Text · Report parliamentary committee draft
On the proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)
Full title
On the proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)
Document CJ53-PR-789987 · COM(2025)1022 – C100363/2025 – 2025/0406(COD)
- Kind
- Report parliamentary committee draft CJ53-PR-789987
- Date
- 16 June 2026
- Committee
- Committee on Public Health Committee on Industry, Research and Energy
- Rapporteur
- Vytenis Povilas Andriukaitis, Wouter Beke
- Dossier
- 2025-0406
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- Formats
- Official page PDF Word
- Reference
- COM(2025)1022 – C100363/2025 – 2025/0406(COD)
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Draft european parliament legislative resolution
–having regard to Article 294(2), 114, 168(4) and 173(3) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C100363/2025),
–having regard to the opinions of the Committee on the Environment, Climate and Food Safety and the Committee on Legal Affairs,
– having regard to the report of the Committee on Public Health and Committee on Industry, Research and Energy (A[100000/2026]),
2.Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;
3.Instructs its President to forward its position to the Council, the Commission and the national parliaments.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. This Regulation establishes a framework to strengthen the competitiveness of the health biotechnology sector in the Union. It creates and reinforces favourable conditions for health biotechnology as defined in Article 2(1), point (2), from research and development to the timely placing on the Union market and production of biotechnology innovations and products, while safeguarding high standards of protection of human health, patient safety and animal health, the environment, ethics, quality of products, food and feed safety and biosecurity. | 1. This Regulation establishes a framework to strengthen the competitiveness of the biotechnology and biomanufacturing sectors in the Union, particularly in the area of health. It creates and reinforces favourable conditions for biotechnology as defined in Article 2(1), point (2), from research and development to the timely placing on the Union market and production of biotechnology innovations and products, while safeguarding high standards of protection of human health, patient safety and animal health, the environment, ethics, quality of products, food and feed safety and biosecurity. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the establishment of a framework for the recognition of, and support measures for, health biotechnology strategic projects and high impact health biotechnology strategic projects; | (a) the establishment of a framework for the recognition of, and support measures for, biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high-impact biotechnology strategic projects; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) novel health biotechnology products and regulatory sandboxes to support innovation and take into account technological and scientific developments and progress; | (b) novel biotechnology products and regulatory sandboxes to support innovation and take into account technological and scientific developments and progress; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the support to promoters of biotechnology projects, SMEs, start-ups and scale-ups and non-profit developers of biotechnology products, by establishing an EU Health Biotechnology Support Network; | (c) the support to promoters of biotechnology projects, SMEs, start-ups and scale-ups and non-profit developers of biotechnology products, by establishing an EU Biotechnology Support Network; |
| Text proposed by the Commission | Amendment |
|---|---|
| (f) the application in a facilitated manner of advanced technologies, including AI in biological applications, into the Union’s health biotechnology ecosystems, while monitoring and mitigating, in line with the Union harmonisation legislation on AI, biological risks arising from the use of such technologies; | (f) the application in a facilitated manner of advanced technologies, including, but not limited to, AI in biological applications, into the Union’s biotechnology ecosystems, while monitoring and mitigating, in line with the Union harmonisation legislation on AI, biological risks arising from the use of such technologies, including where such risks may result from advanced data-driven or automated approaches, and the reduction of fragmentation and the improvement of coordination across the Union market for biotechnology products, in particular in the area of health; |
| Text proposed by the Commission | Amendment |
|---|---|
| (g) the placing on the market in particular of health biotechnology products and biotechnology services in accelerated and streamlined procedures; | (g) the placing on the market in particular of biotechnology products and biotechnology services in accelerated and streamlined procedures; |
| Text proposed by the Commission | Amendment |
|---|---|
| (h) the prevention of the misuse of biotechnologies and the strengthening of biodefence capabilities, without prejudice to, and in complementarity with, activities financed under any defence related Union funding programmes and instruments. | (h) the prevention of the misuse of biotechnologies and the strengthening of biodefence capabilities, without prejudice to, and in complementarity with, activities financed under any defence related Union funding programmes and instruments, including the mitigation of risks arising from emerging biotechnological and technological approaches. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. This Regulation does not affect the application of Directive 2010/63/EU on the protection of animals used for scientific purposes and of Regulation (EU) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). | 5. This Regulation does not affect the application of Directive 2010/63/EU on the protection of animals used for scientific purposes and of Regulation (EU) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), while supporting, where scientifically appropriate, the development, validation, regulatory acceptance and uptake of New Approach Methodologies (NAMs) in biotechnology research, development, risk assessment and clinical trial processes. |
| Text proposed by the Commission | Amendment |
|---|---|
| (1) ‘biotechnology’ means the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, products and services; | (1) ‘biotechnology’ means the research and application of science and technology to living organisms, as well as parts, products, processes and models thereof, to alter living or non-living materials for the production of knowledge, goods, products, processes and services; |
| Text proposed by the Commission | Amendment |
|---|---|
| (3) ‘biotechnology product’ means any good, technology or activity resulting from the application of biotechnology, including any process, action, technique, tool or knowledge involving biotechnology; | (3) ‘biotechnology product’ means any good, technology or activity resulting from the application of biotechnology, including any process, action, technique, tool or knowledge involving biotechnology or hybrid derivatives and applications thereof; |
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) ‘advanced biomanufacturing technology’ means a manufacturing method, platform, process or system used in the development or production of health biotechnology products, which by virtue of its novelty or novel application of an established technology has the potential to substantially improve manufacturing robustness, efficiency, scalability, sustainability or supply resilience within the Union; |
| Text proposed by the Commission | Amendment |
|---|---|
| (5) ‘biomanufacturing’ means the production of biotechnology products at a commercial scale; | (5) ‘biomanufacturing’ means the use of biological systems or materials, living organisms, cells, enzymes, biological materials or biotechnology-enabled processes, alone or in combination with other technologies, for the production of goods, materials, substances, components, products or solutions; |
| Text proposed by the Commission | Amendment |
|---|---|
| (7) ‘project promoter’ means any undertaking or consortium of undertakings developing a health biotechnology strategic project referred to in Article 3 or a high impact health biotechnology strategic project referred to in Article 4; | (7) ‘project promoter’ means any undertaking or consortium of undertakings developing a biotechnology strategic project referred to in Article 3, a high impact biotechnology strategic project referred to in Article 4 or a Pan-European high impact biotechnology strategic project referred to in Article 4a; |
| Text proposed by the Commission | Amendment |
|---|---|
| (8) ‘permit-granting process’ means a process that covers all relevant permits to build, expand, convert and operate health biotechnology strategic projects and high impact health biotechnology strategic projects, including building permits and environmental assessments and authorisations where required, and encompassing all applications and procedures from the acknowledgement that the application for such permits is complete to the notification of the decision on the outcome of the procedure by the single point of contact concerned; | (8) ‘permit-granting process’ means a process that covers all relevant permits to build, expand, convert and operate biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high-impact biotechnology strategic projects, including building permits and environmental assessments and authorisations where required, and encompassing all applications and procedures from the acknowledgement that the application for such permits is complete to the notification of the decision on the outcome of the procedure by the single point of contact concerned; |
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) ‘small mid-cap enterprise (SMC)’ means a small mid-cap enterprise within the meaning of Commission Recommendation (EU) 2025/1099; |
| Text proposed by the Commission | Amendment |
|---|---|
| (19a) ‘One Health’ means One Health as defined in Article 3, point (7), of Regulation (EU) 2022/2371 of the European Parliament and of the Council; |
| Text proposed by the Commission | Amendment |
|---|---|
| (24) ‘benchtop nucleic acid synthesis equipment’ means any equipment that allows a user to synthesise nucleic acids individually or in a core research facility. | (24) ‘benchtop nucleic acid synthesis equipment’ means any equipment that allows a user to synthesise nucleic acids individually or in a core research facility, and that is capable of producing or assembling double-stranded nucleic acid fragments of at least 200 base pairs with high sequence fidelity. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) ‘legitimate need’ in a biotechnology product of concern means the need for such biotechnology for legitimate and peaceful purposes, including handling, production, cultivation, experimentation, preservation, destruction, internal transport, by a legitimate member of the scientific community or a legitimate enterprise, consistent with applicable international treaties, laws, standards and oversight; | (c) ‘legitimate need’ in a biotechnology product of concern means the need for such biotechnology for legitimate and preventative, protective, or other peaceful purposes, including handling, production, cultivation, experimentation, preservation, destruction, internal transport, by a legitimate member of the scientific community or a legitimate enterprise, consistent with applicable international treaties, laws, standards and oversight; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) ‘suspicious transaction’ means any transaction concerning biotechnology products of concern for which there are reasonable grounds, taking into account all relevant factors, to doubt the legitimacy of the prospective customer’s intentions. | (d) ‘suspicious transaction’ means any transaction concerning biotechnology products of concern for which there are reasonable grounds, taking into account all relevant factors, to doubt the legitimacy of the prospective customer’s intentions, institutional affiliation or destination, including, where relevant, indicators set out in Article 46(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (da) 'sequence screening’ means the process by which an economic operator or a benchtop nucleic acid synthesis device assesses a requested or synthesised nucleic acid sequence, in accordance with guidance pursuant to Article 54, to determine whether the sequence presents a biosecurity risk; |
| Text proposed by the Commission | Amendment |
|---|---|
| UNION HEALTH BIOTECHNOLOGY AND BIOMANUFACTURING | UNION BIOTECHNOLOGY AND BIOMANUFACTURING |
| Text proposed by the Commission | Amendment |
|---|---|
| Recognition of health biotechnology strategic projects in the Union | Recognition of Biotechnology strategic projects in the Union |
| Text proposed by the Commission | Amendment |
|---|---|
| Health biotechnology strategic projects | Biotechnology strategic projects |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. To enable access to the support measures laid down in Section 2 of Chapter II, Member States shall recognise projects located in the Union, by means of a reasoned decision, as health biotechnology strategic projects if they make a substantial contribution to at least one of the following specific objectives: | 1. The general objectives of strategic projects are to contribute to reducing fragmentation, in particular regulatory fragmentation, increasing manufacturing capacity, stimulate innovation facilitating cross-border collaboration, and the circulation of research, innovation, knowledge and data within the Union. To enable access to the support measures laid down in Section 2 of Chapter II, Member States shall recognise projects located in the Union as biotechnology strategic projects particularly in the area of health, if they make a contribution to at least one of the following specific objectives: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) strengthening the industrial capacity and value chains in the health biotechnology sector, through one or more of the following activities: | (a) strengthening the industrial capacity and value chains in the biotechnology sector, particularly in the area of health, through one or more of the following activities: |
| Text proposed by the Commission | Amendment |
|---|---|
| (ii) creating new, or significantly expanding, production facilities for biotechnology products, in particular in biotechnology sectors where such facilities do not exist or where they are limited, including for biosimilars; | (ii) creating new, or significantly improving or expanding, production facilities for biotechnology products, in particular in biotechnology sectors where such facilities do not exist or where they are limited, including for biosimilars; |
| Text proposed by the Commission | Amendment |
|---|---|
| (iii) creating or upgrading industrial scale biomanufacturing sites with innovative, sustainable, safe and digitally enabled processes and technologies; | (iii) Creating, improving or upgrading industrial scale biomanufacturing sites with innovative, sustainable, safe and digitally enabled processes and technologies, including process innovation, new technologies, modernisation, digitalisation or decarbonisation of production and manufacturing processes, including production capabilities via Contract and Development Manufacturing Organisations; |
| Text proposed by the Commission | Amendment |
|---|---|
| (iv) reducing dependencies on third-country suppliers for key biotechnology inputs and intermediates; | (iv) reducing dependencies on third-country suppliers and contribute to supply-chain resilience for key biotechnology inputs and intermediates; |
| Text proposed by the Commission | Amendment |
|---|---|
| (va) establishing demonstrable and structured long-term cooperation between academia, research institutions, large industrial actors and small and medium-sized enterprises, start-ups or scale-ups, which may include systematic spin-out or spin-in programmes, early-stage licensing frameworks, or co-development activities that anchor innovation within the Union’s industrial base. |
| Text proposed by the Commission | Amendment |
|---|---|
| (vb) promoting synergies between civil and defence-related research and innovation in biotechnology, where appropriate, in order to strengthen resilience, preparedness and biodefence capabilities in the Union, including in relation to health threats; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) scaling-up or upgrading critical research and technology infrastructures underpinning the development, testing and validation of health biotechnology products, including but not limited to pilot or testing infrastructures for biomanufacturing, data and digital platforms, through one or more of the following activities: | (b) scaling-up or upgrading critical research and technology infrastructures underpinning the development, testing and validation of biotechnology products, particularly in the area of health, including but not limited to pilot or testing infrastructures for biomanufacturing, data and digital platforms, including infrastructures for the development, validation, standardisation and uptake of NAMs, where relevant, through one or more of the following activities: |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) establishing, expanding or upgrading pilot, testing and demonstration infrastructures linking research, development, validation and industrial deployment capacities for biotechnology products and processes; or | (i) establishing, improving, expanding or upgrading pilot, testing and demonstration infrastructures linking research, development, validation and industrial deployment capacities for biotechnology products and processes; or |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) accelerating innovation and technology deployment in health biotechnology through one or more of the following activities: | (c) accelerating innovation and technology deployment in biotechnology, particularly in the area of health, through one or more of the following activities: |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) introducing or scaling up breakthrough innovations in biotechnology that have the potential to strengthen the Union’s industrial competitiveness, including AI-enabled technologies and tools; | (i) introducing or scaling up breakthrough innovations in biotechnology that have the potential to strengthen the Union’s industrial competitiveness, including NAMs and AI-enabled technologies and tools; |
| Text proposed by the Commission | Amendment |
|---|---|
| (iiia) promoting the development, validation or qualification and regulatory acceptance of NAMs, with a view to replacing animal use in biotechnology research, development and safety assessment; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) addressing talent and skills needs or preventing shortages of talent and skills critical to all kinds of jobs in support of the strengthening of the health biotechnology and biomanufacturing sectors, and supporting the creation and maintenance of quality jobs in the EU through one or more of the following activities: | (d) addressing talent and skills needs or preventing shortages of talent and skills critical to all kinds of jobs in support of the strengthening of the biotechnology and biomanufacturing sectors, particularly in the area of health, and supporting the creation and maintenance of quality jobs in the EU through one or more of the following activities: |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) attracting and retaining talent in the Union and aiming to provide adequate upskilling or reskilling opportunities covering the broad range of skills required for biotechnology and biomanufacturing, including technical skills, data science, AI, intellectual property and project management, and entrepreneurial skills, through activities including apprenticeships, traineeships, continuing education and training, in close cooperation with regional and local authorities, education and training institutions, businesses and social partners; | (i) attracting and retaining talent in the Union and aiming to provide adequate upskilling or reskilling opportunities covering the broad range of skills required for biotechnology and biomanufacturing, including technical skills, data science, AI, intellectual property and project management, and entrepreneurial skills, non-animal science, lifelong learning, cross-border training schemes, clinical and regulatory science training, and pathways supporting the transition from academia to company building; |
| Text proposed by the Commission | Amendment |
|---|---|
| (iiia) supporting the development of interdisciplinary curricula and training programmes linking biotechnology, biomanufacturing, clinical research, regulatory science, data science, AI, ethics, intellectual property, technology transfer and entrepreneurship; |
| Text proposed by the Commission | Amendment |
|---|---|
| (iiib) supporting training models developed by European Reference Networks (ERNs), centres of excellence, universities, vocational education and training providers and clinical research networks, in particular where they contribute to addressing skills shortages in rare diseases, advanced therapies and other areas of unmet medical need. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ea) deploying a manufacturing technology designated pursuant to Article 6a within Union production facilities, where the project makes a contribution to at least one of the objectives set out in points (i) to (iv) of Article 6a. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The projects referred to in paragraph 1 may be located on the territory of two or more Member States. | 2. The projects referred to in paragraph 1 may be located on the territory of one or more Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| High impact health biotechnology strategic projects | High impact biotechnology strategic projects |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. To enable access to the support measures laid down in Section 2 of Chapter II, projects located in the Union fulfilling the criteria to be recognised as health biotechnology strategic projects, which demonstrate by virtue of their scale, scope or cross-border relevance, a strong systemic and catalytic potential within the Union’s biotechnology ecosystem to accelerate innovation and enhance the translation of research into market applications shall be recognised by the Commission as high impact health biotechnology strategic projects, including in the following cases: | 1. To enable access to the support measures laid down in Section 2 of Chapter II, projects located in the Union fulfilling the criteria to be recognised as biotechnology strategic projects, particularly in the area of health, which demonstrate by virtue of their scale, scope or cross-border relevance, a strong systemic and catalytic potential within the Union’s biotechnology ecosystem to accelerate innovation, enhance cooperation between large industrial undertakings and SMCs, SMEs, start-ups or scale-ups and enhance the translation of research into market applications shall be recognised by the Commission as high impact biotechnology strategic projects, including in the following cases and guided by: |
| Text proposed by the Commission | Amendment |
|---|---|
| (ea) the project supports cross-border impact and contributes to reducing fragmentation in the Union’s biotechnology ecosystem, in line with the objectives set out in Article 3(1); |
| Text proposed by the Commission | Amendment |
|---|---|
| (eb) the project contributes to ecosystem multiplier effects, including the capacity to connect research, industry, clinical, regulatory, manufacturing, data and financing actors, in line with Articles 3(1) and 20(3); |
| Text proposed by the Commission | Amendment |
|---|---|
| (ec) the project contributes to a resilient biotechnology and biomanufacturing capacity, in line with Article 3(1), point (a), and Articles 24 and 25; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ed) the project includes data and digital readiness, including interoperability, trustworthy AI and secure data infrastructures, in line with Articles 32 and 33; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ee) the project contributes to the availability, security of supply, resilience, substitution, repurposing or development of therapeutic alternatives for critical medicines or medicinal products of common interest within the meaning of Regulation (EU) 2025/102 [Critical Medicines Act]; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. Where appropriate, the Commission may recognise groups of geographically concentrated high impact biotechnology strategic projects, including cross-border high impact biotechnology strategic projects, together with associated infrastructures, clinical centres, accelerators and manufacturing facilities, as constituting an EU Biotech Flagship Zone. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Commission may adopt implementing acts to detail the conditions set out in paragraph 1, to clarify in which cases a project is to be deemed to have a strong systemic and catalytic potential within the Union’s biotechnology ecosystem to accelerate innovation and enhance the translation of research into market applications. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2). | 2. The Commission shall adopt delegated acts to detail the conditions set out in paragraph 1, to clarify in which cases a project is to be deemed to have a strong systemic and catalytic potential within the Union’s biotechnology ecosystem to accelerate innovation and enhance the translation of research into market applications. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. These delegated acts shall be adopted in accordance with the procedure referred to in Article 64. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article4a | |
| Pan-European high impact biotechnology strategic projects | |
| 1. The Commission shall recognise a high impact biotechnology strategic project as a Pan-European high impact biotechnology strategic project where the project fulfils the conditions referred to in Article 4 and demonstrates exceptional cross-border relevance, systemic Union added value and the capacity to reduce fragmentation in the Union’s biotechnology ecosystem. | |
| 2. Member States may encourage participation in a Pan-European high-impact biotechnology strategic project. | |
| 3. For Pan-European high-impact biotechnology strategic projects in the area of health, the European Medicines Agency shall, within its mandate and in cooperation with the Commission, act as the scientific and regulatory coordination body. The Agency shall facilitate, where appropriate, early scientific and regulatory advice, a common regulatory roadmap, coordinated interaction with the Clinical Trials Coordination and Advisory Group, competent authorities of participating Member States, ethics bodies, health technology assessment bodies, interconnected and interoperable ERNs as referred to in Article 40a and relevant Union data infrastructures. | |
| 4. Member States that have participating companies in their jurisdiction shall cooperate with the Commission, the Agency and other participating Member States to avoid duplication, inconsistent information requests and unnecessary administrative delays, while preserving national, local or site-specific requirements under Union law. | |
| 5. Recognition under this Article shall not replace or modify any authorisation, assessment, certification, ethics review, pricing or reimbursement decision or compliance requirement under Union or national law. The coordinated procedure shall not lower applicable standards of quality, safety, efficacy, ethics, data protection, transparency, pharmacovigilance, food and feed safety, animal health, animal welfare or environmental protection. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union as high impact health biotechnology strategic projects in the form of biotechnology development accelerators, only where they comply with the conditions laid down in Article 4(1), and they fulfil at least three of the following conditions: | 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union as high impact biotechnology strategic projects, particularly in the area of health, in the form of biotechnology development accelerators, only where they comply with the conditions laid down in Article 4(1), and they fulfil at least two of the following conditions: |
| Text proposed by the Commission | Amendment |
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| (c) aim to support hands-on and work-based training programmes aligned with the Union’s skills and workforce development objectives in the biotechnology and biomanufacturing sectors or in relation to enabling technologies, such as digital technologies, with specific applicability in biotechnology and biomanufacturing; | (c) aim to support hands-on and work-based training programmes aligned with the Union’s skills and workforce development objectives in the biotechnology and biomanufacturing sectors or in relation to enabling technologies, such as non-animal and digital technologies, with specific applicability in biotechnology and biomanufacturing; |
| Text proposed by the Commission | Amendment |
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| (e) seek to engage in partnerships among industry, academia, and public authorities to ensure the integration of research, innovation, and training in biotechnology and biomanufacturing or their enabling technologies. | (e) seek to engage in structured long-term cooperation between academia, public authorities, large industrial actors and SMEs, start-ups or scale-ups, which may include co-development activities, early-stage licensing arrangements, shared access to infrastructure, joint talent development programmes, or systematic spin-out or spin-in mechanisms to ensure the integration of research, innovation, and training in biotechnology and biomanufacturing or their enabling technologies. |
| Text proposed by the Commission | Amendment |
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| 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union as high impact health biotechnology strategic projects in the form of centres of excellence for advanced therapies, including for advanced therapy medicinal products (ATMPs), only where they comply with the conditions laid down in Article 4[(1) and reinforce the Union’s capability in the area of advanced therapies, by fulfilling all of the conditions set out in paragraph 2 of this Article. | 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union as high impact biotechnology strategic projects in the form of centres of excellence for advanced therapies, including for advanced therapy medicinal products (ATMPs), only where they comply with the conditions laid down in Article 4[(1) and reinforce the Union’s capability in the area of advanced therapies, by fulfilling all of the conditions set out in paragraph 2 of this Article. Those centres of excellence may be structured, inter alia, as public institutions and their networks, including ERNs, joint ventures, public-private partnerships or deeply integrated partnerships between different entities. |
| Text proposed by the Commission | Amendment |
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| (b) provide or coordinate advanced infrastructures including downstream processing, delivery models and the manufacturing of therapies referred to in point (a); | (b) provide or coordinate advanced infrastructures including downstream processing, delivery models and the manufacturing of therapies referred to in point (a), including by making such manufacturing infrastructure accessible to other developers of advanced therapies, subject to appropriate safeguards for the protection of intellectual property and confidential business information; |
| Text proposed by the Commission | Amendment |
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| (d) establish structured cooperation among clinical centres, research organisations, industrial developers of biotechnology products, investors and regulators; | (d) establish structured cooperation among clinical centres, research organisations, industrial developers of biotechnology products, investors, regulators and, where relevant, ERNs. |
| Text proposed by the Commission | Amendment |
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| 2a. The Commission may issue guidance for the operational implementation of centres of excellence for advanced therapies, including for advanced therapy medicinal products. |
| Text proposed by the Commission | Amendment |
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| 2b. The centres referred to in paragraph 1 shall include structured and continuous regulatory science engagement, including through embedded regulatory support and expertise involving the European Medicines Agency, national competent authorities or designated regulatory bodies, in order to facilitate early dialogue, upstream regulatory learning and faster convergence of scientific, clinical and regulatory requirements, without affecting the independence of regulatory decision-making. |
| Text proposed by the Commission | Amendment |
