European Commission Proposes Biotech Act to Boost Health Biotechnology in the EU

On December 16, 2025, the European Commission published its proposal for a regulation establishing a European Biotech Act to strengthen the EU's biotechnology and biomanufacturing sectors with a primary focus on health.

Despite world-class EU life sciences research, Europe faces a competitiveness gap and struggles to translate innovation into commercially viable products and large-scale manufacturing, leading many start-ups to grow and commercialize abroad. This is particularly the case in health biotechnology where legislation has not kept pace with science.

The proposed Biotech Act applies to “health biotechnology”, which it defines as “the application of biotechnology [i.e., applying science and technology to living organisms] for the promotion, protection, or restoration of human health and biotechnological applications relevant to animal health, plant health, veterinary public health, and food safety, insofar as these areas contribute directly or indirectly to the protection of human health.” It applies during the entire product lifecycle, including to the related research, access to funding, development, innovation, testing, validation, manufacturing, placing on the market and use activities. Examples of health biotech can include CAR-T therapies, mRNA therapies, AI-driven cardiac sensors, monoclonal antibodies, etc.

The three-prong overarching objective of the Biotech Act is to strengthen competitiveness and accelerate EU market entry of biotech innovations, while maintaining high safety standards. These overarching objectives are translated into seven pillars addressing barriers across the biotech lifecycle—from early research to deployment and scale-up—with particular attention to SMEs. The structure of the Biotech Act follows these seven pillars through dedicated chapters that contain proposed measures for each pillar (Chapters II-VIII of the proposal, see below).

Strategic projects (Chapter II)

The Biotech Act introduces the concepts of “health biotechnology strategic projects” and “high impact health biotechnology strategic projects” and establishes a framework for the recognition and support of such projects. Any company or consortium of companies developing a project may ask a Member State to designate their project as a “strategic project”. This is similar to the proposed Critical Medicines Act, which introduces similar support measures for strategic projects for “critical medicines” (see our client alert on the Critical Medicines Act).

A strategic project can benefit from fast-tracked permit-granting processes (maximum 10 months for regular strategic projects and eight months for high impact ones) and streamlined environmental assessments, as well as administrative, technical, and financial support from the relevant Member State(s) or the EU, without prejudice to more favorable provisions that might exist in any other EU legislation. Each Member State must also designate a SPOC to facilitate and coordinate the permit-granting process and act as source of information for the project promoter.

The Biotech Act lists five alternative criteria (each with its own alternative sub-criteria) to qualify for “regular” strategic project designation. The project will qualify if it makes a substantial contribution to at least one of these criteria, for example, a substantial contribution to “strengthening the industrial capacity and value chains in the health biotechnology sector” (criterion contained in Article 3(1)(a) of the proposed regulation) by “integrating advanced digital and AI-driven manufacturing and supply-chain management systems to enhance productivity, traceability and sustainability across biotechnology value chains” (sub-criterion (a)(v)).

On the other hand, “high impact” strategic projects can only be recognized as such by the Commission and need to have “a strong systemic and catalytic potential within the Union’s biotechnology ecosystem to accelerate innovation and enhance the translation of research into market applications” (Article 4(1)). An example of such a project might be a biotechnology data quality accelerator or a center of excellence for advanced therapies. The Biotech Act sets out the specific conditions for each of those, with the possibility for the Commission to adopt implementing acts to further detail those conditions.

Notably, any strategic projects that receive financial support from EU programs must offer open, non-discriminatory, transparent, and criteria-based access at market prices to their facilities, equipment, services and training programs for users from all Member States, including SMEs, start-ups and scale-ups and other industrial actors, research organizations or academic institutions.

Access to funding (Chapter III)

Given the capital-intensive nature of biotech and the high probability of non-commercialization of individual projects, access to finance is a structural bottleneck for the biotech sector. The Biotech Act establishes an “EU Health Biotechnology Investment Pilot”, to be run by the Commission in partnership with the European Investment Bank Group (EIBG) and other implementing partners, to mobilize public and private investment in the sector. The pilot will support the full lifecycle of health biotech companies and projects, and is intended to complement various other EU programs, financial support schemes and funding instruments. Member States may also provide national funding, albeit in line with applicable state aid rules.

