Cell and Hydrogen Joint Undertakings (FCH Joint Undertaking and FCH 2 Joint Undertaking) under FP7 and Horizon 2020 as well as by traditional collaborative projects, covering all stages/fields of the hydrogen value chain. The Clean Hydrogen Joint Undertaking should strengthen and integrate Union scientific capacity to accelerate the development and improvement of advanced clean hydrogen applications ready for market, across energy, aviation, maritime and heavy-duty transport, building and industrial end-uses. This will only be possible if combined with strengthening competitiveness of the Union clean hydrogen value chain, and notably SMEs and start-ups .

Amendment 42

Proposal for a regulation

Recital 51

Text proposed by the Commission Amendment (51) Since hydrogen can be deployed as a fuel, energy carrier and for storing energy it is essential that the clean hydrogen partnership establishes structured collaboration with many other Horizon Europe partnerships, notably for end-use. The clean hydrogen partnership should interact in particular with the zero emission road and waterborne transport, Europe’s railway, clean aviation, processes for the planet and clean steel partnerships. For that purpose, a structure should be set up reporting to the Governing Board in order to ensure the co-operation and synergies between these partnerships in the domain of hydrogen. The clean hydrogen initiative would be the only partnership focused on addressing hydrogen production technologies. Collaboration with end-use partnerships should in particular focus on demonstrating the technology and co-defining specifications. (51) Since hydrogen can be deployed as a fuel, energy carrier and for storing energy it is essential that the clean hydrogen partnership establishes structured collaboration with many other Horizon Europe partnerships, notably for end-use , and is involved in Important Projects of Common European Interest (IPCEI) . The clean hydrogen partnership should interact and develop synergies in particular with the zero emission road and waterborne transport, Europe’s railway, clean aviation, processes for the planet and clean steel partnerships. For that purpose, a structure should be set up reporting to the Governing Board in order to ensure the co-operation and synergies between these partnerships in the domain of hydrogen. The clean hydrogen initiative would be the only partnership focused on addressing hydrogen production technologies and infrastructure . Collaboration with end-use partnerships should in particular focus on demonstrating the technology and co-defining specifications.

Amendment 43

Proposal for a regulation

Recital 53

Text proposed by the Commission Amendment (53) The European Green Deal aims to transform the Union into a fair and prosperous society, with a modern, resource-efficient and competitive economy where there are no net emissions of greenhouse gases by 2050 and where economic growth is decoupled from resource use. Priority areas include accelerating the shift to sustainable and smart mobility. (53) The European Green Deal aims to transform the Union into a fair and prosperous society, with a modern, energy and resource-efficient , sustainable and competitive economy where there are no net emissions of greenhouse gases by 2050 and where economic growth is decoupled from resource use. Priority areas include accelerating the shift to sustainable and smart mobility.

Amendment 44

Proposal for a regulation

Recital 54

Text proposed by the Commission Amendment (54) The Commission Communication on a New Industrial Strategy for Europe (22) (March 2020) underlines that sustainable and smart mobility industries, such as the rail industry, have both the responsibility and the potential to drive the digital and green transition, support Europe’s industrial competitiveness and improve connectivity. Therefore road, rail, aviation, and waterborne transport should all contribute to a 90 % reduction in transport emissions by 2050. As a matter of priority, a substantial part of the 75 % of inland freight carried today by road should shift onto rail and inland waterways. (54) The Commission Communication on a New Industrial Strategy for Europe (22) (March 2020) , including its update of May 2021, underline that sustainable and smart mobility industries, such as the rail industry, have both the responsibility and the potential to drive the digital and green transition, support Europe’s industrial competitiveness , boost the recovery and improve connectivity. Therefore road, rail, aviation, and waterborne transport should all contribute to a 90 % reduction in transport emissions by 2050. As a matter of priority, a substantial part of the 75 % of inland freight carried today by road should shift onto rail and inland waterways.

