Changes from report parliamentary committee draft to plenary report

AddedFostering innovation, investment and financing

Added35. Calls for structured EU support to help excellent biotechnology innovation districts in the EU grow and ensure that they have sufficient capacity, resources and scientific edge to promote new groundbreaking biotechnology discoveries, innovation and commercialisation;

Added36. Calls for a balanced innovation system that responds to public health needs, ensures that data-sharing obligations are met and guarantees fairness and sustainability; stresses that this must go hand in hand with timely market entry of biosimilar medicines on Day 1 after a patent expires, supported by a clarified and well-functioning Bolar exemption; underlines, furthermore, the importance of complementary reward mechanisms, such as subscription models, shared risk approaches and joint research or procurement programmes, to encourage investment, safeguard competitiveness and ensure equitable and timely patient access to medicines;

Added37. Underlines the importance of adapting regulatory and access frameworks to the specific characteristics of emerging biological therapies, with proportionate pathways for clinical evidence, quality standards and life cycle management to ensure their safe and effective integration into healthcare systems; expresses concern about frequent delays that block access to more affordable treatments and place a financial burden on national healthcare systems; urges the Member States and the Commission to address the delays;

Added38. Underlines the need to increase public and private investment in biotechnology across the value chain, with particular focus on early-stage development where funding gaps for start-ups and scale-ups remain most acute; highlights the importance of directing these investments towards biotechnologies that address unmet medical needs, such as rare diseases, AMR and chronic conditions where traditional treatments have proven inadequate; stresses the importance of dedicated instruments such as seed and venture capital, public-private co-investment vehicles and risk-sharing mechanisms, as well as strong public funding for basic research; highlights the fact that investment must take into account the long and complex timelines of biomedical projects, which require structured phasing from research to commercialisation, and calls for investment in biotechnology to be progressively increased, with the aim of reaching 3 % of GDP by 2030; points out the need for a transparent regulatory framework that allows for the evaluation of both European and foreign public investment in the development of medicines and medical products, ensuring such investment translates into improved accessibility; emphasises the importance of guaranteeing equitable access to biotechnological and digital therapies for all social groups, particularly persons with disabilities and vulnerable populations, by implementing accessible digital standards and reducing healthcare system digital divides; recalls that much biopharmaceutical R&D is funded outside of the EU and highlights the need for appropriate incentives to secure sustained investment and continued innovation within the EU;

Added39. Highlights the role of funds and programmes, such as Horizon Europe and EU4Health, in supporting the development of the biotechnology sector, the research use of health data and the implementation in our healthcare systems of the solutions generated by such research use; welcomes the STEP programme as a timely initiative to boost EU investment in health biotechnology, but notes with concern that funding and private investment in research, development and innovation remain well below the levels of global competitors such as the United States and China; advocates for increased private investment to complement public funds, alongside faster and more agile financing mechanisms, simplified regulatory and operational frameworks and stronger interconnected value chains, in order to close the innovation gap and address the persistent challenges of scaling up and commercialising research results in Europe; encourages the use of existing instruments, such as InvestEU and the Innovation Fund, to provide targeted support to early-stage biotechnology projects, particularly in the ATMP space;

Added40. Stresses the need to provide adequate and targeted resources to support groundbreaking research and calls for streamlined access to follow-up funding based on research results, in order to accelerate commercialisation, scale-up and the valorisation of innovative biotechnology-based medical products; underlines the importance of ensuring that future EU funding frameworks, including the next multiannual financial framework and the post-2027 Horizon Europe programme, prioritise innovative research in biotechnology, life sciences and digital health;

Added41. Underlines the importance of building an inclusive and equitable biotech ecosystem that supports both innovative and biosimilar medicines, recognising their role in patient access, healthcare sustainability and industrial capacity; stresses the need for appropriate policy support given the shared complexity of biotech manufacturing for patented and off-patent products; calls for strengthened collaboration among Member States with support from the Commission, pooling knowledge and resources, and leveraging public and private investments to address neglected areas;