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| 3. The Commission may adopt implementing acts to detail the conditions listed in paragraph 2 of this Article, with a view to ensure a consistent approach in their implementation across the Member States. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2). | 3. The Commission shall adopt delegated acts to detail the conditions listed in paragraph 2 of this Article, with a view to ensure a consistent approach in their implementation across the Member States. These delegated acts shall be adopted in accordance with the examination procedure referred to in Article 64. |
| Text proposed by the Commission | Amendment |
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| Article 6a | |
| Advanced Biomanufacturing Technology (ABT) Designation | |
| 1. The Commission may, upon application by a natural or legal person established in the Union, grant an Advanced Biomanufacturing Technology Designation (‘ABT Designation’) to a manufacturing technology used in the development or production of biotechnology products, including biological medicinal products for human use as defined in [reference to General Pharmaceutical Legislation]. | |
| 2. The Commission shall grant an ABT Designation where it determines that the manufacturing technology concerned: | |
| (a) incorporates a novel technology or a novel application of an established technology; | |
| (b) maintains or improves the quality, safety or robustness of the manufacturing process including through the use or validation of NAMs; and | |
| (c) contributes to at least one of the following objectives: | |
| (i) strengthening manufacturing capacity within the Union; | |
| (ii) enhancing security or resilience of supply; | |
| (iii) improving development, scalability, efficiency or production lead times; | |
| (iv) reducing environmental impact or improving resource efficiency. | |
| 3. An ABT Designation shall be valid throughout the Union and shall be granted for an indefinite period. | |
| 4. The Commission may suspend or withdraw an ABT Designation where: | |
| (a) it was granted on the basis of incorrect or incomplete information; | |
| (b) serious and substantiated concerns arise regarding the safety, quality or regulatory compliance of the designated technology; | |
| (c) the applicant requests its withdrawal; or | |
| (d) the initial conditions are not met anymore. | |
| 5. For the purposes of the assessment referred to in paragraph 2, the Commission shall request the opinion of the European Medicines Agency and, where relevant, the European Chemicals Agency and the European Food Safety Authority, within their respective mandates. Those bodies shall deliver their opinion within 60 days of receipt of the request. | |
| 6. The Commission shall adopt delegated acts granting ABT Designations. The Commission shall adopt its decision within 90 days of receipt of a complete application. That period may, where duly justified, be extended by 30 days. The Commission shall inform the applicant of any such extension and the reasons therefor. | |
| 7. Where a designated ABT is deployed in the development or production of health biotechnology products: | |
| (a) the Commission and the Union bodies referred to in paragraph 5 shall, within their respective mandates, facilitate prioritised access to scientific advice and technical guidance relating to the designated technology; | |
| (b) competent authorities and relevant Union bodies shall facilitate coordinated and, where appropriate, early-stage regulatory engagement relating to the deployment of the designated technology. | |
| (c) coordination and information exchange among competent authorities and relevant Union bodies shall be facilitated with a view to avoiding duplicative or inconsistent requests relating to the designated technology; | |
| (d) where applicable and without prejudice to Union law, site inspection outcomes from third countries with which the Union has concluded arrangements providing for mutual recognition or equivalence may be taken into account for the purposes of regulatory coordination concerning the designated technology. | |
| 8. The Commission shall record decisions granting, suspending or withdrawing an ABT Designation in the regulatory status repository referred to in Article 35. | |
| 9. The granting of an ABT Designation shall not constitute, replace or affect any authorisation, certification or compliance requirement under Union sectoral legislation and shall not modify the applicable safety, quality or regulatory requirements laid down in Union law. |
| Text proposed by the Commission | Amendment |
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| Designation of the competent authority responsible for assessing applications for recognition of health biotechnology strategic projects and high-impact health biotechnology strategic projects | Designation of the competent authority responsible for assessing applications for recognition of biotechnology strategic projects and high-impact biotechnology strategic projects |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Member States shall designate an authority (‘the designated authority’) responsible for assessing applications for recognition of health biotechnology strategic projects and high impact health biotechnology strategic projects. | 1. Member States shall designate an authority (‘the designated authority’) responsible for assessing applications for recognition of biotechnology strategic projects, in particular in the area of health, and high impact biotechnology strategic projects, in particular in the area of health. |
| Text proposed by the Commission | Amendment |
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| 2. Member States shall inform the Commission within six months from the entry into force of this Regulation of the authority designated pursuant to paragraph 1. | 2. Member States shall inform the Commission within three months from the entry into force of this Regulation of the authority designated pursuant to paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| Application for recognition of a health biotechnology strategic projects or a high impact health biotechnology strategic project | Application for recognition of a biotechnology strategic projects or a high impact biotechnology strategic project |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. An application for the recognition of a project as a health biotechnology strategic project or as a high impact health biotechnology strategic project shall be submitted by the project promoter to the designated authority referred to in Article 7 of a Member State on whose territory the project is located. | 1. An application for the recognition of a project as a biotechnology strategic project, in particular in the area of health, or as a high impact biotechnology strategic project, in particular in the area of health, shall be submitted by the project promoter to the designated authority referred to in Article 7 of a Member State on whose territory the project is located. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The application referred to in paragraph 1 of this Article shall contain the relevant evidence related to the fulfilment of the conditions laid down in Article 3 as regards health biotechnology strategic projects or in Article 4, as regards high impact health biotechnology strategic projects. | 2. The application referred to in paragraph 1 of this Article shall contain the relevant evidence related to the fulfilment of the conditions laid down in Article 3 as regards biotechnology strategic projects or in Article 4, as regards high impact biotechnology strategic projects. |
| Text proposed by the Commission | Amendment |
|---|---|
| Recognition by Member States of health biotechnology strategic projects | Recognition by Member States of biotechnology strategic projects |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The designated authority shall assess the application for the recognition of a project as a health biotechnology strategic project within one month of the receipt of the complete application and communicate a reasoned decision to the project promoter. The assessment process shall be fair and transparent. | 1. The designated authority shall assess the application for the recognition of a project as a biotechnology strategic project within one month of the receipt of the complete application and communicate a reasoned decision to the project promoter. The assessment process shall be fair and transparent. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The Commission may provide its opinion on the assessment of the biotechnology strategic project. Where a Member State rejects the application, the applicant shall have the right to submit the application to the Commission, which shall assess the application within 20 working days. The Commission’s assessment is without prejudice to the Member State’s decision. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where the designated authority concludes that the project fulfils the conditions of Article 3, it shall recognise the project as a health biotechnology strategic project. | 2. Where the designated authority concludes that the project fulfils the conditions of Article 3, it shall recognise the project as a biotechnology strategic project. |
| Text proposed by the Commission | Amendment |
|---|---|
| Recognition by the Commission of high impact health biotechnology strategic projects | Recognition by the Commission of high impact biotechnology strategic projects |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The designated authority shall assess the application for the recognition of a project as a high impact health biotechnology strategic project within one month of the receipt of the complete application and shall communicate its assessment report to the Commission. The assessment process shall be fair and transparent. | 1. The designated authority shall assess the application for the recognition of a project as a high impact biotechnology strategic project within one month of the receipt of the complete application and shall communicate its assessment report to the Commission. The assessment process shall be fair and transparent. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where the designated authority concludes that the project fulfils the conditions of Article 4, the Commission shall, by means of implementing acts, adopt a decision approving or rejecting the application for recognition referred to in paragraph 1 of this Article, based on the assessment referred to in that paragraph and taking into account the views of the Steering Group referred to in Article 20. | 2. Where the designated authority concludes that the project fulfils the conditions of Article 4, the Commission shall, within three months of that conclusion, by means of implementing acts, adopt a decision approving or rejecting the application for recognition referred to in paragraph 1 of this Article, based on the assessment referred to in that paragraph and taking into account the views of the Steering Group referred to in Article 20. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from Article 8 and to paragraphs 1 and 2 of this Article, a project may also be recognised as a high impact health biotechnology strategic project in the framework of calls for proposals launched under Union programmes for the purpose of identifying, selecting and funding such projects, in line with the basic acts setting up those programmes. | By way of derogation from Article 8 and to paragraphs 1 and 2 of this Article, a project may also be recognised as a high impact biotechnology strategic project in the framework of calls for proposals launched under Union programmes for the purpose of identifying, selecting and funding such projects, in line with the basic acts setting up those programmes. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall recognise a project as a high impact health biotechnology strategic project in the context of a call for proposals where it fulfils the conditions set out in Article 4(1) and the specific criteria set out in those calls, based on the evidence submitted by the applicant. | The Commission shall recognise a project as a high impact biotechnology strategic project in the context of an open call for proposals with regular cut-off dates where it fulfils the conditions set out in Article 4(1) and the specific criteria set out in those calls, based on the evidence submitted by the applicant. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The Commission shall adopt implementing acts laying down the format of the assessment report referred to in paragraph 1 of this Article and the procedural rules for the recognition of high impact health biotechnology strategic projects. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2). | 4. The Commission shall adopt delegated acts laying down the format of the assessment report referred to in paragraph 1 of this Article and the procedural rules for the recognition of high impact biotechnology strategic projects. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 64. |
| Text proposed by the Commission | Amendment |
|---|---|
| Support of health biotechnology strategic projects and high impact health biotechnology strategic projects | Support of biotechnology strategic projects and high impact biotechnology strategic projects |
| Text proposed by the Commission | Amendment |
|---|---|
| Single points of contact | Single point of contact |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Each Member State shall designate one or more authorities as single points of contact at the relevant administrative level to facilitate and coordinate the permit-granting process for health biotechnology strategic projects and high impact health biotechnology strategic projects and shall provide information on the general administrative support and the technical and financial support set out in this [Section] through a dedicated webpage. | 1. Each Member State shall designate one authority as a single point of contact at the relevant administrative level to facilitate and coordinate the permit-granting process for biotechnology strategic projects and high impact biotechnology strategic projects and shall provide information on the general administrative support and the technical and financial support set out in this [Section] through a dedicated webpage, including information on relevant Union-level support, cross-border cooperation opportunities and links with the EU Biotechnology Support Network referred to in Article 19. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The single point of contact shall be the sole point of contact for the project promoter during the permit-granting process and shall assist the project promoter in handling any administrative matter relevant to the permit-granting process. | 3. The single point of contact shall be the sole point of contact for the project promoter during the permit-granting process and shall assist the project promoter in handling any administrative matter relevant to the permit-granting process. Project promoters shall have the possibility to contact the relevant administrative unit, within the single point of contact, responsible for the tasks provided for in this Article. If the relevant administrative unit changes, it shall continue to fulfil its responsibilities set out in this paragraph until the project promoter has been notified of such a change. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The single point of contact shall direct project promoters to the relevant national and regional antennas of the EU Health Biotechnology Support Network referred to in Article 19. | 5. The single point of contact shall direct project promoters to the relevant national and regional antennas of the EU Biotechnology Support Network referred to in Article 19, and, where appropriate, facilitate coordination with relevant Union-level structures and bodies, including the European Medicines Agency, ERNs, Union research and data infrastructures, clinical trial networks and health technology assessment coordination structures. |
| Text proposed by the Commission | Amendment |
|---|---|
| 7. Member States shall promote the reuse of existing data, studies and authorisations in order to avoid duplication of procedures, reduce administrative burden and ensure consistency of decision-making. For that purpose, they shall ensure that, when assessing an application, competent authorities duly take into account all relevant studies, assessments and valid permits or authorisations already carried out or issued for the same project or its components, provided that they remain applicable and up to date. | 7. Member States shall promote the reuse of existing data, studies and authorisations in order to avoid duplication of procedures, reduce administrative burden and ensure consistency of decision-making. For that purpose, they shall ensure that, when assessing an application, competent authorities duly take into account all relevant studies, assessments and valid permits or authorisations already carried out or issued for the same project or its components, provided that they remain accessible, applicable and up to date, including where such data, studies, assessments, permits or authorisations have been generated or issued in another Member State or through relevant Union-level procedures, in accordance with applicable Union and national law. |
| Text proposed by the Commission | Amendment |
|---|---|
| 8. Member States shall ensure that the single points of contact and all authorities involved in the permit-granting process have a sufficient number of qualified staff and adequate resources. | 8. Member States shall ensure that the single points of contact and all authorities involved in the permit-granting process have a sufficient number of qualified staff and sufficient financial, technical and technological resources necessary for the effective performance of their tasks under this Regulation, |
| Text proposed by the Commission | Amendment |
|---|---|
| Priority status of health biotechnology strategic projects | Priority status of biotechnology strategic projects |
| Text proposed by the Commission | Amendment |
|---|---|
| Health biotechnology strategic projects shall be considered as contributing to the strengthening of the biomanufacturing capacity and to the supply resilience of biotechnology products in the Union and, therefore, shall be considered to be of public interest. | Biotechnology strategic projects shall be considered as contributing to the strengthening of the biomanufacturing capacity and to the supply resilience of biotechnology products in the Union and, therefore, shall be considered to be of public interest. |
| Text proposed by the Commission | Amendment |
|---|---|
| Health biotechnology strategic projects shall be deemed to contribute to the resilience objectives referred to in Article 14 of Regulation [Regulation on speeding-up environmental impact assessments – permitting regulation]. | Biotechnology strategic projects shall be deemed to contribute to the resilience objectives referred to in Article 14 of Regulation [Regulation on speeding-up environmental impact assessments – permitting regulation]. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. For the purposes of this Article, health biotechnology strategic projects shall be understood to cover also high impact health biotechnology strategic projects. | 2. For the purposes of this Article, biotechnology strategic projects shall be understood to cover also high impact biotechnology strategic projects. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. High impact health biotechnology strategic projects shall be considered to be of public interest and may be considered to have an overriding public interest with specific consideration given to the high impact strategic nature of such projects in accordance with Article 14 of Regulation [Regulation on speeding-up environmental impact assessments – permitting regulation ] and point I of the Annex to that Regulation. | 3. Biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high-impact biotechnology strategic projects shall be considered to be of public interest and may be considered to have an overriding public interest with specific consideration given to the high impact strategic nature of such projects in accordance with Article 14 of Regulation [Regulation on speeding-up environmental impact assessments – permitting regulation ] and point I of the Annex to that Regulation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Where a project is recognised as a health biotechnology strategic project, Member States shall grant that project the status of project with the highest national significance possible, where such a status exists in national law and shall ensure that the relevant process for permit-granting and the licensing procedures, including environmental assessments and spatial planning, are treated in the most rapid way possible in accordance with Union and national law and shall benefit from any accelerated procedures provided for in applicable Union and national law. | 4. Where a project is recognised as a biotechnology strategic project, Member States shall grant that project the status of project with the highest national significance possible, where such a status exists in national law and shall ensure that the relevant process for permit-granting and the licensing procedures, including environmental assessments and spatial planning, are treated in the most rapid way possible in accordance with Union and national law and shall benefit from any accelerated procedures provided for in applicable Union and national law. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Health biotechnology strategic projects shall also benefit, where applicable, from the tacit-approval in accordance with Article 14 and point II of the Annex to [COM Proposal 2025(984) for a Regulation on speeding-up environmental impact assessments – permitting regulation]. | 5. Biotechnology strategic projects shall also benefit, where applicable, from the tacit-approval in accordance with Article 14 and point II of the Annex to [COM Proposal 2025(984) for a Regulation on speeding-up environmental impact assessments – permitting regulation]. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The permit-granting process shall not exceed ten months for health biotechnology strategic projects, and eight months for high impact health biotechnology strategic projects, from the date of acknowledgement of the completeness of the permit application. In duly justified cases requiring complex procedures under Union or national legislation, such as in the case of multi-site or multi-purpose projects, the competent authority may extend the period by up to three additional months, provided that the reasons for such extension are communicated in writing to the project promoter. | 6. The permit-granting process shall not exceed six months for biotechnology strategic projects, and four months for high impact biotechnology strategic projects, from the date of acknowledgement of the completeness of the permit application. In duly justified cases requiring complex procedures under Union or national legislation, such as in the case of multi-site or multi-purpose projects, the competent authority may extend the period by up to one additional month, provided that the reasons for such extension are communicated in writing to the project promoter. |
| Text proposed by the Commission | Amendment |
|---|---|
| 8. No later than 45 days from the receipt of the permit-granting application, the single point of contact shall acknowledge that the application is complete or, if the project promoter has not sent all the information required to process the application, request the project promoter to submit a complete application without undue delay, specifying which information is missing. In the event that the submitted application is deemed to be incomplete for a second time, the single point of contact may, within 30 days of the second submission, make a second request for information. The single point of contact shall not request information in areas not covered in the first request for additional information and shall be entitled only to request further evidence to complete the identified missing information. The date of the acknowledgement of the completeness of the application from the single point of contact shall serve as the start of the permit-granting process for that particular application. | 8. No later than 15 days from the receipt of the permit-granting application, the single point of contact shall acknowledge that the application is complete or, if the project promoter has not sent all the information required to process the application, request the project promoter to submit a complete application without undue delay, specifying which information is missing. In the event that the submitted application is deemed to be incomplete for a second time, the single point of contact may, within 10 days of the second submission, make a second request for information. The single point of contact shall not request information in areas not covered in the first request for additional information and shall be entitled only to request further evidence to complete the identified missing information. The date of the acknowledgement of the completeness of the application from the single point of contact shall serve as the start of the permit-granting process for that particular application. |
| Text proposed by the Commission | Amendment |
|---|---|
| 9. All dispute resolution procedures, litigation, appeals and judicial remedies relating to health biotechnology strategic projects before any national court, tribunal or panel — including mediation or arbitration — shall be treated as urgent, to the extent that national law allows such urgency, and without prejudice to the normal rights of defence of individuals or local communities. Project promoters of health biotechnology strategic projects shall be able to avail themselves of such urgency procedures, where applicable. This shall include the dispute-settlement provision in accordance with Article 14 and point III of the Annex to the Regulation […][Regulation on speeding-up environmental impact assessments]. | 9. All dispute resolution procedures, litigation, appeals and judicial remedies relating to biotechnology strategic projects before any national court, tribunal or panel — including mediation or arbitration — shall be treated as urgent, to the extent that national law allows such urgency, and without prejudice to the normal rights of defence of individuals or local communities. Project promoters of biotechnology strategic projects shall be able to avail themselves of such urgency procedures, where applicable. This shall include the dispute-settlement provision in accordance with Article 14 and point III of the Annex to the Regulation […][Regulation on speeding-up environmental impact assessments]. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Upon request of a project promoter, Member States shall provide administrative support to biotechnology projects located on their territory, including health biotechnology strategic projects and high impact health biotechnology strategic projects and shall take all appropriate measures to facilitate their timely and effective implementation, including: | 1. Upon request of a project promoter, Member States shall provide administrative support to biotechnology projects located on their territory, including biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high-impact biotechnology strategic projects and shall take all appropriate measures to facilitate their timely and effective implementation, including: |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) support and facilitation of permitting and authorisation procedures; and | (b) support and facilitation of permitting and authorisation procedures; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) assistance to inform the public and those in the vicinity of the project with the aim of increasing public acceptance of the project; | (c) assistance to inform the public and those in the vicinity of the project with the aim of increasing public acceptance of the project; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) coordination between relevant national authorities in order to reduce unnecessary administrative delays for biotechnology strategic projects; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. High impact health biotechnology strategic projects shall benefit from priority access to the administrative support measures referred to in paragraph 1, | 2. High impact biotechnology strategic projects and Pan-European high impact strategic projects shall benefit from priority access to the administrative support measures referred to in paragraph 1, |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Member States shall provide online and in a centralised and easily accessible manner, information relevant to promoters of biotechnology projects, including health biotechnology strategic projects and high impact health biotechnology strategic projects covering at least the following elements: | 4. Member States shall provide online and in a centralised and easily accessible manner, information relevant to promoters of biotechnology projects, including biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high impact biotechnology strategic projects covering at least the following elements: |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the single points of contact referred to in Article 11; | (b) the single point of contact referred to in Article 11; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Without prejudice to Articles 107 and 108 TFEU, Member States may make use, where applicable, of the relevant frameworks for providing public support to health biotechnology strategic projects and high impact health biotechnology strategic projects, including national promotional banks and other relevant public support instruments, as provided for in Article 24, paragraphs (4), (5) and (6). Where public support is granted, Member States shall ensure that such support is coordinated with other support measures at Union or national level and is in line with applicable State aid rules. | 1. Without prejudice to Articles 107 and 108 TFEU, Member States may establish dedicated funding mechanisms for biotechnology strategic projects and make use, where applicable, of the relevant frameworks for providing public support to biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high impact biotechnology strategic projects , including national promotional banks and other relevant public support instruments, as provided for in Article 24, paragraphs (4), (5) and (6). Where public support is granted, Member States shall ensure that such support is coordinated with other support measures at Union or national level and is in line with applicable State aid rules. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Projects recognised as high impact health biotechnology strategic projects: | 2. Projects recognised as high impact biotechnology strategic projects and Pan-European high impact strategic projects: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) may be given particular consideration for Union financial support including in the form of blended financing, under Union programmes, funds and financial instruments and for national support as provided for in Article 25, if the basic regulations setting up such Union programmes allow it; | (a) shall be given priority and a fast-track procedure during the consideration for Union financial support including in the form of blended financing, under Union programmes, funds and financial instruments, and where appropriate for future Multiannual Financial Frameworks, and for national support as provided for in Article 25, if the basic regulations setting up such Union programmes allow it; |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Commission, in cooperation with the Member States and, where appropriate, with the Steering Group referred to in Article 20, shall take the following measures to support the implementation of health biotechnology strategic projects and of high impact health biotechnology strategic projects, including through the EU Health Biotechnology Support Network referred to in Article 19: | 3. The Commission, in cooperation with the Member States and, where appropriate, with the Steering Group referred to in Article 20, shall take the following measures to support the implementation of biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high impact biotechnology strategic projects, including through the EU Biotechnology Support Network referred to in Article 19: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) support project promoters in identifying funding opportunities at Union level, and facilitate the liaison between project promoters and investors; | (a) support project promoters in identifying and accessing relevant funding opportunities at Union and national level, and facilitate the liaison between project promoters and investors; |
| Text proposed by the Commission | Amendment |
|---|---|
