EU: Proposal for a European Biotech Act
The European Commission has presented a proposal for a European Biotech Act aimed at strengthening Europe’s biotechnology potential and accelerating the translation of innovation from the laboratory to the market.
Key elements of the proposal include new funding and investment mechanisms for biotech companies, notably a health biotech investment pilot to be developed in cooperation with the European Investment Bank Group, as well as targeted support to boost bio-manufacturing capacity in Europe.
The Biotech Act also seeks to incentivise research and production in the European Union, speed up cross-country clinical trial authorisations, and accelerate the development of cutting-edge therapies through the use of artificial intelligence, data and regulatory sandboxes. In parallel, it aims to simplify EU regulatory requirements, reduce costs and administrative burdens, and introduce single regulatory pathways for complex innovative products.
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