### 8. periodic reviews and evaluations shall be taken into consideration in the winding up , phasing out or possible renewal of the joint undertaking referred to in article 43 , in line with [annex iii] of the horizon europe regulation. within six months after the winding up of a joint undertaking , but no later than four years after the triggering of the winding up procedure referred to in article 43 , the commission shall conduct a final evaluation of that joint undertaking in line with the final evaluation of horizon europe. ### 8. yearly reviews and evaluations shall be taken into consideration in the winding up , phasing out or possible renewal of the joint undertaking referred to in article 43 , in line with [annex iii] of the horizon europe regulation. within six months after the winding up of a joint undertaking , but no later than four years after the triggering of the winding up procedure referred to in article 43 , the commission shall conduct a final evaluation of that joint undertaking in line with the final evaluation of horizon europe.


### 7. other persons , in particular representatives of other european partnerships , executive or regulatory agencies , regional authorities within the union and european technology platforms may also be invited to attend by the chairperson as observers on a case-by-case basis subject to the rules on confidentiality and conflict of interest. ### 7. other persons , in particular representatives of other european partnerships , executive or regulatory agencies , national and regional authorities within the union and european technology platforms may also be invited to attend by the chairperson as observers on a case-by-case basis subject to the rules on confidentiality and conflict of interest.


### 10. the governing board shall adopt its own rules of procedure. ### 10. the governing board shall adopt its own rules of procedure , including measures to avoid any conflict of interest in the decision-making process.


### the commission , in its role in the governing board , shall seek to ensure coordination between the activities of the joint undertakings and the relevant activities of union funding programmes with a view to promoting synergies and complementarities when identifying priorities covered by collaborative research. ### the commission , in its role in the governing board , shall ensure coordination between the activities of the joint undertakings and the relevant activities of union funding programmes with a view to promoting synergies and complementarities when identifying priorities covered by collaborative research.


### appoint , dismiss , extend the term of office , provide guidance and monitor the performance of the executive director; ### appoint , dismiss , extend the term of office , provide guidance and monitor the performance of the executive director , including through the identification of a set of key performance indicators to assess her/his performance;;


### adopt the strategic research and innovation agenda at the beginning of the initiative and amend it throughout the duration of horizon europe , where necessary. the strategic research and innovation agenda shall identify the partnership’s targeted impact , foreseen portfolio of activities , measurable expected outcomes , resources , deliverables , and milestones within a defined timeframe. it shall also identify the other european partnerships with which the joint undertaking shall establish a formal and regular collaboration and the possibilities for synergies between the joint undertaking’s actions and national or regional initiatives and policies based on information received by the participating states or the states’ representatives group as well as synergies with other union programmes; ### adopt the strategic research and innovation agenda at the beginning of the initiative and amend it throughout the duration of horizon europe , where necessary. the strategic research and innovation agenda shall identify the partnership’s targeted impact , foreseen portfolio of activities , measurable expected outcomes , resources , deliverables , and milestones within a defined timeframe. it shall also identify the other european partnerships with which the joint undertaking shall establish a formal and regular collaboration and the possibilities for synergies between the joint undertaking’s actions and national or regional initiatives and policies based on information received by the participating states or the states’ representatives group as well as synergies with other union programmes and policies , including the actions foreseen by the european skills agenda;


### adopt the work programme and corresponding expenditure estimates as proposed by the executive director to implement the strategic research and innovation agenda , including the administrative activities , the content of the calls for proposals , the research areas subject to joint calls and cooperation with other partnerships , the applicable funding rate per call topic , as well as the related rules for submission , evaluation , selection , award and review procedures , with particular attention to the feedback to policy requirements; ### adopt the work programme and corresponding expenditure estimates as proposed by the executive director to implement the strategic research and innovation agenda , including the administrative activities , the content of the calls for proposals , including the criteria to encourage a gender and geographically balanced participation , the research areas subject to joint calls and cooperation with other partnerships , the applicable funding rate per call topic , as well as the related rules for submission , evaluation , selection , award and review procedures , with particular attention to the feedback to policy requirements;


### request scientific advice or analysis on specific issues to the joint underaking’s scientific advisory body or its members , including as regards developments in adjacent sectors; ### request scientific advice or analysis on specific issues to the joint underaking’s scientific advisory body or its members , including as regards developments and synergies in adjacent sectors;


### adopt by the end of 2022 a plan for the phasing-out of the joint undertaking from horizon europe funding upon recommendation of the executive director; ### adopt by the end of 2024 a plan for the phasing-out of the joint undertaking from horizon europe funding upon recommendation of the executive director;


### 1. the executive director shall be appointed by the governing board on the basis of merit and skills , from the list of candidates proposed by the commission , following an open and transparent selection procedure which shall respect the principle of gender balance. ### 1. the executive director shall be appointed by the governing board on the basis of merit and skills , from the list of candidates proposed by the commission , following an open and transparent selection procedure.


### 4. the term of office of the executive director shall be four years. by the end of that period , the commission after consulting the members other than the union shall carry out an assessment of the performance of the executive director and the future tasks and challenges of the joint undertaking. ### 4. the term of office of the executive director shall be four years. by the end of that period , the commission after consulting the members other than the union shall carry out an assessment of the performance of the executive director and the future tasks and challenges of the joint undertaking , including through the evaluation of the set of key performance indicators as set out in point (i) of article 16(2) of this regulation.


