(1 month, 1 week ago)
Lords ChamberTo ask His Majesty’s Government what assessment they have made of the provision of corridor care in the NHS; and what plans they have to mitigate any issues arising.
My Lords, we have introduced new data collection on corridor care, which will be published shortly for the first time. We are taking sustained action to reduce the use of corridor care, ensuring that there are safeguards for patients in the interim to still receive high-quality and safe care with dignity and privacy. We are investing £450 million to expand same-day and urgent care services, and to improve hospital flow, as well as introducing new clinical operational standards.
I thank the Minister for her reply, but I want to understand when a credible long-term delivery plan will be published—rather than “in the near future”—to restore year-round resilience, making whole-system patient flow a core performance priority. Unnecessary stays in hospital are linked to worse patient outcomes, and it should be possible to reduce the nearly 13,000 beds occupied on average each day in 2025 by people medically fit for discharge, in turn reducing the need for corridor care.
Let me say at the outset that corridor care should not be normalised; it is not what we want to see as routine. The reality is that we cannot eliminate it entirely—I think that is understood—but the current situation is not as we would want it to be. In addition to the Urgent and Emergency Care Plan 2025/26, which sets out clear actions to deliver improvements, the most challenged trusts are receiving targeted support. Looking to the future, as the noble Baroness asked about, the medium-term planning framework clearly sets out a trajectory to improve the situation. The introduction of clinical guidelines for the first 72 hours will also increase the proportion of people discharged within 72 hours. I very much recognise the situation the noble Baroness describes.
Baroness Kingsmill (Lab)
My Lords, as a former chair of an NHS community trust, I say that the situation often arises because of the shortage of social and community care. What are the Government doing to address those issues?
On social care, we are making progress on building a national care service. Around £4.6 billion of additional funding has been made available for adult social care by 2028-29. Along with other matters, including funds to improve and provide adaptation so that people can return home when they would not have been able to otherwise, we are providing funding of over £1 billion for adult social care with local authorities. This can be used to expand capacity. Of course, we have an independent commission chaired by the noble Baroness, Lady Casey.
My Lords, in a recent survey 78% of physicians reported undertaking corridor care. It is becoming almost the norm all the year round. It affects patients’ dignity, health and safety, and patient outcomes, because there are greater infection rates. I welcome the Minister’s points on the action that the Government are taking, but it is rather long-sighted and there is a real urgency to do something now.
I agree with the noble Baroness. Corridor care is perhaps one of the most visible and distressing symptoms of an NHS that the noble Lord, Lord Darzi, described as broken. We have to fix a number of the processes. I welcome that we are expanding urgent care access, for example, in primary, community and mental health settings, which will reduce demand on services. However, without publicly available data and the clinical operational standards that we are setting, the change will not be made as quickly as we would all like. There are immediate actions, as well as medium and long-term actions.
I agree with the need for more adult social care, but there is a whole range of factors that affect discharge delays, including the number of people who present. What the noble Lord outlined was not right and not the way in which his mother-in-law should have been dealt with. I know he would not expect me to comment further on individual circumstances, but if somebody is being considered for corridor care, that should be appropriately risk-assessed by clinical teams. The exact point he made is something that I have asked about. There should be a named nurse, and the provisions he talked about, such as food and drink, should have been there.
Baroness Gerada (CB)
We know from evidence that you can avoid hospital admission by improving continuity of care by general practitioners. When will the Minister redress the imbalance whereby GPs are funded from only 8% of the NHS budget yet deliver 70% to 80% of its care?
We very much appreciate the role that GPs play. Corridor care is related to a whole range of factors, not only the position of GPs. I have heard what the noble Baroness has said and will gladly relate it to my ministerial colleague.
The Earl of Effingham (Con)
My Lords, the Minister referenced data collection in her previous responses. In November, hospitals carried out 10% fewer operations than in October, but the Government claim the waiting list went down. Is that because the Government are paying hospitals £3 million per month in a process known as “validation”, and so it appears that the health service is treating more patients than it actually is? Is that the real reason that corridor care numbers are up?
No. I hope that the noble Lord would welcome a greater level of activity in this area. The waiting lists are going down. We have delivered, for example, 5.2 million extra appointments since we came into government, when we had promised just 2 million. Waiting lists are going down, and I am very happy to provide the data again to the noble Lord so that he can investigate that.
My Lords, my recent experience in care homes is that there are vacancies—unfilled beds—in private care homes. When are we going to do something about the mismatch of people in corridors, when beds are available? There needs to be some system introduced to get people into them.
The first thing that needs to happen is that people need to be cared for in the hospital. As I said in answer to an earlier question, everybody should be assessed according to their need. If there is a shortage of beds, it is for that hospital to manage. There will always be a difference of demand. However, where there are problems in hospitals that are not responding as they should, we are putting in improvement teams to ensure that change can be made. Of course, it is only when people are well enough, and it is suitable and safe to discharge them, that they will be discharged. It is important to match up availability of social care beds to needs.
(1 month, 2 weeks ago)
Lords ChamberMy Lords, in the interests of time I do not propose to summarise the many points and questions that have been raised in this debate. However, I wish to speak briefly to Amendment 320A in the name of my noble friend Lord Wolfson. The amendment seeks to set the presumption that the first assessment by the co-ordinating doctor
“must be undertaken in person, except in circumstances where this is not reasonably practicable”.
It is plain from everything that we have heard in the debate that the first assessment is a pivotal moment in the process set out in the Bill. It is the point at which a co-ordinating doctor must satisfy themselves not only of the diagnosis and prognosis but of the patient’s capacity and will and, crucially, the absence of coercion or pressure, as set out in Clause 10. These are human judgments that depend not simply on what a patient says but on the way that they say it, on physical cues and on the broader context in which the conversation takes place.
I listened carefully to the noble Baroness, Lady Finlay, in particular, as I did to other noble Lords, and an in-person assessment undoubtedly allows a clinician to observe matters that may not be apparent on a screen—for example, who else is present in the room, whether the individual appears comfortable speaking freely or whether there are signs, however subtle, of hesitation or external influence. At the same time, I suggest that we need to be patient-focused as well as doctor-focused, which is why my noble friend’s amendment seeks to recognise practical realities. There will surely, from time to time, be circumstances, perhaps in late-stage illness when a person may be in acute distress, where an in-person assessment is genuinely not possible. The reasons for that could be several, but in those cases we need to ask ourselves whether a live video and audio link would be preferable to a delay, or even a complete exclusion from the process.
I emphasise that the amendment is a probing one. If we decide that provision should be made for certain cases then that would surely be a classic area for guidance or codes of practice, but the key test in every instance would be what is reasonable in the circumstances. My noble friend wants to be clear that this amendment is about setting the right default for arguably the most consequential clinical judgment in the entire scheme of the Bill, while preserving professional discretion in response to the needs of the patient where circumstances require flexibility.
I have deliberately spoken in general terms when talking about what might not be reasonably practicable. The question is really the one posed by the noble Baroness, Lady Hayman: how rigid do we wish the Bill to be in prescribing how the system should work? I hope the noble and learned Lord, Lord Falconer, could set out his vision of how this mechanism will work in practice and how he will ensure that the safeguards that we all want to see can still be maintained if an in-person assessment is not possible.
My Lords, I am grateful to all noble Lords for their contributions to this debate. As ever, I will limit my comments to amendments on which the Government have major legal, technical or operational workability concerns.
First, I draw the attention of the Committee to operational workability concerns about Amendments 60 and 65. Under Amendment 60, professionals delivering the service would be responsible for checking whether the person was in England or Wales on multiple occasions before carrying out their duties, even if it had been confirmed that the person was ordinarily resident in England or Wales. That would place a significant burden on professionals delivering an assisted dying service.
My Lords, I express my gratitude to everyone who has taken part in the debate. I make special mention of the noble Baroness, Lady Smith of Newnham, and the noble Lord, Lord Polak, who spoke about the death of their father and mother. Like everyone else, I am grateful for what may have been something that was quite difficult to contribute to the debate. I hope I have not left out anyone else out who has done that.
These amendments fall effectively into two categories. The first is the England and Wales category—what do you have to be in England and Wales to do?—and, secondly, and separately, in what circumstances is a face-to-face meeting between either the patient and the doctors or the patient and the panel required?
I will deal first with the position of England and Wales, raised by Amendment 60, from the noble Baroness, Lady Coffey. Currently, under the provisions of the Bill, the first declaration made by the patient, the second declaration made by the patient, the first assessment of the patient, the second assessment of the patient and assistance being given to the patient all have to take place in England and Wales. There was a range of other things that the noble Baroness wished to take place while the patient was in England and Wales—for example, switching from one doctor to another, which is a process. For my part, I think the Bill has broadly got right when you have to be in England and Wales. Having listened carefully to what the noble Baroness has said, I am not minded to suggest an amendment in relation to that, and I note that it was not picked up as an issue by other people.
The face-to-face issues were much more what the Committee, if I may say so, was interested in through the course of this debate. The effect of the debate has been, in effect, to identify four possibilities. First, Amendment 65 wants each of the occasions, namely the two doctors and the panel, to always involve a face-to-face meeting. Secondly, there should be a face-to-face meeting unless there are—I use this phrase without intending to pick up all the amendments—exceptional circumstances or practicability issues. Thirdly, the third amendment from the noble Lord, Lord Blencathra, which he referred to, is that there should be, to use his language, a “statutory protocol” defining where there can be remote meetings, accepting that the norm is face to face. Fourthly, we could simply rely on the existing provisions of the Bill, which is that codes of practice can be issued by the Minister under the various provisions of the Bill saying when face to face is appropriate and when it is not.
