European biotech act [EU Legislation in Progress]

Written by Laurence.Amand-Eeckhout.

CONTEXT

Health biotechnologies are increasingly important for public health, innovation, and the European Union’s competitiveness in global research and healthcare markets. They encompass, for example, gene therapies for rare diseases, cell therapies to treat cancer, immunotherapies, bio-artificial skin for burn treatment, and mRNA vaccines. Biotechnology is among the fastest-growing economic sectors in the EU, yet the EU continues to lag behind the United States and China in translating biotech innovation into commercially viable products and large-scale manufacturing. Structural challenges remain, particularly in clinical development, regulatory processes, and manufacturing capacity.
On 16 December 2025, the European Commission proposed a package of measures intended to improve the health of EU citizens, and ensure the long-term resilience and competitiveness of the EU health sector. The package includes a proposal for a ‘European biotech act’ setting out an EU-level framework to strengthen the competitiveness of the health biotechnology and biomanufacturing sector in the EU, by simplifying regulatory processes, promoting innovation, boosting EU-based biomanufacturing with new incentives and support tools, and facilitating access to finance, while maintaining high safety, ethics and sustainability standards.
Following this health-focused initiative, the Commission is expected to propose a second European Biotech Act later in 2026, centred on industrial biotechnologies and biomanufacturing, to ensure a competitive internal market for all biotechnology areas.

LEGISLATIVE PROPOSAL

2025/0406(COD) – Proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) – COM(2025) 1022, 16 December 2025.

NEXT STEPS IN THE EUROPEAN PARLIAMENT

For the latest developments in this legislative procedure, see the Legislative Train Schedule:2025/0406(COD)

Read the complete briefing on ‘European biotech act‘ in the Think Tank pages of the European Parliament.