AseBio calls for a Biotech Act I with greater funding, regulatory agility, and a stronger industrial vision

Biotechnology is no longer a future bet; it has become a strategic asset for Europe, essential to its competitiveness, industrial autonomy, and capacity to respond in health, sustainability, security, and defence. In a context of growing global competition, and following the warnings issued in key reports such as those by Mario Draghi and Enrico Letta on the need to strengthen the European Union’s (EU) innovation and industrial capabilities, the European Commission (EC) has introduced the Biotech Act I, its first major regulatory initiative aimed at strengthening Europe’s biotechnology and biomanufacturing ecosystem.

Since the European Commission’s proposed Regulation was published on 16 December—a process in which we actively participated through the call for evidence and public consultation—the Spanish Bioindustry Association (AseBio) has carried out a detailed analysis of the proposal and shared it with our members to gather their perspectives. Based on this work, we have developed a document outlining the key areas that the biotechnology sector believes should be improved to ensure this regulation has a greater impact on the national biotech ecosystem and contributes to its strength, competitiveness, and resilience.

Greater harmonisation in the designation of strategic projects by Member States, with enabling frameworks, sufficient resources, and continuity of support instruments

The Biotech Act seeks to promote strategic biotechnology projects in health through faster procedures and administrative support to accelerate their development. We welcome this measure for its potential to strengthen industrial scale-up and European resilience. However, we believe clearer and more harmonised selection criteria across Member States are needed, alongside guarantees that national authorities have the resources and enabling frameworks required to implement these measures effectively.

One of the biotechnology sector’s main challenges is access to funding. In response, the proposed regulation includes a two-year investment pilot with the European Investment Bank to support companies, as well as another pilot initiative called Capital Booster for advanced-stage companies linked to Strategic Projects. While we welcome this recognition, we believe the proposal requires greater specificity and ambition, with clearly defined instruments, sustained long-term funding, and structural measures that facilitate private capital attraction and allow European companies to scale and grow within the continent.

Expanding incentives, increasing flexibility, and providing legal certainty

The Biotech Act introduces a positive incentive to attract investment and strengthen biotechnology development and manufacturing in Europe by extending industrial protection for certain innovative medicines. We believe this is a significant step forward, although we see the need to broaden its scope and make eligibility criteria more flexible so that its real impact on the European biotech ecosystem is greater.

The proposed regulation also incorporates biodefence as a strategic pillar of European biotechnology policy, which we consider appropriate. However, we believe it is essential to provide greater legal clarity and harmonised criteria among the various ecosystem stakeholders to avoid regulatory uncertainty, ensuring that security measures remain compatible with the sector’s operations and competitiveness.

Regulatory agility, coherence, and risk-based criteria, with the necessary resources for implementation

The Biotech Act introduces significant regulatory changes aimed at accelerating biotechnology innovation in Europe, from streamlining clinical trials to creating regulatory sandboxes and simplifying procedures for certain biotech applications. We recognise the value of this effort to modernise the European regulatory framework and better adapt it to the speed and complexity of today’s innovation, particularly in areas such as clinical trials and the introduction of more proportionate regulatory categories for lower-risk technologies.

However, we believe the real impact of these measures will depend on ambitious, coherent implementation and the availability of resources to deliver them. In the field of clinical trials, it will be essential for European and national agencies to have sufficient capacity to meet the new deadlines and provide effective regulatory support. Likewise, we believe regulatory sandboxes should be designed with greater coherence and broader scope, avoiding exclusions that could hinder innovation in sectors such as food without adequate scientific justification. Regarding genetically modified microorganisms, we support a risk-based approach that simplifies procedures while maintaining safety, although we believe the criteria should be broadened to prevent safe innovations from being excluded due to limitations in the current framework.

AseBio has actively contributed to the development of the Biotech Act I

From the outset, AseBio has played an active role in shaping the Biotech Act, conveying the priorities of the Spanish biotechnology ecosystem to European institutions through proposals developed together with its members and in coordination with EuropaBio. These priorities include the need for a more agile and harmonised regulatory framework, stronger funding mechanisms to support business scale-up, and a more ambitious European industrial strategy to strengthen the sector’s competitiveness.

This advocacy work has taken place at both European and national levels. In Spain, we have promoted a dedicated working group on the Biotech Act I within the Joint Pharmaceutical Industry Committee and held meetings with key ministries, including Health, Industry, Agriculture, and Science, while also sharing our analysis with the Strategic Project for Economic Recovery and Transformation (PERTE) for Vanguard Health. In Brussels, we have defended the perspective of the Spanish biotechnology sector in strategic forums such as the MEP Interest Group EU Biotech and Life Sciences Alliance, contributing to the dialogue on the future of biotechnology and clinical trials in Europe.