On the same day that the Biotech Act proposal was published, the Commission and EIBG announced another initiative, BioTechEU, to mobilize €10 billion in public-private investments in the biotech and life sciences sectors in 2026-27 (see the press release here).

Extension of the supplementary protection certificate (Chapter IV)

The Biotech Act introduces a 12-month extension of the Supplementary Protection Certificate (SPC) for (i) medicinal products developed by means of certain biotechnology processes and (ii) advanced therapy medicinal products (ATMPs), if the following four cumulative conditions are met:

• a new active substance is involved, that is “distinctly different” from that of any other authorized medicinal product in the EU;
• the mechanism of action is “distinctly different” and has a level of safety and efficacy which is at least equivalent to that of any other authorized medicinal product in the EU for the same disease;
• clinical trials evaluating the efficacy of the medicinal product and supporting its marketing authorization have been conducted in more than two Member States; and
• at least one manufacturing step, excluding packaging, quality testing and certification, is performed in the EU.

The European Medicines Agency (EMA) will assess compliance with these conditions and issue a confirmatory statement if they are satisfied.

This represents an important incentive for companies developing advanced therapies and biotech-derived medicines, providing additional protection that will offset lengthy development timelines.

Boost biosimilars’ manufacturing capacity and expertise (Chapter V)

The EMA is tasked with developing non-binding guidelines on a tailored regulatory approach for the development of biosimilars, taking into account a potential reduction of the clinical data required for the development and approval of biosimilars. In March 2025, the EMA published a first draft reflection paper in this regard (available here).

This potential reduction of the regulatory burden is a particularly important element in improving and maintaining the EU’s competitiveness in the biotech sphere in light of recent efforts by the US Federal Drug Administration (FDA) to streamline their approval pathway for biosimilars. Notably, the FDA issued a draft guidance in June 2024 eliminating the requirement for “switching studies” (which were previously needed to demonstrate interchangeability), and another draft guidance in October 2025 with recommendations for assessing the need for comparative efficacy studies (Phase III).

Efficacy studies are the most expensive and time-consuming part of the development and approval process, and it is estimated that waiving the requirement for such studies will reduce the cost of developing biosimilars by more than 90% and cut approval timelines by more than 70%.

Integrate AI and data innovation across the biotech lifecycle (Chapter VI)

The EMA is tasked with developing non-binding guidelines on the deployment and use of advanced technologies, including AI, in (i) the lifecycle of medicinal products (including during pre-clinical research, clinical trials, manufacturing, and post-authorization monitoring), and (ii) marketing authorization procedures. This will be done in cooperation with the Commission (including the AI Office) and national competent authorities.

The Biotech Act will apply without prejudice to the harmonized legal framework of the AI Act.

Introduce flexible regulatory tools for novel products (Chapter VII)

Biotech developers, in particular SMEs, start-ups and scale-ups, often lack the regulatory expertise and capacity needed to identify and plan their entry into the appropriate regulatory procedural pathways. For very innovative and complex biotech products and services, this identification is not always straightforward and full compliance with the legislative framework may be difficult, for example because they combine different components regulated by different EU legislative frameworks or because they require flexibility and targeted adaptations of certain requirements.

There are already a number of specific mechanisms under the current pharmaceutical legislation (Directive 2001/83 and Regulation 726/2004), the Medical Device and In-Vitro Device Regulations, and the SoHO Regulation (for substances of human origin), to determine the regulatory status of products and clarify which legislative frameworks apply to combinations of medicinal products and other products, including the possibility to request a recommendation or opinion from the respective advisory bodies or the EMA, and a binding decision of the Commission on the regulatory status.

