opinion parliamentary committee, 27 May 2026
On the proposal for a regulation of the European Parliament and of the Council on establishing the European Competitiveness Fund ('ECF’), including the specific programme for defence research and innovation activities, repealing Regulations (EU) 2021/522, (EU) 2021/694, (EU) 2021/697, (EU) 2021/783, and amending Regulations (EU) 2021/696, (EU) 2023/588, (EU) [EDIP]
Document SANT-AD-784244 · (COM(2025)0555 – C100165/2025 – 2025/0555(COD))
Committee on Public Health · Rapporteur: Radan Kanev
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Short justification 327 paragraphs
The following SANT opinion’s limited number of amendments aims to ensure that the European Competitiveness Fund (ECF) strengthens Europe’s health, biotech and bioeconomy capacity without diluting core public-health objectives while ensuring governance safeguards and keeping the excellence-based research pipeline.
The amendments introduced here sharpen the ECF’s health window as an engine of European competitiveness without losing sight of public health obligations.
The strongest safeguard I introduce is earmarking for the health, bioenergy and bioeconomy objectives with a dedicated envelope to be reserved for prevention, preparedness, health innovation and health-sector SMEs. This should preserve the integrity of actions inherited from existing Union health instruments (such as EU4Health) and emergency preparedness tools (such as HERA Invest and the synergies with the EU Civil Protection Mechanism) in terms of prevention, preparedness and response to health cross-border issues. In political terms, this prevents the health budget from being crowded out by better-organised sectors and reassures national authorities and health stakeholders that agreed priorities will be financed consistently.
The amendments also aim to make the Fund more credible for taxpayers and investors as it anchors programming in science-based evidence and structured competitiveness assessments. In fact, they clarify that the EU should not default to grants when loans, guarantees, procurement or performance-based contracts can achieve the same objective more efficiently.
On substance, the amendments strengthen resilience and strategic autonomy in medicines, devices and medical countermeasures, aiming to further develop Europe’s international non-cost competitiveness advantage in the sector, but without sacrificing affordability and cost-effectiveness for health systems alongside. They also upgrade the digital dimension: interoperable, secure infrastructures and data and data exchange capabilities are treated as core enablers for modern health systems and cross-border delivery. Finally, the amendments hard-wire the “R&D to production” link by ensuring that excellence-based research feeds systematically into deployment and manufacturing in Europe.
AMENDMENTS
The Committee on Public Health submits the following to the Committee on Industry, Research and Energy, as the committee responsible:
Amendment 1
Proposal for a regulation
Recital 2
| Text proposed by the Commission | Amendment |
|---|---|
| (2) The Union is facing a defining period for its future, from a political, economic, social, environmental, climate and security perspective, including increased risks of conventional military threats. The Draghi report on the future of European Competitiveness3 presented a new vision to reignite sustainable growth in Europe. The Letta report4 outlined that Europe must leverage its Single Market to achieve a leadership position in the global competition. The Commission communication on the Competitiveness Compass5 provided a roadmap for boosting competitiveness, building on the recommendations of these reports. The Commission communication on the Clean Industrial Deal6 outlined the need to accelerate decarbonisation, reindustrialisation and innovation, bringing together climate action and competitiveness under one overarching growth. Sectorial Industrial Action Plans, such as Automotive, Steel and Metals and Chemicals aim to ensure the long-term competitiveness, sustainability, and resilience of the European industry. The State of the Digital decade 20257 highlights the urgent need to foster cooperation and increase public and private investments for strengthening Union’s digital leadership, sovereignty and inclusiveness. The Joint White Paper on European Defence Readiness8 underlines the need to massively and rapidly reinvest in defence in support of Europe’s freedom of action. Moreover, the priorities of the Economic Security Strategy further underline the crucial need to secure the Union’s technological edge and de-risk economic relations including by enhancing the resilience of supply chains and thereby reducing dependencies on others. The European Ocean Pact outlines the need to enhance competitiveness and accelerate the strategic transition across the blue economy sectors, focussing especially on decarbonisation and scaling up innovation. As outlined in the Commission Communication on the Road to the next MFF,9 the next Union long-term budget needs to be more focused, simpler, more flexible, and predictable and better deliver on the Union priorities, including bolstering the Union competitiveness. | (2) The Union is facing a defining period for its future, from a political, economic, social, environmental, climate and security perspective, including increased risks of conventional military threats. The Draghi report on the future of European Competitiveness3 presented a new vision to reignite sustainable growth in Europe. The Letta report4 outlined that Europe must leverage its Single Market to achieve a leadership position in the global competition. The Commission communication on the Competitiveness Compass5 provided a roadmap for boosting competitiveness, building on the recommendations of these reports. The Commission communication on the Clean Industrial Deal6 outlined the need to accelerate decarbonisation, reindustrialisation and innovation, bringing together climate action and competitiveness under one overarching growth. Sectorial Industrial Action Plans, such as Automotive, Steel and Metals and Chemicals aim to ensure the long-term competitiveness, sustainability, and resilience of the European industry. The State of the Digital decade 20257 highlights the urgent need to foster cooperation and increase public and private investments for strengthening Union’s digital leadership, sovereignty and inclusiveness. The Joint White Paper on European Defence Readiness8 underlines the need to massively and rapidly reinvest in defence in support of Europe’s freedom of action. Moreover, the priorities of the Economic Security Strategy further underline the crucial need to secure the Union’s technological edge and de-risk economic relations including by enhancing the resilience of supply chains and thereby reducing dependencies on others. The European Ocean Pact outlines the need to enhance competitiveness and accelerate the strategic transition across the blue economy sectors, focussing especially on decarbonisation and scaling up innovation. As outlined in the Commission Communication on the Road to the next MFF,9 the next Union long-term budget needs to be more focused, simpler, more flexible, and predictable and better deliver on the Union priorities, including bolstering the Union competitiveness. The Niinistö report explained that Union resilience and competitiveness relies on whole-of-society civil and military preparedness9a. The EU’s Global Health Strategy underlines the need to boost global health research to develop technologies and countermeasures which are necessary to improve health9b. The Medical Countermeasures Strategy underlined the need to enhance cross-sectoral collaboration including civil-military cooperation and global collaboration to boost the research, development, production, and availability of medical countermeasures, including dual use, that are necessary to reinforce the EU’s health preparedness9d. The Strategy for European Life Sciences emphasises the goal to position Europe as the world's most attractive place for life sciences by 20309c; |
| 3 The future of European competitiveness: Report by Mario Draghi, September 2024, https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en | 3 The future of European competitiveness: Report by Mario Draghi, September 2024, https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en |
| 4 Enrico Letta's Report on the Future of the Single Market, April 2024, https://www.consilium.europa.eu/media/ny3j24sm/much-more-than-a-market-report-by-enrico-letta.pdf. | 4 Enrico Letta's Report on the Future of the Single Market, April 2024, https://www.consilium.europa.eu/media/ny3j24sm/much-more-than-a-market-report-by-enrico-letta.pdf. |
| 5 Competitiveness compass - European Commission | 5 Competitiveness compass - European Commission |
| 6 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The Clean Industrial Deal: A joint roadmap for competitiveness and decarbonisation, COM(2025) 85 final, 26.2.2025. | 6 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The Clean Industrial Deal: A joint roadmap for competitiveness and decarbonisation, COM(2025) 85 final, 26.2.2025. |
| 7 COM(2025) 290 final State of the Digital Decade 2025: Keep building the EU's sovereignty and digital future. | 7 COM(2025) 290 final State of the Digital Decade 2025: Keep building the EU's sovereignty and digital future. |
| 8 Joint Communication to the European Parliament, the European Council and the Council on ‘European Economic Security Strategy’, JOIN(2023) 20 final, 20.6.2023. | 8 Joint Communication to the European Parliament, the European Council and the Council on ‘European Economic Security Strategy’, JOIN(2023) 20 final, 20.6.2023. |
| 9 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The road to the next multiannual financial framework, COM(2025) 46 final, 11.2.2025. | 9 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The road to the next multiannual financial framework, COM(2025) 46 final, 11.2.2025. |
| 9a Safer Together: Strengthening Europe’s Civilian and Military Preparedness and Readiness, March 2024, https://commission.europa.eu/document/download/5bb2881f-9e29-42f2-8b77-8739b19d047c_en?filename=2024_Niinisto-report_Book_VF.pdf. | |
| 9b EU Global Health Strategy, November 2022, https://ec.europa.eu/commission/presscorner/detail/en/ip_22_7153. | |
| 9c A Strategy for European Life Sciences, July 2025, https://research-and-innovation.ec.europa.eu/document/download/411698e8-6062-41af-96e5-af54474d70f5_en. | |
| 9d Medical Countermeasures Strategy, July 2025, https://health.ec.europa.eu/document/download/1be3e462-bd50-4c64-b147-add9d1d5a580_en?filename=com_2025-529-1_act_en.pdf. |
Amendment 2
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Proposal for a regulation
Recital 5
| Text proposed by the Commission | Amendment |
|---|---|
| (5) This also requires that Union funding facilitates the creation and expansion of innovative and industrial ecosystems, where different actors interact in a synergetic way. Successful ecosystems feature intensive and agile interactions and collaboration between small and large companies, universities research institutions, infrastructure providers, investors as well as public authorities. Without such collaborations within and between individual innovation and industrial ecosystems, innovation potential stays unexploited. | (5) This also requires that Union funding facilitates the creation and expansion of innovative and industrial ecosystems, where different actors interact in a synergetic way. Successful ecosystems feature intensive and agile interactions and collaboration between small and large companies, universities research institutions, infrastructure providers, investors as well as public authorities and relevant stakeholders including civil society organisations dedicated to health. Without such collaborations within and between individual innovation and industrial ecosystems, innovation potential stays unexploited. |
Amendment 3
Proposal for a regulation
Recital 7
| Text proposed by the Commission | Amendment |
|---|---|
| (7) Therefore, the purpose of the ECF is to establish an investment capacity to support European competitiveness in strategic technologies, infrastructures, products and services and sectors, providing for a more seamless investment journey. It will promote the creation, collaboration, and expansion of innovation, private finance and industrial ecosystems. | (7) The purpose of the ECF is to establish an investment capacity to support European competitiveness in strategic technologies, infrastructures, products and services and sectors, providing for a more seamless investment journey. It will promote the creation, collaboration and expansion of innovation, private finance and industrial ecosystems across the Union, paying particular attention to regions with lower investment capacities while preserving a merit and impact-based allocation of support. The Fund should include widening measures for Member States and regions with lower implementation capacity, including targeted capacity-building, technical assistance, simplified access so that they can effectively benefit from ECF support for health resilience, preparedness, digital health and access to medicines and medical devices. |
Amendment 4