The testimony—that is what it felt like—given of cases where remote has gone wrong have enormous power and I think we are all aware of circumstances where face to face will lead to much greater and better communication. The other side of the coin, which was referred to by the noble Baronesses, Lady Pidgeon and Lady Hayman, my noble friends Lady Jay and Lady Blackstone and the noble Earl, Lord Howe, is that there will be circumstances where, if you insist on face to face, you are, in effect, excluding some people from this right when they should have it. There are arguments on both sides.
I come away with the strongest possible feeling that the Committee thinks that face to face where possible is best but that there will be circumstances where it is not appropriate. That brings me to my third and fourth possibilities. It is wrong and dangerous to try to use a phrase such as “reasonably practicable” or “exceptional”; more is required and guidance should be given. This is not a criticism—it is a congratulation—but I do not think the words “statutory protocol” are right, but I get from what the noble Lord, Lord Blencathra, is saying that he wants something that has the force of regulations or something similar that says, “This is what we have in mind”. Whether that is a code of practice or a statutory protocol, I am not sure. I am sure it is not what is called a protocol, but it might be something quite like that. I think the right course for me is to go away and bring back something that satisfies the Committee that there will be something—a statutory protocol or a code of guidance—that indicates when face to face is appropriate or should be the norm, but gives the circumstances where it would not be, because I get the sense of anxiety about that. I hope, in the light of that approach, noble Lords will feel able to withdraw or not to press their amendments.
My Lords, I thank noble Lords for their contributions on this debate on artificial intelligence. It follows the debate yesterday, as referred to by the noble Lord, Lord Deben. The purpose of Amendment 66, tabled by the noble Baroness, Lady Coffey, is to prohibit artificial intelligence from being used to carry out functions under any section of or schedule to the Bill. This amendment is likely to have major workability impacts that could render the Bill unworkable and/or undeliverable.
While this is a policy matter, I will pick up points and considerations that have been made on the use of AI in practice. Broadly, artificial intelligence is absolutely in use in a number of pathways. It was indeed referred to in the 10-year health plan, and the ways it is being used include imaging and diagnosis. As this amendment stands, it would preclude an improvement in speed and in quality of care for patients.
Following my comments on workability, the amendment would incur an administrative burden that is likely to increase over time. AI is increasingly used across the economy and public services, including in the NHS, as set out in the 10-year health plan. The effect of the amendment as drafted is very broad in prohibiting this use of AI from carrying out any functions under the Bill. In the future, when AI is integrated into NHS systems across the board, it may well be difficult or even impossible to quarantine systems that are used for functions under the Bill. Additionally, this may risk creating a parallel system where voluntary assisted dying services are left behind and are potentially less safe for patients.
I am grateful to the noble Baroness, Lady Coffey, for raising artificial intelligence. There was, broadly, a consensus around the Committee, which the noble Baroness supported, that the amendment is much too blunt, but as she said, fairly, it gives us an opportunity to talk about AI. I will also pick up the right reverend Prelate the Bishop of Hereford’s contribution; he rightly said, as has been echoed around the Committee, that there have been huge benefits for patients from AI.
I think four concerns were raised during the debate. The first was: will AI affect decision-making? I think the underlying point there is that we do not want machines to make the decisions that are referred to in the Bill; we want human beings to make them. In particular, the decisions I have in mind are the decision of the first doctor, the decision of the second doctor, the decision of the panel, and the decision of the doctor, at the point that the assistance is being given, that the conditions are still satisfied. Everybody around the Chamber wants that to be decided by a doctor or a panel, depending on which it is, and I completely and unreservedly endorse and accept that.
Does that need to be made even clearer in the Bill? I will consider it, but I do not think that it does. The acid test for me is that if you fail to comply with your obligations as a doctor or as a panel, you can go to prison for up to five years. It is very difficult to imagine how you could put a machine in prison, so it is pretty clear that these decisions must be made by a human being. For my part and for everybody who supports the Bill, that must remain the position.
The second concern is advertising, which the noble Baroness, Lady Berridge, referred to. She is absolutely right. I have made it clear that I will bring forward amendments. Those amendments, which are almost finally drafted, make provision specifically in relation to digital advertising—they do not specifically refer to AI, but we need to address that in the advertising provision. I will lay those amendments so that the House can consider them.
The third concern is slightly generalised, which is that AI is very persuasive, particularly in persuading people to do things that they do not necessarily want to do. The first thing on that is that there is a wider societal requirement to address the pervasive impacts of AI in a whole range of things. We should all try to contribute to that. More focused on this is the question of the safeguards in the Bill, because they then become incredibly important. In particular, the safeguards require that there is doctor-to-patient discussion in relation to the decision for that patient, and they are specifically required in the preliminary conversation, the first conversation and the second conversation. It is those safeguards that one must see as the antidote to the persuasive aspect of AI, but I completely accept what people said on that.
The fourth issue, which was touched on very briefly, was the operation of devices. That, I think, referred to the fact that quite a number of medical devices can be operated by, for example, the blink of an eye or something quite minor. Again, that needs to be properly safeguarded. Those may not necessarily be AI problems but problems with other sorts of developments in technology.
I thank the noble Baroness, Lady Coffey, for raising this. We need to consider all the points she made. At the moment, apart from the advertising amendment, which I will bring forward, I am not sure that it requires amendment to the Bill.
My Lords, I will be very brief. The Government do not have any major technical or operational workability concerns on the amendments tabled by the noble Lord, Lord Sandhurst, and the noble Lord, Lord Harper, which were originally tabled, as we heard, by my noble friend Lord Hendy. To make the usual point, as noble Lords will be aware, these amendments have not had technical drafting support from officials, so further revision and corresponding amendments would be needed to provide consistent and coherent terminology throughout the Bill.
My Lords, I raised the point that the state could be liable in cases where the companies people worked for were nationalised or owned by the state. It seems not unreasonable that in due course the Minister could express a view on behalf of the Government, because the Government could be directly—and financially—affected by the consequences of the Bill.
I appreciate the point the noble Lord is making—and indeed the points that the noble Earl, Lord Howe, made. However, as your Lordships’ House knows, I correctly restrict myself to commentary on what is before us. Should the Bill include this amendment, we will then respond at the appropriate time.
My Lords, there are effectively two entirely separate issues raised by this group of amendments. The first is whether we should extend the current eligibility to people who have an inevitably progressive illness or disease to somebody who is terminally ill because they have injuries—for example, from a car accident—that might make them die within a specified period.
I was not sure whether the noble Lord, Lord Harper, was pressing that as an amendment, because the thrust of his remarks was much more focused on the effect on the Fatal Accidents Act. Whatever his position, I am afraid that I am not in favour of that amendment because the whole Bill has been put together and the argument for it has been based on people who are terminally ill. That is very different, for a whole variety of reasons mentioned by people, from somebody who is the victim of an injury.
I can see that people might say there was considerable moral equivalence, and the noble Lord, Lord Hendy, was right to say how persuasive he was when I spoke to him in relation to it. However, my clear view is that we should not extend the Bill beyond its current eligibility. I should also make absolutely clear that the wording of the Bill is clear; there is no prospect whatever that a court could construe the words “illness” or “disease” as meaning “injury”. What we send from Parliament will be the way it is read.
(1 month, 2 weeks ago)
Lords ChamberTo ask His Majesty’s Government what steps they are taking to address the shortage of batteries for NHS hearing aids.
My Lords, a single type of Energizer hearing aid battery is under supply pressure due to increased demand. It is still available to order and the NHS supply chain has instituted demand management to ensure a fair supply of available stock across the NHS. The NHS supply chain is working with Energizer and an alternative supplier to maximise stock availability and will take steps to improve future resilience. I am glad to say that the supply issue is anticipated to be resolved by 16 March.
I am grateful for that reply. While this is not the most urgent problem facing the NHS and its patients, 80% of people over 70 suffer from hearing loss. Many of them are now switching off their NHS hearing aids to conserve the batteries, and this has an impact on their quality of life. Last November, supply problems began to emerge and, as the noble Baroness has just said, if you go to the NHS supply chain website, it says that the batteries are subject to “demand management”—a euphemism for short supply. Very worryingly, as the noble Baroness has just said, normal service will not be resumed until March 16. So the question for the Minister is: what resilience is there now in the NHS supply chain for this product and others; why is there so much dependence on one supplier for a fairly basic product; and, related to that, why is it going to take so long to restore normal service?
These are very real issues that the noble Lord is raising. There are only three global manufacturers and we get our supplies from two of them. There are limited places to get them from. In terms of future resilience, we work very much in partnership, through our Supply Resilience Directorate, with industry and the wider sector to ensure continuity. Importantly, I very much welcome that there was recently investment in Tyne and Wear in the factory, on UK soil, in order to enhance our domestic manufacturing capability. But we will also conduct a lessons learned exercise after this.
My Lords, is it not the case that it is not just hearing aid batteries and that the NHS is facing problems with the supply of quite a number of pharmaceuticals? Could the Minister tell us precisely which major pharmaceutical products are affected by this, and is this a consequence of Brexit?
I think my noble friend has heard opinions already expressed on that matter. Certainly, Brexit does give us challenges, without a doubt, that this Government continue to work to resolve. I cannot answer the first question that my noble friend asked about, but I will gladly write to him and can assure him that we are working to overcome some of the challenges that we inherited and have been presented with, and that does include Brexit.
It should go without saying that rationing hearing aid batteries is totally unacceptable for some of the most vulnerable people in our society. The RNID say that the uncertainty of not knowing how long a battery will last can be very stressful, and no one should be forced to ration their hearing aid use because of supply problems. Whatever the cause, for sure this should never be allowed to happen again. What steps are the Government taking to make sure that it does not?
