opinion parliamentary committee, 9 September 2026
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 JURI-AD-789902 · (COM(2025)1022 – C100363/2025 – 2025/0406(COD))
Committee on Legal Affairs · Rapporteur: Tiemo Wölken
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Short justification 224 paragraphs
In the current geopolitical context, characterised by increasing global competition, supply chain vulnerabilities and growing dependencies on third-country production, the Union must reinforce its capacity to manufacture medicinal products within Europe. This objective is reflected across several recent policy initiatives, including the proposed Critical Medicines Act, which seeks to strengthen security of supply and reduce strategic dependencies. In this context, the rapporteur wishes to underline the importance of extending the stockpiling provisions under the Supplementary Protection Certificate (SPC) Manufacturing Waiver.
Against this background, allowing unlimited stockpiling of biosimilars during the SPC term would contribute to the Union’s competitiveness and manufacturing base by enabling production within the Union ahead of market entry. Such an approach would ensure that biosimilars manufactured in Europe can not only be exported to third-country markets but can also enter the Union market immediately upon expiry of the supplementary protection certificate (SPC), or of the basic patent where no SPC exists. This measure would facilitate EU-Day-1 entry, enhance competition, improve patient access to affordable medicines and further support the Union’s objectives of strategic autonomy, supply security and industrial resilience.
At the same time, the rapporteur considers that the recently concluded agreement between the co-legislators on the general pharmaceutical legislation has established a comprehensive and carefully balanced framework for pharmaceutical incentives. As that reform specifically addresses the design and calibration of incentives for innovation, the Biotech Act is not the appropriate legislative instrument through which to reopen discussions on additional exclusivity-based incentives. Furthermore, any sector-specific incentive limited to biological medicinal products would risk distorting the innovation landscape by favouring one category of medicines over others, including potentially transformative therapies developed through different technological platforms. The Union’s regulatory framework should remain technology-neutral and support innovation across all therapeutic areas and product categories.
The rapporteur has additionally strengthened the provisions relating to the ethical use of artificial intelligence. While AI offers considerable opportunities to improve research, innovation and healthcare delivery, its use must remain human-centric, adhere to ethical standards and be subject to appropriate safeguards. Particular attention should be paid to transparency, accountability, the prevention of algorithmic bias, data protection and the maintenance of meaningful human oversight. Ensuring the trustworthy and ethical deployment of AI is essential to protecting patient rights, fostering public confidence and ensuring that technological progress benefits all citizens.
AMENDMENTS
The Committee on Legal Affairs submits the following to the Committee on Public Health and the Committee on Industry, Research and Energy, as the committees responsible:
Amendment 1
Proposal for a regulation
Recital 20 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (20a) Effective implementation of this Regulation requires a coherent, transparent and proportionate framework that supports research, innovation, scale-up and manufacturing across the Union while maintaining high standards for the protection of human and animal health, patients, the environment, ethics and biosecurity. The Commission and the Member States should cooperate closely, in consultation with relevant stakeholders, to promote consistent implementation, evidence-based decision-making, regulatory clarity, the exchange of best practices and coordination across relevant Union and national initiatives, with a view to avoiding unnecessary duplication of efforts, assessments and administrative requirements. Such cooperation should contribute to strengthening the Union's biotechnology ecosystem by facilitating access to expertise, research and technology infrastructures, funding opportunities and skilled talent, in particular for SMEs, start-ups, scale-ups, public research organisations and emerging innovation ecosystems. It should also support the balanced development, competitiveness, resilience and sustainability of the Union's biotechnology and biomanufacturing sectors, while contributing, to the affordability and equitable access to biotechnology-based products and solutions, without lowering applicable standards of safety, ethics, scientific quality or environmental protection. |
Amendment 2
Proposal for a regulation
Read the rest (212 paragraphs)
Recital 21
| Text proposed by the Commission | Amendment |
|---|---|
| (21) Recognising the transformative role of data and AI in the area of biotechnology and biomanufacturing, that mapping should also assess access to data, computing capacity and digital infrastructure for the health biotechnology sector and identify measures to foster responsible AI-enabled biotechnology innovation and possible measures to mitigate related risks, building on analyses done in the context of existing Union initiatives such as the European Health Data Space14 , the Apply AI Strategy15 , the Data Union Strategy16 , the AI Continent Action Plan17 and the European Strategy for AI in Science18 . With a view to ensuring appropriate cooperation with the Member States and optimising the use of relevant knowledge and expertise available at Union level, such mapping should be conducted by the Commission in cooperation with relevant Union agencies and bodies, including, where relevant, the AI Board established under the Regulation (EU) 2024/1689, and with the European Health Biotechnology Steering Group (‘the Steering Group’) established in accordance with this Regulation, to facilitate its implementation, provide advice to the Commission and to the Member States, and ensure coordinated action in particular with regard to health biotechnology strategic projects and high impact health biotechnology strategic projects. | (21) Recognising the transformative role of data and AI in the area of biotechnology and biomanufacturing, that mapping should also assess access to data, computing capacity and digital infrastructure for the health biotechnology sector and identify measures to foster responsible AI-enabled biotechnology innovation and possible measures to mitigate related risks, ensuring the ethical use of AI and building on analyses done in the context of existing Union initiatives such as the European Health Data Space14, the Apply AI Strategy15, the Data Union Strategy16, the AI Continent Action Plan17 and the European Strategy for AI in Science18. With respect to AI-enabled biotechnology innovation, specific attention should be given to the ethics standards applicable to AI applications in the field of biotechnology and health, and the potential need to adapt them in light of technological developments and of their potential systemic risks, as foreseen by Regulation (EU) 2024/1689. With a view to ensuring appropriate cooperation with the Member States and optimising the use of relevant knowledge and expertise available at Union level, such mapping should be conducted by the Commission in cooperation with relevant Union agencies and bodies, including, where relevant, the AI Board established under the Regulation (EU) 2024/1689, and with the European Health Biotechnology Steering Group (‘the Steering Group’) established in accordance with this Regulation, to facilitate its implementation, provide advice to the Commission and to the Member States, and ensure coordinated action in particular with regard to health biotechnology strategic projects and high impact health biotechnology strategic projects. |
| 14 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj). | 14 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj). |
| 15 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Apply AI Strategy, COM(2025)723 final of 8 October 2025. | 15 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Apply AI Strategy, COM(2025)723 final of 8 October 2025. |
| 16 Communication from the Commission to the European Parliament and the Council, Data Union Strategy, Unlocking Data For AI, COM(2025) 835 final, 19 November 2025. | 16 Communication from the Commission to the European Parliament and the Council, Data Union Strategy, Unlocking Data For AI, COM(2025) 835 final, 19 November 2025. |
