AseBio positively assesses the foundations of the Biotech Act proposal

Asebio

17 December 2025

Access to innovation

On 16 December 2025, the European Commission presented the Biotech Act I (with the second phase expected in the third quarter of 2026), a new legislative initiative that forms part of an ambitious package of measures aimed at improving the health of European Union (EU) citizens and ensuring the long-term resilience and competitiveness of the healthcare sector.

Biotechnology is one of the fastest-growing sectors in the EU. It currently generates more than 900,000 jobs, 75% of which are in the healthcare field, and contributes around €40 billion to the European economy. Moreover, it has enormous potential to transform healthcare through innovative therapies, more precise diagnostics, and personalized medicine.

However, as highlighted by the Draghi Report, Europe is losing ground to other global competitors. The EU accounts for only 7% of global venture capital investment in health biotechnology, and its share of global commercial clinical trials has fallen from 22% to 12% over the past decade. The combination of insufficient funding, structural barriers, and complex regulation is driving European startups and scientific talent to develop their activities outside the continent.

Within this context, the Biotech Act aims to boost Europe's biotechnological potential and accelerate the transition from research to market, while simultaneously strengthening the EU's industrial capacity and strategic autonomy in health.

Throughout the entire process of drafting the proposal, AseBio has actively participated in its design. In June, we submitted to the European Commission a set of recommendations outlining three urgent priorities for our sector: faster and more accessible funding to allow innovative companies to scale without seeking capital abroad; a more agile, simple, and coherent regulatory framework that reduces duplication and provides legal certainty; and a more cohesive, industrially oriented Europe capable of competing on equal terms with the United States or China. When the public consultation opened in November, we reinforced and expanded our contributions together with our members and in close collaboration with EuropaBio, highlighting the structural challenges facing the biotechnology sector that require ambitious responses such as the Biotech Act.

Main Pillars of Biotech Act I

Improving access to funding

Through economic incentives and a pilot investment program in health biotechnology to be developed in collaboration with the European Investment Bank (EIB) Group starting in 2026. This program will complement the EIB's BiotechEU initiative, aiming to mobilize up to €10 billion for the sector.

Strengthening industrial and innovation capacities

By establishing centers of excellence in advanced therapies, testing environments, and bio-manufacturing training, as well as data quality accelerators and biodefense-oriented projects. Bio-manufacturing is promoted through targeted support, and high-impact biotechnological initiatives will be designated as "strategic projects."

Encouraging European innovation

Through specific extensions of patent rights for key innovations in health and veterinary biotechnology, as well as support for strategic areas such as biosimilars.

Strategic projects will benefit from easier access to EU funding and accelerated administrative, scientific, and regulatory support; key innovations will be rewarded with specific patent right extensions.

Promoting the use of artificial intelligence, data, and digital solutions

Leveraging the deployment of the European Health Data Space, the creation of reliable AI testing environments, and specific support for SMEs and startups to adopt high-performance technologies.

Simplifying and accelerating regulatory procedures

Reducing the time to market for new biotech products through harmonized requirements, controlled regulatory environments, and single pathways for complex innovative products.

EU regulations are simplified to reduce costs and administrative burdens, while single regulatory pathways are established for complex innovative products. "Regulatory sandboxes" provide controlled environments where companies can safely test new solutions and technologies.
At the same time, approvals for multinational clinical trials are accelerated, with significantly reduced approval timelines-for example, from 75 to 47 days when no additional information is required.

Ensuring biosafety

Through measures aimed at preventing misuse of biotechnologies and strengthening the EU's biodefense capabilities. Proportional biosafety safeguards protect human health against potential risks and misuse of biotechnologies, including verifying that buyers of high-risk biotech products (such as pathogenic DNA) have a legitimate need.

The Biotech Act also proposes amendments to specific EU health and food legislation to adapt the ecosystem to current societal and sectoral needs. The published proposal includes revisions to EU clinical trial legislation to streamline authorization procedures, including the voluntary FAST EU initiative, as well as promoting collaboration and simplification of multinational trials. Safe regulatory environments for atypical clinical trials will be created, and a single process for combined trials established, reinforcing risk-based approaches.

The new legislation also proposes specific amendments to regulations related to advanced therapy medicinal products, human-derived substances, veterinary medicines, general food law, human organs, and genetically modified organisms.

The legislative proposal will now be submitted to the European Parliament and the Council for processing and adoption.

AseBio Welcomes the Foundations Laid by Biotech Act I

AseBio positively values the foundations set by the Biotech Act to increase the competitiveness of the European Union, in a context marked by global geopolitical changes that require urgent and ambitious measures such as this legislation. This position is fully aligned with that of EuropaBio.

Although the primary focus of the first phase of this law is health, we recognize initial actions supporting biotechnology in food and feed, and we will work closely to ensure their full implementation in Phase I and all subsequent legislation.

Health biotechnology proposals strengthen the EU's progress toward a future-ready ecosystem. In healthcare, we welcome measures such as the extension of supplementary protection periods, accelerated clinical trials, new regulatory pathways for advanced therapies, testing environments for SoHO, and the EIB pilot investment project.

In food and feed biotechnology, in this first phase, we welcome the EFSA (European Food Safety Authority) pre-submission advice, as it has long been a requested improvement for authorization processes and can accelerate time-to-market in the EU.

This law seeks to streamline EU risk assessments, making EFSA procedures more predictable and faster without compromising food safety. It also strengthens pre-submission advice and provides clear evaluation pathways for genetically modified microorganisms, reducing delays and uncertainty while maintaining scientific rigor.

We support the law's intention to review the GMO Directive to introduce specific requirements for genetically modified microorganisms (GMMs). However, we consider it necessary to address the exclusion of novel foods and GMOs, ensuring their inclusion.

Also relevant to the launched Biotech Act is the Food and Feed Safety Simplification Package, also published on 16 December, which clarifies the scope of genetically modified food and feed regulations. This is a very positive measure for Europe's fermentation industry and strengthens the single market.

AseBio positively values the Biotech Act and welcomes the EU's progress toward an ambitious and coherent strategy that recognizes biotechnology as a key transversal enabler for health, industry, sustainability, and European strategic autonomy. At the national level, it also represents a unique opportunity to drive the growth of the Spanish biotechnology sector. Therefore, in Spain, it should be a priority to leverage the foundations established by the Biotech Act to fully develop the potential of our sector.

This is an initial assessment based on published press releases and preliminary information. AseBio will conduct a thorough analysis of all documents comprising the legislative initiative.

Documents of interest:

• New measures to make EU health sector more innovative, competitive and resilient
• Proposal for a Regulation to establish measures to strengthen the Union's biotechnology and biomanufacturing sectors (European Biotech Act)
• Questions and answers on the European Biotech Act