### participants to indirect actions funded by the global health edctp3 joint undertaking shall ensure that the products and services developed based or partly based on the results of the indirect action are available and accessible to the public at fair and reasonable conditions. for that purpose , where relevant , the work programme shall specify additional exploitation obligations applicable to specific indirect actions. ### participants to indirect actions funded by the global health edctp3 joint undertaking shall ensure that the products and services developed based or partly based on the results of the indirect action are available , accessible and affordable for vulnerable populations and to the public general , in particular in low-resource settings , at fair and reasonable conditions. for that purpose the work programme shall specify additional exploitation obligations applicable to specific indirect actions.


### contribute towards the creation of a union-wide health research and innovation ecosystem that facilitates translation of scientific knowledge into innovations , notably by launching at least 30 large-scale , cross-sectoral projects , focussing on health innovations; ### contribute towards the creation of a union-wide health research and innovation ecosystem that facilitates translation of scientific knowledge into novel products or services , notably by launching at least 30 large-scale , cross-sectoral projects , focussing on health innovations;


### foster the development of safe , effective , people-centred and cost-effective innovations that respond to strategic unmet public health needs , by exhibiting , in at least five examples , the feasibility of integrating health care products or services , with demonstrated suitability for uptake by health care systems. the related projects should address the prevention , diagnosis , treatment and/or management of diseases affecting the union population , including contribution to europe’s beating cancer plan; ### foster the development of safe , effective , people-centred , affordable for patients and for health care systems and cost-effective innovations that respond to strategic unmet public health needs , by exhibiting , in at least five examples , the feasibility of integrating health care products or services , with demonstrated suitability for uptake by health care systems. the related projects should address the prevention , diagnosis , treatment and/or management of diseases affecting the union population , including contribution to europe’s beating cancer plan and the european one health action plan against antimicrobial resistance;;


### contribute towards a better understanding of the determinants of health and priority disease areas; ### contribute towards a better understanding of environmental and health determinants , unmet medical needs , emergency preparedness , infectious diseases , including poverty-related diseases , non-communicable and rare diseases and other priority disease areas;


### integrate fragmented health research and innovation efforts bringing together health industry sectors and other stakeholders , focussing on unmet public health needs , to enable the development of tools , data , platforms , technologies and processes for improved prediction , prevention , interception , diagnosis , treatment and management of diseases , meeting the needs of end-users; ### integrate fragmented health research and innovation efforts bringing together health industry sectors and other stakeholders , focussing on unmet public health needs , to enable the development of tools , data , platforms , technologies and processes for improved prediction , prevention , interception , diagnosis , treatment and management of diseases , meeting the needs of patients and end-users and overcoming market failure for unmet medical needs;


### exploit the full potential of digitalisation and data exchange in health care; ### exploit the full potential of digitalisation and data exchange in health care , while strictly respecting the principles of data protection as defined in article 27 of regulation (eu) 2018/1725 eudpr , while also;


### foster close and long-term cooperation between the union , other members , contributing partners , and other stakeholders involved in health care such as other relevant industries , health care authorities (such as regulatory bodies , health technology assessment bodies and payers) , patient organisations , health care professionals and providers , as well as the academia; ### foster close and long-term cooperation between the union , other members , contributing partners , and other stakeholders involved in health care such as other relevant industries , health care authorities (such as regulatory bodies , health technology assessment bodies and payers) , patient organisations , health care professionals and providers , the academia as well as non-profit civil society organisations;


### ensure that all stakeholders have the possibility of proposing areas for future calls for proposals; ### ensure that all stakeholders have the possibility of proposing areas for future calls for proposals based on meaningful regular open consultations and the organisation of an annual stakeholder forum meeting;


### regularly review and make any necessary adjustments to the strategic research and innovation agenda of the innovative health initiative joint undertaking in light of scientific developments occurring during its implementation or emerging public health needs; ### regularly review and make any necessary adjustments to the strategic research and innovation agenda of the innovative health initiative joint undertaking in light of scientific developments occurring during its implementation or emerging public health needs and emergencies;


### publish information on the projects , including participating entities and the amount of the financial contribution of the innovative health initiative joint undertaking and committed in-kind contributions per participant; ### publish timely information on the projects , including participating entities and the amount of the financial contribution of the innovative health initiative joint undertaking and committed in-kind contributions per participant as well as the minutes of the governing board;


### 2. the contributions referred to in paragraph 1 shall consist of contributions to the innovative health initiative joint undertaking in accordance with article 11(1). ### 2. the contributions referred to in paragraph 1 shall consist of in-kind and financial contributions to the innovative health initiative joint undertaking in accordance with article 11(1).


