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DRAFT REPORT (2025/2008(INI))

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

ITRE-PR-768143

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

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✦ 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.

This draft report on the future of the EU biotechnology and biomanufacturing sector calls for an EU biotech act, streamlined authorisation, harmonised rules, and better funding and coordination to boost competitiveness. It stresses the need for regulatory sandboxes, IP protection, feedstock supply, lower energy prices, skilled workforce, and integration with digital and AI strategies.

Committee position. The rapporteur proposes a resolution calling for an EU biotech act, streamlined authorisation, better coordination, and increased funding to boost the sector's competitiveness.

Key points

  1. Asks that the EU biotech act be accompanied by impact and cost assessments and a Regulatory Scrutiny Board assessment, respecting 'one in, one out'.
  2. Recommends streamlining initiatives and creating a single coordination body, such as a 'Chief Biotechnology Officer', in the Commission.
  3. Calls for a report on implementation of current legislation, sharing study findings, and a biotechnology omnibus to simplify requirements.
  4. Calls for streamlined and simplified authorisation procedures, maintaining risk-proportionate and science-based approach, especially in agency reviews.
  5. Calls for harmonised IP rules, a common clinical trials framework using real-world evidence, and a Commission report on improvements.
  6. Recommends using next-generation regulatory sandboxes to trial emerging applications in a controlled but flexible environment.
  7. Underlines the need to account for bio-based product specificities in chemical and environmental legislation for petrochemical products.
  8. Asks the Commission to examine definitions so that bio-based projects are not denied funding by the European Investment Bank's Paris alignment interpretation.
  9. Underlines that bio-based products' CO2 reduction benefits must be reflected in life cycle assessments, consumer info, and public procurement.
  10. Points out early tastings are important for rapid commercialisation of food biotechnology.
  11. Underlines that biosecurity risks must be addressed with innovation, ensuring responsible access to synthetic biology tools and genetic editing.
  12. Calls for monitoring feedstock supply risks, improving knowledge transfer, lowering energy prices, developing skills, completing capital markets union, and strengthening investment instruments.

Who is affected

  • EU biotechnology and biomanufacturing companies, especially start-ups and SMEs, would benefit from streamlined procedures and better funding.
  • The European Commission would be tasked with presenting reports, assessments, and coordinating bodies.
  • The European Investment Bank may need to adjust its funding criteria for bio-based projects.

Figures and deadlines

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

Legal basis: Articles 9, 151, 152, 153(1) and (2), 173 and 179 of the Treaty on the Functioning of the European Union