At the end of 2025, as part of a bundle of measures to make the EU health sector more innovative, competitive and resilient, the European Commission proposed the EU Biotech Act (the Act) aimed at repositioning the EU as a global biotechnology hub. It includes a wide range of proposals, such as access to funding, streamlined regulatory processes, and increased incentives for innovative products. The proposal signals that the EU institutions are attempting to make the EU a more pro-innovation environment, and many of the proposals will likely be welcomed by industry.
However, the measures in the Act cannot be seen in isolation, as the proposed Act is part of the European Commission’s wider strategies in the life sciences and biotechnology sectors. The Act complements recent initiatives such as the agreement of the EU Pharma Package, proposed amendments to the medical devices regulations, and the EU Digital Omnibus initiative. In addition, a second Biotech Act is planned for late 2026, although its scope and overlap with this proposal remain unclear.
It is therefore uncertain whether the proposals in the Act will be seen by industry as complementary to these measures and the broader regulatory environment, as not going far enough given amendments in other areas that are seen as more challenging for industry, or as adding unnecessary complexity. The Commission—and industry—will need to consider all the proposals together to ensure that overall, they streamline the regulatory process, do not have overlapping requirements, and ultimately, meet the Commission’s aims to support the life sciences sector.
Background
The European Commission has stated that biotechnology is one of the fastest growing innovative industries in the EU, expanding at twice the speed of the EU economy as a whole, and contributing €40 billion to GDP and 900,000 jobs. However, regulatory hurdles are thought to have driven investment to other regions. For example, the Commission has stated that only 7% of global venture capital investment in health biotech is in the EU, and the EU/EEA share of commercial clinical trials dropped from 22% to 12% over the last decade. There are also well reported difficulties with translating research and discoveries into commercial products.
Seeking to address these concerns, the Biotech Act is a major EU policy initiative to modernise biotechnology regulation. It aims to boost Europe’s biotechnology and biomanufacturing capacity, strengthen competitiveness, accelerate regulatory pathways, and create a more supportive environment for innovation, while at the same time maintaining stringent EU health, environmental, ethical and biosecurity standards.
Definition and Scope
The Act establishes a framework to strengthen the competitiveness of the health biotechnology sector in the Union. The following definitions are important:
- “Biotechnology” means the application of science and technology to living organisms to alter living or non-living materials
- “Health biotechnology” means the application of biotechnology for the promotion, protection, or restoration of human health
While the proposal focuses primarily on health biotechnology, it also introduces targeted amendments in relation to food and feed safety, substances of human origin (SoHO) and genetically modified organisms (GMOs). Further, some of the amendments, such as those related to the Clinical Trials Regulation, seem to apply to all products, and not only those that relate to a biotech product.
Key Proposals
The Act proposes changes in a wide range of areas that impact development of these products in the EU. Some of the key proposals include:
Supporting Strategic Projects
The Act introduces the concepts of “health biotechnology strategic projects” that make a substantial contribution to some key stated areas, and “high impact health biotechnology strategic projects,” which, by virtue of their scale, scope or cross-border relevance, demonstrate strong systemic and catalytic potential within the EU’s biotechnology ecosystem. These projects will gain access to fast-tracked regulatory and administrative support, easier access to EU funding, and support structures such as testing environments and biomanufacturing training centres.
The Act also sets up an EU health biotechnology support network of national and regional groups to support biotechnology projects and innovators in navigating regulatory pathways and identifying opportunities for funding, scaling up and networking. The hope is that this will leverage and complement the activities of existing networks that support small and medium-sized enterprises (SMEs).
Boosting Access to Funding
The Act establishes an EU health biotechnology investment pilot with the European Investment Bank Group for an initial period of two years. This will offer a mix of equity instruments and venture-style debt tailored to the sector’s risk profile and aims to attract private capital, strengthen long-term risk finance, and anchor growth and biomanufacturing within the EU. It is interesting that the Commission has chosen to set up a funding pilot as part of a legislative act, which suggests that the Commission considers that other forms of encouragement and cooperation have not been successful in driving funding to the area.