Proposal for a regulation
Recital 9
| Text proposed by the Commission | Amendment |
|---|---|
| (9) The EU outermost regions and overseas countries and territories represent unique and strategic assets that benefit the Union as a whole – including proximity to third countries, exceptional conditions for space and astrophysics research, abundant renewable energy potential, rich biodiversity, and extensive maritime zones. The ECF should leverage their potential as geostrategic outposts, particularly in support of the Union’s objectives on security, preparedness, regional value chains, and competitiveness. | (9) The EU outermost regions and overseas countries and territories (OCTs) represent unique and strategic assets that benefit the Union as a whole – including proximity to third countries, exceptional conditions for space and astrophysics research, abundant renewable energy potential, rich biodiversity, and extensive maritime zones. The ECF should leverage their potential as geostrategic outposts, particularly in support of the Union’s objectives on the environment, security, preparedness including civil and military, climate and health preparedness, regional value chains, and competitiveness. (AM 32 Renew) In this context, the specific characteristics of these regions, including constraints related to remoteness and capacity, may be taken into account, where relevant, including as regards health resilience and preparedness. |
Amendment 5
Proposal for a regulation
Recital 12
| Text proposed by the Commission | Amendment |
|---|---|
| (12) Moreover, to foresee a strong connection with the Competitiveness Coordination Tool, the work programme of the ECF should ensure coherence with the selected projects and competitiveness priorities identified under the Tool. | (12) Moreover, to foresee a strong connection with the Competitiveness Coordination Tool, the work programme of the ECF should ensure coherence with the selected projects and competitiveness priorities identified under the Tool, following a transparent, evidence-based approach grounded in science-based and structured assessments of competitiveness and strategic importance across health, biotech and bioeconomy value chains including projects to support medical countermeasures and dual-use biodefence capacities. |
Amendment 6
Proposal for a regulation
Recital 14
| Text proposed by the Commission | Amendment |
|---|---|
| (14) The ECF should use the whole toolbox of Union budget to unlock additional public and private investments, in particular from institutional investors throughout the whole investment journey. It should contribute to creating an “investment culture” by better leveraging public funds and the de-risking potential of the Union budget. It will maximise the added value of Union action and crowd-in private capital to secure a competitive innovation and industrial base, also by using innovative funding instruments including public-private co-investment with asymmetric risk returns. In this regard, the use of financial instruments that crowd in private investors should be the privileged option wherever possible. | (14) The ECF should use the whole toolbox of the Union budget to unlock additional public, not-for-profit and private investments, in particular from institutional investors throughout the whole investment journey. It should contribute to creating an “investment culture” by better leveraging public funds and the de-risking potential of the Union budget. It will maximise the added value of Union action and crowd-in private capital to secure a competitive innovation and industrial base, including through innovative funding instruments such as public-private co-investment with asymmetric risk returns. In this regard, the use of financial instruments that crowd in private investors should be the privileged option wherever possible, reserving grants primarily for actions that lack viable revenue or saving streams to support repayment, such as civil and military health protection, diagnosis and treatment, military readiness, and prevention or other public interest objectives for which a commercial return is not envisaged. |
Amendment 7
Proposal for a regulation
Recital 28
| Text proposed by the Commission | Amendment |
|---|---|
| (28) While Europe’s digital transformation is accelerating, the many critical dependencies on non-Union suppliers (from raw materials, advanced semiconductors, and AI chips to systems, infrastructures and services) require European alternatives that anchor the digital transformation in Europe’s economy, with our shared values as the essential differentiator, including by leveraging the power of open-source technologies. Support for digital leadership is driven by regulatory and non-regulatory Union policy initiatives in the digital area such as the AI Act, AI Continent and AI Action Plan, the Apply AI Strategy, the Cloud and AI Development Act, the Data Union Strategy, the Digital Networks Act, the EU Quantum Strategy and the Quantum Act, the Cyber-Solidarity Act, the Cyber-Resilience Act and the Cybersecurity Act, the White Paper for European Defence-Readiness 2030, and the revision of the EU Chips Act, and by future policy initiatives. The digital areas to invest in include a number of critical frontier technologies such as Artificial Intelligence (AI) and AI-powered digital twins, robotics, semiconductors, autonomous or quantum technologies. They also include key infrastructures such as digital identity, cloud, high performance and quantum computing, communication, advanced underwater observation infrastructure, and sensing infrastructures, digital connectivity networks, including submarine cables, as well as cybersecurity, defence or space capacities. Fostering their uptake across private and public sectors makes our entire economy more competitive, secure, sovereign, and sustainable, fortifying societal resilience and preparedness. Moreover, interoperable digital technologies are driving the modernisation of the public sector, serving for the integration of the single market, which is our most valuable stepping stone for European digital start-ups to become globally competitive. Technological progress and innovation in every economic sector, and thus their productivity and competitiveness, are essentially driven by the integration of sector-specific digital developments and use of digital solutions that should be supported across the ECF. | (28) While Europe’s digital transformation is accelerating, the many critical dependencies on non-Union suppliers (from raw materials, advanced semiconductors, and AI chips to systems, infrastructures and services) require European alternatives that anchor the digital transformation in Europe’s economy, with our shared values as the essential differentiator, including by leveraging the power of open-source technologies. Support for digital leadership is driven by regulatory and non-regulatory Union policy initiatives in the digital area such as the AI Act, AI Continent and AI Action Plan, the Apply AI Strategy, the Cloud and AI Development Act, the Data Union Strategy, the Digital Networks Act, the EU Quantum Strategy and the Quantum Act, the Cyber-Solidarity Act, the Cyber-Resilience Act and the Cybersecurity Act, the White Paper for European Defence-Readiness 2030, and the revision of the EU Chips Act, and by future policy initiatives. The digital areas to invest in include a number of critical frontier technologies such as Artificial Intelligence (AI) and AI-powered digital twins, robotics, semiconductors, autonomous or quantum technologies. They also include key infrastructures such as digital identity, cloud, high performance and quantum computing, communication, advanced underwater observation infrastructure, and sensing infrastructures, digital connectivity networks, including submarine cables, as well as cybersecurity, defence or space capacities. Fostering their uptake across private and public sectors makes our entire economy more competitive, secure, sovereign, and sustainable, fortifying societal resilience and preparedness. Moreover, interoperable digital technologies are driving the modernisation of the public sector, serving for the integration of the single market, which is our most valuable stepping stone for European digital start-ups to become globally competitive. In this context, digital health is a key public-sector domain where the availability of secure, interoperable and resilient enabling infrastructure is indispensable, including identity and access management, cybersecurity, cloud and edge capabilities, connectivity, and data interoperability tools, in order to support the safe deployment and cross-border use of digital health solutions. Public investment in and support for uptake and access to AI and quantum supercomputing, in particular for medical research, in silico clinical trials and drug discovery is a key component of delivering on the goal set out in the Strategy for European Life Sciences. Technological progress and innovation in every economic sector, and thus their productivity and competitiveness, are essentially driven by the integration of sector-specific digital developments and use of digital solutions that should be supported across the ECF. |
Amendment 8
Proposal for a regulation
Recital 30
| Text proposed by the Commission | Amendment |
|---|---|
| (30) Europe must protect its security interest against suppliers which could represent a persistent security risk due to the potential interference from third countries as well as their security, notably cybersecurity. It is therefore necessary to reduce the risk of persisting dependency on high-risk suppliers in the internal market, including in the ICT supply chain, as they could have potentially serious negative impacts on security for users and companies across the Union and the Union’s critical infrastructure in terms of the integrity of data and services as well as the availability of service. This restriction should be based on a proportionate risk assessment and associated mitigation measures as defined in the Union policies and laws. | (30) Europe must protect its security interest against suppliers which could represent a persistent security risk due to the potential interference from third countries as well as their security, notably cybersecurity. It is therefore necessary to reduce the risk of persisting dependency on high-risk suppliers in the internal market, for critical sectors including in the ICT supply chain, as they could have potentially serious negative impacts on security for users and companies across the Union and the Union’s critical infrastructure in terms of the integrity of data and services as well as the availability of service, as well as biotechnology and biodefence manufacturing facilities that are critical for EU competitiveness, resilience, security and military readiness. This restriction should be based on a proportionate risk assessment and associated mitigation measures as defined in the Union policies and laws. |
Amendment 9
Proposal for a regulation
Recital 31
| Text proposed by the Commission | Amendment |
|---|---|
| (31) A successful deployment of interoperability across borders and sectors has a substantial, untapped potential, especially for the competitiveness of European businesses. Therefore, it is imperative to invest in the development of pan-European digital public infrastructures encompassing interoperable, secure and sovereign digital networks, solutions and services to address the fragmented interoperability landscape across the Union, notably to transform the Member States’ public sector into an interconnected, frictionless, and agile digital ecosystem. The implementation of interoperability by European public administrations at all levels is a precondition for a resilient and innovation-driven public sector which contributes to the Union’s goals of competitiveness, technological sovereignty and security. | (31) A successful deployment of interoperability across borders and sectors has a substantial, untapped potential, especially for the competitiveness of European businesses. Therefore, it is imperative to invest in the development of pan-European digital public infrastructures encompassing interoperable, secure and sovereign digital networks, solutions and services to address the fragmented interoperability landscape across the Union, notably to transform the Member States’ public sector into an interconnected, frictionless, and agile digital ecosystem, including in the area of public health, biotechnology and medical countermeasures, research and innovation. The implementation of interoperability by European public administrations at all levels is a precondition for a resilient and innovation-driven public sector which contributes to the Union’s goals of competitiveness, technological sovereignty and security. |
Amendment 10
Proposal for a regulation