| 17 https://ec.europa.eu/newsroom/dae/redirection/document/114523 | 17 https://ec.europa.eu/newsroom/dae/redirection/document/114523 |
| 18 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: European Strategy for Artificial Intelligence in Science – Harnessing AI for research, innovation and excellence in the Union, COM(2025)724 final of, 8 October 2025. | 18 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: European Strategy for Artificial Intelligence in Science – Harnessing AI for research, innovation and excellence in the Union, COM(2025)724 final of, 8 October 2025. |
Amendment 3
Proposal for a regulation
Recital 57
| Text proposed by the Commission | Amendment |
|---|---|
| (57) Medicinal products developed with innovative biotechnology technologies which will bring a therapeutic advantage to patients should be incentivised with an extension of the Supplementary Protection Certificate. | (57) In view of increasing global competition in the biotechnology and pharmaceutical sectors, the Union should preserve a stable, predictable and innovation-friendly intellectual property framework that supports investment in research, development and manufacturing, in particular within the Union. In order to strengthen the Union's competitiveness and resilience, medicinal products developed using innovative biotechnologies that provide a therapeutic advantage to patients should be eligible for a twelve-month extension of the duration of the Supplementary Protection Certificate (SPC). That incentive aims to support investment in research and development, the manufacturing of medicinal products and the conduct of multi-country clinical trials within the Union. |
Amendment 4
Proposal for a regulation
Recital 57 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (57a) The aim of this Regulation is to allow makers of biosimilars established in the Union to make and store products, or medicinal products containing those products, in a Member State for an unlimited period pending the expiry of the certificate, for the purpose of entering the market of any Member State upon expiry of the corresponding certificate, thereby helping those makers to compete effectively in the Union immediately after protection has expired (‘EU day-one entry’) and thus supporting the Union’s strategic autonomy and competitiveness by fostering a more stable and predictable market environment, encouraging investment and supporting innovation in the pharmaceutical sector. |
Amendment 5
Proposal for a regulation
Recital 57 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (57b) Since the adoption in 1992 of the predecessor to Regulation (EC) No 469/2009, markets have evolved significantly and there has been huge growth in the making of especially of biosimilars, and in the making of their active ingredients, in particular in countries outside the Union (‘third countries’) in which protection does not exist or has expired. |
Amendment 6
Proposal for a regulation
Recital 57 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (57c) Makers of biosimilar medicinal products established in the Union are currently prevented from making biosimilars for the purpose of storing them for an unlimited period before the expiry of the certificate. Those circumstances make it more difficult for those makers, in contrast to makers located in third countries where protection does not exist or has expired, to enter the Union market immediately after expiry of the certificate, given that they are not in a position to build up production capacity for the purpose of entering the market of a Member State until the protection provided by that certificate has expired. |
Amendment 7
Proposal for a regulation
Recital 57 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (57d) Those circumstances put makers of biosimilars established in the Union at a significant competitive disadvantage in comparison with makers based in third countries that offer less or no protection. The Union should strike a balance between restoring a level playing field between those makers and ensuring that the essence of the exclusive rights of holders of certificates (‘certificate holders’) is guaranteed in relation to the Union market. |
Amendment 8
Proposal for a regulation
Recital 57 e (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (57e) Without intervention, the viability of makers of biosimilars established in the Union could be threatened, with consequences for the Union's pharmaceutical industrial base as a whole. That situation could affect the fully effective functioning of the internal market through the loss of potential new business opportunities for makers of biosimilars, thereby possibly diminishing related investments and hampering job creation within the Union. |
Amendment 9
Proposal for a regulation
Recital 57 f (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (57f) The timely entry of biosimilars into the Union market is important, particularly in order to increase competition, to reduce prices and to ensure that national healthcare systems are sustainable and that patients in the Union have better access to affordable medicines. |
Amendment 10
Proposal for a regulation
Recital 61
| Text proposed by the Commission | Amendment |
|---|---|
| (61) AI can enhance the development, safety, efficiency and scale-up of biotechnology and biomanufacturing, provided that its use is responsible and aligned with Union legislation. To pursue this, the Commission and the Member States should promote an AI-first policy approach as introduced in the Apply AI Strategy when implementing this Regulation and the exchange of knowledge, standards and best practices relevant to the responsible application of the AI-First Policy Approach36. The responsible and effective integration of AI can enhance research, development and regulatory processes and thereby support the competitiveness of Union innovators in biotechnology. The Commission and the Member States should therefore encourage the uptake of such approaches and facilitate the exchange of knowledge, standards and best practices relevant to their application. That cooperation should remain fully compliant with Union competition rules. | (61) AI can enhance the development, safety, efficiency and scale-up of biotechnology and biomanufacturing, provided that its use is responsible, transparent and aligned with Union legislation, with a focus on human-centric approach and contributes to the development of a secure, trustworthy and ethical AI, from grassroot research to the placing of products and services onto the Union market. To pursue this, the Commission and the Member States should promote an AI-first policy approach while ensuring a level playing field for all actors as introduced in the Apply AI Strategy when implementing this Regulation and the exchange of knowledge, standards and best practices relevant to the responsible application of the AI-First Policy Approach36. The responsible and effective integration of AI can enhance research, development and regulatory processes and thereby support the competitiveness of Union innovators in biotechnology Such integration should take place within a framework that encourages innovation while prioritizing legal clarity and high ethical standards, supporting a harmonised application of the EU law across the Member States. That framework should promote clear rules on responsibility for biotechnology products, in particular where AI is involved, as well as appropriate safeguards for genetic data, biosecurity and emerging technologies, thereby fostering public trust. The Commission and the Member States should therefore encourage the uptake of such approaches and facilitate the exchange of knowledge, standards and best practices relevant to their application. That cooperation should remain fully compliant with Union competition rules. At the same time ethical and professional standards for scientific research need to be ensured so that AI is used in an ethical and trustworthy way. |
| 36 Communication from the Commission to the European Parliament and the Council, Apply AI Strategy, COM/2025/723 final. | 36 Communication from the Commission to the European Parliament and the Council, Apply AI Strategy, COM/2025/723 final. |
Amendment 11
Proposal for a regulation
Recital 62
| Text proposed by the Commission | Amendment |
|---|---|