Added42. Stresses the need to ensure that the EU is adequately equipped for and appropriately funds the continuous evolution, improvement and transformation of its biotech research, development and manufacturing ecosystem, including for emerging technological platforms and for follow-on biosimilar medicines, in line with the innovation principle;

Added43. Stresses the importance of ensuring that biotechnological therapies are developed in line with patient and societal needs, with patient involvement across all stages; underlines the necessity of facilitating their equal distribution and timely commercialisation in the EU and guaranteeing affordability for all, while ensuring fair pricing that reflects both public investment and the risks undertaken by producers; emphasises the need for innovative regulatory and assessment frameworks, systemic investments to support the sustainable integration of advanced therapies into healthcare systems, and the continued development, production and availability of biosimilar medicines;

AddedSkills, training and talent mobility

Added44. Stresses the need to promote career opportunities in life sciences and address brain drain by offering better working conditions to retain skilled workers and researchers in the EU and attract others to the EU; underlines the importance of specialised academic training, biotechnology education and professional development, including stronger links between academia and industry and the promotion of scientific careers, particularly among women; calls on the Commission and the Member States to invest in training and awareness, accelerate the mutual recognition of professional qualifications and establish coordinated talent attraction mechanisms, such as simplified and harmonised visa procedures, automatic work permits for top graduates, and one-stop shops for global STEM talent; welcomes initiatives such as Choose Europe for Science as strategic opportunities to position the EU as a global hub for scientific careers and innovation;

Added45. Recalls the need for the continuous training and upskilling of healthcare and biotechnology professionals to address the increasing technologisation of healthcare, support the safe handling of biotechnological products and ensure their effective integration into clinical practice; stresses that the biotech ecosystem must adopt a comprehensive skills strategy, based on public-private partnerships, to build a future-oriented workforce and redesign healthcare processes as new roles emerge; underlines the importance of promoting gender equality in STEM education and career pathways, recognising the biotech sector as a key opportunity to enhance the participation of women in science, research and innovation;

Added46. Emphasises the need to retain and attract scientists and highly skilled professionals in order to safeguard the sustainability of the healthcare system and reinforce Europe’s research capacity, while benefiting from an open, international and dynamic research environment; highlights the importance of attracting human capital to European universities, and of early encouragement of research careers through the education system and the implementation of a gender perspective in STEM careers; highlights the importance of strengthening programmes that promote women’s leadership in biotechnology and consolidating intergenerational mentoring networks;

Added47. Points out the importance of funding university careers through public support mechanisms and the relevance of scholarships for students without the necessary resources to advance their university careers, as well as promoting scientific and academic mobility not only through projects, but also through scholarships and funding mechanisms for students and academics;

Added48. Urges the Commission to explicitly address skills shortages in the context of the EU Biotech Act, notably through the strengthening of education, training and lifelong learning initiatives, including the ‘Union of Skills’;

Added49. Highlights the importance of strategic international cooperation in biotechnology; calls on the Commission to support global research initiatives, promote regulatory convergence with like-minded non-EU partners, and diversify partnerships to include a broad range of countries and actors, while facilitating European SMEs’ access to new healthcare markets;

Added50. Calls for the simplification and harmonisation of submission data requirements for manufacturing processes and encourages the EMA to provide up-to-date guidance on biotechnology-derived products, particularly where patient safety may be at risk;

AddedSupport for biotech start-ups, scale-ups and SMEs

Added51. Recognises the challenges biotechnology companies, particularly start-ups and SMEs, face in navigating the EU regulatory framework, and underlines the need for support mechanisms such as the EU biotech hub or biotechnology platform; insists that these support mechanisms must prioritise public health, safety, environmental protection and democratic oversight; encourages the development of regulatory innovation and early communication between developers and regulators to address regulatory and market barriers; supports efforts to facilitate the establishment and scale-up of companies in Europe, while reaffirming the importance of maintaining high safety and quality standards as a key competitive advantage of EU-approved products;

