AseBio participates in the public consultation of the upcoming Biotech Act with proposals to boost European biotechnology

The public consultation period for the future Biotech Act, the European legislative initiative designed to drive biotechnology development across the continent, closes on November 10. This law —to be developed in two phases, as AseBio exclusively announced to its members— seeks to establish a comprehensive regulatory framework that fosters investment, innovation, and competitiveness at a crucial time for Europe’s strategic autonomy.

AseBio, after presenting its initial proposals in June, has now incorporated additional contributions from its members during this public consultation phase to ensure that the Biotech Act reflects the real needs of both the Spanish and European biotechnology industries.

A clearer and more harmonized regulatory framework

AseBio highlights that Europe’s regulatory environment remains fragmented and poorly adapted to the sector, with overlapping frameworks —such as Clinical Trials, GMOs, or Data Protection— creating duplication, higher costs, and delays. To address this, AseBio proposes the creation of a “Biotech Omnibus” to harmonize legislation and adopt technological neutrality, alongside updates to the Clinical Trials Regulation, acceleration of the Unitary Patent, and the implementation of regulatory sandboxes.

A clearer, risk-based, and coordinated regulatory approach among the EMA, EFSA, ECHA, and DG SANTE would help speed up market access. By contrast, countries like the U.S. and China apply more proportional and efficient frameworks, giving them a competitive edge over the EU.

Financing and investment: strategic pillars

Access to finance remains a major challenge. AseBio identifies insufficient support for commercialization and scale-up, as well as barriers to accessing programs such as Horizon Europe, EU4Health, or European Investment Bank instruments.

In response, AseBio proposes initiatives such as Deep Tech / Deep Science programs, Innovative Public Procurement, a Biotech Venture Capital Fund, and reinforcement of the IPCEI, alongside specialized business advisory services. It also calls for integrating financial markets, attracting specialized venture capital, and creating a European Biotechnology Index, supported by tax incentives and co-investment programs.

Clusters and infrastructures: key to innovation

AseBio identifies funding gaps for shared infrastructures —such as pilot plants or scale-up facilities— and a shortage of biotechnology specialists within technology transfer offices. Limited cross-sector collaboration and fragmented regional policies further hinder the translation of research into marketable innovations and the creation of sustainable spin-offs.

Structural challenges in biomanufacturing

European biomanufacturing faces complex authorization processes, high energy and production costs, and a shortage of skilled talent, driving many startups to relocate outside the EU and risking intellectual property loss.

AseBio calls for a coordinated European response to simplify regulation, expand access to capital, strengthen technical training, and prioritize EU-made products in public procurement to ensure a more competitive, resilient, and strategic biomanufacturing sector.

Shortage of biotechnology talent

Europe’s biotechnology sector faces a structural shortage of technical and specialized talent, particularly in biomanufacturing, digital, scientific, and management skills. AseBio’s study “Professional Profiles in the Biotech Sector” highlights the mismatch between education and industry needs, the shortage of lab technicians, and the difficulty SMEs and startups face in offering competitive salaries.

To address this, AseBio proposes updating curricula to align with industry needs, expanding Dual Vocational Training, fostering entrepreneurship, and attracting international talent through streamlined visas, degree recognition, and fiscal incentives such as stock options. It also emphasizes promoting upskilling and reskilling through company training incentives and a skills-first approach.

AI and data: foundations for digital biotechnology

Access to data and the use of artificial intelligence (AI) face significant barriers: fragmented data sources, differing national frameworks, and a lack of single access points. Many companies turn to non-EU data due to clearer legal environments and more favorable intellectual property rules.

AseBio sees the European Health Data Space (EHDS) as a key opportunity to ensure secure, harmonized access to health data, protect IP, and accelerate the creation of regulatory sandboxes. It also calls for modernizing digital infrastructure and fostering trust in AI through coherent and transparent regulation.

Biotechnology, defense, and strategic autonomy

The rapid advance of biotechnology, driven by AI, brings both transformative opportunities and new biosecurity and industrial dependency risks, worsened by limited civil-military coordination and reliance on non-EU materials. AseBio advocates improving communication between sectors, streamlining public procurement, and mapping supply dependencies.

Biotechnology also presents major opportunities for Europe —from detecting biological threats and developing vaccines and antidotes to creating new materials and decentralized production models. AseBio calls for a comprehensive European strategy that promotes R&D funding, prioritizes local production, and strengthens the EU’s technological autonomy, positioning Europe as a global leader in safe and responsible innovation.