EU Biotech Act: Strategic considerations for biotech companies

This blog is part of The Regulatory Navigator series, where we explore the evolving regulatory landscape with actionable insight from Parexel's experts, sharing their experience to maximize success for clinical development and patient access.

The proposed EU Biotech Act will redefine biotechnology regulation across Europe. For biotech firms, this is not just a compliance challenge, it’s a strategic inflection point. We share a guide to the critical considerations and actions you need to take now. 

Introduction: A turning point for European biotechnology 

Biotechnology is no longer a niche scientific discipline. It has become a strategic pillar of global competitiveness, health security, and industrial transformation. From synthetic biology and gene editing to advanced biomanufacturing, biotech innovations are reshaping medicine. Recognizing this, the European Union is preparing to introduce the EU Biotech Act¹, a landmark legislative initiative expected in Q3 2026. Part of a wider strategy by the European Commission to make Europe a global leader in life sciences by 2030, the EU Biotech Act aims to create a more innovation-friendly framework across biotech sectors.² 

For biotech companies, this legislation represents both opportunity and responsibility. It promises faster market access and a more agile regulatory environment, but it also introduces new compliance obligations and risk dimensions. Understanding these dynamics early is essential for maintaining competitive advantage. 

What is the EU Biotech Act? 

The EU Biotech Act aims to create a coherent, innovation-driven, and security-conscious legal framework governing biotechnology and biomanufacturing across the EU. It seeks to streamline regulatory procedures, eliminate bottlenecks, and accelerate time-to-market for biotech innovations. The Act will introduce regulatory sandboxes that allow controlled experimentation with emerging technologies, integrate biosecurity and dual-use controls to mitigate risks of misuse, and strengthen Europe’s strategic autonomy in biotech amid global competition. Anchored in Article 114 TFEU, the Act will intersect with multiple domains – health, agriculture, energy, sustainability, and national security – while aligning with broader EU strategies such as the Bioeconomy Strategy and Preparedness Union. 

Why now? The global context 

The EU is not acting in isolation. The US, China, and other global powers are investing heavily in biotech, positioning it as a driver of economic growth and national security. The U.S. Intelligence Authorization Act for FY2026³ explicitly frames biotechnology as a strategic asset, linking it to outbound investment screening and biodefense. Within this geopolitical context, the EU Biotech Act is designed to make Europe’s internal market more agile, harmonized, and competitive – while safeguarding public health and security. 

Key challenges and considerations for biotech companies  

One of the most pressing challenges addressed by this new legislation is regulatory fragmentation. Today, biotech regulation in the EU is spread across GMO laws, medicinal product rules, clinical trial frameworks, and intellectual property regimes. This patchwork slows innovation and creates uncertainty for investors. The Biotech Act aims to harmonize these processes, reduce duplication, and enable a single market for biotech. Companies should begin by conducting a regulatory gap analysis and preparing documentation for cross-border compliance alignment. 

Another major innovation is the introduction of regulatory sandboxes. These controlled environments could allow for earlier experimentation with technologies such as gene editing and novel biomanufacturing, offering the opportunity for real-time regulatory feedback and reducing approval uncertainty. Biotech firms should identify high-potential projects for sandbox participation and engage with regulators early to secure a place in pilot programs. 

Biosecurity and dual-use compliance will become a central pillar of the new framework. Biotech technologies can be weaponized, and the Act will integrate obligations from the EU Dual-Use Regulation (Regulation (EU) 2021/821). Companies will need to conduct dual-use risk assessments, implement export control compliance, and establish internal biosecurity protocols and audit mechanisms. Building a robust biosecurity governance framework and training teams on dual-use risk awareness should start now. 

Data governance presents another layer of complexity. The European Health Data Space (EHDS) prioritizes privacy and consent, while the Biotech Act emphasizes innovation and data-driven research. These competing logics – rights-based versus growth-centric – could create compliance challenges. EHDS enforces strict consent and purpose limitation, whereas the Biotech Act may enable broader data reuse under public interest exemptions. Companies should align data strategies with EHDS and General Data Protection Regulation (GDPR) while planning for Biotech Act flexibility, investing in privacy-by-design systems and interoperability frameworks. 

Intellectual property and clinical frameworks will also evolve. The Act is expected to push for harmonized IP protection for biotech patents and a common clinical trials framework leveraging real-world evidence. Companies should review their IP portfolios for gaps in EU protection and adapt trial designs to incorporate real-world data. 

The global reach of the Act cannot be underestimated. Like the EU AI Act, it will likely have extraterritorial implications. Non-EU firms trading with Europe will face compliance obligations through contractual clauses, import controls, or equivalency mechanisms. Integrating EU compliance into global risk management frameworks early and monitoring transatlantic regulatory divergence will be essential. 

Finally, the Biotech Act is not just about regulation, it is about geopolitical positioning. Policies related to biotech in the US and China will influence EU policy, particularly around dual-use and security. Biotech firms should develop risk intelligence capabilities to track global regulatory trends and prepare for supply chain resilience planning and export control compliance. 

Conclusion: Opportunity and responsibility 

The EU Biotech Act represents a paradigm shift for biotech companies. It promises a more agile regulatory environment but introduces new compliance burdens and ethical dilemmas. Early preparation is critical – not just for compliance, but for competitive advantage. Be proactive, not reactive. 

Our team of ex-regulators can help you navigate the requirements of the FDA, EMA, PMDA, NMPA, and other major agencies. With deep expertise in global regulations and strategic insights, our Regulatory Consulting group can streamline your path to market, mitigate risks, and optimize regulatory strategies. Our guidance can be crucial in interpreting evolving requirements, preparing robust development plans, and managing interactions with authorities—ultimately helping to bring innovative therapies to patients more efficiently and effectively. 
 

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References  

1. The EU Biotech Act website: https://www.eu-biotech-act.com/ 
2. European Commission. "Commission launches new strategy to make Europe a global leader in life sciences by 2030." Press release, July 2, 2025. 
3. U.S. Congress. Senate Bill 2342, 119th Congress. https://www.congress.gov/bill/119th-congress/senate-bill/2342  

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