Added52. Notes that biotechnology is mainly developed in universities and research centres but also highlights the role of SMEs thanks to their agility and innovation, which foster the exploration and practical application of new ideas; highlights, however, that SMEs face a significant and costly regulatory burden when developing and distributing their products;

Added53. Highlights the unique challenges that biotechnology SMEs face due to the high-risk nature of their R&D, as well as patent fragmentation across the Union; stresses the importance of dedicating support and flexible financing models to assist them from early research to commercialisation; stresses, furthermore, the need to increase access for SMEs to private investment in research, development and innovation to complement public funding and close the innovation gap with other leading countries;

Added54. Underlines the importance of providing early and proactive scientific advice and regulatory guidance from the EMA to innovative biotech SMEs, to help accelerate safe and timely market access; encourages the establishment of targeted funding mechanisms for SMEs developing novel biological therapies, including bacteriophage-based treatments, given their importance for public health, especially in combating AMR; calls on the Commission to promote public-private partnerships involving start-ups, SMEs, academic groups and clinical partners, fostering access to shared tools, datasets and digital validation frameworks such as the European Virtual Human Twins, and to strengthen collaboration through platforms such as STEP;

Added55. Underlines the importance of a tailored, regulatory and competitive intellectual property (IP) framework to support biotechnology SMEs in the EU, taking into account global competitiveness with other geo-economic blocs; stresses the need to evaluate potential IP rights extensions within the biotechnology sector, including exploring data exclusivity enhancements as an alternative incentive to patent-based exclusivities where appropriate, while ensuring that biosimilar medicines can enter the market after the expiration of relevant IP rights to guarantee timely and equitable access for patients; encourages the facilitation of administrative and regulatory procedures and the establishment of mechanisms to mobilise public and private capital to better support biotechnology SMEs, and emphasises the value of providing incentives to promote stronger integration between universities and business programmes, fostering the commercial development of innovation;

Added56. Calls on the Commission to explore the creation of an EU biotech innovation fund to support researchers, academia, start-ups and SMEs conducting R&D and innovation in healthcare biotechnologies, while ensuring complementarity with existing EU instruments, such as Horizon Europe and the European Innovation Council; stresses that the biotech innovation fund should also allocate resources to the EMA and national competent authorities to support regulatory modernisation and the enhancement of interoperable digital tools and databases; stresses the need to accelerate the implementation of the unitary patent system to reduce costs, improve predictability and increase the value of European IP; stresses the importance of ensuring close alignment between the future EU Biotech Act and the broader Pharma Package, including both the future regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency and the future directive on the Union code relating to medicinal products for human use, particularly with regard to incentive mechanisms for innovation in antimicrobials, regulatory sandbox approaches, life cycle management of biologics, and the application of technical, scientific and safety standards, as well as safeguards for the accessibility of medicinal products;

AddedEnsuring ethical standards and fundamental rights

Added57. Highlights the importance of strong ethical oversight in biotechnology, including for AI-based tools;

Added58. Recognises that biotechnological advancements bring both opportunities and challenges, and may entail risks of misuse or unintended consequences or raise ethical concerns; calls on the Commission and the Member States to adopt a regulatory approach that is precautionary yet innovation-enabling, fostering responsible innovation while maintaining the highest standards of safety and reliability in line with scientific knowledge, safeguarding public trust, human rights and strong EU ethical standards;

Added59. Calls for ethical coordination to be guided by the shared constitutional traditions of the Member States, the EU Charter of Fundamental Rights, the European Convention on Human Rights and relevant international human rights instruments; calls on the Commission to promote cooperation among national ethics committees, ensuring impartiality, transparency and the involvement of all relevant stakeholders, while encouraging the exchange of best practice and fostering cross-border dialogue on emerging bioethical issues;

