First Report - The antimicrobial potential of bacteriophages
Select Committee
Science, Innovation and Technology Committee
HC 328
3 January 2024
Recommendations
6 results
9
Rejected
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 …
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Government Response 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.
Department for Science, Innovation and Technology
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14
Rejected
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 …
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Government Response 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.
Department for Science, Innovation and Technology
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20
Rejected
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 …
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Government Response 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 to GMP.
Department for Science, Innovation and Technology
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29
Rejected
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 …
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Government Response 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.
Department for Science, Innovation and Technology
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32
Rejected
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 …
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Government Response 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.
Department for Science, Innovation and Technology
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33
Rejected
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 …
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Government Response 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 AMR national action plan.
Department for Science, Innovation and Technology
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