The Biotech Act complements these existing mechanisms by introducing:

• the possibility for individual assistance upon request from the newly established EU Health Biotechnology Support Network on the appropriate regulatory pathway;
• a Foresight Panel for Emerging Health Innovation, an anticipatory governance mechanism which will conduct structured horizon scanning and advise the Commission on forthcoming scientific and technological developments, to complement the existing individualized, case-by-case classification mechanisms that already exist;
• an EU-wide, cross-framework "Regulatory Status Repository", which will compile existing opinions, recommendations, decisions and guidance at EU level on the regulatory status of products and the qualification as ATMP, as well as the discussion papers delivered by the Foresight Panel. However, the repository will not contain recommendations etc. on the regulatory status of AI systems and models within the scope of the AI Act; and
• regulatory sandboxes (controlled testing environments) for early-stage health biotech products not fitting existing legislative frameworks, similar to the regulatory sandboxes introduced in the new Pharma Package for pharmaceuticals.

Strengthen biodefense (Chapter VIII)

The Biotech Act establishes a framework for preventing the misuse of so-called biotechnology products of concern, which have a significant potential for misuse. It includes obligations on screening, reporting, and tracking suspicious transactions of biotechnology products of concern, and inspection and enforcement mechanisms to ensure compliance. In general, biotechnology products of concern can only be made available to and used by a natural or legal person (inside or outside the EU) who has a “legitimate need” for those products (i.e., for legitimate and peaceful purposes). It is the responsibility of the provider to assess and document this legitimate need. The screening is similar to know-your-customer assessments under anti-money laundering legislation.

A Member State may impose fines not exceeding 5% of the annual total worldwide turnover in the preceding financial year if it finds that a company has intentionally or negligently infringed its obligations under the Biotech Act in this respect.

Streamline key EU sectoral laws to cut time-to-market (Chapter IX)

The proposed Biotech Act will amend a number of existing regulations to streamline the current processes.

ATMP Regulation 1394/2007

Clinical trial sponsors are exempted from submitting environmental risk assessments for certain ATMPs consisting or containing genetically modified organisms (GMOs) which present no or negligible risk to human health and the environment (for example, viral vectors). The sponsor must submit a declaration in this respect as part of the clinical trial application, which is then verified by the Committee for Medicinal Products for Human Use (CHMP). In a similar vein, these types of ATMPs will be exempted from the GMO-related requirements regarding manufacturing and import under the Clinical Trial Regulation.

Clinical Trial Regulation 536/2014 (CTR)

Regulatory complexity and fragmentation have eroded the EU's global share of commercially sponsored clinical trials (22% in 2013 to 12% in 2023). Moreover, EU multinational trial decisions take on average 113 days versus approximately 60 days in other regions. These delays and administrative burdens increase the risk of further loss of R&D to “faster” jurisdictions, such as the U.S. or China. The Biotech Act intends to reverse this trend by introducing a variety of provisions to simplify and streamline the processes in the CTR. These measures include (non-exhaustive list):