| Networks of health biotechnology clusters | Networks of biotechnology clusters |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The Commission and the Member States shall promote and facilitate the cooperation and the establishment of networks among promoters of health biotechnology strategic projects, of high impact health biotechnology strategic projects and other relevant actors. A particular focus shall be placed on fostering cross-border synergies between regional and national health biotechnology clusters, and on supporting the networks constituted under the EU Competitiveness Coordination Tool pilot, in full compliance with EU competition law. | 1. The Commission and the Member States shall promote and facilitate the cooperation and the establishment of networks among promoters of biotechnology strategic projects, high impact biotechnology strategic projects, Pan-European high impact biotechnology strategic projects and other relevant actors. A particular focus shall be placed on fostering cross-border synergies between regional and national biotechnology clusters, and on supporting the networks constituted under the EU Competitiveness Coordination Tool pilot, in full compliance with EU competition law. Biotechnology clusters may support the consolidation and integration of research, clinical and data capacities across Member States, including through links with interoperable and interconnected ERNs and relevant disease registries, as well as, where appropriate, through alignment with and use of data infrastructures and services established under the European Health Data Space, in particular for the secure and interoperable access to and secondary use of electronic health data. |
| Text proposed by the Commission | Amendment |
|---|---|
| (fa) facilitate and support collaboration with clusters and partners at international level to ensure world-class excellence; |
| Text proposed by the Commission | Amendment |
|---|---|
| (fb) establish operational links with existing Union networks and infrastructures, including ERNs, European research infrastructures, cancer centres, EIT Knowledge and Innovation Communities and smart specialisation partnerships, where relevant. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The networks referred to in this Article may establish governance arrangements appropriate to their objectives and may, where necessary, constitute themselves as legal entities under Union law, as appropriate for the implementation of specific actions and investments. | 3. The networks referred to in this Article may establish governance arrangements appropriate to their objectives and may, where necessary, constitute themselves as legal entities under Union law, as appropriate for the implementation of specific actions and investments. Where relevant, strategic projects may establish interoperability and cooperation arrangements with existing Union networks, including ERNs, research infrastructures and cancer centres. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. The networks referred to in this Article may, where relevant, support cooperation between biotechnology clusters, hospitals, universities, research infrastructures, biobanks, patient registries, genomic initiatives, clinical research infrastructures and interconnected and interoperable ERNs, in particular for rare diseases, rare cancers, paediatric conditions and other complex diseases. Such cooperation shall aim to strengthen translational research, clinical trial readiness, patient recruitment, cross-border access to expertise and the development and deployment of advanced therapies across the Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The Steering Group referred to in Article 20 shall provide advice for the support of the federation and networking of biotechnology clusters. | 4. The Steering Group referred to in Article 20 shall provide advice for the support of the federation and networking of biotechnology clusters and may facilitate new and existing ways for data-sharing within the clusters and subsequently within the networks. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article15a | |
| Cross-border infrastructure and patient access | |
| 1. Promoters of high-impact biotechnology projects recognised under this Chapter may, in cooperation with the relevant ERNs, establish and scale Union-wide, interoperable infrastructures, including patient registries, genomic data repositories, and biobanks for rare diseases, in full compliance with Regulation (EU) 2025/327 of the European Parliament and of the Council on the European Health Data Space (EHDS). | |
| 2. These projects may also establish clear and simplified pathways for patient access to clinical trials and authorised treatments, in collaboration with national contact points for cross-border healthcare to facilitate the recognition of clinical assessments and reimbursement, in line with Directive 2011/24/EU. |
| Text proposed by the Commission | Amendment |
|---|---|
| Health biotechnology strategic projects and high impact health biotechnology strategic projects recognised in accordance with this Regulation that receive financial support in accordance with Union programmes shall offer open, non-discriminatory, transparent, and criteria-based access at market prices to their facilities, equipment, services and training programmes for users, including SMEs, start-ups and scale-ups and other industrial actors, research organisations or training institutions. | Biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high impact strategic projects recognised in accordance with this Regulation that receive financial support in accordance with Union programmes shall offer in proportion to the level of co-financing open, non-discriminatory, transparent, and criteria-based access at market prices to their facilities, equipment, services and training programmes for users, including SMEs, start-ups and scale-ups and other industrial actors, research organisations or training institutions. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) any safeguards necessary for the protection of security, confidentiality or economic-security interests, in particular those referred to in paragraph [3]. | (c) any safeguards necessary for the protection of intellectual property, security, confidentiality or economic-security interests, in particular those referred to in paragraph 3. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ea) emerging technologies and innovation trends, by identifying developments relevant to the Union biotechnology ecosystem, including potential impacts on value chains, competitiveness and strategic dependencies; |
| Text proposed by the Commission | Amendment |
|---|---|
| (eb) ERNs, by mapping their capacities, governance models, geographical coverage, patient access pathways, and identifying gaps in expertise and infrastructure for rare and complex diseases. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The strategic mapping shall be based on information from relevant Union bodies and agencies, and, where appropriate, industry stakeholders and research organisations. The Commission may request Member States to submit data necessary for this purpose, while ensuring the protection of confidential and commercially sensitive information. The Member States shall submit such data within 30 days from the request of the Commission. | 3. The strategic mapping shall be based on information from relevant Union bodies and agencies, and, where appropriate, industry stakeholders and research organisations, including existing Union and regulatory data repositories and dossiers, such as the European Medicines Verification System (EMVS), marketing authorisation and regulatory submission data, pharmacovigilance, manufacturing authorisation and inspection-related datasets. The Commission may request Member States to submit data necessary for this purpose, while ensuring the protection of confidential and commercially sensitive information. The Member States shall submit such data within 30 days from the request of the Commission. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The results of the strategic mapping shall be used for the following purposes: | 5. The strategic mapping shall be subject to a dynamic monitoring and may include, where relevant, clinical networks, ERNs, registries, biobanks and diagnostic infrastructures. The results of the strategic mapping shall be used for the following purposes: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) supporting the identification and prioritisation by the Member States and the Commission, as appropriate, of potential health biotechnology strategic projects and high impact health biotechnology strategic projects; | (a) supporting the identification and prioritisation by the Member States and the Commission, as appropriate, of potential biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high impact biotechnology strategic projects |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) informing the advice of the Steering Group on health biotechnology strategic projects and high-impact health biotechnology strategic projects and on initiatives supporting research, innovation, skills and industrial competitiveness in the biotechnology sector. | (c) informing the advice of the Steering Group on biotechnology strategic projects and high-impact biotechnology strategic projects and on initiatives supporting research, innovation, skills and industrial competitiveness in the biotechnology sector. |
| Text proposed by the Commission | Amendment |
|---|---|
| The provisions of this Regulation regarding the permit granting process, the priority status of health biotechnology strategic projects and of high impact health biotechnology strategic projects and support for such projects shall apply without prejudice to more favourable provisions laid down in other Union rules. | The provisions of this Regulation regarding the permit granting process, the priority status of biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high impact biotechnology strategic projects and support for such projects shall apply without prejudice to more favourable provisions laid down in other Union rules. |
| Text proposed by the Commission | Amendment |
|---|---|
| EU Health Biotechnology Support Network | EU Biotechnology Support Network |
| Text proposed by the Commission | Amendment |
|---|---|
| EU Health Biotechnology Support Network | EU Biotechnology Support Network |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The Commission shall set up, coordinate and support an EU Health Biotechnology Support Network (‘the Network’), consisting of national and regional antennas in the Member States (‘the antennas’). | 1. The Commission shall set up, coordinate and support an EU Biotechnology Support Network (‘the Network’), consisting of national and regional antennas in the Member States (‘the antennas’). |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Network shall assist and support the developers of health biotechnology products, in particular SMEs, start-ups and scale-ups, the promoters of biotechnology projects, including health biotechnology strategic projects and high impact health biotechnology strategic projects (‘project promoters’) in identifying the relevant applicable rules and funding, scaling-up and networking opportunities. | 2. The Network shall assist and support the developers of biotechnology products, in particular SMCs, SMEs, start-ups and scale-ups, the promoters of biotechnology projects, including biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high impact biotechnology strategic projects (‘project promoters’) in identifying the relevant applicable rules and funding, scaling-up and networking opportunities. |
| Text proposed by the Commission | Amendment |
|---|---|
| (-a) support the cross-border circulation of research, innovation, knowledge and data in biotechnology, in particular in the area of health, in line with the objective of strengthening the internal market, including through the development of a “fifth freedom” for research, innovation, knowledge, data and education including within the framework of the European Health Data Space; |
| Text proposed by the Commission | Amendment |
|---|---|
| (-aa) support cross-border clinical research and collaboration, including through interoperable and interconnected ERNs; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) provide information on the national and Union rules applicable to the development and placing on the market of health biotechnology products, including on the applicable authorisation procedures for health biotechnology products; | (a) provide information on the national and Union rules applicable to the development and placing on the market of biotechnology products, including on the applicable authorisation procedures for biotechnology products; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) information for the identification and use of the applicable regulatory frameworks and regulatory support mechanisms with regard to innovative health biotechnology products, as provided for in Article 34; | (b) information for the identification and use of the applicable regulatory frameworks and regulatory support mechanisms with regard to innovative biotechnology products, as provided for in Article 34; |
| Text proposed by the Commission | Amendment |
|---|---|
| (e) support project promoters in the identification of scaling up resources, including business support networks providing advice on commercial readiness of health biotechnology projects and testing and training facilities, state-of-the-art pilot plant facilities that simulate a real production environment, and relevant research and technology infrastructures across the Union, including technology centres, cutting-edge facilities, and data-sharing platforms to support the development and testing of health biotechnologies; | (e) support project promoters in the identification of scaling up resources, including business support networks providing advice on commercial readiness of biotechnology projects and testing and training facilities, state-of-the-art pilot plant facilities that simulate a real production environment, and relevant research and technology infrastructures across the Union, including technology centres, cutting-edge facilities, and data-sharing platforms to support the development and testing of biotechnologies; |
| Text proposed by the Commission | Amendment |
|---|---|
| (f) support biotechnology actors in the responsible and effective integration of AI, by providing sector-specific guidance and promoting best practices and standards for trustworthy AI, in coordination with the bodies established under Regulation (EU) 2024/1689, and by providing information and support, in particular to SMEs, start-ups and scale-ups; | (f) support biotechnology actors in the responsible and effective integration of AI, by providing sector-specific guidance and promoting best practices and standards for trustworthy AI, by providing information and support, in particular to SMCs, SMEs, start-ups and scale-ups, in coordination with the bodies established under Regulation (EU) 2024/1689 and the Agency in order to ensure consistency of available guidance; |
| Text proposed by the Commission | Amendment |
|---|---|
| (h) provide incubation, acceleration and mentorship programmes for biotechnology start-ups and scale-ups and connect project promoters with projects and initiatives that address skills and expertise needs in health biotechnology and biomanufacturing, including with testing, training and technical support facilities, and regional skills partnerships; | (h) provide incubation, acceleration and mentorship programmes for biotechnology start-ups and scale-ups and connect project promoters with projects and initiatives that address skills and expertise needs in biotechnology and biomanufacturing, including with testing, training and technical support facilities, and regional skills partnerships including cross-border partnerships; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ha) support talent attraction, retention and cross-border mobility in biotechnology, in particular in the area of health, including for specialised roles in clinical research, ERNs and rare disease research; |
| Text proposed by the Commission | Amendment |
|---|---|
| (hb) support developers in identifying pathways that facilitate timely patient access to innovative health biotechnology products, while maintaining high standards of quality, safety and scientific assessment; |
| Text proposed by the Commission | Amendment |
|---|---|
| (hc) support exchanges of best practices concerning patient-centred innovation, including approaches that facilitate access to innovative health biotechnology solutions addressing unmet medical needs; |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall select the members of the Network based on criteria made public pertaining to the expertise and capabilities required to fulfil the missions referred to in paragraph 3 of this Article, including to the ability to leverage, complement and strenghten existing national and European networks that support SMEs, start-ups and scale-ups, and innovators. | The Commission shall select the members of the Network based on criteria made public pertaining to the expertise and capabilities required to fulfil the missions referred to in paragraph 3 of this Article, including to the ability to leverage, complement and strengthen existing national and European networks that support SMCs, SMEs, start-ups and scale-ups, and innovators. Eligible members shall include national biotechnology industry associations, cluster and patient organisations and other relevant public or private sector bodies, provided they meet the published selection criteria, as well as where appropriate, specialist expertise on rare diseases, advanced therapies, AI, data, biomanufacturing and regulatory science, including ERN-nominated experts. |
| Text proposed by the Commission | Amendment |
|---|---|
| European Health Biotechnology Steering Group | European Biotechnology Steering Group |
| Text proposed by the Commission | Amendment |
|---|---|
| European Health Biotechnology Steering Group | European Biotechnology Steering Group |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The European Health Biotechnology Steering Group (the “Steering Group”) is hereby established. | 1. The European Biotechnology Steering Group (the “Steering Group”) is hereby established. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The Steering Group shall support the translation of research and innovation results into industrial deployment and market uptake in biotechnology, in particular in the area of health, including by promoting coordination between research, investment and demand-side measures, identifying barriers to scale-up and market creation in the Union, and ensuring coherence with the broader EU technology monitoring architecture. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The Steering Group may invite observers, including representatives of the industry, academia, ERNs, patient organisations, SMEs, social partners, EMA, HERA, the EIB Group and independent ethics and scientific experts. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. The Steering Group may establish a dedicated working group on Union biomanufacturing capacity to support mapping, identify key bottlenecks and supply chain vulnerabilities, and facilitate coordination between manufacturing capacity, clinical expertise and strategic investment priorities, in cooperation with Member States, HERA, EMA and relevant stakeholders, including industry. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4b. The Steering Group may establish a dedicated working group on biotechnology capital markets to support the coordination of Union, national and private financing for biotechnology, in cooperation with the European Investment Bank Group, national promotional banks and institutions, and relevant private and institutional investors. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) facilitate the exchange of information and best practices among Member States, the Commission, and relevant stakeholders in relation to the recognition and the implementation of health biotechnology strategic projects and high impact health biotechnology strategic projects; | (a) facilitate the exchange of information and best practices among Member States, the Commission, and relevant stakeholders in relation to the recognition and the implementation of biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high impact biotechnology strategic projects, by ensuring that the needs and perspectives of patients, including with regard to timely access to innovative health biotechnology products and services, are being taken into account; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) discuss, at least once a year, the progress in the recognition of health biotechnology strategic projects and high impact health biotechnology strategic projects and provide advice including to overcome systemic challenges faced by such projects; | (b) discuss, at least once a year, the progress in the recognition of biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high impact biotechnology strategic projects and provide advice including to overcome systemic challenges faced by such projects; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) discuss and coordinate funding for health biotechnology strategic projects, including high-impact health biotechnology strategic projects, without prejudice to the basic acts of the relevant Union programmes; this may include facilitating the liaison between project promoters and potential private and public investors, such as the European Investment Bank Group, national promotional banks and institutions and export credit agencies, to mobilise additional financing, including from private or venture capital sources; | (d) discuss and coordinate funding for biotechnology strategic projects, including high-impact biotechnology strategic projects, without prejudice to the basic acts of the relevant Union programmes; this may include facilitating the liaison between project promoters and potential private and public investors, such as the European Investment Bank Group, national promotional banks and institutions and export credit agencies, to mobilise additional financing, including from private or venture capital sources; |
| Text proposed by the Commission | Amendment |
|---|---|
| (da) facilitate coordination between the Commission, the EIB Group, national promotional banks and institutions and relevant implementing partners on portfolio-based financing for eligible biotechnology projects, in particular in the areas of rare diseases, orphan medicinal products and advanced therapy medicinal products, including through diversified investment portfolios, risk-sharing, credit enhancement, debt-based instruments and blended finance, while taking into account relevant clinical, scientific and infrastructure assets, including ERNs, patient registries, natural history data, biobanks, clinical research infrastructures, manufacturing capacity, stockpiling requirements and supply-chain constraints; |
| Text proposed by the Commission | Amendment |
|---|---|
| (e) provide its views regarding the recognition of a project as a high impact health biotechnology strategic project, in accordance with Article [10][(2)]; | (e) provide its views regarding the recognition of a project as a high impact biotechnology strategic project, in accordance with Article 10(2); |
| Text proposed by the Commission | Amendment |
|---|---|
| (fa) provide advice on biomanufacturing capacity gaps, supply chain dependencies, investment priorities, advanced therapy manufacturing, biosimilar manufacturing and the integration of manufacturing capacity with clinical expertise; |
| Text proposed by the Commission | Amendment |
|---|---|
| (fb) contribute to the identification of regulatory and practical barriers that unnecessarily delay the development and deployment of innovative health biotechnology products within the Union; |
| Text proposed by the Commission | Amendment |
|---|---|
| (fc) monitor the consistent application of the recognition criteria and support measures under this Regulation across Member States and provide guidance to ensure a coherent approach across the Union; |
| Text proposed by the Commission | Amendment |
|---|---|
| (fd) support regulatory convergence by identifying divergent national implementation practices, administrative bottlenecks and cross-framework regulatory challenges affecting biotechnology, particularly in the area of health, and by providing advice, best practices and recommendations to the Commission and Member States; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. To support the financing of, and investments in, companies and projects falling within the scope of this Regulation, the Commission, together with the European Investment Bank Group (EIBG) or other implementing partners, shall develop an EU Health Biotechnology investment pilot (‘the pilot). The pilot is established for an initial period of two years, after which it shall be reviewed. | 1. To support the financing of, and investments in, companies and projects falling within the scope of this Regulation, the Commission, together with the European Investment Bank Group (EIBG) or other implementing partners, shall develop an EU Health Biotechnology investment pilot (‘the pilot). The pilot is established for an initial period of two years, and shall be reviewed and prolonged based on the gaps of financing these specific objectives under the Next Multiannual Financial Framework for a minimum of 7 years with a view to assessing its effectiveness, the mobilisation of private and institutional capital, the adequacy of risk-sharing mechanisms and its possible continuation, scaling-up or integration into the European Biotechnology Scale-Up Fund (EBSF) referred to in Article 22a. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The pilot shall support the full lifecycle of companies and projects in the area of health biotechnology, including SMEs, start-ups and scale-ups through direct and indirect financing, other than direct equity operations, without prejudice to the basic acts to be agreed under the next Multiannual Financial Frameworks. It shall complement and be developed in a coordinated manner with other EU financing instruments. | 2. The pilot shall support the full lifecycle of companies and projects in the area of health biotechnology, including SMCs, SMEs, start-ups and scale-ups through direct and indirect financing, in addition to direct equity operations, without prejudice to the basic acts to be agreed under the next Multiannual Financial Frameworks. It shall complement and be developed in a coordinated manner with other EU financing instruments. |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) provide support to projects, SMEs, including start-ups and scale-ups, and mid-caps across the Union, which are providing solutions and developments that contribute to the objectives of this Regulation; | (b) provide support to projects, SMCs, SMEs, including start-ups and scale-ups, and mid-caps across the Union, which are providing solutions and developments that contribute to the objectives of this Regulation; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) anchor growth and manufacturing activities in the Union in order to gain or maintain strategic autonomy and resilience, as well as boost competitiveness of the sector; | (d) anchor growth and manufacturing activities in the Union in order to gain or maintain strategic autonomy and resilience, as well as boost competitiveness of the sector including for the deployment or integration of an Advanced Biomanufacturing Technology designated pursuant to Article 6a; |
| Text proposed by the Commission | Amendment |
|---|---|
| (e) mobilise private investments, including from institutional investors such as pension funds, and strengthen the availability of long-term risk finance for biotechnology companies established in the Union. Financial actors, including private institutional investors, shall be targeted by leveraging expertise in catalysing private capital and use appropriate risk-sharing mechanisms to achieve this objective; | (e) mobilise private investments, including from institutional investors such as pension funds, insurance undertakings and strengthen the availability of long-term risk finance for biotechnology companies established in the Union. Financial actors, including private institutional investors, shall be targeted by leveraging expertise in catalysing private capital and use appropriate risk-sharing mechanisms to achieve this objective, notably through investments in European venture capital and private equity funds, fund-of-funds structures that crowd in private capital, including through risk-sharing instruments linked to the European Biotechnology Scale-Up Fund (EBSF) referred to in Article 22a; |
| Text proposed by the Commission | Amendment |
|---|---|
| (f) assist early and growth-stage companies through blended and concessional finance, encompassing equity or debt operations, complementing the direct equity support provided by the European Innovation Council Fund and the Scale-Up Europe Fund under the Horizon Europe, including via the development of new products; | (f) assist early and growth-stage companies through blended and concessional finance, encompassing equity or debt operations, including through indirect financing mechanisms such as investments in venture capital and private equity funds, complementing the direct equity support provided by the European Innovation Council Fund and the Scale-Up Europe Fund under the Horizon Europe, including via the development of new products; |
| Text proposed by the Commission | Amendment |
|---|---|
| (fa) cooperate with the capital markets working group established under Article 21(5b), in particular on financing bottlenecks, investment gaps and strategic dependency risks; |
| Text proposed by the Commission | Amendment |
|---|---|
| Article22a | |
| European Biotechnology Scale-Up Fund (EBSF) | |
| 1. By ... [12 months from the date of entry into force of this Regulation], the Commission shall, together with the European Investment Bank Group, the European Investment Fund and, where appropriate, national promotional banks and institutions and other implementing partners, assess and, where appropriate, establish the EBSF to support the scaling-up, late-stage development, industrial deployment and manufacturing capacity of biotechnology companies and projects established or active in the Union. | |
| The EBSF shall be developed in complementarity with the pilot referred to in Article 22 and with relevant Union financing instruments, including the European Competitiveness Fund, InvestEU or successor programmes, the European Innovation Council, the Strategic Technologies for Europe Platform or successor instruments, and relevant public-private partnerships. It may combine resources from the Union budget, the European Investment Bank Group, national promotional banks and institutions, Member States and private and institutional investors. | |
| 3. The EBSF shall operate, where appropriate, as a fund-of-funds or equivalent investment structure designed to mobilise long-term risk-tolerant capital, including from pension funds, insurance undertakings and other long-term institutional investors, through appropriate risk-sharing mechanisms. | |
| 4. The EBSF shall pursue the following objectives: | |
| (a) increase the availability of late-stage venture, and scale-up financing for biotechnology companies and projects across the Union; | |
| (b) support the development, scaling in the Union of innovative biotechnology companies, technologies, manufacturing capacity; | |
| (c) mobilise private and institutional investment through appropriate risk-sharing mechanisms, where necessary to address market failures; | |
| 5. The governance of the EBSF shall ensure professional, independent and market-oriented investment decision-making, transparent reporting, as well as appropriate conflict-of-interest safeguards, in accordance with applicable Union law. | |
| 6. The Commission shall ensure that the EBSF is designed to crowd in private investment and avoid replacing private financing where such financing is available on appropriate terms. | |
| 7. By … [two years after the establishment of the EBSF], and every five years thereafter, the Commission shall report to the European Parliament and to the Council on the implementation of this Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union contributing to an EU biotechnology late-stage capital booster as high-impact health biotechnology strategic projects, only where in addition to the conditions laid down in Article [4][(1)], the projects facilitate access to capital markets in accordance with applicable law, and are led by private-sector operators or consortia, with the potential participation of market-infrastructure providers and investors. | 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union contributing to an EU biotechnology late-stage capital booster as high-impact biotechnology strategic projects, only where in addition to the conditions laid down in Article [4][(1)], the projects facilitate access to capital markets in accordance with applicable law, and are led by private-sector operators or consortia, with the potential participation of market-infrastructure providers and investors. |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) mobilising long-term capital and attracting private investment, including institutional investors, and through private markets, with credible commitments or structures that support liquidity and follow-on financing; | (b) mobilising long-term capital and attracting private investment, including institutional investors, and through private and public markets, with credible commitments or structures that support liquidity and follow-on financing and the development of specialised public market investors capable of supporting biotechnology companies through IPOs and subsequent capital raises; |
| Text proposed by the Commission | Amendment |
|---|---|
