Recommendations & Conclusions
6 items
9
Recommendation
First Report - The antimicrobial potent…
Rejected
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 environment. The Department of Health and Social Care (DHSC) and …
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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 environment. The Department of Health and Social Care (DHSC) and others told us that phages could play an important role in delivering this approach. However, the DHSC acknowledged that they were at an early stage of tracking progress on phages. We believe it is important that—if phages are to play a meaningful part in a ‘One Health’ approach to tackling AMR—progress is reported in a timely and comprehensive manner. We recommend that the DHSC, as the lead department on AMR, reports annually on the progress made on evaluating and developing all phage- related technologies and therapies that affect human, animal or environmental health (referred to as the ‘One Health’ approach). This should be a joined-up assessment bringing together analyses and data from all relevant departments, regulators, public bodies and funders who are in receipt of public funding for work on phages.
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Government response AI summary
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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Department for Science, Innovation and Technology
14
Recommendation
First Report - The antimicrobial potent…
Rejected
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 underpin the production of phage biobanks to be accessed at …
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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 underpin the production of phage biobanks to be accessed at short notice by clinicians providing assurance to both clinicians and patients that phages from biobanks will be of the highest standard of safety and purity. Access to phages manufactured to GMP standards will also allow microbiology laboratories to deal with less common pathogens and tailor phages to be more effective for individual patients when a more agile precision medicine approach is required. However, there may still be a place for non-GMP phages in instances when non-banked phages are needed at short notice for compassionate use as a last resort and can be produced via collaboration between a physician and pharmacist—as in Belgium.
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Government response AI summary
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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Department for Science, Innovation and Technology
20
Recommendation
First Report - The antimicrobial potent…
Rejected
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 on how different pathways for developing phages, such as the …
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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 on how different pathways for developing phages, such as the Innovative Licensing and Access Pathway, and other flexible regulatory approaches will work in practice and how they will align with GMP and non-GMP phage for compassionate use in last resort cases. We recommend that the MHRA publishes guidance on how it intends to regulate phages if they are not produced using a GMP approach. This should include guidance on what developmental pathways are available to phage innovators. (Paragraph 94) Phage clinical trials
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Government response AI summary
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 …
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Department for Science, Innovation and Technology
29
Recommendation
First Report - The antimicrobial potent…
Rejected
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 EU countries, and the USA and Australia. The UK can …
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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 EU countries, and the USA and Australia. The UK can learn from these countries in ensuring that phages are produced to a high standard, albeit not to the exacting standard of GMP. Using monographs, as is the case in Belgium, that stipulate safety and purity standards, would be an ideal starting place. It could build upon existing guidance for the use of unlicensed specials (products that have not been assessed by the regulatory authority for safety, quality and efficacy in the same way as licensed products) within UK clinical settings and oversight procedures within hospitals. (Paragraph 128) 62 The antimicrobial potential of bacteriophages
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Government response AI summary
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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Department for Science, Innovation and Technology
32
Recommendation
First Report - The antimicrobial potent…
Rejected
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 in the AMR strategy, as one approach amongst others. However, …
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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 in the AMR strategy, as one approach amongst others. However, we believe that the Government and its agencies should make a more definitive and positive statement on phages. Clarity is imperative for research funding decisions and for private investment in commercial phages.
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Government response AI summary
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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Department for Science, Innovation and Technology
33
Recommendation
First Report - The antimicrobial potent…
Rejected
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 supported and how the necessary infrastructure and regulatory landscape will …
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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 supported and how the necessary infrastructure and regulatory landscape will be created. (Paragraph 141) The antimicrobial potential of bacteriophages 63
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Government response AI summary
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 …
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Department for Science, Innovation and Technology