The antimicrobial potential of bacteriophages

Science, Innovation and Technology Committee Closed Inquiry
Opened: 9 Nov 2022 Closed: 28 May 2024 Parliament page
This inquiry is informed by the successful pitch to the Committee’s My Science inquiry. The World Health Organisation has warned that antibiotic resistance (AMR) is one of the biggest threats to global health, food security, and development today, while the Government’s Special Envoy on Antimicrobial Resistance, Dame Sally Davies, has … Read more
23 Recommendations
10 Conclusions
1 Report
3 Oral sessions
3 Events
Activity timeline 8 events
1 Mar
2024
Report published
3 Jan
2024
Report published
26 Apr
2023
Oral evidence
26 Apr
2023
Formal meeting (oral evidence session) · Room 15, Palace of Westminster
15 Mar
2023
Oral evidence
15 Mar
2023
Formal meeting (oral evidence session) · Room 6, Palace of Westminster
8 Feb
2023
Oral evidence
8 Feb
2023
Formal meeting (oral evidence session) · The Grimond Room, Portcullis House
Oral evidence sessions 3 sessions
26 Apr 2023
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Panel One; Panel Two
Dr Jonathan Pearce · Medical Research Council Dr Marc Bailey · Medicines and Healthcare products Regulatory Agency Dr Morwenna Carrington · Department for Health and Social Care Dr Tim Jinks · Wellcome Trust Professor Isabel Oliver · UK Health Security Agency Professor Mark Sutton · UK Centre for Ecology and Hydrology Richard Hebdon · Innovate UK
15 Mar 2023
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Dr Hans Petter Kleppen · ACD Pharma Dr Jean-Paul Pirnay · Queen Astrid Military Hospital, Brussels Dr Mzia Kutateladze · George Eliava Institute of Bacteriophage, Microbiology and Virology Greg Merril · Adaptive Phage Therapeutics Naomi Zak · BiomX Professor Jon Iredell · The Westmead Institute for Medical Research Professor Robert Schooley · UC San Diego School of Medicine
8 Feb 2023
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Dr James Soothill · Great Ormond Street Hospital Laboratory Medicine Dr Josh Jones · NHS Tayside Mr David Browning · Fixed Phage LTD Ms Stephanie Lesage · Oxford Silk Phage Technologies Ltd Professor Cath Rees · University of Nottingham Professor Joanne M. Santini · University College London Professor Martha Clokie · University of Leicester
Title HC No. Published Items Response
First Report - The antimicrobial potential of bacteriophages HC 328 3 Jan 2024 33 Responded
Recommendations & Conclusions
33 results
1 Conclusion Acknowledged
First Report - The antimicrobial p…
Robust clinical trial data lacking for long-term phage safety and immune interactions
The safety of phages has been well established mainly on the basis of observational evidence drawn from specific clinical interventions. However, as with all medicines, robust clinical trial data is important to provide and develop assurances around all aspects of … Read more
Government Response
The government outlined ongoing engagement with phage stakeholders and monitoring of the research and clinical trial pipeline. It stated the upcoming 2024-2029 AMR National Action Plan will set out research priorities, including innovation for AMR.
Department for Science, Innovation and Technology
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2 Conclusion Accepted
First Report - The antimicrobial p…
Further clinical trials required to prove consistent effectiveness of phages and combinations
Clinical data indicates that in many cases phages have been observed to reduce bacterial infections in patients. We also heard that their use in animals has also been shown to be effective. However, further clinical trials are required to prove … Read more
Government Response
The government described existing provisions for researchers, including access to bacterial strain panels and expertise, and highlighted funding opportunities through NIHR and UKRI. It specifically noted Innovate UK's recently launched £30 million PACE initiative to accelerate early-stage innovation in AMR, including phage projects.
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3 Recommendation Accepted
First Report - The antimicrobial p…
Consider specific evidence standards for phage safety and effectiveness in UK healthcare settings
We recommend that the Department for Health and Social Care (DHSC), the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE) and National Institute for Health and Care Research (NIHR) should now consider … Read more
Government Response
The MHRA committed to providing non-binding advisory guidance on the specific data needed to evaluate licensed phage products for NHS use. The government also confirmed it will continue to engage with phage stakeholders through the Innovate UK KTN Phage Innovation Network.
