UK health rulebook to support ‘point of care’ manufacturing

The Medicines and Healthcare products Regulatory Agency (MHRA) said a new “principles-based” rulebook for ‘point of care’ (POC) manufacturing would be introduced before the UK parliament later this year. The new rulebook, consulted on by the MHRA in 2021, will apply to all POC products manufactured in the UK including, the MHRA highlighted, some cell and gene therapies. Legislation will be introduced under the framework of the Medicines and Medical Devices Act 2021 which gives the UK government targeted powers to update medicines, medical devices and clinical trials regulations.

In its response to the consultation exercise, the MHRA said: “New types of innovative products, such as those with very short shelf lives, are required to be manufactured and supplied at the point where a patient receives care (POC). The current human medicines legislation is geared for products which can be manufactured at a very small number of sites and supplied globally.”

“In contrast, POC products, may only have a shelf-life of minutes or need to be highly personalised, so have to be manufactured on demand when the patient is present. This could mean manufacturing a POC product at hundreds of sites across the UK alone. A new regulatory framework will support the manufacture and supply of these innovative products,” it said.

The new framework, which does not focus on any particular class of products, will impact on “[…] a wide range of POC product types including blood products, medical gas products, Advanced Therapy Medicinal Products (ATMPs) and small molecule products”.

Helen Cline of Pinsent Masons said the diverse range of products covered will require the new regulatory framework to be flexible so that the regulatory oversight applicable to different products and manufacturing systems is proportionate to the level of risks embedded in the relevant technology.

She added that a willingness to invest in the advanced manufacturing systems needed will depend on the number of sites and the reimbursement models agreed with hospitals.

The new regulatory regime will be based on a so-called ‘hub and spoke’ model, where a single control site would be subject to a licensing framework and the bulk of regulatory requirements, and where the scale-up of subsequent manufacturing sites around the country would be able to happen without the need for subsequent regulatory authorisations. Each manufacturing site would need controls in place to ensure safety and efficacy, and control sites would have oversight responsibilities.

“Good governance in healthcare institutions will be an important element in the successful delivery of this framework, and we will work with partners across the healthcare system to support the institutional readiness of healthcare establishments for this new range of activities,” the MHRA said, stressing that POC manufacturing would not undermine “the current centralised (factorybased) manufacturing model” and would only be justified if “essential because of the nature of the product, e.g. for products with very short shelf-lives”.

Cline said: “Until now, regulatory agencies including the MHRA have overseen the production of therapies in hospitals using regulatory exceptions. In the UK, the MHRA has used the specials framework for the oversight of small-scale bespoke therapy production. However, as POC manufacture is practised more widely and more frequently there is a need for a more specific framework that addresses some of the challenges and limitations of the specials scheme. The MHRA’s POC regulatory framework aims to be innovative, proportionate and flexible and is a solid foundation for the UK to pioneer the large-scale production of therapies in a clinical setting.”

The regulator explained how the new framework would differ from existing exemptions for doctors, dentists and pharmacists concerning the manufacture of medicinal products, which will continue to apply and be unaffected by the changes.

“The POC framework supports the scaled out, consistent and reproducible manufacture of products across a relatively large number of POC sites,” the MHRA said. “This contrasts with the doctors’ and dentists’ exemption which allows for manufacture of individual treatments directly by the doctor or dentist for their individual patient or a patient under the care of another doctor or dentist in the same group or practice.”

The MHRA said it will work to ensure that the UK’s POC manufacturing rules align with those in other jurisdictions.

It said: “To ensure the successful implementation of this new regulatory framework, the MHRA has started work on a joined-up approach with other regulators within the UK and internationally. For the latter, the aim is to facilitate the development of equivalent regulatory approaches in other territories. This will benefit patients in those additional territories through aligned regulatory approaches and further encourage innovation and industrial development in this area of medicinal products supply.”