I certainly agree with the concerns about the impact on individuals. Further to the point raised by the noble Lord, in addition to the noble Baroness, I would recommend that people who are using hearing aids do not ration their hearing. That is not where we want to be, but in fact it is about not giving more supplies than are immediately needed. The real issue is that people are being asked to get their batteries more often. If that is a problem for people, they should raise it with a supplier, who will ensure that, for example, the postal service is used or some other way of getting batteries to individuals.
My Lords, in response to that previous answer from the Minister, I understand that, as a result of these shortages, some patients are being required to return to hospitals as frequently as once a week to obtain replacement batteries, while rationing their use in the meantime. Patients have also reported additional travel costs, and even hospital parking charges, because they are going more frequently to the hospital than they otherwise would. What steps is NHS England taking to mitigate these additional costs, particularly for those on lower incomes: for example, by offering, say, free temporary parking if they are going to the hospital only to pick up their batteries, or other mitigations that would help those people?
Well, it is of course a matter for local ICBs to decide what their best response is, depending on their local community. I should emphasise to your Lordships’ House that the reason for the increased demand is that there was a cyber attack on the alternative supply of batteries. That was an unpredictable issue, but is always one for which we need to have resilience. I do recognise what the noble Lord is saying, but that is why I answered to the noble Baroness that there are alternative ways of getting batteries to individuals.
My Lords, I checked my batteries and I am glad to say they were made in England. But we know that the Chinese dominate the world supply of batteries. Will she send a message to the Prime Minister while he is in China to ensure that, overall, our reliance on China for batteries is not increased? It is really important that we supply ourselves.
I am sure that the Prime Minister will be checking Hansard and will hear what the noble Baroness has said. The important point she made was about expanding our domestic manufacturing capability. These particular batteries are very specific in their manufacture—the noble Baroness is quite right—and that is why I welcome the company’s investment in Tyne and Wear: it is a vote of confidence in the British economy, as well as assisting us in our supplies.
My Lords, I love the idea that the Chinese are listening to our proceedings through your Lordships’ hearing aids. But I say to the Minister that there are many people under the age of 70 who suffer from hearing loss, possibly undiagnosed. It can have a huge impact on people’s cognition and on memory loss, but they are unaware of it. Can the Minister update the House on what the Government are doing to encourage youngsters such as myself to have hearing aid tests as a matter of routine?
I hope I share the noble Lord’s definition. I am enthusiastic about our new approach through the community diagnostic centres that noble Lords will have seen come on stream and be established all around the country. I agree totally about the age range, which is why we promote the fact that free hearing tests are available, and I encourage people to do them. The highest ever number of tests was done in October, over 136,000, which shows that the message is getting out, but I think the all-round approach of community diagnostics centres will really help us here.
Does this not once again reveal the fundamental flaw in the Government’s procurement policy, which the Treasury is still pursuing, of going for “cheapest is best” and ignoring all the lessons both of the pandemic and of the Ukraine war, which showed that relying on single points of failure regularly and consistently delivers problems into our system, in the long term at much greater cost? Do we not need a better-balanced programme?
I understand that point. Actually, that is one of the reasons we are encouraging ICBs to move to rechargeable batteries. As my noble friend says, it is about looking to the longer term. As part of the lessons learned, that is one of the things that we will look at to see how we can improve the underlying situation.
(1 month, 2 weeks ago)
Lords ChamberThat the draft Regulations laid before the House on 16 December 2025 be approved.
Considered in Grand Committee on 28 January.
(1 month, 2 weeks ago)
Grand CommitteeThat the Grand Committee do consider the Medical Devices (Fees Amendment) Regulations 2026.
My Lords, I am glad to introduce these regulations, which will take effect from 1 April. These regulations will amend the fees structure for the relevant medical devices regulations and provide for a new annual medical device fee to replace an existing fee. The fee will enable funding for the MHRA’s strengthened post-market surveillance—or PMS—activities in respect of medical devices. I want to clarify that, for 2026-27, the fee will be part-subsidised by the Department of Health and Social Care, with the intention, subject to further ministerial and parliamentary approval, to move to a fully cost-recovering annual fee from 2027-28.
Why are these regulations needed? Post-market surveillance refers to the work that the MHRA does to collect, review and act on safety and performance issues relating to devices on the market. The Independent Medicines and Medical Devices Safety Review highlighted the need for a high-quality PMS framework. That is necessary because the framework strengthens the medical devices safety and surveillance framework, improving patient safety and supporting the Government’s risk-proportionate, pro-innovation approach to regulation. The framework is estimated to increase the MHRA workload by 60% to 70%, at an annual cost of around £17 million, so it is vital to get the right level of funding. Historically, PMS activities have been funded mainly by subsidy from the DHSC, and partly by the current device registration fee.
I should say that subsidising ongoing regulatory activity through general taxation is not the usual approach of the MHRA to fees and services. The usual approach is based on HM Treasury’s Managing Public Money guidance, which states that fees should be set on a full cost-recovery basis. Therefore, as noble Lords will appreciate, these regulations reduce subsidy by introducing an annual fee, so that those who benefit from access to the market fund the regulatory activity that supports it.
I turn to how the regulations are intended to operate in practice. The new annual fee apportions the overall costs of the MHRA activities by using the Global Medical Device Nomenclature system, or GMDN for short. The fee will be calculated using the number of registered devices with the MHRA. In practice, the MHRA will charge based on the number of chargeable GMDN categories in which a manufacturer has registered devices. If a manufacturer has multiple devices within the same category, it will be charged once a year for that category.
A consultation was done by the MHRA on this fee as part of its last statutory fees uplift, so this is a new fee rather than an additional increase to a fee in the last fees uplift. The consultation ran from the end of August to 24 October 2024, and it was widely promoted, including through an SME webinar. In the consultation, the annual fee was proposed at £210 per GMDN code, using the most granular level of the GMDN structure. Several changes have been made following the consultation feedback, which we appreciated, in response to the concerns that were raised. The MHRA set up a group of industry representatives to assist with this, to discuss the approach and to seek advice on implementation. This has been welcomed and has provided useful feedback and assurance.
To meet the concerns that were raised, the fee is being phased in. It will give the sector time to adapt, as I outlined in my earlier comments. The costs have been fully subsidised in 2025-26, and this instrument introduces a part-subsidised annual fee for 2026-27. The fee was remodelled to be charged at a higher grouping of GMDN category, rather than individual codes, resulting in the costs being more equitably spread. The MHRA estimates that 56% of manufacturers will pay £300 a year and 82% will pay no more than £900 a year. Small and medium-sized enterprises are likely to pay only £300 a year, as they are likely to have a more limited range of products compared to larger companies.
Let me put this in context. The medtech sector generated an estimated £48 billion in turnover in 2023-24, and the total PMS cost of £17 million represents about 0.035% of this. I recognise that businesses would prefer to avoid any additional costs, but I am satisfied that moving to a fair, predictable, cost-recovering approach, along with the changes that have been made, will help address the key concerns and make the measure workable and fair.
On implementation and readiness, the MHRA has been working with the sector. The phased rollout has given the sector time to get ready. The MHRA published guidance explaining the new fee, how it will be calculated, what account holders need to do to ensure that their registration data is accurate, and how and when payment will be made. The MHRA is improving its systems currently, so that businesses will be able to see their GMDN categories, which will help them understand what they will be charged for by 1 April this year.
In closing, these regulations introduce a necessary and fair new annual fee from 1 April to help fund the MHRA’s strengthened PMS work. The approach has been improved in response to consultation feedback—for which we are most grateful, as I said—and is being introduced in a phased way, giving the sector the time it needs to adapt while ensuring that the MHRA has the resource it needs to protect patients and maintain confidence in the market. I beg to move.
My Lords, I am grateful to the Minister for introducing these regulations. Although we support a strong and properly resourced system of post-market surveillance for medical devices, I am afraid we have significant concerns about the Government’s approach to this instrument.
As the Minister said, these regulations introduce a significant shift in how medical device registration is funded. As she outlined, manufacturers will now be required to pay an annual fee of about £300 per device category, replacing the previous one-off registration fee of £261. A further annual maintenance fee of £300 will also apply. This is a substantial change to the cost base for manufacturers. Of course, while large companies may be able to absorb these costs, there is huge concern among the small and medium-sized enterprises that make up a large part of the UK’s health technology sector.
The Government argue that these fees are necessary to fund the MHRA’s post-market surveillance functions. We do not dispute the importance of ensuring that devices used across the NHS are safe, effective and properly monitored. We also do not oppose the notion of charging fees. However, the question before us is not whether surveillance matters but whether the Government have provided the evidence and analysis required to justify the scale, structure and timing of these new changes.
I am afraid that, both here and in the other place, we are concerned that the Government fall short on these. The most striking omission is the absence of the full impact assessment. Instead, the Government relied on de minimis assessment on the grounds that the fee remains partially subsidised for one more year. Of course, we welcome that, because it helps to cut the costs for some of the manufacturers but, at some stage, manufacturers have to be weaned off these subsidies—or what some people term “corporate welfare”. Yet Ministers have already confirmed that the subsidy will be removed in 2027-28, when the full recovery model will be introduced. We think that this is an extraordinarily short-term approach for a regulatory change with such long-term consequences. It is difficult to understand how the Government can justify this new fee regime, when it clearly imposes additional costs on businesses without providing Parliament with a full and transparent assessment of its impact.
