3
Accepted
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 what specific evidence, and to what standard, is needed to fully assess the safety and effectiveness of phages to allow them to be used more widely within the NHS and other UK healthcare settings, including over the long term. DHSC, MHRA, NICE and NIHR should engage with phage researchers to establish a dialogue on these issues. The Phage Knowledge Transfer Network established by Innovate UK to bring together phage stakeholders would be an appropriate forum for this dialogue.
Government Response Summary
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 Network.
Paragraph Reference
41
Government Response
Accepted
Government Response
Accepted
HM Government
Accepted
The MHRA will provide non-binding advisory guidance on the type of quality, safety, and efficacy data needed to evaluate applications for licensed phage products intended for proactive and reactive use in the NHS for common infections. NICE will continue in its world-leading role in producing evidence-based guidance on the use of medicines. In line with the 2024 voluntary scheme for branded medicines pricing access and growth (3), NICE is committed to considering all new active substances and significant indications (symptoms or conditions needing an intervention). As the UK regulator for veterinary medicinal products (VMPs), the Veterinary Medicines Directorate (VMD) continues to work to ensure that only good quality, safe and effective veterinary medicinal products are authorised and available in the UK. The VMD is considering its guidance for phage-based VMPs and the minimum UK standards for the quality, safety and efficacy of these novel products including their manufacture in accordance with 'phage adapted' good manufacturing practice (GMP). The government will continue to engage with phage stakeholders, including through the Innovate UK Knowledge Transfer Network (KTN) Phage Innovation Network. The UK Health Security Agency (UKHSA) provides the chair for Phage Innovation Network’s scientific advisory board. UKHSA supports the goals of the network in developing phage-based products for use in clinical settings and other sectors, alongside developing links with researchers. The MHRA is working closely with the network to understand how it can support phage research and innovation.
Source
Report
First Report - The antimicrobial potential of bacteriophages
03 Jan 2024
HC 328
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age
2.4 yrs
Report published
03 Jan 2024