Recital 31 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (31a) A dedicated Union health programme under the 2021-2027 Multiannual Financial Framework, such as EU4Health, has demonstrated the added value of Union action in supporting public health policy objectives such as resilience and preparedness, prevention, crisis response, digital health and cross-border cooperation. These experiences should be taken into account in the design of future Union funding instruments in the field of health, with a view to ensuring continuity for key public health objectives. Where relevant, the continuity of support for well-established non-profit organisations contributing to prevention, health promotion and patient engagement at Union level should be ensured. The Commission should present, without delaying implementing or holding up funding, a roadmap towards a coherent Union framework for health financing, ensuring strategic coordination between relevant Union instruments and initiatives, including Horizon Europe, EU4Health, Digital Europe, security and military health investments, Europe’s Beating Cancer Plan and the development of dual-use medical countermeasures, with a view to proposing, where appropriate, a dedicated legislative framework, including the possibility for a stand-alone EU4Health programme to strengthen the Union’s strategic health resilience and competitiveness. |
Amendment 11
Proposal for a regulation
Recital 32
| Text proposed by the Commission | Amendment |
|---|---|
| (32) To improve public health and strengthen the competitiveness of the Union, it is crucial to tackle the rise of communicable and non-communicable diseases through targeted health promotion and disease prevention strategies and continued investments, including into the pharmaceutical and medical devices sectors. Such action, coupled with fostering effective, accessible, and resilient health systems, can significantly boost workforce productivity by improving population health and alleviating labour shortages, while also supporting health systems that drive innovation. Leveraging health data is essential in those efforts, enabling informed decision-making. Moreover, fostering innovation by solidifying the evidence-based path from medical breakthroughs to marketable solutions is key to enhancing Union competitiveness and also beneficial to reinforcing supply security. | (32) To improve public health and strengthen the competitiveness of the Union, it is crucial to build a truly innovative and resilient health ecosystem, including by strengthening primary care and accelerating the digital transformation of health systems, and to tackle the rise of communicable and non-communicable diseases including cancer through targeted health promotion and prioritised disease prevention strategies based on the One Health approach and continued investments, including in the pharmaceutical, biotechnology, medical countermeasures and medical devices sectors. Such action, coupled with fostering effective, accessible and resilient health systems, can significantly boost workforce productivity by improving population health and civilian and military health emergency preparedness, alleviating labour shortages while also supporting health systems that foster innovation and health literacy. In this context, healthcare workforce shortages are a critical factor for the resilience of health systems and the competitiveness of the Union. Targeted investments in the training, specialisation and digital skills of healthcare workers, as well as in digital solutions, including artificial intelligence, aimed at reducing workloads and improving the attractiveness of healthcare professions, should be supported. This includes the development and deployment of data-driven solutions for prevention, screening and innovation. Leveraging health data, including disaggregated data, is essential in those efforts, enabling informed decision-making. Some Member States currently disaggregate data by either sex or gender. This Regulation should not affect national rules giving effect to such national practices. Reducing health inequalities and ensuring equitable access to healthcare services and treatments across the Union, constitute essential components of a competitive and resilient Union. Fostering innovation and its effective translation into practice remains essential for strengthening Union competitiveness and improving health outcomes. |
Amendment 12
Proposal for a regulation
Recital 32 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (32a) Health biotechnology is an important driver of the Union’s competitiveness and resilience and is essential to ensure the availability and accessibility of medicinal products, medical devices, diagnostics and other medical countermeasures, including in the context of preparedness and response to serious cross-border threats to health. While biotechnology and the bioeconomy cover a broad range of applications, health biotechnology is characterised by regulated development and deployment pathways and by specific requirements linked to clinical translation, quality, safety and security of supply, including for enabling technologies, upstream inputs and key production components. To ensure coherence and a balanced approach within the Health, Biotech, Agriculture and Bioeconomy window and to support an effective investment journey from research and innovation to industrial deployment and manufacturing, the ECF should therefore implement these priorities through a dedicated sub-objective on ‘health biotechnology’ within biotechnology support, while maintaining complementarity with broader industrial biotechnology objectives linked to the bioeconomy. |
Amendment 13
Proposal for a regulation
Recital 32 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (32b) Supporting the scaling-up and industrial deployment of health innovations through the ECF should also contribute to improving the availability, cost-effectiveness and affordability of health solutions, including medicines, medical devices, pharmaceuticals, diagnostics and medical countermeasures, thereby supporting Member States in optimising health expenditure. Through economies of scale, production capacity optimisation and strengthening of Union-based manufacturing capacity, such support can reduce dependencies on third countries while maintaining innovation incentives and reinforcing the competitiveness, resilience and strategic autonomy of the European health and pharmaceutical sectors. Strengthening manufacturing capacity in the Union and securing key stages of the health value chain from research and development to production, including Union manufacturing of relevant Active Pharmaceutical Ingredients (APIs), is essential to enhance resilience, ensure preparedness and reduce structural vulnerabilities, including by avoiding bottlenecks that create dependencies on third countries. This also contributes to reducing health inequalities and ensuring that innovation benefits are more widely accessible across the Union, including by supporting equitable access to healthcare services, particularly for persons with disabilities and other underserved populations. Cross-cutting health aspects relevant for the implementation of the Fund may also include, among others, the effects of the exposome and of environmental factors on health. Furthermore, support for innovation in biotechnology and advanced therapies should be encouraged as part of strengthening the Union’s capacity to develop and deploy cutting-edge health solutions, given the strategic role of biotechnology in reinforcing the Union’s autonomy. In this context, investment in research and development in biodefence, including support for dual-use medical countermeasures, Union manufacturing capacity and robust supply chains, can contribute to strengthening the Union’s ability to detect, contain and respond to cross-border health threats. |
Amendment 14
Proposal for a regulation
Recital 32 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (32c) The demographic shift towards an ageing population is a challenge shared by all Member States and should be recognised as a strategic priority in the allocation of EU innovation funding. Consequently, the European Competitiveness Fund should be mobilised to support the deployment of innovative health and social care technologies addressing this challenge, specifically by bridging the financing gap between the piloting phase and scalability in areas where private investment is insufficient or risk-averse. |
Amendment 15
Proposal for a regulation
Recital 32 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (32d) Experience from recent cross-border health crises, including the COVID-19 pandemic, has demonstrated the added value of dedicated Union health financing that supports preparedness and crisis response, the deployment of digital tools, cancer prevention and initiatives addressing health and care workforce shortages. In order to ensure continuity, predictability and visibility of such actions following the integration of the EU4Health Programme within the European Competitiveness Fund, a dedicated earmarked financial envelope should be reserved for measures corresponding to the objectives and eligible activities previously supported under the EU4Health Programme, and for complementary actions strengthening the Union’s health emergency preparedness and response capacities, including those supported through HERA Invest and in synergy with the Union Civil Protection Mechanism, in particular for health promotion, disease prevention and preparedness. |
Amendment 16
Proposal for a regulation
Recital 32 e (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (32e) Support for Digital Leadership should be implemented, where it adds clear Union value, in particular to improve patient care and health workforce conditions by building and deploying the secure, interoperable digital infrastructures, services and cybersecurity capabilities needed for digital health and telemedicine, including cross-border connectivity and the interoperability of relevant public sector systems, including the European Health Data Space (EHDS) and the European Reference Networks (ERNs). |
Amendment 17
Proposal for a regulation
Recital 36
| Text proposed by the Commission | Amendment |
|---|---|
| (36) In addition, the geopolitical context, in particular Russia’s war of aggression against Ukraine, has exposed the Union and its Member States to a high risk of materialisation of conventional military threats, in particularly to the ones bordering Russia, Belarus and Ukraine. Considering this, together with the threats on the rest of the EU borders,increased investment in defence is deemed a priority, including for projects such as the Baltic Defence Line and Eastern Border Shield. Defence industry and space are key ecosystems to ensure the European Union’s resilience and strategic autonomy and increase the Union’s readiness and preparedness in line with the White Paper for European Defence – Readiness 2030.16 It also supports the Union’s focus on sustainability, competitiveness, resilience and security and the Union position in the world. A strong European Defence Technological and Industrial Base (EDTIB) is an indispensable prerequisite of defence readiness and credible deterrence. It is also essential for the protection of European citizens, ensuring the Union’s ability to respond to emerging security challenges, to support Ukraine, and to uphold Europe's position as a global actor. The EDTIB is recognised as a strategic asset, contributing to the Union’s economic resilience and security, innovation, technological leadership and strategic autonomy. Across the Union and its Member States, the defence sector is evolving rapidly, with cutting-edge technologies and new actors playing an increasingly important role. Innovation cycles are also accelerating, with growing emphasis on rapid prototyping, testing and validation, including in real operational environments. To improve military mobility, investments in new civilian-military assets, including mobile assets and dual use infrastructure need to be developed. Coordinated and sustained support to the EDTIB is therefore key to reinforce the collective security of the Union and its Member States, the development of Union-wide defence projects of common interest, and Europe’s defence readiness. In relation to this, actions supporting the reinforcement of the Ukrainian defence technological and industrial base should be also financed, as its industry will be essential to support European increased defence needs. To this end, the ECF shall be implemented taking into account the objectives of the Strategic Compass for Security and Defence and shall be consistent with the defence capability priorities commonly agreed by Member States within the framework of the Common Foreign and Security Policy (CFSP). | (36) In addition, the geopolitical context, in particular Russia’s war of aggression against Ukraine, has exposed the Union and its Member States to a high risk of materialisation of conventional and chemical, biological, radiological and nuclear (CBRN) military threats, in particularly to the ones bordering Russia, Belarus and Ukraine. Considering this, together with the threats on the rest of the EU borders, increased investment in defence is deemed a priority, including for projects such as the Baltic Defence Line and Eastern Border Shield. Defence industry and space are key ecosystems to ensure the European Union’s resilience and strategic autonomy and increase the Union’s readiness and preparedness in line with the White Paper for European Defence – Readiness 2030.16 It also supports the Union’s focus on sustainability, competitiveness, resilience and security and the Union position in the world. A strong European Defence