Lord Cryer (Lab)

My Lords, I beg to move that the Committee consider this amendment to the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004. I am grateful for the opportunity today to debate this important amendment, which establishes a tailored regulatory framework to support point-of-care and modular manufacturing UK-wide, enabling decentralised methods of medicine manufacturing and moving innovative medicines closer to the patient. The UK is leading the way as the first country to introduce a framework for these ground-breaking, decentralised methods of medicine manufacturing. We are demonstrating our commitment to supporting medical advances on the cutting edge of technology. The Government are implementing the new framework to enable a new sector of medicine manufacturing, facilitating the development of highly specialised medicines where they are most needed for patients, whether that is in hospital wards, operating theatres, community health centres or, in some cases, even in patients’ own homes. One example of these products in development is a diabetic foot ulcer treatment using blood-derived products obtained from the patient and manufactured at the bedside. Modular manufacture can support early-stage vaccine deployment by allowing vaccines to be locally filled and finished, ensuring efficient supply to mass vaccination centres. These cutting-edge medicines are often very time-sensitive so they cannot just be picked up from a doctor, a pharmacy or a hospital in the traditional way. I will now highlight why this change is needed. Increasingly, with advancing health technology, medicines are being developed that need to be manufactured close to patients. The approach by the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency—the MHRA—needs to adapt to support the development of new technologies. However, current arrangements are geared for centralised factory-based manufacture, with a small number of fixed manufacturing sites named on manufacturing licences and marketing authorisations. Point-of-care and modular manufacturing products may be manufactured at multiple sites across the country. Some of these products are developed to meet the unique needs of each patient, often derived from the patient’s own cells or blood. Some products must be administered within an hour, or even minutes in some cases, of being manufactured. This creates an urgency and a specific need that traditional manufacturing cannot easily accommodate. It would be extremely challenging for these innovative products to be regulated according to current regulations, with significant regulatory and financial hurdles. The objective of this instrument is to provide an enabling framework to allow for the safe and efficient manufacture and supply of emerging medicines still in the early stages of development, with the regulatory clarity necessary to encourage these new products and approaches. It is vital that we have a regulatory framework that is flexible for new innovations but obviously does not compromise on patient safety. I will now set out how the MHRA will ensure that point-of-care and modular manufacture products meet the necessary standards of safety, effectiveness 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 point-of-care and modular manufacturing, including the spokes of individual manufacturing locations and their activities. The control site will be the only named manufacturing site on the manufacturing licence, clinical trial and marketing authorisation applications. The holder of the control site, as its name signifies, will be responsible for ensuring product quality across all manufacturing sites and notifying the MHRA of reportable issues. The diligence of the control site in overseeing manufacturing locations will be scrutinised at routine MHRA inspections, and arrangements for oversight will be scrutinised as part of the licensing process. A number of 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 framework 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 safety, quality and efficacy of the product. There will not be an increased risk to patient safety, with the MHRA retaining regulatory oversight. I turn in more detail to the benefits of this new framework. First, patients and carers will benefit from access to new and more personalised medicines in a timely and more convenient manner, with the potential for some patients to be treated with medicines manufactured at home. This would help to move care from hospitals to communities—I know that this has been discussed for a long time, but this gives us the opportunity to actually do that—reducing the need for patients to stay in hospitals. Secondly, it benefits healthcare professionals by providing a greater range of more effective treatment options, which can improve patients’ response to treatment. Lastly, it benefits innovators and industry, by providing clear regulatory expectations and enabling speedier product development. The new framework will remove regulatory barriers that are not suited to novel manufacturing methods. This benefit will be seen across all sizes of companies—large as well as small and medium-sized enterprises. I am pleased to bring forward this instrument using the powers of the Medicines and Medical Devices Act, allowing us to use effective regulation to support the development of medicines at the forefront of technology, enable patient access to pioneering medicines and help to move innovative medicines closer to the patient.