New UK law allows making personalised treatments at point of care

Patients will have faster access to personalised medical therapies under new UK legislation.

From 23 July 2025, personalised medicines such as gene therapies can be prepared in individual batches at the point of care, in centres local to patients who need them. Previously, these medicines had to be manufactured at centralised facilities and then dispatched to care settings, causing delays in treatment. Now, the final manufacturing steps can be carried out in hospitals, clinics or even at home. This makes the UK the first country to introduce a legal framework which enables personalised medicines to be manufactured at the point of care.

'Patients will now receive highly personalised treatments more quickly and nearer to their bedside, with the same rigorous standards as all medicines,' said Lawrence Tallon, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for enforcing the new legislation. 'This is especially important where every hour matters, or where a treatment is so specific it simply can't be made in advance.'

A range of medicinal products can be locally manufactured under the new law, including cell therapy, gene therapy, tissue-engineered products, 3D printed products, blood products and medical gases. The shelf life of these products can be short, requiring rapid delivery to the patient once the final manufacturing steps are complete. Some require a high degree of personalisation, such as CAR T-cell therapy, a cancer treatment where a patient's immune cells are collected and genetically modified to fight their specific cancer (see BioNews 1292, 1263, 1234, 1231 and 1172).

Local healthcare practitioners will carry out the final manufacturing steps for these products, with regulated protocols and oversight from a central control site. This mirrors current practice for antibiotics and chemotherapies, which can be prepared on demand in clinical settings. The new system may come with its own challenges, such as ensuring that staff are appropriately trained and local infrastructure is in place for product assembly.

'This world-first legislation is a game-changer for patients. Cancer treatments tailored in days, not months. Life-saving therapies made at your bedside, not hundreds of miles away,' said Wes Streeting, the UK Secretary of State for Health and Social Care.

The effectiveness of many innovative medical therapies is ultimately limited by logistics – transport delays and short shelf lives that prevent them from reaching patients when they are most needed. Under the new law, the time from manufacture to patient bedside should be much shorter, unlocking the clinical potential of these treatments.