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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]

Full title

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-PA-784244 · COM(2025)0555 – C100165/2025 – 2025/0555(COD)

Kind
Opinion parliamentary committee draft SANT-PA-784244
Date
3 February 2026
Committee
Committee on Public Health
Rapporteur
Radan Kanev
Dossier
2025-0555
More facts (3)
Subject matter
RDT, INDU
Reference
COM(2025)0555 – C100165/2025 – 2025/0555(COD)
More

In short

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The Committee on Public Health's draft opinion proposes amendments to the proposed regulation establishing the European Competitiveness Fund (ECF), including a specific programme for defence research and innovation. It asks to earmark funding for health promotion, disease prevention, preparedness and health innovation, including support for health-sector SMEs. The amendments require the ECF to reserve grants mainly for actions without viable revenue streams, such as health protection and prevention, and to prioritise procurement and performance-based contracts for digital health capabilities. They strengthen resilience and strategic autonomy in medicines, devices and medical countermeasures, link excellence-based research to deployment and manufacturing in Europe, and treat secure interoperable digital infrastructures and data exchange as core enablers for health systems. The opinion also adds support for biotechnology, the bioeconomy, pollution prevention measures affecting public health, and faster permitting for health manufacturing.

Position. The Committee on Public Health proposes a limited number of amendments to the proposed ECF regulation, aiming to sharpen the Fund's health window, earmark funding for health objectives, prioritise non-grant support where possible, and strengthen resilience, digital health and the link from research to manufacturing.

Key points

  1. The amendments aim to ensure the ECF strengthens Europe's health, biotech and bioeconomy capacity without diluting public-health objectives, while keeping governance safeguards and the excellence-based research pipeline.
  2. A dedicated envelope should be earmarked for prevention, preparedness, health innovation and health-sector SMEs, preserving actions inherited from EU4Health, HERA Invest and the EU Civil Protection Mechanism.
  3. The ECF work programme should follow a transparent, evidence-based approach grounded in science-based and structured assessments of competitiveness and strategic importance across health, biotech and bioeconomy value chains.
  4. Financial instruments that crowd in private investors should be the privileged option, reserving grants mainly for actions lacking viable revenue or saving streams, such as health protection and prevention.
  5. The ECF should build an innovative and resilient health ecosystem, tackle communicable and non-communicable diseases, ensure timely, equal and affordable access to pharmaceuticals and innovation, and align closely with Horizon Europe.
  6. Support for scaling up health innovations should improve cost-effectiveness and affordability, reduce the fiscal burden on national health systems and reduce dependencies on third-country suppliers.
  7. A dedicated earmarked financial envelope should be reserved under Chapter V for measures previously supported under EU4Health and for complementary actions on health emergency preparedness, including HERA Invest and the Union Civil Protection Mechanism.
  8. Support for Digital Leadership should build and deploy secure, interoperable digital infrastructures, services and cybersecurity capabilities for digital health and telemedicine, including cross-border connectivity and interoperability of public sector systems.
  9. The ECF should support rapid mobilisation of technical assistance and end-to-end digitalisation of permitting, in synergy with the upcoming Industrial Accelerator Act and the European Biotech Act.
  10. For health systems resilience and public health protection, the Fund should prioritise procurement and performance-based service contracts, using grants only where repayable support is unsuitable.
  11. Support to biotechnology should contribute to scalable production, uptake, availability and accessibility of medicinal products, medical devices, diagnostics and other medical countermeasures, including industrial biotechnology linked to the bioeconomy.
  12. The amendments add support for Union legislation and targets on climate, environment and public health, and for pollution prevention measures reducing harmful emissions and exposures affecting public health.

Who is affected

  • Health-sector small and medium-sized enterprises, which would receive earmarked support under the Fund.
  • National health systems and budgets, which should benefit from more affordable health solutions and reduced fiscal burden.
  • The pharmaceutical, medical device and biotechnology sectors, which would receive support for production, manufacturing and deployment.
  • Member states, including smaller and less developed economies, which should gain timely and equitable access to affordable health solutions.

