Recommendations & Conclusions
7 items
1
Conclusion
First Report - The antimicrobial potent…
Acknowledged
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 patient safety, including the long-term impact of phages, especially their …
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
4
Conclusion
First Report - The antimicrobial potent…
Acknowledged
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 able to establish key issues such as long-term interactions between …
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 …
Department for Science, Innovation and Technology
7
Conclusion
First Report - The antimicrobial potent…
Acknowledged
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 AMR strategy, if not properly supported, the potential of phages …
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 …
Department for Science, Innovation and Technology
8
Recommendation
First Report - The antimicrobial potent…
Acknowledged
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 to increase the prospects of success for funding bids. It …
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 …
Department for Science, Innovation and Technology
10
Conclusion
First Report - The antimicrobial potent…
Acknowledged
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 so they can draw on shared resources, information, data, and …
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.
Department for Science, Innovation and Technology
19
Conclusion
First Report - The antimicrobial potent…
Acknowledged
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 part of a clear regulatory and safety licensing regime for …
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.
Department for Science, Innovation and Technology
21
Conclusion
First Report - The antimicrobial potent…
Acknowledged
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 medicines is based on a single consistent formulation being shown …
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.
Department for Science, Innovation and Technology