Spain's AseBio Endorses Framework for First Stage of EU Biotech Act

The Spanish Association of Bioenterprises, AseBio, has voiced its approval regarding the foundational elements established for the initial phase of the European Union’s Biotechnology Act, referred to as Biotech Act I. This significant legislative proposal was formally introduced by the European Commission on December 16, 2025. Industry observers view this act as a crucial mechanism designed to bolster the entire bloc’s competitiveness within the biotechnology sector, particularly in light of shifting global geopolitical landscapes that necessitate decisive action.

AseBio’s endorsement aligns closely with the perspective held by EuropaBio, the overarching European employers’ organization representing the interests of the biotech industry across the continent. Both organizations see this legislation as vital for future growth and stability in the sector.

The first installment of this legislation concentrates specifically on medical biotechnology, aiming to unlock and stimulate the latent potential within Europe’s biotech ecosystem. Its primary objectives involve streamlining the journey from initial research findings to successful market entry. Furthermore, the act seeks to fortify industrial capabilities and enhance the European Union’s strategic autonomy, especially concerning healthcare provision. Looking ahead, the second component of the Act, which will address broader industrial policy matters, is anticipated to be unveiled during the third quarter of 2026. EuropaBio has consistently stressed that biotechnology is indispensable for achieving the EU’s overarching goals of fostering competitive, healthy, and sustainable economic models.

AseBio was not a passive observer during the drafting process; the association actively contributed by submitting a series of detailed recommendations in June 2025. These proposals highlighted three core priorities: the urgent need for faster and more accessible financing pathways to staunch the outflow of capital, the requirement for regulatory frameworks that are both flexible and consistent to guarantee legal certainty, and the imperative to cultivate an industry-focused Europe capable of standing toe-to-toe with major global players like the United States and China. Overall, AseBio warmly welcomes the European Commission’s initiative, viewing a robust legislative foundation as essential for fully realizing the vast potential of biotechnology for societal and economic benefit.

Biotech Act I incorporates concrete measures intended to improve access to necessary capital. A key feature is a pilot investment program specifically targeting medical biotechnology. This program, slated for joint launch with the European Investment Bank (EIB) Group starting in 2026, is projected to mobilize up to 10 billion euros for the sector, serving as a supplement to the existing BiotechEU initiative. Industrial capacity will receive a boost through dedicated support for centers of excellence and projects focused on biodefense. Initiatives deemed of strategic importance will be granted the designation of “strategic projects,” thereby qualifying them for expedited funding processes and streamlined administrative assistance.

The legislation also introduces specific extensions to patent terms for critical innovations within both human health and veterinary biotechnology domains. Digital advancement will receive a significant push via the implementation of the European Health Data Space and the establishment of trustworthy testing environments for artificial intelligence, with targeted support earmarked for small and medium-sized enterprises. Regulatory streamlining aims to cut down the time required to bring new products to market by harmonizing requirements and introducing controlled regulatory environments, often termed “sandboxes.” For instance, the authorization timeline for multinational clinical trials could potentially be reduced from the current 75 days down to just 47 days, provided no supplementary information is requested.

Measures addressing biosecurity and biodefense are included, ensuring proportionate safeguards are in place to prevent the misuse of biotechnological advancements. In the context of fierce international competition, the EU is clearly striving to become more agile and self-reliant. The legislative proposal also mandates adjustments to existing regulations, including a review of the Directive concerning Genetically Modified Organisms (GMOs). AseBio supports this review but strongly advocates for the inclusion of novel food products within the updated framework. Currently, the draft legislation is set to proceed for deliberation by both the European Parliament and the Council.