The Biotech Act: a key opportunity for transforming health innovation in the BioRegion of Catalonia

The Biotech Act is a European Union regulation that establishes biotechnology as a pillar of competitiveness, health resilience and technological sovereignty for the European Union. It is a strategic action that aims to correct a long standing imbalance on the old continent: excellent research and strong clinical capabilities that fail to become products, companies, industrial capacity and social impact within the European market. Its formulation as a Regulation, rather than a directive, seeks to ensure uniform application across all Member States.  

The initiative is part of the Strategy for European Life Sciences 2024–2029, “Choose Europe for life sciences”, and includes measures to:  

• accelerate regulatory processes,  
• harmonize currently fragmented legal frameworks,  
• improve conditions for data driven innovation,  
• strengthen industrial competitiveness and
• mobilize new investment instruments to retain and consolidate development, scaleup and manufacturing in Europe.

The proposal also aligns with other regulatory frameworks that the European Union has approved or is implementing at the same time.  Regulation (EU) 2025/327 established the European Health Data Space (EHDS) -which Biocat published an article about “How is Catalonia entering the European Health Data Space? Challenges, opportunities and impact for the health innovation ecosystem”. It creates the conditions for modern data driven innovation that is interoperable and transversal, which is essential for personalized medicine and real world evidence models. At the same time, Regulation (EU) 2024/1689 on artificial intelligence (AI Act) —also addressed by Biocat in “From technology to infrastructure: how AI is rewriting the future of health”—defines the requirements for ensuring AI systems in health are safe, reliable and aligned with European values. In this sense, the Biotech Act is another building block in a rapidly modernizing regulatory ecosystem designed to enable safer, more competitive, more agile innovations. 

Although we are still waiting for the Innovation Act —currently under analysis following the European Commission’s consultation period— and implementation of the Scaleup Strategy, with instruments like the announced Scaleup Europe Fund, the Biotech Act proposal is a significant turning point for the BioRegion of Catalonia. The Regulation comprehensively addresses structural barriers that Biocat has repeatedly identified in its role as an organization that drives the health innovation ecosystem: regulatory fragmentation, difficulties in research translation, insufficient industrial scale up capacity and lack of funding, particularly in the early and intermediate stages of technology development. The effects of this new framework will vary depending on the role of each ecosystem stakeholder.

• Academic research. The Biotech Act may foster a more coherent regulatory environment, particularly in the preclinical and proof of concept stages, and facilitate access to structured and interoperable data through the European Health Data Space (EHDS). This approach can accelerate personalized medicine and reduce the gap between research and industrial application —one of the shortcomings that Biocat has consistently identified and tackled through its own programs and international collaborations.
• Hospitals and healthcare professionals.  The proposal may strengthen the role of healthcare centers as places for validation and adoption, potentially reducing the time it takes for advanced therapies, next generation diagnostics and digital solutions to reach patients.  
• Startups and spinoffs. Under the Biotech Act, they will benefit from regulatory procedures that are more suitable for high risk innovation, including sandboxes, fast tracks and acceleration tools. This is particularly relevant for deep tech biomedical firms, which require predictability and support in the early stages. The initiative also aims to reduce Europe’s venture funding deficit, potentially creating a more competitive environment for scientific entrepreneurship.  
• SMEs. They will be able to work within a more streamlined, coherent set of requirements, with fewer differences between countries and more opportunities to access strategic European projects. The push for manufacturing and scaleup may benefit SMEs that specialize in GMP processes, bioproduction or technology services.  
• Large corporations. They will find a more stable European environment for investing in R&D and reindustrializing strategic capabilities. The Biotech Act seeks to counter dependence on other continents and create incentives for large companies to maintain or expand their operations in Europe.  
• Venture capital funds. They will be able to operate in a more predictable regulatory environment, with explicit public support for industrial scalability and translation.  
• Policy makers. They will have a clear European framework to align innovation, industrial and health policies. The Biotech Act introduces instruments for coordination among Member States and evaluation mechanisms that can strengthen the coherence of national and regional strategies.  
• Patients. They will be the ones to benefit most. Regulatory acceleration and faster adoption of innovation will lead to more equitable, timely access to advanced therapies, digital diagnostics, personalized treatments and data driven health solutions.  

In this context, Catalonia is starting from a solid position. Several programs and projects promoted by Biocat have anticipated the strategic lines now laid out in the Biotech Act for years now. ATMP Catalonia and the ATMP Catalyst program drive the development and scaleup of advanced therapies, strengthening manufacturing capabilities under pharmaceutical quality standards and facilitating clinical validation in hospital settings. The Healthcare System Access Program (PASS) facilitates the adoption of innovation within the healthcare system, reducing the time between solution validation and patient use; d·HEALTH Barcelona and CRAASH Barcelona provide specialized talent, generate startups and promote transfer; and the Invest BioRegion Portal connects innovators and investors to advance toward a more efficient, impactful investment ecosystem.  

On the European level, Biocat’s participation in initiatives like PRECISEU, BRIDGE, FLASH and InnoMed Catalyst, as well as completed programs like EHAB, Bioman4R2 and EDAH strengthens interregional cohesion and development of European value chains. The BioRegion of Catalonia Report provides essential data, analyses and indicators to measure the sector’s impact —an aspect explicitly highlighted in the new Regulation.  

Biocat, which currently holds the presidency of the Council of European BioRegions (CEBR), is bolstering its strategy to position Catalonia as a European benchmark in the sector and is actively helping reduce the fragmentation that the Biotech Act seeks to address. As Biocat Strategic Foresight and International Relations Director and CEBR President Montserrat Daban said: “Europe needs a biotechnology policy that lives up to its scientific potential. This proposed Regulation is a step in the right direction and confirms the essential role of clusters and territorial ecosystems. At Biocat, we have been working for years along the lines that the Biotech Act now establishes, and we are ready to actively contribute to its implementation.” 

This commitment to building a more cohesive European biotechnology policy is also reflected in specific initiatives designed to anticipate and support ongoing regulatory changes. One of these is the PRECISEU Policy Program, promoted by Biocat to generate knowledge, alignment and impact capacity before the new European frameworks are fully in force. Scheduled for March 2026, the program will generate strategic intelligence, recommendations and spaces for debate to ensure that the BioRegion is well positioned in the new regulatory landscape. Its goal is twofold: to prepare the sector to fully leverage the potential of the Biotech Act and related regulations and to amplify the BioRegion’s voice in European debates on innovation, data, digital health and manufacturing.