| (62) The rapid expansion and increasing complexity of AI applications throughout the medicinal-product lifecycle requires structured and coherent guidance to ensure their safe, effective and trustworthy use. The Agency is developing expertise in this area through initiatives such as the Good Manufacturing Practice (GMP) Annex 22 – Artificial Intelligence, Q&A in AI in Pharmacovigilance, the GCP Annex to the Guideline on computerised systems and electronic data in clinical trials and AI in Clinical Development. It is therefore appropriate for the Agency to develop non-binding guidance on the deployment and use of systems based on advanced technologies, including of AI systems and of general-purpose AI models across development, manufacturing, clinical trials, and post-authorisation activities for compliance with applicable Union legislation in the health area. To ensure consistency across the health and digital domains, when developing or updating such guidance, the Agency should cooperate with the Commission, including the AI office and should consult relevant national competent authorities and stakeholders, and relevant expert coordination groups established under Union legislation in the health and digital areas, as appropriate. | (62) The rapid expansion and increasing complexity of AI applications throughout the medicinal-product lifecycle requires structured and coherent guidance to ensure their safe, effective, ethical and trustworthy use. The Agency is developing expertise in this area through initiatives such as the Good Manufacturing Practice (GMP) Annex 22 – Artificial Intelligence, Q&A in AI in Pharmacovigilance, the GCP Annex to the Guideline on computerised systems and electronic data in clinical trials and AI in Clinical Development. It is therefore appropriate for the Agency to support the AI Office and the AI Board established under Regulation (EU) 2024/1689 to develop non-binding guidance on the deployment and use of systems based on advanced technologies, including of AI systems and of general-purpose AI models across development, manufacturing, clinical trials, and post-authorisation activities for compliance with applicable Union legislation in the health area. To ensure consistency across the health and digital domains, when developing or updating such guidance, the Agency should cooperate with the Commission, including the AI Office and should consult relevant national competent authorities and stakeholders, and relevant expert coordination groups established under Union legislation in the health and digital areas, as appropriate. |
Amendment 12
Proposal for a regulation
Recital 63
| Text proposed by the Commission | Amendment |
|---|---|
| (63) Moreover, the Agency should develop non-binding guidance on the deployment and use of AI systems and of general-purpose AI models also in the procedures for the authorisation of medicinal products, with a view to optimising processes and increasing efficiency of regulatory activities. Such guidance should be developed and published in agreement with the Commission, the AI Board and the competent authorities. | (63) Moreover, the Agency should support the AI Office and the AI Board established under Regulation (EU) 2024/1689 to develop non-binding guidance on the deployment and use of AI systems and of general-purpose AI models also in the procedures for the authorisation of medicinal products, with a view to optimising processes and increasing efficiency of regulatory activities. Such guidance should be developed and published in agreement with the Commission, the AI Board and the competent authorities. Such guidance shall furthermore support a homogenous application of common ethical principles enshrined in law when developing, deploying and using artificial intelligence, especially high-risk AI. |
Amendment 13
Proposal for a regulation
Recital 64
| Text proposed by the Commission | Amendment |
|---|---|
| (64) In order to accelerate the development and scale-up of biotechnology innovations that are enabled, enhanced or significantly supported by AI and advanced computational methods, the Union requires dedicated testing environments that combine experimental, computational and data-driven capabilities. Given their essential role for supporting AI-enabled biotechnology innovations, it is appropriate to establish requirements in this Regulation for the recognition by the Commission and the support for high-impact health biotechnology strategic projects in the form of biotechnology testing environments, under certain conditions. | (64) In order to accelerate the development and scale-up of biotechnology innovations that are enabled, enhanced or significantly supported by AI and advanced computational methods, the Union requires dedicated testing environments that combine experimental, computational and data-driven capabilities, while upholding high safety and ethical standards. Given their essential role for supporting AI-enabled biotechnology innovations, it is appropriate to establish requirements in this Regulation for the recognition by the Commission and the support for high-impact health biotechnology strategic projects in the form of biotechnology testing environments, under certain conditions. Particular attention should be given to areas where significant unmet medical needs persist, including women's health, and the EU should support the development of strategic projects and centres of excellence that advance innovation in these areas. The Agency should also require the generation of robust evidence on the safety and effectiveness of medicinal products for women throughout the medicinal product lifecycle. The Commission should furthermore put in place sufficient, effective and specific technical and organisational measures to safeguard the fundamental rights, high safety and ethical standards and interests of data subjects in line with Union Law. |
Amendment 14
Proposal for a regulation
Recital 65
| Text proposed by the Commission | Amendment |
|---|---|
| (65) Such environments could provide the wet-lab, bioprocess, pilot-line and translational validation capacities necessary for AI-enabled biotechnology development, and should complement, without duplicating, the functions of regulatory sandboxes established under Union or national law as well as the testing and experimentation facilities established in accordance with Regulation (EU) 2024/1689. Where relevant, they should also leverage health data and the European Health Data Space in accordance with Union legislation. These infrastructures should support the development of biotechnology applications where the use of AI has the potential to accelerate progress, in particular in health-related areas such as advanced therapies, where AI can improve efficacy and safety — for example through optimised CRISPR site prediction, tumour antigen identification, sequence engineering, delivery-vehicle design, or the matching of diverse patient cancer-cell variants with CAR-T cell types. | (65) Such environments could provide the wet-lab, bioprocess, pilot-line and translational validation capacities necessary for AI-enabled biotechnology development, and should complement, without duplicating, the functions of regulatory sandboxes established under Union or national law as well as the testing and experimentation facilities established in accordance with Regulation (EU) 2024/1689. Where relevant, they should also leverage health data and the European Health Data Space in accordance with Union legislation. These infrastructures should support the development of biotechnology applications where the use of AI has the potential to accelerate progress, in particular in health-related areas such as advanced therapies, where AI can improve efficacy and safety — for example through optimised CRISPR site prediction, tumour antigen identification, sequence engineering, delivery-vehicle design, or the matching of diverse patient cancer-cell variants with CAR-T cell types. Given the high sensitivity of personal electronic data pertaining to the health status of a data subject, this Regulation should provide sufficient safeguards at both Union and national level to ensure a high degree of data protection, security, confidentiality and ethical use. Such high protection standards and safeguards are necessary to promote trust in safe handling of electronic health data and in the development of biotechnology using it. Such safeguards should also contribute to preventing discriminatory outcomes and mitigating risks of bias in AI-enabled biotechnology applications, thereby supporting compliance with fundamental rights and the principle of non-discrimination under Union law. |
Amendment 15
Proposal for a regulation
Recital 66
| Text proposed by the Commission | Amendment |
|---|---|
