Draft Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024

Karin Smyth Excerpts

Wednesday 27th November 2024 General Committees

[The Minister for Secondary Care (Karin Smyth)]

I beg to move,

That the Committee has considered the draft Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024.

It is a pleasure to serve under your chairmanship this morning, Mr Betts. I am grateful to be debating this important amendment to establish a tailored regulatory framework to support decentralised methods of medicine manufacture, moving innovative medicines closer to the patient.

The draft regulations will amend the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004. The regulations create an enabling pathway for innovative manufacturing from early-stage development in clinical trials through to the administration of medicines to patients. The UK is leading the way as the first country to introduce a framework for these groundbreaking, decentralised methods of medicine manufacturing. We are taking action to support medical advancements that are on the cutting edge of technology to benefit patients across the country.

The new framework is being brought forward pre-emptively to encourage increased manufacture and supply of innovative medicines that can only be manufactured at or close to the point of care or by modular manufacturing, where products are manufactured in relocatable units. The framework will help to develop a new sector of medicines manufacturing, enabling safe innovation and development of highly specialised treatments. It will provide the flexibility to deliver medicines directly where patients most need them, whether that is a hospital ward, an operating theatre, a community health centre or even a patient’s home. These products are currently in early development. An example of a point-of-care product is a diabetic foot ulcer treatment using products derived from blood obtained from the patient and manufactured at their bedside. Modular manufacture offers significant advantages to support the faster roll-out of vaccines, for example, by allowing vaccines to be filled and finished on a local or district basis to supply mass vaccination centres.

I will highlight why the change is needed. Advancing health technology increasingly means that new medicines are being developed that need to be manufactured close to the healthcare setting. Our traditional regulatory models need to change to support the new technologies. The current regulations are suited to centralised, factory-based manufacture at a small number of fixed manufacturing sites that are named on manufacturing licences and marketing authorisations. Point-of-care and modular manufacture products may be manufactured at hundreds of different sites for specific patients, when those patients need them.

It would be extremely challenging for these innovative products to be regulated within the currently legislation, and it would cause significant regulatory and financial burden. The products are often developed to meet the unique needs of individual patients, using the patient’s own cells or blood, and they may need to be administered within an hour or even minutes of being manufactured. The urgency and specificity of the products cannot easily be accommodated by traditional manufacturing or by the current regulations.

We need to adapt our regulatory approach to be suitable for manufacturing medicines at many different sites across the country, while maintaining regulatory oversight to ensure that manufacture is safe and consistent. The new framework will provide regulatory clarity to encourage new products and innovative approaches to support the future supply of treatments that are emerging in early-development stages and that may be life-changing for patients.

Patient safety is central to the new legislation. We need to provide a regulatory framework that is flexible for new innovations but does not compromise the safety of patients who receive innovative medicines. I will set out how the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency, will ensure that point-of-care and modular manufacturing products meet the necessary standards of safety, efficacy and quality.

The new framework is centred on a hub-and-spoke model, with a single control site as the hub for each product, overseeing all aspects of the point-of-care and modular manufacturing system, including the spokes—individual manufacturing locations—and their activities. The control site will be the only named manufacturing site on manufacturing licence, clinical trial and marketing authorisation applications. The holder of the control site will, as the name signifies, be responsible for notifying the MHRA of reportable issues and ensuring product quality across all the manufacturing sites, the spokes.

The diligence of the control site in overseeing the manufacturing locations will be scrutinised at routine MHRA inspections of the site; arrangements for that oversight will be scrutinised as part of the licensing process. A number of manufacturing spoke locations will be sampled and will be subject to inspections to ensure that the oversight claimed by the control site is independently supported by inspection findings.

The new framework is a modified form of the current system for evaluation of regulatory compliance at manufacturing sites and safety monitoring. There will be no change in the expected standards that must be met for the safety, quality and efficacy of the product. As the MHRA is retaining regulatory oversight, there will be no increased risk to patient safety.

I turn to the benefits. First, patients and carers will benefit from access to new and more personalised treatments in a timely and more convenient manner. There is even the potential for some patients to be treated with medicines manufactured at home, which aligns with our wider ambition to move care from hospitals to communities and reduce the need for patients to stay in hospital. Secondly, healthcare professionals will see a greater range of more effective treatment options for their patients, which will help to improve patients’ response to treatment. Lastly, innovators and industry will have clear regulatory expectations suited to innovation. The new framework will remove regulatory barriers, enabling speedier product development. Companies of all sizes—large, small and medium-sized enterprises—will benefit from that.

The new framework will allow us to use effective regulation to support the development of medicines at the forefront of technology. I am pleased to bring forward the draft regulations, using powers under the Medicines and Medical Devices Act 2021, to move innovative treatments closer to the patient and support patients’ access to pioneering medicines. That work that has been ongoing for some time within the agency. I hope that hon. Members will join me in supporting these important regulatory changes. I commend the draft regulations to the Committee.

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[Karin Smyth]

I thank the hon. Member for Sleaford and North Hykeham for her comments. As I say, this is work that was long in progress under the previous Administration; I am pleased that colleagues from the MHRA are here today to see that work come to fruition. We are leading the world in this work.

We are highly committed to encouraging our life sciences sector to take innovations directly to patients. I am pleased to have cross-party support for the draft regulations. I look forward to working with the hon. Lady and others to ensure that we make this a reality for patients.

Question put and agreed to.