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REPORT (2025/2008(INI))

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

A-10-2025-0123

Committee on Industry, Research and Energy · Rapporteur: Hildegard Bentele

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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 a comprehensive EU biotech act, streamlined authorisation, and better coordination to boost competitiveness. It urges the Commission to define biomanufacturing, ensure regulatory coherence, and consider non-EU frameworks without lowering standards. The resolution stresses the need for a robust bioeconomy, secure feedstock supply, and support for SMEs, start-ups, and scale-ups. It calls for increased R&D investment, including doubling the EU research budget, and for addressing biosecurity risks.

Committee position. The Committee on Industry, Research and Energy proposes a resolution calling for a comprehensive EU biotech act, streamlined authorisation, and increased investment to boost the sector's competitiveness.

Key points

  1. Calls on the Commission to propose an EU biotech act that addresses concrete gaps, is cross-sectoral, and includes impact assessments and competitiveness checks.
  2. Urges the Commission to define biomanufacturing in a future-proof, technology-neutral way.
  3. Recommends streamlining initiatives and ensuring coherence across all measures affecting biotechnology and biomanufacturing.
  4. Calls for shorter authorisation procedures and simplified approvals for products approved by trusted regulators in like-minded countries.
  5. Asks for a report on implementation of current legislation and simplification of requirements across regulatory frameworks.
  6. Calls for a common clinical trials framework and swift implementation of the Clinical Trials Regulation.
  7. Urges the Commission to present an updated bioeconomy strategy and incentivise sustainable bio-based products.
  8. Calls for an EU biosecurity registry for synthetic DNA and equipment, and stronger international cooperation on biosecurity.
  9. Stresses the need for skilled workforce, increased investment in education, and attracting talent from non-EU countries.
  10. Calls for completion of the capital markets union and dedicated support for SMEs, start-ups, and scale-ups to access funding.
  11. Reiterates the call to double the EU's research budget and reach 3% of GDP for R&D by 2030.
  12. Calls for integrating biotechnology into digital and AI strategies, with risk-based approach to AI use.

Who is affected

  • EU biotechnology and biomanufacturing companies, especially SMEs, start-ups, and scale-ups, would benefit from streamlined procedures and funding support.
  • 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 called on to propose de-risking instruments and improve outreach for biotech projects.
  • Member States are urged to implement measures to support deployment of biotechnology infrastructure and simplify permitting.

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