EU Biotech Act: The European Commission’s landmark proposal to strengthen biotechnology in Europe

In December 2025, the European Commission published its proposal for the European Biotech Act.¹ The proposal is a centerpiece of the Commission's broader strategy to position the EU as a global leader in biotechnology, responding to competitive pressure from other markets, explicitly from the United States and China.

Background

Biotechnology is one of the most transformative and strategically critical sectors of the 21st century economy. From advanced biologics and cell and gene therapies to agricultural biotech and industrial fermentation, the sector touches virtually every corner of the modern economy. Examples of health biotechnology include medical breakthroughs, such as CAR T-cell therapies and mRNA therapies. Despite hosting world-class research institutions and innovative companies, the EU has fallen behind its major competitors in translating scientific excellence into commercial success. The EU Biotech Act is the Commission's response to this competitive gap. It sits alongside other legislative initiatives as part of an effort to reduce strategic dependencies and build European industrial and technological sovereignty.

Key Elements of the Proposal

The Biotech Act introduces a broad set of measures to keep European biotech innovation in Europe and translate innovation into commercially viable products and large-scale manufacturing.

Strategic Projects and Support Measures

The Biotech Act introduces a framework for recognizing and supporting "health biotechnology strategic projects" and "high impact health biotechnology strategic projects." These projects will benefit from accelerated permitting, administrative and technical support, and priority access to funding at both the EU and Member State level. Strategic mapping of the EU's biotech ecosystem will guide the identification of gaps, dependencies and investment needs, informing policy and funding decisions.

Faster and More Predictable Regulatory Pathways

The proposal amends key EU legislation—including the Clinical Trials Regulation² and the Advanced Therapy Medicinal Products Regulation³—to reduce time-to-market and harmonize procedures. Notably, the Biotech Act shortens clinical trial approval timelines for multinational trials, introduces a new category of "low-intervention clinical trials" and enables parallel substantial modifications, among other measures. Parallel procedural and safety requirements for chemicals under the Regulation (EU) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals ("REACH") and for genetically modified organisms ("GMOs") under the Directive 2009/41/EC on the contained use of genetically modified micro-organisms will still apply. Further, the Commission proposes the introduction of regulatory sandboxes to allow companies to test innovative biotech products and processes in a controlled environment before full market authorization, without being subject to the full regulatory burden.

Access to Funding and Investment

The Biotech Act establishes an EU Health Biotechnology Investment Pilot in partnership with the European Investment Bank ("EIB") Group, aiming to mobilize public and private capital across the biotech lifecycle, with a focus on late-stage and scale-up financing. High-impact projects may receive particular consideration for EU and national financial support, including blended finance and access to the Strategic Technologies for Europe Platform ("STEP").

AI and Data as Enablers

The proposal encourages the integration of artificial intelligence ("AI") and data-driven approaches throughout the biotech value chain, including the development of trusted AI testing environments and data quality accelerators. The European Medicines Agency ("EMA") will issue guidance on the use of AI in the medicinal product lifecycle⁴ that should be coherent with the regulatory requirements of the AI Act.⁵

Biosecurity and Biodefense

The Biotech Act introduces harmonized rules for the prevention of biotechnology misuse, including screening and reporting obligations for certain high-risk products and benchtop nucleic acid synthesis equipment. An Advisory Group on Biosecurity will monitor emerging risks, including those posed by AI models in biological applications.

International Competitiveness and IP Framework

To strengthen Europe's position vis-à-vis the US and China, the proposal also includes measures to improve the predictability and enforcement of intellectual property ("IP") rights in the biotech sector, including adjustments to Supplementary Protection Certificates ("SPCs") and addresses procedural inefficiencies in patent proceedings. The proposed Act further facilitates international partnerships and joint research programs with allied nations.

Opportunities at a Glance

• Faster approval pathways for multinational clinical trials
• Priority in the approval process for recognized strategic projects
• New EU contact points for regulation, funding and networking
• EIB Pilot as a lever for growth capital and scale-up financing
• Biosimilar push driven by EMA Guidance and a focus on project funding
• Improved data/AI infrastructure for validation and development
• EU-wide harmonized minimum biosecurity standards

Implications for Biotech Companies and Investors

The Biotech Act has significant implications across the biotech value chain.

Biotech Companies

• Faster regulatory pathways and improved coordination between EMA and national authorities may reduce time-to-market for biological medicines, biosimilars and advanced therapies.
• Changes to the SPC framework and improved IP enforcement could affect market exclusivity calculations and generic/biosimilar entry strategies.

SMEs and Start-Ups

• Access to shared biomanufacturing infrastructure and regulatory sandboxes will be particularly valuable for early-stage companies that currently lack the capital and regulatory resources of larger players.
• Simplified access to public funding streams may open new financing avenues.
• Testing environments and data quality accelerators facilitate validation and data quality.

