Asebio Welcomes the EU Biotech Act as a Boost to Competitiveness and Health Autonomy

The Spanish Association of Biotechnology Companies (Asebio) positively assessed the foundations established by the first part of the Biotech Act, presented on December 16th by the European Commission, considering that it represents a relevant step to strengthen the competitiveness of the European biotechnology ecosystem and advance the strategic autonomy of the European Union in the field of health.

The new legislative initiative is part of a broader package of measures aimed at improving the health of European citizens and ensuring the long-term resilience and competitiveness of the healthcare sector. The second phase of this legislation is planned for the third quarter of 2026.

Asebio highlights the Biotech Act as a strategic step to strengthen Europe’s biotechnology sector, innovation capacity, and health sovereignty

In this context, Asebio noted that biotechnology is one of the fastest-growing sectors in the EU. It currently generates over 900,000 jobs, 75% of which are in the healthcare sector, and contributes around €40 billion to the European economy. Furthermore, it has significant potential to transform healthcare through innovative therapies, more precise diagnostics, and the development of personalized medicine.

However, Europe has lost ground to other global competitors. As the so-called Draghi Report shows, the EU accounts for only 7% of global venture capital investment in health biotechnology, while its global share of commercial clinical trials has fallen from 22% to 12% in the last decade. The combination of insufficient funding, structural barriers, and complex regulations has pushed startups and scientific talent to develop their activities outside the continent, Asebio confirms.

Throughout the entire proposal development process, Asebio actively participated in its design. In June, it submitted a set of recommendations to the European Commission that summarized three priorities for the sector: faster and more accessible financing, more agile and coherent regulation, and a more cohesive Europe with a clear industrial focus.

Subsequently, when the public consultation was opened in November, Asebio reinforced and expanded these contributions together with its partners and in close collaboration with EuropaBio, highlighting the structural challenges of the biotechnology sector and the need for ambitious responses such as the Biotech Act.

Key aspects of the Biotech Act and why Asebio backs the regulation

The proposed legislation outlines measures to improve access to financing through economic incentives and a pilot investment program in health biotechnology, to be developed from 2026 onwards in collaboration with the European Investment Bank Group. This program will complement the BiotechEU initiative and aims to mobilize up to €10 billion for the sector.

Furthermore, the plan anticipates strengthening industrial and innovation capabilities through the creation of centers of excellence in advanced therapies, testing environments, and training in biofabrication , as well as projects focused on biodefense. Within this framework, the designation of high-impact strategic biotechnology initiatives as “strategic projects” will be promoted.

The regulation also includes measures to incentivize European innovation, such as the specific extension of patent rights for key innovations in health and veterinary biotechnology, and support for strategic areas such as biosimilars. This will give strategic projects faster access to European funding and accelerated administrative, scientific, and regulatory support. Asebio

Another pillar of the Biotech Act is the promotion of the use of artificial intelligence, data and digital solutions, supported by the deployment of the European Health Data Area and the creation of reliable AI testing environments, with special attention to SMEs and startups.

Regulatory simplification and biosecurity

The proposal also aims to simplify and accelerate regulatory procedures to reduce the time to market for new biotechnology products. To achieve this, it proposes harmonized requirements, single regulatory pathways for complex innovative products, and the implementation of controlled regulatory environments or sandboxes.

In parallel, efforts are underway to accelerate the authorization of multinational clinical trials, with a significant reduction in approval times, which could be reduced, for example, from 75 to 47 days when no additional information is required.

The Biotech Act also incorporates specific measures to ensure biosafety , aimed at preventing the misuse of biotechnologies and strengthening the EU’s biodefense capabilities, through proportionate safeguards that protect human health.

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(Featured image by Lukas S via Unsplash)

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First published in diariofarma. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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