Changes from report parliamentary committee draft to plenary report

AddedAL. whereas ensuring a stable and autonomous supply of critical raw materials and feedstock is essential for the EU’s strategic sovereignty, economic resilience and leadership in biotechnology;

Removed24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare, ensuring that it is always used in favour of patients, safeguards human dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities;

AddedAM. whereas security policy in the EU should address health security issues and fund investment in healthcare as part of the security strategy, as highlighted by the Niinistö report;

Removed25. Recalls that EU legislation should not interfere with national laws in terms of ethics; calls on the Commission to promote cooperation among national ethics committees, ensuring impartiality and involving all parties concerned;

AddedAN. whereas the biotechnology regulation must take into account crisis preparedness and the EU’s strategic autonomy, from the perspective of security, public health and the ability to respond to health threats, such as those addressed by Regulation (EU) 2022/2371 on serious cross-border threats to health, and the upcoming regulation on compulsory licensing for crisis management agreed on by the co-legislators on 21 May 2025;

Removed26. Calls on the Commission to address ethical concerns regarding gene editing technologies like CRISPR; welcomes the fact that germ line modifications are banned due to their unpredictable impact on individuals and future generations;

AddedAO. whereas, in the light of rising AMR, the EU Biotech Act should acknowledge the significance of innovative biological therapies such as bacteriophages in advancing the EU’s One Health goals, enhancing healthcare system resilience, and fostering sustainable and targeted biocontrol strategies; whereas in July 2022, the Commission, together with the Member States, identified AMR as one of the top three priority health threats in the EU;

Removed27. Recognises the Universal Declaration on the Human Genome and Human Rights as a guide for ethical and legal frameworks in biotechnology;

AddedAP. whereas biotechnology is one of the EU’s fastest growing and most innovative sectors, contributing significantly to economic growth and job creation; whereas in 2018 alone, the sector directly generated EUR 31 billion in GDP and provided over 210 000 direct jobs across healthcare and other sectors, while supporting more than 625 000 additional jobs indirectly;

Removed28. Stresses the importance of data processing in biotechnology research; calls on the Member States to strengthen the protection of health-related personal and genetic data;

AddedAQ. whereas regulatory and health technology assessment (HTA) sandboxes represent effective tools to future-proof healthcare systems by providing controlled environments for testing and refining innovative solutions, ensuring the safe and effective integration of new technologies and methodologies into healthcare;

Removed29. Highlights the legal and ethical challenges of biomedical data in AI systems; stresses the need for human oversight and dynamic validation of AI;

AddedAR. whereas biotechnologies offer an important opportunity for the EU to enhance its scientific leadership and competitiveness; whereas it raises ethical and security considerations that must be addressed through clear, science-based and transparent governance frameworks;

RemovedWay forward towards the EU Biotech Act

AddedExploring the potential of biotechnologies in healthcare

Removed30. Stresses that biotechnologies should work alongside other technologies, fostering parallel development to achieve more effective solutions and innovation, in line with a technology-neutral approach;

Added1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and other ATMPs, are transforming care and prevention, particularly for previously untreatable diseases;

Removed31. Calls on the Commission to conduct an impact assessment before the publication of the EU Biotech Act, taking stakeholders’ input into due account;

Added2. Stresses that during the COVID-19 pandemic, biotechnology played a key role in the swift development of innovative vaccines, including mRNA vaccines and advanced molecular diagnostic tools; highlights that this proves the need for long-term strategic investment in biotechnological research;

Removed32. Calls on the Commission to support the Member States in launching attractive programmes for health-related biotechnology companies, such as industrial parks that offer a collaborative environment for development;

Added3. Stresses that the EU’s competitiveness in life sciences must encompass a strong patient perspective, ensuring that research and innovation translate into timely access to effective treatments and medicines across the EU;

Removed33. Urges the Commission to promote the acceleration of permitting and licensing processes across the EU for biotechnology-related activities;

Added4. Emphasises that the application of biotechnology in preventive medicine and therapies has a growing impact on treating and preventing diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune and infectious diseases, and metabolic disorders;

Removed34. Highlights that institutions should act as enablers of health-related biotechnology innovation;

Added5. Underlines the role of off-patent biological medicine in enhancing the sustainability of healthcare systems and ensuring equitable and timely access to treatment for patients;