The Minister will know that industry bodies, including the Association of British HealthTech Industries and the British In Vitro Diagnostics Association, have repeatedly raised concerns about the uncertainty surrounding long-term fee levels. It is only right, therefore, that we raise their concerns here. The BIVDA has warned that, under the original proposals, some IVD manufacturers could have faced fee increases of up to 5,000% due to the granularity of the GMDN categories. Let us be clear: we are grateful that the Government have since moved to a higher-level categorisation—they should be given credit for that—but the underlying uncertainty remains. The MHRA’s own modelling suggests that the full cost recovery could require charges of more than £800 per device category. This is not a marginal adjustment for some of those small companies. It could be the difference between entering the UK market and walking away from it.
The Minister will be aware that these concerns were echoed in a Delegated Legislation Committee in the other place. Yet, despite these legitimate questions, the Government have still not provided clarity on how the new fee structure will affect different types of manufacturers. Unfortunately, they have also still not provided clarity on how they intend to mitigate the risk of reduced product availability, particularly for low-volume devices, including those used in diagnosis of rare diseases.
This is not an isolated change; it follows recent regulations on post-market surveillance on in vitro diagnostic devices. The cumulative effect is a regulatory environment that is shifting rapidly without the stability or predictability that businesses need in order to plan investment and product development.
We are disappointed by these regulations—not really their content but more the lack of the full impact assessment. The Government have not provided clarity on the long-term fee levels, addressed industry concerns about the risk of product withdrawal or given Parliament the information that it requires to scrutinise the consequences of this new fee regime. A proper impact assessment should have been conducted to avoid problems later.
Noble Lords will know that I take an interest in the phenomenon of unintended consequences. They will be aware of the “dash to diesel” when, in 2001, the then Chancellor of the Exchequer introduced a system of car tax to incentivise motorists to switch to diesel cars in order to meet lower CO2 emissions targets. That was understandable, but it was later found to have also led to an increase in emissions of harmful nitrogen dioxide and particulates. The reason I raise this is that, at the time, it had been claimed that some civil servants raised concerns about this consequence but were ignored.
This is not a party-political issue. The question is whether Governments of any colour have learned the lessons from that incident. How do we make sure that, when potential consequences are raised with the Government, they are seriously taken on board, particularly in terms of a full impact assessment? Given the current concerns that have been raised, rather than introducing these new charges now only to find out that, as a result of the consequences, they will have to be reversed or tweaked, surely it would be better for the Government to pause the process to introduce the new charging regime until a proper and full impact assessment has been conducted.
We understand that the running costs of the MHRA have to be met somehow and we agree with the Government that they have to wean companies off those subsidies in the adjustment. However, in the other place, my honourable friend the shadow Minister for Health, Caroline Johnson, pointed out that previous calculations of the cost base of the MHRA had not taken account of, for example, the impact of the rise in NI contributions on the running costs of the MHRA, so the Government have had to find some extra money to plug that gap. Perhaps that is why this SI has been rushed through without a proper, full impact assessment, although it may well not be.
My honourable friend also asked about a consultation that revealed widespread concern, with only 10% support. The Minister replied that changes had been made following discussions with a “trusted advisory group”. My honourable friend then asked:
“Who is in the trusted advisory group? Whose voices from micro and small businesses were heard in that group?”.—[Official Report, Commons, Third Delegated Legislation Committee, 21/1/26; col. 7.]
Unfortunately, she has not had an answer.
I am grateful to the noble Lord for his interest in this important subject and for expressing his concerns, which I will address. I know that he is more than supportive of patient safety and taking a risk-proportionate and pro-innovation approach —I hope that is not putting words into his mouth, but that is my experience of him—and that is what this is about. I have heard his request to defer consideration of these regulations. I would not want to agree to that, not least because of the timetable we have set out. In running the consultation and responding very directly to the concerns raised, which were very real and appreciated, as well as by working with industry and being transparent and prepared, we feel that it is time for these regulations.
The noble Lord, Lord Kamall, referred to substantial additional costs on businesses. The impact on business is estimated at £4.3 million a year in total. Of course, de minimis assessments are not usually published. However, we have included that figure in the Explanatory Memorandum and committed—I hope that this will be helpful—to a full impact assessment for the fully cost-recovering fee in 2027-28. I hope that that will go some way to assist the noble Lord.
My Lords, the noble Lord, Lord Kamall, asked further questions about the timing of the full impact assessment and why it is not being done this year. The reason is that the full impact assessment will refer to 2027-28, when the fees will be paid in full. Currently, because they are being subsidised for one year only, a de minimis assessment is required, but, when we have the full-fat version, that will be the right time for the impact assessment.
The noble Lord raised some questions that had been asked in the other place by Dr Caroline Johnson MP. I assure him that my ministerial colleague with responsibility for this area, Dr Zubir Ahmed MP, will reply to that Member of Parliament, and I will of course make sure that the noble Lord sees a copy of that response.
A question was raised about obsolescence and PMS. In response, I can say that if a manufacturer stops supplying a medical device, the company or its UK responsible person must update the MHRA registration by removing the product or stating that it has stopped being sold. Devices already on the market can stay in the supply chain or be used, as long as they are not recalled, and manufacturers are responsible for post-market surveillance duties. So, if the manufacturer no longer exists and has no legal successor, these duties do not transfer. For manufacturers outside the UK, the UK responsible person has to keep and provide plans and reports if requested. If there are any concerns, the MHRA will continue to monitor device safety and can act. The main summary is that manufacturers themselves or the UK responsible person are responsible for updating the MHRA.
The noble Lord, Lord Kamall, asked about the impact on small and medium-sized enterprises. I recognise, as I said in my opening, that new regulatory costs can be felt more sharply in this area, and that is why the MHRA listened carefully. It is also why the fee has been designed to spread costs more equitably across the sector, and why, once we had the consultation and the feedback, charging is to be based on a number of the GMDN categories that a manufacturer’s registered devices fall into, rather than the much more granular GMDN code. That matters for small and medium-sized enterprises because they are more likely to have closely related product variants that may attract multiple level 5 terms that sit within a single level 2 category. Under this approach, multiple products that are in one level 2 category are charged once a year, reducing repeat charges for minor product variations, which is important to SMEs. To re-emphasise, the MHRA estimates that about 56% of manufacturers will pay a single unit fee of £300 a year. It is SMEs that are most likely to fall into this lower charging group because they typically have a narrower product range than larger companies.
I can say to the noble Lord, Lord Kamall, that, as I said earlier, the charge is designed to be proportionate. I should say that if there were to be any waivers— I know that he did not specifically ask that but raised general concerns—that would simply shift costs elsewhere. We need to keep the charge predictable and proportionate, and to phase it in.
My final point is that SMEs stand to benefit from a stronger PMS framework. It will mean earlier identification of issues, fewer surprises and a more risk- proportionate, predictable regulatory approach. That is what supports responsible innovation, and I know that is of concern to the Grand Committee.
Taken together, these regulations put the funding of a strengthened PMS on a clearer, more sustainable and fairer footing, so that those who benefit from access to the UK market contribute fairly to the ongoing regulatory work that supports that access, because that regulatory work has to be paid for in some way. I cannot emphasise enough how the fee has been redesigned following the consultation. Often, noble Lords question the value of a consultation and whether it really makes change. I can say that, on this one, without a doubt, it has done, and I am grateful to all those who contributed.
Today, these regulations, if agreed by your Lordships’ Grand Committee, will mean that we can maintain confidence in the safety and performance of medical devices, support continued access, and ensure that the MHRA has the capacity to act quickly and proportionately should issues arise. For those reasons, I hope noble Lords will support these changes.
(1 month, 3 weeks ago)
Lords Chamber
Baroness Hughes of Stretford
To ask His Majesty’s Government what action they plan to take in response to the finding in the MBRRACE-UK report Maternal mortality 2022–2024, published on 8 January, that the maternal death rate in pregnancy rose by 20 per cent between 2009–11 and 2022–24.
My Lords, MBRRACE’s report highlights the need to improve maternity safety, to which this Government are fully committed. We have commissioned an independent investigation that will present recommendations in the spring, while the National Maternity and Neonatal Taskforce, chaired by the Secretary of State, will transform these into a deliverable national action plan to drive change. In the meantime, we are taking various actions, including piloting Martha’s rule and expanding the maternal medicine networks.
Baroness Hughes of Stretford (Lab)
I thank my noble friend for that Answer. She will know that the Conservatives promised to halve maternity mortality by 2025. Instead, as the report shows, it has risen substantially, with stark disparities for older women and those from BME and disadvantaged backgrounds. Between 2021 and 2023, over 600 women died either during or shortly after pregnancy—a tragedy compounded by the fact that, in the majority of cases, this was from a preventable complication of the pregnancy itself. I know the Government are taking certain actions, to which she referred. Those are welcome, but they are not being applied consistently in every area. More importantly, trusts are not required to inform NHS England of the plans they are making. In short, I say to my noble friend that there seems to be a lack of robust oversight. How will the Government ensure that the standards and new procedures that they want to implement will be implemented effectively by every trust and in relation to every pregnant woman?
My noble friend is right to use the word “tragedy” in respect of maternal deaths, particularly those from preventable causes. She is also correct that, sadly, most aspects of the maternal safety ambition that was set under the previous Government are very unlikely to be achieved. We have to make sure that, for any future target, the system can deliver. As one example, the maternal care bundle sets clear standards across all services for implementation by NHS providers and commissioners, and is focused very much on the main causes of maternal death and harm, as my noble friend asks for.
My Lords, the Government have launched a maternity inquiry, but we have already had lots of maternity inquiries and reports from the charity sector, such as the Muslim Women’s Network— I declare my interest as its CEO—Five X More and Birthrights, all with similar findings and recommendations. Instead of having more inquiries, why do the Government not just get on with it and implement actions? What do they expect to find that they do not already know? Can the Minister share how she is implementing existing recommendations?
