The Proposed European Biotech Act, 100 Days On
On December 16, 2025, the European Commission (the "Commission") published a proposal for a European Biotech Act (the "Proposed Biotech Act" or "Proposal"). The Proposed Biotech Act is a central pillar of the Commission's broader life sciences strategy, which aims to position the EU as what the Commission has described as the world's most attractive destination for life sciences by 2030.
Nearly 100 days since the Proposal's publication, two other significant developments have taken place. First, the European Data Protection Board ("EDPB") and the European Data Protection Supervisor ("EDPS") issued their Joint Opinion 3/2026 on March 10, 2026, broadly supporting the Proposal's objectives while also offering recommendations to maintain strong data protection safeguards for the protection of clinical trial personal data. Second, the FAST-EU pilot program, a 23-Member State fast-track initiative for clinical trial authorizations, became operational in January 2026, providing the first real-world stress test of the Proposal's ambition to reduce authorization timelines.
It is also anticipated that a second legislative package—currently referred to as "Biotech Act II"—covering industrial, agri-food, and marine biotechnology, will be published in the autumn of 2026. This means that the current health-focused Proposal would likely serve as the regulatory blueprint for the broader European bioeconomy.
The Proposal is currently open for further feedback (here), with the consultation period being extended on a rolling basis until the Proposal is available in all official EU languages. Stakeholders are encouraged to consider providing input both individually and through industry associations.
Background: Europe's Competitiveness Challenge and the Proposal's Response
Over the past decade, the EU biotechnology industry has grown more than twice as fast as the overall EU economy, making it one of Europe's most dynamic innovative sectors. Yet, the EU continues to struggle with turning its science into commercially successful products, particularly when scaling up manufacturing. The Commission reports that the EU's global share of venture capital investment in health biotechnology stands at just 7%, and its share of commercial clinical trials has declined from 22% to 12% over the past decade. Start-ups often end up investing, producing, and placing their products on the market outside the EU.
Key barriers include: fragmented governance and limited coordination across Member States, underutilized biomanufacturing capacity, and limited access to scale-up funding. Regulatory complexity and slower approval timelines—113 days on average for multinational clinical trials, compared with 60 days in other regions—further hinder competitiveness. Divergent national data protection requirements for multinational clinical trials add further compliance burden for sponsors operating across multiple Member States. Additionally, the EU has yet to fully leverage the potential of artificial intelligence ("AI") in biotechnology, due to fragmented data and limited testing environments.
Against this background, the overall objective of the Proposed Biotech Act is to create an enabling environment that makes it easier to bring biotechnology products from the laboratory to the factory and then onto the market. To achieve this, the Proposed Biotech Act both establishes new standalone frameworks—including for strategic projects, funding mechanisms, and institutional coordination—and amends a range of existing EU legislation spanning clinical trials, advanced therapy medicinal products, substances of human origin, veterinary medicinal products, general food law, human organs, and genetically modified organisms. Notably, however, because many of these amendments operate on existing horizontal frameworks, the Proposal's relevance extends well beyond biologicals. For example, amendments to the Clinical Trials Regulation would apply to all clinical trials for medicinal products, whether of biological or chemical nature.
Key Amendments to the Clinical Trials Regulation
The most significant amendments concern the Clinical Trials Regulation (EU) No 536/2014 ("CTR"). The Proposal includes, among other things:
Reduced Timelines: A reduction of approval timelines for multinational clinical trials from 106 days to 76 days is proposed. Where no request for additional information is issued to the sponsor, the timeline would fall from 75 days to 47 days from submission to decision. Timelines for substantial modifications would be compressed from 96 days to 47 days (or 33 days if there is no request for additional information), with an option for sponsors to submit parallel modifications on distinct aspects of the dossier. The additional 50-day assessment period currently applicable to advanced therapy medicinal products ("ATMPs"), such as gene therapy medicines, would be eliminated entirely.