### implement the communications policy of the joint undertaking; ### propose a citizen and sme-friendly communication policy of the joint undertaking to the governing board and implement it;


### 2. there shall be a balanced representation of experts among the members of the scientific advisory body , within the scope of the activities of the joint undertaking , including with respect to gender balance. collectively , the members of the scientific advisory body shall have the necessary competences and expertise covering the technical domain in order to make science-based recommendations to the joint undertaking , taking into account the socio-economic impact of such recommendations and the objectives of the joint undertaking. ### 2. there shall be a balanced representation of experts among the members of the scientific advisory body , within the scope of the activities of the joint undertaking , including with respect to gender and geographical balance. collectively , the members of the scientific advisory body shall have the necessary competences and expertise covering the technical domain in order to make science-based recommendations to the joint undertaking , taking into account the socio-economic impact of such recommendations and the objectives of the joint undertaking as well as the gender impacts of the research carried out by the joint undertaking.


### 6. the scientific advisory body shall meet at least twice a year and meetings shall be convened by the chairperson. the chairperson may invite other persons to attend its meetings as observers. the scientific advisory body shall adopt its own rules of procedure. ### 6. the scientific advisory body shall meet at least twice a year and meetings shall be convened by the chairperson. the chairperson may invite other persons to attend its meetings as observers. the scientific advisory body shall adopt its own rules of procedure , including measures to avoid any conflict of interest in the decision-making process.


### advise on the scientific achievements to be described in the annual activity report; ### advise on the scientific achievements to be described in the consolidated annual activity report;


### 8. after each meeting of the scientific advisory body , its chairperson shall submit to the governing board a report outlining the body’s and its members’ opinions on the matters discussed during the meeting. ### 8. after each meeting of the scientific advisory body , its chairperson shall submit to the governing board a report outlining the body’s and its members’ opinions on the matters discussed during the meeting. the report shall be made publicly available in the website of the joint undertaking.


### involvement of smes. ### involvement of smes and smes business organisations.


### 9. the states’ representatives group shall submit , at the end of each calendar year , a report describing the national or regional policies in the scope of the joint undertaking and identifying specific ways of cooperation with the actions funded by the joint undertaking. ### 9. the states’ representatives group shall submit , at the end of each calendar year , a report describing the national or regional policies in the scope of the joint undertaking and identifying specific ways of cooperation with the actions funded by the joint undertaking. the report shall be made publicly available in the website of the joint undertaking.


### 2. the stakeholders group shall be open to all public and private stakeholders , including organised groups , active in the field of the joint undertaking , international interest groups from member states , associated countries as well as from other countries. ### 2. the stakeholders group shall be open to all public and private stakeholders , including organised groups and organisations representing the civil society active in the field of the joint undertaking , international interest groups from member states , associated countries as well as from other countries.


### 4. the meetings of the stakeholders group shall be convened by the executive director. ### 4. the meetings of the stakeholders group shall be convened by the executive director at least twice a year.


### 2. the members other than the union shall agree on how to share their collective contribution among them in accordance with the financial rules of the joint undertaking. ### 2. the members other than the union shall agree on how to share their collective contribution among them.


### 2. the staff resources shall be determined in the staff establishment plan of each joint undertaking indicating the number of temporary posts by function group and by grade and the number of contract staff expressed in full-time equivalents , in line with its annual budget. ### 2. the staff resources shall be determined in the staff establishment plan of each joint undertaking indicating the number of temporary posts by function group and by grade and the number of contract staff expressed in full-time equivalents , in line with its annual budget , also taking into account the principle of gender balance


### 1. the joint undertaking , its bodies and staff shall avoid any conflict of interest in the implementation of their activities. ### 1. the joint undertaking , its bodies and its members as well as its staff shall avoid any conflict of interest in the decision-making process leading to definition of the joint undertaking’s activities as well as in their implementation.


### 2. the governing board shall adopt rules for the prevention , avoidance and management of conflicts of interest in respect of the staff of the joint undertaking , the members and other persons serving the governing board and in the other bodies or groups of the joint undertaking , in accordance with the financial rules of the joint undertaking and with the staff regulations in respect of staff. ### 2. the governing board shall adopt rules for the prevention , avoidance and management of conflicts of interest in respect of the staff of the joint undertaking , the members and other persons serving the governing board and in the other bodies or groups of the joint undertaking , in accordance with this regulation , the financial rules of the joint undertaking and with the staff regulations in respect of staff.


### communicate and promote innovative bio-based solutions towards policy makers , industry , ngos and consumers at large. ### communicate and promote innovative bio-based solutions towards policy makers , smes , industry , ngos and consumers at large.


### communication , dissemination and awareness raising activities. ### communication , dissemination and awareness raising activities among the smes and the general public.


### 5. in the strategic meeting additional chief executive officers or officers with decision-making power of leading european bio-based companies and the commission , shall be invited. the chairpersons of the states’ representatives group , the scientific committee and the deployment groups may be invited as observers. ### 5. in the strategic meeting additional chief executive officers or officers with decision-making power of leading european bio-based companies , the commission as well as , where appropriate , other relevant stakeholders , including from the civil society and research community shall be invited. the chairpersons of the states’ representatives group , the scientific committee and the deployment groups shall be invited as observers.


### 2. the composition of the deployment groups shall ensure appropriate thematic focus and representativeness of the bio-based innovation stakeholders. any stakeholder other than the members of the bio-based industry consortium , their constituents or their affiliated entities may express its interest to become members of a deployment group. the governing board shall set out the envisaged size and composition of the deployment groups , the duration of the mandates and the possibility of renewal of its members , and select their members. the list of members shall be publicly available. ### 2. the composition of the deployment groups shall ensure appropriate thematic focus and representativeness of the bio-based innovation stakeholders. any stakeholder other than the members of the bio-based industry consortium , their constituents or their affiliated entities may express its interest to become members of a deployment group. the governing board shall set out the envisaged size and composition of the deployment groups , the duration of the mandates and the possibility of renewal of its members , and select their members in line with the provisions set out in article 21 of this regulation. the list of members shall be publicly available.


