Breaking Down the Barriers to Phage Therapy in the UK
While many people are aware of antimicrobial resistance (AMR), the same can’t be said for phage therapy [1].
AMR has become one of the greatest global health threats facing modern medicine, rendering many antibiotics ineffective and killing at least 1.27 million people worldwide each year [2].
Phages, viruses which only infect and kill bacteria, could potentially be used to treat antibiotic-resistant infections [3]. Humans have always been in contact and exposure to phages. Various clinical trials have proved the effectiveness and safety of utilising phage therapy to treat human bacterial infections [4].
Despite their potential, phage therapy is not widely known in the UK despite the global crisis of AMR. Phages have been mentioned in the UK’s 2024 to 2029 AMR national action plan, yet there are still multiple hurdles hindering the implementation of phage therapy into national mainstream medicine [5].
The UK Health Security Agency (UKHSA) has sourced phages for various cases, however currently, no phages are licensed in the UK. However, they are sometimes used as unlicensed products for compassionate case uses, when other alternatives are not viable for the patient [1,4]. Without a structured programme in place, the usage of phages for experimental purposes in the UK is likely to continue until scalable and well-sourced phages can be delivered under Good Manufacturing Practice (GMP) [4]. This increases the threat of defeating AMR as each year passes, emphasising the importance of raising awareness on phage therapy [1].
This blog will not only cover the potential barriers hindering the common use of phage therapy in the UK, but will also highlight the importance of healthcare professionals, universities, phage research groups, policymakers and the public in driving necessary action to finally tackle antibiotic resistance and advocate for lasting change.
Why phage therapy?
Antibiotics are over-utilised due to inappropriate prescriptions including viral infections, allowing bacteria to evolve through producing genetic mutations and resistant genes that are able to withstand antibiotic use even at stronger doses [6]. While phage therapy was used well before the creation of penicillin during the 1930s, it is now reinvigorated from increased AMR rates, as alternative treatments for patients are crucial to prevent millions of deaths by 2050 [7]. Unlike antibiotics which target a variety of bacterial strains, phage therapy is a much more targeted approach with its high specificity characteristics [6].
So why hasn't the UK implemented licensed phage therapy use? Let's look at some key barriers that may be affecting the UK’s phage therapy journey.
BARRIERS to the legislation and implementation of phage therapy in the UK
1. Lack of Awareness
Unfamiliarity surrounding phage therapy amongst the UK public may spike potential scepticism and worry, especially since phages are ‘viruses’, which can be seen as a threat rather than a treatment method [8]. This can lead to misinformation and rumours regarding phages, which further prevents the widespread implementation of phage therapy across the UK [9]. Composing a carefully curated dialogue is essential to avoid any misinterpretations, as seen with genetically modified (GM) crops and the COVID-19 pandemic [9]. While many clinicians and healthcare professionals are also unaware of the presence of phage therapy, their vital collaboration is essential for progress to be seen.
Furthermore, the lack of standardised quality control and industry standards towards the production of phage therapeutics offers another way to impact the public’s trust, highlighting the need to educate both healthcare professionals and the public on the regulatory and clinical aspects of phage therapy [9]. The increase in regulatory approved phage products, FDA approved safety (GRAS), and the MHRA may assist in building trust amongst the public [8].
Many funders are also unaware of the prospects of phage therapy, causing a lack of involvement on its various development stages, a major hindrance towards adequate funding [9]. This is a very common issue amongst drug discovery [9].
While many PhD researchers and independent research groups are focused on finding the next major breakthrough in innovation, collective action is crucial to finally bring phage therapy into mainstream medicine. Only when the collaboration of academia, industries and regulatory bodies come together can we see visible change in the trajectory of phage therapy in the UK, ensuring everyone invested in the world of phage development is aligned to the same distinct visions and goals [10].
2. Lack of clinical trials
Not all phages can be used for successful therapeutic use, hence, investment has to be made to distinguish phages that effectively kill target bacteria [8].