### 6. work programmes of the innovative health initiative joint undertaking may set out specific limits for in-kind contributions to operational costs incurred in third countries other than countries associated with horizon europe at an indirect action level. the decisions on such specific limits shall take into account in particular the objectives and the impact sought by the actions concerned and shall not result in an excess of the ceiling set out in paragraph 5 at the innovative health initiative programme level. ### 6. work programmes of the innovative health initiative joint undertaking shall set out specific limits for in-kind contributions to operational costs incurred in third countries other than countries associated with horizon europe at an indirect action level. the decisions on such specific limits shall take into account in particular the objectives and the impact sought by the actions concerned and shall not result in an excess of the ceiling set out in paragraph 5 at the innovative health initiative programme level.


### 2. where relevant , project proposals shall include a plan for their related additional activities. costs associated to such project-specific additional activities must be incurred between the date of submission of the proposal and up to two years after the end date of the indirect action. ### 2. where relevant , project proposals shall include a plan quantifying their related additional activities. costs associated to such project-specific additional activities do not substitute for the in kind contributions from the members other than the union or their constituent entities and must be incurred between the date of submission of the proposal and up to two years after the end date of the indirect action.


### 3. in order for the costs to be accounted for as in-kind contributions referred to in point (b) of article 11(1) , the underlying additional activities shall be carried out in the european union or countries associated to horizon europe. ### 3. the underlying additional activities shall be carried out in the european union or countries associated to horizon europe.


### the innovation panel; ### the stakeholders group;


### (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 council10 (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 council10 (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 , 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.


### (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 un sustainable development goals , the union’s commitment under the paris agreement and a green and digital europe and should contribute to a socially , economically and environmentally resilient 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 complex challenges to the benefit of society.


### (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 relevant stakeholders across europe including industry , universities , research organisations , bodies with a public service mission at local , regional , national or international level , and civil society organisations , including foundations and ngos 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.


### (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) 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.


### (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 and should contribute to the latter's climate mainstreaming target of at least 35%. 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 , and in order to respond to global challenges and increase economic and social cohesion , reduce imbalances and environmental impacts.


### (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 , 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.


### (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. 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.


### (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 and contribute to global sustainable development , notably through a broad dissemination of results and pre-deployment activities across the union.


### (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 cash and in-kind contributions to operational costs of the joint undertaking. in the case of in-kind contributions , 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 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. flagship projects , may be considered as an eligible cost in line with the applicable legal framework.


### (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) 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) , 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 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.


### (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 , it should be possible to expand the membership base of joint undertakings after they are established with associated members selected following regular open 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.


### (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 providing political signalling , enhanced planning and investor certainty over a period of seven years. 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 input of all partners , including the private sector , the scientific community , member states representatives and non-profit civil society organisations active in the field of the respective joint undertaking. founding members and associated members and if applicable representing their constituent entities together with all other relevant stakeholders should therefore be consulted on the joint undertaking's agenda and priority setting 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. the actual drafting of strategic research and innovation agenda and the annual work programmes should be led by the commission , the scientific committee , and the member states group ensuring the joint undertakings priorities’ alignment with public interest and societal added value.


### (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) 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 respective joint undertaking and 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 non-existence of conflict of interest during their implementation , notably for priority setting and for participation in calls for proposals.


### (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 that should be made publicly in a timely manner on the website of the respective joint undertaking should be prepared by the executive director of the governing board based on regular assessments by independent external experts 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.


### (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 quantified 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 quantifying and 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 quantifying 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.


### (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 fit to keep pace with fast-changing socio-economic , socio-ecological 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 , 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 , 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 including representatives from non-profit civil society and end-user organisations..


### (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 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. members of other governing bodies of the joint undertakings shall not be part of the scientific advisory body to ensure independence. the scientific advice should concern , in particular , the strategic research and innovation agenda , the annual work plans , additional activities anticipated long-term socio-economic , environmental and climate impacts , potential new members as well as any other aspect of the joint undertakings’ tasks , as necessary.