| (66) Having high-quality, interoperable, provenance-verified and well-annotated datasets is essential for the development, testing and validation of trustworthy and competitive AI systems and models used in biotechnology applications. For example, datasets generated in the course of provision of healthcare are usually recorded in a way that supports their initial purpose, such as diagnosis or treatment. Often, they are technically not easily usable and fit for training, testing and validation of AI systems, for example due to the use of different data standards or lacking annotations. Given the potential of AI systems and models to support research and innovation in biotechnology applications, it is important to ensure that high-quality data are available for training, testing and validating AI systems and models used in health biotechnology applications. To make such data more easily usable for those purposes, it is appropriate to facilitate the enhancement of the quality of that data. Therefore, this Regulation should lay down provisions for the recognition by the Commission of high impact health biotechnology strategic projects in the form of biotechnology data quality accelerators, to provide assistance to entities that lawfully hold relevant data to improve data quality, standardize such data and make further improvements. | (66) Having high-quality, interoperable, provenance-verified and well-annotated datasets is essential for the development, testing and validation of trustworthy and competitive AI systems and models used in biotechnology applications. For example, datasets generated in the course of provision of healthcare are usually recorded in a way that supports their initial purpose, such as diagnosis or treatment. Often, they are technically not easily usable and fit for training, testing and validation of AI systems, for example due to the use of different data standards or lacking annotations. Given the potential of AI systems and models to support research and innovation in biotechnology applications, it is important to ensure that high-quality data are available for training, testing and validating AI systems and models used in health biotechnology applications. To make such data more easily usable for those purposes, it is appropriate to facilitate the enhancement of the quality of that data. Therefore, this Regulation should lay down provisions for the recognition by the Commission of high impact health biotechnology strategic projects in the form of biotechnology data quality accelerators, to provide assistance to entities that lawfully hold relevant data to improve data quality, standardize such data and make further improvements, while ensuring that ethical standards of AI use are adhered to. In order to support compliance with fundamental rights and the principle of non-discrimination, efforts to improve data quality should, where appropriate, include measures to minimise bias and enhance the representativeness of datasets. |
Amendment 16
Proposal for a regulation
Recital 67
| Text proposed by the Commission | Amendment |
|---|---|
| (67) Such biotechnology data quality accelerator projects should complement Union initiatives such as data labs37 and by addressing the specific data-quality requirements of biotechnology, ensuring that biological and health datasets are reliable, interoperable and usable for the development of advanced AI models. | (67) Such biotechnology data quality accelerator projects should complement Union initiatives such as data labs37 and by addressing the specific data-quality requirements of biotechnology, ensuring that biological and health datasets are reliable, interoperable, without any discriminatory impacts and unfair biases and usable for the development of advanced AI systems and models. |
| 37 Proposed in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A European Strategy for Artificial Intelligence in Science – Paving the way for the Resource for AI Science in Europe (RAISE), COM(2025) 724 final of 8 October 2025. | 37 Proposed in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A European Strategy for Artificial Intelligence in Science – Paving the way for the Resource for AI Science in Europe (RAISE), COM(2025) 724 final of 8 October 2025. |
Amendment 17
Proposal for a regulation
Recital 85
| Text proposed by the Commission | Amendment |
|---|---|
| (85) The biotechnology landscape is evolving at an unprecedented speed, driven by advances in synthetic biology and genome editing, which, coupled with AI, make biotechnology stand at the forefront of innovation, offering unprecedented opportunities for advancing health and protecting against biological threats. These advances also make biotechnological misuse faster, cheaper, and more accessible. Biotechnologies can pose serious and distinctive risks that call for continuous assessment and anticipatory safeguards. Therefore, a limited set of biotechnology products with significant potential for misuse (‘biotechnology products of concern’) require a specific framework to prevent and protect against their misuse. | (85) The biotechnology landscape is evolving at an unprecedented speed, driven by advances in synthetic biology and genome editing, which, coupled with AI, make biotechnology stand at the forefront of innovation, offering unprecedented opportunities for advancing health and protecting against biological threats. These advances also make biotechnological misuse faster, cheaper, and more accessible. Biotechnologies can pose serious and distinctive risks that call for continuous assessment and anticipatory safeguards. Therefore, a limited set of biotechnology products with significant potential for misuse (‘biotechnology products of concern’) require a specific framework to prevent and protect against their misuse. Where the risk related to health are particularly high, increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate, while avoiding discriminatory impacts and unfair biases in accordance with Union or national law. |
Amendment 18
Proposal for a regulation
Recital 86
| Text proposed by the Commission | Amendment |
|---|---|
| (86) Union and international rules address certain aspects related to biological threats, biological incidents or biological risks, in particular in relation to serious cross-border threats to health42 , the control of exports, brokering, technical assistance, transit and transfer of dual-use items43 , resilience in biosafety and biosecurity through the Biological and Toxin Weapons Convention (BTWC)44 , the Chemical Weapons Convention (CWC), the contained use of genetically modified micro-organisms45 , workers’ protection from risks related to exposure to biological agents at work46 , in relation to AI systems and models through Regulation (EU) 2024/1689. However, the approach remains fragmented and does not sufficiently address all aspects related to the misuse related to biotechnologies. A consistent and high level of protection throughout the Union should therefore be ensured in order to guarantee biotechnology remains trustworthy and provides legal certainty for economic operators in the biotechnology sector. | (86) Union and international rules address certain aspects related to biological threats, biological incidents or biological risks, in particular in relation to serious cross-border threats to health42, the control of exports, brokering, technical assistance, transit and transfer of dual-use items43, resilience in biosafety and biosecurity through the Biological and Toxin Weapons Convention (BTWC)44, the Chemical Weapons Convention (CWC), the contained use of genetically modified micro-organisms45, workers’ protection from risks related to exposure to biological agents at work46, in relation to AI systems and models through Regulation (EU) 2024/1689. However, the approach remains fragmented and does not sufficiently address all aspects related to the misuse related to biotechnologies. A consistent and high level of protection throughout the Union should therefore be ensured in order to guarantee biotechnology remains ethical, trustworthy and provides legal certainty for economic operators in the biotechnology sector. |
| 42 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/, p. 26. ELI: http://data.europa.eu/eli/reg/2022/2371/oj. | 42 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/, p. 26. ELI: http://data.europa.eu/eli/reg/2022/2371/oj. |
| 43 Regulation (EU) 2021/821 of the European Parliament and of the Council of 20 May 2021 setting up a Union regime for the control of exports, brokering, technical assistance, transit and transfer of dual-use items , OJ L 206, 11.6.2021, pp. 1. ELI: http://data.europa.eu/eli/reg/2021/821/oj. | 43 Regulation (EU) 2021/821 of the European Parliament and of the Council of 20 May 2021 setting up a Union regime for the control of exports, brokering, technical assistance, transit and transfer of dual-use items , OJ L 206, 11.6.2021, pp. 1. ELI: http://data.europa.eu/eli/reg/2021/821/oj. |
| 44 Council Decision (CFSP) 2023/2636 of 20 November 2023 amending Decision (CFSP) 2021/2072 in support of building resilience in biosafety and biosecurity through the Biological and Toxin Weapons Convention, no longer in force. OJ L, 2023/2636, 22.11.2023, ELI: http://data.europa.eu/eli/dec/2023/2636/oj | 44 Council Decision (CFSP) 2023/2636 of 20 November 2023 amending Decision (CFSP) 2021/2072 in support of building resilience in biosafety and biosecurity through the Biological and Toxin Weapons Convention, no longer in force. OJ L, 2023/2636, 22.11.2023, ELI: http://data.europa.eu/eli/dec/2023/2636/oj |