Amendment 45

Proposal for a regulation

Recital 56

Text proposed by the Commission Amendment (56) The objective of Europe’s Rail Joint Undertaking should be to deliver a high capacity integrated European railway network by eliminating barriers to interoperability and providing solutions for full integration, covering traffic management, vehicles, infrastructure and services. This should exploit the huge potential for digitalisation and automation to reduce rail’s costs, increase capacity, and enhance its flexibility and reliability, and should be based upon a solid Reference Functional System Architecture shared by the sector, in coordination with the European Union Agency for Railways. (56) The objective of Europe’s Rail Joint Undertaking should be to deliver a high capacity integrated European railway network which aims to the highest standards of safety for both end-users, including passengers, and rail workers by eliminating barriers to interoperability and providing solutions for full integration, covering traffic management, vehicles, infrastructure and services including through ticketing . This should exploit the huge potential for digitalisation and automation to reduce rail’s costs, increase capacity, and enhance its flexibility and reliability, safety and inclusiveness and should be based upon a solid Reference Functional System Architecture shared by the sector, in coordination with the European Union Agency for Railways.

Amendment 46

Proposal for a regulation

Recital 58

Text proposed by the Commission Amendment (58) Rail is a complex system, with very close interactions between infrastructure managers, rail undertakings (train operators) and their respective equipment (infrastructure and rolling stock). It is impossible to deliver innovation without common specifications and strategy across the rail system. Therefore, the System Pillar of the Europe’s Rail Joint Undertaking should enable the sector to converge on a single operational concept and system architecture, including the definition of the services, functional blocks, and interfaces, which form the basis of rail system operations. It should provide the overall framework to ensure that research targets customer requirements and operational needs that are commonly agreed and shared customer requirements and operational needs. The governance model and the decision making process of the Europe’s Rail Joint Undertaking should reflect the Commission’s leading role in unifying and integrating Europe’s railway system, especially in rapidly and effectively delivering the single operational concept and system architecture, while involving the private partners in advisory and technical support roles. (58) Rail is a complex system, with very close interactions between infrastructure managers, rail undertakings (train operators) and their respective equipment suppliers ( e.g. infrastructure and rolling stock). It is impossible to deliver innovation without common specifications and strategy across the rail system. Therefore, the System Pillar of the Europe’s Rail Joint Undertaking should enable the sector to converge on a single operational concept and system architecture, including the definition of the services, functional blocks, and interfaces, which form the basis of rail system operations. It should provide the overall framework to ensure that research targets customer requirements and operational needs in order to deliver enhanced passenger rights that are commonly agreed and shared customer requirements and operational needs. The governance model and the decision making process of the Europe’s Rail Joint Undertaking should reflect the Commission’s leading role in unifying and integrating Europe’s railway system, especially in rapidly and effectively delivering the single operational concept and system architecture, while involving the private partners in advisory and technical support roles and taking into account the needs of end-users, including passengers, and workers with specific reference to safety and inclusiveness .