| (e) mobilising private capital through biotechnology accelerators and venture builders, including potential use of risk-sharing mechanisms. | (e) mobilising private capital through venture capital and private equity funds, as well as through biotechnology accelerators and venture builders that support company creation and early-stage development across all stages of company development, including early-stage and scale-up financing and through potential use of risk-sharing mechanisms. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Union programmes may support biotechnology as a strategic technology for the Union’s innovation capacity, sovereignty, resilience and leadership in line with the objectives set out in the Regulations establishing those Union programmes. | 1. Union programmes shall support biotechnology as a strategic technology for the Union’s innovation capacity, sovereignty, resilience and leadership in line with the objectives set out in the Regulations establishing those Union programmes. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Commission may adopt calls, windows or compartments for biotechnology and may establish instruments in the implementation of those programmes, funds and instruments, that support biotechnology companies, projects and initiatives falling within the scope of this Regulation, in line with the objectives and rules set out in the regulations establishing those programmes, funds and instruments. | 2. The Commission shall adopt calls, windows or compartments for biotechnology and shall establish instruments in the implementation of those programmes, funds and instruments, that support biotechnology companies, projects and initiatives falling within the scope of this Regulation, in line with the objectives and rules set out in the regulations establishing those programmes, funds and instruments. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Member States shall pursue the support as referred to in paragraph 4, including for health biotechnology strategic projects and high impact health biotechnology strategic projects, in the implementation at national level of the relevant Union programmes that are shared-management basic acts. | 5. Member States shall pursue the support as referred to in paragraph 4, including for biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high-impact biotechnology strategic projects , in the implementation at national level of the relevant Union programmes that are shared-management basic acts. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Where State aid instruments, designed in compliance with Union competition law and making use of related EU guidance, are used by Member States for the purpose of supporting the health biotechnology sector or parts thereof, Member States shall give particular consideration to high-impact health biotechnology strategic projects for support under such instruments. | 6. Where State aid instruments, designed in compliance with Union competition law and making use of related EU guidance, are used by Member States for the purpose of supporting the biotechnology sector or parts thereof, Member States shall give priority to high-impact biotechnology strategic projects and Pan-European high impact strategic projects for support under such instruments. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. The Commission, the EIB Group and relevant implementing partners shall assess the feasibility of portfolio-based and risk-sharing financing instruments for health biotechnology projects, including orphan medicines, advanced therapy medicinal products and rare disease pipelines, including in the framework of the EBSF referred to in Article 22a. Such instruments may include diversified project portfolios, credit enhancement mechanisms, debt-based instruments and blended finance. |
| Text proposed by the Commission | Amendment |
|---|---|
| Funding for high impact health biotechnology strategic projects | Funding for high impact biotechnology strategic projects and Pan-European high impact strategic projects |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. High impact health biotechnology strategic projects may be given particular consideration for financial support under Union funds, programmes and instruments in accordance with the objectives set out in the regulations establishing those funds, programmes and instruments. | 1. High impact biotechnology strategic projects and Pan-European high impact strategic projects may be given priority for financial support under Union funds, programmes and instruments in accordance with the objectives set out in the regulations establishing those funds, programmes and instruments. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where high impact health biotechnology strategic projects benefit from financial support under Union funds, programmes and instruments, in accordance with the respective legal bases and eligibility criteria of those funds, programmes and instruments, such support may be used in combination with financing from the European Investment Bank Group, from national promotional banks and institutions or from other development or public financial institutions, as well as in combination with financing from private-sector finance institutions and from public-sector or private-sector investors, including through public–public or public–private partnerships. | 2. Where high impact biotechnology strategic projects and Pan-European high-impact biotechnology strategic projects benefit from financial support under Union funds, programmes and instruments, in accordance with the respective legal bases and eligibility criteria of those funds, programmes and instruments, such support may be used in combination with financing from the European Investment Bank Group, from national promotional banks and institutions or from other development or public financial institutions, as well as in combination with financing from private-sector finance institutions and from public-sector or private-sector investors, including through public–public or public–private partnerships. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. When preparing and implementing the annual and multiannual work programmes of the relevant Union funds, programmes and instruments referred to in paragraph 1, the Commission may give particular consideration to actions supporting high-impact health biotechnology strategic projects. | 3. When preparing and implementing the annual and multiannual work programmes of the relevant Union funds, programmes and instruments referred to in paragraph 1, the Commission may give particular consideration to actions supporting high-impact biotechnology strategic projects. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The Commission shall ensure the coordination and the complementarity among the relevant Union funds, programmes and instruments that support actions under this Regulation, and shall provide strategic guidance for the implementation of such funds, programmes and instruments with regard in particular to the high impact health biotechnology strategic projects, including in cooperation with the Steering Group, referred to in Article 20, where appropriate. | 4. The Commission shall ensure the coordination and the complementarity among the relevant Union funds, programmes and instruments that support actions under this Regulation, and shall provide strategic guidance for the implementation of such funds, programmes and instruments with regard in particular to high impact biotechnology strategic projects and Pan-European high impact biotechnology strategic projects , including in cooperation with the Steering Group, referred to in Article 20, where appropriate. Such guidance may clarify the interlinkages of clinical, registry, biobank and ERN-linked infrastructures where they form part of a biotechnology strategic project. |
| Text proposed by the Commission | Amendment |
|---|---|
| Coordination of financing for health biotechnology strategic projects | Coordination of financing for biotechnology strategic projects |
| Text proposed by the Commission | Amendment |
|---|---|
| The Steering Group referred to in Article 20 may coordinate investments into health biotechnology strategic projects, including high impact health biotechnology strategic projects, with the project promoters and other relevant interested parties, in compliance with Union competition law. | The Steering Group referred to in Article 20 may coordinate investments into biotechnology strategic projects, including high impact biotechnology strategic projects and Pan-European high impact strategic projects, with the project promoters and other relevant interested parties, in compliance with Union competition law. |
| Text proposed by the Commission | Amendment |
|---|---|
| Guidance on the deployment and use of systems based on advanced technologies, including AI, in the lifecycle of medicinal products | Guidance on the deployment and use of systems based on advanced technologies, including AI and NAMs, in the lifecycle of medicinal products |
| Text proposed by the Commission | Amendment |
|---|---|
| The Agency shall publish and regularly update, as appropriate, non-binding guidance on the deployment and use of systems based on advanced technologies, including AI, in the lifecycle of medicinal products development, including during pre-clinical research, clinical development and trials, manufacturing and post-authorisation monitoring. | The Agency shall publish and regularly update, as appropriate, non-binding guidance on the deployment and use of systems based on advanced technologies, including AI and NAMs, in the lifecycle of medicinal products development, including during pre-clinical research, clinical development and trials, manufacturing and post-authorisation monitoring. Such guidance shall, where appropriate, address the use of real-world data, registries and observational evidence in the development, validation and deployment of such systems, with appropriate safeguards against bias and with meaningful human oversight. |
| Text proposed by the Commission | Amendment |
|---|---|
| Such guidance shall ensure full coherence with the requirements laid down in Regulation (EU) 2024/1689 and with any guidance issued under that Regulation regarding general-purpose AI models or AI systems. | AI guidance shall ensure full coherence with the requirements laid down in Regulation (EU) 2024/1689 and with any guidance issued under that Regulation regarding general-purpose AI models or AI systems. |
| Text proposed by the Commission | Amendment |
|---|---|
| In developing and updating the guidance referred to in paragraph 1, the Agency shall consult the relevant authorities, at national and European level, and stakeholders as appropriate. | In developing and updating the guidance referred to in paragraph 1, the Agency shall consult the relevant authorities, at national and European level, and stakeholders including developers and users of AI, NAMs and other advanced technologies as appropriate. |
| Text proposed by the Commission | Amendment |
|---|---|
| To the extent that the guidance concerns the deployment and use of systems based on advanced technologies, including AI, across the clinical trials lifecycle, the Agency shall further cooperate with the Clinical Trials Coordination [and Advisory] Group (‘CTAG’) referred to in Article [85] of Regulation (EU) No 536/2014, with the Medical Device Coordination Group (‘MDCG’) referred to in Article 103 of Regulation (EU) 2017/745 and with the Artificial Intelligence Board referred to in Article 65 of Regulation (EU) 2024/1689, as appropriate and shall publish that guidance in agreement with the consulted entities referred to in this subparagraph. | To the extent that the guidance concerns the deployment and use of systems based on advanced technologies, including AI and NAMs, across the clinical trials lifecycle, the Agency shall further cooperate with the Clinical Trials Coordination [and Advisory] Group (‘CTAG’) referred to in Article [85] of Regulation (EU) No 536/2014, with the Medical Device Coordination Group (‘MDCG’) referred to in Article 103 of Regulation (EU) 2017/745 and with the Artificial Intelligence Board referred to in Article 65 of Regulation (EU) 2024/1689, as appropriate and shall publish that guidance in agreement with the consulted entities referred to in this subparagraph. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Agency shall develop and publish in agreement with the Commission, including the AI Office where appropriate, and in cooperation with the national competent authorities, non-binding guidance on the deployment and use of advanced technologies, including AI, in the procedures for the authorisation of medicinal products. | 3. The Agency shall develop and publish after consultation with stakeholders and in agreement with the Commission, including the AI Office where appropriate, and in cooperation with the national competent authorities, non-binding guidance on the deployment and use of advanced technologies, including AI, in the procedures for the authorisation of medicinal products. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union as high impact health biotechnology strategic projects in the form of trusted testing environments for advanced health biotechnology innovations, where such innovations are enabled, enhanced or significantly supported by AI or advanced computational methods, only where they comply with the criteria laid down in Article 4(1) and substantially strengthens the Union’s capacity for responsible experimentation, development, testing and validation of such innovations and they fulfils all of the following conditions: | 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union as high impact health biotechnology strategic projects in the form of trusted testing environments for advanced health biotechnology innovations, where such innovations are enabled, enhanced or significantly supported by AI and NAMs or advanced computational methods, only where they comply with the criteria laid down in Article 4(1) and substantially strengthens the Union’s capacity for responsible experimentation, development, testing and validation of such innovations and they fulfils all of the following conditions: |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) aim to enable innovation in biotechnology areas where the use of AI-enabled or computationally enhanced methods can be particularly impactful, such as enhancing efficacy and safety of immunology treatments and of ATMP gene therapies, or developing NAMs that combine advanced experimental and computational approaches; | (c) aim to enable innovation in biotechnology areas where the use of NAMs or AI-enabled or computationally enhanced methods can be particularly impactful, such as enhancing efficacy and safety of immunology treatments and of ATMP gene therapies, or developing NAMs that combine advanced experimental and computational approaches; including, where appropriate, for rare and ultra-rare diseases through interoperable registries, real-world data infrastructures and specialised clinical networks referred to in Article 40a, to support evidence generation, clinical utility validation and safeguards against bias; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) make available, under fair and transparent conditions, evidence, results and lessons learned generated within such testing environments, to inform Union guidance, standardisation and best-practice frameworks, and, where appropriate, the design or implementation of regulatory sandboxes in accordance with Union or national law. | (d) make available, under the conditions referred to in Article 16, evidence, results and lessons learned generated within such testing environments, to inform Union guidance, standardisation and best-practice frameworks, and, where appropriate, the design or implementation of regulatory sandboxes in accordance with Union or national law. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union as high impact health biotechnology strategic projects in the form of biotechnology data quality accelerators, only where they comply with the criteria laid down in Article 4(1) and fulfil the conditions laid down in paragraph 2 of this Article and they make a significant contribution to the curation, maintenance and responsible use of high-quality, appropriately annotated and provenance-verified datasets that are essential for the training, validation and testing of AI systems and models used in health biotechnology applications. | 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union as high impact biotechnology strategic projects in the form of biotechnology data quality accelerators, only where they comply with the criteria laid down in Article 4(1) and fulfil the conditions laid down in paragraph 2 of this Article and they make a significant contribution to the curation, maintenance and responsible use of high-quality, appropriately annotated and provenance-verified datasets that are essential for the training, validation and testing of AI systems and models used in biotechnology, particularly in the area of health applications. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) aim to foster the development and deployment of trustworthy and competitive AI systems in health biotechnologies, including large-scale and general-purpose models relevant for biological, biomedical or biomanufacturing use cases; | (a) aim to foster the development and deployment of trustworthy and competitive AI systems in biotechnologies, particularly in the area of health, including large-scale and general-purpose models relevant for biological, biomedical or biomanufacturing use cases; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ea) support, where appropriate, federated learning and other privacy-preserving data use models enabling the training, testing and validation of AI systems on distributed datasets, including clinically curated datasets and ERN-based registries, without requiring unnecessary centralised data movement; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Data quality accelerators supported under this Article shall, where relevant, promote Union-level coordination, interoperability and secure data sharing, in particular where fragmented or small patient populations require cross-border cooperation. |
| Text proposed by the Commission | Amendment |
|---|---|
| Entities that lawfully hold relevant datasets enhanced as provided for in paragraph 2, point (b) of this Article, shall make available such datasets under fair, reasonable and non-discriminatory conditions, ensuring equitable access for users including research organisations, SMEs and public institutions, under the conditions referred to in Article 16 of this Regulation. | Entities that lawfully hold relevant datasets enhanced as provided for in paragraph 2, point (b) of this Article, shall make available such datasets under fair, reasonable and non-discriminatory conditions, ensuring equitable access for users including research organisations, SMEs and public institutions, under the conditions referred to in Article 16 of this Regulation. In the context of rare and ultra-rare diseases, such access may support adaptive evidence generation, external control methodologies, regulatory assessment and health technology assessment. |
| Text proposed by the Commission | Amendment |
|---|---|
| Electronic health data referred to in Article 51 of Regulation (EU) 2025/327 shall be made available in accordance with that Regulation. | Electronic health data referred to in Article 51 of Regulation (EU) 2025/327 shall be made available in accordance with that Regulation including through transparent access conditions, proportionate fees and, where supported by Union funding, data use models that prioritise public value, scientific collaboration and fair access for SMCs, SMEs, start-ups and scale-ups. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Entities that lawfully hold relevant datasets enhanced as provided for in paragraph 2, point (b) of the Article, shall support, where appropriate, the integration of such datasets into Union infrastructures, including the European Research Area data spaces, data labs, AI factories and the infrastructures operated by high impact health biotechnology strategic projects. | 6. Entities that lawfully hold relevant datasets enhanced as provided for in paragraph 2, point (b) of the Article, shall support, where appropriate, the integration of such datasets into Union infrastructures, including the European Research Area data spaces, data labs, AI factories and the infrastructures operated by high impact health biotechnology strategic projects, including, where relevant, ERNs and associated cross-border rare-disease registries and evidence-generation infrastructures. |
| Text proposed by the Commission | Amendment |
|---|---|
| 7. The decision of the Commission regarding the recognition of a high impact health biotechnology strategic project in the form of a biotechnology data quality accelerators, referred to in Article 10(2), shall specify the modalities of processing of personal data necessary to achieve the purpose of the project. In particular the Commission shall specify the categories of data to be processed, the roles of the entities participating in the project, the categories of the entities which may use the curated data and the safeguards. | 7. The decision of the Commission regarding the recognition of a high impact health biotechnology strategic project in the form of a biotechnology data quality accelerators, referred to in Article 10(2), shall specify the modalities of processing of personal data necessary to achieve the purpose of the project. In particular the Commission shall specify the categories of data to be processed, the roles of the entities participating in the project, the categories of the entities which may use the curated data and the safeguards. Dataset access rules shall include equitable conditions for SMCs, SMEs, academic users and public-interest research. |
| Text proposed by the Commission | Amendment |
|---|---|
| 8a. The Commission shall, through the European Biotechnology Support Network and in cooperation with relevant Union initiatives, and building on existing Union programmes and resources, facilitate access for qualifying biotechnology SMEs, start-ups and scale-ups to federated data infrastructures, data quality accelerators, high-performance computing capacity, AI factories, testing environments and relevant advisory services. Such support may include, where appropriate, targeted assistance on data governance, interoperability, regulatory compliance, cybersecurity, AI implementation and ethics. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 33a | |
| European health biotechnology data coordination | |
| 1. The Commission shall, in cooperation with Eurostat, the European Medicines Agency, relevant Union bodies and agencies, Member States and, where appropriate, ERNs referred to in Article 40a, support Union-level coordination, interoperability, interconnectivity and availability of high-quality aggregated, statistical and, to the extent possible, reusable data relevant to biotechnology, particularly in the area of health, building on existing Union data infrastructures and governance frameworks, including the European Health Data Space established by Regulation (EU) 2025/327 and the European statistical system. | |
| 2. That coordination shall support the mapping, standardisation, linkage and reuse of relevant datasets, metadata and indicators, and the European Health Data Space, without duplicating existing reporting obligations or data-governance structures under Union law. | |
| 3. Particular attention shall be given to areas where small or fragmented patient populations require Union-level cooperation, in order to support responsible research, innovation, regulatory science and the development, training, validation and monitoring of AI systems and NAMs. | |
| 4. Eurostat shall establish and maintain a Union health biotechnology data dashboard providing comparable statistical information relevant to the implementation of this Regulation. | |
| 5.The Commission shall be empowered to adopt delegated acts in accordance with Article 64 to supplement this Regulation by specifying the detailed content, structure, indicators, reporting categories, update frequency, presentation format and interoperability and interconnectivity requirements of the dashboard referred to in paragraph 4. | |
| 6. Member States shall provide the statistical information referred to in paragraph 3 in accordance with the standardised templates and reporting methodologies established by the Commission. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The EU Health Biotechnology Support Network referred to in Article 19 shall, upon request, assist developers, in particular SMEs, start-ups and scale-ups, with identifying and using the appropriate regulatory procedural pathway and regulatory support mechanisms with regard to innovative health biotechnology products or biotechnology services for human use that exhibit characteristics that raise questions on the application or applicability of the Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) 2024/1938, Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] and Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 192 final] Regulation (EC) 1394/2007 and Directive 2010/45/EU. | 1. The EU Biotechnology Support Network referred to in Article 19 shall, upon request, assist developers, in particular SMEs, SMCs, start-ups and scale-ups, with identifying and using the appropriate regulatory procedural pathway and regulatory support mechanisms with regard to innovative biotechnology products or biotechnology services for human use that exhibit characteristics that raise questions on the application or applicability of the Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) 2024/1938, Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] and Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 192 final] Regulation (EC) 1394/2007 and Directive 2010/45/EU including by acting as a single regulatory window for preliminary cross-framework navigation where products, services or technologies interact with more than one Union regulatory framework. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) the interaction between regulatory procedural pathways under Union law on clinical trials, advanced therapy medicinal products, medical devices and in vitro diagnostic medical devices, chemicals, data protection, genetically modified organisms and other relevant health, safety and environmental rules; |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. In providing the support referred to in this Article, the EU Health Biotechnology Support Network referred to in Article 19 may request the assistance of the Foresight Panel for Emerging Health Innovation. | 4. In providing the support referred to in this Article, the EU Biotechnology Support Network referred to in Article 19 may request the assistance of the Foresight Panel for Emerging Health Innovation and, where appropriate, the relevant working groups and subgroups of the Steering Group referred to in Article 21. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) delegated acts adopted by the Commission pursuant to Article 6a granting, suspending or withdrawing an Advanced Biomanufacturing Technology Designation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Member States shall make publicly available, through the relevant national platforms or registries, decisions, opinions, scientific recommendations, and other outputs issued at national level concerning the regulatory status of health biotechnology products. Member States shall inform the Commission where such information is made available. | 3. Member States shall make publicly available, through the relevant national platforms or registries, decisions, opinions, scientific recommendations, and other outputs issued at national level concerning the regulatory status of health biotechnology products. Member States shall inform the Commission where such information is made available. Access restrictions shall be proportionate and shall not go beyond what is necessary to protect security, public health, biosecurity, data protection, intellectual property or economic security. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) conduct horizon scanning by analysing, identifying and discussing emerging science and technology with the potential to drive the development of health biotechnology products, including upon request from the Commission, the Agency, Union-level advisory bodies or competent authorities in the Member States in the area of health, and develop and publish related considerations in the form of discussion papers | (a) conduct horizon scanning by analysing, identifying and discussing emerging science and technology, in particular regarding NAMs and AI-driven tools, with the potential to drive the development of health biotechnology products, including, where relevant, in areas characterised by a major public health and persistent innovation gaps, upon request from the Commission, the Agency, Union-level advisory bodies or competent authorities in the Member States in the area of health, and develop and publish related considerations in the form of discussion papers |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks. The panel may invite external experts selected to assist with specific tasks when such relevant external expertise is needed. | 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the ERNs and other specialised cross-border clinical and research infrastructures, the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks. The panel may invite external experts selected to assist with specific tasks when such relevant external expertise is needed. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. Where the Foresight Panel identifies a significant regulatory gap or fragmentation risk, the Commission shall publish a response within 12 months, indicating whether it intends to issue guidance, propose implementing measures, establish sandbox rules or consider legislative review. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) promoting knowledge sharing, by facilitating the exchange of information, experiences and best practices, including on regulatory approaches, technological challenges, and emerging scientific insights and the appropriate regulatory responses (cross-framework knowledge sharing); | (a) promoting knowledge sharing, by facilitating the exchange of information, experiences and best practices, including on regulatory approaches, technological challenges, and emerging scientific insights and the appropriate regulatory responses and performance data on NAMs (cross-framework knowledge sharing); |
| Text proposed by the Commission | Amendment |
|---|---|
| Regulatory sandboxes for novel health biotechnology products not falling under other regulatory sandboxes in Union legislation in the area of health | Regulatory sandboxes for novel health biotechnology products not falling under other regulatory sandboxes in Union legislation particularly in the area of health |
| Text proposed by the Commission | Amendment |
|---|---|
| Upon a substantiated request from developers, the Commission may set up a regulatory sandbox that provides a controlled regulatory environment for the testing and development of a health biotechnology product, that: | Upon a substantiated request from developers, or from an ERN, the Commission may set up a regulatory sandbox that provides a controlled regulatory environment for the testing and development of a biotechnology product, particularly in the area of health that: |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. A regulatory sandbox under this Article shall remain exceptional, time-limited and case-specific. It shall maintain standards of evidence, patient safety, data protection, ethics, quality, efficacy or regulatory oversight applicable under Union law. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. Developers may, where relevant, draft a transition plan setting out the steps, applicable requirements, evidence needs and competent authorities involved in moving from the regulatory sandbox to full regulatory compliance, authorisation and where relevant, market access and post-marketing surveillance. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. When assessing the applications received in accordance with paragraph 3 of this Article and when developing and implementing the sandbox plan, the Commission may consult the Agency, the SCB, the MDCG, or the Foresight Panel, as appropriate. | 6. When assessing the applications received in accordance with paragraph 3 of this Article and when developing and implementing the sandbox plan, the Commission may consult the Agency, the SCB, the MDCG, or the Foresight Panel, as appropriate. Where the application concerns a novel therapy for a rare disease, in particular an advanced therapy medicinal product, the Commission shall also consult the relevant ERNs on the design, feasibility, and clinical relevance of the proposed sandbox. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 40a | |
| Interconnected and interoperable ERNs and other health networks | |
| 1. The Commission and the Member States shall support the further development of ERNs and other cross-border health networks as interconnected and interoperable clinical, research and data infrastructures contributing to a stronger European Health Union, in particular for rare diseases, rare cancers, complex conditions, advanced therapies and other areas of unmet medical need. | |
| 2. To that end, ERNs and other cross-border health networks shall, where appropriate and within their mandate, be linked with relevant Union infrastructures and processes, including the European Medicines Agency, the EU portal and EU database for clinical trials, the European Health Data Space, DARWIN EU, relevant biobanks, registries, genomic initiatives, clinical research infrastructures, health technology assessment cooperation and the Clinical Trials Coordination and Advisory Group, including its voluntary ethics coordination sub-group. | |