### to ensure that aeronautics-related research and innovation activities contribute to the global sustainable competitiveness of the union aviation industry , and to ensure that climate-neutral aviation technologies meet the relevant aviation safety requirements ,48 and remains a secure , reliable , cost-effective , and efficient means of passenger and freight transportation; ### to ensure that aeronautics-related research and innovation activities contribute to the global sustainable competitiveness of the union aviation industry , and to ensure that climate-neutral aviation technologies meet the relevant aviation safety requirements ,48 and remains a competitive , secure , reliable , cost-effective , and efficient means of passenger and freight transportation;


### to expand and foster integration of the climate-neutral aviation research and innovations value chains , including academia , research organisations , industry , and smes , also by benefitting from exploiting synergies with other national and european related programmes. ### to expand and foster integration of the climate-neutral aviation research and innovations value chains , including academia , research organisations , industry , and smes , also by benefitting from exploiting synergies with other national and european related programmes and by supporting the uptake of industry-related skills across the value chain.


### publish on relevant websites all the information necessary for the preparation and submission of proposals for the clean aviation joint undertaking; ### publish on relevant websites all the information necessary for the preparation and submission of proposals for the clean aviation joint undertaking in a transparent and user-friendly way;


### private research and innovation projects complementing projects on the strategic research and innovation agenda; ### private research and innovation projects complementing projects on the strategic research and innovation agenda as well as activities contributing to the uptake of industry-specific skills across the value chain;


### nine representatives of the members other than the union chosen by and from the founding members and associated members ensuring a balanced representation of the aeronautical value chain such as aircraft integrators , engine manufactures and equipment manufacturers. the governing board shall establish in its rules of procedure a rotation mechanism for the allocation of the seats of the members other than the union. the selected representatives shall include at least one representative of the european smes , one representative of the research organisations and one representative of the academic institutions. ### twelve representatives of the members other than the union chosen by and from the founding members and associated members ensuring a balanced representation of the aeronautical value chain such as aircraft integrators , engine manufactures and equipment manufacturers. the governing board shall establish in its rules of procedure a rotation mechanism for the allocation of the seats of the members other than the union. the selected representatives shall include at least one representative of the european smes , one representative of the research organisations and one representative of the academic institutions.


### nine representatives of the members other than the union chosen by and from the founding members and associated members ensuring a balanced representation of the aeronautical value chain such as aircraft integrators , engine manufactures and equipment manufacturers. the governing board shall establish in its rules of procedure a rotation mechanism for the allocation of the seats of the members other than the union. the selected representatives shall include at least one representative of the european smes , one representative of the research organisations and one representative of the academic institutions. ### seven representatives of the members other than the union chosen by and from the founding members and associated members ensuring a balanced representation of the aeronautical value chain such as aircraft integrators , engine manufactures and equipment manufacturers. the governing board shall establish in its rules of procedure a rotation mechanism for the allocation of the seats of the members other than the union. the selected representatives shall include at least one representative of the european smes , one representative of the research organisations and one representative of the academic institutions.


### 1. the european clean aviation advisory body shall be the scientific advisory body of the clean aviation joint undertaking set up in accordance with point (a) of article 19(1). ### 1. the european clean aviation advisory body shall be the scientific advisory body of the clean aviation joint undertaking set up in accordance with the provisions of article 19.


### 3. the chairperson of the european aviation advisory body shall be elected for the duration of two years. ### 3. the chairperson of the european aviation advisory body shall be elected for the duration of two years from among its permanent members.


### to contribute to the objectives set out in the 2030 climate target plan51 , and the european green deal52 , by raising the eu's ambition on reducing greenhouse gas emissions to at least 55% below 1990 levels by 2030 , and climate neutrality by 2050; ### to contribute to the objectives set out in the 2030 climate target plan51 , the european green deal52 and the european climate law , by raising the eu's ambition on reducing greenhouse gas emissions to at least 55% below 1990 levels by 2030 , and climate neutrality by 2050;


### to contribute to the implementation of the 2020 european commission’s hydrogen strategy for a climate neutral europe53 ; ### to contribute to the implementation of the 2020 european commission’s hydrogen strategy for a climate neutral europe53and the european parliament's own initiative report on a european hydrogen strategy for europe;


### to strengthen the competitiveness of the union clean hydrogen value chain , with a view to supporting , notably the smes involved , accelerating the market entry of innovative competitive clean solutions; ### to strengthen the competitiveness of the union renewable hydrogen value chain , with a view to supporting , notably the smes involved , accelerating the research , development and the market entry of innovative competitive clean solutions;


### to stimulate clean hydrogen production , distribution , storage and end use applications. ### to stimulate renewable hydrogen production , transport , storage and end use applications.


### improve through research and innovation the cost-effectiveness , reliability , quantity and quality of clean hydrogen solutions , including production , distribution , storage and end uses developed in the union such as more efficient and cheaper hydrogen electrolysers and cheaper transport and industrial applications; ### improve through research and innovation the cost-effectiveness , reliability , quantity and quality of renewable hydrogen solutions , including production , transport , storage and end uses developed in the union such as more efficient and cheaper hydrogen electrolysers and cheaper aviation , maritime , heavy-duty and rail transport , industrial applications as well as the safety and the availability of its production , transport and storage;


### strengthen the knowledge and capacity of scientific and industrial actors along the union’s hydrogen value chain; ### strengthen the knowledge and capacity of scientific and industrial actors along the union’s hydrogen value chain while supporting the uptake of industry-related skills;


### carry out demonstrations of clean hydrogen solutions with the view to local , regional and union-wide deployment , addressing renewable production , distribution , storage , and use for transport and energy-intensive industries as well as other applications; ### carry out demonstrations of renewable hydrogen solutions with the view to local , regional and union-wide deployment , addressing renewable production , transport , storage , and use for hard-to-abate sectors such as maritime , aviation , heavy-duty and rail transport , energy-intensive industries as well as other applications;


### increase public and private awareness , acceptance , and uptake of clean hydrogen solutions , in particular through cooperation with other european partnerships under horizon europe. ### increase public and private awareness , acceptance , and uptake of renewable hydrogen solutions and infrastructure , in particular through cooperation with other european partnerships under horizon europe as well as with initiatives such as european clean hydrogen alliance.