Technological and Industrial Base (EDTIB) is an indispensable prerequisite of defence readiness and credible deterrence. It is also essential for the protection of European citizens, ensuring the Union’s ability to respond to emerging security challenges, to support Ukraine, and to uphold Europe's position as a global actor. The EDTIB is recognised as a strategic asset, contributing to the Union’s economic resilience and security, innovation, technological leadership and strategic autonomy. Across the Union and its Member States, the defence sector is evolving rapidly, with cutting-edge technologies and new actors playing an increasingly important role. Innovation cycles are also accelerating, with growing emphasis on rapid prototyping, testing and validation, including in real operational environments. To strengthen the EU's civilian and military resilience, and to serve as an enabler of EU military readiness, investments in new or upgraded dual-use assets including hospitals, field hospitals and ‘ever-warm’ EU facilities for the manufacturing of vaccines and antimicrobials and other countermeasures contributing to European biodefence will need to be made. To improve military mobility, investments in new civilian-military assets, including mobile assets and dual use infrastructure need to be developed. Coordinated and sustained support to the EDTIB is therefore key to reinforce the collective security of the Union and its Member States, the development of Union-wide defence projects of common interest, and Europe’s defence readiness. In relation to this, actions supporting the reinforcement of the Ukrainian defence technological and industrial base should be also financed, as its industry will be essential to support European increased defence needs. To this end, the ECF shall be implemented taking into account the objectives of the Strategic Compass for Security and Defence and shall be consistent with the defence capability priorities commonly agreed by Member States within the framework of the Common Foreign and Security Policy (CFSP). |
| 16 Commission, the High Representative have present, White Paper for European Defence – Readiness 2030, 19.03.2025. | 16 Commission, the High Representative have present, White Paper for European Defence – Readiness 2030, 19.03.2025. |
Amendment 18
Proposal for a regulation
Recital 37
| Text proposed by the Commission | Amendment |
|---|---|
| (37) Union Space technology, data and services have become indispensable in the daily lives of Europeans and play an essential role in preserving strategic interests. Space contributes to all sectors of the economy from agriculture to banking. It is a critical enabler for security and defence, and for the well-functioning and competitiveness of the economy for example by providing accurate position-services for a broad spectrum of sectors and users, ranging from aviation to maritime, and thereby playing a key role for Europe and European citizens’ independence and sovereignty. Space is crucial for the achievement of EU's priorities and its strategic goals, including for economic prosperity and economic security, decarbonisation, green and digital transition. Space contributes to the economic security of the Union and its Member States. It also drives scientific research and technological innovation, with spill-over effects in a wide range of sectors. Finally, space offers a platform for international cooperation and space diplomacy to underpin the Union’s position as a reliable partner on the global scene. | (37) Union Space technology, data and services have become indispensable in the daily lives of Europeans and play an essential role in preserving strategic interests. Space contributes to all sectors of the economy from agriculture to banking. It is a critical enabler for security and defence including disaster preparedness and response, and for the well-functioning and competitiveness of the economy for example by providing accurate position-services for a broad spectrum of sectors and users, ranging from aviation to maritime, and thereby playing a key role for Europe and European citizens’ independence and sovereignty. EU space assets are increasingly crucial for global health, including vector monitoring and early warning, as well as for the Global Gateway and Africa-EU partnership. Space is crucial for the achievement of EU's priorities and its strategic goals, including for economic prosperity and economic security, decarbonisation, green and digital transition. Space contributes to the economic security of the Union and its Member States. It also drives scientific research and technological innovation, with spill-over effects in a wide range of sectors. Finally, space offers a platform for international cooperation and space diplomacy to underpin the Union’s position as a reliable partner on the global scene. |
Amendment 19
Proposal for a regulation
Recital 40
| Text proposed by the Commission | Amendment |
|---|---|
| (40) Increasingly, we see the same technologies used for market and defence applications, often driven by startups innovators. It is therefore imperative to seek measures to better exploit the potential civil-defence synergies and of dual-use technologies. Dual-use technologies, materials, knowledge, or products that can be used for both civilian and military purposes may be supported across the ECF, to ensure a better connection of the Union’s technological industry to its defence industrial base as well as to the technological innovation capital of Europe. | (40) Increasingly, we see the same technologies used for market and defence applications, often driven by startups innovators. It is therefore imperative to seek measures to better exploit the potential civil-defence synergies and of dual-use technologies including for medical countermeasures. Dual-use technologies, materials, knowledge, or products that can be used for both civilian and military purposes may be supported across the ECF, to ensure a better connection of the Union’s technological industry to its defence industrial base as well as to the technological innovation capital of Europe. |
Amendment 20
Proposal for a regulation
Recital 53
| Text proposed by the Commission | Amendment |
|---|---|
| (53) To deliver on the objective of translating research results into markets and strengthening Union’s industrial presence in strategic technologies and sectors, Regulation (EU) [XXX] [Horizon Europe framework programme for Research and Innovation] will be tightly linked with ECF and will support research and innovation activities as laid down by the policy windows of ECF. The ECF work programmes will include collaborative research and innovation actions, in a specific dedicated part. This may also include contributions to European Partnerships established under the Framework Programme for Research and Innovation, where necessary to achieve the ECF objectives. The ECF work programmes should also set out policy priorities that will steer EIC challenges. | (53) To deliver on the objective of translating research results into markets and strengthening Union’s industrial presence in strategic technologies and sectors, and to deliver measurable improvements in the Union’s overall competitiveness and, in particular, its non-cost competitiveness at international level, notably vis-à-vis other major industrial economies, Regulation (EU) [XXX] [Horizon Europe framework programme for Research and Innovation] should be tightly linked with ECF and support research and innovation activities as laid down in the ECF policy windows. In the health sector, actions that also improve affordability and cost-effectiveness should be encouraged. The ECF work programmes should include a specific dedicated part for collaborative research and innovation actions. This may also include contributions to European Partnerships established under the Framework Programme for Research and Innovation, where necessary to achieve the ECF objectives. The ECF work programmes should also set out policy priorities that will steer EIC challenges. |
Amendment 21
Proposal for a regulation
Recital 59
| Text proposed by the Commission | Amendment |
|---|---|
| (59) The ever-evolving geopolitical situation underlines the need for Europe to ensure its own strategic autonomy and avoid strategic dependencies. The ECF will include the possibility to support production ramp up and undertake accelerated competitiveness actions for projects that offer specific support to European strategic autonomy. This is for example the case for projects that have been selected as strategic under Regulation (EU) 2024/1252 (Critical Raw Materials Act), Regulation (EU) 2024/1724 (Net Zero Industry Act) and the Regulation (EU) 2025/102 (Critical Medicines Act). | (59) The ever-evolving geopolitical situation underlines the need for Europe to ensure its own strategic autonomy and avoid strategic dependencies. The ECF will include the possibility to support production ramp up and undertake accelerated competitiveness actions for projects that offer specific support to European strategic autonomy. This is for example the case for projects that have been selected as strategic under Regulation (EU) … [COM 2025/102] (Critical Medicines Act), Regulation (EU) 2024/1252 (Critical Raw Materials Act) and Regulation (EU) 2024/1735 (Net Zero Industry Act). Taking into account the objectives of the Critical Medicines Act —namely to prevent and mitigate shortages of critical medicinal products, improve their accessibility, and strengthen the European Union’s strategic autonomy in the supply of medicines essential to the health and survival of its citizens— it is justified that projects contributing to these objectives be accorded priority in the allocation of funding from the Union budget. |
Amendment 22
Proposal for a regulation
Recital 63
| Text proposed by the Commission | Amendment |
|---|---|
| (63) Where necessary and duly justified, the ECF should also be able to provide an ‘accelerated intervention’ mechanism to accelerate the provision of Union support to address urgent funding needs to enable the successful implementation of important business ideas in the single market where such funding is not available, at a sufficient level, on the market. For this purpose, due to the urgency, certain checks should be conducted only after the provision of funding, facilitating and limiting administrative burden for recipients and providing financial certainty in the fastest possible manner while accepting a reasonable level of financial risk to the Union commensurate with the objectives pursued. | (63) Where necessary and duly justified, the ECF should also be able to provide an ‘accelerated intervention’ mechanism to accelerate the provision of Union support to address urgent funding needs to enable the successful implementation of important business ideas in the single market where such funding is not available, at a sufficient level, on the market. For this purpose, due to the urgency, certain checks should be conducted only after the provision of funding, facilitating and limiting administrative burden for recipients and providing financial certainty in the fastest possible manner while accepting a reasonable level of financial risk to the Union commensurate with the objectives pursued. To enable timely, transparent and predictable permitting procedures for health manufacturing, biotechnologies and other critical health-system infrastructure , including EU manufacturing of vaccines and antimicrobials contributing to European biodefence thereby strengthening preparedness and resilience, the ECF should, where appropriate, support the mobilisation of technical assistance, delivered in cooperation with Member States and relevant implementing partners, at national and regional level, including end-to-end digitalisation of permitting and interoperable one-stop permitting interfaces, in full synergy with the upcoming Industrial Accelerator Act and the European Biotech Act. |
Amendment 23
Proposal for a regulation
Recital 76 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (76a) The European Competitiveness Fund (ECF) should play a decisive role in driving access to innovative medicinal products, EU competitiveness and strengthening the case for innovative companies to base themselves in the EU by providing guarantees, venture debt and venture capital, and blended finance to de-risk First of a Kind (FOAK) manufacturing facilities and to thereby anchor production capacity in Europe. FOAK is already well-established under the EU Innovation Fund (IF) and the Strategic Technologies for Europe Platform (STEP). FOAK manufacturing facilities can incur substantial upfront capital investment before revenues materialise and are therefore difficult to finance through private capital alone. |
Amendment 24
Proposal for a regulation
Article 3 – paragraph 1 – point a
| Text proposed by the Commission | Amendment |
|---|---|
| (a) delivering technological, economic and environmental impact from the Union's investments, including by developing disruptive and incremental innovation, and emerging, cutting-edge, dual-use, and strategic technologies with significant economic potential, including by developing and accelerating their manufacturing and industrial deployment; | (a) delivering technological, economic and environmental impact from the Union's investments, including by developing disruptive and incremental innovation, and emerging, cutting-edge, dual-use, and strategic technologies with significant economic potential, including by developing and accelerating their manufacturing and industrial deployment as well as by ensuring equitable access to those strategic technologies across the Union; |