Amendment 47

Proposal for a regulation

Recital 61

Text proposed by the Commission Amendment (61) In the context of the Commission’s priorities of the United Nations Sustainable Development Goals , in particular SDG 3, and the Communication Towards a Comprehensive Strategy with Africa (23), the Union is committed to contribute to ensure healthy lives and promote well-being for all, to build an even stronger partnership between our two continents and to support the development of research and innovation capacities within Africa. The Global Health EDCTP3 Joint Undertaking should address the lack of appropriate diagnostics, treatments and vaccines, among other so-called health technologies, to address infectious diseases, such as HIV, malaria and tuberculosis, but also other poverty related and neglected infectious diseases, that are prevalent in Africa, especially in sub-Saharan Africa. The COVID19 pandemic has revealed that with the increased connectivity of different regions in the world, through world trade and tourism, infectious diseases can rapidly spread all over the world. Developing health technologies is therefore crucial to limit the spread of infectious diseases, as well as to fight them once they have spread, to protect the health of the citizens in the countries concerned and in the Union. In order to achieve a stronger global health leadership than the current EDCTP2 initiative, the scope of the partnership should be extended to cover response to emerging infectious diseases threats, the increasing problems of antimicrobial resistance and non-communicable diseases co-morbidities. (61) In the context of the Commission’s priorities of the UN SDGs , in particular SDG 3, and the Communication Towards a Comprehensive Strategy with Africa (23), the Union is committed to contribute to ensure healthy lives and promote well-being for all, to build an even stronger partnership between our two continents and to support the development of research and innovation capacities within Africa. The Global Health EDCTP3 Joint Undertaking should address the lack of appropriate diagnostics, treatments and vaccines, among other so-called health technologies, to address infectious diseases, such as HIV, malaria and tuberculosis, but also other poverty related and neglected infectious diseases, that are prevalent in Africa, especially in sub-Saharan Africa. The COVID19 pandemic has revealed that with the increased connectivity of different regions in the world, through world trade and tourism, infectious diseases can rapidly spread all over the world. Developing health technologies is therefore crucial to limit the spread of infectious diseases, as well as to fight them once they have spread, to protect the health of the citizens to improve and foster health in the countries concerned and in the Union by supporting health promotion and disease prevention, reducing health inequalities and ensuring equal and full access to health . In order to achieve a stronger global health leadership than the current EDCTP2 initiative, the scope of the partnership should be extended to cover response to emerging infectious diseases threats, the increasing problems of antimicrobial resistance and non-communicable diseases co-morbidities.

Amendment 48

Proposal for a regulation

Recital 62

Text proposed by the Commission Amendment (62) Tackling infectious diseases affecting sub-Saharan Africa with modern technology tools requires the involvement of a large set of actors and long-term commitments. The Global Health EDCTP3 Joint Undertaking should broker productive and sustainable North–South and South–South networking and cooperation, building relationships with multiple private and public sector organisations to strengthen project and institutional collaborations. The programme should also help to establish new North–South and South-South collaborations to conduct multi-country, multi-site studies in sub-Saharan Africa. In addition, a regular international conference, the EDCTP Forum, should provide a platform for scientists and relevant networks from Europe, Africa, and elsewhere to share findings and ideas, and to establish collaborative links. (62) Tackling infectious diseases affecting sub-Saharan Africa with modern technology tools requires the involvement of a large set of actors and long-term commitments. The Global Health EDCTP3 Joint Undertaking should broker productive and sustainable North–South and South–South networking and cooperation, building relationships with multiple private , not-for-profit and public sector organisations to strengthen project and institutional collaborations. The Global Health EDCTP3 Joint Undertaking should establish strong links and synergies with the initiatives so far implemented by the European Development Fund and should improve coordination in the different fields of activity, collaborating in capacity building and sharing facilities and infrastructures, with the actions supported by the Neighbourhood, Development and International Cooperation Instrument in Africa. The programme should also help to establish new North–South and South-South collaborations to conduct multi-country, multi-site studies in sub-Saharan Africa. In addition, a regular international conference, the EDCTP Forum, should provide a platform for scientists and relevant networks from Europe, Africa, and elsewhere to share findings and ideas, and to establish collaborative links.

Amendment 49

Proposal for a regulation

Recital 64

Text proposed by the Commission Amendment (64) It is essential that the research activities funded by Global Health EDCTP3 Joint Undertaking or otherwise covered by its work 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. Furthermore, the Global Health EDCTP3 Joint Undertaking should require that the innovations and interventions developed based on results of the indirect actions supported by the programme be affordable and accessible for vulnerable populations. (64) It is essential that the research activities funded by Global Health EDCTP3 Joint Undertaking or otherwise covered by its work programme, are in full compliance with the Charter, 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. Furthermore, the Global Health EDCTP3 Joint Undertaking should require that the innovations and interventions developed based on results of the indirect actions supported by the programme be affordable and accessible for vulnerable populations living in low-resource settings . The Global Health EDCTP3 Joint Undertaking should also support the establishment of ethics committees in African countries, in support of research and innovation activities.