### (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 , not-for profit civil society organisation , and international interest groups from member states , associated countries as well as from other countries , active in the field of the joint undertaking.


### (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 council12 . ### (30) the joint undertakings should be implemented using a structure and rules that enhance their impact , 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 council12 .


### (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) 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 new communication technologies , 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.


### (39) in the context of the european commission’s priority of “a european green deal”13 supported by the revised union bioeconomy strategy14 , the eu biodiversity strategy15 , the clean planet for all communication16 , the circular economy action plan17 and the new farm to fork communication18 , 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 union’s priority of “a european green deal”13 supported by the revised union bioeconomy strategy14 , the eu biodiversity strategy15 , the clean planet for all communication16 , the circular economy action plan17 and the new farm to fork communication18 , the european bio-based sector , including smes , regions and primary producers should become climate neutral , circular and environmentally sustainable while remaining competitive on the global scale. a strong , circular and resource efficient bio-based innovation ecosystem that operates within planetary boundaries and protects biodiversity and the integrity of the remaining functioning ecosystems in europe and abroad can decrease dependency on and accelerate competitiveness and 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 residues from biological origin through sustainability and circularity-driven innovation. to enable this , the guiding principle of a biomass hierarchy should be integrated across eu policies concerning biomass use and 'cascade utilization' of biomass should be supported: first directed to high-value applications such as biochemicals and biomaterials then lower value applications (biofuels , bioenergy). such ecosystem can also create value from local feedstock – based on waste and residues – to deliver jobs , economic development throughout the union not only in urban areas but also in rural and coastal territories and that are often peripheral regions that rarely benefit from industrial development.


### (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 cover the entire bio-based value chain and involve a wider range of stakeholders including the primary sector (across technologies , agriculture , aquaculture , fisheries and forestry) , providers of waste and residues , regional authorities and investors to prevent market failures and unsustainable bio-based processes as well as representative of the non-profit and civil society sector. in particular it shall ensure openness to smaller actors , such as from the non-conventional agriculture sectors. to deliver on its objectives , it should only fund projects that are respecting principles of circularity , sustainability and planetary boundaries and that do not come at the expense of essential social and environmental demands , such as food production or the integrity of the remaining functioning ecosystems in europe and in third countries , avoiding unsustainable land-use conversion or land-grabbing practices , while having a positive impact on biodiversity and ecosystems.


### (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 , including from the non-conventional agriculture sector , and non-profit sector civil society organisations , 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 , scientists 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.


### (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 alternative and more environmental friendly means of transport as well as zero emission aviation technologies for their earliest possible deployment , therefore significantly contributing to the ambitious environment impact mitigation goals of the european green deal , in particular the 55% greenhouse gas emissions reduction by 2030 compared to 1990 levels , and climate neutrality by 2050 at the latest. this objective can 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 clean aviation remains safe , secure and efficient for the transportation of passengers and goods by air.


### (43) the clean aviation joint undertaking builds on the experience gained from the clean sky and clean sky 2 joint undertakings. the new partnership should be more ambitious by focusing on developing breakthrough demonstrators. in line with the findings of the interim evaluation of the clean sky 2 joint undertaking , a new initiative should ensure that every demonstrator has a 'business case' basis in order for the technologies developed to really serve the "earliest possible deployment" which is a key priority. therefore , the new initiative should focus on increasing the visibility of its individual exploitation objectives and strengthening the monitoring , management and reporting capabilities of the joint undertaking to reflect the complexity of the research and innovation effort required for the partnership to reach its objectives. ### (43) the clean aviation joint undertaking builds on the experience gained from the clean sky and clean sky 2 joint undertakings. the new partnership should be more ambitious by focusing on developing breakthrough demonstrators. in line with the findings of the interim evaluation of the clean sky 2 joint undertaking , a new initiative should ensure that every demonstrator has a 'business case' basis in order for the zero-emission and silent technologies developed to really serve the "earliest possible deployment" which is a key priority. therefore , the new initiative should focus on increasing the visibility of its individual exploitation objectives and strengthening the monitoring , management and reporting capabilities of the joint undertaking to reflect the complexity of the research and innovation effort required for the partnership to reach its objectives.


