Is the European Biotech Act a one-shot solution for the biotech sector?

For European Biotech Week, Diana Turner and Dr Claire Skentelbery, Director General, EuropaBio, examine the potential impact of the European Biotech Act. The European Biotech Act was first introduced by Ursula von der Leyen in 2024 in her paper ‘Europe’s Choice: Political Guidelines For The Next European Commission 2024−2029’. She stated: “In order to make it easier to bring biotech from the laboratory to factory and then onto the market we will propose a new European Biotech Act in 2025. This will be part of a broader Strategy for European Life Sciences to look at how we can support our green and digital transitions and develop high-value technologies. To lead on innovation, we need to create the conditions for researchers to thrive. This means providing the infrastructure and innovative laboratories they need to test and develop ideas through new public-private partnerships, such as joint undertakings.” In May 2025, the Act gained new momentum, when the Commission launched “a call for tender for a study into measures that could strengthen innovation and competitiveness in biotechnology across the EU”. It said that the study will help with the preparation of the Biotech Act, by identifying concrete measures to enhance the EU’s biotechnology ecosystem. The call revealed that the Act could be expected in 2026 and that it will contribute to reinforcing Europe’s position as a global leader in cutting-edge, safe and sustainable biotechnologies. In response, the European Federation of Pharmaceutical Industries and Associations (EFPIA) urged coordinated and urgent action to: reinforce internationally competitive Intellectual Property (IP) protection rules; simplify, speed up and harmonise the EU framework for clinical trials; establish a centre of excellence for manufacturing innovation; modernise the EU regulatory ecosystem; unlock broader use of private investments; and boost digitalisation for biotech development. A next-generation economy The European biotech market already has enormous strength, boasting the world's highest fermentation capacity, for example, which supports biomanufacturing of materials across incredibly diverse sectors. Latest figures have shown that European employment in biotechnology is growing at six times the rate of other industries and its average productivity is over twice as high as the EU average1. “This is literally the definition of a next generation economy,” explains Dr Claire Skentelbery, Director General at EuropaBio, when I speak to her to Life Sciences Baltics 2025. “As a critical technology biotechnology is the one that Europe is most likely to be able to continue to grow as a global leader. There's huge competition from everywhere else in the world, but Europe has built a really amazing biotech footprint. The European Union (EU) has got fantastic research programmes, freedom of movement, and very good integrated skills development.” EuropaBio is a non-profit industry association that represents biotechnology or innovative bioindustries at European level, including the EU, the UK and Switzerland. It aims to build the right legislative and regulatory framework for the successful commercial development of biotechnology, to raise awareness of the role biotech plays in daily life, and to support the development of the ecosystem. However, Europe’s biotech strengths are balanced by the challenges of a highly fragmented regulatory system and competition from other markets like China, which is becoming a strong innovator in the biotechnology sector. Skentelbery expands on this: “It is slower to bring novel technologies to maturation in Europe than in other regions. Whether it's the European Medicines Agency or the European Standards Agency, you can't predictably say you will get a decision in a set amount of time and because of that, it's very difficult to bring investment into an early-stage innovation. If you can't give potential investors a concrete answer about what your pathway to market looks like, it just makes a high-risk venture even higher risk. “That's where the greatest benefits can come, because if you can accelerate a safe pathway to market without changing any safety standards, you then unlock greater confidence and greater investment.” Creating an agile path to market The European Biotech Act is one of various upcoming pieces of legislation designed to strengthen the sector and improve regulatory systems and the investment situation. One important aspect of this will be defragmenting the 27 member states of the EU as much as possible to remove inconsistent information requirements and processes, especially when it comes to regional differences within the nations of the EU. “We need the member states to look beyond their own immediate priorities and ask how do we contribute together to create a more coherent market?” says Skentelbery. She explains that while governments can play a role in funding early innovative research, at some point the technology push has got to become a market pull, and so the role of governments is to create this through legislative change by de-risking investments and allowing the scale of investment to come. “The European Biotech Act is part of a huge landscape of legislation right now. It isn’t one button that suddenly fixes all ills and opens all pathways for biotech,” Skentelbery concludes. “What it should do is create very strong future-proof, agile pathways for biotechnology. We want to see faster ability to scale up manufacturing, faster ability to grow, faster access to finance, and to build in future agility to regulatory pathways rather than trying to retrofix things. The Biotech Act won’t fix what is already there, but it’s designed to create new, clearer biotech-appropriate pathways of development with all the different biotech sectors in mind.” Reference: https://www.europabio.org/wp-content/uploads/2025/03/WifOR_EuropaBio2025.pdf Biography Claire holds a PhD in biochemistry and has led organisations that champion and advocate for commercial delivery of science for 25 years, starting within the Cambridge UK biotechnology cluster. She has worked to lead biotechnology across sectors through the Council of European BioRegions and the European Biotechnology Network and joined EuropaBio as Director General in 2020.