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
Oral evidence sessions 3 sessions
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
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
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
Recommendations & Conclusions
33 results
1 Conclusion
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
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2 Conclusion
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
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3 Recommendation
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
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4 Conclusion
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
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5 Conclusion
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
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6 Recommendation
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
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7 Conclusion
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
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8 Recommendation
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
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9 Recommendation
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
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10 Conclusion
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
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11 Recommendation
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
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12 Recommendation
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
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13 Recommendation
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
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14 Recommendation
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
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15 Conclusion
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
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16 Recommendation
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
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17 Recommendation
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
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18 Recommendation
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
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19 Conclusion
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
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20 Recommendation
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
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21 Conclusion
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
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22 Recommendation
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
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23 Recommendation
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
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24 Conclusion
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
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25 Recommendation
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
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26 Recommendation
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
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27 Recommendation
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
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28 Recommendation
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
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29 Recommendation
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
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30 Recommendation
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
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31 Recommendation
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
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32 Recommendation
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
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33 Recommendation
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
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