### (44) the clean aviation joint undertaking should build on a diverse membership base , bringing together a broad spectrum of stakeholders and ideas. in view of identifying the most promising approaches and entities capable of pursuing them , the commission launched a call for expression of ideas and potential members19 . the governing board should be allowed to select associated members based on the results of that call in order to provide for a swift expansion of the group of members. ### (44) the clean aviation joint undertaking should build on a diverse membership base , bringing together a broad spectrum of stakeholders and ideas , including scientific experts and relevant civil society organisations in the fields of environment and climate. in view of identifying the most promising approaches and entities capable of pursuing them , the commission launched a call for expression of ideas and potential members19 . the governing board should be allowed to select associated members based on the results of that call in order to provide for a swift expansion of the group of members.


### (45) in order to maximise and accelerate the impact of the research and innovation activities undertaken by the clean aviation and single european sky atm research 3 joint undertakings on effective emission reduction and the digitalisation of the aviation industry , they should seek close collaboration with the european union aviation safety agency (easa) in the work of the partnership , ensuring an early exchange of knowledge on new technologies developed. that will be crucial to accelerate market uptake , by facilitating the certification process of resulting products and services as required by regulation (eu) 2018/118920 . ### (45) in order to maximise and accelerate the impact of the research and innovation activities undertaken by the clean aviation and single european sky atm research 3 joint undertakings on effective emission reduction and the digitalisation of the aviation industry , they should seek close collaboration with the european union aviation safety agency (easa) in the work of the partnership , ensuring an early exchange of knowledge on new zero-emission technologies developed. that will be crucial to accelerate market uptake , by facilitating the certification process of resulting products and services as required by regulation (eu) 2018/118920 .


### (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 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. therefore , the clean aviation joint undertaking should support the european representatives in international standardisation and international legislative efforts.


### (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. 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 hydrogen stakeholders together to identify technology needs , investment opportunities and regulatory barriers to build a renewable hydrogen ecosystem in the union. being only one-two investment cycles away from 2050 , priority areas include fully renewable based hydrogen , fuel cells , other alternative fuels and energy storage. it is more critical than ever to avoid investments and policy decisions which may lock the eu into fossil dependence or that become stranded assets. with major global economies developing hydrogen strategies and committing to climate neutrality , the hydrogen electrolyser market is widely expected to expand in the coming years. eu companies are well-placed to gain competitiveness benefits from electrolyser market growth , due to a leading position along the whole value chain.


### (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 renewable hydrogen joint undertaking should strengthen and integrate union scientific capacity to accelerate the development and improvement of advanced renewable hydrogen applications ready for market , across end-uses where renewables-based electrification or no other cost-effective or technical alternative exists , such as steel production and the chemical industry , and long haul transport , especially maritime and air applications. this will only be possible if combined with strengthening competitiveness of the union renewable hydrogen value chain , and notably smes.


### (50) to achieve the scientific objectives of the clean hydrogen joint undertaking , all sectors concerned by the hydrogen economy should be given the possibility to get involved in preparing and implementing its strategic research and innovation agenda. the public sector should also be involved , especially regional and national authorities , the latter being responsible for setting up climate policies and measures related to market mechanisms , to fill in the gaps between ready-to-market technology development and large-scale uptake. ### (50) to achieve the scientific objectives of the clean hydrogen joint undertaking , all sectors concerned by the hydrogen economy should be given the possibility to give input to strategic research and innovation agenda. the scientific community should help to determine renewable hydrogen applications and to identify research gaps , whereas public and non-profit civil society actors should also be involved , especially regional and national authorities , the latter being responsible for setting up climate and energy policies and measures related to market mechanisms , to fill in the gaps between ready-to-market technology development and large-scale uptake.


### (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 renewable hydrogen can be deployed as a fuel , energy carrier and for storing energy it is essential that the renewable 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 waterborne transport , clean aviation and 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. the results and findings of the renewable hydrogen partnership should be easily accessible and widely published and made available to a wide range of actors , including in the fields of energy system integration , climate research and civil society as well as the hydrogen industrial alliance.


### (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 , 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 , with rail at its forefront.


### (54) the commission communication on a new industrial strategy for europe22 (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 europe22 (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 100% 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 secondarily to inland waterways.


### (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 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 improve the service to the end user , such as with through-ticketing , 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.