| 45 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance), OJ L 125, 21.5.2009, p. 75. ELI: http://data.europa.eu/eli/dir/2009/41/oj. | 45 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance), OJ L 125, 21.5.2009, p. 75. ELI: http://data.europa.eu/eli/dir/2009/41/oj. |
| 46 Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC), OJ L 262, 17.10.2000, p. 21. ELI: http://data.europa.eu/eli/dir/2000/54/oj. | 46 Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC), OJ L 262, 17.10.2000, p. 21. ELI: http://data.europa.eu/eli/dir/2000/54/oj. |
Amendment 19
Proposal for a regulation
Recital 98
| Text proposed by the Commission | Amendment |
|---|---|
| (98) Certain tools with a potential to be misused without further modification and to cause serious harm to public health and safety, agricultural crops and other plants, to animals, the environment, material or government security (dual-use research of concern - ‘DURC’) are increasingly affordable and accessible, also through progress in AI capabilities, which elevates the risk of misuse by actors lacking appropriate competence, oversight, legitimate or peaceful intent. A proportionate and risk-based framework is therefore necessary to minimise opportunities for misuse of DURC, including on AI models in biological applications, while preserving legitimate research and innovation. | (98) Certain tools with a potential to be misused without further modification and to cause serious harm to public health and safety, agricultural crops and other plants, to animals, the environment, material or government security (dual-use research of concern - ‘DURC’) are increasingly affordable and accessible, also through progress in AI capabilities, which elevates the risk of non-ethical use and misuse of AI by actors lacking appropriate competence, oversight, legitimate or peaceful intent. A proportionate and risk-based framework is therefore necessary to minimise opportunities for misuse of DURC, including on AI models and systems in biological applications, while preserving legitimate research and innovation. |
Amendment 20
Proposal for a regulation
Recital 102
| Text proposed by the Commission | Amendment |
|---|---|
| (102) AI offers significant potential to enhance the Union’s competitiveness and innovation capacity, including in the area of biotechnology. This potential should be realised in a safe and responsible manner. In this regard, Regulation (EU) 2024/1689 lays down harmonised rules for placing on the market putting into service and use of AI systems and models in the Union, prohibitions of certain AI practices, harmonised transparency rules for certain AI systems, rules on market monitoring, market surveillance, governance and enforcement as well as measures to support innovation. AI systems and general-purpose AI models can lower the barrier for actors to misuse biotechnology. The provisions of Regulation (EU) 2024/1689 governing AI systems and general-purpose AI models aim to mitigate this. Further, AI models, as described in Regulation (EU) 2024/1689, used in biological applications, that are not covered by Regulation (EU) 2024/1689 (‘AI models in biological applications’) can also pose risks, including different types of systemic biological risks. | (102) AI offers significant potential to enhance the Union’s competitiveness and innovation capacity, including in the area of biotechnology. This potential should be realised in a safe, ethical and responsible manner. In this regard, Regulation (EU) 2024/1689 lays down harmonised rules for placing on the market putting into service and use of AI systems and models in the Union, prohibitions of certain AI practices, harmonised transparency rules for certain AI systems, rules on market monitoring, market surveillance, governance and enforcement as well as measures to support innovation. AI systems and general-purpose AI models can lower the barrier for actors to misuse biotechnology. The provisions of Regulation (EU) 2024/1689 governing AI systems and general-purpose AI models aim to mitigate this. Further, AI models, as described in Regulation (EU) 2024/1689, used in biological applications, that are not covered by Regulation (EU) 2024/1689 (‘AI models in biological applications’) can also pose risks, including different types of systemic biological risks. |
Amendment 21
Proposal for a regulation
Recital 104
| Text proposed by the Commission | Amendment |
|---|---|
| (104) The Advisory Group should therefore monitor the capabilities of AI models in biological applications, working closely with scientists and companies developing such models and should be tasked to issue a qualified alert to the Commission if it identifies that an AI model in biological applications not covered by Regulation (EU) 2024/1689 poses biological systemic risk. The Advisory Group should inform the Scientific Panel of independent experts established under Article 68 of Regulation (EU) 2024/1689, if it has reasonable grounds to suspect that an AI model covered by that Regulation poses biological systemic risks. That panel could in turn issue a qualified alert to the AI Office in accordance with Regulation (EU) 2024/1689. Considering that the AI Office established by Commission Decision C(2024) 39047 has as its mission to develop Union expertise and capabilities in the field of AI and to contribute to the implementation of Union law on AI, that office should participate in the establishment of the Advisory Group. | (104) The Advisory Group should therefore closely collaborate with the AI Office and the AI Board to monitor the capabilities of AI models in biological applications, working closely with scientists and companies developing such models and should be tasked to issue a qualified alert to the Commission if it identifies that an AI model in biological applications not covered by Regulation (EU) 2024/1689 poses biological systemic risk. The Advisory Group should inform the Scientific Panel of independent experts established under Article 68 of Regulation (EU) 2024/1689, if it has reasonable grounds to suspect that an AI model covered by that Regulation poses biological systemic risks. That panel could in turn issue a qualified alert to the AI Office in accordance with Regulation (EU) 2024/1689. Considering that the AI Office established by Commission Decision C(2024) 39047 has as its mission to develop Union expertise and capabilities in the field of AI and to contribute to the implementation of Union law on AI, that office should participate in the establishment of the Advisory Group. |
| 47 Commission Decision of 24.1.2024 establishing the European Artificial Intelligence Office C(2024) 390. | 47 Commission Decision of 24.1.2024 establishing the European Artificial Intelligence Office C(2024) 390. |
Amendment 22
Proposal for a regulation
Recital 157
| Text proposed by the Commission | Amendment |
|---|---|
| (157) The integration of AI in clinical trials presents opportunities to enhance the clinical trials’ design, execution, and oversight. This technological advancement offers substantial benefits to clinical trial sponsors, regulators, and ultimately patients. Among the possible enhancements are improved endpoint determination, advanced statistical analysis, optimized patient selection, enhanced data handling and analysis. While AI tools aim to accelerate the development of medicinal products, it is imperative that their use in clinical trials adheres to applicable legislation. This includes, when applicable, compliance with Regulation (EU) 2024/1689, Regulation (EU) 2017/746, Regulation (EU) 2017/745 and Regulation (EU) 2016/679. | (157) The integration of AI in clinical trials presents opportunities to enhance the clinical trials’ design, execution, and oversight. This technological advancement offers substantial benefits to clinical trial sponsors, regulators, and ultimately patients. Among the possible enhancements are improved endpoint determination, advanced statistical analysis, optimized patient selection, enhanced data handling and analysis, without compromising privacy rights. While AI tools aim to accelerate the development of medicinal products, it is imperative that their use in clinical trials adheres to applicable legislation. This includes, when applicable, compliance with Regulation (EU) 2024/1689, Regulation (EU) 2017/746, Regulation (EU) 2017/745 and Regulation (EU) 2016/679. |
Amendment 23
Proposal for a regulation
Recital 158
| Text proposed by the Commission | Amendment |
|---|---|
