PhageEU is calling on co-legislators to:

• Recognise collective and cumulative infrastructure, including curated phage libraries, bacterial host collections, and interoperable data systems within Strategic Health Biotechnology Projects;
• Ensure regulatory sandboxes accommodate adaptive biological products, including those whose composition may evolve within defined quality and safety parameters;
• Adapt clinical trial provisions to allow susceptibility-guided enrolment, adaptive designs, and platform protocols suited to phage therapies;
• Commission EMA and EFSA to develop coordinated regulatory guidance covering classification, manufacturing standards, and adaptive clinical development;
• Make the EU Health Biotechnology Investment Pilot accessible to phage SMEs at clinical development and scale-up stage;
• Include phage production facilities within EU biomanufacturing support initiatives.
• PhageEU is also proposing a dedicated chapter on bacteriophages within the Act, consistent with Chapter V on biosimilars, reflecting the technology’s unique potential to reshape antimicrobial treatment in Europe.                                                                                     

Failing to act would mean a lost opportunity. Europe has the science. The Biotech Act can provide the framework. Now is the time to make it work for phages.