Removed35. Calls on the Commission to consider the financial needs of the biotechnology sector to foster a coherent, efficient and flexible financial framework that creates opportunities;

Added6. Emphasises that biotechnological innovation can play a major role in reducing and replacing animal testing, such as through laboratory-grown tissues or the use of stem cells, as well as in promoting regenerative medicine, disease modelling and drug testing through procedures such as ‘organ-on-a-chip’ for therapies, clinical trials and testing; highlights the importance of continuous innovation in biomanufacturing processes throughout the entire technology life cycle, including among off-patent medicine actors;

Removed36. Call for a broad and forward-looking approach to the various needs of the biotech health sector that addresses potential challenges related to the supply and cost of raw materials, equipment and components;

Added7. Stresses the importance of blue biotechnology (marine biotechnology) for the development of health applications, for example in the discovery and development of new medicines with antimicrobial properties, treatments modulating the immune and anti-inflammatory response, new materials for tissue regeneration, cosmetic and dermatological applications, and the identification of enzymes and biosensors for use in medical diagnostic systems;

Removed37. Calls for a European-wide, dynamic matchmaking platform that connects technology readiness level-mature research, funding bodies, incubators and investors with shared analytics and performance indicators;

Added8. Recalls that molecular diagnostics using genomic and proteomic biomarkers are essential for the early detection and personalised treatment of serious diseases, and, where appropriate, enable the implementation of public policies for population-wide disease screening, whether selective or general depending on the case;

Removed38. Instructs its President to forward this resolution to the Council and the Commission.

Added9. Underlines the need to scale up genomic sequencing capacity to support early diagnosis and screening; calls for adequate funding and improved coordination of national genetic testing programmes, including the adoption of EU guidelines to harmonise newborn screening;

Added10. Emphasises the importance of genetic surveillance of pathogens and the rapid design of vaccines for epidemiological control and public health;

Added11. Underlines that biotechnology innovations influence the biosecurity of human populations in the era of new viral and microbial hazardous agents responsible for high mortality rates, which constitute significant biohazardous factors;

Added12. Stresses that new applications of biotechnology, such as phage therapies, can provide solutions to AMR, which is directly responsible for the death of more than 1 million people globally each year and for increased costs for healthcare systems and society; highlights that bacteriophage therapy is a leading example of innovative biotechnology with the potential to tackle the growing challenge of AMR; stresses that this targeted approach offers a promising alternative or complement to traditional antibiotics; notes with concern that, despite its potential, the field receives little commercial interest and limited funding; calls, therefore, for increased public investment in R&D for phage therapy and similar biotechnological solutions to AMR;

Added13. Stresses the importance of biotechnology R&D in addressing unmet medical needs, such as treatments for rare and paediatric diseases; calls for public funding to be directed towards these priorities;

Added14. Highlights that integrating these techniques into the healthcare systems of the Member States has the potential to enhance the efficiency of primary and hospital care, contributing to more effective service delivery and the deployment of new opportunities in preventive medicine;

AddedShaping the future EU Biotech Act

Added15. Calls for the EU Biotech Act to review, simplify and optimise the regulatory framework for biotechnology in healthcare so as to foster innovation, including off-patent-led developments, while maintaining high standards of safety, quality, efficacy and ethical compliance, as well as public health and environmental protection; underlines that such a framework must remain science-based, coherent with evolving EU legislation and international best practice, and take due account of the specific characteristics of different categories of biotechnology, including orphan medicinal products and ATMPs; stresses, furthermore, the need to streamline procedures, building on evidence and practical experience, in order to improve patient access to treatments and ensure a clearer, more effective and globally competitive regulatory environment; urges regulators, healthcare providers, researchers and industry to collaborate on ATMPs throughout their entire life cycle, including future off-patent versions, in order to improve oversight through reporting systems, anticipate availability and affordability, and ensure timely patient access; stresses the need to simplify and rationalise the interplay between intersecting legislative frameworks, such as the SoHO (Substances of Human Origin) and ATMP regulations, and to enhance regulatory coherence and clarity so as to avoid additional burdens;