| 3. Such interoperability shall support clinical trial feasibility, patient identification and recruitment, clinical validation, post-authorisation evidence generation, assessment of unmet medical need, reuse of data, cross-border exchange of clinical expertise and reduction of duplicative administrative requirements, while fully respecting Union and national law on data protection, health data governance, cybersecurity, patient consent and patients’ rights. |
| Text proposed by the Commission | Amendment |
|---|---|
| (-1) The Commission shall establish the EU Biothreat Radar (hereinafter ‘the Radar’), as a Union-level mechanism to support the detection, identification, characterisation, analysis and assessment of biological threats, including threats arising from novel, unknown and engineered pathogens. The implementation of the Radar shall build, among others, on existing Union capacities and infrastructures established under Regulation (EU) 2022/2371, including surveillance, laboratory and early warning systems coordinated by the European Centre for Disease Prevention and Control (ECDC). |
| Text proposed by the Commission | Amendment |
|---|---|
| (-1a)– ECDC, in cooperation with the Commission and relevant Union agencies, shall support the scientific and technical coordination of the Radar. |
| Text proposed by the Commission | Amendment |
|---|---|
| (-1b)– The Commission, supported by ECDC, shall promote secure, interoperable and timely mechanisms for the exchange of surveillance, laboratory and risk assessment information relevant to the Radar. Such mechanisms shall support coordinated preparedness and response capacities while respecting applicable Union and national rules relating to confidentiality, data protection and security. The Commission shall be empowered to adopt delegated acts supplementing this Regulation as regards operational environment for the Radar data sharing in the context of cross-border surveillance of biological threats. |
| Text proposed by the Commission | Amendment |
|---|---|
| (-1c)– The Radar shall support cooperation between relevant Union and national actors involved in preparedness for biological threats, including public health authorities, laboratories, environmental authorities, food and feed authorities, research infrastructures and other relevant stakeholders. Where appropriate, cooperation may include structured technical exchanges with relevant Union bodies and agencies active in public health, civil protection, law enforcement and other preparedness-related domains, in accordance with their respective mandates. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. Where information generated by projects referred to in paragraph 5, or by threat assessments provided by relevant Union agencies or bodies, indicates a novel, unknown, or engineered pathogen, they shall notify the Commission and make available relevant data within 24 hours upon identification. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1b. Both assessments shall be carried out in coordination with Member States and relevant Union agencies and bodies and shall consider whether further action at Union level is necessary to ensure an effective biological threat response. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1c. Member States shall designate national contact points responsible for liaising with the Radar. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1d. Such cooperation shall be conducted in full compliance with applicable Union and national rules on confidentiality, classified information, data protection, and the protection of sensitive security-related information. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1e. The Commission shall lay down the procedures for the Radar, setting out the data standards, ensuring interoperability and interconnectivity, transmission intervals for Radar outputs, secure communication channels and procedures and criteria for the classification of pathogens as novel, unknown or engineered. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The outputs of the Radar shall, where relevant, inform preparedness and response actions, including the prioritisation of biodefence capability of high impact strategic projects related to vaccines in accordance with Article 42. |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) rapid surge capacity for safe sampling, testing sequencing and swift manufacturing of rapid diagnostics; | (b) rapid surge capacity for relevant medical countermeasures, including for vaccines, therapeutics, protective equipment, safe sampling, testing sequencing and swift manufacturing of rapid diagnostics; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) robust pathogen-agnostic pharmaceutical and non-pharmaceutical defences against biological threats; | (d) research, including translational research, and development to produce and validate robust pathogen-agnostic pharmaceutical and non-pharmaceutical defences against biological threats; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ea) promoting synergies between civil and defence-related research and innovation in biotechnology, where appropriate, in order to strengthen resilience, preparedness and biodefence capabilities, while ensuring compliance with applicable Union and international obligations; |
| Text proposed by the Commission | Amendment |
|---|---|
| (f) civilian and defence research, testing or demonstration infrastructures for biotechnology activities relevant to defence, security and resilience, provided that governance ensures clear separation of mandates and access regimes, with appropriate confidentiality and security safeguards, in line with relevant requirements arising from the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (‘BTWC’), Union and national law. | (f) civilian and defence research, including translational research, testing or demonstration infrastructures for biotechnology activities relevant to defence, health security, security and resilience, provided that governance ensures clear separation of mandates and access regimes, with appropriate confidentiality and security safeguards, in line with relevant requirements arising from the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (‘BTWC’), Union and national law; |
| Text proposed by the Commission | Amendment |
|---|---|
| (fa) rapid surge capacity for the development, manufacturing, quality control, batch release and distribution of vaccines necessary to respond to biological threats and serious cross-border threats to health; |
| Text proposed by the Commission | Amendment |
|---|---|
| (fb) secure, tiered and criteria-based access by eligible and vetted Union actors to advanced AI capabilities in biological applications, including general-purpose AI models, general-purpose AI models with systemic risk, general-purpose AI systems and AI systems. Such access shall contribute to strengthening Union preparedness, response and biodefence capabilities and to accelerating the research, including translational research, development, testing, validation or manufacturing of medical countermeasures. They shall be designed to prevent broader or uncontrolled access that could facilitate biological misuse. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 42a | |
| EU FAB | |
| The Commission may activate the Network of ever-warm Production Capacities for Vaccines and Therapeutics manufacturing (EU-FAB) facilities in order to make available reserved surge manufacturing capacities to ensure the delivery of relevant medical countermeasures to address any misuse of biotechnology. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Commission is empowered to adopt delegated acts in accordance with Article 64 (2) to amend Annex I by adding, removing or modifying categories of biotechnology products of concern, setting or adjusting thresholds or exclusions, and specifying technical parameters, in order to reflect developments in scientific evidence, biosecurity and biosafety risks or patterns of misuse, also considering the latest developments under relevant international fora and instruments. | 2. The Commission is empowered to adopt delegated acts in accordance with Article 64 (2) to amend Annex I by adding, removing or modifying categories of biotechnology products of concern, setting or adjusting thresholds or exclusions, and specifying technical parameters, in order to reflect developments in scientific evidence, biosecurity and biosafety risks or patterns of misuse, also considering the latest developments under relevant international fora and instruments. Amendments to Annex I pursuant to this paragraph shall be limited to technical updates necessary to reflect scientific and technological developments. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. This Section shall not apply to making available, acquisition, possession or use of biotechnology products of concern by the armed forces, law enforcement authorities, civil protection authorities, public health authorities or other competent public authorities of the Member States, in accordance with national law |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purposes of conducting the verification referred to in paragraph 1, the economic operator shall request the following information from the prospective customer prior to facilitating the exchange: | For the purposes of conducting the verification referred to in paragraph 1, the economic operator shall obtain and review the following information from the prospective customer prior to facilitating the exchange: |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) institutional or corporate affiliation; | (b) proof of institutional or corporate affiliation; |
| Text proposed by the Commission | Amendment |
|---|---|
| (da) delivery address of the product; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (db) where appropriate, information on the method of payment used for the transaction. |
| Text proposed by the Commission | Amendment |
|---|---|
| The first subparagraph, with the exception of transaction recording, shall not apply where the economic operator has conducted an equivalent verification for the same customer within the preceding five years and the new transaction does not significantly deviate in nature or scale from previous transactions. | The first subparagraph, with the exception of transaction recording, shall not apply where the economic operator has conducted an equivalent verification for the same customer and product within the preceding five years and the new transaction does not significantly deviate in nature or scale from previous transactions. |
| Text proposed by the Commission | Amendment |
|---|---|
| (e) documentation establishing the existence of suitable facilities, competencies and biosafety arrangements appropriate to the intended use. | (e) documentation establishing the existence of suitable facilities, competencies and biosafety and biosecurity arrangements appropriate to the intended use. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Each Member State shall set up at least one national contact point with clearly identified contact details, web form or other effective tool for the reporting of suspicious transactions of biotechnology products of concern. The contact point shall be part of or have direct links to law enforcement and national inspection authorities. | 3. Each Member State shall set up at least one national contact point with clearly identified contact details, web form or other effective tool for the reporting of suspicious transactions of biotechnology products of concern. The contact point shall be part of or have direct links to law enforcement and national inspection authorities. The Commission shall provide dedicated support to Member States in order to ensure the exchange of best practices regarding the establishment and scaling up of their capacities. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Economic operators and online marketplaces shall refuse a suspicious transaction. They shall report any suspicious transaction or attempted suspicious transaction within 24 hours of determining that it is suspicious. Reports shall include, where possible, the identity of the prospective customer and the facts that led to the suspicion and shall be addressed to the national contact point of the Member State where the transaction was concluded or attempted. | 4. Economic operators and online marketplaces shall refuse a suspicious transaction. They shall report any suspicious transaction or attempted suspicious transaction within 24 hours of determining that it is suspicious to the national contact point of the Member State, as specified in Article 46(3), where the transaction was concluded or attempted. Reports shall be based on the information collected pursuant to Article 44 and include the identity of the prospective customer and the facts that led to the suspicion. Information reported pursuant to this Article shall be handled by competent authorities, in accordance with applicable Union law on data protection and data governance. Competent authorities shall, where appropriate, provide feedback to reporting entities on the outcome or relevance of reported transactions. Reporting pursuant to this paragraph shall not affect the obligation of economic operators to retain transaction records in accordance with Article 44. The Commission shall, by means of guidance issued pursuant to Article 54, establish standard reporting templates to ensure consistent and complete reporting of suspicious transactions across Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Member States shall ensure the participation of national inspection authorities, as appropriate, in the relevant activities of the Steering Group, in particular for the exchange of information on implementation practices, inspection findings and emerging risks.Member States shall ensure risk-based audits of economic operators, verifying, in particular, the existence and effectiveness of screening mechanisms for legitimate need, record-keeping as provided for in Article [44][(6)] and detection of suspicious transactions and incidents, and response procedures. | 4. Member States shall ensure the participation of national inspection authorities, as appropriate, in the relevant activities of the Steering Group, in particular for the exchange of information on implementation practices, inspection findings and emerging risks. Member States shall adopt common ontologies and metadata standards to ensure that the results of national activities can be compared. Member States shall ensure risk-based audits of economic operators, verifying, in particular, the existence and effectiveness of screening mechanisms for legitimate need, record-keeping as provided for in Article [44][(6)] and detection of suspicious transactions and incidents, and response procedures. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. In fixing the amount of the fine or periodic penalty payment, regard shall be had to the nature, gravity and duration of the infringement, taking due account of the principles of proportionality and appropriateness. | 3. In fixing the amount of the fine or periodic penalty payment, regard shall be had to the nature, gravity and duration of the infringement, taking due account of the principles of proportionality and appropriateness. Member States shall consider the application of corrective measures and warnings prior to the imposition of fines for procedural infringements where there is no evidence of intentional misuse or deliberate disregard of applicable obligations. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Advisory Group shall provide independent scientific advice to the Commission on biosecurity risks arising from the rapid development of biotechnology, including from AI models as described in Regulation (EU) 2024/1689 in biological applications (‘AI models in biological applications’). It shall be selected and operate in accordance with the Commission’s framework for expert groups73 . | 2. The Advisory Group shall provide independent scientific advice to the Commission on biosecurity risks arising from the rapid development of biotechnology, including from AI models as described in Regulation (EU) 2024/1689 in biological applications (‘AI models in biological applications’) and research that advances toward the creation of mirror-reflected molecular building blocks as well as synthetic biology, gene-editing technologies, nucleic acid synthesis, biological materials and other emerging biotechnological or technological approaches with potential for misuse. It shall be selected and operate in accordance with the Commission’s framework for expert groups73 . |
| 73 Commission Decision establishing horizontal rules on the creation and operation of Commission expertgroups, C(2016)3301. | 73 Commission Decision establishing horizontal rules on the creation and operation of Commission expertgroups, C(2016)3301. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The Advisory Group shall also support cooperation between the Commission, Member States, competent authorities and relevant Union bodies on biosecurity risks linked to biotechnology products of concern, nucleic acid synthesis screening, dual-use risks, cyber-bio convergence and cross-border biosecurity incident preparedness. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2b. In carrying out the tasks referred to in paragraph 2a, the Advisory Group shall cooperate, where appropriate and within their respective mandates, with HERA, ECDC, ENISA, EMA, EDA, the AI Office, national competent authorities, relevant standard-setting bodies, ERNs and other cross-border health networks, academic experts, industry, civil society, SMEs, while ensuring independence, transparency and the prevention of conflicts of interest. |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) monitoring the capabilities and risk profile of AI models in biological applications throughout their life cycle; | (b) monitoring the capabilities and risk profile of AI models in biological applications identifying and assessing risks arising from the convergence of AI models and biological technologies, including cybersecurity and their potential implications for biosecurity and the misuse of biotechnology throughout their life cycle |
| Text proposed by the Commission | Amendment |
|---|---|
| (da) publish non-confidential summaries of its opinions, recommendations and principles adopted pursuant to paragraph 8, subject to appropriate protection of sensitive biosecurity information. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Advisory Group shall be composed of up to 25 globally leading independent experts appointed by the Commission based on their recognized expertise in the areas of biotechnology, biosecurity, biodefence and AI. | 6. The Advisory Group shall be composed of up to 25 globally leading independent experts appointed by the Commission based on their recognized expertise in the areas of biotechnology, biosecurity, biodefence and AI, including by five independent experts representing civil society. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The Commission shall monitor biological systemic risk from AI models in biological applications and propose mitigating actions, based on advice provided by the Advisory Group and in line with the Union harmonisation legislation on AI, including boosting biodefence capabilities or regulation, including on assessment and mitigation of systemic risk from those AI models, as appropriate. | 1. The Commission shall monitor biological systemic risk in biological applications, such as research that advances toward the creation of mirror-reflected molecular building blocks or stemming from AI models, and propose mitigating actions, based on advice provided by the Advisory Group and in line, inter alia, with the Union harmonisation legislation on AI, including boosting biodefence capabilities or regulation, including on assessment and mitigation of systemic risk from AI models, as appropriate. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a qualified alert is issued by the Advisory Group as referred to in Article 52(3), point (d), the Commission and the Member States shall take appropriate measures to ensure a proper control of risks. | 2. Where a qualified alert is issued by the Advisory Group as referred to in Article 52(4) or (5), the Commission and the Member States shall take appropriate measures to ensure a proper control of risks. Where appropriate measures include new obligations on economic operators, the Commission shall publish guidance on the expected scope and timeline of such measures and shall consult affected operators before implementation, except where the urgency of the biosecurity risk justifies immediate action, in which case the Commission shall provide written justification for the absence of prior consultation. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission, based on advice by the Advisory Group on Biosecurity, and where appropriate, in cooperation with the Steering Group, may issue and regularly update guidance, to assist actors in the supply chain and the competent authorities. The guidance may provide: | The Commission, based on advice by the Advisory Group on Biosecurity, and where appropriate, in cooperation with the Steering Group, shall issue and regularly update guidance, to assist actors in the supply chain and the competent authorities, including by specifying minimum performance standards where necessary to ensure consistent implementation across Member States. The guidance may provide: |
| Text proposed by the Commission | Amendment |
|---|---|
| (ia) standards and procedures for nucleic acid synthesis screening, including sequence screening, customer screening, verification of legitimate need, treatment of suspicious transactions, blind testing, third-party audits and transparent registries of certified providers, taking into account relevant international standards and best practices. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 54a | |
| Phased implementation of nucleic acid synthesis screening | |
| 1. The Commission shall, based on advice by the Advisory Group on Biosecurity and after consultation of relevant stakeholders, establish a phased pathway for the implementation of harmonised nucleic acid synthesis screening requirements across the Union. | |
| 2. The pathway referred to in paragraph 1 shall support the progressive adoption of sequence screening, customer screening, verification of legitimate need and reporting of suspicious transactions by providers of nucleic acid synthesis services, including SMEs, and shall take into account relevant international standards and best practices. | |
| 3. The pathway shall include targeted support for SMEs, including practical guidance, training, tools and transitional incentives to facilitate compliance. 4. The Commission shall, where necessary, ensure a consistent level playing field in the internal market, including the possible consideration of minimum performance standards for nucleic acid synthesis screening. |
| Text proposed by the Commission | Amendment |
|---|---|
| 21a. ‘One Health’ means One Health as defined in Article 3, point (7), of Regulation (EU) 2022/2371 of the European Parliament and of the Council. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Where Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion, the Authority shall, at the request of a potential applicant or notifier, provide advice on the content of the application or notification, prior to its submission, including the rules applicable to and the required content thereof as well as on the design of the studies and testing strategies to support such an application or notification. Such advice provided by the Authority shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Scientific Panels. | 1. Where Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion, the Authority shall, at the request of a potential applicant or notifier, provide advice on the content of the application or notification, including, where relevant, for novel foods, food for special medical purposes, personalised nutrition and other health-related food innovations, prior to its submission, including the rules applicable to and the required content thereof as well as on the design of the studies and testing strategies to support such an application or notification. Such advice provided by the Authority shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Scientific Panels. |
| The Authority shall record the main scientific and procedural issues discussed during pre-submission advice and make them available to the potential applicant or notifier. Where, during the subsequent assessment, the Authority requests additional information on issues substantially addressed during pre-submission advice, it shall provide a scientific justification for that request. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) all stages of the production, processing and distribution of food with the exception of novel foods, and also of the feed produced for, or fed to food-producing animals; | (a) all stages of the production, processing and distribution of food, including novel foods and innovative food production methods, provided that the sandbox plan includes appropriate scientific risk assessment, monitoring, traceability, consumer and health protection safeguards, and also of the feed produced for, or fed to food-producing animals; |
This amendment is relevant to both SANT and ITRE competences, as novel foods have significant potential in supporting disease, especially metabolic disease, treatment and enhancing patient care, by providing targeted nutritional support, improving recovery outcomes, and reducing the risk of complications. Their bioactive compounds aid in managing chronic conditions and are an essential part of rare congenital disease treatment. Innovative food production also represents an important emerging industrial sector linked to biotechnology, biomanufacturing, research and innovation. The European Biotech Act should therefore recognise the potential of biotechnology to support health, nutrition and public health objectives, accelerate access to scientifically validated products, benefiting both patients and healthcare systems through more personalized and preventive care, while maintaining a high level of safety and consumer protection, and at the same time ensuring that Europe does not fall behind global competitors in a strategically important field for industrial competitiveness, investment, scale-up and technological sovereignty.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) products, other than food and feed, containing or consisting of genetically modified organisms as defined in Article 2, point (2), of Directive 2001/18/EC. | (c) products, other than food and feed, containing or consisting of genetically modified organisms as defined in Article 2, point (2), of Directive 2001/18/EC, provided that existing testing, notification or authorisation pathways under Union law are not duplicated and that the sandbox plan includes enhanced safeguards, including risk assessment, traceability, monitoring, containment where appropriate and measures to prevent adverse effects on human health, animal health, plant health and the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) supporting evidence generation and regulatory learning for safe and sustainable food and feed biotechnology, including novel foods and innovative food production methods, with a view to reducing regulatory uncertainty and supporting coherent Union-level assessment pathways. |
This amendment is relevant to both SANT and ITRE competences, as novel foods have significant potential in supporting disease, especially metabolic disease, treatment and enhancing patient care, by providing targeted nutritional support, improving recovery outcomes, and reducing the risk of complications. Their bioactive compounds aid in managing chronic conditions and are an essential part of rare congenital disease treatment. Innovative food production also represents an important emerging industrial sector linked to biotechnology, biomanufacturing, research and innovation. The European Biotech Act should therefore recognise the potential of biotechnology to support health, nutrition and public health objectives, accelerate access to scientifically validated products, benefiting both patients and healthcare systems through more personalized and preventive care, while maintaining a high level of safety and consumer protection, and at the same time ensuring that Europe does not fall behind global competitors in a strategically important field for industrial competitiveness, investment, scale-up and technological sovereignty.
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Where the regulatory sandbox concerns novel foods or innovative food production methods, the sandbox plan may include strictly limited and controlled sensory evaluations prior to authorisation, provided that such evaluations do not constitute placing on the market and are subject to prior safety assessment, informed consent, traceability, adverse-event monitoring and appropriate oversight by competent authorities or independent experts. |
This amendment is relevant to both SANT and ITRE competences, as novel foods have significant potential in supporting disease, especially metabolic disease, treatment and enhancing patient care, by providing targeted nutritional support, improving recovery outcomes, and reducing the risk of complications. Their bioactive compounds aid in managing chronic conditions and are an essential part of rare congenital disease treatment. Innovative food production also represents an important emerging industrial sector linked to biotechnology, biomanufacturing, research and innovation. The European Biotech Act should therefore recognise the potential of biotechnology to support health, nutrition and public health objectives, accelerate access to scientifically validated products, benefiting both patients and healthcare systems through more personalized and preventive care, while maintaining a high level of safety and consumer protection, and at the same time ensuring that Europe does not fall behind global competitors in a strategically important field for industrial competitiveness, investment, scale-up and technological sovereignty.
| Text proposed by the Commission | Amendment |
|---|---|
| 3b. For innovative fermentation-based foods, the sandbox plan shall, where relevant, specify whether genetically modified microorganisms are used in contained production processes and shall include safeguards ensuring that the final product does not contain viable genetically modified organisms, where required under applicable Union law. |
This amendment is relevant to both SANT and ITRE competences, as novel foods have significant potential in supporting disease, especially metabolic disease, treatment and enhancing patient care, by providing targeted nutritional support, improving recovery outcomes, and reducing the risk of complications. Their bioactive compounds aid in managing chronic conditions and are an essential part of rare congenital disease treatment. Innovative food production also represents an important emerging industrial sector linked to biotechnology, biomanufacturing, research and innovation. The European Biotech Act should therefore recognise the potential of biotechnology to support health, nutrition and public health objectives, accelerate access to scientifically validated products, benefiting both patients and healthcare systems through more personalized and preventive care, while maintaining a high level of safety and consumer protection, and at the same time ensuring that Europe does not fall behind global competitors in a strategically important field for industrial competitiveness, investment, scale-up and technological sovereignty.
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The Authority shall also ensure the necessary revisions of its guidance where relevant and appropriate on the basis of those annual reports. | 4. The Authority shall also ensure the necessary revisions of its guidance where relevant and appropriate on the basis of those annual reports, in particular where sandbox evidence demonstrates the need to clarify data requirements, risk assessment methodologies, monitoring obligations or proportionate pathways for novel foods, innovative food production methods or feed applications. |
This amendment is relevant to both SANT and ITRE competences, as novel foods have significant potential in supporting disease, especially metabolic disease, treatment and enhancing patient care, by providing targeted nutritional support, improving recovery outcomes, and reducing the risk of complications. Their bioactive compounds aid in managing chronic conditions and are an essential part of rare congenital disease treatment. Innovative food production also represents an important emerging industrial sector linked to biotechnology, biomanufacturing, research and innovation. The European Biotech Act should therefore recognise the potential of biotechnology to support health, nutrition and public health objectives, accelerate access to scientifically validated products, benefiting both patients and healthcare systems through more personalized and preventive care, while maintaining a high level of safety and consumer protection, and at the same time ensuring that Europe does not fall behind global competitors in a strategically important field for industrial competitiveness, investment, scale-up and technological sovereignty.