The lack of clinical trials makes it difficult to build evidence to show the effectiveness of phage therapy [9]. This ignites hesitance in the thorough exploration of phage therapy. However, the breakthrough of multiple successful clinical trials can help shift both the government and policymaker’s perspectives [9]. CPI, a leading independent technology innovation centre, has limitations to execute beyond pre-clinical studies, due to the lack of infrastructure to commit to full clinical trials [10].
Some state that the evidence for the effectiveness of phage therapy is still “mixed”, where adequate and repeatable randomised controlled trials are still missing alongside a majority of clinical trials in phase I and II [11].
3. Regulatory Hurdles: GMP and licensing barriers
Another significant challenge in integrating phage therapy into the UK is navigating existing regulatory frameworks. While these regulations are essential processes to ensure efficacy, quality and safety, the extended approval times slows down the ability for further investment into clinical trials and thus, national implementation [1]. This forms a feedback loop, where the lack of investment into clinical data surrounding the safety of phages in the Western world further restricts the regulatory processes, which then again hinders investment [9].
The UK currently only approves phages produced to GMP standards before entering clinical applications or medicines [1]. However, no GMP manufacturing facilities are available to produce phages in the UK, increasing the delay because researchers have to seek international manufacturers, which can be costly and carries more barriers into implementation [1].
4. Inadequate Funding
Phage therapy receives only 2% of public and philanthropic funding towards antimicrobial research, especially during the intermediate stage required for phage therapeutics development, one of the most crucial phases for GMP manufacturing and clinical trial usage [9]. Hence, there is inadequate public research, funding, and pharmaceutical companies that invest into the progression of phage therapy [11]. Increasing investment into the facilities for phage development, GMP grade production facilities, and regulation updates are the first steps for successful progress and to bring eventual return on investment [10,12].
However, the NHS created a model known as the antimicrobial subscription to incentivise the development of more antimicrobials [13]. Including phage therapy in the future may help the funding towards this sector.
5. Inadequate Manufacturing
As of now, only Portugal, Slovenia, Norway, and the United States have the facilities for GMP production [11]. Similar to the barriers in funding, there is still insufficient infrastructure in the UK to support manufacturing capabilities, giving a pause to their development [11]. This makes it harder to scale and produce phage therapeutics in compliance with GMP, an essential procedure to ensure phages meet the global guideline requirements, confirming safety and high quality standards [11,12]. This makes it a difficult task to bridge into a successful clinical trials and introduce phages into the commercial market [11,12]. MPs suggest the government begin with a small-scale start or a collaborative manufacturing facility to meet the GMP standards [11].
6. Barriers in Scaling and Development
While there are many researchers contributing to early research on phage therapy studies, the facilities to successfully formulate, manufacture, scale-up and develop phage therapy innovations using a specialised workforce remains a challenge [9]. A solid and feasible national strategy is required for the development and usage of phages in a medical context [10]
Furthermore, the limited success stories on the return of investment and economic growth possibilities for phage therapy makes the development process more difficult [9].
7. Is it Feasible?
There are 2 major formats for phage therapies [12]. The first one includes personalised phage treatments targeted towards a particular pathogen that a patient has, which can be detected through screening [12]. The other method is known as phage therapy ‘cocktails’, a mixture of various bacteriophages to target a range of bacteria - an “off the shelf” approach [12]. However, this requires constant updates and checks to tackle evolving bacterial strains, similar to updating flu vaccines yearly without requiring an entirely new authorisation process [11]. While flu jabs prove it is possible to apply a similar scheme to phages, ensuring feasibility for companies on how this method would work for phage therapy will surpass another huge barrier [10]. Ethical considerations raise another flag as we consider how to navigate double-blind and placebo-controlled trials despite phage therapy treatments being so personalised [11].
Phage Australia has introduced a scheme called STAMP (Standardised Treatment and Monitoring Protocol) for personalised phage treatments for patients [12]. This allows the assessment and regulation of all clinical processes to provide phage therapy through this scheme, with the confirmation that all other viable treatment options have been utilised [12]. This provides a clear pathway for a structured rollout of phage therapy treatments being utilised in other countries, proving its potential feasibility in the UK [12].
Moreover, the lack of financial models that back the investment from pharmaceutical companies and manufacturers poses one of the main challenges towards bringing phage therapy into the market [1].