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4 Conclusion Acknowledged
First Report - The antimicrobial p…
Further research needed on long-term phage interactions and optimal engineering strategies
Phages have been used as therapy for over a hundred years, and much of the fundamental science relating to phages is understood. However, there is still more that the global and UK research communities can learn. Further research will be … Read more
Government Response
The government recognised the importance of research into non-traditional therapies like phages and committed to continuing to monitor the AMR clinical and research pipeline. It also stated it would not produce annual reports exclusively on phages but would regularly review the broader 5-year AMR National Action Plan.
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5 Conclusion Accepted
First Report - The antimicrobial p…
Funders show reticence towards promising phage research despite general acceptance
However, the apparent reticence of funders to commit to phages is despite a general acceptance in the evidence we took that phages show promise and need more research alongside clinical trials. It is important to understand and reflect on the … Read more
Government Response
The government welcomed the UK KTN Phage Innovation Network's role and stated it would consider its report recommendations, but clarified it does not plan a public response. It highlighted the existing AMR Funders Forum, chaired by the MRC, as the body that supports coordination of AMR research.
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6 Recommendation Deferred
First Report - The antimicrobial p…
Review status of phages in AMR plans and improve research funding prospects
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 … Read more
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 phages within AMR plans or NIHR/UKHSA engagement.
Department for Science, Innovation and Technology
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7 Conclusion Acknowledged
First Report - The antimicrobial p…
UK translational phage research faces funding gap risking untapped potential
We were disappointed to hear that there is a translational phage research “gap” in the UK. We agree that funding, and especially public funding, should be awarded with care. However, we are concerned that, despite being included in the Government’s … Read more
Government Response
The government acknowledges manufacturing challenges and points to existing and newly announced capital grant programmes for life sciences manufacturing. NHS England has also committed to consider whether its antimicrobial subscription model may be relevant to phage products and to review criteria if deemed appropriate in the future.
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8 Recommendation Acknowledged
First Report - The antimicrobial p…
Review phage translational research funding arrangements, bottlenecks, and specific assistance requirements
We recommend that the Department of Health and Social Care (DHSC) reviews the current funding arrangements for phage translational research and identifies what are the bottlenecks for such research. A review should consider what specific assistance phage translational research requires … Read more
Government Response
The government explains that NIHR does not ringfence funding and awards depend on application quality, noting few past applications for phage research. It states that NIHR and DHSC are exploring approaches with UKRI to improve phage research capacity, but does not commit to a specific review of funding bottlenecks or dedicated funding.
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9 Recommendation Rejected
First Report - The antimicrobial p…
Report annually on 'One Health' progress for phage technologies and therapies
The Government, the World Health Organisation and a number of the witnesses we heard from have highlighted the importance of a “One Health” approach to tackling AMR across sectors including human and animal health, the food supply chain, and the … Read more
Government Response
The government rejects the recommendation to produce annual reports exclusively focused on phages, stating it is reluctant to prioritize any one technology, but will regularly review progress on its 5-year AMR National Action Plan, which will include phages.
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10 Conclusion Acknowledged
First Report - The antimicrobial p…
UK phage expertise and resources remain fragmented, hindering potential exploitation
For the potential benefits of phages to be fully explored and, if possible, exploited in the UK, with competitive advantage, it is important that existing phage- related assets are properly aligned and integrated, connecting the various sectors, institutions, and actors … Read more
Government Response
The government welcomes the insights and acknowledges the importance of a robust network for phage-related knowledge sharing, expressing support for the existing UK KTN Phage Innovation Network and describing other relevant coordination efforts.
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11 Recommendation Deferred
First Report - The antimicrobial p…
Require DHSC to respond to phage network proposals and outline plans for knowledge sharing
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 … Read more
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.
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12 Recommendation Deferred
First Report - The antimicrobial p…
Integrate phage clinical use into medical training and ensure access information for healthcare staff
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 … Read more
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.
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13 Recommendation Deferred
First Report - The antimicrobial p…
Public acceptance of phages is crucial for their effective role in tackling AMR
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 … Read more
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.
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14 Recommendation Rejected
First Report - The antimicrobial p…
Good Manufacturing Practice standards remain essential for high-quality phage production and biobanks
The set of consensus high standards for pharmaceutical production, known as Good Manufacturing Practice (GMP), should continue to be required in the UK for high quality phages manufactured for generic products targeting the most common bacterial pathogens. It should also … Read more
Government Response
The government states that GMP requirements remain appropriate for named-patient use, thereby rejecting the committee's suggestion for non-GMP phages for compassionate use. It notes MHRA guidance for licensed products is in development.
