Statement following the European Commission’s proposal for the Biotech Act I on 16 Dec. 2025 as urged by rani and its partners.
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This is a great day for biosecurity in Europe. The Biotech Act shows that the European Commission understands the need for action both to unlock innovation, deliver what industry has asked for, and advance critical biosecurity safeguards to protect Europeans and guard against disaster.
The biosecurity pillar takes important steps to advance mandatory synthesis screening. Not only will this requirement protect Europeans from potential dangerous misuse of synthetic biological materials, but it will also provide clarity and certainty for industry as countries like the U.S. and U.K. move ahead on similar measures. Synthesis screening will help close gaps in Europe’s biosecurity and biosafety oversight and unlock a new era of safe innovation.
The establishment of an Advisory Group on Biosecurity is also welcome. We need a place for these issues to ‘live’, be debated, discussed, and advised on.
This proposal will go to the Council and the Parliament where Member States and MEPs will have their say. We look forward to working with the brilliant community of industry players, academics, civil society stakeholders, and national experts that care about advancing technology while keeping society safe.
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Read the Joint Position on the EU Biotech Act and Wider Legislative Efforts to Strengthen Europe’s Bioeconomy.
Read the Priorities to Uphold European Biosecurity in 2025 policy brief.