Amendment 50

Proposal for a regulation

Recital 65

Text proposed by the Commission Amendment (65) For the Global Health EDCTP3 Joint Undertaking to succeed and incentivise participation in the partnership, the joint undertaking funding should be restricted to legal entities eligible for funding under the Horizon Europe programme and established in constituent states of the European and Developing Countries Clinical Trials Partnership (EDCTP) Association. The entities established in other Union member states, associated countries and sub-Saharan African countries should still be able to participate in the calls without receiving funding. Additionally it should also be possible for entities established in other countries than members of the EDCTP3 Association to be eligible for funding in specific call topics or in case of a call addressing a public health emergency, where it is provided for in the work programme. The Global Health EDCTP3 Joint Undertaking should take all appropriate measures, including contractual, to protect the financial interests of the Union. The conclusion of science and technology agreements with third countries should be sought. Before their conclusion, where entities established in a third country without such an agreement participate with funding in an indirect action, alternative measures to safeguard Union interests should be applied by the EDCTP3 JU: the financial coordinator of the action should be established in a Member State or associated country and the amount of pre-financing as well as liability provisions of the grant agreement should be adapted to adequately take the financial risks into account. (65) For the Global Health EDCTP3 Joint Undertaking to succeed and incentivise participation in the partnership, the joint undertaking funding should be restricted to legal entities eligible for funding under the Horizon Europe programme and established in constituent states of the European and Developing Countries Clinical Trials Partnership (EDCTP) Association. The entities established in other Union member states, associated countries and sub-Saharan African countries should still be able to participate in the calls without receiving funding. Additionally it should also be possible for entities established in other countries than members of the EDCTP3 Association to be eligible for funding in specific call topics or in case of a call addressing a public health emergency, where it is provided for in the work programme. The Global Health EDCTP3 Joint Undertaking should take all appropriate measures, including contractual, to protect the financial interests of the Union. The conclusion of science and technology agreements with third countries should be sought. Before their conclusion, where entities established in a third country without such an agreement participate with funding in an indirect action, alternative measures to safeguard Union interests should be applied by the EDCTP3 JU: except in cases of projects led by African entities and countries, the financial coordinator of the action should be established in a Member State or associated country and the amount of pre-financing as well as liability provisions of the grant agreement should be adapted to adequately take the financial risks into account.

