Recommendations & Conclusions
9 items
6
Recommendation
First Report - The antimicrobial potent…
Deferred
Because phages have had relatively limited recent research funding from public sources, we recommend that the Government reviews the status of phages within its plans to tackle AMR. We also recommend more specifically that the National Institute for Health and Care Research and the UK Health Security Agency engage with …
Government response. The government supports the principle of phage education but states that medical and veterinary training standards and curricula are the responsibility of independent statutory bodies (GMC, RCVS, and schools), thereby deflecting responsibility. It does not address the recommendation to review …
Department for Science, Innovation and Technology
11
Recommendation
First Report - The antimicrobial potent…
Deferred
We recommend that the Department for Health and Social Care responds to the UK’s Phage Knowledge Transfer Network’s proposals within six months of their publication. The Department should set out how it will help develop a network for phage-related knowledge sharing and assets such as biobanks. The Department should also …
Government response. The government states it has committed to establishing general clinical trial acceleration networks with funding, but does not specifically address responding to the Phage Knowledge Transfer Network's proposals or developing a phage-specific knowledge sharing network or biobanks.
Department for Science, Innovation and Technology
12
Recommendation
First Report - The antimicrobial potent…
Deferred
If phages are to be used more widely within the UK’s healthcare system it is important that healthcare professionals are aware that they are an antimicrobial alternative, especially when antibiotics have failed or are failing. We recommend that information about the clinical use of phages is included within medical training …
Government response. The government supports the principle of education and training on phages but redirects responsibility for medical and veterinary training standards and curricula to the independent General Medical Council, Royal College of Veterinary Surgeons, and medical schools.
Department for Science, Innovation and Technology
13
Recommendation
First Report - The antimicrobial potent…
Deferred
The public will need to be convinced that phages are safe and effective. This will be key if phages are to play a role in addressing AMR in healthcare and as part of a One Health approach to addressing AMR across various sectors, such as the food industry and the …
Government response. The government supports training on phage therapy but redirects responsibility for medical and veterinary training standards to the General Medical Council (GMC) and the Royal College of Veterinary Surgeons (RCVS), stating they determine curriculum content.
Department for Science, Innovation and Technology
16
Recommendation
First Report - The antimicrobial potent…
Deferred
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 …
Government response. 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 …
Department for Science, Innovation and Technology
18
Recommendation
First Report - The antimicrobial potent…
Deferred
For phages to be effective they will need to keep pace with bacterial resistance and be amenable to adaptation for individual patients. Genetically engineered (GE) phages may be one way of ensuring this. GE phages have already been used in the UK and elsewhere. However, if they are to be …
Government response. The government's response consists solely of a list of references and links, providing no specific textual reply or commitment regarding guidance for GE phages or extracted phage enzymes.
Department for Science, Innovation and Technology
28
Recommendation
First Report - The antimicrobial potent…
Deferred
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 …
Government response. 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.
Department for Science, Innovation and Technology
30
Recommendation
First Report - The antimicrobial potent…
Deferred
We recommend that the Medicines and Healthcare products Regulatory Agency (MHRA) revisits the regulation of the clinical use of non-GMP phages produced in the UK for last resort compassionate cases where antibiotics or other antibacterial interventions have failed. The MHRA should review the use of non-GMP phages in such cases …
Government response. The government reiterates that all medicines must be manufactured to GMP and states that new non-binding advisory guidance is under development by MHRA. However, the production of a monograph specifically for non-GMP phages, as recommended, will be deferred.
Department for Science, Innovation and Technology
31
Recommendation
First Report - The antimicrobial potent…
Deferred
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. 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.
Department for Science, Innovation and Technology