Added16. Calls for a harmonised, streamlined and science-based clinical trials framework to increase efficiency, transparency and cross-border collaboration, including reducing approval timelines to 30 days through risk-based assessments; emphasises that the approval of biotechnology products, such as monoclonal antibodies, gene therapies and mRNA-based treatments, should be based on thorough, independent assessments of health risks; calls for a precautionary approach that focuses on preventing harm rather than reacting to it once it occurs; stresses the need for better scientific coordination among regulatory authorities and unified processes for biotechnologies involving in vitro diagnostics, medical devices and drug-device combination products, as well as improvements to the Clinical Trials Information System (CTIS); welcomes the Accelerating Clinical Trials in the EU (ACT EU) initiative and the Commission’s plan to explore a targeted revision of the Clinical Trials Regulation; underlines that the EU Biotech Act must align with the revision of pharmaceutical legislation and the proposed Critical Medicines Act to ensure policy coherence, avoid fragmentation and strengthen Europe’s strategic autonomy; notes that greater use of multi-country clinical trials is key to unlocking the value of the single market and positioning the EU as a global leader in clinical research; calls for adapted regulatory pathways and fee structures for public-sector innovators, such as university hospitals, recognising their societal value;

Added17. Calls on the Commission to explore the establishment of a centralised coordination mechanism for clinical research governance, aimed at providing developers of medicines, medical devices and combination products with a more predictable and efficient interface for scientific advice, assessments and authorisations; suggests that the European Medicines Agency (EMA) could play a coordinating role in this structure, in close cooperation with notified bodies and national competent authorities; stresses that adequate resources, staffing and training for national regulatory authorities are essential to ensure the timely and effective assessment of innovations;

Added18. Highlights the need to streamline and make more predictable the work of national ethics committees in approving clinical trials, including cross-border clinical trials; stresses that this could be achieved via clear and unified Commission guidelines, more centralised review processes supported by standardised EU templates, and the harmonisation and standardisation of responsibilities and ways of working;

Added19. Highlights the importance of further developing and rolling out multi-country platform trials embedded in clinical practice to ensure the efficient and streamlined testing of novel interventions and their effective implementation in EU public healthcare systems;

Added20. Underlines that EU clinical trials should be fully representative of Europe’s population, including women, which would be a competitive advantage for the EU life sciences ecosystem as a whole and which would help deliver effective medical products for all EU citizens;

Added21. Stresses the need to simplify, align and better coordinate clinical approval processes across the EU, which are currently fragmented due to multiple, disconnected regulatory pathways with divergent timelines, requirements and systems; notes in particular that key legislative texts, such as the Clinical Trials Regulation, the In Vitro Diagnostic Regulation and the Medical Device Regulation, are interpreted and implemented inconsistently across Member States, undermining legal certainty and delaying innovation;

Added22. Highlights the potential of regulatory frameworks such as the hospital exemption in improving access to innovative therapies and fostering research environments linked to clinical practice, thereby supporting the development of marketable innovations in collaboration with industry;

Added23. Highlights the importance of specific support schemes for orphan medicines, including frameworks for unmet medical needs, conditional authorisations and HTAs;

Added24. Strongly supports shared public-private ownership of biotechnologies developed with the contribution of public funding; stresses the importance of fair and equitable pricing to ensure accessibility for all, particularly in the context of publicly funded research and innovation;

Added25. Recalls the use of next-generation regulatory and HTA sandboxes to test emerging biotechnologies in a secured, controlled and adaptable framework that upholds EU standards of safety, efficacy, quality, public health and bioethics; stresses that sandboxes should not evolve into parallel regulatory systems and calls for EMA consultation and oversight in their design and assessment; urges the Commission to expand their scope to include cross-sectoral innovations such as medicinal products, medical devices and in vitro diagnostics, AI and substances of human origin, while fostering EU-wide collaboration to enable mutual learning and supporting a product-centred regulatory approach that ensures continuity of knowledge from early clinical applications through to marketing authorisation;

Added26. Stresses the need for regulatory mechanisms that enable biological therapies, including biosimilars, to evolve over their life cycle, allowing updates to composition or manufacturing processes when supported by scientific or clinical evidence; recalls the importance of improving interoperability and open access to drug and clinical trial databases to foster collaboration and scale up research; urges the creation of clear guidelines for the use of scientific and real-world evidence in both regulatory and HTA decision-making, ensuring transparency in how this data is generated and used;