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15 Conclusion Accepted
First Report - The antimicrobial p…
Cost and low investment deter pharmaceutical firms from establishing UK GMP phage facilities
One of the main obstacles to establishing Good Manufacturing Practice (GMP) facilities in the UK is the cost and the reluctance of pharmaceutical firms to invest in phages and antimicrobials more generally because of an uncertain return on investment compared … Read more
Government Response
The government acknowledges manufacturing challenges and highlights existing capital grant programmes that incentivize life sciences manufacturing investment. NHS England has also committed to consider whether its antimicrobial subscription model may be relevant to phage products in the future.
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16 Recommendation Deferred
First Report - The antimicrobial p…
Establish a publicly-funded GMP facility for phage production and address industry investment barriers
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 … Read more
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 production, nor the question of pharmaceutical company investment.
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17 Recommendation Accepted
First Report - The antimicrobial p…
Require MHRA to provide guidance on regulating phage cocktails based on individual ingredients
We recommend that the MHRA provides guidance on how phage cocktails will be regulated. It should consider the case of influenza vaccines, and allow phage permutations to be assessed on the basis of their individual constituent ingredients meeting agreed purity … Read more
Government Response
The government states that the MHRA is developing non-binding advisory guidance for the licensing requirements of phage products, which will address regulatory frameworks and genetic modifications, with public input.
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18 Recommendation Deferred
First Report - The antimicrobial p…
Require MHRA to produce guidance on regulating GE phages and enzymes for GMP compliance
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 … Read more
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.
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19 Conclusion Acknowledged
First Report - The antimicrobial p…
Regulatory divergence on GE phages presents a competitive opportunity for the UK
If the UK government supports the commercial production of genetically engineered (GE) phages, it will inevitably lead to regulatory divergence from the EU. However, we believe this divergence offers the UK an opportunity that should be pursued. This should be … Read more
Government Response
The government acknowledges that genetic modifications influence regulatory frameworks and states that MHRA's upcoming non-binding advisory guidance will clarify this. The Veterinary Medicines Directorate is also reviewing existing requirements for genetically modified organisms in phage-based veterinary medicines.
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20 Recommendation Rejected
First Report - The antimicrobial p…
Publish MHRA guidance on regulatory pathways for GMP and non-GMP phage development
We welcome the willingness of the MHRA to adopt a flexible approach to accelerating the authorisation of the use of phage therapies and its offer to work with phage innovators to support their development. However, the MHRA should provide clarity … Read more
Government Response
The government rejects the premise of regulating non-GMP phages, stating all medicines must be manufactured to GMP standards. It clarifies that specific developmental pathways are not needed for compassionate use phages and that MHRA guidance under development will provide information on manufacturing phage-based medicinal products to GMP.
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21 Conclusion Acknowledged
First Report - The antimicrobial p…
Current regulatory framework for clinical trials ineffective for phage specificity
Our evidence suggests that current regulations for clinical trials and the manufacturing of medicines are unlikely to be effective for phages as they are for other drugs or antibiotics. This is because the current regulatory approach to testing and manufacturing … Read more
Government Response
The government acknowledges the issues with current regulations for phages, stating that new MHRA guidance under development will address safety testing, extrapolation between strains, and clarify that named-patient use requires GMP but not clinical trials.
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22 Recommendation Accepted
First Report - The antimicrobial p…
Require MHRA to outline regulatory approach for clinical safety of diverse phage scenarios
The MHRA should set out how they propose to regulate and ensure clinical safety for each of the scenarios set out above. This would allow for the narrowing of R&D and production work to prevent wasted effort and allow an … Read more
Government Response
The government states that MHRA non-binding advisory guidance for licensed phage products is in development, scheduled for public consultation in 2024, and will define safety tests and extrapolation for bacteriophages. It also confirms GMP requirements for named-patient use.
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23 Recommendation Accepted
First Report - The antimicrobial p…
Mandate MHRA to outline support for personalised medicine development within one year
The MHRA should also set out more broadly how current clinical trial structures can support the development and regulation of new personalised medicines. This should include an outline of what changes may be required to underpin this emerging and promising … Read more
Government Response
The government commits to reviewing clinical trial legislation, with accompanying guidance to be published in 2024, and is establishing clinical trial acceleration networks to support innovation and new ways of delivering trials.
