Changes from report parliamentary committee draft to plenary report

AddedH. whereas biotechnology has been identified as a critical technology area for the EU; whereas investment in this field represents a strategic opportunity to reduce dependencies on other regions, strengthen Europe’s health sovereignty and build resilience in essential sectors; whereas the EU can build on its scientific excellence, world-class research institutions and dynamic innovation ecosystem to develop a competitive biotechnology sector that supports high-quality job creation, contributes to strategic autonomy and reinforces the EU’s clinical, scientific and manufacturing leadership in a context of growing global technological competition;

RemovedI. whereas one of STEP’s target investment areas is biotechnology; whereas, according to the EU Competitiveness Compass, a strategy for European life science will be presented in 2025 and an EU Biotech Act in 2026;

AddedI. whereas resilient supply chains are critical for a strong biotechnology sector; whereas barriers to trade should be addressed to ensure a level playing field that supports innovation;

RemovedJ. whereas biotechnologies offer an important opportunity for the EU, but also carry significant challenges and risks that must be carefully considered, such as those related to ethical and security concerns;

AddedJ. whereas a JRC analysis of March 2024 showed that biotechnology patents accounted for approximately 5 % of all patent applications filed between 2001 and 2020; whereas the United States held a leading position in biotechnology patent development in 2020, accounting for 39 % of total biotech patents, followed by the EU with an 18 % share, with China rapidly gaining ground with a 10 % share; whereas these figures highlight the importance of strengthening the EU’s competitive position in the biotechnology sector; whereas the overwhelming majority of these patents – over 96 % – are linked to industrial and medical applications;

RemovedThe potential application of biotechnologies in the healthcare sector

AddedK. whereas biotechnology is a key tool within a comprehensive approach to health policies, due to its ability to enhance and integrate key innovations into the healthcare system as a public service, as well as the opportunity to incorporate innovative therapies and improve the quality of healthcare, all of which contribute to the improvement of healthcare for the citizens of the Union; whereas innovations in biotechnology can be game changers for all patients, particularly those living with rare diseases and certain disabilities; whereas four out of five people with an autoimmune disease are women, and women with cardiovascular conditions are often underdiagnosed and undertreated; whereas the holistic development of knowledge within the life sciences must systematically take into account the gender dimension and other relevant vulnerability factors, in order to achieve a better understanding of underlying causes and mechanisms;

Removed1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases;

AddedL. whereas integrating human, animal and environmental health under the One Health approach into research and development (R&D) strategies can enable the underlying causes of diseases to be identified and addressed more effectively by biotechnology-based treatments;

Removed2. Emphasises that biotechnology therapies have a growing impact on diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders;

AddedM. whereas scientific knowledge from which biotechnological applications arise stems from basic and preclinical research, which is mostly carried out by universities and research centres;

Removed3. Stresses the potential of biotechnology in enhancing research into genetic conditions such as Down syndrome and enabling early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;

AddedN. whereas clinical research and innovation in biotechnology enhance disease prevention, diagnosis and treatment, and offer significant advances in the management of chronic, rare, autoimmune and metabolic diseases, thereby contributing to more resilient and sustainable healthcare systems across Europe;

Removed4. Underlines the role of biotechnology innovation, such as lab-grown tissues, in advancing regenerative medicine and drug testing;

AddedO. whereas it is the responsibility of public authorities both to promote research activities and to encourage the development of applications that contribute to advancing solutions for the benefit of human health; whereas adequate protection of the conditions under which research is conducted is crucial for the development of biotechnological research, covering labour and professional conditions, access to and the continuation of academic and educational progression, as well as scholarships, internships and the incorporation of a gender perspective in access to and promotion within academic careers, especially in science, technology, engineering and mathematics (STEM) fields;

Removed5. Recalls that molecular diagnostics using genomic and proteomic biomarkers are key for early detection and personalised treatment of major diseases;

AddedP. whereas biotechnology must be developed in accordance with the highest standards for the protection of fundamental rights, and taking into account that its development involves extensive use of highly sensitive data, both through the large-scale use of health data and medical records for developments such as those based on artificial intelligence, and due to the sensitivity of data used in many bioengineering applications; whereas the architecture for the design, collection, processing and sharing of data must therefore be guided by the fundamental rights recognised under the Charter of Fundamental Rights of the European Union, the European Convention on Human Rights, and the common constitutional traditions of the Member States, in their objective dimension;

Removed6. Stresses that functional epigenomics and integrative multi-omics represent a crucial advancement in biomedical research and can significantly help guide clinical action;

