On public health aspects of biotechnology and life sciences

(2025/2087(INI))

The European Parliament,

–having regard to the Treaty on the Functioning of the European Union, in particular Articles 9, 151, 168, 173 and 179 thereof,

–having regard to the Treaty on European Union, in particular Article 5(3) thereof and Protocol No 2 thereto on the application of the principles of subsidiarity and proportionality,

–having regard to 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,

–having regard to Regulation (EU) 2024/795 of the European Parliament and of the Council of 20 February 2024 establishing the Strategic Technologies for Europe Platform (STEP), and amending Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/241,

–having regard to Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU,

–having regard to the Commission communication of 20 March 2024 entitled ‘Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU’ (COM(2024)0137),

–having regard to the Commission communication of 3 February 2021 entitled ‘Europe’s Beating Cancer Plan’ (COM(2021)0044),

–having regard to Commission Recommendation (EU) 2023/2113 of 3 October 2023 on critical technology areas for the EU’s economic security for further risk assessment with Member States,

–having regard to the Commission communication of 29 January 2025 entitled ‘A Competitiveness Compass for the EU’ (COM(2025)0030),

–having regard to the Commission Annual Report on European SMEs 2023/2024 of 4 July 2024,

–having regard to the Universal Declaration on the Human Genome and Human Rights, adopted by UNESCO on 11 November 1997,

–having regard to the 2025 concluding remarks on the European Union of the UN Committee on the Rights of Persons with Disabilities,

–having regard to Rule 55 of its Rules of Procedure,

–having regard to the report of the Committee on Public Health (A100000/2025),

A.whereas biotechnology applies the principles and mechanisms intrinsic to biology to develop or modify products and processes for specific purposes, including in the healthcare and pharmaceutical sectors;

B.whereas the sequencing of the DNA structure marked a pivotal moment in understanding human genetics and accelerating biotechnology development;

C.whereas biotechnology has been identified as a critical technology area for the EU;

D.whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;

E.whereas deepening our knowledge of life sciences can drive innovation in biotechnology, particularly in the pharmaceutical industry;

F.whereas the EU leads in scientific publications in biotechnology, but struggles to turn research into market solutions;

G.whereas the regulatory framework for biotech-based medicinal products is complex, with multiple laws overlapping, both at national and EU level; whereas the rapid pace of biotech innovation has outpaced current legal frameworks;

H.whereas small and medium-sized enterprises (SMEs) represent over 99 % of EU businesses and constitute the majority in the biotechnology field;

I.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;

J.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;

The potential application of biotechnologies in the healthcare sector

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

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

3.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;

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

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

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

Regulatory framework

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

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

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

10.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;

Challenges in health-related technology transfer, commercialisation and investment

11.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;

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

13.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;

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

15.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;

16.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;

17.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;

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

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

Support for biotech SMEs

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

21.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;

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

Ethical and legal implications

23.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;

24.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;

25.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;

26.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;

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

28.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;

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

Way forward towards the EU Biotech Act

30.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;

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

32.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;

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

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

35.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;

36.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;

37.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;

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