Amendment 51

Proposal for a regulation

Recital 66

Text proposed by the Commission Amendment (66) In the context of the European Commission’s priorities of ‘An economy that works for people’ and ‘A Europe fit for the digital age’, the European industry, including SMEs, should become greener , more circular and more digital while remaining competitive on the global scale. The Commission has emphasized the role of medical devices and digital technologies addressing emerging challenges and the use of e-health services to provide high-quality health care, along with a call for ensuring the supply of affordable medicines to meet the Union’s needs, whilst supporting an innovative and world-leading European pharmaceutical industry. The Innovative Health Initiative Joint Undertaking aims to contribute towards strengthening the competitiveness of the Union’s health industry, a cornerstone of the Union’s knowledge-based economy, to an increased economic activity in the development of health technologies, notably of integrated health solutions, and thus serve as a tool for increasing technological sovereignty and fostering the digital transformation of our societies. Such political priorities can be achieved by bringing together the crucial players: the academia, companies of various sizes and end-users of health innovations, under the umbrella of a public-private partnership in health research and innovation. The Innovative Health Initiative Joint Undertaking should help reach the objectives of the ‘Europe’s Beating Cancer Plan’ (9) and the ‘European One Health Action Plan against Antimicrobial Resistance’ (10). The Innovative Health Initiative Joint Undertaking should be aligned with the new Industrial Strategy for Europe (11), the Pharmaceutical Strategy for Europe (12) and the SME strategy for a sustainable and digital Europe (13). (66) In the context of the Commission’s priorities of ‘An economy that works for people’ and ‘A Europe fit for the digital age’, the European industry, including SMEs and start-ups , should become environmentally sustainable , more circular and more digital while remaining competitive on the global scale. The Commission has emphasized the role of medical devices , enhanced diagnostics, treatments and digital technologies addressing emerging health challenges and the use of e-health services to provide high-quality health care, along with a call for ensuring the supply of affordable medicines to meet the patients’ needs, whilst supporting an innovative and world-leading European pharmaceutical industry. The Innovative Health Initiative Joint Undertaking aims to contribute towards strengthening the competitiveness of the Union’s health industry in the development of health technologies, notably of integrated health solutions, and thus improving the quality and delivery of health services throughout the Union, serve as a tool for increasing technological development and innovative solutions and fostering the digital transformation of our societies. Such political priorities can be achieved by bringing together the crucial players: the public sector, the academia, companies of various sizes and end-users of health innovations, under the umbrella of a public-private partnership in health research and innovation. The Innovative Health Initiative Joint Undertaking should help reach the objectives of the ‘Europe’s Beating Cancer Plan’ (9) , the Horizon Europe Mission on Cancer and the ‘European One Health Action Plan against Antimicrobial Resistance’ (10) , and should also enhance the collaboration with the different European initiatives for rare diseases . The Innovative Health Initiative Joint Undertaking should be aligned with the new Industrial Strategy for Europe (11) and its update , the Pharmaceutical Strategy for Europe (12) and the SME strategy for a sustainable and digital Europe (13). Synergies with the European Health Emergency Preparedness and Response Authority (HERA) should be sought to provide a structural collaborative system to enable the Union to anticipate and tackle health-related threats more effectively. Cooperation mechanisms and synergies with the EU4Health programme are also beneficial to boosting the Union’s preparedness to cross border health threats, strengthen health systems and improve availability and affordability of pharmaceutical innovation products. The Joint Undertaking should also develop synergies with the European Health Data Space as well as with the research initiatives in the field of rare diseases.

Amendment 52

Proposal for a regulation

Recital 67

Text proposed by the Commission Amendment (67) The Innovative Health Initiative Joint Undertaking builds on the experience gained from the Innovative Medicine Initiative 2 Joint Undertaking (IMI2 Joint Undertaking) including the work done by this initiative to combat the COVID-19 pandemic. In line with the recommendations of the interim evaluation of IMI2 Joint Undertaking (14), a successor initiative needs to ‘enable the active engagement of other industry sectors with the pharmaceutical industry to capitalise on their expertise in the development of new health care interventions’. Therefore, the industry sectors need to cover the biopharmaceutical, biotechnology and medical technology sectors, including companies active in the digital area. The scope of the initiative should cover prevention, diagnosis, treatment and disease management and must be established taking due account of the high burden for patients and/or society due to the severity of the disease and/or the number of people affected, as well as the high economic impact of the disease for patients and for health care systems. The funded actions must respond to the Union public health needs, supporting the development of future health innovations that are safe, people-centred , effective, cost-effective and affordable for patients and for health care systems. (67) The Innovative Health Initiative Joint Undertaking builds on the experience gained from the Innovative Medicine Initiative 2 Joint Undertaking (IMI2 Joint Undertaking) including the work done by this initiative to combat the COVID-19 pandemic. In line with the recommendations of the interim evaluation of IMI2 Joint Undertaking (14), a successor initiative needs to ‘enable the active engagement of other industry sectors with the pharmaceutical industry to capitalise on their expertise in the development of new health care interventions’. Therefore, the industry sectors need to cover the biopharmaceutical, biotechnology and med