These proposed reforms are already being tested in practice. FAST-EU (Facilitating and Accelerating Strategic Clinical Trials), a voluntary pilot initiative launched by the heads of Medicines Agencies, the Clinical Trials Coordination Group, and MedEthics EU, became operational in January 2026 within the existing CTR framework. The voluntary pilot applies to initial applications for multinational clinical trials involving more than one Member State across all categories of investigational medicinal products and targets an overall duration of 70 calendar days from submission to decision by all Member States concerned, including sponsor response times. FAST-EU's objectives are closely aligned with the Proposal's timeline ambitions, and its outcomes are likely to inform the legislative debate on whether the proposed statutory timelines are achievable in practice.
Regulatory Efficiency: The Proposal streamlines the assessment process of multi-country clinical trials by strengthening the role of the lead "reporting" Member State, whose assessment would serve as a reference for all other participating countries, reducing duplication of effort. Currently, clinical trial dossiers are assessed in two parts: Part I, which covers scientific and regulatory aspects and is coordinated by the reporting Member State (i.e., the Member State chosen by the sponsor to lead on the review), which must take due account of any considerations raised by other Member States concerned; and Part II, which covers ethical and national aspects and is assessed independently by each Member State where the trial takes place. To increase efficiency and speed, the Proposal would, among other things: (i) integrate ethical review into Part I, to be conducted by the reporting Member State's ethics committee; (ii) limit the grounds on which other Member States may raise considerations; (iii) introduce a principle of mutual trust and reliance, under which other Member States should complement the reporting Member State's assessment only when necessary; and (iv) allow Member States to rely on the ethical review of the reporting Member State for common elements of the Part II assessment.
In addition, the Proposed Biotech Act introduces several new mechanisms, including: a simplified "minimal-intervention" trial category for lower-risk studies using already-authorized products, which would require only an ethical review before commencement; an investigational medicinal product core dossier allowing sponsors to maintain a single product file referenced across multiple trials; an accelerated procedure for clinical trials during public health emergencies; a unified assessment process for combined studies involving medicines together with medical devices or diagnostics; explicit authorization of electronic informed consent for trial participants; and mandatory harmonized templates for certain national-level submissions to reduce divergence between Member States.
Harmonized Data Protection Rules: To reduce fragmentation and compliance cost for sponsors of multinational trials, a harmonized legal basis for processing personal data in clinical trials under the General Data Protection Regulation (the "GDPR") is proposed, as well as a prohibition on Member States from imposing additional conditions, including supplementary consent requirements.
The EDPB and EDPS, in Joint Opinion 3/2026, broadly welcomed the Proposal's objectives but identified several areas requiring further clarity. In particular, they recommended: (i) clarifying the respective roles of sponsors and investigators as data controllers/processors under the GDPR; (ii) clarifying minimum retention periods; (iii) further clarifying the purposes and safeguards for secondary use of clinical trial data for other scientific research; and (iv) requiring the use of pseudonymization whenever the processing of directly identifiable data is not necessary. The EDPB and EDPS Joint Opinion, while not binding, carries significant weight, and its recommendations may be incorporated through amendments during the Proposal's legislative process (see "Next Steps" section below).
Regulatory Sandboxes: Regulatory sandboxes are controlled environments where developers can test innovative products and technologies under regulatory supervision and relaxed regulatory requirements before full market entry. The Proposed Biotech Act establishes such sandboxes across multiple domains to foster innovation while maintaining oversight, such as for clinical trials, for novel health biotechnology products that do not fit within existing EU frameworks, substances of human origin, food and feed safety matters, and veterinary medicinal products. The EU had already tested this concept in the EU Pharma Package with a view to adding flexibility to regulatory procedures (see our December 2025 Commentary "The EU Pharma Package Is a Done Deal: a Holiday Gift, or Not?").
Rules and Guidance on Artificial Intelligence: Sponsors would be required to evaluate the benefits and risks related to patient safety and data robustness of any AI models or systems used in the context of a clinical trial, and to describe the AI tools and their purposes in the trial protocol. The EDPB and EDPS have recommended clarifying that these obligations apply in addition to the requirements already applicable under the EU AI Act, which separately regulates AI systems and General-Purpose AI models based on their risk profile.
In addition, the Proposal requires the European Medicines Agency ("EMA") to publish and regularly update guidance on the deployment and use of systems based on advanced technologies, including AI, across the medicinal product life cycle, from pre-clinical research through clinical development, manufacturing, and post-authorization monitoring. This guidance must be developed in agreement with the Commission and in cooperation with relevant authorities and stakeholders.
