16 Deferred

Establish a publicly-funded GMP facility for phage production and address industry investment barriers

Recommendation
We recommend that the Department for Health and Social Care considers bringing together funders with relevant catapults and innovation centres, such as the Centre The antimicrobial potential of bacteriophages 59 for Process Innovation, to build a GMP facility that can be accessed and used by phage innovators, the NHS and those seeking to produce microbiome products. The Government should also consider investment in existing spare and disused laboratory space, such as the currently for sale Rosalind Franklin Laboratory, to develop a GMP facility for phage production. In addition, the Government should consider why there is a reluctance by pharmaceutical companies to invest in phages, and what steps it can take to address this.
Government Response Summary
The government indicates DHSC should review current guidance for non-GMP phages, and MHRA is developing new non-binding advisory guidance for them. However, it does not address the recommendation to build a GMP facility or invest in existing spaces for phage production, nor the question of pharmaceutical company investment.
Paragraph Reference
84
Government Response
Deferred
HM Government Deferred
Department for Health and Social Care should review and report on what changes, if any, will be required to ensure that current guidance and oversight procedures are sufficient for the preparation and use of UK produced non-GMP phages in UK healthcare settings. 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.
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 2.4 yrs
Report published 03 Jan 2024