Insights

The publication of Part I of the EU Biotech Act on 16 December 2025 represents an important political signal for the future of health-related biotechnology in Europe. While the proposal does not yet constitute an applicable legal framework, it already outlines the regulatory priorities the EU intends to pursue, and therefore deserves close attention from biotech companies, particularly small and medium-sized enterprises (SMEs).

Part I focuses on health biotechnology and aims to improve Europe’s attractiveness for innovation, clinical development and investment. The legislative process has just started and is expected to continue at least into late 2026, and potentially beyond. Nevertheless, the measures proposed already provide an early indication of how the regulatory environment may evolve in the coming years.

Key regulatory areas to watch

More efficient and predictable clinical trials

A core objective of the proposal is to improve the efficiency of the EU clinical trials framework, especially for multinational studies. The Biotech Act points towards reduced procedural complexity, stronger coordination between Member States and greater predictability compared to the current implementation of the Clinical Trials Regulation. For biotech companies, this could support more reliable development planning and earlier decision-making.

Early regulatory dialogue and sandboxes

Part I promotes earlier and more structured interactions between developers and regulators, including regulatory sandboxes. For SMEs, these tools could help clarify regulatory expectations at an early stage, reduce uncertainty and de-risk development programmes before significant investments are made.

Targeted incentives and investment support

The proposal introduces the concept of targeted incentives for highly innovative biotech products, including advanced therapy medicinal products (ATMPs). These include potential additional intellectual property incentives, subject to strict eligibility criteria and still under legislative discussion. In parallel, the Commission has highlighted the importance of improving access to funding, including through dedicated EU-level investment initiatives aimed at supporting scale-up and competitiveness in the biotech sector.

Addressing regulatory overlaps

The Biotech Act acknowledges long-standing challenges at regulatory interfaces, such as those between ATMP and GMO frameworks. It signals a move towards more proportionate, risk-based approaches intended to reduce unnecessary administrative burden while maintaining high safety standards.

Industry feedback: support with open questions

Initial reactions from industry associations have been broadly positive, welcoming the Biotech Act as a step towards strengthening Europe’s biotech ecosystem. At the same time, stakeholders have highlighted several open issues, including the need for clearer implementation mechanisms, realistic timelines and consistent application across Member States.

Some sectors have also pointed out perceived gaps in scope, noting that not all biotechnology areas benefit equally from proposed tools such as regulatory sandboxes. These early reactions underline that the legislative debate is still very much open and that further refinements can be expected as discussions progress.

What happens next and why it matters now

Part I of the Biotech Act will now be discussed and potentially amended within the EU legislative process. Final adoption and application remain some distance away. Nevertheless, the proposal already provides valuable insight into future regulatory priorities.

For biotech companies, now is the right moment to stay informed, assess potential implications for development and regulatory strategies, and prepare to adapt as the framework takes shape.

RPN will continue to monitor the evolution of the EU Biotech Act closely and support clients in navigating emerging regulatory and market access developments.