Point of Care Medicines Manufacture Regulations

Statement

I am pleased to announce that the draft Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 were laid before Parliament yesterday. When approved by Parliament, this instrument will create a new regulatory framework for innovative manufacturing methods for medicines that must be made near the patient, innovative medicines manufactured at the ‘point of care’, and modular manufacturing (MM), where products are manufactured in modular, relocatable units.

The UK will be the first country worldwide to introduce such a regulatory framework. These regulatory changes will support the development of medicines at the forefront of technology, enable patient access to pioneering medicines, and help move treatment closer to the patient.

Point of Care manufactured products are often highly personalised, such as cell or gene therapies, 3D-printed medicines, or treatments derived from a patient’s own blood. These products can have extremely short shelf lives, sometimes as brief as an hour or even a few minutes. This requires manufacturing and supply either at the point of care or close to where the patient is being treated. This could include in hospital wards, operating theatres, community health centres, or even the patient's home.

The current regulations are not geared for manufacturing at multiple different sites across the country in this way, and current regulatory barriers would make such manufacture complicated and burdensome. Current regulations also 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 for 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. A tailored framework will ensure that these novel medicines meet the same rigorous standards of safety, quality, and efficacy as more traditional treatments, whilst removing barriers to using innovative manufacturing methods.

The new framework will bring a range of benefits to:

• Patients and carers – will benefit from access to new and more personal treatments in a timely and more convenient manner with the potential for less travel and time in hospitals
• Healthcare professionals – by providing a greater range and more effective treatment options and improving patients’ response to treatment
• Innovators – by providing clear regulatory expectations and enabling speedier product development.

This instrument follows a public consultation which gained feedback from a range of individuals and organisations across the UK and internationally. The overwhelming majority of responses were positive, with 91% of responders agreeing that a new framework was required, and 94% agreeing with the framework proposed.

The regulations, along with the associated explanatory memorandum and impact assessment, have been published on GOV.UK.