| (158) Sponsors hold the responsibility to evaluate the potential impact and risk of AI tools on patient safety based on guidelines. Untested systems may introduce gender and other biases and errors, risking unreliable outcomes or failures in interpreting medical data accurately. Such risks could lead to misdiagnosis, incorrect treatment, or inaccurate patient selection, especially hazardous in extensive clinical trials with numerous participants. The guidelines on the developments and deployment of AI tools developed by the Agency, in cooperation with the Clinical Trials Coordination and Advisory Group, and as appropriate, with other expert groups established under Union law, should assist the sponsors, national competent authorities and ethics committees in assessment of AI tools benefits and risks in the context of the lifecycle of clinical trials. | (158) Sponsors hold the responsibility to evaluate the potential impact and risk of AI tools on patient safety based on guidelines. Untested systems may introduce gender and other biases and errors, risking unreliable outcomes or failures in interpreting medical data accurately. Such risks could lead to misdiagnosis, incorrect treatment, or inaccurate patient selection, especially hazardous in extensive clinical trials with numerous participants. The guidelines on the developments and deployment of AI tools developed by the Agency, in cooperation with the Clinical Trials Coordination and Advisory Group, and as appropriate, with other expert groups established under Union law, should assist the sponsors, national competent authorities and ethics committees in assessment of AI tools benefits and risks in the context of the lifecycle of clinical trials. The guidelines shall include the principles of human agency and oversight; technical robustness and safety; privacy and data governance; ethics, transparency, diversity, non-discrimination and fairness; societal and environmental well-being and accountability, as well as public health interest. |
Amendment 24
Proposal for a regulation
Recital 158 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (158a) The risk-based approach to AI use, as set down in Regulation (EU) 2024/1689, is the basis for a proportionate and effective set of binding rules. It is important to recall the 2019 Ethics Guidelines for Trustworthy AI developed by the independent AI HLEG appointed by the Commission. In those guidelines, the AI HLEG developed seven non- binding ethical principles for AI which are intended to help ensure that AI is trustworthy and ethically sound. The seven principles include human agency and oversight; technical robustness and safety; privacy and data governance; transparency; diversity, non-discrimination and fairness; societal and environmental well-being and accountability. Without prejudice to the legally binding requirements of this Regulation and any other applicable Union law, those guidelines contribute to the design of coherent, trustworthy and human-centric AI, in line with the Charter of Fundamental Rights of the European Union and with the values on which the Union is founded. According to the guidelines of the AI HLEG, human agency and oversight means that AI systems are developed and used as a tool that serves people, respects human dignity and personal autonomy, and that is functioning in a way that can be appropriately controlled and overseen by humans. Technical robustness and safety means that AI systems are developed and used in a way that allows robustness in the case of problems and resilience against attempts to alter the use or performance of the AI system so as to allow unlawful use by third parties, and minimise unintended harm. Privacy and data governance means that AI systems are developed and used in accordance with privacy and data protection rules, while processing data that meets high standards in terms of quality and integrity. Transparency means that AI systems are developed and used in a way that allows appropriate traceability and explainability, while making humans aware that they communicate or interact with an AI system, as well as duly informing deployers of the capabilities and limitations of that AI system and affected persons about their rights. Diversity, non-discrimination and fairness means that AI systems are developed and used in a way that includes diverse actors and promotes equal access, gender equality and cultural diversity, while avoiding discriminatory impacts and unfair biases that are prohibited by Union or national law. |
Amendment 25
Proposal for a regulation
Recital 166
| Text proposed by the Commission | Amendment |
|---|---|
| (166) Veterinary medicinal products developed by means of biotechnology processes to diagnose, treat or prevent zoonotic diseases should be entitled to an extra year of supplementary protection certificate (‘SPC’) in order to support their development. | (166) Veterinary medicinal products developed by means of biotechnology processes to diagnose, treat or prevent zoonotic diseases should be eligible for a twelve-months extension of supplementary protection certificate (‘SPC’) in order to support their development. In accordance with the One Health approach, this incentive should recognise the public health value of the prevention of zoonoses and address the insufficient level of investment in that area, thereby contributing to the Union's preparedness for animal health threats. |
Amendment 26
Proposal for a regulation
Article 1 – paragraph 2 – point f
| 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 AI in biological applications, into the Union’s health biotechnology ecosystems, while monitoring and mitigating, in line with the Union legislation on AI, biological risks arising from the use of such technologies; |
Amendment 27
Proposal for a regulation
Article 1 – paragraph 5 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. This Regulation shall apply without prejudice to Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data. |
Amendment 28
Proposal for a regulation
Article 17 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The Commission, in close cooperation with the Steering Group referred to in Article 20 and where appropriate the AI Board established under the Regulation (EU) 2024/1689, shall conduct, no later than six months after the entry into force of this Regulation, and maintain thereafter a strategic mapping of the biotechnology ecosystem in the Union. | 1. The Commission, in close cooperation with the Steering Group referred to in Article 20 and the AI Board established under the Regulation (EU) 2024/1689, shall conduct, no later than six months after the entry into force of this Regulation, and maintain thereafter a strategic mapping of the biotechnology ecosystem in the Union. |
Amendment 29
Proposal for a regulation
Article 17 – paragraph 2 – point e
| Text proposed by the Commission | Amendment |
|---|---|
| (e) use of data and AI, by assessing access to data, computing and digital infrastructures for biotechnology and identifying opportunities to foster responsible AI-enabled innovation and mitigate related risks. | (e) use of data and AI, by assessing access to data, computing and digital infrastructures for biotechnology and identifying opportunities to foster ethical and responsible AI-enabled innovation and mitigate related risks, used in a manner that guarantees human oversight, promotes transparency regarding the intended purpose and limitations of AI systems, and includes appropriate safeguards against discriminatory outcomes and bias. |
Amendment 30
Proposal for a regulation
Article 17 – paragraph 3 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. The Commission shall, where appropriate, make use of existing data collection mechanisms and aim to avoid duplication of reporting obligations under Union law. |
Amendment 31
Proposal for a regulation
Article 19 – paragraph 3 – point f
| 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 rapid, responsible and effective integration of AI, by providing sector-specific guidance and promoting best practices and standards for ethical and trustworthy AI, including transparency, traceability, human oversight and mechanisms enabling independent verification of compliance with Union rules, in coordination with the bodies established under Regulation (EU) 2024/1689, and by providing legal certainty through regulatory support and targeted assistance, in particular to SMEs, start-ups, scale-ups, and SMCs, to facilitate innovation, investment, and market uptake across the Union; |
Amendment 32
Proposal for a regulation
Article 27 – paragraph 1 – introductory part
