28
Deferred
Mandate DHSC and MHRA to review phage clinical use rules for domestic and imported alignment
Recommendation
The current situation whereby in the absence of UK GMP facilities only phages imported from abroad can be used, which may themselves be non-GMP, is irrational and discriminatory. This is a costly approach based on a fragile supply chain, which is denying very ill patients rapid access to a therapy that is allowed in some other jurisdictions. It is also hindering the UK’s clinical development and evaluation of phages and holding back the strengthening of expertise across the UK’s health system. There is also a knock-on impact on the UK’s phage innovators. The greater compassionate use of phages in the UK in cases of last resort would be more likely to give the opportunity to demonstrate their potential, which could encourage more investment in clinical trials and GMP facilities, to drive forward the commercial use of phages in the UK and exports. We recommend that the Department of Health and Social Care and the Medical and Healthcare products Regulatory Agency reviews the current rules regarding the clinical use of phages in the UK. This should aim to ensure alignment between domestically produced and imported phages.
Government Response Summary
The government states new non-binding advisory guidance on phage regulation is under development by MHRA, but the production of a monograph will be deferred until MHRA gains experience from this guidance.
Paragraph Reference
118
Government Response
Deferred
Government Response
Deferred
HM Government
Deferred
All medicines are required to be manufactured to GMP but may be provided outside of the marketing authorisation framework as unlicensed medicines on an individual patient basis. In the UK, all imported unlicensed medicines including those that may incorporate bacteriophages are currently subject to review to ensure that they have been manufactured at equivalent standards to, or in compliance with, GMP regulations. New non-binding advisory guidance is under development by MHRA. The production of a monograph will be deferred until MHRA has gained experience from writing the non-binding advisory guidance.
Source
Report
First Report - The antimicrobial potential of bacteriophages
03 Jan 2024
HC 328
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age
2.4 yrs
Report published
03 Jan 2024