Amid the European Commission’s (EC’s) public consultation on the EU Biotech Act, EuropaBio has called for the EU to adopt a “bold approach to investment” to close the gap between research and commercialisation.
The act, announced in EC President Ursula von der Leyen’s political guidelines for 2025 in July 2024, aims to make Europe a more competitive area for biotech to work and invest, as well as accelerating lab to market times. Key areas in the act include regulatory simplification, financing for startups, workforce skills, and the use of AI in biotech.
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While welcoming the initiative, EuropaBio, the European association for bioindustries, makes a number of recommendations based on these key areas, as well as other areas of concern it highlights, to help accelerate biotech in the EU and achieve the desired objectives of the act.
These recommendations include more funding, streamlined regulation, empowered clusters, skilled talent, and digital leadership.
EuropaBio’s director general Dr Claire Skentelbery said: “The EU Biotech Act is a generational opportunity for Europe and must not be squandered. Its ambition and boldness much match Europe’s oft-stated vision for competitiveness, as the critical technology with the most potential from our rich research base and which addresses societal, economic and climate needs.”
EuropaBio calls on a “bold approach to investment” amid a need to “integrate fragmented and risk-averse EU capital markets, mobilise private investment, and support high-risk, high-reward biotech innovation”.
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By GlobalDataThe association also emphasises the importance of stronger, better-connected biotechnology clusters and manufacturing hubs, including the completion of the “Single Market”, as well as harmonisation of procurement, tax, and intellectual property practices, and support for regional biotech ecosystems.
EuropaBio believes this will help scale up industrial biotech and foster cross-sectoral collaboration across the continent.
Another challenge in Europe is a skills gap, which EuropaBio suggests should be rectified by upskilling and reskilling pipelines, improving talent mobility through the EU Blue Card scheme, and harmonising training programmes.
It also calls on barriers in data and AI, such as fragmented data ecosystems, compliance uncertainty, and limited AI-ready datasets. In response, the association calls for EU-wide regulatory sandboxes, harmonised data standards, and dedicated AI-biotech testbeds.
Finally, it recommends establishing an EU Biosecurity and Defence Coordination Platform, investing in dual-use research and development infrastructure, and promoting secure supply autonomy for critical biotech inputs.
This comes at a critical time for Europe, as many pharma and biotech companies are considering moving operations to the US, as President Trump’s administration threatens tariffs on those manufacturing outside the country.
Efforts are being made on top of the EU Biotech Act to make Europe a more attractive region. Speaking at the Arena International Outsourcing in Clinical Trials (OCT) conference ion Copenhagen, Denmark, in October 2025, Lene Grejs Petersen, senior adviser to EU CT-policy at the Danish Medicines Agency (DMA), said EU member states are working to provide clarifications for D17 requirements, considerations for deletion or retention, and is strengthening the role of the reporting member state by improving the Clinical Trials Regulation (CTR).