Amendment 25
Proposal for a regulation
Article 3 – paragraph 1 – point f
| Text proposed by the Commission | Amendment |
|---|---|
| (f) developing Union cross-border and critical infrastructure key to the Union’s competitiveness, and strategic independence in particular energy and transport, digital and security, defence and space infrastructure as well as social infrastructure and related data and services; | (f) developing Union cross-border and critical infrastructure key to the Union’s competitiveness, and strategic independence in particular energy and transport, public health, digital and security, defence and space infrastructure as well as social infrastructure and related data and services; |
Amendment 26
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1) For support to health: |
Amendment 27
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1a) in synergy with other relevant Union actions, including through a health-in-all and One Health policies approach, supporting actions for disease prevention, for health promotion and for addressing health determinants, the reduction of damage to health resulting from addiction, supporting actions to address inequalities in health, promoting access to healthcare for people with disabilities, closing the gender health gap, disease prevention across the life span, health literacy, patient rights, patient safety, quality of care and cross-border healthcare, including support to relevant stakeholders and civil society organisations dedicated to health, and supporting actions for the improvement of the surveillance, diagnosis and treatment of communicable and non-communicable diseases, in particular cancer and paediatric cancer, rare diseases, as well as supporting actions to improve mental health, with special attention given to new care models and the challenges of long term care, in order to strengthen the resilience of the health systems in the Union; |
Amendment 28
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1b) strengthening the capability of the Union for prevention of, preparedness for, and rapid response to, serious cross-border threats to health in accordance with relevant Union legislation, and improving the management of health crises, particularly through the coordination, provision and deployment of emergency healthcare capacity, supporting data gathering, information exchange, surveillance, the coordination of voluntary stress testing of national healthcare systems, and the development of quality healthcare standards at national level; |
Amendment 29
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1c) supporting actions to enhance the availability, accessibility and affordability of medicinal products, medical devices, medical countermeasures and crisis-relevant products by encouraging sustainable production and supply chains and innovation in the Union, while supporting the prudent and efficient use of medicinal products, in particular antimicrobials, and actions to support the development of medicinal products that are less harmful for the environment, as well as the environmentally friendly production and disposal of medicinal products and medical devices; |
Amendment 30
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1d) in synergy with other Union instruments, programmes and funds, without prejudice to Member State competences, and in close cooperation with relevant Union bodies, supporting actions complementing national stockpiling of essential crisis-relevant products, at Union level, where needed; |
Amendment 31
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 e (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1e) in synergy with other Union instruments, programmes and funds, without prejudice to Member State competences and in close cooperation with the ECDC, establishing a structure and training resources for a reserve of medical, healthcare and support staff allocated voluntarily by Member States for its mobilisation in the event of a health crisis; |
Amendment 32
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 f (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1f) strengthening the use and re-use of health data for the provision of healthcare and for research and innovation, promoting the uptake of digital tools and services, cybersecurity as well as the digital transformation of healthcare systems, including by developing the European health data space; |
Amendment 33
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 g (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1g) enhancing access to quality, patient-centered, outcome-based healthcare and related care services, with the aim of achieving equitable health coverage; |
Amendment 34
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 h (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1h) supporting the development, implementation and enforcement and, where necessary, the revision of Union health legislation and supporting the provision of valid, reliable and comparable high-quality data for evidence-based decision-making and monitoring, and promoting the use of health impact assessments of other relevant Union policies; |
Amendment 35
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 i (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1i) supporting integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, supporting work on HTA, and strengthening and scaling up networking through interoperable and interconnected ERNs and other transnational networks, including in relation to diseases other than rare diseases, to increase the coverage of patients and improve the response to low prevalence and complex communicable and non-communicable diseases; |
Amendment 36
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 j (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1j) supporting global commitments and health initiatives by reinforcing the Union’s support for actions by international organisations, in particular actions by the WHO, and fostering cooperation with third countries; |
Amendment 37
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 k (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1k) prevention, screening, early detection, breakthrough cancer therapies, with attention given to those related to paediatric and rare cancers, innovation and the uptake of new technologies, as well as cross border and regional cooperation, in full coherence with the objectives of Europe’s Beating Cancer Plan; |
Amendment 38
Proposal for a regulation
Article 3 – paragraph 2 – point b – point -1 l (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1l) promotion of advanced research and development of medical countermeasures, including dual use, leveraging of public funding to incentivise private investment in medical countermeasures, related technologies, and increased strategic autonomy guaranteed by HERA Invest. |
Amendment 39
Proposal for a regulation
Article 3 – paragraph 2 – point b – point 1
| Text proposed by the Commission | Amendment |
|---|---|
| (1) For support to health, the specific objectives of fostering innovation and competitiveness of the health sector while ensuring supply security and the industrial capacity and capability to manage future serious cross-border threats to health; improving and protecting public and population health, by prioritising health promotion and disease prevention across the life span through a health-in-all and One Health policies approach, and by strengthening innovation and resilience of health systems. | (1) For support to competitiveness in the health sector, the specific objectives of fostering innovation and industrial competitiveness of the European health sector notably vis-à-vis other major industrial economies, increasing the overall non-cost competitiveness of the EU Health Industry, promote medical breakthrough innovation in diagnostics and access to innovative treatments, including support to SMEs, not-for-profit product developers, start-ups and scaleups, while ensuring supply security, Union civil and military health preparedness and resilience, broad and equitable access to novel health technologies, and the industrial capacity and capability to manage future serious cross-border threats to health; improving and protecting public and population health, including by prioritising health promotion, diagnosis and treatment, and by strengthening innovation and resilience of health systems, and their long-term strategic autonomy, as well as guaranteeing the availability and affordability of essential medicinal products under fair conditions throughout the Union. For health systems resilience and public health protection, in particular for Union-wide or cross-border digital capabilities such as digital public health infrastructure, interoperable data exchange and related tools, the Fund shall prioritise procurement and performance-based service contracts. Grants should be selected as the primary form of support only where the action is not suitable for repayable forms of support under the Fund or where the expected revenue or savings stream would materialise only over a timeframe that does not allow economically viable repayment terms, including for prevention, affordability-related measures, capacity-building and cooperation activities for areas of need, including for certain vaccines and antimicrobial resistance, for which there is little commercial revenues available and which are key for the Union's civil and military health preparedness. |
Amendment 40
Proposal for a regulation
Article 3 – paragraph 2 – point b – point 2
| Text proposed by the Commission | Amendment |
|---|---|
| (2) For support to biotechnology, the specific objectives of contributing to the development and scalable production and uptake, availability and accessibility of medicinal products, medical devices, diagnostics and other medical countermeasures. | (2) For support to biotechnology, the specific objectives are to contribute to the research, development, scalable production and uptake, availability and accessibility of medicinal products, medical devices, diagnostics and other medical countermeasures, including by supporting biotechnology applications across relevant domains and the enabling technologies and inputs needed for their development and manufacture, and by fostering industrial biotechnology that reinforces innovation and production capacities linked to the bioeconomy. To ensure coherence within this policy window, these priorities shall be implemented through a dedicated sub-objective on ‘health biotechnology’ within the biotechnology support, focusing on medicinal products, medical devices, diagnostics and medical countermeasures and their enabling technologies and inputs, while maintaining complementarity with broader industrial biotechnology objectives linked to the bioeconomy. For the development of medical countermeasures, including EU manufacturing of vaccines and antimicrobials and other countermeasures contributing to European biodefence, the Fund shall support innovation and the continuity of EU manufacturing among others through pre-commercial procurement as well as other types of funding instruments, and shall provide support for bringing to the market innovations that might face market failures or might otherwise stall without public intervention. The Fund shall also strengthen emerging value chains, including through integrated cross-border industrial ecosystems, and address upstream inputs and key production components whose disruption would significantly hinder manufacturing capacity. |
Amendment 41
Proposal for a regulation
Article 3 – paragraph 2 – point d – point 2
| Text proposed by the Commission | Amendment |
|---|---|
| (2) For support to EU defence industry. the specific objectives of promoting defence industrial readiness of the Union and its Member States through the strengthening of the competitiveness, responsiveness and ability of the European Defence Technological and Industrial Base (EDTIB), including support to start-ups, scale-ups and SMEs, fostering an innovative EU defence ecosystem; Collaborative research and development of defence products and technologies, including disruptive technologies for defence; Cooperation throughout the life-cycle of defence equipment, in particular in defence procurement and for the development of European defence projects of common interest; Adjustment of industry to structural changes. | (2) For support to EU defence industry. the specific objectives of promoting defence industrial readiness of the Union and its Member States through the strengthening of the competitiveness, responsiveness and ability of the European Defence Technological and Industrial Base (EDTIB), including support to start-ups, scale-ups and SMEs, fostering an innovative EU defence ecosystem; Collaborative research and development of defence products, including dual-use medical countermeasures, and technologies, including disruptive technologies for defence; Cooperation throughout the life-cycle of defence equipment, in particular in defence procurement and for the development of European defence projects of common interest; Adjustment of industry to structural changes and military health and health preparedness; measures to strengthen cybersecurity in hospitals and other critical health infrastructure, including secure systems, incident response capabilities and protection of medical data, as part of the Union’s security and preparedness objectives. |