### assess and monitor technological progress and technological , economic and societal barriers to market entry; ### assess and monitor technological progress , the progress related to necessary infrastructure as well as technological , economic , regulatory and societal barriers to market entry;


### notwithstanding the commission’s policy prerogatives , under the commission’s policy guidance and supervision , contribute to the development of regulations and standards with the view to eliminating barriers to market entry and to supporting interchangeability , inter-operability , and trade across the internal market and globally; ### notwithstanding the commission’s policy prerogatives , under the commission’s policy guidance and supervision , contribute to the development of regulations and standards with the view to eliminating barriers to market entry and to supporting transparency , interchangeability , inter-operability , and trade across the internal market and globally;


### support the commission in its international initiatives on the hydrogen strategy , such as the international partnership on the hydrogen economy (iphe) , mission innovation and the clean energy ministerial hydrogen initiative. ### notwithstanding the commission’s policy prerogatives , under the commission’s policy guidance and supervision , support and provide technical expertise , including during meetings , to the international initiatives on the hydrogen strategy , such as the international partnership on the hydrogen economy (iphe) , mission innovation and the clean energy ministerial hydrogen initiative.


### awareness-raising activities on hydrogen technologies and safety measures; ### awareness-raising activities on hydrogen technologies and safety measures including across the value chain;


### foster synergies with relevant activities and programmes at union , national , and regional level , in particular with those supporting the deployment of research and innovation solutions , infrastructure , education and regional development on the use of clean hydrogen; ### foster synergies with relevant activities and programmes at union , national , and regional level , in particular with those supporting the deployment of research and innovation solutions , infrastructure , education and regional development on the use of clean hydrogen , with a special focus on hard-to-abate sectors such as industry , aviation , maritime , heavy duty and rail transport;


### encourage market uptake of technologies and solutions for achieving the european green deal’s objectives. ### encourage market uptake of technologies and solutions for achieving the european green deal’s objectives and enhancing the european renewable hydrogen ecosystem.


### propose activities that favour synergies with relevant activities and programmes at union , national , and regional level; ### propose and implement synergies with relevant activities and programmes at union , national , and regional level;


### support and contribute to other union initiatives related to hydrogen , subject to approval by the governing board; ### support and contribute to other union initiatives related to hydrogen such as the european clean hydrogen alliance or ipcei , subject to approval by the governing board;


### 2. the stakeholders group shall consist of representatives of sectors which generate , distribute , store , need or use clean hydrogen across the union , including the representatives of other relevant european partnerships , as well as representatives of the european hydrogen valleys interregional partnership. ### 2. the stakeholders group shall consist of representatives of sectors which generate , transport , store , need or use clean hydrogen across the union , including the representatives of other relevant european partnerships , as well as representatives of the european hydrogen valleys interregional partnership and representatives of civil society organisations and of the scientific community.


### provide input on the strategic and the technological priorities to be addressed by the clean hydrogen joint undertaking as laid down in the strategic research and innovation agenda or any other equivalent document and associated detailed technological roadmaps , taking due account of the progress and needs in adjacent sectors; ### provide input on the strategic , infrastructure and technological priorities to be addressed by the clean hydrogen joint undertaking as laid down in the strategic research and innovation agenda or any other equivalent document and associated detailed technological roadmaps , taking due account of the progress and needs in adjacent sectors;


### ensure a fast transition to more attractive , user-friendly , competitive , affordable , efficient and sustainable european rail system , integrated into the wider mobility system; ### ensure a fast transition to a safer , more attractive , user-friendly , competitive , affordable , efficient , inclusive , more digital and sustainable european rail system , integrated into the wider mobility system;


### deliver an integrated european railway network by design , eliminating barriers to interoperability and providing solutions for full integration , covering traffic management , vehicles , infrastructure and services , and providing the best answer to the needs of passengers and businesses , accelerating uptake of innovative solutions to support the single european railway area , while increasing capacity and reliability and decreasing costs of railway transport; ### deliver an integrated european railway network by design , eliminating barriers to interoperability and providing solutions for full integration , covering traffic management , vehicles , infrastructure and services , and providing the best answer to the needs of passengers , rail workers and businesses , accelerating uptake of innovative solutions to support the single european railway area , while increasing capacity and reliability and decreasing costs of railway transport;


### 1. in addition to the tasks set out in article 5 , the europe’s rail joint undertaking together with the commission shall also prepare and submit for adoption by the governing board the master plan , developed in consultation with all relevant stakeholders in the railway system and rail supply industry. ### 1. in addition to the tasks set out in article 5 , the europe’s rail joint undertaking together with the commission shall also prepare and submit for adoption by the governing board the master plan , developed in consultation with all relevant stakeholders in the railway system and rail supply industry , including at the local , regional and national level.


