Last week, new UK-wide regulations aiming to get personalised treatments like CAR-T to patients faster became active.
The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 outline how cell and gene therapies can be made on-site at or near hospitals, where they can reach patients faster and more cheaply, instead of hundreds of miles away at manufacturing sites.
CAR-Ts are innovative new treatments that have already helped over 1,000 patients with blood cancer in the UK since 2018. The treatment involves removing a patient’s cells and genetically editing them to recognise and destroy cancer cells.
Currently, all the CAR-Ts used in the UK are made by large pharmaceutical companies in a complex production process which involves transporting the patients’ cells to be genetically modified at facilities long distances away. This means it can take weeks or months for the treatment to be ready, and the process is very costly – hundreds of thousands of pounds per CAR-T treatment.
An alternative way of making personalised treatments like CAR-T is to genetically modify the cells much closer to the patient – either in the hospital they are being treated at, or nearby. This could in theory be done in a rapid timescale and at a much lower cost to the NHS.
We already see these types of “homegrown” CAR-Ts being produced in other countries like Germany, Spain, Canada and India. They are doing this at much lower cost than the therapies developed at pharmaceutical manufacturing sites - doctors in India have been able to produce a CAR-T that meets their local requirements for around $50,000 per dose, and expect this to drop even further. [1][2][3]
Up to now, there hasn’t been a legal framework or guidance around this kind of “point of care” manufacturing in the UK, which has meant there is too much risk for hospitals to make their own CAR-T products. With the help of this new regulation, we – and the Government – hope this will change. The new regulations clarify the licenses and quality standards that hospitals and academic groups need to safely produce CAR-Ts and other personalised treatments on-site, and are explicitly designed to encourage more advanced therapies to reach patients faster.
The change follows our call for urgent intervention to unlock the potential of cell and gene therapies, outlined in our Cell Therapy Roadmap last year. As well as improved infrastructure, we highlighted the need for more investment in the cell therapy workforce to ensure the UK has enough highly skilled specialist doctors, nurses and laboratory staff to deliver complex CAR-T therapies. We also urged the government to consider support systems to make CAR-T therapies more equitable for all patients – like by providing funding to help patients travel to receive treatment and provide specialist prehabilitation and rehabilitation support as standard.
“The potential of this legislation and our other recommendations for change could be enormous for patients. Point-of-care manufacturing could dramatically expand access to lifesaving treatments in rare and complex disease areas with limited other treatment options.
“What’s more, this new regulation could bring more of these highly innovative and personalised treatments to patients in a more sustainable way, in an era where the cost pressures on the NHS are rising significantly.”
Caitlin Farrow, Director of Strategy and Influencing at Anthony Nolan