Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will bring forward legislative proposals to introduce a magistral phage model to allow UK phages to be produced without requiring GMP licensing.

In its March 2024 response to the Science, Innovation and Technology Committee’s report on bacteriophages, the Government acknowledged the challenges in manufacturing phage materials in the United Kingdom, including the requirement to meet Good Manufacturing Practice (GMP) standards. The principles of GMP are considered necessary to ensure the medicines are of the appropriate quality, safety, and efficacy. The Government committed to considering the case for the development of a UK-based GMP facility to support phage innovators.

In parallel, the Government is engaging with professional regulators and the specialist pharmacy service to clarify how existing regulations address liability for the use of non-GMP produced phages. Unlicensed phages can currently be used in the UK for compassionate cases with appropriate controls. The Medicines and Healthcare products Regulatory Agency will be publishing regulatory considerations for therapeutic use of bacteriophages in the UK in the second quarter of 2025, which will offer guidance on these matters.