Investors

• Improved regulatory predictability and faster approval timelines are widely regarded as key factors in improving the attractiveness of EU biotech investments.
• The strengthening of the EU's IP framework and strategic autonomy agenda will be relevant to investment thesis development and due diligence.

Regulatory Approaches Biotech Companies Should Know

Biosecurity: Mandatory Screening, Recordkeeping and Reporting

The Biotech Act creates a Union framework for the "biotechnology products of concern" listed in Annex I, with the Commission empowered to update Annex I via delegated acts to reflect evolving scientific and biosecurity developments. Economic operators—including online marketplaces—must verify the identity and affiliation of customers, assess their "legitimate need" for each transaction, record all transactions, refuse suspicious transactions, report suspicious or attempted suspicious transactions, and retain transaction records for three years. Similar screening obligations apply to non-operator entities such as labs and universities, subject to limited intra-entity exceptions. Suspicious transactions must be reported within 24 hours to national contact points linked to law enforcement and inspection authorities. Member States must establish effective, proportionate and dissuasive penalties, with the possibility of fines up to five percent of worldwide annual turnover for intentional or negligent infringement. In practice, these obligations can and must be aligned with applicable restrictions under national cross-border transfers of biotech-related equipment, materials, software, technology or know-how outside the EU—including by electronic transmission—under the Dual-Use-Regulation (EU) 2021/821, while laboratory biosafety requirements are not affected by this change.

AI in Biological Applications: New Systemic Risk Monitoring

An independent Advisory Group on Biosecurity is established to advise on biosecurity risks—including from "AI models in biological applications"—to monitor AI model capabilities and risk profiles, and to support guidance and best practices. The Commission must monitor "biological systemic risk" from AI models in biological applications and propose mitigating actions. Qualified alerts trigger measures by the Commission and Member States.

Cybersecurity Obligations for Supported Infrastructures

Strategic and high-impact projects receiving Union program support must offer open, non-discriminatory access at market prices and must comply, where applicable, with NIS2 cybersecurity risk-management and reporting obligations.

Action Items

Stakeholders may not wait for the Biotech Act to be finalized before taking action. Even before the Regulation is formally adopted, companies are advised to watch for Commission action through delegated acts and administrative initiatives, which may begin implementing elements of the framework earlier. The following steps may be taken already.

Biotech Companies, SMEs and Start-Ups

• Conduct a regulatory impact assessment. Map your existing product pipeline and regulatory submissions against the proposed new framework. Identify where faster approvals could benefit your development plans. Utilize regulatory sandboxes to test and validate innovative products and processes in a controlled environment.
• Assess opportunities to have projects recognized as "health biotechnology strategic projects" or "high impact health biotechnology strategic projects" to benefit from accelerated permitting, administrative support and priority access to EU and national funding.
• Monitor developments in AI and data governance. Establish data quality, standards, governance and permissible data use (e.g., EHDS references). Review existing data sharing agreements and internal data governance policies for compatibility with the emerging framework.
• Review your IP portfolio strategy. In light of the proposed changes to SPC rules and patent-related measures, review your IP lifecycle strategy, particularly for products approaching the end of primary patent protection.
• Ensure readiness for new biosecurity and reporting obligations, particularly if handling high-risk biotechnology products or technologies.

Investors

• Evaluate the expanded EU-level funding instruments and the new Health Biotechnology Investment Pilot as potential vehicles for investment, especially for late-stage and scale-up biotech ventures.
• Identify and track strategic projects recognized under the Biotech Act, as these may offer enhanced investment security, access to public-private partnerships, and priority in EU funding programs.
• Consider the impact of regulatory simplification and harmonization on the risk profile and time-to-market for portfolio companies.
• Stay informed about the evolving landscape for AI-enabled biotech and biosecurity compliance, which may affect due diligence and risk assessment.

Conclusion

The EU Biotech Act proposal marks a significant step toward a more unified, competitive and innovation-friendly biotech landscape in the EU. By streamlining regulation, enhancing access to capital and fostering digital and scientific excellence, the Biotech Act aims to position the EU as a global leader in biotechnology and biomanufacturing. The legislative process is still at an early stage and the final shape of the Act will depend on negotiations between the Commission, Parliament and Council. However, the direction of travel is clear, and stakeholders across the biotech sector should begin preparing now.

_{1 Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act).
2 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
3 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.
4 In January 2026, the European Medicines Agency ("EMA") and the US Food and Drug Administration ("FDA") published a set of ten Guiding Principles of Good AI Practice in Drug Development as best practices for AI. We refer to our corresponding Client Alert "New bilateral AI collaboration between the EMA and FDA" of January 21, 2026, here.
5 See the White & Case EU AI Act Handbook for details, here.}

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_{This article is prepared for the general information of interested persons. It is not, and does not attempt to be, comprehensive in nature. Due to the general nature of its content, it should not be regarded as legal advice.}

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