Opportunities: Why the UK must act now
The “One Health” Approach: A global responsibility:
Antimicrobial resistance (AMR) is not just confined to humans, but it affects animals, food production, and the environment too [14].
Achieving One Health from antimicrobial resistance using a unified approach fulfils various UN sustainable development goals, where the increase in AMR strikes an alarming signal to tackle the bacteria carrying resistant genes present in all sectors [1,15]. A ‘One Health’ approach to this situation has been recognised, alongside the government stating its vision of controlling AMR by 2040 [5]. However, achieving this goal is not an easy task. It requires proactive investment into methods like phage therapy, where phages have been known to be applicable for treatments and prevention methods for animals, and can also bring positive changes to the environment [3].
Economical Advantage
While the initial investment costs for phage therapy research and infrastructure may seem daunting, the long-term economic and healthcare benefits anticipated from phage therapy has the chance to save millions for the NHS.
The UK has stated its desire to be a global leader for science and technology, where phage therapy has the potential to transform lives and take the lead in this sector worldwide. Investment into infrastructure and utilities required to carry out effective clinical trial studies, will help build increased evidence and bring phage therapy into the commercial market [12]. This will navigate the global AMR crisis, bring a potential return of investment, and save the NHS millions from the effects of antibiotic resistance. The UK taking the initiative to lead the phage therapy industry can increase job opportunities, attract international companies and researchers, promote industrial development and hence increase the economy for the UK [12].
What can you do?
The existing barriers in the UK may all seem overwhelming, but change begins with any small action, including the more we collectively speak about phage therapy. Raising awareness amongst healthcare professionals, the public, and pushing for clinical integrations will help connect research and real-world investment into phage therapy. Here are some ways you can help progress the implementation of phage therapy in the UK, as everyone has a part to play.
Raising awareness through general conversations, keeping updated on latest phage therapy research, and spreading awareness are some key ways to help educate each other on this potential alternative solution. Healthcare professionals can help empower local clinics and staff across the NHS, increasing collaboration within healthcare sectors [16].
Students and university representatives can assist in holding local phage therapy awareness events, seminars, social media campaigns, and establishing networks to coordinate phage therapy research. Education is a key way to advocacy, the main tool required for healthcare policy changes and eventual clinical integration. Encouraging students to pursue further studies in phage therapy will help tackle existing workforce challenges in the UK [10].
As recommended by the CPI, supporting their idea in creating a collective UK-based microbiome and phage bioprocess innovation centre may help overcome the current barriers the UK faces in implementing phage therapy [10]. This allows researchers, support for start-ups, biotech firms, entrepreneurs, and the NHS to work in a united manner and create a space for active phage-therapy progression. This will also spread a positive light on phage therapy, handling any misinformation especially within the scientific sectors.
Conclusion
Phage therapy is not a futuristic concept, hence it is time we stop treating it like one. It is an opportunity to overcome one of the most deadly public health threats, saving millions of lives and providing a cost-effective alternative to antibiotics in the long run. Overlooking its potential benefits and treating it as a distant possibility widens the gap for immediate action, where the UK urgently requires investment into the manufacturing, regulations and innovative research of phage therapy [12].
The UK government has made a promising start in the exploration of phage therapy, however sustained momentum is required to ensure sufficient infrastructure is in place for successful implementation of phage therapy, before further extreme damage is caused by AMR [1]. The question has changed from whether the UK should implement phage therapy, to a matter of how soon can we make it happen.
Overcoming these challenges and hurdles are the only way to discover the true potential of phage therapy [11].
If not now, then when?
To learn more about how the Phage Collection Project is trying to tackle these barriers reach out to us or check out our website!
References
1. The antimicrobial potential of bacteriophages (2024). Available at: https://committees.parliament.uk/publications/42708/documents/212244/default/ (Accessed: 29 April 2025).
2. Antimicrobial resistance (2023) World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance (Accessed: 29 April 2025).
