Biotech Act I: Driving biotech innovation
Europe has the scientific excellence, talent and health system infrastructure to lead the world in biotechnology
Despite these strengths, many innovations struggle to move discovery research onto large-scale trials and commercialisation.
For this edition of our Think Tank report series, we brought together a range of voices from across Europe to explore how Europe’s innovation pathways can be supported.
What is the Biotech Act?
Published on 16 December 2025, the Biotech Act I is the European Commission’s proposal to strengthen health biotechnology in Europe.
The Act aims to support the biotech innovation journey from research and clinical trials to manufacturing and commercialisation. The Act proposes to do this by changing and implementing new EU rules on clinical trials, data sharing for research and start-up funding.
Our objectives
To understand how the European Biotech Act can strengthen Europe’s position as a global biotechnology leader, our working group discussions with experts and report aimed to:
- Map the biotechnology innovation pathway, identifying key policy, funding and ecosystem challenges across the full innovation lifecycle.
- Identify key opportunities to strengthen Europe’s biotechnology sector, aligned with the Biotech Act and related EU policy.
- Synthesise insights and best practices from across Europe’s biotechnology ecosystem to inform the Biotech Act and broader decision-making.
Our approach
EIT Health’s Biotech Think Tank report reflects the insights generated through focused working groups, bringing together representatives from start-ups, small and medium-sized enterprises (SMEs) and research organisations, alongside investors, policymakers and academic experts.
The working groups covered themes of innovation, competitiveness and futureproofing, and agreed:
- With world-leading universities, effective clinical trial ecosystems and highly skilled workforces, Europe could lead the world in Biotech.
- If Europe’s innovation capacity remains isolated within individual countries, Europe will struggle to match the scale of China and the United States.
- Consolidating and integrating national efforts by implementing measures in the Biotech Act, could unlock a positive virtuous cycle of innovation in Europe.
Publications
Skills, scale and science: Uniting European Innovation Ecosystems through the Biotech Act
Innovation – turning European biotechnology into clinical trials
Europe has a strong foundation for biotechnology innovation through its world-leading science and research institutions. Turning scientific discoveries into market ready biotech products that can enter clinical trials is a long process. It requires a range of skills and different types of funding compared to basic science.
Gaps in funding, limited coordination across borders as well as complex and overlapping regulations limit Europe’s ability to progress scientific discoveries into clinical trials.
Experts highlighted the importance of innovation clusters, funding instruments specific for the needs of biotech and the skills needed to move biotech from the lab into trials.
Competitiveness – creating a thriving European biotech ecosystem
Europe has the capabilities to compete globally in biotechnology, but across some stages of biotech development it has started to lose out, relative to both the US and China.
A competitive innovation ecosystem would allow biotech start-ups to grow and scale within Europe. However, fragmented market access for start-ups, whether regulation can keep pace with technology, and limited availability of scale-up finance, all make it harder for biotech companies to grow within Europe.
Experts highlighted the importance of making the single market function in practice, improving predictability and enabling companies to scale across borders, to ensure Europe remains an attractive place to invest and grow.
Future-proofing – ensuring European biotech resilience
Biotechnology is constantly evolving, and new technologies like cell and gene therapy require new skillsets and new processes.
Technological developments could change the type of skills, supply chains and health data biotech relies on. If the innovation ecosystem does not keep pace with these developments, Europe risks limiting the long-term impact of its strengths.
Experts noted that investing in skills, talent mobility, modernising data governance, and taking a more coordinated approach could future-proof the biotech sector.
Driving biotech innovation
We help startups develop new cutting-edge innovations to transform healthcare. Discover some of our opportunities here:
Opportunities page: https://eithealth.eu/get-involved/new-call-opportunities/
Got questions?
Contact us for more information
Boosting Innovation
As well as providing thought leadership, we are developing new products and services that deliver cutting-edge innovations to transform healthcare. Discover some of our projects.