Figures and deadlines

  • Technology Readiness Level 6 or above, the threshold for biotechnology innovations from Horizon Europe-funded research.

Legal basis. Articles 168, 191 and 114(3) TFEU and Article 3 TEU.

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Short justification

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 12

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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.

Or. en

Amendment 2

Proposal for a regulation

Recital 14

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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 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, reserving grants primarily for actions that lack viable revenue or saving streams to support repayment, such as health protection and prevention or other public interest objectives for which a commercial return is not envisaged.

Or. en

Amendment 3

Proposal for a regulation

Recital 28

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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. 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.

Or. en

Amendment 4

Proposal for a regulation

Recital 32

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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, which strengthens primary care; to tackle the rise of communicable and non-communicable diseases through targeted health promotion and prioritised disease prevention strategies and continued investments, including into the pharmaceutical and medical devices sectors strategies, ensuring timely, equal and affordable access to pharmaceuticals and innovation, and accelerating the digital health transformation. Such action, coupled with fostering effective, accessible, and resilient health systems, can significantly boost workforce productivity by improving population health and health emergency preparedness, 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. In order to safeguard the EU’s leading role in the medicinal and pharmaceutical industries and services, the European Competitiveness Fund should be designed in close alignment with Horizon Europe, so that excellence-based research and innovation seamlessly feed into targeted industrial deployment. By building structured links between Horizon-funded projects and ECF scale-up windows, the Union can foster the rapid identification of solutions, support their scaling in Europe, promote EU's medical countermeasures deployment capacity, and systematically reduce structural vulnerabilities in health and pharmaceutical systems, including over-dependence on a limited number of suppliers and third-country production.

Or. en

Justification

The amendment aligns the recital with the ECF’s stated objective to foster innovation and competitiveness in the health and biotech sectors while ensuring supply security and resilient health systems. By explicitly linking primary care, disease prevention, health data use and Horizon-funded excellence-based research to ECF-supported industrial deployment and EU-based manufacturing, it operationalises the Fund’s role in reducing strategic dependencies and strengthening the Union’s open strategic autonomy in pharmaceuticals and medical countermeasures.​

Amendment 5

Proposal for a regulation

Recital 32 a (new)

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(32a) Supporting the scaling-up and industrial deployment of health innovations through the ECF should also contribute to improving the cost-effectiveness and affordability of health solutions, thereby enabling Member States to optimise their health expenditure while ensuring equitable access to medicines, medical devices, diagnostics, medical countermeasures, and other health-related innovations. Through economies of scale in manufacturing, production capacity optimisation, and supply chain localisation in the Union, health innovations supported by the ECF should reduce in the long run the fiscal burden on national health systems and budgets, and reduce dependencies on third countries, while maintaining innovation incentives and competitiveness of the European health and pharmaceutical sectors. In particular, by fostering EU-based manufacturing capacity and reducing dependencies on third-country suppliers, the ECF health window should strengthen the ability of all Member States, including smaller and less developed economies, to ensure timely and equitable access to affordable health solutions, as well as sufficient preparedness and increased capacity to manage health crisis.

Or. en

Amendment 6

Proposal for a regulation

Recital 32 b (new)

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(32b) 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 under Chapter V 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.

Or. en

Amendment 7

Proposal for a regulation

Recital 32 c (new)

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(32c) Support for Digital Leadership should be implemented, where it adds clear Union value, in particular 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.

Or. en

Amendment 8

Proposal for a regulation

Recital 53

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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.

Or. en

Amendment 9

Proposal for a regulation

Recital 63

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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, thereby strengthening preparedness and resilience, the ECF should, where appropriate, support the rapid 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.

Or. en

Amendment 10

Proposal for a regulation

Article 3 – paragraph 2 – point b – point 1

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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 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 and their long-term strategic autonomy. 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.

