On 4 August 2025, the European Commission launched a public consultation to prepare the European Biotech Act. The initiative builds on the March 2024 Communication on biotechnology and biomanufacturing and the reports prepared by Enrico Letta and Mario Draghi. The Biotech Act is designed to strengthen EU competitiveness by improving conditions for biotechnology and biomanufacturing. It aims to ease the transition from laboratory research to production and market access while maintaining high standards of health and environmental protection.
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The consultation will remain open until 10 November 2025, inviting contributions from different stakeholders (citizens, innovators, companies, investors, researchers, civil society organisations, trade unions and public authorities). The purpose is to collect evidence on the obstacles faced by the sector and to gather perspectives on potential EU actions. Stakeholder input will feed into the impact assessment that will accompany the legislative proposal.
The questionnaire covers a wide range of topics. It begins with general views on biotechnology before moving to the regulatory environment, where respondents can identify barriers that delay or complicate product development and authorisation. Other sections address access to finance, the performance of biotechnology clusters, and the operational challenges of manufacturing at scale. Workforce skills are also a focus, with questions on education, training and talent retention. The role of data and artificial intelligence in research and product deployment is examined, while questions on biosecurity and dual-use risks in the defence and security domain reflect wider geopolitical challenges.
Responses to this consultation can be submitted online in any official EU language. For transparency reasons, organisations and businesses taking part are encouraged to register in the EU’s Transparency Register. Once the consultation closes, the Commission will publish the contributions. By engaging a broad range of stakeholders, the process is intended to ensure that the Biotech Act reflects both the opportunities and the risks of biotechnology and provides a clear strategy to support innovation, investment and Europe’s long-term competitiveness.
More information available at:
EU Biotech Act Public Consultation - Link
Communication on biotechnology and biomanufacturing Link
Report “Much More Than a Market” by Enrico Letta - Link
Report on competitiveness by Mario Draghi - Link