### develop in its system pillar a system view that brings together the rail manufacturing industry , the rail operating community and other rail private and public stakeholders , including bodies representing customers , such as passengers and freight and staff , as well as relevant actors outside the traditional rail sector. the “system view” shall encompass: ### develop in its system pillar a system view that brings together the rail manufacturing industry , the rail operating community and other rail private and public stakeholders , including bodies representing customers , such as passengers and freight as well as workers and other relevant actors outside the traditional rail sector. the “system view” shall encompass:


### 1. the system pillar steering group shall be composed of representatives of the commission , representatives of the rail and mobility sector and of relevant organisations , the executive director of the europe’s rail joint undertaking and representatives of the european union agency for railways. the commission shall take the final decision on the composition of the group. when justified , the commission may invite additional relevant experts and stakeholders to attend the meetings of the system pillar steering group as observers. ### 1. the system pillar steering group shall be composed of representatives of the commission , representatives of the rail and mobility sector and of relevant organisations , the executive director of the europe’s rail joint undertaking and representatives of the european union agency for railways. the commission shall take the final decision on the composition of the group also taking into due account geographical and gender balance. when justified , the commission may invite additional relevant experts and stakeholders to attend the meetings of the system pillar steering group as observers.


### 2. the deployment group shall be open to all stakeholders as the system pillar steering group. the governing board shall select the members of the deployment group and set out in particular the size and composition of the deployment group , the duration of the mandate and the terms of renewal of its members. the composition of the deployment group shall ensure appropriate thematic focus and representativeness. the list of members shall be published on the website of the europe’s rail joint undertaking. ### 2. the deployment group shall be open to all stakeholders as the system pillar steering group. the governing board shall select the members of the deployment group and set out in particular the size and composition of the deployment group , the duration of the mandate and the terms of renewal of its members. the composition of the deployment group shall ensure appropriate thematic focus and representativeness including with reference to end-user and passenger associations as well as worker representatives. the list of members shall be published on the website of the europe’s rail joint undertaking.


### to reduce the socio-economic burden of infectious diseases in sub-saharan africa promoting the development and uptake of new or improved health technologies; ### to reduce the socio-economic burden of infectious as well as poverty-related and neglected diseases in sub-saharan africa promoting the development and uptake of new or improved health technologies that are affordable , accessible and fit for low-resource settings;


### to strengthen research and innovation capacity and the national health research systems in sub-saharan africa for tackling infectious diseases; ### to strengthen and increase research and innovation capacity and the national health research systems in sub-saharan africa for tackling infectious diseases , including the proportion of projects with local leadership;


### activities of constituent entities of the edctp association aligned with similar activities from other constituent entities of the edctp association and independently managed in accordance with national funding rules; ### activities of constituent entities of the edctp association aligned , co-programmed and/or coordinated with similar activities from other constituent entities of the edctp association and independently managed in accordance with national funding rules , the alignment of the activities referred in this paragraph shall be demonstrated;


### provide advice on the review of any calls for proposals and other programmes; ### as well as assess applications of aspirant contributing partners to the global health edctp3 joint undertaking , including advising the governing board on whether to accept these applications and on the scope that a potential collaboration should have;


### the global health edctp3 joint undertaking shall ensure a close collaboration with the european medicine agency and european centre for disease prevention and control. ### the global health edctp3 joint undertaking shall ensure a close collaboration with the european medicine agency and european centre for disease prevention and control as well as with relevant african agencies and organisations such as the african centres for disease control and prevention , african union’s regional economic communities , the african academy of sciences and the auda-nepad.


### 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 in general , especially citizens living in low-resource settings , at fair and reasonable conditions. for that purpose , where relevant , the work programme shall specify additional exploitation obligations applicable to specific indirect actions.


### 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 and cost-effective innovations as well as products and treatments that are affordable both for citizens and healthcare systems and 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 as well as the european one health action plan against antimicrobial resistance;


### drive cross-sectoral health innovation for a globally competitive european health industry , and contribute to reaching the objectives of the new industrial strategy for europe and the pharmaceutical strategy for europe. ### drive cross-sectoral health innovation for a globally competitive european health industry , and contribute to reaching the objectives of the new industrial strategy for europe , including its update (may 2021) , and the pharmaceutical strategy for europe.


### exploit the full potential of digitalisation and data exchange in health care; ### exploit the full potential of digitalisation and data exchange in health care , deploying synergies with initiatives such as the european health data space;


### effectively support pre-competitive health research and innovation , especially actions that bring together entities of several health care industry sectors to work jointly on areas of unmet public health need; ### effectively support pre-competitive health research and innovation , especially actions that bring together entities of several health care industry sectors to work jointly on areas of unmet public health need while ensuring the principles of accessibility , affordability and availability;


### 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 in collaboration with health professionals and patient associations as well as with the innovation panel;


### organise regular communication , including at least one annual meeting with interest groups and with its stakeholders to ensure openness and transparency of the research and innovation activities of the innovative health initiative joint undertaking; ### organise regular communication , including at least one annual meeting with interest groups and with its stakeholders to ensure inclusiveness , openness and transparency of the research and innovation activities of the innovative health initiative joint undertaking;


### 5. costs incurred in indirect actions in third countries other than countries associated to horizon europe shall be justified and relevant to the objectives set out in article 113. they shall not exceed 20% of the in-kind contributions to operational costs provided by members other than the union and by contributing partners at the level of the innovative health initiative programme. costs in excess of 20% of the in-kind contributions to operational costs at the level of the innovative health initiative programme shall not be considered as in-kind contributions to operational costs. ### 5. costs incurred in indirect actions in third countries other than countries associated to horizon europe shall be justified and relevant to the objectives set out in article 113 provided that the these actions have positive externalities on the union.. they shall not exceed 10% of the in-kind contributions to operational costs provided by members other than the union and by contributing partners at the level of the innovative health initiative programme. costs in excess of 10% of the in-kind contributions to operational costs at the level of the innovative health initiative programme shall not be considered as in-kind contributions to operational costs.