### (57) the europe’s rail joint undertaking should define in its master plan its priority research and innovation activities , and overall system architecture and harmonised operational approach , including large-scale demonstration activities , required to accelerate the penetration of integrated , interoperable and standardised technological innovations necessary to support the single european railway area. ### (57) the europe’s rail joint undertaking should define in its master plan , the joint undertaking’s strategic research and innovation agenda , its priority research and innovation activities , and overall system architecture and harmonised operational approach , including large-scale demonstration activities , required to accelerate the penetration of integrated , interoperable and standardised technological innovations necessary to support the single european railway area.


### (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 (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 , in order to deliver enhanced passenger rights. 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.


### (63) the global health edctp3 joint undertaking should build on the experience gained during the edctp and edctp2 programmes , achieving results by harnessing investments of the union , the member states , associated countries and african countries which could not have been achieved by individual countries or by the union research framework programme alone. the edctp association , representing the states participating in the programme , should contribute financially and with additional activities , to the edctp3 programme and its implementation. it should provide meaningful participation and involvement of the sub-saharan countries in the decision-making process , which is essential for tackling the burden of diseases in sub-saharan countries. the initiative should include other international research funders , such as philanthropies , the pharmaceutical industry and other third countries , that should contribute to the partnership as contributing partners on an ad hoc basis. furthermore , to increase the impact of the programme , the global health edctp3 joint undertaking should have , for specific calls , the possibility to identify legal entities that could participate in indirect actions. it should be possible to provide in the work programme that such legal entities would not be eligible for funding by the joint undertaking. ### (63) the global health edctp3 joint undertaking should build on the experience gained during the edctp and edctp2 programmes , achieving results by harnessing investments of the union , the member states , associated countries and african countries which could not have been achieved by individual countries or by the union research framework programme alone. the edctp association , representing the states participating in the programme , should contribute financially and with additional activities , to the edctp3 programme and its implementation. it should provide meaningful participation and involvement of the sub-saharan countries in the decision-making process , which is essential for tackling the burden of diseases in sub-saharan countries. the initiative should include other international research funders , such as philanthropies , the pharmaceutical industry and other third countries , that should contribute to the partnership as contributing partners on an ad hoc basis. furthermore , to increase the impact of the programme , the global health edctp3 joint undertaking should collaborate closely with the ihi joint undertaking and have , for specific calls , the possibility to identify legal entities that could participate in indirect actions. it should be possible to provide in the work programme that such legal entities would not be eligible for funding by the joint undertaking.


### (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’24 and the ‘european one health action plan against antimicrobial resistance’25 . the innovative health initiative joint undertaking should be aligned with the new industrial strategy for europe26 , the pharmaceutical strategy for europe27 and the sme strategy for a sustainable and digital europe28 . ### (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 environmentally sustainable , circular and more digital while remaining competitive on the global scale. the commission has emphasized the role of enhanced diagnostics , treatments , medical devices 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 addressing key challenges in public health and improving the quality and delivery of health services throughout the union , while supporting economic activity in the development of health technologies and treatments , notably of integrated health solutions , and thus 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 , academia , companies of various sizes and end-users , 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’24 and the ‘european one health action plan against antimicrobial resistance’25 . the innovative health initiative joint undertaking should be aligned with the new industrial strategy for europe26 , the pharmaceutical strategy for europe27 and the sme strategy for a sustainable and digital europe28 and the european green deal.


### (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 undertaking29 , 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 undertaking29 , 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 new initiative should first and foremost be driven by public health and patient needs , with leadership of public authorities and structured engagement of civil society and patient organisations. the scope of the initiative should cover prevention , diagnosis , treatment and disease management and should 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 and patient-centred , effective , cost-effective , accessible and affordable for patients and for health care systems.