Or. en

Amendment 11

Proposal for a regulation

Article 3 – paragraph 2 – point b – point 2

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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 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.

Or. en

Amendment 12

Proposal for a regulation

Article 15 – paragraph 1 – point h a (new)

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(ha) actions that support the implementation of Union legislation and the achievement of Union targets, including those related to climate, environment, and public health.

Or. en

Amendment 13

Proposal for a regulation

Article 33 – paragraph 1 – point k

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(k) Pollution prevention, control and remediation.(k) Pollution prevention, control and remediation, including measures that reduce harmful emissions and exposures affecting public health.

Or. en

Justification

Reflects the Union’s duty to ensure a high level of health and environmental protection under Articles 168, 191 and 114(3) TFEU and Article 3 TEU, as well as the commitments set out in the 8th Environment Action (8EAP). Provides clarity that pollution-prevention objectives should be pursued through measures reducing harmful emissions, wider air pollutants (e.g., AAQD), and exposures in key sectors.

Amendment 14

Proposal for a regulation

Article 36 – paragraph 2 a (new)

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
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, in particular for actions previously supported under the EU4Health Programme and HERA Invest.

Or. en

Amendment 15

Proposal for a regulation

Article 37 – paragraph 1 – point a

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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 and disease prevention across the life course, by strengthening innovation and through a health-in-all and One Health policies approach, with a special emphasis on communicable and non-communicable diseases and the interlinkages thereof, 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. This activity should 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 prevention, health promotion, disease prevention and preparedness, complementing national policies and ensuring continuity with measures enabling a Union health security and preparedness.

Or. en

Justification

To discuss

Amendment 16

Proposal for a regulation

Article 37 – paragraph 1 – point b

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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 and digital tools, infrastructures and services, including to strengthen and support the European Health Data Space, 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 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), supporting multi-country clinical trials for public health priority diseases, providing digital solutions for monitoring and coordinating and encouraging integrated work among national health systems to ensure coherence and efficiency across the Union.

Or. en

Amendment 17

Proposal for a regulation

Article 37 – paragraph 1 – point c

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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, production capacity, manufacturing and industrial deployment of health 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 of Union medicinal products, medical devices, critical medicinal products, 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

Or. en

Amendment 18

Proposal for a regulation

Article 37 – paragraph 1 – point d

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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 and 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 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 for communicable and non-communicable diseases to meet the unmet medical needs for specific medicinal products as well as drug research, discovery and development to all four phases of clinical trials.

Or. en

Justification

Fostering manufacturing capacity and promoting sustainable and resilient production along the value chain (this includes strengthening the production of critical raw materials, APIs and medicines).

Amendment 19

Proposal for a regulation

Article 37 – paragraph 1 – point f

Amendment: Text proposed by the Commission and Amendment
Text proposed by the CommissionAmendment
(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 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 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 1a 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, startups, scale ups and innovators.
1a 2025/0406 (COD)

Or. en

Back matter, 1

Parts that accompany the text rather than belong to it: explanatory statement, annexes, opinions appended by other committees. Collapsed.

Annex: declaration of input 1 block

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 register, 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.

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25 September 2026

Cite as

European Parliament (2026). “DRAFT OPINION 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]”. Text, 3 February 2026. docId SANT-PA-784244. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/SANT-PA-784244 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/SANT-PA-784244 (CC BY 4.0).
BibTeX
@misc{epw-text-sant-pa-784244,
  author = {{European Parliament}},
  title = {{DRAFT OPINION 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]}},
  year = {2026},
  date = {2026-02-03},
  howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/SANT-PA-784244}},
  url = {https://news.eu-parl.st-solutions.dev/texts/SANT-PA-784244},
  urldate = {2026-09-25},
  publisher = {EU Parl Watch Research},
  note = {Text. docId SANT-PA-784244. Data: EP Open Data API: document record (CC BY 4.0)}
}