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 …
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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 the phage The antimicrobial potential of bacteriophages 57 researchers to improve prospects for phage related applications for research funding. Without proper support, the full potential of phages will not be realised within the Government’s AMR strategy.
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Government response AI summary
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 phages within AMR plans or …
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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 …
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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 indicate how phage-related research and development across different sectors might be joined up as part of its overarching ‘One Health’ approach to tackling AMR.
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Government response AI summary
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.
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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 …
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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 courses and that information about how to access phages or phage expertise is readily available to clinicians and other healthcare staff within each hospital.
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Government response AI summary
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.
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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 …
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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 environment. Careful and transparent promotion of phages’ antimicrobial ability to reduce or eradicate bacterial pathogens and re-weaponise antibiotics, would help make their use more acceptable. (Paragraph 72) Manufacturing phages
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Government response AI summary
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.
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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 …
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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.
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Government response AI 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 …
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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 …
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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 produced commercially, GE phages will need to be aligned with GMP. We recommend that the MHRA produces guidance on how GE phages will be regulated and how they will meet GMP. The MHRA should also provide guidance on how extracted phage enzymes will meet GMP requirements.
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Government response AI summary
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.
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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 …
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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.
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Government response AI 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.
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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 …
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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 in other countries and produce a monograph to govern and ensure their safety and purity. The MHRA should publish its review and proposals for a non-GMP phage monograph and any changes that will be required to change necessary regulation to underpin this change. The 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.
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Government response AI summary
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.
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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.
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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.
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Government response AI 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.
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Department for Science, Innovation and Technology