Amendment 42
Proposal for a regulation
Article 3 – paragraph 2 – point d – point 4
| Text proposed by the Commission | Amendment |
|---|---|
| (4) For support to civil industrial security, the specific objectives of strengthening the competitiveness and responsiveness of the European civil security industry, in the application areas of security, resilience of critical and dual-use infrastructures, technologies including critical energy infrastructure, and solutions for the control of goods and persons at borders, the protection of borders, maritime security, customs security and civil preparedness against security threats, as well as reinforcing the capabilities of the relevant end-users in the civil security sector. | (4) For support to civil industrial security, the specific objectives of strengthening the competitiveness and responsiveness of the European civil security industry, in the application areas of security and civil protection, resilience of critical and dual-use infrastructures including civilian and military hospitals, technologies including critical energy infrastructure, and solutions for the control of goods and persons at borders, the protection of borders, maritime security, customs security and civil preparedness against security, biological and public health threats, as well as reinforcing the capabilities of the relevant end-users in the civil security sector. |
Amendment 43
Proposal for a regulation
Article 4 – paragraph 2 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (c) EUR 20 393 000 000 for the specific objectives referred to in Article 3(2), point (b); | (c) EUR 20 393 000 000 for the specific objectives referred to in Article 3(2), point (b): |
Amendment 44
Proposal for a regulation
Article 4 – paragraph 2 – point c – point i (new)
| Text proposed by the Commission | Amendment |
|---|---|
| i) including EUR 10 050 000 000 in current prices for the specific objectives referred to in Article 3(2), point (b)(-1), of which: | |
| - EUR 2 500 000 000 for the specific objectives referred to in Article 3(2), point (b)(-1 k), and 400 000 000 for the specific objectives referred to in Article 3(2), point (b)(-1 l), |
Amendment 45
Proposal for a regulation
Article 4 – paragraph 2 – point c – point ii (new)
| Text proposed by the Commission | Amendment |
|---|---|
| ii) including at least EUR 5 500 000 000 in current prices for the specific objectives referred to in Article 3(2), point (b)(1); |
Amendment 46
Proposal for a regulation
Article 4 – paragraph 2 – point d
| Text proposed by the Commission | Amendment |
|---|---|
| (d) EUR 51 493 000 000 for the specific objectives referred to in Article 3(2), point (c); | (d) EUR 51 493 000 000 for the specific objectives referred to in Article 3(2), point (c), with a minimum of EUR 2 000 000 000 dedicated to digital health; |
Amendment 47
Proposal for a regulation
Article 4 – paragraph 2 – point e
| Text proposed by the Commission | Amendment |
|---|---|
| (e) EUR 125 204 000 000 for the specific objectives referred to in Article 3(2), point (d); | (e) EUR 125 204 000 000 for the specific objectives referred to in Article 3(2), point (d), with a minimum of EUR 5 200 000 000 dedicated to military health and health preparedness; |
Amendment 48
Proposal for a regulation
Article 7 – paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The ECF will be implemented in synergy with other Union funds, including the Global Europe Fund, in particular to support global competitiveness, ensure diversified supply sources, and strengthen export potential and opportunities of European companies. | 3. The ECF will be implemented in synergy with other Union funds, including the Global Europe Fund and in line with the AU-EU Innovation Agenda, the EU’s Global Health Strategy and the EU’s Global Approach to Research and Innovation, in particular to support global competitiveness, ensure diversified supply sources, and strengthen export potential and opportunities of European companies. |
Amendment 49
Proposal for a regulation
Article 8 – paragraph 4
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Strategic projects under CRMA, NZIA, CMA and other strategic projects identified in Union legislation that fulfil the conditions in paragraph 1, will be directly granted the Competitiveness Seal. | 4. Strategic projects under CMA, CRMA, NZIA and other strategic projects identified in Union legislation that fulfil the conditions in paragraph 1, will be directly granted the Competitiveness Seal. |
Amendment 50
Proposal for a regulation
Article 12 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The ECF InvestEU Instrument shall be the privileged option for implementation to unlock additional public and private investments. |
Amendment 51
Proposal for a regulation
Article 15 – paragraph 1 – point h a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ha) actions that support the implementation of Union legislation and the achievement of Union targets, including those related to public health and One Health approach; |
Amendment 52
Proposal for a regulation
Article 15 – paragraph 1 – point h b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (hb) actions that support EU strategic autonomy as well as civilian and military readiness, crisis preparedness and response; |
Amendment 53
Proposal for a regulation
Article 20 – paragraph 1 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the action is duly justified by an imperative public interest, and/or is of a time-sensitive nature, or both; | (b) the action is duly justified by an imperative public interest, and/or is of a time-sensitive nature, or both, including in the event of a public health emergency or serious cross-border threats to health; |
Amendment 54
Proposal for a regulation
Article 22 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Commission shall in particular develop a Scale-up facility in cooperation with the EIB Group, other international financial institutions and National Promotional Banks. The facility shall provide in a coordinated and consistent manner, a comprehensive set of financing tools tailored to the unique needs of scale-ups, including indirect and direct equity and quasi-equity, venture debt, loans, guarantees and blended finance, with a view to attract private investors in supporting scale up financing and facilitate exit options. The facility shall target SMEs and small mid-cap companies and Mid-cap companies. | 2. The Commission shall in particular develop a Scale-up facility in cooperation with the EIB Group, other international financial institutions and National Promotional Banks. The facility shall provide in a coordinated and consistent manner, a comprehensive set of financing tools tailored to the unique needs of scale-ups, including indirect venture and growth capital, and also direct equity and quasi-equity, venture debt and venture capital, loans, guarantees and blended finance, with a view to attract private investors in supporting scale up financing and facilitate exit options. The facility shall target SMEs and small mid-cap companies and mid-cap companies. The facility shall, where appropriate, inter alia in the context of high-risk, high reward sectors including life sciences and biotechnology innovation, adopt a venture and growth capital, equity-, quasi-equity driven approach, recognising their central role and the role of private equity and venture capital in enabling companies with high growth potential to scale rapidly, crowd in private investment, contribute industry expertise, and help strengthen the Union’s innovation ecosystem in life sciences and biotechnology. |
Amendment 55
Proposal for a regulation
Article 33 – paragraph 1 – point a a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) EU manufacturing of medicinal products, including vaccines and antimicrobials and other countermeasures contributing to European biodefence: providing support for innovative and clean manufacturing of medical countermeasures that are critically important to EU civil and military readiness and preparedness that may face market failures or might otherwise stall without public intervention, thus helping prevent the shutting down of critical EU manufacturing capacity, or alternatively the loss or relocation of such manufacturing capacity to third countries. |
Amendment 56
Proposal for a regulation
Article 33 – paragraph 1 – point k
| Text proposed by the Commission | Amendment |
|---|---|
| (k) Pollution prevention, control and remediation. | (k) Pollution prevention, control and remediation, including measures that reduce harmful emissions and exposures affecting public health. |
Amendment 57
Proposal for a regulation
Article 33 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Support provided through the activities referred to in paragraph 1, may be provided in any form, including through collaborative research and innovation activities set out in Regulation (EU) [XXX] [Framework Programme for Research and Innovation] and identified in a specific dedicated part of the Work Programme. | 2. Support provided through the activities referred to in paragraph 1, may be provided in any form, including through collaborative research and innovation activities set out in Regulation (EU) [XXX] [Framework Programme for Research and Innovation] and identified in a specific dedicated part of the Work Programme, while ensuring that the Programme’s R&I funding is safeguarded against use for deployment funding. |
Amendment 58
Proposal for a regulation
Article 36 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Within the amount referred to in the second paragraph, an earmarked financial envelope shall be reserved for actions contributing to health promotion, disease prevention, preparedness, and health innovation, including research and development, as well as for support to Union SMEs in the health sector. |
Amendment 59
Proposal for a regulation
Article 37 – paragraph 1 – point a
| Text proposed by the Commission | Amendment |
|---|---|
| (a) Improving and protecting health, including cross-border health, by prioritising health promotion and disease prevention across the life course through a health-in-all and One Health policies approach, with a special emphasis on communicable and non-communicable diseases, including mental health, degenerative health, autism, cardiovascular diseases, cancer and other non-communicable diseases, including those related to pollution, sexual and reproductive health and enhancing international health initiatives and cooperation. | (a) Improving and protecting health, including cross-border health, by prioritising health promotion, disease prevention and treatment across the life course taking into account the need to promptly address the healthcare workforce shortage, by strengthening innovation and through a health-in-all and One Health policies approach, including by prioritising horizontal actions across sectoral plans to coordinate and support Member States in their efforts to step up prevention, early detection, diagnosis and access to specialised care, including through cross-border cooperation, with a special emphasis on communicable and non-communicable diseases and the interlinkages thereof, including mental health, degenerative health conditions, neurodevelopmental conditions, including autism, cardiovascular diseases, women’s health, anti-microbial resistance (AMR), rare diseases, cancer and other non-communicable diseases, including those related to pollution, sexual and reproductive health and enhancing international health initiatives and cooperation. This activity shall be consistently implemented through a dedicated, earmarked financial envelope within the appropriations under Article 4, reserved for the actions referred to in this point, aligned with health promotion, disease prevention and preparedness, complementing national policies and ensuring continuity with measures enabling a Union health security and preparedness. |
Amendment 60
Proposal for a regulation