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24 Conclusion Accepted in Part
First Report - The antimicrobial p…
Good Manufacturing Practice requirements create impasse for UK phage development
One of the major obstacles to phage clinical trials in the UK has been the requirement for GMP phages. However, regulators require that for phages to achieve GMP standards they must themselves have first been subject to clinical trials. This … Read more
Government Response
The government states that MHRA's draft non-binding advisory guidance will define standards for licensed phages and clarifies that phages for named-patient use require GMP standards but not clinical trials or marketing authorization, thus providing clarity on the described conundrum.
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25 Recommendation Accepted
First Report - The antimicrobial p…
Require MHRA to clarify phage standards for clinical trials and GMP acquisition
We recommend that the MHRA sets out what standard of phages will be required for UK clinical trials and how GMP will be acquired by UK produced phages if they cannot be assessed by a clinical trial. This guidance should … Read more
Government Response
The government states that the MHRA's draft non-binding advisory guidance on phage regulation, intended for public consultation later this year, will define quality, safety, and efficacy standards for licensed phages. It also clarifies that phages for named-patient use require GMP standards but not clinical trials.
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26 Recommendation Accepted
First Report - The antimicrobial p…
Mandate DHSC, NIHR and MHRA to support phage researchers' clinical trial applications
The funding of clinical trials, especially later trials, has proved an obstacle for phages. We were pleased to hear that the National Institute for Health and Care Research would welcome applications from phage researchers and companies to access public funding … Read more
Government Response
The government states that the NIHR offers an existing Research Support Service for researchers, including those working on phages, and that MHRA's upcoming guidance will recommend sponsors engage with them for scientific advice, which MHRA already provides.
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27 Recommendation Accepted
First Report - The antimicrobial p…
Require MHRA to outline use of international and non-health data for phage regulation
We are pleased that the MHRA is open to using phage data from a variety of sources as long as it is of sufficient quality. We recommend that the MHRA outlines how it will use clinical data from other countries … Read more
Government Response
The government states that the MHRA has mutual recognition agreements and has introduced the International Recognition Procedure (IRP) from January 2024, which allows it to recognise the decision-making of trusted reference regulators to expedite market approval for products in the UK.
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28 Recommendation Deferred
First Report - The antimicrobial p…
Mandate DHSC and MHRA to review phage clinical use rules for domestic and imported alignment
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 … Read more
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.
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29 Recommendation Rejected
First Report - The antimicrobial p…
Compassionate use of UK-produced non-GMP phages should be permitted for last resort cases
We believe that the UK should allow the compassionate use of non-GMP phages produced in the UK for last resort medical cases where other medical approaches have failed or are failing. This would bring the UK in line with several … Read more
Government Response
The government rejects allowing non-GMP phages for compassionate use, stating all medicines must meet GMP standards, and defers the production of a monograph until MHRA gains experience from developing new advisory guidance.
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30 Recommendation Deferred
First Report - The antimicrobial p…
Require MHRA to review and regulate UK non-GMP phages for compassionate use, producing monograph
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 … Read more
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.
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31 Recommendation Deferred
First Report - The antimicrobial p…
Review current regulations governing liability for clinicians and hospitals using UK non-GMP phages.
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 … Read more
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.
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32 Recommendation Rejected
First Report - The antimicrobial p…
Government and agency statements on phage role in AMR lack clarity.
If the antimicrobial use of phages is to move beyond ad hoc compassionate cases, the Government and its agencies should reflect on what role they are to play in the fight against AMR. At the moment, phages are referred to … Read more
Government Response
The government rejects producing a further definitive statement on phages or a roadmap at this time, stating it will continue to monitor developments and include phages as one of many research areas in the upcoming AMR national action plan.
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33 Recommendation Rejected
First Report - The antimicrobial p…
Produce clear Government statement on phages and comprehensive support plan for AMR.
We recommend that the Government produces a clear statement on its assessment of phages. If it concludes that phages are to play a significant role in fighting AMR, it should produce a comprehensive plan as to how they will be … Read more
Government Response
The government rejects producing a new clear statement on phages or a comprehensive plan for their support and regulatory landscape at this time. It states that existing evidence is promising but requires more robust data, and that phages will be recognised in the upcoming 2024-2029 AMR national action plan.
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Government Response AI assessment · 33 of 23 classified
Accepted 10
Accepted in Part 1
Acknowledged 7
Deferred 9
Rejected 6
Total 23 recs + 10 conclusions