Biotech Act is seen by experts as a major opportunity to strengthen Europe’s competitiveness in clinical research and innovation. Commission has now confirmed to EU Perspectives that the proposal will be presented in two parts and that the split is deliberate as ’different sectors within biotech need different approaches.’
“The Commission acknowledges that different sectors within biotech need different approaches. That is why we are taking a two-staged approach,” a Commission’s spokesperson said.
The first proposal, Biotech Act I, is planned for presentation before the end of this year and will ’predominantly focus on health-related biotech’. The Commission says it has widely engaged with stakeholders and identified a clear need for urgent action in this area.
According to the Commission, the package will also introduce simplification measures. Notably on clinical trials and aspects of the food and feed industry. As part of a broader health package, it will appear alongside the targeted revision of EU rules for medical and in-vitro diagnostic medical devices. The Commission says the move underscores its “continued commitment to support a competitive health sector and robust health systems.”
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Major opportunity for clinical research and innovation
The confirmation was echoed this week by senior officials. At the ACT-EU Multi-Stakeholder Platform Annual Meeting on 29 October, Commission Director-General for Health Sandra Gallina described the forthcoming Biotech Act as “a major opportunity, vital opportunity” to strengthen Europe’s competitiveness in clinical research and innovation.
“It aims to create a more favourable environment for biotechnology, innovation, technology development,” she said. “This is not just about making changes to rules. It’s clear that we are committed to creating an environment that attracts also investment and drives scientific breakthroughs.”
Ms Gallina stressed the need to overcome fragmentation across member states. She said the Commission would “continue to harmonise, to streamline the rules across all member states so that we don’t have this fragmentation.” She also underlined the link between the Biotech Act and Europe’s wider effort to make its clinical trial and research environment more coherent.
A second strand, to follow in 2026, will broaden the scope to the wider biotech ecosystem. The aim is to establish what the Commission calls a ’consistent and forward-looking framework for building a competitive internal market for biotechnology’.
A strategic pillar of Europe’s competitiveness
In its response, the Commission underlined that biotechnology is not only a health priority. It’s also a strategic industrial sector underpinning Europe’s wider economic and environmental goals.
The Biotech sector in Europe is of huge strategic importance. We are a global leader in research in this area. — European Commission’s spokesperson
“Biotechnology helps the EU to modernise its industry and health, agriculture, forestry, energy, food and feed sectors. The Biotech sector in Europe is of huge strategic importance. We are a global leader in research in this area,” Commission’s spokesperson said.
To sustain that leadership, the sector requires substantial investment, a supportive regulatory environment, and skilled workforces capable of turning cutting-edge science into market-ready applications. The Commission added that success also depends on a dynamic innovation ecosystem, advanced infrastructure, and reliable supply chains.
“The Biotech Act, in both its parts, will address these needs,” the Commission said. “It will set a predictable framework for the sector, reduce regulatory burden, encourage investment, foster innovation. And bring solutions to patients and industry more quickly.”
MEP Bosse: Biotech Act must deliver for patients
In the European Parliament, MEP Stine Bosse (Renew/DNK) welcomed the Biotech Act’s appearance in the 2026 Commission Work Programme. She wrote on LinkedIn that its ambition must live up to biotechnology’s transformative potential.
The Biotech Act will come in two parts, and it is imperative that we get it right, making sure that we make the best out of the transformative potential of biotechnology across key sectors. – MEP Stine Bosse (Renew/DNK)
“It will come in two parts. It is imperative that we get it right, making sure that we make the best out of the transformative potential of biotechnology across key sectors,” Ms Bosse wrote.
The Danish MEP said the Biotech Act should serve as a broad initiative that delivers for patients and for Europe’s sustainable future, linking health innovation with industrial and clean-economy applications. Ms Bosse also tied the initiative to the EU Life Sciences Strategy and Europe’s goal to lead in advanced therapies and personalised medicine by 2030, while calling for joint EU-level ethics committees to speed up clinical trials in rare and paediatric conditions.
Stakeholders welcome the split, with caution
Industry voices also reacted to the Commission’s decision to split the Biotech Act into two phases. In a statement, the EU Biotech and Life Sciences Alliance said the move “signals the Commission’s commitment to addressing both the health and industrial dimensions of biotech, a welcome recognition of the breadth of the biotech sector, which calls for a comprehensive regulatory framework.”
However, the Alliance warned that “the real impact will depend on the substance of the proposals.” Both parts of the Act, it added, must “act as a unified whole, coherent and aligned with each other,” cautioning that “rushing the process could undermine the potential of a truly ambitious and integrated Biotech Act, one that delivers for people, patients, consumers, industry, and Europe’s sustainable future.”