Added27. Points out that while security standards must be of the highest level in all cases, audit requirements must be considerably strengthened when applying for public funding; notes that this must be accompanied by accessibility commitments in return for the funding received; calls on the Commission to publish a report on how current EU legislation on biotechnology and biomanufacturing is being implemented, including an assessment of existing gaps and regulatory barriers that may hinder the sector’s growth and contribute to the EU’s loss of clinical research market share to global competitors;

AddedDigital transformation of healthcare through biotechnology

Added28. Encourages the use of cloud-based technologies to support regulatory assessments throughout the process from clinical trial applications to marketing authorisation and their ongoing management;

Added29. Underlines that personalised medicine, particularly for rare diseases, represents a transformative advancement, with emerging therapies and biomarker-driven diagnostics enabling targeted interventions tailored to individual patient profiles; notes the growing role of AI in healthcare, particularly in personalised medicine, diagnostics, treatment, clinical research, and its integration into medical devices; underlines AI’s potential to contribute to bioprocess design, the optimisation of metabolic pathways for biopharmaceuticals, and the development of more efficient and humane research methods; calls on the Commission to develop sector-specific and harmonised ethical guidelines for the use of AI across the life cycle of medicines, ensuring coherence with the AI Act; asks the Commission to prioritise the use of open-source software and AI, ensuring transparency, security and control in processing sensitive data without compromising clinical effectiveness; recognises the value of real-world data in improving the evidence base on how medicines are used, how safe they are and how effective they are in real-life settings, as a complement to data from clinical trials;

Added30. Calls for targeted support for initiatives such as the European Virtual Human Twins to enable low-cost early-stage therapeutics and improve translational readiness; encourages the development of EU standards for the validation of digital tools used in preclinical and clinical research, in coordination with EMA and HTA bodies; supports sustained investment in key research infrastructure, including biobanks and modelling databases; calls for the development of new approach methodologies for safety assessments of emerging biotechnologies; underlines the need for a common EU framework ensuring the secure, interoperable and ethical use of health data, aligned with the European Health Data Space and grounded in transparent bioethical rules;

Added31. Recalls that valuable research in the EU has often been lost due to insufficient follow-up and weak links to market application; stresses the need for fit-for-purpose mechanisms to ensure the traceability and effective translation of publicly funded research into marketable solutions; underlines the importance of a cohesive EU life sciences ecosystem, encompassing academic and clinical research institutions, regulators, investors, start-ups and scale-ups, data and AI developers, manufacturers, clinicians and distributors, to support biotechnology development at all stages and ensure that innovation translates into effective patient care; reaffirms that commitment to basic research and scientific excellence is essential for a strong technological base;

Added32. Calls on the Commission and the Member States to support the development of regional biotechnology innovation hubs, integrating good manufacturing practices (GMP), regulatory expertise, clinical infrastructure and workforce training to accelerate the scale-up and delivery of advanced therapies;

Added33. Highlights the need for the European life sciences strategy and the EU Biotech Act to position Europe as the leading destination for investment in biotechnology R&D, manufacturing and clinical trials, while ensuring tangible benefits for citizens; stresses the importance of stronger collaboration between universities, research centres, hospitals, patient organisations, start-ups, SMEs and industry across all phases of biotechnology development, including biosimilars; emphasises the need to improve knowledge and technology transfer to translate EU-funded research into commercial and industrial applications, supported by public-private partnerships, development hubs and a coordinated European biobanking infrastructure; calls for better coordination, long-term planning and investment mechanisms, as outlined in the Draghi and Letta reports; underlines the importance of closing the gap between preclinical and clinical research to accelerate innovative diagnostics and treatments, particularly in the area of unmet medical needs;

Added34. Stresses that the European life sciences strategy should be continuously evaluated through key performance indicators (KPIs) and adjusted to ensure it delivers both for citizens and EU competitiveness; proposes patient-centric KPIs, such as improved quality of life, longer lifespans and better access to innovative and generic therapies, medical devices and combination products, alongside competitiveness-oriented KPIs, including patent production, foreign direct investment, faster time to market, translational research output and capital raised for start-ups and scale-ups compared with other regions; recalls, in this context, the need to support university ecosystems and research infrastructure, and to develop health centres of excellence to strengthen Europe’s research networks;