### (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 transitions towards sustainable development goals and a green and digital europe and should contribute to recovery from the unprecedented covid-related crisis in line with the enhancement of european industrial leadership. european partnerships address complex cross-border challenges that require an integrated approach. they make it possible to address the transformational , systemic and market failures described in the impact assessments accompanying this regulation by bringing together a broad range of players across the value chains and ecosystems to work towards a common vision and translating it into concrete roadmaps and coordinated implementation of activities. furthermore , they allow concentrating efforts and resources on common priorities to solve the complex challenges.


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


### (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 as well as to contribute to achieving the sustainable development goals , 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-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. however , the reduction of the funding rates should not apply to non-profit entities such as research organisations , universities and other public bodies since their mission includes , among other things , maintaining non-commercially viable research and technology infrastructures or carrying out research in non-profitable knowledge areas with a high societal 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 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 , promoting a gender and geographically balanced participation.


### (23) further simplification is a cornerstone of the horizon europe framework programme. in that context , there should be a simplified reporting mechanism for partners , who are no longer required to report on non-eligible costs. in-kind contributions to operational activities should be accounted solely on the basis of eligible costs. that allows for the automated calculation of in-kind contributions to operational activities via the horizon europe it tools , lowers the administrative burden for partners and makes the reporting mechanism for contributions more effective. in-kind contributions to operational activities should be closely monitored by the joint undertakings and regular reports should be prepared by the executive director of the governing board in order to establish whether the progress towards reaching the in-kind contributions targets is satisfactory enough. the governing board should assess both the efforts made and the results achieved by the members contributing to operational activities , as well as other factors , such as the level of participation of smes and attractiveness of the initiative to newcomers. when necessary , it should take appropriate remedial and corrective measures taking into account the principles of openness and transparency. ### (23) further simplification is a cornerstone of the horizon europe framework programme. in that context , there should be a simplified reporting mechanism for partners , who are no longer required to report on non-eligible costs. in-kind contributions to operational activities should be accounted solely on the basis of eligible costs. that allows for the automated calculation of in-kind contributions to operational activities via the horizon europe it tools , lowers the administrative burden for partners and makes the reporting mechanism for contributions more effective. in-kind contributions to operational activities should be closely monitored by the joint undertakings and regular reports should be prepared by the executive director of the governing board 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 , the attractiveness of the initiative to newcomers and a fair geographical balance. when necessary , it should take appropriate remedial and corrective measures taking into account the principles of openness and transparency.


### (25) the governance of joint undertakings should ensure that their decision-making processes are fit to keep pace with fast-changing socio-economic and technological environment and global challenges. joint undertakings should benefit from the expertise , advice and support from all relevant stakeholders , in order to effectively implement their tasks and ensure synergies at union and national level. therefore , joint undertakings should be empowered to set up advisory bodies with a view to providing them with expert advice and carrying out any other task of an advisory nature that is necessary for the achievement of the joint undertakings' objectives. in setting up the advisory bodies , joint undertakings should ensure a balanced representation of experts within the scope of the activities of the joint undertaking , including with respect to gender balance. the advice provided by these bodies should bring in scientific perspectives as well as those of national and regional authorities and of other stakeholders of joint undertakings. ### (25) the governance of joint undertakings should ensure that their decision-making processes are transparent and fit to keep pace with fast-changing socio-economic and technological and environmental global challenges. the governance of joint undertakings should also take into account the principle of gender balance. 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 and geographical balance. the advice provided by these bodies should bring in scientific perspectives , those of national and regional authorities as well as those of civil society organisations and of other stakeholders of joint undertakings.


### (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 scientific advice and support to the respective joint undertaking independently from members of other governing bodies of the 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. moreover , in order to effectively integrate the necessary gender perspective in research fields such as health , transport , climate change and digitalisation , gender experts should be consulted.


### (29) the joint undertakings should operate in an open and transparent way , providing all relevant information in a timely manner to their appropriate bodies as well as promoting their activities , including information and dissemination activities , to the wider public. ### (29) the joint undertakings should operate in an open and transparent way and should ensure that activities they carry out are visible to the general public audience and properly communicated and disseminated through the timely communication of relevant information , including that regarding the meetings of their bodies , on their institutional websites as well as through communication activities aiming to reach out to a wide range of stakeholders , including smes , academia , civil society organisations and the general public.


### (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 industrial , scientific , technological sovereignty as well as climate neutrality. moreover , the post pandemic recovery highlights the need to invest in key technologies such as 5g , ai , cloud , cybersecurity , green tech and necessary infrastructures as well as 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.


### (42) the main objective of the clean aviation joint undertaking should be to contribute to reducing the ecological footprint of aviation by accelerating the development of climate neutral aviation technologies for their earliest possible deployment , therefore significantly contributing to the ambitious environment impact mitigation goals of the european green deal , that is to say a 55% emissions reduction by 2030 compared to 1990 levels , and climate neutrality by 2050. this objective can only be achieved through accelerating and optimising the research and innovation processes in aeronautics and by improving the global competitiveness of the union aviation industry. the clean aviation joint undertaking should also ensure that cleaner aviation remains safe , secure and efficient for the transportation of passengers and goods by air. ### (42) the main objective of the clean aviation joint undertaking should be to contribute to reducing the ecological footprint of aviation by accelerating the development of climate neutral aviation technologies for their earliest possible deployment , therefore significantly contributing to the ambitious environment impact mitigation goals of the european green deal and the european climate law , 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 , competitive and efficient for the transportation of passengers and goods by air.