| Text proposed by the Commission | Amendment |
|---|---|
| (2) The following Article 4a is inserted: | (2) The following Articles 4a and 4b are inserted: |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of exemption from Article 5a of Regulation (EU) No 536/2014 [as added by the revised Regulation No (EC) 726/2004], sponsors of clinical trials that concern advanced therapy investigational medicinal products as defined in Article 2(7) of that Regulation, consisting or containing GMOs, are not required to submit an environmental risk assessment, if those products belong to at least one of the following categories: | 1. By way of exemption from Article 5a of Regulation (EU) No 536/2014 [as added by the revised Regulation No (EC) 726/2004], sponsors of clinical trials that concern advanced therapy investigational medicinal products as defined in Article 2(7) of that Regulation, consisting or containing GMOs, are not required to submit an environmental risk assessment, if those products belong to at least one of the following categories and are intended exclusively for medicinal use. This Article shall not affect Union law applicable to food or feed: |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 4b | |
| ERN-associated ATMP administration and follow-up sites | |
| For advanced therapy medicinal products intended for rare, ultra-rare or complex diseases, Member States shall ensure that healthcare providers participating in ERNs may be designated, where they meet applicable quality, safety and traceability requirements, as preferred sites for administration, patient monitoring, safety reporting and long-term follow-up. Such sites shall be eligible for multinational clinical trials and post-authorisation evidence generation, including cross-border referral and shared ERN protocols. |
| Text proposed by the Commission | Amendment |
|---|---|
| (12) ‘Member State concerned’ means the Member State where an application for authorisation of a clinical trial or a combined study of a substantial modification has been submitted under Chapters II, IIa or III of this Regulation respectively;” | (12) ‘Member State concerned’ means the Member State with an ongoing application for authorisation of a clinical trial or a combined study, or with a valid authorisation of the clinical trial or combined study. |
| Text proposed by the Commission | Amendment |
|---|---|
| (13) ‘Substantial modification’ means any change to any aspect of the clinical trial which is made after the notification of a decision referred to in Article 8 in at least one Member State concerned and which is likely to have a substantial impact on the safety or rights of the subject or on the reliability and robustness of data generated in the clinical trial; | (13) ‘Substantial modification’ means any change to any aspect of the clinical trial which is made after the notification of a decision referred to in Article 8 or an authorisation decision issued pursuant to Article 14b a (paragraphs 7 to 12) with an outcome of authorisation or authorisation subject to condition in at least one Member State concerned or participating Member State and which is likely to have a substantial impact on the safety or rights of the subject or on the reliability and robustness of data generated in the clinical trial;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (47a) ‘ERN-coordinated rare disease clinical trial’ means a multinational clinical trial concerning a rare and complex disease, orphan medicinal product or advanced therapy medicinal product that is coordinated by, or conducted with the documented involvement of, the relevant European Reference Network and its patient representatives, |
| Text proposed by the Commission | Amendment |
|---|---|
| (47b) ‘New Approach Methodologies (NAMs)’ means innovative methods that do not involve live animals, such as in vitro (cell or tissue-based), in chemico (chemical-based), or in silico (computer-based) approaches as well as combinations of these. |
| Text proposed by the Commission | Amendment |
|---|---|
| (47c) 'Rare disease' means a prevalence of no more than 5 in 10 000 in the Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| (47d) 'ultra-rare disease' means a prevalence of no more than 1 in 50 000 in the Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Member States concerned shall cooperate closely and efficiently to ensure the effective and timely application of the provisions of this Regulation. | 2. Member States concerned shall cooperate closely and efficiently to ensure the effective and timely application of the provisions of this Regulation and shall avoid divergent, duplicative or disproportionate requests that are not necessary for the protection of subjects, data robustness or ethical review. |
| Text proposed by the Commission | Amendment |
|---|---|
| In clinical trials concerning more than one Member States (multinational clinical trials) all the Member States concerned including the reporting Member State shall cooperate in good faith and in spirit of mutual trust and reliance. The reporting Member State shall have a leading role in the assessments. | In clinical trials concerning more than one Member State (multinational clinical trials) the scientific and ethical review of Part I of the application dossier referred to in Article 6 shall be conducted by the Clinical Trials Expert Committee, established under Article 85a. The reporting Member State shall have a leading role in the assessments. |
| Text proposed by the Commission | Amendment |
|---|---|
| Each Member State shall ensure that the organisation, timelines and procedures for the review by an ethics committee are compatible with the timelines and procedures set out in this Regulation for the assessment of the application for authorisation of a clinical trial and substantial modifications thereof. | Each Member State shall ensure that the organisation, timelines and procedures for the review by an ethics committee are compatible with the timelines and procedures set out in this Regulation for the assessment of the application for authorisation of a clinical trial and substantial modifications thereof. For clinical trials authorised under Article 14b a, paragraphs 7 to 12, participating Member States shall ensure that any national, local or site-specific requirements not covered by the integrated ethical review are organised in a manner compatible with the timelines set out in that Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States concerned throughout the Portal referred to in Article 80 (‘the EU portal’) referred to in Article 25. The date on which the sponsor submits the application for an authorisation of a clinical trial is referred to within this Chapter as the submission date. | 1. In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States concerned and, if the trial is a multinational trial, to the Clinical Trials Expert Committee, throughout the Portal referred to in Article 80 (‘the EU portal’) referred to in Article 25. For clinical trials submitted under Article 14b a, paragraphs 7 to 12, the application dossier shall be submitted to the Agency through the EU portal in accordance with that Article. The date on which the sponsor submits the application for an authorisation of a clinical trial is referred to within this Chapter as the submission date. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The authorisation procedure of a clinical trial consists of three steps: | 2. The authorisation procedure of a clinical trial consists of three steps , except where Article 14b a, paragraphs 7 to 12, provides for a specific procedure: |
| Text proposed by the Commission | Amendment |
|---|---|
| – an assessment of Part II, as set out Article 7 of the application dossier, of the elements listed in Part II of Annex I, that constitute Part II of the application dossier. | – an assessment of Part II, as set out in Article 7 of the application dossier, of the elements listed in Part II of Annex I, that constitute Part II of the application dossier. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. The reporting Member State’s regulatory authority representative on the Clinical Trial Expert Committee shall be the rapporteur. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5b. This Article shall not apply to clinical trials submitted under Article 14b a, paragraphs 7 to 12. For those clinical trials, scientific rapporteurs shall be nominated in accordance with Article 14b a, paragraphs 7 to 12. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. This Article shall not apply to clinical trials submitted under Article 14b a, paragraphs 7 to 12. For those clinical trials, validation shall be carried out by the Agency in accordance with that Article and the implementing acts adopted pursuant to it. |
| Text proposed by the Commission | Amendment |
|---|---|
| The reporting Member State shall assess the application relying on the information and the documents listed in Part I of Annex I, with regard to the following aspects: | For clinical trials concerning only one Member State, the Member State concerned shall assess the application relying on the information and documents listed in Part I of Annex I. For multinational clinical trials, the rapporteur shall prepare the draft Part I assessment report within the Clinical Trials Expert Committee established under Article 85a, relying on the information and documents listed in Part I of Annex I. This Article shall not apply to clinical trials submitted Article 14b a,paragraphs 7 to 12, except where that Article expressly provides otherwise. The assessment shall cover the following aspects: |
| Text proposed by the Commission | Amendment |
|---|---|
| – reliability and robustness of the data generated in clinical trial, taking into account of statistical approaches, design of the clinical trial and methodology, including sample size and randomisation, comparator and endpoints; | – reliability and robustness of the data generated in clinical trial, taking into account of statistical approaches, design of the clinical trial and methodology, including sample size and randomisation, comparator and endpoints, and, where scientifically appropriate, evidence generated through validated NAMs supporting the scientific rationale, dose selection, patient stratification, endpoint selection, risk assessment or reduction of unnecessary animal use; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) compliance of the master informed consent form with the requirements for informed consent set out in Chapter V; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) compliance with Regulation (EU) 2016/679 of the European Parliament and of the Council; |
| Text proposed by the Commission | Amendment |
|---|---|
| The reporting Member State shall draw up an assessment report. The assessment of the aspects referred to in paragraph 1 shall constitute Part I of the assessment report. | The reporting Member State shall draw up an assessment report. The assessment of the aspects referred to in paragraph 1 shall constitute Part I of the assessment report, including in particular the risk and inconveniencies for the subjects taking into account the factors listed in paragraph 1, point (a)(ii). |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. This paragraph shall not apply to clinical trials submitted under Article 14b a, paragraphs 7 to 12, for which the integrated ethical review shall be conducted in accordance with that Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The reporting Member state shall submit, through EU portal, the final Part I of the assessment report, including its conclusions, to the sponsors and to the other Member States concerned within 42 days from the submission date. | 4. For clinical trials concerning only one Member State the reporting Member state shall submit, through the EU portal, the final Part I of the assessment report, including its conclusions, to the sponsors within 28 days from the submission date. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) an initial assessment phase within 28 days from the submission date; | (a) an initial assessment phase within 21 days from the submission date; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) a review phase within seven days from the end of the initial assessment; | (b) a committee review phase within seven days from the end of the initial assessment; |
| Text proposed by the Commission | Amendment |
|---|---|
| During the initial assessment phase, the reporting Member State shall assess Part I of the application dossier and draw up a draft Part I of the assessment report and circulate it to all other Member States concerned within 28 days from the submission date. | During the initial assessment phase, the reporting Member State shall assess Part I of the application dossier and draw up a draft Part I of the assessment report and the Rapporteur shall circulate it to the Clinical Trials Expert Committee within 21 days from the submission date. |
| Text proposed by the Commission | Amendment |
|---|---|
| During the review phase, within seven days from the circulation of the draft assessment report all Member States concerned shall review the application based on the draft Part I of the assessment report and shall share considerations for their Member States relevant to the application. The consideration may be raised only on one of the following grounds: | During the committee review phase, within seven days from the circulation of the draft assessment report all Member States concerned shall review the application based on the draft Part I of the assessment report and shall share considerations for their Member States relevant to the application. The consideration may be raised only on: |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) issues that would lead to a negative opinion of the ethics committee of the Member State concerned. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| During the consolidation phase, the reporting Member State shall take due account of the considerations of the other Member States concerned and finalise Part I of the assessment report and shall record how all considerations have been dealt with. The reporting Member State shall submit the final Part I of the assessment report to the sponsor and all other Member States concerned within seven days from the end of the review phase.” | During the consolidation phase, the Rapporteur shall take due account of the comments of the members of the Clinical Trials Expert Committee and finalise Part I of the assessment report and shall record how all considerations have been dealt with. The Rapporteur shall submit the final Part I of the assessment report to the Clinical Trials Expert Committee for a final opinion within three days from the end of the review phase.” |
| Text proposed by the Commission | Amendment |
|---|---|
| At the end of the consolidation phase, the Clinical Trials Expert Committee shall adopt an opinion on the assessment report. The Clinical Trials Expert Committee shall use its best endeavours to reach a consensus on the final assessment report. If such a consensus cannot be reached, the Clinical Trials Expert Committee shall adopt an opinion consisting of the position of the majority of the Member States concerned. Upon adoption of the opinion by the Clinical Trials Expert Committee, the Rapporteur shall immediately submit the opinion and the final assessment report to the sponsor. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. Where the clinical trial is a minimal-intervention clinical trial, other Member States concerned may only raise during the review phase considerations referred to in paragraph 5related to ethical aspects of the draft assessment report.” | 5a. Where the clinical trial is a minimal-intervention clinical trial, members of the Clinical Trials Expert Committee may only provide comments during the review phase related to ethical aspects of the draft assessment report.” |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. For the purpose of this Chapter, the date on which the final Part I of the assessment report is submitted by the reporting Member State to the sponsor and to the other Member States concerned through the EU portal shall be the reporting date.” | 6. For the purpose of this Chapter, the date on which the final Part I of the assessment report and the opinion of the Clinical Trials Expert Committee is submitted by the Rapporteur to the sponsor through the EU portal shall be the reporting date. |
| Text proposed by the Commission | Amendment |
|---|---|
| Between the validation date and the reporting date, only the reporting Member State may request additional information from the sponsor, taking into account the considerations referred to in paragraph 5. | Between the validation date and the reporting date, only the reporting Member State may request additional information from the sponsor, taking into account any comments provided by the Clinical Trials Expert Committee. |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purpose of obtaining and reviewing this additional information from the sponsor, the reporting Member State may extend the period referred to in paragraph 4 by maximum of 28 days. | For the purpose of obtaining and reviewing this additional information from the sponsor, the reporting Member State may extend the period referred to in paragraph 4 by a maximum of 21 days. |
| Text proposed by the Commission | Amendment |
|---|---|
| The sponsor shall submit the requested information within the period set by the reporting Member State which shall not exceed 14 days from the receipt of the request. | The sponsor shall submit the requested information within the period set by the reporting Member State which shall not exceed 7 days from the receipt of the request. |
| Text proposed by the Commission | Amendment |
|---|---|
| Upon receipt of the requested additional information, the Member State concerned shall review additional information provided by the sponsor and shall identify and share with the reporting Member State any unaddressed considerations, relevant for the application. The coordinated review shall be performed within maximum 7 days of the receipt of the additional information and the further consolidation shall be performed within maximum seven days of the end of the coordinated review. When finalising Part I of the assessment report, the reporting Member State shall take due account of the considerations of the other Member States concerned and shall record how the considerations have been dealt with. | Upon receipt of the requested additional information, the members of the Clinical Trials Expert Committee shall review additional information provided by the sponsor and provide any further comments to the Rapporteur. The coordinated review shall be performed within maximum 7 days of the receipt of the additional information and the further consolidation shall be performed within maximum seven days of the end of the committee review. When finalising Part I of the assessment report, the reporting Member State shall take due account of the comments of the Clinical Trials Expert Committee and shall record how the comments have been dealt with. |
| Text proposed by the Commission | Amendment |
|---|---|
| 7a. This Article shall not apply to clinical trials submitted under Article 14b a, paragraphs 7 to 12, except where Article 14b expressly provides otherwise. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) compliance with the requirements for informed consent set out in Chapter V; | (a) compliance of the master informed consent form with the requirements for informed consent set out in Chapter V; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) compliance with Regulation (EU) 2016/679 of the European Parliament and of the Council*; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. For clinical trials authorised under Article 14b a, paragraphs 7 to 12, participating Member States may assess only national, local or site-specific aspects not covered by the Agency assessment or the integrated ethics opinion under that Article. Such assessment shall not require a separate national authorisation procedure and shall not duplicate the assessment of matters already covered under Article 14b a, paragraphs 7 to 12. |
| Text proposed by the Commission | Amendment |
|---|---|
| Each Member State concerned shall complete the assessment within 42 days from the submission date and submit, through the EU portal, Part II of the assessment report, including its conclusions, to the sponsor. | Each Member State concerned shall complete the assessment within 21 days from the submission date and submit, through the EU portal, Part II of the assessment report, including its conclusions, to the sponsor. |
| Text proposed by the Commission | Amendment |
|---|---|
| Each Member State concerned may within the period referred to in this paragraph, and through EU portal, request on duly justified grounds additional information , from the sponsor regarding the aspects covered in paragraph 1 or to request to complement the documentation, required pursuant to Part II of Annex I, if such documentation is missing or documentation provided is not adequate or is incomplete. | Each Member State concerned may within the period referred to in this paragraph, and through EU portal, request on duly justified grounds additional information , from the sponsor regarding the aspects covered in paragraph 1 or to request to complement the documentation, required pursuant to Part II of Annex I, if such documentation is missing or documentation provided is not adequate or is incomplete For clinical trials authorised under Article 14b a, paragraphs 7 to 12, such a request shall not concern matters already covered by the Agency assessment or the integrated ethics opinion under that Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Member State concerned may decide within 28 days of the submission date to rely on the ethical review of the ethics committee of the reporting Member State of the common elements of the application dossier of Part II and inform the sponsor accordingly. | The Member State concerned shall rely on the ethical review of the ethics committee of the reporting Member State of the common elements of the application dossier of Part II. For clinical trials authorised under Article 14b a, paragraphs 7 to 12, participating Member States shall rely on the integrated ethics opinion issued under that Article for all matters covered by that opinion. |
| Text proposed by the Commission | Amendment |
|---|---|
| Each Member State concerned may extend the assessment period referred to in paragraph 2 by a maximum of 28 days: | Each Member State concerned may extend the assessment period referred to in paragraph 2 by a maximum of 21 days: |
| Text proposed by the Commission | Amendment |
|---|---|
| For clinical trials authorised under Article 14b a, paragraphs 7 to 12, any national, local or site-specific assessment under paragraph 1a shall not delay the authorisation decision issued by the Agency, except where a participating Member State raises a duly justified objection on the limited grounds provided for in Article 14b a, paragraphs 7 to 12. |
| Text proposed by the Commission | Amendment |
|---|---|
| The sponsor shall submit the requested additional information and documentation within the period set by the Member State concerned which shall not exceed 14 days from the receipt of the request. | The sponsor shall submit the requested additional information and documentation within the period set by the Member State concerned which shall not exceed 7 days from the receipt of the request. |
| Text proposed by the Commission | Amendment |
|---|---|
| Upon receipt of the additional information and documentation, the Member State concerned shall complete its assessment within maximum of 14 days from the submission of the requested information by the sponsor. | Upon receipt of the additional information and documentation, the Member State concerned shall complete its assessment within maximum of 7 days from the submission of the requested information by the sponsor. |
| Text proposed by the Commission | Amendment |
|---|---|
| Each Member State concerned shall notify the sponsor through the EU portal and by way of one single decision as to whether the clinical trial is authorised, authorised subject to conditions, or whether authorisation is refused. | Each Member State concerned shall notify the sponsor through the EU portal and by way of one single decision as to whether the clinical trial is authorised, authorised subject to conditions, or whether authorisation is refused, except for clinical trials authorised under Article 14b a, paragraphs 7 to 12, for which the Agency shall issue the authorisation decision in accordance with that Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| The notification shall be made within five days from the reporting date or from the last day of the assessment referred to in Article 7, whichever is later. | The notification shall be made within one day from the reporting date or from the last day of the assessment referred to in Article 7, whichever is later. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the conclusion of the reporting Member State as regards Part I of the assessment report is that the conduct of the clinical trial is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of the Member States concerned. | Where the conclusion of the Clinical Trials Expert Committee as regards Part I of the assessment report is that the conduct of the clinical trial is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of the Member States concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| Notwithstanding the first subparagraph of this paragraph, a Member State concerned may disagree with the conclusion of the reporting Member State as regards Part I of the assessment report only on the following grounds, provided that the corresponding consideration was raised during the process pursuant to Article 6(5) point (b) and the Member State concerned considers that it was not sufficiently addressed: | Notwithstanding the first subparagraph of this paragraph, a Member State concerned may disagree with the conclusion of the Clinical Trials Expert Committee as regards Part I of the assessment report only on the following grounds, provided that the corresponding consideration was raised during the committee review pursuant to Article 6(5) point (b) and the Member State concerned considers that it was not sufficiently addressed: |
| Text proposed by the Commission | Amendment |
|---|---|
| Where a Member State concerned disagrees with the conclusion, it shall communicate its disagreement, together with a detailed justification, through the EU portal, to the Commission, to all Member States, and to the sponsor. | Where a Member State concerned disagrees with the conclusion of the Clinical Trials Expert Committee, it shall communicate its disagreement, together with a detailed justification, through the EU portal, to the Commission, to all Member States, and to the sponsor. For clinical trials authorised under Article 14b a, paragraphs 7 to 12, a participating Member State may refuse acceptance of the Agency authorisation only in accordance with the limited grounds and procedure set out in that Article.’ |
| Present text | Amendment |
|---|---|
| (7a) in Article 8, paragraphs 4 and 5 are replaced by the following: | |
| 4. A Member State concerned shall refuse to authorise a clinical trial if it disagrees with the conclusion of the reporting Member State as regards Part I of the assessment report on any of the grounds referred to in the second subparagraph of paragraph 2, or if it finds, on duly justified grounds, that the aspects addressed in Part II of the assessment report are not complied with, or where an ethics committee has issued a negative opinion which in accordance with the law of the Member State concerned is valid for that entire Member State. That Member State shall provide for an appeal procedure in respect of such refusal. | 4. A Member State concerned shall refuse to authorise a clinical trial if it disagrees with the conclusion of the reporting Member State as regards Part I of the assessment report on any of the grounds referred to in the second subparagraph of paragraph 2, or if it finds, on duly justified grounds, that the aspects addressed in Part II of the assessment report are not complied with. That Member State shall provide for an appeal procedure in respect of such refusal. |
| 5. Where the conclusion of the reporting Member State as regards Part I of the assessment report is that the clinical trial is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned. | 5. Where the conclusion of the Clinical Trials Expert Committee as regards Part I of the assessment report is that the clinical trial is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| Member States shall ensure, including through the institutional safeguards, that persons validating and assessing the application do not have conflicts of interest, are independent of the sponsors, or the clinical trial site and the investigators involved and of persons financing the clinical trial, as well as free of any other undue influence and ensure their sufficient independence in performance of their tasks. | Member States shall ensure, including through the institutional safeguards, that persons validating and assessing the application, including their members of the Clinical Trials Expert Committee, do not have conflicts of interest, are independent of the sponsors, or the clinical trial site and the investigators involved and of persons financing the clinical trial, as well as free of any other undue influence and ensure their sufficient independence in performance of their tasks. |
| Text proposed by the Commission | Amendment |
|---|---|
| In order to guarantee independency and transparency, the Member States shall ensure that persons validating and assessing the application as regards the aspects covered in Parts I and II of the assessment report have no financial or personal interests which could affect their impartiality. These persons shall make an annual declaration of their financial interest. | In order to guarantee independency and transparency, the Member States shall ensure that persons validating and assessing the application as regards the aspects covered in Parts I and II of the assessment report, including their members of the Clinical Trials Expert Committee, have no financial or personal interests which could affect their impartiality. These persons shall make an annual declaration of their financial interest. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. For clinical trials submitted under Article 14b a, paragraphs 7 to 12, the Agency shall ensure equivalent safeguards for persons involved in validation, scientific assessment and integrated ethical review, including members of the Ethics Panel and scientific rapporteurs nominated in accordance with that Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Where potential subjects of a clinical trial belong to vulnerable populations, Member States concerned and sponsors shall consider and weigh the harms and benefits of their inclusion as opposed to their exclusion from a clinical trial. The Member States concerned and sponsors shall assess in particular whether the exclusion of those subjects from a clinical trial could inadvertently perpetuate or exacerbate their vulnerabilities, particularly in relation to their specific health needs. | 6. Where potential subjects of a clinical trial belong to vulnerable populations, the Clinical Trials Expert Committee, Member States concerned and sponsors shall consider and weigh the harms and benefits of their inclusion as opposed to their exclusion from a clinical trial. The Clinical Trials Expert Committee, Member States concerned, the Agency and the Ethics Panel referred to in Article 14b a, paragraphs 7 to 12, where applicable, and sponsors shall assess in particular whether the exclusion of those subjects from a clinical trial could inadvertently perpetuate or exacerbate their vulnerabilities, particularly in relation to their specific health needs.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the sponsor so requests, the application for authorisation of a clinical trial, its assessment and the conclusion shall be limited to the aspects covered by Part I of the assessment report. | Where the sponsor so requests, the application for authorisation of a clinical trial, its assessment and the conclusion shall be limited to the aspects covered by Part I of the assessment report, except for clinical trials submitted under Article 14b a, paragraphs 7 to 12. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the sponsor submits only Part I of the application dossier to all of the Member States concerned, the sponsor shall declare at the time of the first submission of Part II of the application dossier to any of the Member States concerned that the sponsor is not aware of any new substantial scientific information that would change the validity of any item submitted in the application on the aspects covered by Part I of the assessment report. If an update of Part I of the application dossier is necessary, the sponsor shall submit a substantial modification of Part I of the application dossier, at the latest, at the same time as the submission of Part II of the application dossier to at least one of the Member States concerned. | Where the sponsor submits only Part I of the application dossier to the reporting Member State, the sponsor shall declare at the time of the first submission of Part II of the application dossier to any of the Member States concerned that the sponsor is not aware of any new substantial scientific information that would change the validity of any item submitted in the application on the aspects covered by Part I of the assessment report. If an update of Part I of the application dossier is necessary, the sponsor shall submit a substantial modification of Part I of the application dossier, at the latest, at the same time as the submission of Part II of the application dossier to at least one of the Member States concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. When the sponsor submits a substantial modification of Part I of the application dossier with regard to clinical trial that is subject to a request referred to in paragraph 1 and has been authorised or authorised subject to conditions by at least one Member State concerned, all Member States concerned that received the initial application shall participate in the assessment of that substantial modification in accordance with Article 18 or 22 as appropriate. | 2. When the sponsor submits a substantial modification of Part I of the application dossier with regard to clinical trial that is subject to a request referred to in paragraph 1 and has been authorised or authorised subject to conditions by at least one Member State concerned, all Member States concerned that received the initial application shall participate in the assessment of that substantial modification through the Clinical Trials Expert Committee in accordance with Article 18 or 22 as appropriate.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| For clinical trials authorised under Article 14b a, paragraphs 7 to 12, extension to an additional participating Member State shall be carried out in accordance with that Article and shall not require reassessment of matters already covered by the Agency assessment or the integrated ethics opinion. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) paragraph 4 is deleted; | (c) paragraph 4 is replaced by the following: |
