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New research from Mehrunisha Suleman, Susan Bull and colleagues, published in the Journal of Medical Ethics, draws attention to the crucial importance of establishing good manufacturing practice for phage therapy in the UK and the ethical argument that underpins this.
There is a growing need for novel therapies to tackle antimicrobial (AMR) resistance and to reduce our use of and reliance on antibiotics. Phage therapy is a promising alternative antimicrobial strategy.
In the UK currently, the application of phage therapy occurs only on an ad hoc basis, and availability is limited due to procurement difficulties and a lack of sustainable access to phages manufactured according to Good Manufacturing Practice (GMP).
The paper provides a critical analysis of the ethical justifications for addressing these issues and establishing GMP phage manufacturing in the UK. These include benefits for patient care and outcomes, upskilling of practitioners, opportunities for innovation and systematic research, increased preparedness for outbreaks, enhanced antibiotic stewardship, as well as reducing NHS costs from infections, amputations and complex surgical care.
The authors recommend that in order to provide phage therapy optimally, safely and equitable, onshore GMP phage manufacturing needs to be accompanied by a national central GMP-equipped phage centre that provides support to all Trusts for the use of phage therapy.
They argue that such a system is important not just for current patients but also for future patients and population health, because AMR already poses a huge health burden and this is only likely to increase.
Suleman M, Clark JR, Bull S, et al Ethical argument for establishing good manufacturing practice for phage therapy in the UKJournal of Medical Ethics Published Online First: 11 February 2024. doi: 10.1136/jme-2023-109423