From lab to market: Europe’s new Biotech Act

On December 16, 2025, the European Commission (EC) published the Proposal for a Regulation of the European Parliament and of the Council establishing a framework of measures for strengthening the Union’s biotechnology and biomanufacturing sectors, particularly in the area of health (the European Biotech Act). The Proposal marks a significant legislative step aimed at improving the conditions under which health biotechnology is developed, scaled and brought to market in the European Union (EU).

The initiative is driven by the Commission’s assessment that, despite strong scientific foundations, the EU is facing growing competitive pressure from other global regions in the development of innovative biological products. Fragmented regulatory pathways, limited late-stage financing and lengthy administrative procedures are identified as key barriers preventing research excellence from translating into industrial scale and market leadership.

The European Biotech Act covers the entire lifecycle of health biotechnology products[1] and services, from early-stage research and funding to development, manufacturing, authorization and effective use. It is the first step in a phased approach, with a second proposal expected during the third trimester of 2026 to address the wider biotechnology ecosystem, including agriculture, energy, defense and industrial biotechnology.

Key points of the European Biotech Act

• Strategic biotech projects on a fast track

At the heart of the European Biotech Act is a new framework to identify health biotechnology strategic projects and high-impact health biotechnology strategic projects carried out in the EU.

Such projects may benefit from:

• accelerated administrative and permitting procedures;
• enhanced regulatory coordination; and
• dedicated technical and administrative support at both EU and national level.

In this respect, the approach mirrors the model adopted under the Critical Medicines Act, where projects of strategic importance receive coordinated regulatory and administrative support.

• Closing Europe’s biotech funding gap

The European Biotech Act envisages the creation of an EU Health Biotechnology Investment Pilot, to be developed in cooperation with the European Investment Bank Group. The pilot is intended to mobilize public and private capital through tailored financing instruments, including equity and venture-debt solutions, supporting companies throughout the biotech value chain.

In addition, projects recognized as strategic or high-impact are expected to benefit from greater visibility and improved access to existing EU funding instruments.

• One year extension of the supplementary protection certificate

One of the most notable market-based incentives introduced by the Proposal is the possibility of a 12-month extension of the Supplementary Protection Certificate (SPC) for certain biotechnology medicinal products and advanced therapy medicinal products (ATMPs).

The extension would be available only where all the following cumulative conditions are met:

• the use of a new active substance that is “distinctly different” from existing authorized products;
• a distinctly different mechanism of action with at least equivalent safety and efficacy;
• supporting clinical trials conducted in more than two Member States; and
• the performance of at least one manufacturing step within the EU, excluding packaging, testing or certification.

A comparable, narrowly framed SPC extension is also foreseen for certain veterinary medicinal products addressing zoonotic diseases, subject to specific eligibility criteria.

• Faster clinical trials and quicker market access

The European Biotech Act proposes targeted amendments to Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.

In particular, the key measures include:

• the introduction of risk-proportionate clinical trial categories, including minimal-intervention trials subject to simplified procedures;
• the possibility for sponsors to rely on a single core dossier for investigational medicinal products across related trials;
• coordinated authorization procedures for combined studies involving medicinal products and medical devices or in vitro diagnostics;
• the use of regulatory sandboxes to support innovative trial designs; and
• shortened timelines and improved coordination for multinational clinical trial authorizations.

• Integrating AI and data into the biotech lifecycle

The proposal also looks to the future by embedding artificial intelligence (AI) and data-driven tools into the biotechnology ecosystem.

Here, the focus is on enabling innovation through better data availability, increased reliability for advanced analytics and controlled environments for experimentation. These initiatives are designed to align with broader EU data frameworks, including the European Health Data Space.

• Regulatory navigation for complex biotech products

Recognizing the complexity of existing EU regulatory frameworks, the European Biotech Act introduces navigation and support mechanisms for developers of novel, combined or borderline biotech products.

Through the EU Health Biotechnology Support Network, developers may receive guidance on:

• identifying applicable regulatory pathways;
• navigating overlaps between regulatory regimes (e.g. ATMPs, substances of human origin, medical devices); and
• accessing regulatory sandboxes where uncertainty itself constitutes a barrier to innovation. 

• Strengthening biosecurity and managing dual-use risks

Finally, the Act addresses the security dimension of biotechnology. Specific provisions aim to prevent misuse and strengthen EU biosecurity and biodefence, particularly in relation to dual-use technologies.

These measures rely on enhanced transparency, screening and coordination, with the objective of supporting innovation while safeguarding against misuse. 

Sector perspective: a welcome shift, with open questions ahead

Overall, the European Biotech Act has been positively received by the sector. Europe moves beyond asking only "does this comply?" and starts considering whether a project is strategic, how it can be supported to reach market, and what is needed to retain biotech innovation within the EU. For many stakeholders, this signals a more proactive industrial policy approach to health biotechnology.

At the same time, the sector has identified several open issues, which are generally framed as areas requiring clarification as the legislative process and its implementation evolve. Two of the most recurrent concerns are detailed below:

• Ambiguity in the definition of strategic projects
  
  The absence of objective thresholds or clearly articulated selection criteria limits ex ante predictability for developers and investors and may lead to uneven application across Member States. The sector therefore calls for additional guidance or implementing measures to enhance legal certainty.

• Uncertainty around national-level implementation
  
  Moreover, stakeholders highlight that the effectiveness of the European Biotech Act will largely depend on national administrative implementation. While EU-level coordination is strengthened, procedural heterogeneity across Member States remains. There is a risk that differences in administrative capacity could result in asymmetric acceleration, undermining a level playing field within the internal market. 

Conclusion

Overall, the European Biotech Act seeks to connect the dots across regulation, funding and innovation. By streamlining procedures, improving access to capital and strengthening coordination across the biotech ecosystem, the proposal aims to shorten time-to-market for health biotechnology products while maintaining high standards of safety and oversight.

Its ultimate impact, however, will depend on how effectively the framework is clarified and implemented in practice, including the definition of strategic projects, its administrative execution at Member State level and the timely adoption of the broader legislative phase expected in 2026.

If adopted, the Act would establish a foundational EU framework for health biotechnology, while preparing the ground for further legislative initiatives covering the wider biotechnology sector.

For more information, please contact our specialists through the Knowledge and Innovation Area.