Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024
Lord Cryer
That the Grand Committee do consider the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024.
Relevant document: 6th Report from the Secondary Legislation Scrutiny Committee
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.
Lord Kamall (Con)
My Lords, in rising, I thank the Minister. It is also my first opportunity to welcome him to his place and, just as with his colleague, the noble Baroness, Lady Merron, I look forward to working with him in the constructive way that I do with her.
We may be surprised that there is not a massive queue of speakers lining up to take this debate into tomorrow, but part of the reason is that this instrument really is not that controversial. There is consensus on this and we welcome the intent of innovation. With a lot of legislation, particularly when it comes to technology, we know that there are two debates: one is on the precautionary principle and the other is on the innovation principle. I know that we always have to balance those two issues out. It is really important that the UK continues to be a leader in innovation, particularly health innovation.
From these Benches, we support this statutory instrument, particularly, as the noble Lord says, to enable manufacturers to produce medicines with a shorter shelf life closer to the patients. What is not to like about that? I have a couple of quick questions, not in any way to trip up the Minister or score points but simply for information.
The impact assessment talks about supporting
“innovation and flexibility, for example by introducing a Control Site and framework to preclude the need for each”
point of care and modular manufacturing
“site to be named on the marketing authorisation and to be individually inspected by the MHRA”.
I just wonder whether contingencies have been thought about. We know that there are quite often unintended consequences with any legislation, even if well intentioned, but also in what contingencies have been put in place. Is there an ironclad chain of responsibility? For example, if the single control site becomes inoperable or goes down, what contingencies do the Government have to provide relief to the manufacturers? I am sure that he appreciates the intent behind that question, but that would be very helpful.
Secondly, I would be extremely grateful if the Minister could reassure us what measures there are to ensure an ironclad chain of responsibility. We know that in the modern manufacture of medicines, thinking about the recent Covid vaccine, for example, that components can come from all around the world—it is like a modern supply chain. While only one manufacturer is named on a system, are there instances involving more than one manufacturer in the process? Therefore, how do the regulator, the Government and patients know who is responsible for their medicines at which stage? I know this is done very close to the patient, but there might be questions about who is held responsible. If this is a surprise question or the Minister does not have the answer, I am perfectly happy for him to write.
I know that I might sound like a country-club bore but, as a former Minister, particularly in technology, innovation and life sciences, I have continued to maintain an interest in this area, so I can share the pride that the Government have in this system being one of the first of its kind in the world. It sends a very positive signal to the world, building on our reputation of the UK being a leader in medicine manufacturing, which was obviously highlighted when we developed the Covid vaccine very quickly. As this system is the first of its kind, we hope that the Government will commit to closely monitoring its impact and provide the results in a transparent manner, but also to highlight anything that goes wrong or is unintended so that we can learn from it.
One of the questions I generally ask about legislation is on unintended consequences. They are often there and we cannot foresee them. What guardrails or safeguards are there in place? If an unintended consequence arises, how do we remedy that? Will it simply be laying another SI to correct the error? I would be very interested in what the Minister has to say.
Overall, there is no real contention on this. We very much welcome this SI. I look forward to hearing the answers from the Minister—and I hope I have waffled on for long enough that he can get the answers from his officials, who I thank on that. In particular, I know he has an official from Lithuania, so I say “ačiū”, which I hope is the correct way of pronouncing “thank you” in Lithuanian.
Lord Cryer (Lab)
I am grateful to the noble Lord for both his contribution and his welcome. He can tell that I am still shuffling papers around.
I suppose that there are always unintended consequences to any piece of legislation; we have all been around long enough to know that. Part of the answer here is that the new hub-and-spoke method creates a degree of flexibility while not compromising health and safety standards, which means that, if there are problems in the supply chain, it would be pragmatic to put in measures that would compensate for those. If you simply have a big factory churning out tons of drugs and treatments and that factory has a problem, it is much more difficult to alleviate that problem. Also, the factories, inspection plants and other points along the hub-and-spoke model will be subject to inspections in order to ensure health and safety and quality. That is principally the MHRA but there are also—this is off the top of my head—nine other third-party agencies that are used, for want of a better phrase, by the MHRA to conduct inspections.
I want to make a few comments in closing that will partly touch on the points raised by the noble Lord. I shall summarise the key aims of the new framework and how the MHRA is already preparing to deliver these changes. Having met MHRA officials, I can say with some confidence that they have been planning for this for a long time. It is vital that the regulatory framework supports the development of new medicines while protecting patient safety, which is in essence what the noble Lord was talking about.
The safety of patients remains the paramount interest in the new framework. The regulations are not about relaxing patient safety requirements; they are about making sensible changes to reflect the circumstances in which medicines are being manufactured. The new regulatory framework is based on and links into the current regulatory processes but, obviously, the existing regulatory processes address a very different method of manufacture and distribution. The new system will ensure that point-of-care and modular manufacture products meet the necessary standards of safety, effectiveness and quality.
The new framework will also bring a wide range of benefits to patients. By opening up a new sector of medicines manufacturing, patients will benefit from access to new and more personalised medicines in a timely and convenient manner. There is potential for patients to be treated with medicines outside hospital settings, even in their own homes, thus reducing travel time; in some cases, there will be no travel time because they will be manufactured by a small device in the patient’s home. The framework supports the concept of moving care from hospitals to communities, relieving pressures on the NHS. This may also reduce the overall treatment and social care cost.
The MHRA is ensuring that the health and care sector is ready to adapt to this new framework so that the benefits can be realised. Engagement is happening now, has been happening for a while and will continue to take place with a wide range of key health partners in industry, academia and other UK regulators, including the Care Quality Commission, the Human Tissue Authority and the Health Research Authority; obviously, the GMC and the NHS are also part of the extensive stakeholder engagement network to ensure institutional readiness. The MHRA’s engagement with stakeholders through the development of the regulations, including a formal public consultation, has shown widespread support; I am talking about cross-industry support for the new framework. Industry continues to be supportive of the framework. The Government and the MHRA will continue to engage with industry and manufactures, as noble Lords might expect.
As far as international collaboration is concerned, the MHRA is working internationally to ensure maximum alignment of regulatory approaches across international regulators. That is not global, but it is as far as can be reasonably practicable. This will enable the benefits of point-of-care and modular manufacture products to reach patients across the world. This international work is particularly important as the UK is the first country to introduce a framework to enable innovative ways of manufacturing medicine, so, in effect, the UK leads the way in this field—and this is UK-wide.
In short, these changes will support wider access to life-saving, innovative medicines. I hope that noble Lords will agree with them and, on this basis, join me in supporting these important regulatory changes.