Securing Europe’s Biotechnology Future: Our European Biotech Act Submission

These recommendations were submitted on June 11th, 2025.

Europe stands at a critical juncture in biotechnology development. While maintaining world-class research capabilities, the European Union faces declining competitiveness and dangerous dependencies that threaten both innovation potential and strategic security. The share of clinical trials conducted in the EU has fallen from 25% to 19% over the last decade, while the United States maintains twice as many early-stage venture capital deals and three times as many late-stage deals in biotechnology.

We submitted recommendations to the European Commission’s consultation on the European Biotech Act, emphasising that security and innovation are complementary objectives. Our submission leverages key insights from biosecurity policy, technology governance, and supply chain resilience to propose frameworks that would position Europe as the global leader in responsible biotechnology development.

Key Recommendations

1. Establish EU-wide screening requirements for synthetic nucleic acids with sequence screening and customer verification procedures, harmonised with international best practices to reduce regulatory burden whilst maintaining security standards.
2. Integrate biosecurity investment criteria into European funding frameworks, prioritising investments that strengthen strategic autonomy in critical biotechnology capabilities, with dedicated funding streams for defensive biotechnology applications, including pathogen surveillance and medical countermeasure development.
3. Create distributed biotechnology manufacturing clusters focused on critical capabilities such as active pharmaceutical ingredient production and vaccine manufacturing platforms, supported by cross-border resilience partnerships to ensure European supply chain security during biological crises.
4. Develop a centralised biotechnology funding hub that consolidates information on EU innovation and scale-up funding initiatives across multiple programmes, national schemes, and regional initiatives, providing a single access point where industry and academia can efficiently navigate, access, and compete for biotechnology development support whilst addressing the current fragmented landscape that creates barriers, particularly for SMEs and start-ups.
5. Implement supply chain transparency requirements for critical biotechnology applications, including real-time visibility of dependencies, disclosure of single points of failure in essential production, and integration with EU monitoring systems to enable the rapid identification of vulnerabilities and alternative sourcing during biological crises, while addressing the current opacity that undermines crisis response capabilities.

Our recommendations aim to establish European leadership in responsible biotechnology development, thereby strengthening both competitiveness and security capabilities. A safe and secure EU biotechnology sector requires integrated approaches that serve both economic and security interests through adaptive governance that keeps pace with technological development.