Strategic Projects Framework
The Proposed Biotech Act introduces a framework for the recognition and support of health biotechnology strategic projects and high-impact health biotechnology strategic projects, aimed at strengthening the EU's industrial biomanufacturing capacity and value chain. Projects that can be recognized as such include projects that: create or expand production facilities for biotechnology products; establish biomanufacturing sites with innovative and digitally-enabled processes; integrate AI-driven manufacturing systems; or establish pilot and testing infrastructures for biomanufacturing. Strategic projects would be recognized at the Member State level, while high-impact projects—namely those with systemic and cross-border relevance—would be recognized by the Commission.
Recognized projects could benefit from accelerated permit timelines, streamlined regulatory procedures, and facilitated access to financial support. For example, permit-granting processes would be limited to 10 months for strategic projects and eight months for high-impact projects, with a possible extension of up to three months in exceptional circumstances. Recognized projects would also be granted "the highest national significance" available under Member State law and receive corresponding procedural advantages, including priority treatment and coordinated permit-granting.
SPC Extension
The Proposal introduces a 12-month extension of the Supplementary Protection Certificate ("SPC")—an intellectual property right that currently extends patent protection for medicinal products by up to five years beyond the standard patent term to compensate for the time spent obtaining regulatory approval—for medicinal products developed by means of biotechnology processes and for ATMPs, incentivizing the development of products using innovative biotechnology technologies.
Biosimilars
The Proposal includes dedicated provisions to strengthen EU capabilities in biosimilar research, development, and manufacturing. Strategic health biotechnology projects focused on biosimilars may receive recognition and support under the Proposed Biotech Act, and the Proposal promotes international cooperation between economic operators and biotechnology clusters in this area. The EMA is also encouraged to develop guidance on facilitating the authorization of biosimilar medicinal products, including consideration of a potential reduction of the clinical data requirements based on robust analytical and non-clinical evidence. This follows a trend we have seen also in the United States, where the U.S. Food and Drug Administration ("FDA") in its draft guidance "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies," proposes relying on comparative analytical assessments in lieu of clinical studies with efficacy endpoints (comparative efficacy studies) to support a demonstration of biosimilarity (see also our November 2025 Alert "FDA Proposes to Remove Comparative Efficacy Studies to Accelerate Biosimilar Development").
Access to Funding and Institutional Support
To address the so-called "valley of death" challenge, where promising biotechnology companies struggle to access late-stage funding to scale their innovations, the Proposal establishes an EU Health Biotechnology Investment Pilot in partnership with the European Investment Bank Group and other partners. This pilot brings together equity instruments and venture-style debt tailored to biotechnology-specific risk profiles, aiming to mobilize private investment into the sector.
On the institutional side, the establishment of the EU Health Biotechnology Support Network is proposed, which would assist developers of health biotechnology products to navigate applicable rules, funding opportunities, as well as scaling-up and networking opportunities. A European Health Biotechnology Steering Group, made of representatives from all EU Member States and the European Commission, would be tasked to facilitate coordination on project recognition, funding, cluster networking, and biosecurity enforcement.
Next Steps
The Proposed Biotech Act is currently subject to an additional period of public consultation.
Following the feedback period (currently expected to close in May 2026, though subject to further extension), all feedback received will be summarized by the Commission and presented to the European Parliament and the Council, who will consider the Commission's Proposal and the input received. Once the Parliament and Council have each adopted their respective positions, trilogue negotiations between the three institutions are expected to commence, possibly in the fourth quarter of 2026. Adoption of the European Biotech Act is not expected before the end of 2026.
We will continue to monitor the Proposal's progress through the legislative process, which is poised to materially reshape the operating environment for life sciences companies across the EU. As it progresses, stakeholders—in particular clinical trial sponsors, biotechnology companies, and biomanufacturing operators—are encouraged to engage in any consultation process to assess and comment on how the proposed amendments may affect their regulatory and funding strategies, and make use of emerging institutional resources, such as the EU Biotech and Biomanufacturing Hub.
Jones Day associates Justine Naessens and Laura de Arroyo Garcia contributed to this article.