Added60. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare that enables advanced innovation, ensures it is always used in favour of patients and underlines the need to safeguard human dignity, promote inclusiveness and prevent discrimination; underlines the importance of integrating principles of social justice, gender equality and environmental sustainability into ethical assessments of biotechnological development and use; encourages open dialogue with civil society, patients and experts to ensure broad societal support for emerging technologies, including gene therapies;

Added61. Stresses the need for transparent and clear communication on ethical considerations and science-based decision-making; underlines the importance of building and maintaining public trust in modern science and the biotechnology sector by strengthening health literacy, including through accessible formats for communicating new technologies, both for the general public and as part of healthcare professional training; emphasises that biotechnology in healthcare should be used exclusively for therapeutic purposes; rejects any attempt to impose global uniformity in bioethics at the expense of national traditions and values; calls for tailored regulatory and financial support to improve their market access and strengthen competition, while upholding high standards of patient safety;

Added62. Warns against the use of genetic tests for purposes that lack clinical utility and recalls their prohibition in the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes;

Added63. Emphasises that the commercialisation of genetic tests without a clear health-related purpose is often accompanied by personal data collection practices that may not comply with EU standards on informed consent, data processing and data sharing; urges the Commission to develop mechanisms to monitor and address such practices and ensure full compliance with EU data protection law;

Added64. Highlights that the growing use of crowdsourced and smartphone-based health data poses challenges to the consistency of health information and the effectiveness of informed consent; underlines that healthcare professionals must be involved in data collection processes to guarantee data quality and ensure that patient rights are upheld; stresses the need for adequate training for these professionals, both in understanding the nature of the data collected and the legal and ethical rights of patients;

Added65. Stresses the importance of addressing ethical and legal considerations related to emerging gene editing technologies, such as CRISPR; emphasises the need for ongoing dialogue with the scientific community, ethics bodies and the public to ensure responsible and transparent governance of these technologies; notes that germ line modifications are banned in the EU and considers that human embryos and gametes cannot be treated as commercial or industrial products; calls on the Commission to assess the broader impact of biotechnology on the environment, to re-evaluate medical research practices involving animals and to incorporate a gender perspective in biomedical research;

Added66. Emphasises that biosecurity risks must be managed alongside advances in biotechnology and biomanufacturing, ensuring responsible access to and use of synthetic biology tools, gene-editing technologies and biological materials; calls for enhanced international cooperation on biosecurity lex artis, including the adoption of coordinated screening recommendations, attribution and traceability protocols, and database integrity, which should be managed by an EU public body, aligned with global state-of-the-art practices, so that EU-based biotech companies can benefit from international best practices while preserving their competitiveness;

Added67. Supports cross-border collaboration and regulatory harmonisation to speed up patient access to safe and effective biotech products; calls for early dialogue between developers, HTA bodies and payers;

Added68. Emphasises the critical role of high-quality biomedical and genetic data in accelerating research and personalised medicine; calls on the Commission to strengthen data governance frameworks that ensure privacy, security and interoperability, enabling trusted and responsible cross-border data sharing for research and innovation; underlines the strategic importance of the European Health Data Space as a cornerstone for enabling secure access to and secondary use of health data across the EU, and calls for its effective implementation in order to support biomedical innovation and improve patient outcomes;

Added69. Highlights the legal and ethical challenges of processing biomedical data in AI systems; stresses the importance of human oversight and dynamic validation of AI, adapted to the specificities of the sector and aligned with existing EU rules and ethical frameworks; underlines the need to address risks linked to AI systems operated from outside the Union, particularly where data protection standards do not meet EU requirements, given the sensitive nature of health and genetic data; calls on the Commission to ensure the smooth functioning of the single market for life sciences and biotechnology, working closely with Member States to prevent regulatory fragmentation and to guarantee legal certainty, predictability and timely pathways to market for innovative products; calls on the Commission, furthermore, to facilitate long-term and practical international data-sharing agreements to enable global collaboration on AI-driven biomedical research and innovation;