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Where a marketing authorisation is granted by the Union to a medicinal product for human use developed by means of biotechnological processes referred to in paragraph 1 of Annex I to Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] or to an advanced therapy medicinal product referred to in paragraph 2 of that Annex, and that is protected either by a supplementary protection certificate in accordance with Regulation (EC) No 469/2009 of the European Parliament and of the Council69, or by a patent which qualifies for the granting of such supplementary protection certificate, the holder of a patent or of such certificate shall be entitled to a 12-month extension of the periods referred to in Article 13, paragraphs (1) and (2), of Regulation (EC) No 469/2009, provided that the marketing authorisation applicant demonstrates that all of the following conditions are met: | 1. Where a marketing authorisation is granted by the Union to a medicinal product for human use developed by means of biotechnological processes referred to in paragraph 1 of Annex I to Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] or to an advanced therapy medicinal product referred to in paragraph 2 of that Annex, and that is protected either by a supplementary protection certificate in accordance with Regulation (EC) No 469/2009 of the European Parliament and of the Council69, or by a patent which qualifies for the granting of such supplementary protection certificate, the holder of a patent or of such certificate shall be entitled to a twelve-month extension of the periods referred to in Article 13, paragraphs (1) and (2), of Regulation (EC) No 469/2009, provided that the marketing authorisation applicant demonstrates that all of the following conditions are met: |
| 69 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, OJ L 152, 16.6.2009, pp. 1. | 69 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, OJ L 152, 16.6.2009, pp. 1. |
Amendment 33
Proposal for a regulation
Article 27 – paragraph 1 – point a
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the medicinal product contains a new active substance distinctly different from that of any authorised medicinal product in the Union; | (a) the medicinal product contains a new active substance different from that of any authorised medicinal product in the Union or the medicinal product has a mechanism of action different and shows a level of safety and efficacy which is at least equivalent to that of any authorised medicinal product in the Union for the same indication; |
Amendment 34
Proposal for a regulation
Article 27 – paragraph 1 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the medicinal product has a mechanism of action distinctly different and shows a level of safety and efficacy which is at least equivalent to that of any authorised medicinal product in the Union for the same disease; | deleted |
Amendment 35
Proposal for a regulation
Article 27 – paragraph 1 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the clinical trials evaluating the efficacy of the medicinal product and supporting its marketing authorisation were conducted in more than two Member States; | (b) the clinical trials evaluating the efficacy of the medicinal product and supporting its marketing authorisation were conducted in more than two Member States; |
Amendment 36
Proposal for a regulation
Article 27 – paragraph 1 – point d
| Text proposed by the Commission | Amendment |
|---|---|
| (d) at least a manufacturing step, excluding packaging, quality testing and certification is performed in the Union. | (c) at least one manufacturing step is carried out in the Union other than import, repackaging, packaging other than immediate packaging, labelling, quality testing and, where applicable, certification. |
Amendment 37
Proposal for a regulation
Article 31 – paragraph 1 – subparagraph 1
| 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 its ethical use, in the lifecycle of medicinal products development, including during pre-clinical research, clinical development and trials, manufacturing and post-authorisation monitoring, with a view to facilitating innovation, accelerating the ethical, safe and responsible uptake of advanced technologies, and providing regulatory clarity and predictability for developers, in particular SMEs, start-ups and scale-ups. |
Amendment 38
Proposal for a regulation
Article 31 – paragraph 3
| 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 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 and its ethical use, in the procedures for the authorisation of medicinal products. |
Amendment 39
Proposal for a regulation
Article 32 – paragraph 1 – point a
| Text proposed by the Commission | Amendment |
|---|---|
| (a) operate under trusted conditions ensuring compliance and alignment with relevant Union and national legislation and complements where appropriate testing and experimentation facilities and AI regulatory sandboxes established in accordance with Regulation (EU) 2024/1689, while ensuring consistency and synergies in their implementation; | (a) operate under trusted and ethical conditions ensuring compliance and alignment with relevant Union and national legislation and complements where appropriate testing and experimentation facilities and AI regulatory sandboxes established in accordance with Regulation (EU) 2024/1689, while ensuring consistency and synergies in their implementation; |
Amendment 40
Proposal for a regulation
Article 32 – paragraph 1 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) seek, where appropriate, to leverage AI systems or other advanced computational tools, alongside advanced technologies and analytics, to optimise workflows and increase efficiency; | (b) seek, where appropriate, to leverage AI systems and models or other advanced computational tools, alongside advanced technologies and analytics, to optimise workflows and increase efficiency; |
Amendment 41
Proposal for a regulation
Article 32 – paragraph 1 – point d
| 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 fair and transparent conditions, evidence, results and lessons learned, including on the ethical use of AI, 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. |
Amendment 42
Proposal for a regulation
Article 33 – paragraph 1
| 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 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, ethical 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. |
Amendment 43
Proposal for a regulation
Article 33 – paragraph 2 – point a
| 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 ethical, trustworthy and competitive AI systems; without unfair bias in health biotechnologies, including large-scale and general-purpose models relevant for biological, biomedical or biomanufacturing use; |
Amendment 44
Proposal for a regulation
Article 33 – paragraph 2 – point e
| Text proposed by the Commission | Amendment |
|---|---|
| (e) be aligned with and complement Union initiatives such as the Data Union Strategy, including data labs and AI factories, while addressing the specific requirements of biotechnology datasets, including biological metadata, scientific taxonomies, experimental traceability and regulatory-grade data quality. | (e) be aligned with and complement Union initiatives such as the Data Union Strategy, including data labs, AI factories and AI gigafactories, while addressing the specific requirements of biotechnology datasets, including biological metadata, scientific taxonomies, experimental traceability and regulatory-grade data quality. |
Amendment 45
Proposal for a regulation
Article 33 – paragraph 6
| 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, the European Health Data Space as established in Regulation (EU) 2025/327, data labs, AI factories, AI gigafactories, and the infrastructures operated by high impact health biotechnology strategic projects. |
Amendment 46
Proposal for a regulation
Article 52 – paragraph 2
| 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. It shall be selected and operate in accordance with the Commission’s framework for expert groups73. The Advisory Group shall closely cooperate with the AI Office and the AI Board established under Regulation (EU) 2024/1689 with respect to AI systems and models used for biological applications (‘AI systems and models in biological applications’). |
| 73 Commission Decision establishing horizontal rules on the creation and operation of Commission expert groups, C(2016)3301. | 73 Commission Decision establishing horizontal rules on the creation and operation of Commission expert groups, C(2016)3301. |
Amendment 47
Proposal for a regulation
Article 52 – paragraph 3 – point b
| 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 systems and models in biological applications throughout their life cycle, as well as the ethical use of AI in the biotechnology sector; |
Amendment 48
Proposal for a regulation
Article 59 – paragraph 1 – point 6
Regulation (EU) 2019/6
Article 40 a – paragraph 1 – introductory part