I understand what the noble Baroness is saying and her frustration, which I am sure many of us share. The purpose of the investigation by my noble friend Lady Amos is to pull together all the learning and all the inquiries. She has, for example, given a real voice to those affected, speaking to 170 affected family members. Those voices are what has been missing, and that cannot go on. We are determined to draw a line under where we have unfortunately been and to move forward, while taking direct actions, including, for example, a national programme to support struggling trusts to make improvements.
My Lords, recent Health Service Journal investigative journalism has found that the Chief Midwifery Officer wrote to trusts last year identifying gross failures in home births safety, yet the Government have chosen to keep this information private while women are pushed into unsupported births. Is it acceptable for NHS England to hide this evidence of systematic safety risk from the public when the home birth services of 14 trust have effectively ceased to exist, despite the legal duty to provide them?
I am not fully up to speed with the article that the noble Lord raises, but I undertake to look at it and get back to him, because this is a very important matter.
My Lords, many NHS trusts are facing deficits in midwives. There is not a sufficient workforce. What are the Government doing to tackle this issue? New parents, and new mothers during their birth, are not being supported, and there are significant problems as a direct result of this.
Midwives are absolutely crucial, and I pay tribute to them and to the wider maternity team. As of October 2025, there has been an increase of some 3.6%—that is 878 more midwives—compared to October 2024. Importantly, we are seeing the introduction of a range of initiatives to improve retention in the maternity workforce, including in midwifery. That will include mentoring and giving better advice and support on pensions and flexible retirement options, because we are keen to retain the long years of service that many midwives and other staff have.
My Lords, touching partly on the question from the noble Baroness, Lady Gohir, data from MBRRACE-UK shows that black women are three times more likely to die during pregnancy or childbirth than white women. Do the department and NHS England have any evidence on the reasons for these disparities that the Minister can share with the House? Will she tell noble Lords how NHS England and the department intend to tackle these disparities?
I am glad to say that my noble friend Lady Amos will be very much focusing on this area. I referred earlier to the maternal care bundle, which focuses on the five main causes of maternal death and harm, as well as on setting up best practice. A number of the risk factors are particularly associated with groups who live in areas of greater disadvantage, those who have pre-existing conditions and, as the noble Lord rightly says, sadly, black women, who are three times more likely to die—something that is totally unacceptable in any day and age, but certainly now. We cannot allow this to go on. That is why we have picked up a key recommendation from the Black Maternal Health inquiry for mechanisms for surveillance of severe maternal morbidity. The first data are expected in the summer.
My Lords, a confidential inquiry into maternal deaths is a good indicator of the quality of maternity services. The fact that the rate has gone up from 9 per 100,000 in my time to 12.8 now suggests that there is a failure of maternity services. To use an example, 155 women who had a history of psychiatric problems—mental health problems—died within a year of delivering a baby. That compares to the total number of 611 maternal deaths. It is a significant number, and yet the specialist perinatal maternity health services that are supposed to look after women with a mental health history have failed. It should be a duty on ICBs to produce a plan, so that women with a mental health history are looked after and have a care plan during pregnancy.
This is absolutely crucial. I welcome that, as of June last year, maternal mental health services are available in all parts of England. We also now have 153 operational mother and baby unit beds providing in-patient care to women experiencing severe mental health difficulties during and before pregnancy. In addition, mental health services are available for women who have pre-existing mental health needs, as well as for those who experience challenges because of their pregnancy or labour. The GP check-up six to eight weeks after birth is absolutely crucial.
My Lords, something is happening. In the last decade or so, I have been watching the extraordinary increase in the number of healthy young mothers having C-sections. Why is this phenomenon—if I might call it that, though that is probably the wrong word to use—happening? Is this something that is part of the inquiry? Are people trying to understand whether it is because those in the midwifery world are afraid that natural births lead to more deaths?
This may be something that my noble friend Lady Amos looks at. She is very much focused on maternity services, which will include mortality and looking at the range of options. The noble Baroness will understand that there is an important balance to be struck between the voice and choice of patients, which we respect, and safety, which must be paramount.
(1 month, 3 weeks ago)
Lords ChamberMy Lords, the amendments in this group relate to two fundamental question: first, who should have the legal right to assistance under this Bill and, secondly, who should not. They are both important questions. We have heard concerns about eligibility throughout the discussion in Committee. In particular, the question of whether the person must be in pain to access assistance has been a point of contention. I think that will come up in the next group, on motivation.
I hope all noble Lords across the Committee will agree that the Bill needs sufficient safeguards to ensure that those asking for an assisted death meet three conditions: first, that they have sufficient reason to do so; secondly, that they have the mental capacity to do so; and, thirdly, that they are fully aware of what they are asking for. If any one of those conditions is not met then someone should not be able to ask for an assisted death on their part. That is because the Bill is generally—intentionally, as I understand it from the noble and learned Lord, Lord Falconer of Thoroton—a tightly drawn proposal. Therefore, it would not be right for the Bill to become law without its provisions tightly defining assistance in line with Parliament’s intentions. I know that reports of incidents in other countries where people have used assisted dying services to end their lives for reasons other than terminal illness are concerning. Therefore, I understand the reasons why the various noble Lords have put forward the amendments in this group.
I will pick up a couple of the amendments. Amendment 28, from the noble Baroness, Lady Finlay, seeks to ensure that people who seek assistance are not doing so out of financial difficulties. As I understand the course of the debates, that does not run contrary to the underlying principle set out by the noble and learned Lord, so I hope he will be able to explain how protections for those in financial difficulty would function under the Bill. Can we strengthen its provisions to ensure that those in financial difficulty who are also terminally ill are not choosing to end their life mainly because of their financial circumstances?
I also highlight Amendment 39, from the noble Baroness, Lady Grey-Thompson, which would require a heightened evidential standard for those living in care homes and nursing homes. We know from events not only but perhaps in particular during the pandemic that those living in care homes and nursing homes are particularly vulnerable. They can be taken advantage of, so I understand the noble Baroness’s motivation in probing the noble and learned Lord on whether there are sufficient protections for vulnerable residents of care homes. Amendment 38, in the name of the noble Baroness, Lady O’Loan, focuses on another particularly vulnerable group: those with certain mental health conditions.
The impetus of this legislation is concern for those who seek an assisted death because they are considered to be in distress or in pain and vulnerable. But in legislating for that vulnerable group, it is important that we do not unintentionally endanger other vulnerable people and groups. I therefore look forward not only to the contribution from the Minister, but to the reply from the noble and learned Lord, Lord Falconer of Thoroton, particularly on whether, going forward, we will receive amendments from him on a rolling basis. That would help not only those on the Committee but on the Front Bench to plan our work.
I thank all noble Lords for their contributions to the debate. As I have said previously, I will limit any detailed comments to amendments about which the Government have major legal, technical or operational workability concerns. To that point, I would like to clarify for the noble Baroness, Lady Berridge, that that does include interaction with other legislation, on account of the Government’s clear duty to the statute book. I heard the noble Baroness make a request for government engagement. Should Parliament choose to pass the Bill, we will work with stakeholders to design a robust and effective service, but in the meantime, engagement is a matter for the sponsor.
The specific issue I raised relates to a different piece of legislation for which the Minister has responsibility. Once the legislation is passed, if it is not compatible, it is too late. May I make this request? I am not requesting a meeting under the TIA Bill; I am requesting a meeting for the Royal College of Psychiatrists and Professor Sir Alex Ruck Keene under the Mental Health Act. I do not understand why the Minister cannot grant that meeting.
For the reasons I have already outlined. That is why I clarified that, when I say I am only speaking about where there are particular concerns, if I do not refer to them, there are no concerns to raise for the attention of your Lordships’ House, which I would always be very clear in doing.
The noble Baroness, Lady Finlay, asked about Peers’ access to technical drafting support. To reiterate, as we all know, it is the sponsor who leads on engagement with Peers on policy content. To meet our responsibilities as a Government, we have been working with the sponsor of the Bill on amendments to ensure operational workability, were the Bill to pass. It might be helpful for the noble Baroness if I say that, where amendments were passed in the other place, there was support for the sponsor to ensure that the amendments met the test of being fully workable, effective and enforceable. In those cases, it was for the sponsor to table amendments to address any workability concerns.
I apologise for interrupting the Minister, who is being extremely helpful, but one point needs to be clarified as a result of what she just said. I understood the Government to say that, if an amendment is passed on Report, assistance will then be available of the same kind that was available to the sponsor, so that the amendment can become workable in the context of the Bill and other law by the time the Bill is passed. That was a very clear understanding given to me in various quarters. Are we hearing now that that facility will not be given if an amendment is passed on Report? If so, why?
I am not sure that there is that difference, but I will review the Hansard of this debate and ensure that I come back to the noble Lord and place a copy of my response in the Library. I am not entirely clear about the point the noble Lord is making. I realise that that is disappointing for him.
I will intervene only once more. It seems to be fundamentally necessary that, if an amendment is passed on Report that changes something put in the Bill by the sponsor, who has had the advantage of the consultation process we have discussed at length in these proceedings, the same attention should be given to it—and I am sure that is exactly what the noble and learned Lord expects. Otherwise, we run the risk of asking people like the noble and learned Baroness, Lady Butler-Sloss—if there is anyone like her—to move the goalposts, rather than do what she really does, which is be extremely nimble between the goalposts.