Added70. Stresses the importance of developing human capital with expertise in biotechnology, promoting cross-border recognition of qualifications, and supporting the mobility of highly specialised professionals; calls for stronger partnerships between universities, research centres and technology-based SMEs and start-ups to foster biotech entrepreneurship and increase innovation capacity across the EU;

Added71. Acknowledges that advances in biotechnology, particularly in the fields of medically assisted reproduction and genetic testing for therapeutic and preventive purposes, represent a major opportunity to strengthen individual freedoms, improve reproductive health outcomes and support responses to fertility challenges in Europe, including the demographic decline in some Member States; reaffirms, in line with its resolution of 24 June 2021 on the situation of sexual and reproductive health and rights in the European Union, that all persons must have equal and unequivocal access to medically assisted reproduction, free from any form of discrimination; underlines the need for inclusive, rights-based and non-discriminatory policies in this field; encourages the development and transparent oversight of genetic innovations for therapeutic purposes, notably as a tool to help prevent the transmission of serious, debilitating or life-threatening hereditary conditions, in full respect of autonomy, informed consent and fundamental rights;

AddedCross-sectoral dimensions of biotechnology

Added72. Highlights the importance of assessing the long-term health and environmental impacts of biotechnologies, particularly in areas such as food and agriculture, engineered microbes and other emerging applications beyond the healthcare sector;

Added73. Calls for ecosystem impact assessments to be included in the evaluation of biotechnologies, especially in agriculture; emphasises that environmental changes linked to the use of technologies such as genetically modified organisms (GMOs) may have significant long-term consequences for public health;

Added74. Emphasises that biotechnologies must be developed within a holistic and forward-looking framework, encouraging synergies with digital, AI and other key technologies; stresses that biotechnologies should work alongside other technologies, fostering parallel development to achieve more effective solutions and innovation, in line with a technology-neutral and forward-looking approach; emphasises the importance of encouraging synergies between biotechnology, digital technologies, AI and other emerging fields;

AddedEnsuring a simplified and future-proof regulatory environment for European biotech

Added75. Stresses the need to simplify, align and better coordinate clinical approval processes across the EU, which are currently fragmented due to the fact that there are 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;

Added76. Points out that accountability in biotechnology must be ensured through risk assessment and auditing mechanisms; stresses that, whenever possible, these should be integrated directly into data management models and supported by reliable third-party certification schemes; calls for the development of integrated biosecurity applications as part of biotechnology promotion programmes; urges the Commission to propose, within the framework of the future EU Biotech Act, a comprehensive and integrated approach covering all key biotechnology sectors, in order to foster innovation and enhance the competitiveness of the European biotech ecosystem; calls for stronger alignment between the EU’s industrial, innovation and health policies, to ensure that access and regulatory pathways can keep pace with scientific progress; supports early dialogue between regulators, HTA bodies, and developers to improve efficiency and patient access;

Added77. Stresses the need to build a coherent and accessible European framework for biotechnology that enhances regulatory clarity, improves cross-border patient access, and fosters innovation while maintaining high safety, ethical and environmental standards;

Added78. Calls on the Commission to include a clear and operational definition of biotechnology in the upcoming EU Biotech Act, in order to provide clarity for regulators, researchers and industry stakeholders; urges the Commission to promote the acceleration of authorisation, permitting and licensing processes across the EU for biotechnology-related activities, while ensuring regulatory coherence and harmonisation among Member States; urges, furthermore, the acceleration of clinical trial assessment timelines, to enhance the EU’s global competitiveness and enable European patients to participate in multi-country trials; stresses that efforts to streamline regulatory procedures must not compromise public health, long-term safety monitoring or environmental sustainability; highlights the importance of maintaining the EU’s strong record on environmental protection and sustainable water management; calls on the Commission to promote the implementation of the Clinical Trials Regulation through projects that empower and streamline the conduct of multi-country trials in the EU, to make it a more competitive region, including for the development of advanced therapies and personalised medicine;