Article 37 – paragraph 1 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) Strengthening the efficiency and resilience of health systems by reinforcing access, use and re-use of health data and digital tools, infrastructures and services, including to support the European Health Data Space, deployment of Artificial Intelligence and robotics based solutions in healthcare, advancing the digital transformation of healthcare, enhancing access to healthcare services, with particular focus on public health and healthcare workforce, developing and implementing Union health legislation, also by use of digital technologies, promoting evidence-based decision-making, (including by supporting Health technology Assessment), providing digital solutions for monitoring and coordinating and encouraging integrated work among national health systems to ensure coherence and efficiency across the Union. | (b) Strengthening the efficiency and resilience of health systems by equipping it with the necessary infrastructure, networks, and capacity to accelerate and de-risk innovation across the entire value chain, from discovery to deployment, including healthcare systems’ readiness: reinforcing access, coordination, quality check and control, use and re-use of health data, including sex-disaggregated data and digital tools, infrastructures and services, including to strengthen and support the European Health Data Space (EHDS) and the European Reference Networks (ERNs), including gathering data on the interlinkages between communicative and noncommunicative diseases, deployment of Artificial Intelligence and robotics based solutions in healthcare, advancing the digital transformation of healthcare, enhancing equitable access to healthcare services, with particular focus on delivering affordable public health policies and services and strengthening the capacity of the healthcare workforce, implementing Union health legislation, also by use of digital technologies, promoting evidence-based decision-making, (including by supporting Health technology Assessment), supporting multi-country clinical trials, providing digital solutions for monitoring and coordinating and encouraging integrated work among national health systems to ensure coherence and efficiency across the Union. Strengthening cybersecurity in hospitals and health systems, including safer AI deployment and protection of personal health data. |
Amendment 61
Proposal for a regulation
Article 37 – paragraph 1 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (c) Fostering the development, production capacity, manufacturing and industrial deployment of health and bioeconomy technologies, to increase the competitiveness of the sector, and ensure availability of Union medicinal products, medical devices, digital solutions and medical countermeasures relevant for preparedness and response to cross-border threats to health, as well as the competitiveness and resilience of the sectors by ensuring that such products are innovative, safe, accessible, available, and affordable, thereby promoting equitable access across the Union. | (c) Fostering the development, research and innovation, production capacity, manufacturing and industrial deployment of health and bioeconomy technologies, to increase the competitiveness of the sector, including through the development of advanced medical technology and therapies such as regenerative medicine, bioprinting, ATMPs (Advanced Therapy Medicinal Products), and ensure availability, in the Union, of medicinal products, medical devices, critical medicinal products and dual use medical countermeasures including vaccines and antimicrobials, digital solutions and medical countermeasures relevant for preparedness and response to cross-border threats to health, as well as the competitiveness and resilience of the sectors by ensuring that such products are innovative, safe, accessible, available, and affordable, thereby promoting equitable access across the Union. To this end, the Fund shall support the relocation and consolidation of pharmaceutical and medical device manufacturing capacity within the territory of the Union, while prioritising strategic devices and critical medicines, hence reducing strategic dependence on third country suppliers. |
Amendment 62
Proposal for a regulation
Article 37 – paragraph 1 – point d
| Text proposed by the Commission | Amendment |
|---|---|
| (d) Supporting the discovery, development, derisking, demonstration, piloting and use, and scaling-up of biotechnology innovations, accelerating the market introduction and market uptake of biotechnology solutions, strengthening emerging value chains and providing access to finance and other support for SMEs, startups, scale ups and innovators. | (d) Supporting the discovery, development, derisking, demonstration, piloting and use, and scaling-up of health related biotechnology and other non-health biotechnology innovations, including those reaching at least Technology Readiness Level 6 or above from Horizon Europe-funded research, accelerating the market introduction and market uptake of biotechnology solutions, innovative medicinal products, medical countermeasures and emerging manufacturing technologies fostering advanced and preventive therapies and precision medicine solutions, strengthening emerging value chains, including through integrated cross-border industrial ecosystems, and providing access to finance and other support for SMEs, startups, scale ups and innovators. The Fund shall also focus on supporting the research, discovery and development of medicinal products and medical devices to meet the unmet medical needs, including for specific medicinal products as well as drug research and development to all four phases of clinical trials. |
Amendment 63
Proposal for a regulation
Article 37 – paragraph 1 – point d a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (da) Supporting the strengthening and robustness of supply chains for biotechnology and for EU manufacturing of vaccines, antimicrobials and countermeasures contributing to EU biodefence in particular by co-financing supplier modernisation, localisation and scale-up, supporting sustainable and reliable sourcing of raw materials, intermediate materials, and finished products alongside the whole value chain, reinforcing supply chain resilience across the biotech value chain, thereby supporting EU civil and military preparedness, readiness and strategic autonomy amid global state aid competition, and given the increasing EU dependence on third country suppliers for critical components such as Active Pharmaceutical Ingredients (APIs). |
Amendment 64
Proposal for a regulation
Article 37 – paragraph 1 – point e
| Text proposed by the Commission | Amendment |
|---|---|
| (e) Protecting people by supporting the development, implementation and monitoring of health security policies, in cooperation with Member States authorities and stakeholders, as well as coordinating Union and national prevention, preparedness and response plans. | (e) Protecting people by supporting the development, implementation and monitoring of health civil, military preparedness and security policies, in cooperation with Member States authorities and stakeholders, as well as coordinating Union, national and international prevention, preparedness and response plans, including by ensuring synergies with the Union Civil Protection Mechanism and rescEU capacity. |
Amendment 65
Proposal for a regulation
Article 37 – paragraph 1 – point f
| Text proposed by the Commission | Amendment |
|---|---|
| (f) Fostering an innovative and competitive bioeconomy sector in the Union, including in the areas of health biotech, biobased materials and products, valorising farm and forest residues, carbon negative products, biomanufacturing and biochemicals, in particular by supporting the discovery, development, derisking, demonstration, piloting, and scaling-up of bioeconomy innovations; by accelerating the market introduction and market uptake of bio-based materials from agriculture and forestry and bioeconomy solutions; by strengthening emerging value chains; by building a skilled workforce, by providing access to finance and other support for SMEs, startups, scale ups and innovators. | (f) Fostering an innovative, competitive and sustainable bioeconomy sector in the Union, including in the areas of health biotech, biobased materials and products, valorising farm and forest residues, carbon negative products, biomanufacturing and biochemicals and upstream inputs and key production components whose disruption would significantly hinder manufacturing capacity, in particular by supporting the discovery, development, derisking, demonstration, piloting, and scaling-up of bioeconomy innovations; by accelerating the market introduction and market uptake of bio-based materials from agriculture and forestry and bioeconomy solutions; by providing technical assistance, both on the national and regional levels, through end-to-end digitalisation of permitting and interoperable one-stop permitting interfaces, in full synergy with the upcoming Industrial Accelerator Act and the European Biotech Act in order to enable timely, transparent and predictable permitting procedures; by building a skilled workforce, by providing access to finance and other support for SMEs, start-ups, scale-ups and innovators, through programmes like HERA Invest. |
| 1a 2025/0406 (COD) |
Amendment 66
Proposal for a regulation
Article 37 – paragraph 1 – point h a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ha) Strengthening the resilience, performance and inclusiveness of health systems by encouraging innovation-driven and cost-effective solutions to help reduce health inequalities and improve access to quality care, including for persons with disabilities; promoting proportionate investment in prevention-oriented technologies and digital tools, alongside initiatives supporting healthy lifestyles; funding telemedicine scale-up, especially in rural, border and outermost areas as a measure complementary to the efforts to deploy appropriate healthcare workforce; supporting the development of skills and training for healthcare professionals to better respond to the needs of persons with disabilities; facilitating early childhood development; and reinforcing strategic capacity in areas of significant disease burden, such as cardiovascular diseases, cancer and rare diseases, in coherence with the dedicated Union public health programme, while fully respecting Member States’ competences. |
Amendment 67
Proposal for a regulation
Article 39 – paragraph 2 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (c) Enabling the power of digital for businesses and citizens by deploying state-of-the-art and sustainable digital applications, infrastructures and services across the Union. The implementation shall include, but not be limited to, actions to research and innovate, develop, produce, manufacture, or deploy advanced digital infrastructures at scale across the Union (e.g. high-performance computing, telco-cloud-edge, AI Factories and Gigafactories, data and data spaces, testing and experimentation facilities, semiconductor, photonics and quantum chips pilot lines, quantum computing, communication and sensing infrastructures, cybersecurity hubs, the EU for Business Network, European Digital Innovation Hubs, advanced connectivity infrastructures including submarine cables and non-terrestrial networks), the EU Digital Identity Wallets and trust services as well as the European Business Wallets and services, secure and interoperable digital public infrastructure, to act as a key enabler of the digital transformation and in support of societal resilience and preparedness, bringing clear added-value to businesses, public services and citizens. Where relevant, these actions shall be coordinated with national investments and shall otherwise exploit untapped potential to create a domestic market for advanced digital technologies ‘made in Europe’. Such actions may be provided under the framework of Multi-Country Projects established in accordance with Decision (EU) 2022/2481, including notably those implemented through the European Digital Infrastructure Consortia or Joint Undertakings. | (c) Enabling the power of digital for businesses and citizens by deploying state-of-the-art and sustainable digital applications, infrastructures and services across the Union. The implementation shall include, but not be limited to, actions to research and innovate, develop, produce, manufacture, or deploy advanced digital infrastructures at scale across the Union (e.g. high-performance computing, telco-cloud-edge, AI Factories and Gigafactories, data and data spaces, testing and experimentation facilities, semiconductor, photonics and quantum chips pilot lines, quantum computing, communication and sensing infrastructures, cybersecurity hubs, the EU for Business Network, European Digital Innovation Hubs, advanced connectivity infrastructures including submarine cables and non-terrestrial networks), the EU Digital Identity Wallets and trust services as well as the European Business Wallets and services, secure and interoperable digital public infrastructure, to act as a key enabler of the digital transformation and in support of societal resilience and preparedness, bringing clear added-value to businesses, public services, citizens, patients and hospitals. Where relevant, these actions will facilitate access to AI and quantum supercomputing capabilities, including in order to facilitate medical research, clinical trials, and drug discovery and to support missions, partnerships and bioclusters as outlined in the European Strategy for Life Sciences and the Centres of Excellence for Advanced Therapies as foreseen by the European Biotech Act. Where relevant, these actions shall be coordinated with national investments and shall otherwise exploit untapped potential to create a domestic market for advanced digital technologies ‘made in Europe’. Such actions may be provided under the framework of Multi-Country Projects established in accordance with Decision (EU) 2022/2481, including notably those implemented through the European Digital Infrastructure Consortia or Joint Undertakings. |
Amendment 68
