Recommendation 16

HM Government · verbatim extract Deferred

The government acknowledges that challenges in the manufacturing of phage materials in the UK are considered by a range of stakeholders to be a barrier to the development and use of phage therapies in the UK. A number of capital grant programmes have been delivered by the Office for Life Sciences (OLS) to incentivise life sciences manufacturers to invest in the UK: • the Medicines and Diagnostics Manufacturing Transformation Fund • the Life Sciences Innovative Manufacturing Fund • the Biomanufacturing Fund Since 2022, OLS capital grants programmes have helped secure investments at 11 manufacturing sites and delivered £416 million joint public and private investment, creating and securing over 1,400 jobs. The recent announcement of a transformative £520 million fund over 5 years (2025 to 2030) (6) will further support ambitions to ensure the UK remains one of most attractive locations for life sciences manufacturing investments. These investments complement the highly regarded research and development ecosystem in the UK, which includes a high-quality science base and network of manufacturing innovation centres, such as the forthcoming Oligonucleotide Manufacturing Innovation Centre of Excellence. The government will consider the case for development of a GMP facility to support phage innovators by undertaking engagement with key stakeholders including relevant funders and research organisations. The committee’s report makes a strong case for the development of manufacturing capability to underpin the future evaluation and implementation of phage in the clinic. The provision of such manufacturing capacity, as part of future UK infrastructure within the public sector, would provide significant impetus for the future development of phage therapy across the 'One Health' agenda. Generating phage under GMP will be essential for the translation of some, if not all phage therapies, subject to some of the considerations by MHRA on whether magistral preparations would be suitable for compassionate use cases. Any such activity would require targeted, strategic investment to develop, establish and maintain such facilities and ensure they meet regulatory standards. Development of a GMP phage manufacturing facility in an appropriate location as part of UKHSA’s scientific estate is not a proposal that government can commit to funding at present. UKHSA has expertise and specialist capabilities to partner and engage in phage manufacturing but does not have the suitable laboratory capacity to act as a GMP facility for phage production. The OLS maintains strong relationships with pharmaceutical companies and engages frequently with them through multiple routes, such as the Life Sciences Council and its expert sub-groups, as well as bilateral conversations with individual stakeholders. OLS will use the available engagement routes to consider why there is a reluctance by companies to invest in phages, and what steps can be taken to address this. As phage technology is in its infancy, engagement with industry to understand the issues for commercialisation will be important. The MHRA provides information on how new medicines products are considered for licencing. The route to market for all medicines is also set out by NHS England (NHSE) in the NHS commercial framework for new medicines (7). NHSE has devised a novel approach - the subscription model - as a positive, proactive and world-leading step to commercially incentivise antimicrobial drug development. However, there are complex manufacturing and regulatory challenges that create unique challenges for phage products. Working with MHRA and NICE, NHS England has committed as part of the current UK AMR NAP to consider whether the scheme may be relevant to other innovative antimicrobial products including, for example, bacteriophages. If the antimicrobial subscription model is deemed appropriate for phage products in the future, work will be undertaken to review and revise eligibility and award criteria to enable assessment of the effectiveness of phage products.