Added79. Encourages the development of regulatory science capacities and dedicated guidance to support the assessment of the quality, safety and effectiveness of emerging biological therapies, including using real-world evidence where appropriate; underlines the urgent need for greater transparency in clinical trials; notes that the lack of publicly available data holds back scientific progress, as it prevents researchers from learning from past studies, including those with negative or inconclusive results; warns that this lack of transparency leads to duplication of efforts, waste of resources and missed opportunities for innovation; calls, therefore, for full disclosure of all clinical trial outcomes as a key element of a strong evidence base and of public health-driven research;

Added80. Stresses the need for the Commission to enforce the Cross-Border Healthcare Directive and to support Member States in applying its provisions to advanced cell and gene therapies and other ATMPs, in order to improve patient access to specialised treatments across the EU; recognises that many Member States lack national capacity in this field and that relying on a limited number of specialised centres at EU level is the most cost-effective and equitable solution;

Added81. Calls on the Commission to issue guidance on reimbursement pathways that would enable broader access to life-saving therapies; encourages the Commission to make use of voluntary joint public procurement to pilot voluntary EU-level coordination for the procurement of medical products and ATMPs targeting ultra-rare conditions, where national access may currently be constrained by limited patient cohort;

Added82. Calls for the revision of the Cross-Border Healthcare Directive to ensure greater access to treatment for patients, in particular as regards orphan drugs and ATMPs, across borders with a single set of authorisation rules and a single appeals system for rejections that may be unwarranted;

Added83. Calls on the Commission to support the creation of a dedicated EU matchmaking platform to connect translation-ready academic research with investors, manufacturers and experienced developers, with the goal of accelerating the clinical development and commercialisation of promising biotechnology discoveries; highlights that national institutions should act as enablers of health-related biotechnology innovation, including off-patent-led advances in technology, manufacturing and medicinal products; emphasises that innovation should serve the public interest, uphold the highest standards of safety and ethics and apply the precautionary principle where appropriate; underlines the importance of democratic governance, independent oversight and public participation in guiding the development and responsible use of biotechnologies in healthcare; stresses, furthermore, the role of national institutions in promoting the integration of health-related innovations into healthcare systems to ensure that patients can effectively benefit from biotechnological progress;

Added84. Emphasises that biotechnology must be accessible to all EU citizens, regardless of their place of residence, socio-economic status or other barriers to healthcare access; stresses the importance of strengthening European Reference Networks and establishing swift, simplified and efficient cross-border healthcare mechanisms, particularly for innovative therapies that, due to their cost, complexity or rarity, cannot be made available in all Member States; underlines the strategic importance of the upcoming negotiations on the multiannual financial framework;

Added85. Calls for an ambitious budget that allocates sufficient resources to research, health and innovation, enabling Europe to remain globally competitive while addressing societal challenges through cutting-edge science;

Added86. Calls on the Commission to support the Member States in launching attractive programmes for health-related biotechnology companies, providing a collaborative environment for development through initiatives such as ecosystem hubs, innovation campuses, industrial parks, incubators, and technology transfer offices at universities and research centres; calls, furthermore, for the development and implementation of national biotechnology strategies to integrate biotech into healthcare systems, including clear plans for modernising the role of biotechnology in healthcare, strengthening research networks and connecting them to the European Health Data Space;

Added87. Encourages the integration of environmental and ethical impact assessments in biotech development strategies, ensuring alignment with the Union’s sustainability goals;

Added88. Calls for a broad and forward-looking approach to address the diverse needs of the medical biotechnology sector; stresses the importance of tackling supply chain and operational challenges, including dependence on non-EU countries for critical technologies, access to raw materials, essential equipment and a skilled workforce, through coordinated EU action that fosters a resilient and innovation-driven environment;