31 Deferred

Review current regulations governing liability for clinicians and hospitals using UK non-GMP phages.

Recommendation
We recommend that the MHRA reviews how current regulations would govern liability for clinicians and hospitals who used UK non-GMP phages, produced to a magistral monograph. It should consider what changes, if any, could be made to provide greater reassurance regarding liability, where appropriate safety and purity standards were met.
Government Response Summary
The government rejects the recommendation, stating that regulation for pharmacy practice is beyond the remit of the MHRA and that liability for unlicensed medicines currently rests with the prescriber.
Paragraph Reference
131
Government Response
Deferred
HM Government Deferred
Regulation for pharmacy practice is beyond the remit of MHRA and any liability on the use of an unlicensed medicine currently rests with the prescriber.
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 2.4 yrs
Report published 03 Jan 2024