Amendments to Incentives
The Act proposes a 12-month extension to supplementary protection certificates (SPCs) for biotechnology-derived medicinal products and advanced therapy medicinal products (ATMPs), provided that four conditions are satisfied:
- The product contains a new active substance that is distinctly different from any authorised medicinal product in the EU;
- The product’s mechanism of action is distinctly different, with safety and efficacy at least equivalent to existing treatments for the same disease;
- Clinical trials evaluating the product’s efficacy and supporting marketing authorisation have been conducted in more than two member states; and
- At least one manufacturing step (excluding packaging, testing, and certification) is performed within the EU.
This amendment is intended to drive the development of biotech therapies that offer clear benefits to patients, while supporting and encouraging clinical research and manufacturing of these products within the EU.
Biosimilars
The Act encourages the development of guidelines from the European Medicines Agency on facilitating the authorisation of biosimilar medicinal products, which will include “reduction of the clinical data required for the development and approval of biosimilars.” This follows a general push to support and encourage adoption of biosimilar products, including the publication of the findings from the AUGMENT study “Capacity building to support the uptake of biosimilars” in November 2025, which sets out findings and recommendations on best practices for biosimilar uptake.
Harnessing Artificial Intelligence and Data
The Act promotes the use of AI and data technologies in biotechnology, including through the European Health Data Space. It will establish trusted AI testing environments and data-quality accelerators.
Simplifying Regulatory Procedures
A central priority is reducing time-to-market by streamlining regulatory pathways. These proposals aim to reduce administrative burden and improve Europe’s attractiveness as a location for clinical research and product development. Importantly, these proposals seem to go beyond trials with biotech products and would apply to all products. These changes include:
- Amendments to the Clinical Trials Regulation to reduce authorisation timelines from 75 to 47 days where no additional information is required, and from 106 to 76 days where further information is requested, as well as shortening timelines for substantial modifications (from 64 to 33 days, or 96 to 47 days).
- The additional 50 days for assessing applications for trials involving ATMPs will be eliminated.
- Regulatory sandboxes will be introduced for innovative or atypical trials where it is challenging to identify a suitable regulatory procedure.
- A single authorisation pathway for combined medicinal product/medical device and IVD trials will be developed. This is particularly important and has been an area of difficulty for innovative products, which currently have to meet the requirement of both the medicinal and devices legislation. Any proposals in the Act will have to align with changes proposed to the medical devices regulations.
There is also an acknowledgment that some products, such as ATMPs, have to comply with a number of overlapping regimes, including the rules on medicinal products, GMOs and SoHOs. To address this, the Biotech Act introduces more flexible, risk-based assessment approaches. For example, where clinical trials involve GMOs, they will no longer need to submit an environmental risk assessment in certain circumstances.
Biosecurity and Biodefence
In recognition of the risks associated with advanced biotechnology, the Act introduces harmonised EU-wide biosecurity rules.
At the same time as the Act, the Commission also published a proposal relating to genetically modified micro-organisms (GMMs) that aims to create a tailored, more efficient and streamlined regulatory framework for these products. The proposal introduces the concept of low-risk GMMs, and sets a framework for a streamlined authorisation procedure for these products.
Impact on Manufacturers
The proposal is expected to reduce the costs and time for the development of biotech products as a result of shortened regulatory timelines and harmonised requirements across member states. The legislation-backed access to funding may be the most significant change, and will be welcomed by SMEs in particular. Similarly, strengthening manufacturing capacity within the EU is an important development and will hopefully help streamline and standardise the manufacturing process. As noted above, it will be important to ensure that these proposals align with other amendments in the area so that the intended impact is seen.
The proposal will now be discussed by the European Parliament and Council, which will both introduce amendments to the text proposed by the Commission. An agreement is unlikely to be reached in time for adoption of the Act before the end of 2026.