### (47) europe faces the challenge of having to play a leading role in internalising the societal costs of greenhouse gas emissions in the air transport business model while continuing to ensure a ‘level playing field’ for european products in the global market. therefore , the clean aviation joint undertaking should support the european representatives in international standardisation and international legislative efforts. ### (47) europe faces the challenge of having to play a global leading role in internalising the societal costs of greenhouse gas emissions in the air transport business model while continuing to ensure a ‘level playing field’ for european products in the global market as well as the right to connectivity and the competitiveness of the sector. therefore , the clean aviation joint undertaking should support the european representatives in international standardisation and international legislative efforts.


### (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 renewable 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 renewable 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” , in the parliament's own initiative report "european strategy for hydrogen" voted in may 2021 as well as for the launch of the european clean hydrogen alliance that should bring all stakeholders together to identify technology , research and infrastructure needs , investment opportunities and regulatory as well as economic barriers to build a renewable hydrogen ecosystem in the union.


### (49) dedicated research and innovation activities related to hydrogen applications have been supported since 2008 , mainly through the fuel cell and hydrogen joint undertakings (fch joint undertaking and fch 2 joint undertaking) under fp7 and horizon 2020 as well as by traditional collaborative projects , covering all stages/fields of the hydrogen value chain. the clean hydrogen joint undertaking should strengthen and integrate union scientific capacity to accelerate the development and improvement of advanced clean hydrogen applications ready for market , across energy , transport , building and industrial end-uses. this will only be possible if combined with strengthening competitiveness of the union clean hydrogen value chain , and notably smes. ### (49) dedicated research and innovation activities related to hydrogen applications have been supported since 2008 , mainly through the fuel cell and hydrogen joint undertakings (fch joint undertaking and fch 2 joint undertaking) under fp7 and horizon 2020 as well as by traditional collaborative projects , covering all stages/fields of the hydrogen value chain. the clean hydrogen joint undertaking should strengthen and integrate union scientific capacity to accelerate the development and improvement of advanced renewable hydrogen applications ready for market , across energy , aviation , maritime , heavy-duty transport , rail , and industrial end-uses while taking into account their long-term availability and affordability. this will only be possible if combined with strengthening competitiveness of the union renewable hydrogen value chain , and notably smes while building up the necessary ecosystem , including infrastructure.


### (51) since hydrogen can be deployed as a fuel , energy carrier and for storing energy it is essential that the clean hydrogen partnership establishes structured collaboration with many other horizon europe partnerships , notably for end-use. the clean hydrogen partnership should interact in particular with the zero emission road and waterborne transport , europe’s railway , clean aviation , processes for the planet and clean steel partnerships. for that purpose , a structure should be set up reporting to the governing board in order to ensure the co-operation and synergies between these partnerships in the domain of hydrogen. the clean hydrogen initiative would be the only partnership focused on addressing hydrogen production technologies. collaboration with end-use partnerships should in particular focus on demonstrating the technology and co-defining specifications. ### (51) since hydrogen can be deployed as a fuel , energy carrier and for storing energy it is essential that the clean hydrogen partnership establishes structured collaboration with many other horizon europe partnerships , notably for end-use. the clean hydrogen partnership should interact and develop synergies in particular with the zero emission road and waterborne transport , europe’s railway , clean aviation , processes for the planet and clean steel partnerships. for that purpose , a structure should be set up reporting to the governing board in order to ensure the co-operation and synergies between these partnerships in the domain of hydrogen. the clean hydrogen initiative would be the only partnership focused on addressing hydrogen production technologies and infrastructure. collaboration with end-use partnerships should in particular focus on demonstrating the technology and co-defining specifications.


### (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 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. the commission communication that has updated the 2020 new industrial strategy (may 2021) has confirmed the crucial role of sustainable transport and mobility in accelerating the twin transition and in boosting the recovery.


### (56) the objective of europe’s rail joint undertaking should be to deliver a high capacity integrated european railway network by eliminating barriers to interoperability and providing solutions for full integration , covering traffic management , vehicles , infrastructure and services. this should exploit the huge potential for digitalisation and automation to reduce rail’s costs , increase capacity , and enhance its flexibility and reliability , and should be based upon a solid reference functional system architecture shared by the sector , in coordination with the european union agency for railways. ### (56) the objective of europe’s rail joint undertaking should be to deliver a high capacity integrated european railway network which aims to the highest standards of safety for both end-users , including passengers , and workers 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 , reliability , safety and inclusiveness and should be based upon a solid reference functional system architecture shared by the sector , in coordination with the european union agency for railways.


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


### (62) tackling infectious diseases affecting sub-saharan africa with modern technology tools requires the involvement of a large set of actors and long-term commitments. the global health edctp3 joint undertaking should broker productive and sustainable north–south and south–south networking and cooperation , building relationships with multiple private and public sector organisations to strengthen project and institutional collaborations. the programme should also help to establish new north–south and south-south collaborations to conduct multi-country , multi-site studies in sub-saharan africa. in addition , a regular international conference , the edctp forum , should provide a platform for scientists and relevant networks from europe , africa , and elsewhere to share findings and ideas , and to establish collaborative links. ### (62) tackling infectious diseases affecting sub-saharan africa with modern technology tools requires the involvement of a large set of actors and long-term commitments. the global health edctp3 joint undertaking should broker productive and sustainable north–south and south–south dialogue , networking and cooperation , building relationships with multiple private and public sector organisations to strengthen project and institutional collaborations. the programme should also help to establish new north–south and south-south collaborations to conduct multi-country , multi-site studies in sub-saharan africa. in addition , a regular international conference , the edctp forum , should provide a platform for scientists and relevant networks from europe , africa , and elsewhere to share findings and ideas , and to establish collaborative links.


