Source · Select Committees · Science, Innovation and Technology Committee
Recommendation 1
1
Acknowledged
Paragraph: 39
Robust clinical trial data lacking for long-term phage safety and immune interactions
Conclusion
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 interaction with human immune systems, such as anaphylaxis and auto immune response.
Government response summary AI-generated
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.
Summary of the government's response below — read the verbatim text to verify.
Paragraph Reference:
39
Government Response
Acknowledged
HM Government · verbatim extract
Acknowledged
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. DHSC works closely with NIHR and UK Research and Innovation (UKRI) to monitor the research and clinical trial pipeline for antimicrobials and alternative therapies. Where phage research opportunities are identified, NIHR can engage researchers to encourage and support funding applications. The government is developing the 2024 to 2029 AMR NAP. The NAP will set out the government's research priorities, including innovation of new products for tackling AMR.
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