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Adopted text

Future of the EU biotechnology and biomanufacturing sector: leveraging research, boosting innovation and enhancing competitiveness

TA-10-2025-0165 · P10_TA(2025)0165 · PE768.143

✦ In short · AI summary of this text, generated 4 Sept 2026

Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

Parliament's resolution on the future of the EU biotechnology and biomanufacturing sector calls for an EU biotech act, streamlined authorisations, and a common clinical trials framework. It urges the Commission to define biomanufacturing, update the bioeconomy strategy, and ensure IP protection, while addressing biosecurity and AI risks. It stresses the need for funding, skills, and infrastructure to scale up innovation and maintain EU competitiveness.

Key points

  1. Calls on the Commission to propose an EU biotech act that addresses gaps, reduces burdens, and has a cross-sectoral scope, with impact assessments.
  2. Calls on the Commission to define biomanufacturing in a future-proof, technology-neutral way.
  3. Urges streamlining and harmonising initiatives, ensuring coherence across legislation, and taking account of non-EU regulatory frameworks.
  4. Calls for a report on implementation, simplification of requirements, and faster approval procedures while maintaining a risk- and science-based approach.
  5. Requests guidance on the Net-Zero Industry Act and Clean Industrial Deal, and considers simplified approvals for products approved by trusted bodies.
  6. Calls for streamlined authorisation procedures, adequately resourced EU agencies, and simplified labelling practices.
  7. Underlines the need for robust IP protection, longer patent terms, and a common clinical trials framework.
  8. Calls for an updated bioeconomy strategy, incentives for bio-based products, and fair sustainability criteria for biomass.
  9. Calls for an EU biosecurity registry, a study on biological materials, and stronger international cooperation on biosecurity.
  10. Stresses the need for secure feedstock supply, affordable energy, and a skilled workforce, including attracting more women and non-EU talent.
  11. Calls for completing the capital markets union, strengthening investment instruments, and exploring a biotechnology Important Project of Common European Interest.
  12. Calls for doubling the EU research budget, integrating biotech into digital strategies, and applying a risk-based approach to AI.

Who is affected

  • EU biotechnology and biomanufacturing companies, especially start-ups and SMEs, would benefit from streamlined approvals and better access to funding.
  • EU agencies like the European Food Safety Authority, European Medicines Agency, and European Chemicals Agency would need adequate resources for timely authorisations.
  • The European Investment Bank is asked to propose de-risking instruments and improve outreach for biotech projects.
  • Member States are called on to implement measures for biomanufacturing infrastructure and improve policy coherence.

Figures and deadlines

  • 3 % of EU gross domestic product devoted to R & D by 2030

Legal basis: Articles 9, 151, 152, 153(1) and (2), 173 and 179 TFEU