Proposal for a regulation
Article 39 – paragraph 2 – point d
| Text proposed by the Commission | Amendment |
|---|---|
| (d) Supporting the Union’s digital transformation of public and private sectors, including to support the development and the circulation of digital skills. The implementation shall include, but not be limited to, providing the necessary support to accelerating and deepening the uptake and deployment of digital solutions across economic sectors, through research, innovation and deployment, to boost their productivity and competitiveness, with a focus on more complex technologies, as well as to achieve societal benefits. Support to public sector applications as well as the broader digitalisation of the public sector shall aim at ensuring a cohesive Union-wide interoperable digital public services landscape, support technological sovereignty, maximising their efficiency for businesses and citizens. The digital transformation of economic and public sectors shall also be supported by the other sectoral windows of the ECF. | (d) Supporting the Union’s digital transformation of public and private sectors, including to support the development and the circulation of digital skills. The implementation shall include, but not be limited to, providing the necessary support to accelerating and deepening the uptake and deployment of digital solutions across economic sectors, through research, innovation and deployment, to boost their productivity and competitiveness, with a focus on more complex technologies, as well as to achieve societal benefits. Support to public sector applications as well as the broader digitalisation of the public sector shall aim at ensuring a cohesive Union-wide interoperable digital public services and health landscape, support technological sovereignty, maximising their efficiency for businesses and citizens. The digital transformation of economic and public sectors shall also be supported by the other sectoral windows of the ECF. |
Amendment 69
Proposal for a regulation
Article 39 – paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Activities under this Section shall support the development, deployment and procurement of advanced cybersecurity capacities, infrastructures, technologies and capabilities, with a view to ensure the security of critical infrastructures & digital supply chains, develop an Union situational picture of the threat landscape as well as improve detection capacities and incident response capabilities; supporting the competitiveness of the Union cybersecurity industrial base, cybersecurity skills development together with the cyber maturity of the European industrial basis, including SMEs. | 3. Activities under this Section shall support the development, deployment and procurement of advanced cybersecurity capacities, infrastructures, technologies and capabilities, with a view to ensure the security of critical infrastructures, including civilian and military hospitals, EU manufacturing facilities for dual-use vaccines and antimicrobials contributing to European biodefence & digital supply chains, develop an Union situational picture of the threat landscape as well as improve detection capacities and incident response capabilities; supporting the competitiveness of the Union cybersecurity industrial base, cybersecurity skills development together with the cyber maturity of the European industrial basis, including SMEs. |
Amendment 70
Proposal for a regulation
Article 45 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. European Defence Projects of Common Interest shall consist of collaborative industrial projects aimed at reinforcing the competitiveness of the EDTIB throughout the Union while contributing to the development of Member States’ military capabilities and systems of common interest and/or use, including those securing access to all operational domains, namely land, maritime, air, space and cyber. | 1. European Defence Projects of Common Interest shall consist of collaborative industrial projects aimed at reinforcing the competitiveness of the EDTIB throughout the Union while contributing to the development of Member States’ military capabilities and systems of common interest and/or use, including biodefence and including those securing access to all operational domains, namely land, maritime, air, space and cyber. |
Amendment 71
Proposal for a regulation
Article 45 – paragraph 6
| Text proposed by the Commission | Amendment |
|---|---|
| 6. A European Defence Project of Common Interest shall be considered to contribute to the defence capabilities critical for the security and defence interests of the Union and its Member States and therefore to be in the public interest. They may be established in the framework of Structures for European Armament Programmes established in accordance with Regulation (EU) [XXX] [European Defence Industry Programme]. | 6. A European Defence Project of Common Interest shall be considered to contribute to the defence capabilities critical for the security and defence, including biodefence and military health readiness, interests of the Union and its Member States and therefore to be in the public interest. They may be established in the framework of Structures for European Armament Programmes established in accordance with Regulation (EU) [XXX] [European Defence Industry Programme]. |
Amendment 72
Proposal for a regulation
Article 46 – paragraph 1 – point e a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ea) collaborative research and development actions for dual-use medical countermeasures and biotechnology with military and defence applications. |
Amendment 73
Proposal for a regulation
Article 47 – paragraph 1 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the building-up and making available of reserved surge manufacturing capacities (ever warm facilities) of defence products, their components and corresponding raw materials, insofar as those components and raw materials are intended or used wholly for the production of defence products, in accordance with ordered or planned production volumes; | (c) the building-up and making available of reserved surge manufacturing capacities (ever warm facilities) of defence products, including medical countermeasures, their components and corresponding raw materials, insofar as those components and raw materials are intended or used wholly for the production of defence products, in accordance with ordered or planned production volumes; |
Amendment 74
Proposal for a regulation
Article 47 – paragraph 1 – point f a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (fa) strengthening military health readiness and reducing industrial strategic dependencies of EU manufacturing of dual use vaccines and antimicrobials contributing to EU biodefence by supporting the continuity of EU-based manufacturing, ‘ever-warm’ facilities and surge capacity through the EU FAB network, supporting supplier modernisation, localisation and scale-up, supporting supplier switching to EU manufacturers, and reinforcing supply chain resilience alongside the whole value chain, thereby supporting EU civil and military preparedness and strategic autonomy amid increasing EU dependence on third country suppliers of critical components such as Active Pharmaceutical Ingredients (APIs). |
Amendment 75
Proposal for a regulation
Article 48 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The Programme shall support activities that aim at increasing cooperation among Member States and associated countries in joint certification capability development, procurement, maintenance and availability of defence capabilities, thereby reducing fragmentation and enhancing interoperability, achieving economies of scale, ensuring faster access to needed equipment, and strengthening collective defence readiness. | 1. The Programme shall support activities that aim at increasing cooperation among Member States and associated countries in joint certification capability development, procurement, maintenance and availability of defence and biodefence capabilities, thereby reducing fragmentation and enhancing interoperability, achieving economies of scale, ensuring faster access to needed equipment, and strengthening collective defence readiness. |
Amendment 76
Proposal for a regulation
Article 49 – paragraph 1 – introductory part
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Activities related to the enhancement of military mobility in the Union by supporting dual use of civilian-military assets, including equipment, infrastructure and superstructures, facilitating, enabling and supporting military movements and access to military mobility capabilities, including, through the pooling and sharing of military mobility assets,; this also includes supporting military bases, encompassing housing for military personnel and social infrastructure, to enable and sustain increased stationing of military personnel in Member States; may cover: | 1. Activities related to the enhancement of military mobility in the Union by supporting dual use of civilian-military assets, including equipment, infrastructure and superstructures, facilitating, enabling and supporting military movements and access to military mobility capabilities, including, through the pooling and sharing of military mobility assets and military health readiness assets; this also includes supporting military bases, field hospitals, encompassing housing for military personnel and social infrastructure, to enable and sustain increased stationing of military personnel in Member States; may cover: |
Amendment 77
Proposal for a regulation
Article 49 – paragraph 1 – point c a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) The support to military health, health preparedness and biosecurity. |
Amendment 78
Proposal for a regulation
Article 49 – paragraph 1 – point e
| Text proposed by the Commission | Amendment |
|---|---|
| (e) The training, reskilling, and upskilling of personnel to enhance the availability of skilled personnel for the transportation of defence products, components and supplies, notably for the safe and efficient movement of oversized, overweight, and dangerous goods. | (e) The training, reskilling, and upskilling of personnel to enhance the availability of skilled personnel for the transportation of defence products, components and supplies, notably for the safe and efficient movement of oversized, overweight, and dangerous goods including biodefence assets and Chemical, Biological, Radiological, and Nuclear (CBRN) countermeasures. |
Amendment 79
Proposal for a regulation
Article 80 – paragraph 1 – point d a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (da) Technologies, capabilities and industrial manufacturing solutions, including dual-use, dedicated to the prevention of, preparedness for and response to public health crises and natural and climate-related disasters, including specialised land and aerial assets, associated systems, and the industrial value chains necessary for their design, production and operational maintenance. |
Amendment 80
Proposal for a regulation
Article 83 – paragraph 1 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (c) Health, Biotech, Agriculture and Bioeconomy Committee for matters concerning specific objectives set out in Article 3(2), point (b); | (c) Health, Biotech, Agriculture and Bioeconomy Committee, including a sub-committee specifically on health, for matters concerning specific objectives set out in Article 3(2), point (b); |
Annex: declaration of input 1 paragraph
The rapporteur for opinion declares under his exclusive responsibility that he did not include in his opinion input from interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register1, or from representatives of public authorities of third countries, including their diplomatic missions and embassies, to be listed in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.
Procedure pages
How the committees handled the text, and how their members voted on it.
Procedure – committee asked for opinion 1 paragraph
| Title | Establishing the European Competitiveness Fund (’ECF’), including the specific programme for defence research and innovation activities | |
| References | COM(2025)0555 – C10-0165/2025 – 2025/0555(COD) | |
| Committee(s) responsible Date announced in plenary | ITRE 23.10.2025 | |
| Opinion by Date announced in plenary | SANT 23.10.2025 | |
| Rapporteur for opinion Date appointed | Radan Kanev 28.11.2025 | |
| Discussed in committee | 24.2.2026 | 18.3.2026 |
| Date adopted | 6.5.2026 | |
| Result of final vote | +: –: 0: | 25 2 5 |
Final vote by roll call by the committee asked for opinion 3 paragraphs
25 · For
- ECR
- Aurelijus Veryga
- No group
- Ondřej Dostál
- EPP
- Bartosz Arłukowicz, Jens Gieseke, Michalis Hadjipantela, Adam Jarubas, Radan Kanev, András Tivadar Kulja, Norbert Lins, Jessica Polfjärd, Manuela Ripa, Tomislav Sokol
- Renew
- Stine Bosse, Veronika Cifrová Ostrihoňová, Andreas Glück, Irena Joveva
- S&D
- Vytenis Povilas Andriukaitis, Biljana Borzan, Christophe Clergeau, Vivien Costanzo, Nikos Papandreou, Marta Temido
- Greens
- Martin Häusling, Ignazio Roberto Marino, Tilly Metz
2 · Against
- ESN
- Christine Anderson
- Patriots
- Gerald Hauser
5 · Abstained
- No group
- Kateřina Konečná
- Patriots
- Laurent Castillo, Viktória Ferenc, Hermann Tertsch
- The Left
- Catarina Martins