### (64) it is essential that the research activities funded by global health edctp3 joint undertaking or otherwise covered by its work programme , are in full compliance with the charter of fundamental rights of the european union , the european convention on human rights and its supplementary protocols , ethical principles included in the world medical association’s declaration of helsinki of 2008 , the standards of good clinical practice adopted by the international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use , relevant union legislation and local ethics requirements of the countries where the research activities are to be conducted. furthermore , the global health edctp3 joint undertaking should require that the innovations and interventions developed based on results of the indirect actions supported by the programme be affordable and accessible for vulnerable populations. ### (64) it is essential that the research activities funded by global health edctp3 joint undertaking or otherwise covered by its work programme , are in full compliance with the charter of fundamental rights of the european union , the european convention on human rights and its supplementary protocols , ethical principles included in the world medical association’s declaration of helsinki of 2008 , the standards of good clinical practice adopted by the international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use , relevant union legislation and local ethics requirements of the countries where the research activities are to be conducted. furthermore , the innovations and interventions developed , based on results of the indirect actions supported under the globalhealth edctp3 joint undertaking , should be affordable and accessible for vulnerable populations.


### (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 greener , more circular and more digital while remaining competitive on the global scale. in 2017 , the european parliament , the council and the commission proclaimed the european pillar of social rights which includes , among other principles , the right to healthcare intended as “the right to timely access to affordable , preventive and curative health care of good quality” and the action plan to implement the pillar , which sets concrete initiatives to ensure social protection and inclusion. 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 , the horizon europe mission on cancer and the ‘european one health action plan against anti microbial resistance’. the innovative health initiative joint undertaking should be aligned with the new industrial strategy for europe (march 2020) , its updated version (may 2021) , the pharmaceutical strategy for europe and the sme strategy for a sustainable and digital europe. the joint undertaking should develop synergies with the initiatives aiming at creating an european health data space as well as with the research initiatives in the field of rare diseases.


### (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 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 , their families and/or society due to the severity of the disease and/or the number of people affected or likely to be affected , as well as the high economic impact of the disease for patients , their families 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 , including those affected by a rare disease , 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 , patients and their families , health care professionals and health care providers should provide input into the strategic design and activities of the initiative. the joint undertaking should ensure that the activities it carries out address these 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.


### (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 and effective 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.


### (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 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. the alliance on processors and semiconductor technologies and the alliance for industrial data , edge and cloud should also complement the initiatives of the joint undertaking.


### (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 the digital transformation of the european union and its technological leadership 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.


### this regulation sets up nine joint undertakings within the meaning of article 187 of the treaty on the functioning of the european union for the implementation of institutionalised european partnerships defined in [article 2(3)] and referred to in point [(c)] of [article 8(1)] of the horizon europe regulation. it determines their objectives and tasks , membership , organisation and other operating rules. ### this regulation sets up nine joint undertakings within the meaning of article 187 of the treaty on the functioning of the european union for the implementation of institutionalised european partnerships defined in [article 2(3)] and referred to in point [(c)] of [article 8(1)] of the horizon europe regulation. it determines their objectives and tasks , membership , organisation and other operating rules , including on transparency and accountability.


### securing sustainability-driven global leadership of union value chains and union open strategic autonomy in key technologies and industries in line with the industrial strategy for europe; ### securing and supporting sustainability-driven global leadership of union value chains and union open strategic autonomy in key technologies and industries in line with the industrial and sme strategy for europe;


### develop and accelerate the uptake of innovative solutions throughout the union addressing climate , environmental , health and other global societal challenges contributing to union strategic priorities , in particular to reach the united nations sustainable development goals and achieve climate neutrality in the union by 2050. ### developing and accelerating the uptake of innovative solutions throughout the union addressing climate , digital , environmental , health and other global societal challenges contributing to union strategic priorities , in particular to reach the united nations sustainable development goals and achieve climate neutrality in the union by 2050.


### accelerate the social , ecological and economic transitions in areas and sectors of strategic importance for union priorities , in particular to reduce greenhouse gas emissions by 2030 in accordance with the targets set in line with the european green deal; ### accelerate the social , ecological and economic transitions in areas and sectors of strategic importance for union priorities , in particular to reduce greenhouse gas emissions by 2030 in accordance with the targets set in line with the european green deal and with the european climate law;


### reinforce and spread excellence , including by fostering wider participation throughout the union; ### reinforce and spread excellence , including by fostering wider participation throughout the union , including from member states that are currently considered modest and moderate innovators according to the european innovation scoreboard;


### stimulate research and innovation activities in smes and contribute to the creation and scaling-up of innovative companies , in particular start-ups , smes , and in exceptional cases small mid-caps; ### stimulate research and innovation activities in smes and contribute to the creation and scaling-up of innovative companies , in particular start-ups , smes , and , in exceptional and justified cases , small mid-caps;


### reinforce the link between research , innovation , and where appropriate , education and other policies , including complementarities with national and regional and union research and innovation policies and activities; ### reinforce the link between research , innovation , and where appropriate , gender equality , education and other policies , including complementarities with national and regional and union skills , research and innovation policies and activities;


### accelerate industrial transformation , including through improved skills for innovation; ### accelerate industrial transformation and resilience across the value chains , including through improved skills for innovation;


### promote the involvement of smes in their activities and take measures ensuring information to smes , in line with the objectives of horizon europe; ### promote the involvement of smes and their associations in their activities and take measures ensuring information to smes , in line with the objectives of horizon europe;


### monitor progress towards the achievement of the objectives set out in this regulation as well as according to those set out in [article 45] and [annex v] of the horizon europe regulation; ### monitor progress towards the achievement of the objectives set out in this regulation as well as according to those set out in [article 45] and [annex iii and v] of the horizon europe regulation;