• Accelerated timelines: several CTR timelines will be shortened, for example, from 75 to 47 days from submission to decision for initial clinical trial authorizations where there is no request for information to the sponsor; from 106 to 75 days for multinational clinical trials (including validation and ethical review); from 96 to 47 days for the assessment of substantial modifications (with a new possibility for sponsors to introduce parallel substantial modifications); and the elimination of the additional 50 days assessment period for ATMPs.
• Minimal-intervention clinical trials: the authorization and oversight requirements for clinical trials are tailored based on a risk-proportionate approach, considering the risks for the trial subjects. The existing definition of low-intervention clinical trials is amended to introduce a new concept of “minimal-intervention clinical trials”, which is a trial where (i) the investigational medicinal products (IMPs) are authorized, (ii) according to the protocol of the clinical trial, the IMPs are used in accordance with the terms of the marketing authorization, and (iii) the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden as regards the safety of the subjects, when compared to normal clinical practice in any Member State concerned. Among other things, clinical trials that meet the criteria for minimal-intervention clinical trials require only a limited ethical review before the clinical trial can begin.
• Combined studies pathway: a new single assessment process will be introduced for combined studies involving the investigation of a medicine together with a medical device or an in-vitro device. Combined studies involve a clinical trial for a medicinal product combined with a clinical investigation and/or a performance study for a medical device and an in-vitro device respectively. This is particularly important for companies developing personalized medicine through combination products or companion diagnostics.
• Part II templates: mandatory EU templates for the submission of the Part II documents of clinical trial applications will be developed to enable harmonization and simplify the application and assessment procedures.
• Clinical trial regulatory sandbox: in addition to the regulatory sandboxes previously mentioned, the CTR will also contain the option to establish a regulatory sandbox at EU level for the testing of innovative approaches in clinical trials where the full application of the CTR is not possible or appropriate.
• Direct-to-Subject Delivery: a framework is introduced for the “direct-to-subject” delivery of IMPs and auxiliary medicinal products under the remote supervision of the investigator, whereby the product is delivered directly to the trial subject’s place of residence. For certain trials, distribution through a dispensing pharmacy or another authorized person may also be permitted. Good distribution standards (GDP) will be adopted specifically for IMPs and auxiliaries. These new controlled delivery options are particularly interesting for decentralized and multinational clinical trials.
• Data protection harmonization: the proposal establishes a harmonized legal basis for processing personal data in clinical trials. The CTR will list a number of purposes where sponsors and investigators are required to process personal data, including genetic and health data, to comply with a legal obligation (i.e., Article 6(1)(c) of the General Data Protection Regulation (GDPR)), and for reasons of public interest in the area of public health, in particular for ensuring high standards of medicinal products (i.e., Article 9(2)(i) of the GDPR). The proposal also clarifies that the sponsors and investigators are considered to be controllers in the context of such processing activities. Lastly, it is explicitly stated that the Member States cannot maintain or introduce further conditions and limitations for the processing of personal data in the context of clinical trials under Article 9(4) of the GDPR. These measures address a longstanding fragmentation issue that has been a complicating factor, in particular for multinational clinical trials.

Note that, while the CTR provisions (and these amendments) apply equally to all clinical trials, irrespective of the biological or chemical nature of the IMP, the proposed amendments are particularly relevant for biologicals, as the development of biologicals relies heavily on multinational clinical trials to be able to recruit the necessary number of trial subjects.

Substances of Human Origin Regulation 2024/1938 (SoHO Regulation)

Substances of human origin (SoHO) are a key pillar of biotech, as they can be starting materials for innovative medicinal products. The Biotech Act amends the SoHO Regulation to introduce the possibility of a regulatory sandbox in the SoHO framework. These regulatory sandboxes will be established and supervised not at EU level, but at Member State level by the SoHO competent authority(ies) concerned. In addition, the Commission is empowered to establish time limits for all actors involved in the consultation process, at national and EU level, including the SoHO competent authorities and the Substances of Human Origin Coordination Board.

For the sake of completeness, the Biotech Act also contains amendments to the General Food Law (Regulation 178/2002) and the Veterinary Medicines Regulation 2019/6, which we will not discuss further in this alert.

Conclusion

The Biotech Act is part of the EU’s life sciences strategy “Choose Europe for Life Sciences”, which is itself part of the overarching Competitiveness Compass. It is only one component in the EU’s ongoing, comprehensive effort to reform the existing legislative framework and strengthen competitiveness and strategic autonomy in the life sciences sector. The Biotech Act therefore complements the recently agreed Pharma Package (see our client alert series on the Pharma Package), the AI Act and the EU Data Union Strategy, the proposed Critical Medicines Act, and the proposed simplifications to the Medical Device and In-Vitro Device Regulations (see our client alert on the simplification proposal which will be published tomorrow).

The proposal will now proceed through the ordinary legislative procedure, with the Parliament and Council each discussing the Commission’s proposal and potentially proposing amendments.

The proposal states that the regulation would start to apply immediately on the day of its entry into force, i.e., 20 days after its publication in the EU’s Official Journal, except for certain amendments to the CTR for which a transitional period of six-nine months is foreseen.