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

Debate between Lord Kamall and Lord Cryer

Thursday 28th November 2024 Grand Committee

[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.

Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

Debate between Lord Kamall and Lord Cryer

Thursday 28th November 2024 Grand Committee

[Lord Kamall (Con)]

My Lords, as with the previous instrument, this side welcomes the instrument being laid. Once again, the lack of people queuing up to speak in this debate demonstrates that it is relatively uncontroversial; we now outnumber the audience, as it were.

We obviously support this instrument. The Minister was absolutely right to refer to the report by the noble Baroness, Lady Cumberlege, and to the pain and misery that the valproate scandal—and other scandals—caused so many women. On that, I know that the Minister will not be able to answer me now but I wonder whether he can write to me on the recent report by the Patient Safety Commissioner. He suggested an initial sum to be paid to the victims of that scandal, as well as looking at future remedies. Are the Government any closer to considering the Patient Safety Commissioner’s recommendations? These women have suffered enough. They have been out of pocket and have suffered physically, financially and emotionally. I would welcome an answer on that at some stage, probably in writing.

It is obviously right that we increase the scope for post-market surveillance. As a quick aside, noble Lords may know that I was a Member of the European Parliament for a few years. British companies used to lobby me on their concern that manufacturers could go to certain jurisdictions to get a CE mark then sell that product across the EU; they sometimes wondered whether the surveillance or testing of that product was sufficiently strong compared to in the UK. This gives us a huge opportunity now to be more aware of CE marks. The Health and Safety Executive for Northern Ireland says that

“the CE mark is not a quality mark, nor a guarantee that the product meets all of the requirements of relevant EU product safety law”.

It places an onus on suppliers to make sure that they comply, but not every product is tested.

That is why it is important, particularly given the scandal to which the noble Baroness, Lady Cumberlege, referred in her report, that we now take the opportunity to ensure that these products are as safe as they claim to be—not only those manufactured in the UK and GB but, particularly, those coming from abroad. I want some sort of assurance that the Minister thinks this will be an effective way to make sure that we avoid that problem.

Secondly, having left the EU a few years ago, we have to be aware that there was clearly some friction. Hopefully, we will move to a better relationship between the UK and the EU. We want to avoid unnecessary conflict, but has the Minister thought about what happens when, in the post-market surveillance, the UK regulator deems that a product from an EU country which might have a CE mark is not safe? How do we ensure that that does not cause conflict with the EU regulators for that product, and is it going be a constructive relationship?

Are the EU standards organisations fully acquainted with what we will be doing here in the UK, and open to the fact that we might find that some products are not high quality and will therefore remove them from the UK market? Will that cause conflict with the EU, given that those products have a CE marking? It will be one way of trying to reduce some of that post-Brexit friction. We might be doing it for the best reasons, but they may feel it is undermining the CE mark.

Lastly, can the Minister commit to ensuring that Northern Irish regulations remain closely aligned to Great Britain’s, so as to avoid confusion and delay? We know that the Windsor Framework produced a solution for Northern Ireland after the Brexit negotiations, but there are concerns for people in Northern Ireland about alignment with GB, understanding that there is also an alignment with the EU. Can the Minister make some commitment or give an assurance that Northern Ireland will remain as closely aligned to GB as it possibly can?

With that, these regulations are not particularly controversial. We welcome the fact that there is post-market surveillance. We wish we could have done it as strongly before, given that there have been concerns about certain medical devices. It is really important that we learn the lessons from those scandals, particularly the pelvic mesh and other scandals that have caused so much misery and suffering. We must make sure that we do not see that sort of suffering again.

[Lord Cryer (Lab)]

I am very grateful to the noble Lord for his comments. The Committee will not know, but he mentioned to me beforehand that he might raise products from other jurisdictions and that I might have to write to him. I should just like to say that his prediction was right: I will have to write, but I shall say a couple of things briefly.

As far as product safety from other jurisdictions is concerned—I will come to the European Union and other jurisdictions later in my closing remarks—there is a scheme for implant cards. I mentioned at the beginning that this SI will, in all probability, be the first of a number which will, at some point, cover putting implant cards into products so that their exact provenance can then be traced. If something comes from another jurisdiction that does not use that method, obviously I hope that that is in itself a way of ensuring some level of safety.

