Recommendations & Conclusions
10 items
2
Conclusion
First Report - The antimicrobial potent…
Accepted
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 the consistent effectiveness of phages. Such studies need to include …
Government response. The government described existing provisions for researchers, including access to bacterial strain panels and expertise, and highlighted funding opportunities through NIHR and UKRI. It specifically noted Innovate UK's recently launched £30 million PACE initiative to accelerate early-stage innovation in AMR, …
Department for Science, Innovation and Technology
3
Recommendation
First Report - The antimicrobial potent…
Accepted
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 what specific evidence, and to what standard, is needed to …
Government response. The MHRA committed to providing non-binding advisory guidance on the specific data needed to evaluate licensed phage products for NHS use. The government also confirmed it will continue to engage with phage stakeholders through the Innovate UK KTN Phage Innovation …
Department for Science, Innovation and Technology
5
Conclusion
First Report - The antimicrobial potent…
Accepted
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 reasons for this. The recently established Innovate UK Phage Knowledge …
Government response. The government welcomed the UK KTN Phage Innovation Network's role and stated it would consider its report recommendations, but clarified it does not plan a public response. It highlighted the existing AMR Funders Forum, chaired by the MRC, as the …
Department for Science, Innovation and Technology
15
Conclusion
First Report - The antimicrobial potent…
Accepted
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 to other medicines and drugs. However, investing in a small, …
Government response. The government acknowledges manufacturing challenges and highlights existing capital grant programmes that incentivize life sciences manufacturing investment. NHS England has also committed to consider whether its antimicrobial subscription model may be relevant to phage products in the future.
Department for Science, Innovation and Technology
17
Recommendation
First Report - The antimicrobial potent…
Accepted
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 and safety standards and not for each new combination of …
Government response. The government states that the MHRA is developing non-binding advisory guidance for the licensing requirements of phage products, which will address regulatory frameworks and genetic modifications, with public input.
Department for Science, Innovation and Technology
22
Recommendation
First Report - The antimicrobial potent…
Accepted
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 agile approach, allowing non-generic phage production for specific patients but …
Government response. The government states that MHRA non-binding advisory guidance for licensed phage products is in development, scheduled for public consultation in 2024, and will define safety tests and extrapolation for bacteriophages. It also confirms GMP requirements for named-patient use.
Department for Science, Innovation and Technology
23
Recommendation
First Report - The antimicrobial potent…
Accepted
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 area. This should include early and regular engagement by regulators …
Government response. The government commits to reviewing clinical trial legislation, with accompanying guidance to be published in 2024, and is establishing clinical trial acceleration networks to support innovation and new ways of delivering trials.
Department for Science, Innovation and Technology
25
Recommendation
First Report - The antimicrobial potent…
Accepted
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 be published within six months of the publication of this …
Government response. The government states that the MHRA's draft non-binding advisory guidance on phage regulation, intended for public consultation later this year, will define quality, safety, and efficacy standards for licensed phages. It also clarifies that phages for named-patient use require GMP …
Department for Science, Innovation and Technology
26
Recommendation
First Report - The antimicrobial potent…
Accepted
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 to conduct clinical trials. We recommend that DHSC and the …
Government response. The government states that the NIHR offers an existing Research Support Service for researchers, including those working on phages, and that MHRA's upcoming guidance will recommend sponsors engage with them for scientific advice, which MHRA already provides.
Department for Science, Innovation and Technology
27
Recommendation
First Report - The antimicrobial potent…
Accepted
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 and non-health evidence to inform its decision-making on regulating phages. …
Government response. The government states that the MHRA has mutual recognition agreements and has introduced the International Recognition Procedure (IRP) from January 2024, which allows it to recognise the decision-making of trusted reference regulators to expedite market approval for products in the …
Department for Science, Innovation and Technology