Debate contribution: Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024

Debate contribution by Mr Mike Nesbitt on 13 January 2025.

MLA

Mr Mike Nesbitt

Party at the time

Ulster Unionist Party

Date

13 January 2025

Type

Debate contribution (made as a minister)

Business

Executive Committee Business

Heading

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

Assembly identifier

Official Report component 4738008

Read the official Assembly record

Text

I beg to move

Thank you, Madam Principal Deputy Speaker. I seek the Assembly's approval for the making of the draft statutory instrument (SI), which will amend the Human Medicines Regulations 2012 — the "HMRs", as they are known — and the Medicines for Human Use (Clinical Trials) Regulations 2004. That will enable the introduction of a new, tailored regulatory framework to support point-of-care (POC) and modular manufacturing (MM). In turn, that will decentralise methods of medicine manufacturing and move innovative medicines closer to the patient while maintaining robust regulatory standards and ensuring patient safety. The introduction of the framework is intended to proactively support the development of new medical advances on the cutting edge of technology and new means of medicine manufacturing, facilitating the development of highly specialised medicines where they are most needed for patients, whether that be on hospital wards or in operating theatres, community health centres or even patients' homes. The products are in the early stages of development, but one example of the type of innovative treatment that may be enabled by the new framework is a diabetic foot ulcer treatment that uses blood-derived products obtained from the patient and manufactured at their bedside. Modular manufacture can support early-stage vaccine deployment, allowing vaccines to be locally filled and finished and ensuring efficient supply to mass vaccination centres. The amendments are needed as, with advancing health technology, innovative medicines are increasingly being developed that will need to be manufactured close to patients and healthcare settings. The traditional approach by the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), therefore needs to adapt to support the development of the new technologies. Current arrangements are suited to centralised factory-based manufacture, with a small number of fixed manufacturing sites named on manufacturing licences and on marketing authorisations. Point-of-care and modular manufacture products may be manufactured at multiple sites across the country. Some of the products are developed to meet the unique needs of each patient when the patient needs them and are often derived from the patient's cells or blood; indeed, some products must be administered within an hour or, in some cases, even minutes of being manufactured. That creates an urgency and a specific demand that traditional manufacturing cannot easily accommodate. It would be extremely challenging for those innovative products to be regulated in accordance with the current regulations, and that results in significant regulatory and financial hurdles. The objective of the instrument is therefore to provide an enabling framework to allow the safe and efficient manufacture and supply of those emerging medicines, which are still in the early stages of development, and provide the regulatory clarity necessary to encourage the development of those new products and approaches. The benefits of that approach will extend to patients and carers, who will benefit from access to new and more personalised medicines in a timely and more convenient manner with the potential, as I said, for some patients to be treated with medicines manufactured at their home. It will help to move care from hospitals to communities, which is, of course, consistent with my direction of travel for health and social care delivery. Secondly, healthcare professionals will benefit from the ability to provide a greater range of more effective treatment options, thus improving patients' response to treatment and delivering better outcomes. Lastly, innovators in industry will benefit from clear regulatory expectations and the enabling of speedier product development. The new framework will remove regulatory barriers that are not suited to novel manufacturing methods. That benefit will be seen across companies of all sizes, be they large, medium or small enterprises. It is vital that the medicines regulatory framework is flexible for new innovations but does not compromise patient safety. I will set out how the MHRA will ensure that point-of-care and modular manufacture products meet the necessary standards of safety, effectiveness and quality that are expected of all medicines. 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 systems, including the spokes: the individual manufacturing locations and their activities. The control site will be the only named manufacturing site on the manufacturing licence and on the clinical trial and marketing authorisation applications. The holder of the control site will, as the name signifies, be responsible for ensuring product quality across all manufacturing sites and for notifying the MHRA of reportable issues. The diligence of the control site in overseeing the manufacturing locations will be scrutinised at routine MHRA inspections, and arrangements for oversight will be examined as part of the licensing process. Several manufacturing spoke locations will also be sampled and subject to inspections to ensure that the oversight claimed by the control site can be independently supported by inspection findings. The new framework is a modified form of the current regulatory system for the 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. There will not be an increased risk to patient safety, with the MHRA retaining regulatory oversight. There is not a different approach to implementation in Northern Ireland. I emphasise to Members that the proposed framework will apply across the United Kingdom, and there is no difference in the approach to implementation here. In practice, there are currently no point-of-care manufacturing sites in Northern Ireland, as point-of-care products have not moved past the clinical trial phase. While it may take some years before point-of-care products become widely available, the plan is to implement the new framework pre-emptively in order to provide certainty for the industry about the regulatory requirements that they will be required to meet and to promote the UK as a great place to invest in clinical trials and product development. There was a UK-wide joint public consultation on the proposal, and it received significant support. In the consultation responses, 91% agreed that a new framework was required, and 94% agreed with the proposed framework. My officials attended the Health Committee at its meeting on 21 November, where they outlined the full policy intent of the draft SI, and again on 12 December to provide some further necessary clarification on the new framework to be introduced by the statutory instrument prior to it possibly being debated in the Assembly. I am pleased to confirm that the Committee raised no issues on the policy intent at its meeting on 21 November and was content with the further clarification given by officials on 12 December. On both occasions, the Committee indicated that it was content for the SI to be laid in draft form at the Assembly Business Office to allow for the debate today following the Christmas recess. It is, therefore, with the Committee's support that I bring the statutory instrument before the wider Assembly today. I commend the motion to the Assembly.

1,163 words. Text as published by the Northern Ireland Assembly.

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