European Biotech Forum 2026

Biotechnology is becoming a decisive capability for Europe’s competitiveness, industrial resilience and strategic autonomy. But Europe enters the next institutional cycle with a fragmented policy landscape, uneven regulatory capacity, and persistent scale-up barriers. The Commission’s Biotech Communication I and Biotech Communication II set out an initial toolbox, but fall short of an end-to-end industrial framework comparable to the US. The gap between ambition and execution remains significant. To what extent do these communications address the core challenges of Europe’s biotech sector? Where are the structural gaps that still block growth and industrial deployment?

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Where does Europe stand in global health biotechnology today, and what are the biggest barriers to competitiveness and scale-up?

What should the Biotech Act prioritise to strengthen Europe’s biotech ecosystem — from regulatory coherence and finance to research, data, skills and public–private collaboration?

How can the Biotech Act deliver real impact for innovators, patients and health systems, and what additional measures may be needed to ensure long-term success?

To what extent do current proposals address the real regulatory bottlenecks holding back Europe’s biotech and clinical research ecosystem?

How can better alignment between EU-level bodies and Member States improve consistency, predictability and speed of implementation? What governance mechanisms are needed to translate EU-level guidance into real convergence?

How can Europe create a regulatory environment that accelerates clinical research, supports the uptake of new technologies such as AI, and shortens timelines—while safeguarding patient safety, data robustness and public confidence?

Vice President of Regulatory Affairs for Europe, Latin America, Middle East, Africa and Canada
Amgen
MEP (EPP, Belgium)
European Parliament
MEP (S&D, Lithuania)
European Parliament
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