3. Bacteriophages and their use in combating antimicrobial resistance (2025) World Health Organization. Available at: https://www.who.int/europe/news-room/fact-sheets/item/bacteriophages-and-their-use-in-combating-antimicrobial-resistance#:~:text=Phage%20therapy%20can%20be%20useful,longer%20respond%20to%20antimicrobial%20medicines. (Accessed: 29 April 2025).
4. Jones JD, Trippett C, Suleman M, Clokie MRJ, Clark JR. The Future of Clinical Phage Therapy in the United Kingdom. Viruses. 2023 Mar 10;15(3):721. doi: 10.3390/v15030721. PMID: 36992430; PMCID: PMC10053292.
5. Government’s response to the Science, Innovation and Technology Committee’s report ‘the antimicrobial potential of bacteriophages’ (2024) GOV.UK. Available at: https://www.gov.uk/government/publications/the-antimicrobial-potential-of-bacteriophages-report-government-response/governments-response-to-the-science-innovation-and-technology-committees-report-the-antimicrobial-potential-of-bacteriophages#:~:text=The%20government%20is%20developing%20the,infections%20in%20humans%20and%20animals. (Accessed: 29 April 2025).
6. Olawade , D.B. (2024) Phage therapy: A targeted approach to overcoming antibiotic resistance, Microbial Pathogenesis. Available at: https://www.sciencedirect.com/science/article/pii/S0882401024005552 (Accessed: 29 April 2025).
7. Strathdee, S. (2023) Phage therapy: From biological mechanisms to future directions, Cell. Available at: https://www.sciencedirect.com/science/article/pii/S0092867422014611#:~:text=After%20d’Herelle%20successfully%20used,was%20first%20brought%20to%20market. (Accessed: 29 April 2025).
8. Loc-Carrillo C, Abedon ST. Pros and cons of phage therapy. Bacteriophage. 2011 Mar;1(2):111-114. doi: 10.4161/bact.1.2.14590. PMID: 22334867; PMCID: PMC3278648.
9. Cullen, L. (2024) Exploring perceptions of bacteriophage use in the UK across the One Health Spectrum: A Roundtable Discussion | Sustainable Microbiology | Oxford academic, sustainable microbiology. Available at: https://academic.oup.com/sumbio/article/1/1/qvae030/7888902 (Accessed: 29 April 2025).
10. Trippett, C. (2025) The UK’s phage therapy gap – and how to close it, CPI. Available at: https://www.uk-cpi.com/blog/the-uks-phage-therapy-gap-and-how-to-close-it (Accessed: 29 April 2025).
11. Matthews, D. (2024) Call for more funding and flexible regulatory framework for phage R&D, Science. Available at: https://sciencebusiness.net/news/antimicrobial-resistance/call-more-funding-and-flexible-regulatory-framework-phage-rd (Accessed: 29 April 2025).
12. Written evidence submitted by dr Clare Trippett on behalf ... (2019) Science and Technology Committee Inquiry. Available at: https://committees.parliament.uk/writtenevidence/121142/pdf (Accessed: 29 April 2025).
13. Antimicrobial products subscription model: guidance on commercial arrangements (2024) NHS choices. Available at: https://www.england.nhs.uk/long-read/antimicrobial-products-subscription-model-guidance-on-commercial-arrangements/ (Accessed: 29 April 2025).
14. One Health (2023) World Health Organization. Available at: https://www.who.int/health-topics/one-health#tab=tab_1 (Accessed: 29 April 2025).
15. Directorate, V.M. (2023) UK one health report: Joint report on antibiotic use, antibiotic sales and antibiotic resistance., GOV.UK. Available at: https://www.gov.uk/government/publications/uk-one-health-report-joint-report-on-antibiotic-use-antibiotic-sales-and-antibiotic-resistance (Accessed: 29 April 2025).
16. Jones, J.D. (2024) How to: Assess patient suitability for unlicensed phage therapy in the United Kingdom, Clinical Microbiology and Infection. Available at: https://www.sciencedirect.com/science/article/pii/S1198743X24003550 (Accessed: 29 April 2025).
The information and opinions expressed in this blog post represent those of the original author of the blog. They do not necessarily reflect and represent the views and opinions of the Phage Collection Project or its staff.