AddedQ. whereas the principle of equal treatment and non-discrimination in the medical field requires particular vigilance when automated decision-making, diagnostic, or evaluation mechanisms are incorporated, whether in administrative or medical decisions; whereas the use of artificial intelligence (AI) and automated decision-making must therefore be implemented in a manner that prevents both direct and indirect discriminatory outcomes, through the explicit legal protection of individuals against multiple and interconnected forms of discrimination in all areas of life, including sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation;

RemovedRegulatory framework

AddedR. whereas access to innovative treatments must be universal and biotechnology should be made available to all citizens of the Union, regardless of their place of residence, socio-economic status, or any other factors that may affect their access to healthcare services; whereas this should entail the development of a fast, simplified and effective cross-border healthcare system for innovative therapies which, due to their nature, the potential number of patients benefiting, cost and/or access conditions, cannot be made available in all Member States;

Removed7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;

AddedS. whereas biotechnological applications have increasing uses in the field of health and in the production of healthcare products for human health, including recombinant proteins, which are used, for example, in the in vitro production of insulin, as well as monoclonal antibodies, interferons and interleukins, among others;

Removed8. Recognises the challenges biotechnology companies face in navigating the regulatory framework and highlights the need for support mechanisms, such as the EU biotech hub;

AddedT. whereas biotechnology holds significant potential for development in the field of personalised medicine, such as by tailoring treatments and preventing adverse effects; whereas this potential should be harnessed to strengthen the preventive approach of our healthcare systems, in the interest of both promoting health and enhancing the efficiency of the healthcare systems of the Member States;

Removed9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;

AddedU. whereas biotechnology applied to diagnostics, through integrated AI, biosensors, or nanotechnology, has the potential to offer even greater precision and to enhance medical decision-making for the benefit of patients’ health;

Removed10. Notes the growing role of artificial intelligence (AI) in healthcare, especially in personalised medicine; calls on the Commission to create sector-specific guidelines for AI in diagnosis and treatment;

AddedV. whereas reproductive and prenatal biotechnology warrants special attention with regard to its diagnostic and therapeutic possibilities, particularly in relation to therapeutic models that are not yet available but hold great potential for improving treatment options for a wide range of currently complex diseases, such as in utero gene therapy;

RemovedChallenges in health-related technology transfer, commercialisation and investment

AddedW. whereas innovation in biotechnology is often driven by progress in life sciences, with breakthroughs in one area, such as healthcare, enabling cross-sectoral applications in fields including agriculture, environmental technologies and beyond; whereas biotechnology strengthens the development of biological manufacturing processes that produce sustainable alternatives to synthetic chemicals, reducing environmental pollution and its negative impact on human and animal health; whereas the role of biotechnology, following the One Health approach, is multifaceted and multisectoral, covering various challenges and improving the Union’s capacity to protect the health of all living beings and the environment;

Removed11. Recalls that valuable research has been lost due to a lack of follow-up and weak links to market application; stresses the need for mechanisms for the traceability of research outcomes to ensure their effective translation into marketable solutions;

AddedX. whereas the Commission, through the Health Emergency Preparedness and Response Authority (HERA), and with financial support from the European Investment Bank, can provide an incentive to start-ups and scale-ups to bring innovations to the market and manage health crises more quickly and efficiently;

Removed12. Stresses the need for collaboration between universities, research centres and industry to address all biotechnology development phases;

AddedY. whereas rare diseases in the EU are defined as conditions affecting no more than 1 in 2 000 people; whereas it is estimated that there are between 6 000 and 8 000 different rare diseases affecting approximately 36 million people in the EU; whereas rare diseases are recognised across the EU and worldwide as an urgent public health challenge; whereas around 80 % of these conditions have a genetic origin, and the limited number of patients per disease results in a lack of investment in R&D; whereas in 2018, 25 EU Member States had established national action plans for rare diseases, 19 of which were time-limited; whereas many of these plans have since become outdated, with end dates dating back to 2020, 2018, or even 2013;

Removed13. Highlights the need to guarantee intellectual property (IP) protection and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;

AddedZ. whereas universities and research centres in the Union, most of which are publicly owned, possess strong research capabilities in the field of biotechnology – leading in scientific publications – yet they face persistent challenges in translating research breakthroughs into innovative medical products and commercially viable solutions, due in part to obstacles in early-stage development, limited access to scientific and regulatory guidance, fragmentation of clinical trial processes and insufficient support for manufacturing scale-up;

Removed14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development;