I am grateful for the clarification on goalposts moving. What the noble Lord is saying is correct, and there is not going to be any change to what has been said previously. I hope that he and your Lordships’ House will forgive me if I have not put it as clearly as certainly the noble Lord would have liked. I will still make a review of the words and ensure that everything is clear. I hope that will be helpful.
I listened really carefully to the Minister. Am I to understand, in my simplistic, non-legal and non-ministerial way, that the drafting of an amendment will be down to us and the Public Bill Office? If that wording, however inadequate, is then voted into the Bill at that stage, advice on workability would be given, and therefore a further correction to vote would be at Third Reading. Is that correct?
That is the normal way of doing things. I hope that too is helpful.
Amendment 27, tabled by the noble Baroness, Lady Finlay, would require a terminally ill person to have
“made independent contact with their local voluntary assisted death service for information”
in order to be eligible to request assistance under the Bill. However, the fact is that a local voluntary assisted death service is not defined, and the concept does not feature anywhere else in the Bill. Furthermore, no mechanism is provided for assessing whether this eligibility requirement has been met. That would render the Bill unworkable as drafted, and would require further amendments to ensure its workability.
Amendment 28, also tabled by the noble Baroness, Lady Finlay, would add two eligibility requirements for a person seeking an assisted death under the Bill: first, that the person was eligible for benefits from the Department for Work and Pensions via the Special Rules for end of life, the SERL process; and, secondly, that the person had received a home visit from their GP in the six months preceding their request for an assisted death. Not all terminally ill people opt to apply for, or are eligible for, certain benefits at the end of their life. Those people who do not claim would therefore become ineligible under the provision as drafted.
The Bill and the SERL system also have different definitions for end of life. The Bill defines “terminally ill” as six months to live while the SERL process uses 12 months. That would be operationally confusing. Equally, not all terminally ill people will necessarily have had a recent home visit by a GP. That again poses operational challenges for GP resources.
Amendment 28 refers to SR1, the medical evidence form that clinicians issue to evidence that a person is at the end of their life. It is unusual for forms of this nature to be put into primary legislation, and the form by itself does not establish eligibility for benefits. Furthermore, referring to the form in primary legislation could result in delivery challenges should the DWP amend that form at any point in future.
Amendment 38, tabled by the noble Baroness, Lady O’Loan, would introduce several qualifications to the eligibility criteria in Clause 1. This amendment could cause operational challenges for assessing doctors and panels. As drafted, the amendments contain undefined and unclear terminology and it is not evident how these new criteria should be assessed. Noble Lords may also note the risk that the amendments could give rise to challenge on ECHR grounds as they would lead to a difference in treatment for those who have a history of mental health conditions, suicidal ideation or self-harm. Any differential treatment would need to be objectively and reasonably justified to comply with ECHR obligations.
My Lords, this has been another rather long but interesting debate. It is important that noble Lords who wanted to speak had their voices heard. It touches on something we touched on very early. Noble Lords will remember when we debated another version of motivation and talked about coercion. A number of noble Lords put forward amendments to talk about encouragement. In that debate, we saw how difficult it was to distinguish between encouragement and coercion, to say whether encouragement is a form of coercion, and to legally define something such as encouragement.
Now we have the very same issue with motivation. In some ways, as the noble Baroness, Lady Cass, said, motivation is the internal version: it is self-encouragement or self-coercion, not wanting to feel a burden. We have debated what it means to feel like a burden. It is important that we understand the motivation. As the noble Baroness said, professionally, doctors need to do that to understand what help or assistance that patient could be given. It could be, if this Bill passes, that they are allowed or helped to progress to assisted dying, but it could be that they are offered something else that they feel very comfortable with that gives them a bit longer to live and to have that quality time that the noble Baroness, Lady Fox, talked about having with her family. When I was a Health Minister, one of the things that I learned about palliative care from the noble Baroness, Lady Finlay, when I first spoke to her was that people who live longer, even though they may have wanted their life to end “now”, appreciated that extra time with their family, once they entered palliative care, to close those unclosed things, to make up with friends and family they may have fallen out with, and to bring closure to their life before they went. It is important that we recognise that. I do not want to go back into the whole debate about palliative care, but it is important that it is seen as an option to give that closure to people, even if they do not want it and they decide, “I’ve made my mind up”. That is probably a more informed choice.
We need to be very careful about trying to define exactly what the one word that sums up the debate is. If it is about choice and only choice, pretty soon after the Bill reaches the statute book, people will say, “I only have 12 months to live. Why can’t I have the same choice as people who have six months?” Surely it is about not just choice or suffering but a combination of factors. That makes it incredibly difficult for the lawyers, but also for the medical people, to determine. We need to unpick some of that.
Noble Lords who have spoken on this group have picked up a number of issues: people feeling like a burden, mental health disorders, disabilities, and remembering that not all disabilities are visible. On that point, I welcome back the noble Baroness, Lady Campbell of Surbiton—I should know her title because she lives down the road from me; next time she sees me on the high street, she will probably prod me on that. There are also financial considerations, self-motivation and avoiding physical pain. The Bill does not require a specific motive as part of the eligibility criteria. Obviously, the whole Bill is about eligibility—the first few words are about who is eligible to seek assisted death services or terminally ill adult services—but it would be helpful if the noble and learned Lord, Lord Falconer of Thoroton, could expand on the thought process behind his very tight definition of “eligibility”.
I must say to noble Lords who have teased the noble and learned Lord a little bit about things that he may have said in the past that we are all entitled to change our mind when we learn new facts or hear a different view. I do not see it as a weakness in an argument if someone changes their mind when they have heard new facts. I find myself defending the noble and learned Lord, but I do not think we should be too harsh. I should remind people that I am personally very torn on this Bill, and I have not made up my mind. I am waiting to see the outcome of this debate before I make up my own mind about how I vote on this.
We also heard about dignity. I teach at a Catholic university, and dignity is a very important concept in Catholic social teaching. But what is dignity? It can be subjective. One person could be told that they have to wear incontinence pads for the rest of their life, and someone else could be told, “I’m sorry, you can’t walk for the rest of your life”, but other people have quite a full life even if they face those challenges or find themselves disabled. It is really difficult to define dignity; in many ways, it is subjective.
I have read many of the papal encyclicals about all this. By the way, I am a Muslim teaching at a Catholic University; in many ways I am the diversity, if you like. It is important that we consider what we really mean by dignity. We all think we know what it means, but we all have a different perspective on what it is.
A point that has come up many times in the debate is that we hear the words “pain” and “suffering”, but they are not in the Bill. We have to ask the noble and learned Lord, the sponsor of the Bill, about the thought process behind why he decided not to put “pain” and “suffering” in the Bill so that we can all understand, given that many noble Lords have asked that question about pain and suffering, why they are not explicitly there.
I ask the Minister this very carefully. A number of times during Committee, we have put questions to the Government but they have constrained themselves as to what they answer. It is important that the Government tell us what the implications would be if the Bill were to pass into law and what that would mean for resources in the department and for decisions that the Department of Health may have to make, as well as what it might mean for other departments of government. That is important. We cannot just say, “I’m going to confine myself to these few clauses”, because this will have implications. Some will say that it may have implications for wider society—a society that allows people to take their lives earlier or encourages death. It changes the sort of society we live in. Many people will welcome that and will say it is a society of choice, while others will say, “No, we don’t want to live in that sort of society”. We have to remember the implications of this Bill.
I ask the Minister to set out the Government’s considered view. I know that the Minister will say that some of these amendments as drafted are not legally sound—we understand all that—but these are probing amendments. This is a Committee stage and the amendments are not meant to be completely technically sound. We need to know, if they were to pass and were to be tidied up by the government lawyers or the officials, what that would mean for the workability of the wider health and care system and not just in respect of these issues that we are debating or the individual clauses in the Bill. We need to have a clear view of how this will change things and of the challenges that any Government will face when a new Bill comes in. That would be helpful.
I will stop there. I have asked a few questions to the noble and learned Lord, Lord Falconer of Thoroton, about the motivations for some of the decisions that he made in drafting the Bill, but also to the Minister speaking on behalf of the Government to answer the very real implications for resources, et cetera, not only in the Department of Health and Social Care but more widely across government.
My Lords, I, too, welcome back to the Chamber and to this House the noble Baroness, Lady Campbell. It is a pleasure to see her back with us and I thank her and other noble Lords for their contributions in this group of amendments.
I once again make it clear that I will keep any detailed comments limited to amendments on which the Government have major legal, technical or operational workability concerns. It is important to remind your Lordships’ House of that. I say to the noble Lord, Lord Kamall, that the Government are doing only what any Government would do, which is to be scrupulously neutral, as your Lordships would expect us to be, and to handle it in that way. If Parliament passes the Bill into law, of course we will ensure its safe and effective implementation, but until that point I am afraid that I will be sticking scrupulously to what the role of any Government would be. I am sure that the noble Lord understands.
Amendment 30, tabled by the noble Baroness, Lady Foster, was spoken to by the noble Lord, Lord Weir, and Amendment 30ZA, in the name of the noble Baroness, Lady Lawlor, seek to prevent a terminally ill person in England or Wales from being eligible for an assisted death if they are motivated by certain specified factors. These amendments would introduce uncertainty around definitions and concepts, such as what constitutes “adequate housing”. They would also create an internal inconsistency in the Bill, as they are not reflected in later provisions that set out the assessment process. Drafting difficulties and internal inconsistencies are likely to result in confusion on eligibility, and significant further consequential amendments and policy development would be needed to produce predictable legal effects.
The Government also have some further practical operational concerns, which I will note for the Committee’s consideration. The amendment’s exclusion of those
“substantially motivated by… a disability”,
while excluding terminal illness from “disability”, would be potentially complex to operationalise. It may also be that somebody has multiple motivations. It is unclear how these could be separated or who would be able to make a final judgement.
