Brussels, 12 November 2025 – EuropaBio, the European Association for Bioindustries, has submitted its official response to the European Commission’s public consultation on the EU Biotech Act. This response reflects the collective expertise and priorities of European biotechnology across sectors, calling for ambitious action to unlock innovation, competitiveness, and resilience across the EU.

The response identifies regulatory barriers throughout the biotech lifecycle, from early research and development to market scale-up. EuropaBio calls for simplified permitting, harmonisation of GMO, environmental, and clinical rules, and a shift towards risk-based, product-focused regulation. Fast-track pathways for sustainable bioprocesses and clearer frameworks for genetically modified microorganisms are essential to enable innovation and market access.

EuropaBio urges the EU to adopt a bold approach to investment with a suite of financial instruments to close the gap between research and commercialisation. The submission highlights the need to integrate fragmented and risk-averse EU capital markets, mobilise private investment, and support high-risk, high-reward biotech innovation, including work towards an EU NASDAQ.

EuropaBio emphasises the importance of stronger, better-connected biotechnology clusters and manufacturing hubs. The organisation calls for completion of the Single Market, harmonisation of procurement, tax, and intellectual property practices, and support for regional biotech ecosystems. Expanding shared technology infrastructures and leveraging EU-level initiatives will help scale up industrial biotech and foster cross-sectoral collaboration.

Addressing persistent skills gaps, EuropaBio recommends targeted upskilling and reskilling pipelines, improved talent mobility through the EU Blue Card scheme, and harmonised training programmes. Support for dual-degree programmes and expanded Erasmus+ opportunities will ensure Europe’s workforce is ready for the future of biotechnology.

The submission highlights the transformative potential of data and artificial intelligence, while noting barriers such as fragmented data ecosystems, compliance uncertainty, and limited AI-ready datasets. EuropaBio calls for EU-wide regulatory sandboxes, harmonised data standards, and dedicated AI-biotech testbeds. Investment in FAIR-compliant biodata repositories and talent pipelines will accelerate responsible innovation.

EuropaBio’s response also addresses the strategic importance of biotechnology for EU defence and security. Recommendations include establishing an EU Biosecurity and Defence Coordination Platform, investing in dual-use research and development infrastructure, and promoting secure supply autonomy for critical biotech inputs.

EuropaBio’s consultation response sets out a clear vision for the EU Biotech Act: ambitious funding, streamlined regulation, empowered clusters, skilled talent, and digital leadership. These measures are vital to ensure Europe’s biotechnology sector remains globally competitive, innovative, and resilient.

Dr. Claire Skentelbery, Director General of EuropaBio had this to say: “The EU Biotech Act is generational opportunity for Europe and must not be squandered. It’s ambition and boldness much match Europe’s oft-stated vision for competitiveness, as the critical technology with the most potential from our rich research base and which addresses societal, economic and climate needs.”

Read and download the full press release, consultation response and annex below