AddedAA. whereas the freedom of scientific research, as enshrined in Article 13 of the EU Charter of Fundamental Rights, is a fundamental principle of the Union; whereas respect for academic freedom is essential for independent, ethical and responsible research in the fields of biotechnology and the life sciences, with particular attention to public health;

Removed15. Welcomes the STEP programme as a timely move to boost EU investment in health biotechnology, but notes that current funding remains lower compared to global competitors;

AddedAB. whereas for the last two decades, the EU has pioneered the development of the scientific and regulatory principles, R&D and manufacturing evolution of biosimilar medicines, contributing to the availability, accessibility and affordability of key biologic therapies for millions of patients, and to the economic sustainability of healthcare systems;

Removed16. Stresses the importance of ensuring that biotechnology therapies meet patient needs, highlighting the need to facilitate their commercialisation in the EU and ensure affordability for all;

AddedAC. whereas supporting biotech innovation requires early-stage engagement with regulators and the use of scientific evidence in a responsible way, within a stable and predictable environment;

Removed17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU;

AddedAD. whereas the industrial dependency of European research on certain inputs that are not produced in Europe, such as DNA sequencers, may hinder its development;

Removed18. Highlights the importance of strategic international cooperation in biotechnology; calls on the Commission to support worldwide research initiatives with non-EU like-minded partners;

AddedAE. whereas there is a need to ensure that current and future legislative initiatives are aligned with the complete body of EU legislation in the areas of biotechnology, pharmaceuticals and health in general, and thereby establish mutually synergistic links including with the Pharma Package, the Medical Device Regulation, the In Vitro Diagnostic Regulation, the Clinical Trials Regulation, the Orphan Medicinal Products Regulation, the Critical Medicines Act and the AI Act, among others; whereas the rapid pace of innovation in biotechnology has created challenges for existing regulatory systems, making the development of clear, coherent regulatory pathways essential to support innovation and ensure patient safety;

Removed19. Urges regulators, healthcare providers, researchers and industry to collaborate on ATMPs to improve oversight through reporting systems;

AddedAF. whereas an effective regulatory framework for conducting clinical trials is essential to the competitiveness of the most innovation-intensive aspects of the EU’s pharmaceutical and biotechnology sectors; whereas the divergence in standards applied by national competent authorities and ethics committees across Member States slows down the assessment of applications for multi-country trial approvals, making the process more costly and burdensome;

RemovedSupport for biotech SMEs

AddedAG. whereas small and medium-sized enterprises (SMEs) constitute a significant part of the industrial fabric dedicated to biotechnology; whereas it is important to support growth environments and business university programmes that enable companies in this sector to gather knowledge of basic research and to achieve both financial independence and sufficient economies of scale to be competitive in the international market, as they play a key role particularly in driving early-stage innovation, advancing emerging technologies and contributing to medicine discovery and development;

Removed20. Notes that biotechnology thrives in SMEs due to their agility and innovation, which foster the exploration of new ideas;

AddedAH. whereas close cooperation between the pharmaceutical sector, patient associations and public health bodies plays a crucial role in advancing and applying biotechnological and life science innovations that meet patient needs and contribute to better health outcomes; whereas there is a need to strengthen public-private partnerships that support scientific research and facilitate fair and timely access to novel therapies;

Removed21. Highlights the unique challenges which biotechnology SMEs face due to the high-risk nature of their research and development; stresses the importance of dedicating support and flexible financing models to assist SMEs from early research to commercialisation;

AddedAI. whereas effective global supply chains are essential for resilience, especially for products such as critical medicines; whereas trade barriers should be tackled to ensure fair conditions for innovation, and tariffs on inputs and equipment should be avoided, as they increase overall supply chain costs and reduce competitiveness;

Removed22. Underlines the importance of tailored IP support for biotechnology SMEs; stresses the need to evaluate potential IP rights extensions within the biotechnology sector;

AddedAJ. whereas one of the target investment areas of the Strategic Technologies for Europe Platform (STEP) is biotechnology; whereas, according to the EU’s Competitiveness Compass, the European life sciences strategy and the EU Biotech Act will be presented by the Commission; whereas the Commission only commissioned its preparatory study on the Biotech Act in early 2025;

RemovedEthical and legal implications

AddedAK. whereas the recent trends in international trade and the impact on European research projects and universities of the United States’ budget cuts and policy shifts regarding research, higher education and academic management, must be addressed;

Removed23. Highlights that biotechnological advancements can entail risks of misuse or unintended consequences; calls on the Member States and the Commission to adopt a precautionary yet innovation-enabling regulatory approach;