We have both mentioned pelvic mesh, for instance, which has been absolutely deadly. I will say something about that in a minute, but a few years ago there was another scandal involving really nasty breast implants which leaked. When this is fully rolled out, if a woman has a breast implant, we will have the implant card attached to the product and its provenance can be immediately seen: you can see exactly where it came from. That will hopefully ensure an increased level of safety.

As far as the victims—I think that “victims” is the right description—of pelvic mesh are concerned, I know that this has been going on for a while, but the Government are now looking at various options and, at some point in the near future, there will be an announcement on what exactly will be done.

This instrument marks an important change in how we manage medical devices in Great Britain. It will enable not only the MHRA but the whole of the health system to better protect patients. That is what this entire SI is about. The Government acknowledge that patient safety remains paramount, and these regulations must be carefully balanced to support innovation and ensure patients have access to the most effective medical devices.

Where appropriate, the new draft PMS regulations align with international requirements—which the noble Lord mentioned—helping to support the availability and favourability of the Great Britain market and reduce the additional burden on manufacturers supplying medical devices across multiple jurisdictions. The new PMS requirements will also provide a level of regulatory certainty for manufacturers, hopefully making the UK a more attractive location to launch their products.

As I mentioned in my opening comments, this draft statutory instrument represents the first legislative step towards broader medical devices regulatory reform. It will create a strong foundation for further regulatory amendments that enhance the safety of medical devices, ensuring their availability and supporting innovation. It will do this by introducing measures for medical devices after they are placed on the market.

The MHRA is also developing measures for medical devices before they are placed on the market, with the intention to lay additional draft legislation before Parliament in 2025. As I mentioned at the beginning, this will include measures for unique device identifiers—implant cards—and new rules to ensure that claims are consistent with the intended purpose of a device, although there is already existing legislation that covers that to a degree. It will also deliver changes to the classification of some medical devices.

As part of this subsequent legislation, we intend to introduce a framework for international reliance that takes into account, where it is safe to do so, decisions made by comparable regulators in Australia, Canada, the EU and the USA when determining whether a product can be sold in the UK.

Delivering these regulations first, ahead of wider regulatory reform, enables this framework by providing the MHRA with stronger assurance that devices are safe and perform as intended. It demonstrates the Government’s commitment to patient safety and responds directly to the Independent Medicines and Medical Devices Safety Review, which I and the noble Lord mentioned earlier, led by my noble friend Lady Cumberlege. The review highlighted the terrible consequences for patients when medical devices do not do what they are supposed to.

The MHRA has taken a pragmatic approach to the development of this instrument and prioritised patient safety while supporting global harmonisation across the UK medical device industry.

These regulations will be subject to a six-month implementation period. The majority of devices registered with the MHRA have EU regulatory approval and already comply, or are moving towards compliance with, EU PMS requirements. Therefore, given the similarity of these requirements with those in the EU, we do not expect manufacturers to have difficulty meeting these new GB requirements within this timeframe; however, the MHRA will continue to monitor the situation, and talk to and support industry to get it to readiness.

The MHRA is prepared for these regulations. The strengthened PMS requirements are expected to increase the volume of data and vigilance reports submitted to the MHRA. However, we anticipate that accompanying improvements to data quality will off-set this burden and support automation within the existing MHRA systems.

Before I move to my conclusion, there was one more point, about Northern Ireland. As the noble Lord mentioned, this SI, unlike the previous one, is covered by the Windsor Framework, so a separate process applies to Northern Ireland.

Having said that, I trust that we have demonstrated the need for these regulations to ensure that patients and the public continue to benefit from safe access to medical devices. As the first legislative step of the wider medical devices regulatory reform, this instrument will create a strong foundation and allow for future changes to enhance the safety of medical devices, ensuring their availability and supporting innovation. In turn, we intend to support our life sciences sector to create an environment that fosters safe innovation—I emphasise that.

[Lord Kamall (Con)]

I would like to have some more details, in writing, about the conversations that we will have with the EU if our post-market surveillance finds something wrong with a product that has a CE mark to make sure that that will be done co-operatively and will not be seen as causing unnecessary friction. I know that the Minister discussed international co-operation in an earlier answer. There is no need to answer now, but if he could include that in a letter to me that would be welcome.

[Lord Cryer (Lab)]

A process of consultation has been ongoing for quite a while. It has been done in a very constructive way on all sides, I hope, and certainly on the UK side. I will write to the noble Lord about that, as he asked.