That is a fair point to be made. It is why the question was asked, and I thank the noble Baroness for answering it.
I thank my noble friend Lord Frost for provoking this debate, because there are still other arguments for using the phrase “assisted suicide”, particularly in terms of clarity. I look forward to the consideration of the arguments made by my noble friend Lord Frost from the noble and learned Lord, Lord Falconer, and the Minister.
My Lords, I will be very brief. The amendments tabled by the noble Lord, Lord Frost, do not present significant workability concerns. As noble Lords will be aware, the amendments have not had technical drafting support from officials. Therefore, further revision and corresponding amendments would be needed to provide consistent and coherent terminology throughout the Bill.
(1 month, 3 weeks ago)
Lords ChamberMy Lords, I am delighted to pledge the Government’s full support for this Bill. It is very much aligned with our commitments, it strengthens the research ecosystem and, most importantly—I agree with many comments today—it gives hope to patients and families affected by rare cancers. I am glad that the Bill has the support of the noble Lords, Lord Kamall and Lord Palmer, on behalf of their Benches.
I am most grateful to noble Lords for their points and proposals today. I will be reflecting on them after this debate with the Minister in this area, Ashley Dalton MP, and also Zubir Ahmed MP. I was very touched that so many Peers shared their personal experiences, whether their own or those of their loved ones. I feel that the Bill stands in tribute to the memory of so many, including the late Baronesses, Lady McDonagh and Lady Jowell. It also stands in tribute to the memory of so many who I believe have been brought into the Chamber today by the very touching words and reflections of so many noble Lords. I realise how difficult that is.
I congratulate my noble friend Lady Elliott on her tenacity and clarity in bringing forward this important Bill before the House. I associate myself with the thanks to the many campaigners and charities who have worked on this for so many years, and I know they will continue to do so. My noble friend Lady Morgan made that point particularly clearly. I say to the House, and particularly to the noble Lord, Lord Kamall, that the Government are quite clear that no patient should be left behind simply because their cancer is less common.
The national cancer plan is soon to be published— I heard what the noble Lord, Lord Polak, hopes will be in there, and he will not have to wait too long for it—and it will build on the progress of this Bill. They work very well together, because they both seek to improve outcomes for cancer patients across the country, including those with rare cancers. It is by fighting cancer on all fronts—prevention, diagnosis, treatment and research—that we will make that change.
Much has been said today, and rightly so, about a number of cancers, but I want to say a particular word on how little is currently known about the prevention, diagnosis and management of brain tumours. They remain one of the hardest cancers to treat, and we also know how crucial early diagnosis is for improving survival rates for all cancers, including brain tumours. That is why we have committed to an additional £6 billion capital investment on new diagnostic, elective and urgent care capacity. The noble Lord, Lord Patel, called for genome sequencing for brain tumours. I can say to him that the national cancer plan will include detail on how we ensure that patients have access to the latest treatments and technology, including genetic treatments.
Important points were raised by the noble Baroness, Lady Grey-Thompson, and the noble Lord, Lord O’Shaughnessy, among others, about how the £40 million commitment to NIHR funding for brain tumour research will be met. That commitment absolutely remains in place, but there is no upper limit to our funding of high-quality brain tumour research and we are committed to exceeding the £40 million target. I should also add that there is no limit to our funding of high-quality childhood cancer research.
Clinical research, rightly, is at the core of this Bill. It is one of the most powerful tools that we have. I believe that the Bill will complement the ambitions in our 10-year health plan and the forthcoming national cancer plan to embed that research across the NHS and give patients greater control. It will make it much easier for researchers to connect with patients with rare cancers and streamline the recruitment for clinical trials and will ensure our regulatory framework delivers for those who need it most.
The noble Lord, Lord O’Shaughnessy, and the noble Baronesses, Lady Finlay and Lady Browning, raised the database. The database is live across the UK; it is a UK-wide registry. I urge everyone to sign up to be part of research in order to connect with trials. The noble Baroness, Lady Browning, also asked about strengthening the orphan drug regulations. We must ensure that there is a detailed review before any decisions are made on the regulations.
I say to the noble Lord, Lord Polak, that we will ensure that we do all we can to improve how we use data for research and raise public awareness of consent. I certainly fully support the digitisation of advance consent, which he referred to.
It is key that we incentivise research and continue to support and develop cutting-edge research for rare cancers and other rare diseases through the NIHR. For example, in December, we launched a pioneering new brain tumour research consortium to accelerate research into new treatments through the NIHR, which is investing an initial £13.7 million, with significant further funding expected to be announced shortly. We are also ensuring the effective co-ordination of research from other funders and charities through the Office for Strategic Coordination of Health Research, which is chaired by the noble Lord, Lord Kakkar.
We published Transforming the UK clinical research system: August 2025 update outlining how we fully delivered against all the recommendations in the review conducted by the noble Lord, Lord O’Shaughnessy, who I thank for his work on commercial clinical trials. We will go still further to deliver on our 10-year health plan and cut clinical trial set-up times to under 150 days by March—a target driven by the Prime Minister. We are taking forward the most significant reform of clinical trials regulations in more than 20 years. We need a more efficient and adaptable regulatory framework, and that is what we will deliver.
Concerns were raised about timings of implementation and market authorisation of clinical trials. The timeframe in the Bill is a legal boundary, and we certainly expect to publish the report rather sooner. The noble Lord, Lord Mott, asked about the UK’s ranking for approving orphan drugs. The lessons learned from the review of the regulations will inform how we best approach the regulation of UK orphan medicines.
On the abolition of NHSE, work is under way on primary legislation. That will enable its functions, powers and responsibilities to transfer formally to the department. That will include responsibility for this Bill. I heard loud and clear from a number of noble Lords the wish to see a speciality lead for rare cancers in post and getting to work as soon as possible. I certainly agree on their importance. I heard what the noble Lord, Lord Blencathra, said, but this is the way we will go forward. We will ensure that that appointment is made as soon as possible.
As I said at the outset, many useful points have been made. They will be part of our consideration, but the main thing I want to say is how glad we are to fully support this Bill and how we will do all we can to help progress it. It reflects ambition and our support for the goal for the UK to be the global leader in clinical research, which noble Lords called for. This is about patients, particularly those facing rare cancers. They deserve and need greater choice, speed and opportunity to participate in vital studies. Every breakthrough is key because it means that we can maximise people’s access to the benefits. I thank my noble friend for bringing the Bill forward, all noble Lords who have contributed and all those who continue to champion its cause.
Lord Winston (Lab)
I apologise for keeping the House waiting a moment longer, but I want to ask the noble Baroness something very important. This has been a fantastic debate of a high standard, in the best interests of the House of Lords. There was a great focus on focused research on rare cancers, but does she agree that continued basic research on cell biology, embryology and a whole range of things about cell development, which has contributed so much to cancer research and to rare cancer research, is also important?
As my noble friend said, this has been an extremely valuable, well-informed and moving debate. At present, we are focusing on rare cancers because of the nature of the Bill, but I absolutely take his point about the importance of work outside rare cancers and the overlap with that. I thank him for it.
(2 months ago)
Grand CommitteeMy Lords, I am most grateful to my noble friend Lady Ritchie for her thorough introduction and for securing this debate. I am also grateful to all noble Lords for their considered contributions. The subject of today’s debate reflects my noble friend’s steadfast commitment to improving access to immunisation and her tireless efforts to ensure that vaccination matters continue to receive the attention that they undoubtedly deserve. As the noble Lord, Lord Kamall, said, this is a very important debate to have and I welcome the probing that it provides.
Let me say at the outset that I believe we in the UK can be proud that we have one of the most extensive vaccination programmes in the world. We protect people across their life course and it is underpinned by rigorous scientific evidence and a commitment to equitable access—a point made both by the noble Lord, Lord Kamall, and my noble friend Lady Goudie.
The question of international comparators was raised. Our vaccination progress serves as a global benchmark for innovation and best practice, and many nations look to align their immunisation schedule with ours.
I will focus on the specifics as best I can in the time available. On the JCVI, the noble Lord, Lord Bethell, made a number of comments suggesting what I might say, and in a number of cases he will be entirely right, so I am grateful to him for shining a light on some of those points. Decisions on introducing or changing vaccination programmes are informed by advice from the Joint Committee on Vaccination and Immunisation. It is an independent and expert committee and world leader in this field, as has been recognised in this debate. It bases its advice on high-quality data, disease burden, vaccine safety and efficacy, and the impact and cost-effectiveness of programmes, and it ensures that we maintain public confidence in our policies. I know that all these things are important to noble Lords.
On the current approach to evaluating vaccines, the cost effectiveness analysis used by the JCVI compares the cost of a vaccine relative to the health benefits it provides. I appreciate that this debate is about extending beyond that, but that is what it does. It looks at the health benefits provided for a vaccinated individual and others—this point was raised in the course of the debate—and it considers direct cost savings to the health and social care system resulting from immunisation, such as averting hospitalisation and the need for social care.
My noble friend Lady Ritchie suggested that the current approach somehow undervalues prevention, can delay innovation and does not take into account benefits beyond those to the individual patient. I would put this rather differently to my noble friend, because the methodology is entirely focused on prevention. As I mentioned, the positive benefits are not just for the person who has been vaccinated but for those around them. We look to reduce the incidence of infection, and we are also mindful about the transmission of conditions and infections to others.
