First Report - The antimicrobial potential of bacteriophages

Select Committee
Science, Innovation and Technology Committee HC 328 3 January 2024
Report Status Response document linked Recorded deadline: 3 Mar 2024

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Conclusions & Recommendations 33 items (23 recs)
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Government response
Government's response to the Science, Innovation and Technology Committee's report 'The antimicrobial potential of bacteriophages' · published 1 Mar 2024
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Recommendations & Conclusions

33 results
1 Conclusion
Para 39
Robust clinical trial data lacking for long-term phage safety and immune interactions
Conclusion
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
Department for Science, Innovation and Technology
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2 Conclusion
Para 40
Further clinical trials required to prove consistent effectiveness of phages and combinations
Conclusion
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
Department for Science, Innovation and Technology
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3 Recommendation
Para 41
Consider specific evidence standards for phage safety and effectiveness in UK healthcare settings
Recommendation
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
Para 48
Further research needed on long-term phage interactions and optimal engineering strategies
Conclusion
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
Para 49
Funders show reticence towards promising phage research despite general acceptance
Conclusion
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
Para 50
Review status of phages in AMR plans and improve research funding prospects
Recommendation
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
Para 56
UK translational phage research faces funding gap risking untapped potential
Conclusion
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
Para 57
Review phage translational research funding arrangements, bottlenecks, and specific assistance requirements
Recommendation
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
Para 63
Report annually on 'One Health' progress for phage technologies and therapies
Recommendation
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
UK phage expertise and resources remain fragmented, hindering potential exploitation
Conclusion
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
Para 68
Require DHSC to respond to phage network proposals and outline plans for knowledge sharing
Recommendation
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
Para 70
Integrate phage clinical use into medical training and ensure access information for healthcare staff
Recommendation
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
Public acceptance of phages is crucial for their effective role in tackling AMR
Recommendation
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
Para 78
Good Manufacturing Practice standards remain essential for high-quality phage production and biobanks
Recommendation
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
Para 83
Cost and low investment deter pharmaceutical firms from establishing UK GMP phage facilities
Conclusion
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
Para 84
Establish a publicly-funded GMP facility for phage production and address industry investment barriers
Recommendation
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
Para 86
Require MHRA to provide guidance on regulating phage cocktails based on individual ingredients
Recommendation
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
Para 88
Require MHRA to produce guidance on regulating GE phages and enzymes for GMP compliance
Recommendation
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
Para 90
Regulatory divergence on GE phages presents a competitive opportunity for the UK
Conclusion
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
Publish MHRA guidance on regulatory pathways for GMP and non-GMP phage development
Recommendation
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
Para 100
Current regulatory framework for clinical trials ineffective for phage specificity
Conclusion
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
Para 101
Require MHRA to outline regulatory approach for clinical safety of diverse phage scenarios
Recommendation
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
Para 102
Mandate MHRA to outline support for personalised medicine development within one year
Recommendation
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
Good Manufacturing Practice requirements create impasse for UK phage development
Conclusion
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
Para 106
Require MHRA to clarify phage standards for clinical trials and GMP acquisition
Recommendation
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
Department for Science, Innovation and Technology
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26 Recommendation
Para 110
Mandate DHSC, NIHR and MHRA to support phage researchers' clinical trial applications
Recommendation
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
Require MHRA to outline use of international and non-health data for phage regulation
Recommendation
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
Department for Science, Innovation and Technology
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28 Recommendation
Para 118
Mandate DHSC and MHRA to review phage clinical use rules for domestic and imported alignment
Recommendation
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
Compassionate use of UK-produced non-GMP phages should be permitted for last resort cases
Recommendation
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
Para 129
Require MHRA to review and regulate UK non-GMP phages for compassionate use, producing monograph
Recommendation
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
Para 131
Review current regulations governing liability for clinicians and hospitals using UK non-GMP phages.
Recommendation
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
Department for Science, Innovation and Technology
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32 Recommendation
Para 140
Government and agency statements on phage role in AMR lack clarity.
Recommendation
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
Produce clear Government statement on phages and comprehensive support plan for AMR.
Recommendation
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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