
EU Biotech Act: Have your say!
The European Commission has launched a public consultation to support the development of the European Biotech Act, which is now being prioritised after a previous delay. The Commission plans to publish the legislative proposal by the end of 2025 and is inviting stakeholders across the biotechnology sector to provide feedback on regulatory, financial, and operational barriers.
Redirection of major funds towards biotech and deep tech: The European Commission has proposed increasing its medium-term budget from €1.2 trillion to €2 trillion, with a strategic shift in how funds are allocated. The two largest programmes — the Common Agricultural Policy and the Cohesion Fund, each making up around one third of the EU budget — would be redirected to support high-tech investment. Funding would be increasingly tied to innovation in biotechnology, artificial intelligence, quantum computing, and deep tech. The aim is to boost Europe’s competitiveness in strategic technologies. However, approval from the EU Council and Parliament remains uncertain. Lobby groups representing agriculture and structurally weaker regions are expected to oppose any cuts to existing allocations.
Improving EU Biotech Regulation: The consultation aims to better understand the challenges that biotech stakeholders face when translating scientific ideas into market-ready solutions. According to the Commission, the responses will help identify policy areas that could be addressed at EU level through the upcoming Biotech Act. Although the feedback will not directly influence the legal text, it will inform the impact assessment that accompanies the legislative process.
Who Can Participate? The consultation is open to a broad audience, including companies active in biotechnology, biomanufacturing and clinical testing, along with researchers, investors, public authorities, NGOs, biotech and pharmalobby groups such as EuropaBio and EFPIA or think tanks such as the Good Food Institute Europe, along with national biotech associations and EU citizens. The Commission is seeking a comprehensive picture of the sector’s needs to ensure that the final legislation is informed by practical insights from across the ecosystem.
Topics Covered: The online survey addresses a wide range of issues relevant to the biotech industry. These include the EU’s regulatory environment, access to capital, the development of biotech clusters and manufacturing capabilities, workforce availability and skills development, the role of data and artificial intelligence, as well as questions of biosecurity and defence-related biotechnology.
Deadline: The public consultation will remain open for 14 weeks. Stakeholders are invited to submit their responses by 10 November 2025 (Midnight). At the end of June, European Commissioner for Health and Animal Welfare Olivér Várhelyi promised that the European Commission will present a draft EU Biotech Act in 2025.