The Biotech Act will be divided into two phases: the first, focused on health, is expected by the end of 2025
It will take the form of an omnibus law, bringing together multiple provisions on health, clinical trials, in vitro diagnostics, medical devices, food, and feed. The second phase, focused on industrial policy, is expected in the third quarter of 2026.
The Biotech Act, a legislative initiative of the European Commission aimed at strengthening biotechnology development in Europe, will move forward in two phases. The law seeks to establish a comprehensive regulatory framework to boost investment, innovation, and competitiveness in the sector — at a key moment for the European Union’s strategic autonomy. The regulation is currently in the public consultation phase (“Call for Evidence”), open until November 10, 2025, during which key stakeholders from the biotech ecosystem, such as AseBio, are submitting their proposals.
Following the recent publication of the European Commission’s 2026 Work Programme and statements by President Ursula von der Leyen, EuropaBio has confirmed that the Biotech Act will be divided into two phases. The first, scheduled for the end of 2025 and led by Commissioner for Health and Animal Welfare Olivér Várhelyi, will take the form of an omnibus law, grouping together multiple provisions on health, clinical trials, in vitro diagnostics, and medical devices, as well as on food and feed. The second phase, which will develop the European Biotechnology Act II, will focus on industrial policy, creating a broad and forward-looking ecosystem, and impact assessment. It will be led by Stéphane Séjourné, Vice-President of the European Commission, and is expected in the third quarter of 2026.
In June 2025, we submitted to the European Commission a set of key proposals. Among them, we highlighted the need for rapid and stable access to funding through strong investment ecosystems, tax incentives, European co-investment, and dedicated funds for SMEs and industrial scale-up. We also proposed the creation of a European Biotechnology Index to enhance visibility and access to capital.
From a regulatory standpoint, we advocated for simplifying and streamlining existing frameworks, through a “Biotechnology Omnibus Package” that incorporates technological neutrality, updated clinical trials, early collaboration, promotion of unitary patents, and efficient public-private partnerships. Therefore, at AseBio, we welcome the inclusion of our proposal in this first phase. We also emphasize the need for coordination among European agencies and strong governance, proposing the creation of a Biotechnology and Life Sciences Office within the European Commission.
At the industrial level, we underline measures to strengthen scalability, prioritizing European suppliers, modernizing public procurement, and enhancing human capital and digitalization, including the integration of artificial intelligence and secure digital platforms.
At AseBio, we continue to gather input from our members to consolidate with EuropaBio, ensuring that the future Biotech Act reflects the realities and needs of the Spanish and European biotechnology industries, and showcases their full potential under this new regulatory framework. The public consultation period ends on November 10.