UK to introduce framework for the manufacture of medicines at point of care

The UK is set to be “the first country in the world” to introduce a tailored framework for the regulation of medicines manufactured at or close to where a patient is receiving care, the government has announced.

In a statement published on 21 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that a statutory instrument had been laid in parliament, “which will provide a new regulatory framework meaning that medicines with a very short, shelf life and highly personalised medicines can more easily be made in or near a hospital setting”.

The MHRA added that manufacturing medicines at the point of care will mean the medicines “can get to the patients who need them safely and much more quickly”.

The statutory instrument will also allow for “modular manufacturing” where innovative medicines, such as cell or gene therapies, are manufactured in portable units that can be set up close to patients, “who may be too sick to travel or whose reduced immunity precludes travel,” the MHRA said.

The executive agency added that the framework will also help to relieve pressures on hospitals by enabling care to be delivered in community settings and patients’ homes, “supporting the ambition to expand ‘hospital at home’ services such as virtual wards”.

In a statement to parliament, health minister Karin Smyth, said point-of-care medicines also include “3D-printed medicines or treatments derived from a patient’s own blood” that have shelf lives “sometimes as brief as an hour or even a few minutes”.

Smyth added: “Current regulations limit other innovative manufacturing models, such as modular, where products need to be manufactured in relocatable units; for example, where cancer biopsies and blood-derived components are taken from a patient and sent to a local manufacturing site to manufacture a personalised cancer vaccine specific to that patient’s disease.

“Many of these technologies are currently in early development. Providing regulatory clarity now will enable new products and manufacturing approaches to be developed.”

The regulation could become law in summer 2025, following a proposed six-month implementation period, once parliamentary processes have concluded.

Ian Rees, point of care lead at the MHRA, said the framework will “enable new and innovative ways of manufacturing medicines closer to the patients who need them, whilst ensuring their quality, safety and efficacy, with the consequent benefits both to patients and the healthcare system”.

The regulation follows a consultation with stakeholders in 2021, which “showed a high level of support for proposals for a regulatory framework for point of care and modular manufacture of medicinal products”, the MHRA said.

Commenting on the introduction of the framework, Royal Pharmaceutical Society president, Claire Anderson, said: “Pharmacists play a vital role in ensuring the safe and effective delivery of medicines in hospitals, community settings, or even at home.

“Robust regulation, team support and investment in facilities will be essential to safely implement this framework and support the expansion of hospital-at-home services and virtual wards, relieving pressure on hospitals.”

The regulator is developing guidance and will engage with industry, academia and healthcare institutions to support the implementation of the new regulations, the MHRA added.