### (68) to ensure the best opportunity for generating new scientific ideas and successful research and innovation activities , the key actors in innovative health initiative joint undertaking should be researchers from various types of entities , public and private. at the same time , end-users such as union citizens , health care professionals and health care providers should provide input into the strategic design and activities of the initiative , ensuring that it addresses their needs. furthermore , union-wide and national regulatory authorities , health technology assessment bodies and health care payers should also provide early input to the partnership’s activities , while ensuring the absence of any conflicts of interest , in order to increase the likelihood that the results of funded actions meet the requirements necessary for uptake and thus reaching the expected impacts. all that input should help better target research efforts towards areas of unmet need. ### (68) to ensure the best opportunity for generating new scientific ideas and successful research and innovation activities , the key actors in innovative health initiative joint undertaking should be researchers from various types of entities , public and private. at the same time , end-users such as union citizens , consumer and patient groups , health care professionals and health care providers should provide input into the strategic design and activities of the initiative , ensuring that it addresses their needs. furthermore , union-wide and national regulatory authorities , health technology assessment bodies and health care payers should also provide early input to the partnership’s activities , while ensuring the absence of any conflicts of interest , in order to increase the likelihood that the results of funded actions meet patients' needs and the requirements necessary for uptake and thus reaching the expected impacts. all that input should help better target research efforts towards areas of unmet or underfinanced needs.


### (70) the partnership’s objectives should focus on the pre-competitive area , thereby creating a safe space for efficient collaboration between companies active in different health technologies. to reflect the integrative nature of the initiative , help break the silos between health industry sectors and strengthen the industry-academia collaborations , the majority of the projects funded by the initiative should be cross-sectoral. ### (70) the partnership’s objectives should focus on the pre-competitive area , thereby creating a safe space for efficient collaboration between companies active in different health technologies and treatments. to reflect the integrative nature of the initiative , help break the silos between health industry sectors and strengthen the industry-academia collaborations , the majority of the projects funded by the initiative should be cross-sectoral and involve patient and end-users groups from the outset of the r&i activities.


### (71) the term key digital technologies refers to electronic components and systems that underpin all major economic sectors. the commission highlighted the need to master those technologies in europe , notably in the context of delivering on european policy priorities such as digital technology autonomy30 . the importance of the area and the challenges faced by the stakeholders in the union require urgent action in order to leave no weak link in europe’s innovation and value chains. a mechanism at union level should therefore be set up to combine and focus the provision of support to research and innovation in electronic components and systems by member states , the union and the private sector. ### (71) the term key digital technologies refers to electronic components and systems that underpin all major economic sectors. the commission highlighted the need to master those technologies in europe , notably in the context of delivering on european policy priorities such as digital technology resilience30 . the importance of the area and the challenges faced by the stakeholders in the union require urgent action in order to leave no weak link in europe’s innovation and value chains. a mechanism at union level should therefore be set up to combine and focus the provision of support to research and innovation in electronic components and systems by member states , the union and the private sector.


### (72) the key digital technologies joint undertaking should address clearly defined topics that would enable european industries at large to design , manufacture and use the most innovative technologies in electronic components and systems. structured and coordinated financial support at european level is necessary to help research teams and european industries maintain their current strengths at the leading edge in a highly competitive international context and close the gap in technologies that are critical for a digital transformation in europe that reflects core union values including privacy and trust , security and safety. collaboration among stakeholders of the ecosystem , representing all segments of the value chains , is essential for the development of new technologies and the fast market uptake of innovation. openness and flexibility to integrate relevant stakeholders , including in particular smes , in emerging or adjacent areas of technology , or in both , is also vital. ### (72) the key digital technologies joint undertaking should address clearly defined topics that would enable european industries at large to design , manufacture and use the most innovative technologies in electronic components and systems. structured and coordinated financial support at european level is necessary to help research teams and european industries maintain their current strengths at the leading edge in a highly competitive international context and close the gap in technologies that are critical for a digital transformation in europe that reflects core union values and fundamental rights including privacy and trust , security and safety at all levels of the value chains. collaboration among stakeholders of the ecosystem , representing all segments of the value chains , is essential for the development of new technologies that are based on privacy and security by design and their fast market uptake. openness and flexibility to integrate relevant stakeholders , including in particular smes and non profit civil society organisations , in emerging or adjacent areas of technology , or in both , is also vital.


