The European Commission (EC) has launched a public consultation on the proposed EU Biotech Act, inviting input from stakeholders to help shape legislation aimed at accelerating biotechnology products from the laboratory to the market. The consultation runs until November 10, 2025, and will inform the Commission’s impact assessment before formal adoption, planned for the third quarter of 2026.

The Biotech Act is a core component of the EC’s Strategy for Life Sciences and seeks to enhance the global competitiveness of Europe’s biotech sector. It will propose measures to streamline regulation, improve access to financing, scale production, develop skills, and integrate advanced data and artificial intelligence (AI) capabilities into biotechnology.

Key priorities include reducing “time-to-market” for biotech products—particularly for start-ups—through regulatory simplification, while maintaining stringent safety standards. The Commission is also exploring funding solutions for early-stage companies, strengthening existing incentives, and expanding access to EU infrastructure for research, development, and manufacturing.

Skills development is another major focus, with plans to equip academic researchers with entrepreneurial expertise and attract global talent in R&D and manufacturing. On the digital front, the EC envisions “AI Factories” to help biotech innovators leverage data effectively, complementing initiatives like the European Health Data Space.

The EC is urging companies, research institutions, non-profits, and the public to participate in the consultation to ensure the legislation reflects the sector’s needs while fostering a safe, inclusive, and dynamic biotech ecosystem.

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