| If the clinical trial has only been authorised previously in a single Member State and has not been reviewed by the Clinical Trials Expert Committee in accordance with Article 6, the Rapporteur shall submit Part I of the reporting Member State’s existing assessment report to the Clinical Trials Expert Committee, (which for this purpose shall include representatives of the additional Member State concerned,) within 21 days of the submission date, and the committee review phase and the consolidation phase, each as described in Article 6(5), shall apply to the assessment of part 1 of the application. |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) paragraph 5 to 8 are replaced by the following: | deleted |
| 5. Within 42 days following the submission date referred to in paragraph 1, the additional Member State concerned may communicate to the reporting Member State and the other Member States concerned any considerations through the EU portal. |
| Text proposed by the Commission | Amendment |
|---|---|
| Between the submission date referred to in paragraph 1 and the expiry of the period referred to in paragraph 3, only the reporting Member State may request additional information from the sponsor concerning the aspects covered in Part I of the assessment report, taking into account the considerations referred to in paragraph 5. | Between the submission date referred to in paragraph 1 and the expiry of the period referred to in paragraph 3, only the reporting Member State may request additional information from the sponsor concerning the aspects covered in Part I of the assessment report, taking into account the considerations raised by the Clinical Trials Expert Committee in accordance with Article 6(5). If the reporting Member State requests additional information from the sponsor, Article 6(7) shall apply and the period referred to in paragraph 3 may be extended by a maximum of 24 days.. |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purpose of obtaining and reviewing this additional information from the sponsor in accordance with the third and fourth subparagraphs, the reporting Member State may extend the period referred to in the first subparagraph of paragraph 3 by a maximum of 28 days. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| The sponsor shall submit the requested additional information within the period set by the reporting Member State, which shall not exceed 14 days from receipt of the request. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Upon receipt of the additional information the reporting Member State, the additional Member State concerned and all other Member States concerned shall review any additional information provided by the sponsor together with the original application and shall share any unaddressed considerations relevant to the application. The coordinated review shall be performed within a maximum of seven days from the receipt of the additional information and the further consolidation shall be performed within a maximum of seven days from the end of the coordinated review. The reporting Member State shall take due account of the considerations of the Member States concerned and shall record how the considerations have been dealt with. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the sponsor does not provide additional information within the period set by the reporting Member State in accordance with the third subparagraph, the application shall be deemed to have lapsed in the additional Member State concerned. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| The request for additional information and the additional information shall be submitted through the EU portal | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. Where the conclusion of the Clinical Trials Expert Committee as regards Part I of the assessment report is that the clinical trial is not acceptable, the reporting Member State may choose to allow the previously authorised trial to continue or may choose to revoke the authorisation of a clinical trial, suspend the clinical trial, or require the sponsor to modify any aspect of the clinical trial in accordance with Article 77(1) and shall inform the Clinical Trials Expert Committee of its decision. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. This Article shall not apply to clinical trials authorised under Article 14b a, paragraphs 7 to 12. For those clinical trials, the Agency shall remain responsible for coordinating the procedure in accordance with that Article.’’: |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 14b | deleted |
| Accelerated procedure for the authorisation of multinational clinical trials in the context of public health emergencies | |
| 1. During a recognised public health emergency at Union level pursuant to Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council, Member States shall apply an accelerated procedure for the authorisation of multinational clinical trials for medicinal products intended for the treatment, prevention or medical diagnosis of the disease or condition which are directly related to the public health emergency. | |
| 2. To address an emergence or development of a serious cross-border threat to health as defined in Article 3(1) of Regulation 2022/2371 that is likely to lead to the recognition of a public health emergency at Union level in accordance with Article 23(1) of Regulation (EU) 2022/2371, Member States shall apply an accelerated procedure for the authorisation of multinational clinical trials when this procedure is declared applicable in accordance with the criteria in paragraph 3 of this Article. The application of the accelerated procedure shall ensure the availability of medicinal products in order to prevent or swiftly contain the emerging serious cross-border health threat, to provide timely treatment options grounded in scientifically robust evidence or to facilitate medical diagnosis of the disease or condition directly related to the specific serious cross-border health threat. | |
| 3. The Commission shall, by means of implementing acts, lay down the detailed criteria and the processes for declaring applicability of the accelerated authorisation procedure to address an emergence or development of serious cross-border threat to health that is likely to lead to the recognition of a public health emergency at Union level in accordance with Article 23 (1) of Regulation (EU) 2022/2371. | |
| The criteria for declaring applicability of an accelerated authorisation procedure shall at least include the epidemiological situation and its dynamics as well as the availability of treatment, prevention and diagnostics options addressing the emerging serious cross-border threat to health. The process of declaring applicability of the accelerated authorisation procedure shall involve consultations with relevant Union agencies, expert groups and advisory bodies in the field of public health and clinical trials. | |
| The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 88. | |
| 4. When submitting the application for the clinical trial authorisation during a public health emergency as referred to in paragraph 1 or when the accelerated procedure referred to in paragraph 2 is declared applicable to address an emerging serious cross-border health threat, pursuant to the procedure referred to in paragraph 3, the sponsor shall indicate whether the investigational medicinal products are intended for the treatment, prevention or medical diagnosis of a disease or a condition directly related to the specific serious cross-border threat to health. The reporting Member State shall confirm whether the accelerated procedure is applicable to the clinical trial application. | |
| 5. The Commission shall adopt delegated acts in accordance with Article 89 to supplement this Regulation by setting out the procedures for an accelerated authorisation of multinational clinical trials, including timelines, criteria for evaluating whether a clinical trial qualifies for an accelerated procedure and an integrated ethical review, and by laying down simplified requirements for the application dossier. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 14b a(new) | |
| Accelerated and special procedure for the authorisation of multinational clinical trials. | |
| 1. The accelerated procedure laid down in this Article shall apply to multinational clinical trials in any of the following cases: | |
| (a) a public health emergency at Union level recognised under Article 23 of Regulation (EU) 2022/2371, where the trial concerns a medicinal product for the diagnosis, prevention or treatment of the disease or condition directly related to that emergency; | |
| (b) a serious cross-border threat to health within the meaning of Article 3(1) of Regulation (EU) 2022/2371, where the reporting Member State, after consulting the Member States concerned and, where appropriate, the Agency, considers acceleration necessary to contain the threat or to provide timely treatment or diagnosis on scientifically robust evidence; | |
| (c) a rare or ultra-rare disease, in particular where the trial addresses an unmet medical need, concerns an orphan medicinal product, a paediatric condition or an advanced therapy medicinal product, or requires recruitment in more than one Member State due to low prevalence; | |
| (d) a medicinal product on the Union list of critical medicinal products or of common interest under Regulation (EU) …/… [Critical Medicines Act], where the trial is relevant for availability, security of supply, resilience, substitution, repurposing or therapeutic alternatives. | |
| 2. The sponsor shall indicate the grounds relied on and provide a concise justification; for trials under point (c) the sponsor may instead opt for the procedure under paragraphs 7 to 12. The reporting Member State shall confirm applicability through the EU portal within five days of validation, after giving the sponsor up to three days to clarify before any refusal. Where the accelerated procedure does not apply, the application shall continue under the standard procedure without resubmission. | |
| 3. Applications under paragraph 1 shall, unless the sponsor opts for the procedure under paragraphs 7 to 12, be assessed by the reporting Member State and the Member States concerned through the EU portal and database on a single coordinated timetable. Where the application is assessed within the Clinical Trials Expert Committee established under Article 85a, the Rapporteur shall perform the tasks of the reporting Member State. | |
| 4. The following timelines shall apply: validation within five days of submission (with one request to complete an incomplete dossier within five days, and validation within three days of receipt); a draft Part I assessment report within 25 days of validation; considerations from Member States concerned within 15 days of validation; completion of Part II within 25 days of validation; and notification of the Part I conclusion and of each national decision within five days of completion. Where further information on Part I is needed, the reporting Member State or Rapporteur shall issue a single consolidated request through the EU portal, replacing separate national requests on the same issues; the sponsor shall reply within ten days and the assessment shall be completed within ten days of receipt. | |
| 5. Member States concerned shall rely on the assessment of the reporting Member State or Rapporteur, who shall integrate their relevant considerations, including ethical aspects of Part I, into the draft report. Considerations and divergent positions shall be limited to, and justified by, subject safety, scientific robustness, ethical requirements or national law in areas not harmonised by this Regulation, and notified with reasons through the EU portal; silence within five days of circulation of the draft Part I report shall be deemed agreement. | |
| 6. Ethical review shall be conducted within these timelines; common Part I issues shall be assessed an once by the reporting Member State or Rapporteur and reflected in the Part I report, without precluding assessment of Part II or national-law ethical aspects within the same timelines. Member States concerned may rely on common elements of Part II not specific to national law or local trial-site conditions. Applications shall use the harmonised templates available through the EU portal, and no additional national documents shall be required for Part I where the information is already included. The sponsor may request non-binding pre-submission advice through the EU portal, which shall not affect the independence of the assessment. | |
| 7. Trials under paragraph 1, point (c), investigating orphan-designated medicinal products or products for a rare or ultra-rare disease may, at the sponsor's request, be authorised through a voluntary opt-in procedure administered by the Agency, which validates the application. The Agency's authorisation shall be valid in all participating Member States without further national authorisation, and the coordinated accelerated procedure under paragraphs 2 to 6 and the standard procedure shall not apply to such trials. Simplified dossier and recruitment thresholds shall be adapted to ultra-rare populations. | |
| 8. Paragraphs 7 to 12 apply to ERN-coordinated rare disease clinical trials within the meaning of Article 2(48). For such trials the application may be submitted by the sponsor or by ERN clinical trial office on behalf of the participating ERN healthcare providers, and shall rely on the investigational medicinal product core dossier under Article 27a and on ERN registries. Duplicate product- or population-level information shall not be requested absent new evidence of a material risk to subject safety or data robustness. An ERN may act as sponsor or co-sponsor through its coordinating healthcare provider or a designated ERN clinical trial office constituted as a legal person, assuming the sponsor's responsibilities, including civil liability and insurance; shared sponsorship shall be allocated in writing. | |
| 9. A standing Ethics Panel within the Agency, composed of the Agency’s ethics experts, experts nominated by participating Member States, patient representatives with rare disease expertise and at least one ERN-designated clinical expert shall conduct a single integrated ethical review covering trial design, informed consent, risk-benefit, protection of vulnerable participants and data protection. Its single ethics opinion shall be binding on, and shall replace all national ethics committee assessments otherwise required of, participating Member States, which undertake not to conduct separate reviews. | |
| 10. Member States may notify the Commission of their participation at any time and may withdraw without prejudice to trials already authorised.The Commission shall publish and regularly update a list of participating Member States. Participating Member States shall accept authorisation decisions and ethics opinions without re-assessment, and may refuse acceptance only where implementation would conflict with fundamental rights protected by their constitution or where the trial involves interventions prohibited by national law on public-policy grounds, notifying the Commission and the Agency within ten days with detailed legal justification; the Commission may pursue unjustified refusals through infringement proceedings. The authorisation shall remain valid in all participating Member States. | |
| 11. The CTAG shall facilitate the procedure, maintain the list of participating Member States, provide a forum for best practice and advise the Commission, and shall nominate two scientific representatives from technical experts in participating Member States for the Part I scientific assessment, involving at least one ERN-designated expert for ERN-coordinated trials. The Agency shall issue its authorisation decision, including the integrated ethics opinion, within seven calendar days of validation. | |
| 12. The Commission shall adopt implementing acts, in accordance with the examination procedure under Article 88, on simplified dossier requirements, eligibility and prevalence and enrolment thresholds, the operation of the Ethics Panel, and coordination with national authorities for post-authorisation supervision, inspection and safety monitoring. | |
| 13. The choice between the centralised voluntary procedure, the coordinated accelerated procedure and the standard procedure rests with the sponsor, and is made at initial submission. Sponsors not using the centralised procedure shall suffer no disadvantage as to subsequent marketing authorisation. This shall not lower the standards of subject safety, scientific robustness, data quality, ethical review, informed consent, protection of vulnerable subjects, data protection or good clinical practice under this Regulation. | |
| 14. The Agency shall ensure coordination with the Clinical Trials Expert Committee, including by making assessment reports for corresponding trials mutually available to avoid duplication and divergent conclusions. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The Member States concerned shall assess the single application by means of a coordinated assessment procedure under the direction of a reporting Member State chosen from among the Member States concerned. If a combined study involves only one Member State, that Member State shall be the reporting Member State. | 4. If a combined study involves only one Member State, that Member State shall be the reporting Member State and it shall review the application in accordance with the procedure referred to in Article 6(4). If a combined study involves more than one Member State, the coordinated assessment shall be conducted by the Clinical Trials Expert Committee in accordance with Article 6(5). |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The coordinated assessment procedure shall include the assessment by the competent authorities and review by ethics committees. During the assessment procedure, the Member States concerned may only raise considerations related to the following: | 5. During the committee review phase of the assessment procedure, Member State representatives on the Clinical Trial Expert Committee may raise considerations on the grounds referred to in Article 78(8) of Regulation (EU) 2017/746 or Article 75(8) of Regulation (EU) 2017/745. |
| (a) the grounds referred to in Article 14a(5) of this Regulation, Article 78(8) of Regulation (EU) 2017/746 or Article 74(8) of Regulation (EU) 2017/745; or | deleted |
| (b) issues that would lead to ethics committee of the Member State concerned issuing a negative opinion. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the conclusion of the reporting Member State as regards the area of coordinated assessment is that the conduct of the combined study is acceptable, or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of all Member States concerned. | Where the conclusion of the as regards the area of the Clinical Trials Expert Committee coordinated assessment is that the conduct of the combined study is acceptable, or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of all Member States concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| Notwithstanding the first subparagraph of this paragraph, a Member State concerned may disagree with the conclusion of the reporting Member State concerning the area of coordinated assessment but only on one of the following grounds, provided that the corresponding consideration was raised during the assessment process and the Member State concerned has substantiated comments that were not sufficiently addressed: | Notwithstanding the first subparagraph of this paragraph, a Member State concerned may disagree with the conclusion of the Clinical Trials Expert Committee concerning the area of coordinated assessment but only on one of the following grounds, provided that the corresponding consideration was raised during the assessment process and the Member State concerned has substantiated comments that were not sufficiently addressed: |
| Text proposed by the Commission | Amendment |
|---|---|
| The reporting Member State shall submit, through the EU portal, the final assessment report including its conclusions, to the sponsor and to the other Member States concerned within 28 days from the submission date. | For clinical trials concerning only one Member State the reporting Member State shall submit, through the EU portal, the final assessment report including its conclusions, to the sponsor within 14 days from the submission date. |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purpose of this Article and of Articles 19 and 23, the reporting date shall be the date on which the final assessment report is submitted to the sponsor and the other Member States concerned. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| For clinical trials involving more than one Member State the assessment process of substantial modification shall include three phases: | For clinical trials involving more than one Member State, the reporting Member State’s regulatory authority representative on the Clinical Trial Expert Committee shall be the Rapporteur and the assessment process of substantial modification shall include three phases: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) an assessment phase performed by the reporting Member State within 21 days from the submission date. The assessment phase shall end when the reporting Member State circulates the draft assessment report; | (a) an assessment phase performed by the reporting Member State within 14 days from the submission date. The assessment phase shall end when the Rapporteur circulates the draft assessment report; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) a review phase performed within three days from the end of the assessment phase, involving all the Member States concerned, and; | (b) a committee review phase performed within seven days from the end of the assessment phase and; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) a coordination phase performed within four days from the end of the review phase. | (c) a consolidation phase performed within three days from the end of the review phase. |
| Text proposed by the Commission | Amendment |
|---|---|
| During the assessment phase, the reporting Member State shall develop a draft assessment report and circulate it to all the Member States concerned. | During the assessment phase, the Rapporteur shall develop a draft assessment report and shall circulate it to the Clinical Trials Expert Committee. |
| Text proposed by the Commission | Amendment |
|---|---|
| During the review phase, all Member States concerned shall review the application on the basis of the draft assessment report and shall share considerations for their Member State that are relevant to the application. | During the committee review phase, the Clinical Trials Expert Committee shall review the application on the basis of the draft assessment report and each member of the Clinical Trials Committee may share considerations for their Member State that are relevant to the application. |
| Text proposed by the Commission | Amendment |
|---|---|
| Considerations may only be raised on: | deleted |
| — one or more grounds referred to in Article 19(2) of this Regulation. | |
| — on matters that would lead the ethics committee issuing negative opinion. |
| Text proposed by the Commission | Amendment |
|---|---|
| During the consolidation phase, the reporting Member State shall take due account of the considerations of the other Member States concerned when finalizing the assessment report and shall record how the considerations have been addressed. The reporting Member State shall submit the final assessment report to the sponsor and all the other Member States concerned by the reporting date. | During the consolidation phase, the Rapporteur shall take due account of the considerations of the members of the Clinical Trials Expert Committee concerned when finalizing the assessment report and shall record how the considerations have been addressed. The Rapporteur shall submit the final assessment report to the Clinical Trials Expert Committee within four days from the end of the review phase. At the end of the consolidation phase, the Clinical Trials Expert Committee shall adopt an opinion on the assessment report. The Clinical Trials Expert Committee shall use its best endeavours to reach a consensus on the final assessment report. If such a consensus cannot be reached, the Clinical Trials Expert Committee shall adopt an opinion consisting of the position of the majority of the members from the Member States concerned with the trial. Upon adoption of the opinion by the Clinical Trials Expert Committee, the Rapporteur shall immediately submit the opinion and the final assessment report to the sponsor. |
| Text proposed by the Commission | Amendment |
|---|---|
| Between the validation date and the reporting date, only the reporting Member State may request additional information from the sponsor, taking into account the considerations referred to in paragraph 4. | Between the validation date and the reporting date, only the reporting Member State may request additional information from the sponsor, taking into account the considerations referred to in paragraph 4. For the purpose of this Article and of Articles 19 and 23, the reporting date shall be the date on which the final assessment report is submitted to the sponsor. |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purpose of obtaining and reviewing this additional information from the sponsor in accordance with the third and fourth subparagraph, the reporting Member State may extend the period referred to in the first subparagraph of paragraph 3 by a maximum of 14 days. | For the purpose of obtaining and reviewing this additional information from the sponsor in accordance with the third and fourth subparagraph, the reporting Member State may extend the period referred to in the first subparagraph of paragraph 3 by a maximum of 7 days. |
| Text proposed by the Commission | Amendment |
|---|---|
| Upon receipt of the additional information, the Member States concerned shall review any additional information provided by the sponsor and shall share any unaddressed considerations relevant to the application. The review shall be performed within a maximum of three days from the receipt of the additional information and further consolidation shall be performed within a maximum of seven days from the receipt of additional information from the sponsor. When finalising the assessment report, the reporting Member State shall take due account of the considerations of the other Member States concerned and shall record how the considerations have been dealt with.; | Upon receipt of the additional information, the members of the Clinical Trials Expert Committee shall review any additional information provided by the sponsor and shall identify and share with the Rapporteur any unaddressed considerations relevant to the application. The review shall be performed within a maximum of three days from the receipt of the additional information and further consolidation shall be performed within a maximum of seven days from the receipt of additional information from the sponsor. When finalising the assessment report, the reporting Member State shall take due account of the considerations of the Clinical Trials Expert Committee and shall record how the considerations have been dealt with.’; |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the conclusion of the reporting Member State is that the substantial modification is acceptable or acceptable subject to compliance with specific conditions, that conclusions shall be deemed to be the conclusions of the Member State concerned. | Where the conclusion of the Clinical Trials Expert Committee is that the substantial modification is acceptable or acceptable subject to compliance with specific conditions, that conclusions shall be deemed to be the conclusions of the Member State concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| Notwithstanding the first subparagraph, a Member State concerned may disagree with that conclusion of the reporting Member State only on the following grounds, provided that the consideration was raised during the process pursuant to Article 18(4) and it considers that it was not sufficiently addressed: | Notwithstanding the first subparagraph, a Member State concerned may disagree with that conclusion of the Clinical Trials Expert Committee only on the following grounds, provided that the consideration was raised during the process pursuant to Article 18(4) and it considers that it was not sufficiently addressed: |
| Text proposed by the Commission | Amendment |
|---|---|
| A Member State concerned shall refuse to authorise a substantial modification if it disagrees with the conclusion of the reporting Member State as regards Part I of the assessment report on any of the grounds referred to in the second paragraph or where an ethics committee has issued a negative opinion which, in accordance with the law of that Member State concerned, is valid for the entire Member State. That Member State shall provide for an appeal procedure in respect of such refusal. | A Member State concerned shall refuse to authorise a substantial modification if it disagrees with the conclusion of the Clinical Trials Expert Committee as regards Part I of the assessment report on any of the grounds referred to in the first paragraph. That Member State shall provide for an appeal procedure in respect of such refusal.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| Notification shall be done by way of a single decision within 28 days from the submission date. | Notification shall be done by way of a single decision within 14 days from the submission date. |
| Text proposed by the Commission | Amendment |
|---|---|
| Notwithstanding the first subparagraph, a Member State concerned may disagree with the conclusion of the reporting Member State only on the following grounds, provided that the consideration was raised during the process pursuant to Article 18(4) and it considers that it was not sufficiently addressed: | Notwithstanding the first subparagraph, a Member State concerned may disagree with the conclusion of the Clinical Trials Expert Committee only on the following grounds, provided that the consideration was raised during the process pursuant to Article 18(4) and it considers that it was not sufficiently addressed: |
| Text proposed by the Commission | Amendment |
|---|---|
| The list of required documentation and information for Part I is set out in Part I of Annex I. The list of required documentation for Part II is set out in Part II of Annex I.; | ‘The list of required documentation and information for Part I is set out in and shall be limited to Part I of Annex I. The list of required documentation for Part II is set out in and shall be limited to Part II of Annex I. Where information or documentation has already been submitted through the EU portal and remains applicable and up to date, the sponsor may cross-refer to that information or documentation. Such information or documentation shall not be re-submitted, unless strictly necessary and duly justified.’; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1c. To draw up and update, when necessary, harmonised templates to be used by sponsors, the Commission shall be empowered to adopt implementing acts in accordance with Article 88. The harmonised templates may include standardised sections for documents referred to in Article 7(2) and in Annex I. | 1c. To draw up and update, when necessary, harmonised templates to be used by sponsors, the Commission shall be empowered to adopt implementing acts in accordance with Article 88. The harmonised templates shall include standardised sections for documents referred to in Article 7(2) and in Annex I. |
| Text proposed by the Commission | Amendment |
|---|---|