### (73) the key digital technologies joint undertaking should combine the financial and technical means that are essential to master the escalating pace of innovation in this area , to generate important spill-overs for society , and to share risk-taking by aligning strategies and investments towards a common european interest. therefore , the members of the key digital technologies joint undertaking should be the union , member states and associated countries to horizon europe on a voluntary basis , and associations as private members representing their constituent companies [and other legal entities active in the field of electronics components and systems in europe] participation of member states will furthermore facilitate a coherent alignment with national programmes and strategies , reducing overlap and fragmentation of efforts while ensuring synergies across stakeholders and activities. ### (73) the key digital technologies joint undertaking should combine the financial and technical means that are essential to master the escalating pace of innovation in this area , to generate important spill-overs for society , by aligning strategies and investments towards a common european interest. therefore , the members of the key digital technologies joint undertaking should be the union , member states and associated countries to horizon europe on a voluntary basis , and associations as private members representing their constituent companies [and other legal entities active in the field of electronics components and systems in europe] participation of member states will furthermore facilitate a coherent alignment with national programmes and strategies , reducing overlap and fragmentation of efforts while ensuring synergies across stakeholders and activities.


### (74) in accordance with [article 8(1)(c)] of the horizon europe regulation , participating states should entrust the key digital technologies joint undertaking with the implementation of their contribution to their national participants in indirect actions. the beneficiaries should sign a single grant agreement with the joint undertaking following the horizon europe rules , including the respective framework for intellectual property rights , depending on the union programme supporting the corresponding grant activity. the key digital technologies joint undertaking should process the cost claims and execute the payments to the beneficiaries. ### (74) in accordance with [article 8(1)(c)] of the horizon europe regulation , participating states should entrust the key digital technologies joint undertaking with the implementation of their contribution to their national participants in indirect actions. the beneficiaries should sign a single grant agreement with the joint undertaking following the horizon europe rules , including the respective framework for open access , depending on the union programme supporting the corresponding grant activity. public financial support should always result in public results and technologies , and open collaboration models like open source software and hardware should be encouraged. the key digital technologies joint undertaking should process the cost claims and execute the payments to the beneficiaries.


### (76) as a continuation of the practice established in the ecsel joint undertaking , a derogation from [article 30] of the horizon europe regulation is necessary in order to allow different reimbursement rates depending on the type of participant , namely smes and non-profit legal entities , and the type of action , to be applied invariably across beneficiaries from all participating states. that should ensure the right balance of stakeholders’ participation in the actions funded by the key digital technologies joint undertaking and foster a higher involvement of smes as recommended in the ecsel joint undertaking interim evaluation. ### (76) as a continuation of the practice established in the ecsel joint undertaking , a derogation from [article 30] of the horizon europe regulation is necessary in order to allow different reimbursement rates depending on the type of participant , namely smes and non-profit legal entities , and the type of action , to be applied invariably across beneficiaries from all participating states. that should ensure the right balance of stakeholders’ participation in the actions funded by the key digital technologies joint undertaking and foster a higher involvement of smes as recommended in the ecsel joint undertaking interim evaluation as well as the enhanced involvement of the non profit civil society sector.


### (77) the union’s single european sky legal framework31 seeks to reform the european air traffic management (atm) system through institutional , operational , technological and regulatory actions with the aim of improving its performance in terms of capacity , safety , efficiency and environmental impact. ### (77) the union’s single european sky legal framework31 seeks to reform the european air traffic management (atm) system through institutional , operational , technological and regulatory actions with the aim of improving its performance in terms of capacity , safety , efficiency , climate and environmental impact , including air and noise pollution.


### (78) the single european sky air traffic management (atm) research and development project (the ‘sesar project’)32 aims to modernise atm and to bundle technological and operational innovation in support of the single european sky. it aims at providing the technological solutions for a highly performing atm by 2035 to enable an uncongested , even safer and more environmentally friendly functioning of the air transport sector. the sesar project comprises three interrelated , continuous and evolving collaborative processes that define , develop and deploy innovative technological systems and operational procedures underlying the digital european sky defined in the european atm master plan33 . ### (78) the single european sky air traffic management (atm) research and development project (the ‘sesar project’)32 aims to modernise atm and to bundle technological and operational innovation in support of the single european sky. it aims at providing the technological solutions for a highly performing atm by 2035 to enable an uncongested , even safer and more environmentally and climate friendly functioning of the air transport sector allowing it to comply with the objectives ob the european green deal and the emissions’ reduction targets of the european climate law. the sesar project comprises three interrelated , continuous and evolving collaborative processes that define , develop and deploy innovative technological systems and operational procedures underlying the digital european sky defined in the european atm master plan33 .