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Where a marketing authorisation is granted by the Union to a veterinary medicinal product developed by means of a biotechnology process referred to in paragraphs 2(a) of Article 42 of Regulation (EU) 2019/6 that is intended to diagnose, treat or prevent zoonotic diseases, and that is protected either by a supplementary protection certificate in accordance with Regulation (EC) No 469/200974 of the European Parliament and of the Council , or by a patent which qualifies for the granting of such supplementary protection certificate, the holder of a patent or of such certificate shall be entitled to a 12-month extension of the periods referred to in Article 13, paragraphs 1 and 2 of Regulation (EC) No 469/2009, provided that the marketing authorisation applicant demonstrates that all of the following conditions are met: | 1. Where a marketing authorisation is granted by the Union to a veterinary medicinal product developed by means of a biotechnology process referred to in paragraphs 2(a) of Article 42 of Regulation (EU) 2019/6 that is intended to diagnose, treat or prevent zoonotic diseases, and that is protected either by a supplementary protection certificate in accordance with Regulation (EC) No 469/200974 of the European Parliament and of the Council, or by a patent which qualifies for the granting of such supplementary protection certificate, the holder of a patent or of such certificate shall be entitled to a twelve-month extension of the periods referred to in Article 13, paragraphs 1 and 2 of Regulation (EC) No 469/2009, provided that the marketing authorisation applicant demonstrates that all of the following conditions are met: |
| 74 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, OJ L 152, 16.6.2009, pp. 1 | 74 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, OJ L 152, 16.6.2009, pp. 1 |
Amendment 49
Proposal for a regulation
Article 59 – paragraph 1 – point 6
Regulation (EU) 2019/6
Article 40 a – paragraph 1 – point a
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the medicinal product contains a new active substance distinctly different from that of any authorised medicinal product in the Union; | (a) the medicinal product contains a new active substance different from that of any authorised medicinal product in the Union or the veterinary medicinal product has a mechanism of action different and shows a level of safety and efficacy which at least equivalent to that that of any authorised veterinary medicinal product in the Union for the same zoonotic indication; |
Amendment 50
Proposal for a regulation
Article 59 – paragraph 1 – point 6
Regulation (EU) 2019/6
Article 40 a – paragraph 1 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the veterinary medicinal product has a mechanism of action distinctly different and shows a level of safety and efficacy which at least euivalent to that that of any authorised veterinary medicinal product in the Union for the same zoonotic disease; and | deleted |
Amendment 51
Proposal for a regulation
Article 59 – paragraph 1 – point 6
Regulation (EU) 2019/6
Article 40 a – paragraph 1 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (c) at least a manufacturing step, excluding packaging, quality testing and certification is performed in the Union. | (b) at least one manufacturing step is carried out in the Union other than import, repackaging, packaging other than immediate packaging, labelling, quality testing and, where applicable, certification. |
Amendment 52
Proposal for a regulation
Article 61 a (new)
Regulation (EC) No 469/2009
Article 5
| Present text | Amendment |
|---|---|
| Article 61a | |
| Amendments to Regulation (EC) No 469/2009 | |
| Regulation (EC) No 469/2009 is amended as follows: | |
| 1) Article 5 is amended as follows: | |
| (a) Paragraph (2) point (a) is replaced by the following: | |
| 2.By way of derogation from paragraph 1, the certificate referred to in paragraph 1 shall not confer protection against certain acts which would otherwise require the consent of the holder of the certificate (‘the certificate holder’), if the following conditions are met: | ‘2. By way of derogation from paragraph 1, the certificate referred to in paragraph 1 shall not confer protection against certain acts which would otherwise require the consent of the holder of the certificate (‘the certificate holder’), if the following conditions are met: |
| (a) the acts comprise: | (a) the acts comprise: |
| (i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or | (i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or |
| (ii) any related act that is strictly necessary for the making, in the Union, referred to in point (i), or for the actual export; or | (ii) any related act that is strictly necessary for the making, in the Union, referred to in point (i), or for the actual export; or |
| (iii) the making, no earlier than six months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; or | (iii) the making of a product, or a medicinal product containing that product, where that medicinal product is a biosimilar medicinal product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; or the making of a product, or a medicinal product containing that product, where that medicinal product is a generic medicinal product, no earlier than six months before the expiry of the corresponding certificate, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; or |
| (iv) any related act that is strictly necessary for the making, in the Union, referred to in point (iii), or for the actual storing, provided that such related act is carried out no earlier than six months before the expiry of the certificate. | (iv) any related act that is strictly necessary for the making, in the Union, referred to in point (iii), or for the actual storing; provided that such related act is carried out no earlier than six months before the expiry of the certificate where the medicinal product is a generic medicinal product.' |
Annex: declaration of input 4 paragraphs
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur for opinion declares that he included in his opinion input on matters pertaining to the subject of the file that he received, in the preparation of the opinion, prior to the adoption thereof in committee, 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 |
| A. Menarini Industrie Farmaceutiche Riunite s.r.l. |
| AstraZeneca PLC |
| BEUC |
| BIO Deutschland |
| BioEquity Europe |
| Breakthrough T1D |
| Bristol-Myers Squibb Company |
| Bundesärtzekammer |
| Bundesverband der Deutschen Industrie e.V. (BDI) |
| Covington Burling LLP |
| Deutsche Krankenhausgesellschaft e.V. |
| Deutsche Sozialversicherung Europavertretung (DSV) |
| EFPIA - European Federation of Pharmaceutical Industries and Associations |
| Eli Lilly and Company |
| EORTIC |
| European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) |
| European CRO Federation |
| European Patients’ Forum |
| European Social Insurance Platform (ESIP) |
| Food Forward Europe |
| Genmap |
| GSK |
| Humane Society International/Europe |
| Johnson & Johnson |
| Medicines for Europe |
| Médecins Sans Frontières International |
| Merck Sharp & Dohme Europe Belgium SRL |
| Novo Nordisk |
| Pandemic Action Network |
| PAREA |
| Phage EU |
| Resilience Action Network International |
| Standing Committee of European Doctors |
| 2. Representatives of public authorities of third countries, including their diplomatic missions and embassies |
The list above is drawn up under the exclusive responsibility of the rapporteur for opinion.
Where natural persons are identified in the list by their name, by their function or by both, the rapporteur for opinion 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.
Procedure pages
How the committees handled the text, and how their members voted on it.
Procedure – committee asked for opinion 1 paragraph
| Title | 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) | |
| References | COM(2025)1022 – C10-0363/2025 – 2025/0406(COD) | |
| Committee(s) responsible Date announced in plenary | SANT 18.5.2026 | ITRE 18.5.2026 |
| Opinion by Date announced in plenary | JURI 18.5.2026 | |
| Rapporteur for opinion Date appointed | Tiemo Wölken 5.3.2026 | |
| Discussed in committee | 3.6.2026 | 23.6.2026 |
| Date adopted | 7.9.2026 | |
| Result of final vote | +: –: 0: | 19 5 1 |
Final vote by roll call by the committee asked for opinion 3 paragraphs
19 · For
- ESN
- Mary Khan
- EPP
- Maravillas Abadía Jover, Henrik Dahl, Angelika Niebler, Paulius Saudargas, Axel Voss, Adrián Vázquez Lázara, Michał Wawrykiewicz
- Renew
- Ilhan Kyuchyuk, Lukas Sieper, Dainius Žalimas
- S&D
- René Repasi, Birgit Sippel, Krzysztof Śmiszek, Tiemo Wölken, Lara Wolters
- The Left
- Arash Saeidi
- Greens
- Sergey Lagodinsky, Tineke Strik
5 · Against
- ECR
- Emmanouil Fragkos, Elena Yoncheva
- Patriots
- Ton Diepeveen, Juan Carlos Girauta Vidal, Pascale Piera
1 · Abstained
- ECR
- Mario Mantovani