| 9a. Where evidence generated through validated NAMs is submitted as part of the scientific rationale, risk assessment, dose selection, patient stratification, endpoint selection or reduction of unnecessary animal use, national competent authorities and ethics committees shall assess such evidence as part of the relevant application dossier and shall not require duplicative studies or additional documentation unless duly justified for reasons of subject safety, data robustness or ethical review. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. For ERN-coordinated rare disease clinical trials, the sponsor or an ERN clinical trial office acting on behalf of participating ERN healthcare providers may request the establishment of an investigational medicinal product core dossier. Once established, the core dossier shall be relied upon by the reporting Member State and all Member States concerned for subsequent corresponding trials, and duplicate product-level information shall not be requested unless justified by new evidence of a material risk to subject safety or data robustness. For ERN-coordinated rare disease clinical trials, the sponsor or an ERN clinical trial office acting on behalf of participating ERN healthcare providers may request the establishment of an investigational medicinal product core dossier. Once established, the core dossier shall be relied upon by the reporting Member State and all Member States concerned for subsequent corresponding trials, and duplicate product-level information shall not be requested unless justified by new evidence of a material risk to subject safety or data robustness. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. After receiving the request for a change to the core dossier, independently of whether a change is submitted in the context of an assessment of an application related to a corresponding clinical trial or independently, the depositary Member State shall verify whether the core dossier, once changed, will continue to fulfil the requirements listed in paragraph 3 points (a), (b) and (c). The Member State concerned with the core dossier shall not duplicate the assessment of the depositary Member State. The depositary Member State may consult the Member State concerned as appropriate. | 4. After receiving the request for a change to the core dossier, independently of whether a change is submitted in the context of an assessment of an application related to a corresponding clinical trial or independently, the depositary Member State shall verify whether the core dossier, once changed, will continue to fulfil the requirements listed in paragraph 3 points (a), (b) and (c). The Member State concerned with the core dossier shall not duplicate the assessment of the depositary Member State. The depositary Member State may consult the Clinical Trials Expert Committee or Member State concerned as appropriate. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The sponsor shall assess whether a change to the investigational product core dossier makes it necessary to submit a substantial modification in corresponding clinical trials that are ongoing. | 6. The sponsor shall assess whether a change to the investigational product core dossier makes it necessary to submit a substantial modification in corresponding clinical trials that are ongoing. Where such a substantial modification is necessary, the sponsor may submit the request for a change of the investigational medicinal product core dossier and the substantial modification in parallel. The assessment of the change of the investigational medicinal product core dossier and of the substantial modification may be carried out under aligned timelines and concluded through a coordinated procedure, without requiring the prior approval of the change of the investigational medicinal product core dossier. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The Agency shall support consistency in the establishment, assessment, update and use of investigational medicinal product core dossiers, including through guidance, harmonised templates and technical support to reporting Member States and depositary Member States, in order to avoid divergent requirements, duplicative information requests and unnecessary reassessment between Member States concerned.” |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. For ERN-coordinated rare disease clinical trials, direct delivery and remote trial activities may be organised across Member States through ERN-associated investigators, dispensing pharmacies or other authorised persons, under the responsibility of the investigator and in accordance with the authorised protocol. Member States shall not require a separate local site authorisation solely because delivery, monitoring or follow-up is performed remotely, provided that subject safety, traceability, data protection and pharmacovigilance safeguards are ensured. |
| Text proposed by the Commission | Amendment |
|---|---|
| The sponsor and the investigator shall keep a clinical trial master file. The clinical trial master file shall at all times contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated, taking into account all characteristics of the clinical trial, including in particular whether the clinical trial is a minimal-intervention or low-intervention clinical trial.; | The sponsor and the investigator shall keep a clinical trial master file. The clinical trial master file shall at all times contain the essential records relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated, taking into account all characteristics of the clinical trial, including in particular whether the clinical trial is a minimal-intervention or low-intervention clinical trial.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The EU database shall be established to enable cooperation between the competent authorities of the Member States concerned to the extent that it is necessary for the application of this Regulation and to search for specific clinical trials. It shall also enable communication between sponsors and Member States concerned and reporting Member State as appropriate for the purpose of swift regulatory procedures. It shall enable sponsors to refer to previous submissions of an application for authorisation of a clinical trial or a substantial modification. It shall also enable citizens of the Union to have access to clinical information about medicinal products. To this end all data held in the EU database shall be in an easily searchable format, all related data shall be grouped together by way of the EU trial number, and hyperlinks shall be provided to link together related data and documents held on the EU database and other databases managed by the Agency.; | 2. The EU database shall be established to enable cooperation between the competent authorities of the Member States concerned to the extent that it is necessary for the application of this Regulation and to search for specific clinical trials. It shall also enable communication between sponsors and Member States concerned and reporting Member State as appropriate for the purpose of swift regulatory procedures. It shall enable sponsors to refer to previous submissions of an application for authorisation of a clinical trial or a substantial modification. It shall also enable citizens of the Union to have access to clinical information about medicinal products. To this end all data held in the EU database shall be in an easily searchable format, all related data shall be grouped together by way of the EU trial number, and hyperlinks shall be provided to link together related data and documents held on the EU database and other databases managed by the Agency. The Commission and the Agency shall ensure, within their respective mandates, that a cybersecure EU portal and EU database are developed and operated with a view to interoperability with relevant Union health data infrastructures, including the European Health Data Space, DARWIN EU and, where appropriate, interconnected and interoperable ERNs and their registries. Such interoperability shall support the reuse of data, feasibility assessment, patient identification, recruitment, post-authorisation evidence generation and the reduction of duplicative administrative requirements, while fully respecting Union data protection law. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ia) to assess applications for clinical trial authorisations in accordance with Article 6 and applications for substantial modifications in accordance with Article 18. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ib) to support the exchange of best practices on national approaches to the financing or reimbursement of already authorised standard-of-care treatments used in clinical trials, with a view to identifying barriers to multinational clinical trials and avoiding unnecessary duplication of costs where such treatments would otherwise be provided as part of routine care, without prejudice to Member States’ competences for the organisation and financing of healthcare systems |
| Text proposed by the Commission | Amendment |
|---|---|
| (47a) The following article is inserted: | |
| Article 85a | |
| Clinical Trials Expert Committee | |
| 1. A Clinical Trials Expert Committee is hereby established. The purpose of the Clinical Trials Expert Committee shall be to assess applications for clinical trial authorisations in accordance with Article 6 and applications for substantial modifications in accordance with Article 18 without prejudice to Article 14b a, paragraphs 7 to 12. | |
| 2. Where an application is submitted under the procedure provided for in Article 14b a, paragraphs 7 to 12 , it shall be assessed in accordance with that Article and shall not be submitted to the Clinical Trials Expert Committee. The European Medicines Agency shall ensure coordination between the assessment conducted under Article 14b a, paragraphs 7 to 12 , and the Clinical Trials Expert Committee, including by making assessment reports for corresponding clinical trials mutually available to avoid duplication of assessment and divergent conclusions. | |
| 3. Each Member State shall appoint to the Clinical Trials Expert Committee one representative. The members of the Clinical Trials Expert Committee shall be chosen for their competence and experience in the field of clinical trials. They shall represent the competent national authorities and the ethics committees of the Member States. The names and affiliations of members and alternates shall be made public by the Commission. The alternates shall represent and vote for the members in their absence. | |
| 4. For the purpose of the fulfilment of their tasks, Clinical Trials Expert Committee members shall be able to rely on the contribution of experts from national competent authorities and ethics committees and, for applications concerning rare diseases, orphan medicinal products or paediatric conditions, on the contribution of experts designated by the relevant ERNs established under Directive 2011/24/EU. | |
| 5. The Clinical Trials Expert Committee shall use its best endeavours to reach consensus on any application. If such a consensus cannot be reached, the Clinical Trials Expert Committee shall decide by taking the position of the majority of the members from the Member States concerned with the trial. Members with diverging positions may request that their position and the grounds on which they are based are recorded. | |
| 6. For the assessment of each application, the Clinical Trials Expert Committee shall comprise the representatives of each Member State concerned with the trial. A representative from the European Medicines Agency with expertise in the field of clinical trials shall be added to the Clinical Trials Expert Committee for all applications. Additional patient representatives or other representatives or experts may be invited to participate in the Clinical Trials Expert Committee assessment of the application by the Rapporteur. For applications concerning orphan medicinal products, rare diseases, paediatric conditions or advanced therapy medicinal products, the Rapporteur shall ensure that the assessment includes at least one expert designated by the relevant ERN and at least one patient representative. | |
| 7. The Clinical Trials Expert Committee shall be chaired by the European Medicines Agency. | |
| 8. The Clinical Trials Expert Committee shall meet whenever the situation requires, at the request of the Rapporteur for the relevant application. | |
| 9. Coordination and secretarial support shall be provided by the European Medicines Agency. | |
| 10. The Clinical Trials Expert Committee shall draw up its rules of procedure. The rules of procedure shall be made public |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Personal data collected and processed in accordance with this Regulation may be further processed by the same controller for the purposes of other clinical trials conducted under this Regulation, or for scientific research with the aim of protecting public health, improving standard of care and fostering the innovation capacity of European medical research. | 6. Personal data collected and processed in accordance with this Regulation may be further processed for the purposes of other clinical trials conducted under this Regulation, or for scientific research with the aim of protecting public health, improving standard of care and fostering the innovation capacity of European medical research. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. For ERN-coordinated rare disease clinical trials, further processing under paragraph 6 may include pseudonymised data sharing between participating ERN healthcare providers, ERN registries, sponsors and investigators for feasibility assessment, recruitment, safety monitoring, long-term follow-up, post-trial evidence generation and scientific research, subject to informed consent or another valid legal basis under Union law, data minimisation, governance and appropriate technical and organisational safeguards. Member States shall not maintain or introduce additional conditions that disproportionately prevent such cross-border ERN data use. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Union GMO legislation shall not apply to veterinary medicinal products containing or consisting of genetically modified organisms that are authorised or manufactured in accordance with this Regulation. The administration of veterinary medicinal products shall not bring the treated animal or their products under the scope of the GMO rules. | “The Union GMO legislation shall not apply to veterinary medicinal products containing or consisting of genetically modified organisms that are authorised or manufactured in accordance with this Regulation. The administration of veterinary medicinal products shall not bring the treated animal or their products under the scope of the GMO rules, provided that the assessment, authorisation, pharmacovigilance and official control of such veterinary medicinal products ensure a high level of protection of health, animal health, food and feed safety and the environment, in accordance with this Regulation and other applicable Union law.” |
| Text proposed by the Commission | Amendment |
|---|---|
| (47a) ‘One Health’ means an approach as defined in Article 3, point (7), of Regulation (EU) 2022/2371 of the European Parliament and of the Council; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. In case of clinical trials with veterinary medicinal products containing or consisting of genetically modified organisms, the competent authorities shall assess potential adverse effects on human health and the environment, having regard to the specific characteristics of the product and in accordance with the principles for environmental risk assessment set out in Annex II. Where appropriate, the implementation of risk mitigation measures shall be required. | 2a. In case of clinical trials with veterinary medicinal products containing or consisting of genetically modified organisms, the competent authorities shall assess potential adverse effects on health and the environment, having regard to the specific characteristics of the product and in accordance with the principles for environmental risk assessment set out in Annex II, taking into account, where scientifically appropriate, evidence generated through validated NAMs. Where appropriate, the implementation of risk mitigation measures shall be required. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) it can be expected that those technologies, methods or products will have a positive impact on animal health without unacceptable negative impacts on human health or the environment; | (a) it can be expected that those technologies, methods or products will have a positive impact on animal health , in line with a One Health approach, without unacceptable negative impacts on health or the environment; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) estimation of potential benefits and potential risks to animal or human health or the environment; | (c) estimation of potential benefits and potential risks to health, animal health, animal welfare and the environment, in line with a One Health approach; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) develop and make publicly available technical and scientific requirements for technologies, methods or products developed under the regulatory sandbox, taking due account of the potential risks of thereof for human and animal health and the environment; | (a) develop and make publicly available technical and scientific requirements for technologies, methods or products developed under the regulatory sandbox, taking due account of the potential risks to health, animal health, animal welfare and the environment, in line with a One Health approach; |
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Health biotechnology strategic projects, including high-impact health biotechnology strategic projects recognised in accordance with Regulation […] [European Biotech Act ] shall be deemed to contribute to the STEP objectives referred to in paragraph 1, point (a)(iii) or point (b), as appropriate. | 9. Biotechnology, particularly in the area of health, strategic projects, including high-impact biotechnology strategic projects recognised in accordance with Regulation […] [European Biotech Act ] shall be deemed to contribute to the STEP objectives referred to in paragraph 1, point (a)(iii) or point (b), as appropriate. |
| Text proposed by the Commission | Amendment |
|---|---|
| (60) ‘regulatory sandbox’ means a regulatory framework which allows to develop, assess and test innovative or adapted regulatory solutions within a controlled environment pursuant to a specific plan, for a limited time and under regulatory supervision and which facilitates the development, assessment, authorisation or monitoring of innovative activities or substances which are likely to fall within the scope of this Regulation. | (60) ‘regulatory sandbox’ means a regulatory framework which allows to develop, assess and test innovative or adapted regulatory solutions within a controlled environment pursuant to a specific plan, for a limited time and under regulatory supervision and which facilitates the development, assessment, authorisation or monitoring of innovative activities or substances which are likely to fall within the scope of this Regulation, without lowering the standards of donor and recipient protection, ethics, traceability, quality, safety, data protection and fundamental rights laid down in this Regulation. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may adopt implementing acts setting out criteria and procedures for the consultation of advisory bodies established under other relevant Union legislation in relation to the performance of the SCB tasks, including time limits for those bodies to issue their opinions in the framework of such consultation. | The Commission may adopt implementing acts setting out criteria and procedures for the consultation of advisory bodies established under other relevant Union legislation, including the European Medicines Agency where the substance, product or activity may fall within or interact with the framework for medicinal products, advanced therapy medicinal products or clinical trials, in relation to the performance of the SCB tasks, including time limits for those bodies to issue their opinions in the framework of such consultation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Where a regulatory sandbox concerns SoHO-based innovations that may be used as starting materials for, or otherwise be linked to, advanced therapy medicinal products, medicinal products or clinical trials, the competent authorities shall ensure appropriate coordination with the European Medicines Agency, national competent authorities for medicinal products and, where relevant, the competent authorities responsible for clinical trials. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2b. Where a regulatory sandbox concerns rare diseases, rare cancers, paediatric conditions or other complex diseases with high unmet medical need, competent authorities shall, where appropriate, take into account input from relevant clinical networks, including interconnected and interoperable ERNs, in relation to clinical expertise, patient identification, referral pathways, feasibility, evidence generation and post-use outcome monitoring. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall publish and keep up to date a list of health biotechnology strategic projects and high impact health biotechnology strategic projects. | The Commission shall publish and keep up to date a list of biotechnology strategic projects, high impact biotechnology strategic projects and pan-European high impact biotechnology projects. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 62a | |
| Union scientific and regulatory capacity | |
| 1. The Commission shall ensure that relevant Union agencies and bodies, including the European Medicines Agency, the European Centre for Disease Prevention and Control, the European Food Safety Authority, the European Chemicals Agency, the European Environment Agency and the European Defence Agency, have the necessary resources to support the implementation of this Regulation within their respective mandates. | |
| 2. The Commission shall promote structured cooperation and regular exchange between the agencies and bodies referred to in paragraph 1, within their respective mandates, in order to ensure coherent scientific advice, avoid unnecessary duplication and administrative burden, identify cross-sector risks and support coordinated regulatory preparedness for biotechnology applications. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The evaluation referred to in paragraph 1 shall include, in particular, an assessment of: | |
| (a) the impact of this Regulation on the acceleration, simplification and coordination of clinical trials in the Union; | |
| (b) remaining regulatory and administrative fragmentation between Member States and the potential necessity for further Union-level coordination and convergence; | |
| (c) the impact of supplementary protection certificate extensions | |
| (d) Union and international developments in biosecurity, biosafety and bioterrorism-related risks; and | |
| (e) the financial incentives and recognition of strategic projects on the footprint of the biotechnological industry in the Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Member States shall, upon request, provide the Commission with any relevant information they have and that the Commission may need for its assessment pursuant to in paragraph 1. | 2. The Member States shall, upon request, provide the Commission with any relevant information they have and that the Commission may need for its assessment pursuant to in paragraphs 1 and 2. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Before adopting implementing acts under Articles 4(2), 6(3), 10(4), 35, 37 and relevant data provisions, the Commission shall consult relevant stakeholders and publish a summary of how comments were addressed. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) Article 58, points (5) to (12) and points (15) to (24) shall apply as of [OP, please insert date: six months after entry into force of this Regulation]; | (a) Article 58, points (5) to (12) and points (15) to (24) shall apply as of [OP, please insert date: four months after entry into force of this Regulation]; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) Article 58, point (13) shall apply as of [OP, please insert date: nine months after entry into force of this Regulation]; | (b) Article 58, point (13) shall apply as of [OP, please insert date: three months after entry into force of this Regulation]; |
Back matter, 2
Parts that accompany the text rather than belong to it: explanatory statement, annexes, opinions appended by other committees. Collapsed.
Explanatory statement 11 blocks
For the past decades, Europe has been a centre of excellence in biotechnology, especially in the area of health, with world-class research, talent and scientific leadership. However, internal fragmentation and a shifting geopolitical landscape are now reshaping that position. The entire ecosystem surrounding biotechnological innovation has become deeply strategic in nature with strong competition from others, such as China and the United States. This new reality is now more tangible than ever. Across almost every stage of the biotech lifecycle - from access to capital and clinical trials to manufacturing, commercialisation and thus access to patients - Europe is losing market share to its global competitors. If the Union wants to keep up its ambitions on strategic autonomy and resilience in the domain of life sciences, it will have to embrace its strengths while acknowledging its issues and act accordingly.
The European Biotech Act I should therefore support our European ecosystem to turn scientific excellence into accessible innovation, and into a competitive and thriving biotechnology and biomanufacturing base, resilient industrial capacity, faster multinational clinical trials and concrete benefits for patients, citizens and society. The draft report therefore seeks to shape the Act as a broad biotechnology framework with health as its central priority, while keeping a coherent, science-based approach to biotechnology applications beyond health, including novel foods, sustainable food innovation and other emerging uses where safety is demonstrated.
First and foremost, building a coherent European biotechnology innovation ecosystem, with health at its centre, is crucial to compete against our global competitors. For too long, fragmentation was refraining our inherent talent from flourishing. The Union already has many of the necessary building blocks, including the European Health Data Space, European Reference Networks, biobanks, genomic initiatives, hospitals, universities, public research infrastructures, biotech clusters and innovative SMEs. However, these elements remain siloed, lacking the links needed to function as one ecosystem. The amendments therefore aim to better connect research, clinical care, regulators, manufacturers, public payers, patients and industry, in order to support a stronger translational continuum from research to patient access. This includes stronger pan-European clusters and collaboration in areas such as rare diseases including rare cancers, cancer, multicomplex metabolic and other diseases, clinical trials, advanced therapies, gene editing and personalised medicine, within and between all Member States.
This goes hand in hand with strengthening European biotechnology and industrial capacity and promoting resilient supply chains. Europe should remain globally competitive and reduce strategic dependencies. The proposed amendments therefore underline the need for resilient biomanufacturing, stronger support for SMCs, SMEs, start-ups and scale-ups, better access to risk-tolerant capital and a coherent financing framework across the full innovation chain.
Reducing regulatory burden, fragmentation and mobilising strategic projects are different sides of one competitiveness argument for securing European biomanufacturing capacity. Regulatory fragmentation and administrative burden must be tackled both to improve competitiveness and patient access: divergent national rules, duplicative requirements and slow, unpredictable procedures act as a tax on European innovators and deter investment. The same logic of priority and acceleration is given concrete form through biotechnology strategic projects, high impact biotechnology strategic projects and Pan-European high impact strategic projects, which, in recognition of their contribution to Union biomanufacturing capacity and supply resilience, are treated as being in the public interest: they are granted the highest national significance available under national law, priority and time-bound permitting — capped at six months for strategic projects and four months for high-impact projects — priority administrative support, and a fast-track route to Union financial support, including blended financing and support from national promotional banks and European Investment Bank.
The proposed changes to the Clinical Trials Regulation are essential to achieve those objectives and to reverse the decline and fragmentation of clinical trial activity in Europe. Without fast and predictable procedures, the Union’s market share will continue to decrease, while delays and divergent national procedures remain a major barrier for patients, researchers and innovative companies, particularly for multinational clinical trials. A more centralized approach, including a firm reduction of timelines, serves this goal, as well as the additional and more specific accelerated procedures for public health emergencies, cross-border threats to health, rare and ultra-rare diseases and critical medicines. Such coordination is especially important for rare diseases including rare cancers, cancer, multicomplex metabolic diseases and advanced therapies, where patient populations are small, expertise is dispersed across Member States and cross-border recruitment is essential. Only with a clear and more harmonized framework, our ecosystem will be able to thrive and compete against third countries. Those changes shall not lower the standards of subject safety, scientific robustness, data quality, ethical review, informed consent, protection of vulnerable subjects, data protection or good clinical practice under this Regulation.
It is clear that no Member State can alone provide the expertise, patient pools, data, infrastructure and investment needed to address rare, low-prevalence and complex diseases. The amendments therefore seek to promote a more integrated European research, innovation and care ecosystem, using rare diseases and interoperable and interconnected European Reference Networks as a flagship example of what a stronger European Health Union can deliver. This includes stronger links between ERNs, biobanks, registries, genomic initiatives, clinical research infrastructures and advanced therapy centres, as well as more operational cross-border patient pathways where treatment cannot be provided in all Member States.
The amendments to the regulation underline that biosecurity, including bioterrorism-related risks, should be addressed through coherent minimum safety standards at Union and global level, preventing misuse while safeguarding legitimate research and promoting better cooperation between EU agencies based on One Health approach.
In an ever-more interconnected and data-driven world, accelerating responsible data and AI is becoming more important than ever. The responsible use of real-world evidence, the European Health Data Space and trustworthy AI can improve diagnostics, support personalised medicine and accelerate patient-centred innovation. This requires robust data protection, cybersecurity, anonymisation or pseudonymisation, and meaningful human oversight. Clinical trials, datasets, innovation pathways and New Approach Methodologies must reflect real-world diversity in order to avoid bias and unequal outcomes.
Taken together, these priorities aim to ensure that the European Biotech Act becomes more than a narrow ’one-issue instrument’. It should bring together industrial competitiveness with clear health benefits for patients. It should therefore establish a European biotechnology model that is competitive, fair and scientifically robust, leading to concrete benefits to European industry and people. More broadly, the Act should help Europe remain and strengthen its competitiveness of biotechnology as a cross-sectorial enabling technology. The objective is to build a Union-wide biotechnology ecosystem that strengthens Europe’s strategic capacity, creates quality jobs, supports resilient systems and ensures that the benefits of biotechnology reach patients, industry, citizens and society across all Member States.
Annex: declarations of input 10 blocks
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he included in his report input on matters pertaining to the subject of the file that he received, in the preparation of the draft report, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:
| 1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register |
| European Patients' Forum (EPF) |
| EuropeaBio |
| European Commission |
| European Medicines Agency |
| European Food Safety Authority |
| European Defence Agency |
| European Environment Agency |
| European Chemicals Agency |
| Medicines for Europe |
| Eurogroup for Animals |
| European Federation of Pharmaceutical Industries and Associations |
| Burson Cohn & Wolfe SRL |
| Resilience Action Network International |
| Novartis International AG |
| Corteva Agriscience International SARL |
| Psychedelic Participant Advocacy Network |
| AstraZeneca PLC |
| Läkemedelsindustriföreningen |
| CropLife Europe |
| BeOne Medicines I GmbH |
| Pfizer Inc. |
| Bayer AG |
| Johnson & Johnson |
| Merck Sharp & Dohme Europe Belgium SRL |
| Breakthrough T1D |
| SANOFI |
| Digestive Cancers Europe |
| Deutsche Sozialversicherung Europavertretung |
| European CRO Federation |
| IQVIA Solutions B.V. |
| GSK |
| Brunswick Group Limited srl |
| American Chamber of Commerce to the European Union |
| Food Supplements Europe |
| Bristol-Myers Squibb |
| Kaneka Europe Holding Company N.V. |
| A. Menarini Industrie Farmaceutiche Riunite s.r.l. |
| European Organisation for Rare Diseases |
| Rijksinstituut voor ziekte- en invaliditeitsverzekering |
| BIOTON S.A. |
| EUCOPE |
Where natural persons are identified in the list by their name, by their function or by both, the rapporteur declares that he has submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he included in his report input on matters pertaining to the subject of the file that he received, in the preparation of the draft report, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:
| 1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register |
| AbbVie |
| AIM |
| Amgen |
| argenx |
| ARM |
| AstraZeneca |
| Bankinter Innovation Foundation |
| BAYER |
| bio.be/Essencia |
| BioMarin |
| Breakthrough T1D |
| Bristol Myers Squibb |
| Corbion |
| Cytiva |
| EFPIA |
| EFSA |
| EORTC |
| EUCOPE |
| EUCROF |
| Eurogroup for Animals |
| EuropaBio |
| European Reference Networks |
| Food Fermentation Europe |
| GE Healthcare |
| Good Food Institute Europe |
| GSK |
| HIPRA |
| IBMA Belgium |
| Johnson & Johnson |
| KU Leuven |
| Labcorp |
| Legend Biotech |
| LSMA |
| Medaxes |
| Medicines for Europe |
| Menarini |
| MSD Belgium |
| Novartis |
| NOVE |
| Novo Nordisk |
| Parea |
| Pfizer |
| Pharma.be |
| Rani |
| Sanofi |
| TRANSFORM Alliance |
| UHasselt |
| Ultragenyx |
| Valneva SE |
| VIB |
| VLEVA |
| VOKA |
Where natural persons are identified in the list by their name, by their function or by both, the rapporteur declares that he has submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.
Connections
The dossier, the decisions on this text and its other versions.
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Sources & citation
Where the facts on this page come from, and how to cite it.
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2026). “DRAFT REPORT on the proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)”. Text, 16 June 2026. docId CJ53-PR-789987. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/CJ53-PR-789987 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/CJ53-PR-789987 (CC BY 4.0).
BibTeX
@misc{epw-text-cj53-pr-789987,
author = {{European Parliament}},
title = {{DRAFT REPORT on the proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)}},
year = {2026},
date = {2026-06-16},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/CJ53-PR-789987}},
url = {https://news.eu-parl.st-solutions.dev/texts/CJ53-PR-789987},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId CJ53-PR-789987. Data: EP Open Data API: document record (CC BY 4.0)}
}