My noble friend also asked about changes to thresholds. I can say to her that we are actively considering the impact of changes to thresholds in vaccination programmes. Perhaps I will only be a little cautious, but there is the potential that such a change would increase the costs of existing programmes, perhaps by incentivising higher prices from suppliers. But there is a recognition of the role that such a change could play in encouraging innovation, and I know that my noble friend is very keen to see that.
I am not sure this came up too much in the debate, but it is an important point. Our use of data to establish cost effectiveness has ensured that we get value for money from manufacturers, and that has allowed us to deliver a comprehensive programme. It is important that we continue to keep that value for money.
On wider societal and economic impacts, it is the case that wider benefits can be highlighted by officials or the JCVI when advising government on vaccination programmes, but it is also true that it does not account for the impact of vaccination that I have heard all noble Lords call for. A key reason for this—the noble Lord, Lord Bethell, pre-empted this—is that the wider benefits cannot be quantified consistently across all vaccination programmes. There is currently a lack of available high-quality data on socioeconomic benefits. As the noble Lord said, robust data may be available for very few programmes. Basing decisions on wider benefits would create disparities whereby vaccination programmes with high-quality data and wider benefits were considered more valuable. So we do not have the basic situation to achieve what we all want.
There are also many uncertainties when modelling socioeconomic benefits. Unpaid care was mentioned, for example; I think my noble friend Lady Goudie referred to it. Quantifying the impact on that would be extremely complicated, and there is no clarity on how estimating or modelling this or other impacts should be approached. That concern was echoed by NICE when it did an appraisal on this very topic in 2022, and it agreed to maintain the approach that it currently takes.
On the point about supply that I mentioned earlier, there can also be a risk that by adding wider benefits into formal evaluation methods we send a signal to suppliers that we could be open to paying higher costs for the same vaccines or medicines. I see noble Lords both nodding and shaking their heads, which is the purpose of a debate.
There are additional ethical concerns. As was mentioned, vaccination programmes for working populations, important though they are, could be preferred over programmes for those who are not economically active. That is not a basis on which we would want to proceed because it would exacerbate inequalities and undermine the equity of our approach.
I recognise that my noble friend Lady Ritchie has raised this Question as part of a focus to broaden vaccination access. That is a goal to which we are absolutely committed. We have been putting plans into action to provide new programmes—for example, launching programmes to protect infants and older adults against RSV. Just this month, we announced that a vaccine against chickenpox would go into the routine childhood immunisation schedule. That is expected to save the NHS some £15 million a year in costs for treating vaccinations.
The important matter of improving uptake has been raised. We are delivering vaccinations in new ways via community pharmacists, and pilots for administering vaccinations within health visits are starting this month. Through this targeted outreach, we offer an opportunity to increase uptake and reduce inequalities by providing vaccinations to those who might not otherwise access vaccinations. We are also working with healthcare professionals so that they can confidently discuss immunisation with concerned patients, because it is vital to tackle vaccine information. We are exploring innovative delivery models and delivering trusted messaging, to take up the point made by the noble Lord, Lord Rennard, who spoke about other influences that we would not welcome.
A number of questions have been asked, and I will be glad to write to noble Lords to pick up their specific points. I realise that my remarks in general will not be the ones that my noble friend and other noble Lords will have hoped for, but I hope I have been able to outline some of the difficulties while appreciating the points that have been made.
Before my noble friend sits down, I ask that she and her ministerial colleagues in the Department of Health and Social Care give particular attention to establishing the independent committee to evaluate the existing vaccine health technology assessment process so that the impact of vaccines on the economy, education and wider society can be seen clearly.
I understand why my noble friend is raising that, but NICE is seen as a world leader in that regard and has processes in place to review its processes and methods to ensure that they remain fit for purpose. I am not entirely convinced, as my noble friend will see, that we need to establish an independent committee, but doubtless she will pick up this point, and I will be pleased to hear from her further on it.
(2 months, 3 weeks ago)
Lords ChamberMy Lords, I begin by thanking the Government for their sensitive language in handling this delicate issue. I recall the noble Baroness, Lady Cass, telling the House that puberty blockers are currently licensed only for much younger children with precocious puberty or older adults with certain cancers. Trials are therefore needed to determine whether they are safe for adolescents with gender incongruence and to understand the interaction with the different processes of puberty. I understand that children taking part in the trials must have their parents’ consent, but can the Minister clarify two points that are clearly raising concern? First, what is the maximum and minimum age of children taking part in these trials? Secondly, what assurances can the Government definitively give that children taking part in these trials will not experience fertility issues or loss of sexual function or any conditions that are irreversible later in life? I also wish all noble Lords, staff and officials a merry Christmas, happy Hanukkah, happy new year and, as our American cousins say, happy holidays.
My Lords, I am grateful to the noble Lord for acknowledging the sensitive language. This is indeed a sensitive issue. For all the division and divided opinion that I know there is, there is also a determination—including across the House, I am sure—that we get this right. The clinical trial is just part of the PATHWAYS study. With regard to the clinical trial, it is extremely unlikely that anyone under the age of 11 will qualify as a potential participant and it runs up to the 16th birthday, so I hope that that is helpful. Can the noble Lord remind me of his second question?
What assurance can be given so that any health developments under these trials are not irreversible?
I thank the noble Lord. Before participants enter the trial—and it is an extremely high bar, as it should be; there will be at least 226 participants required, but that is not a target and there will be no drive to get up to that number—certainly any possible impacts such as those the noble Lord describes will be fully discussed and mitigations will be explained and made available, particularly in terms of fertility. I absolutely take the point that the noble Lord raises.
Baroness Cass (CB)
My Lords, we are faced with a situation where, for 15 years, clinicians in this country have told children and young people that these medications are safe, fully reversible and indeed life-saving. Last year, they were rightly banned from clinical practice. However, the upshot is that now, of the 75 children a month who are coming to the new services, about 20% are getting these medications and, worse, testosterone and oestrogen from unlicensed and unregulated sources—and those are the ones we know about. In addition, referrals to the new services have dropped from 200 a month to only 30 a month, so we think that a large number of those young people are also being harmed through those mechanisms.
We are concerned about this much broader harm; children are voting with their feet now. Does the Minister agree with me that, for the very tiny number of young people who clinicians believe will ultimately have a long-standing gender incongruence and will therefore be eligible for this trial, it is better that they get their medication under careful clinical supervision rather than on the dark web? Secondly, does she think that this trial will be a way of attracting that broader group of young people back into the NHS who do not need medical treatment but need holistic wraparound care?
Let me first say to the noble Baroness how grateful we are for her continued professional attention and sensitivity in dealing with this. There was a cross-party approach to the Cass review, and I pay tribute to Sir Sajid Javid, the former Health Secretary for seeing the need for this. We have always been supportive of the Cass review. I agree with both points that the noble Baroness has made. The fact is that this is about the need to face up to what the review found: shocking levels of unprofessionalism, a lack of clinical oversight and puberty blockers being prescribed to children without sufficient evidence. That was not safe and not beneficial and it could not go on.
My Lords, I first join my noble friend the Minister in congratulating the noble Baroness, Lady Cass, and I also congratulate my right honourable friend the Secretary of State, for the transparency with which this has already been dealt. Members will be aware that, across parties and across both Houses, there was a briefing that involved all the scientists who will be carrying out this research. Can my noble friend assure the House that that transparency and information giving will continue?
I can confirm to my noble friend that the transparency will continue and I am grateful for the comments that she made about my right honourable friend the Health Secretary, who I believe has not just been transparent but extremely honest. I very much welcome that.
My Lords, the backdrop to this research is an extensive international religious nationalist campaign against women’s rights and LGBT rights. Since this research has been designed according to standard research protocols, has been approved by the NHS ethics committees and will be carried out by professionals who are bound by professional regulation, does the Minister agree with me that those professionals should be enabled to get on with their job free from ideological interference?
I do agree with that point. We are seeking to protect the safety and interests of children and young people through evidence, and it is right and proper that we get on with that. As the noble Baroness has said, this is a trial; it is being led by King’s College London and the South London and Maudsley NHS Foundation Trust. It has been carefully checked by independent scientists who advise the NIHR and by the MHRA and it has also received approval from a research ethics committee. I would say that we are treading cautiously and correctly in this area, because all that matters is the safety of children.
My Lords, I understand the concern about illicit provision on the dark web, which is a very serious matter and difficult to manage. None the less, I must ask what provision is being made to meet potential claims for damages from young people like Keira Bell in the future who sustain permanent damage to sexual function and emotional well-being after being on the trial?
It is probably helpful to say that no one is required to be on the trial. Nobody will be accepted on to the trial unless there is an extremely rigorous and clinically led judgment about whether a young person is suitable. On the point about transparency, all that information is available online and I would urge noble Lords to look at it. The temporary ban was brought in by the previous Health Secretary, Victoria Atkins, and, in my view, it was absolutely right that we made it a permanent one. However, the issues remain, and we must work out how best to support children and young people who suffer gender incongruence.
My Lords, in the case that children cannot consent, which is widely acknowledged, given the age of the children, we know that single-parent consent will be permissible for the PATHWAYS trial. We also know from litigation to date on these vexed matters that parents are going to court to ascertain whether a single parent can consent to this. Will the Government review single-parent consent and insist that both parents must give consent to these potentially irreversible changes, where children’s consent is not possible?
As the noble Baroness rightly says, children, by definition, cannot consent to being on the trial, so places will require parental consent as well as the assent of young people. I can assure your Lordships’ House that, as I have already mentioned, there are strict eligibility criteria to join the PATHWAYS clinical trial. Part of the assessment by the professionals making the decision about engagement involves the role of parents, including whether there has been any undue pressure and a whole range of considerations. I urge the noble Baroness to refer to the details of how young people will be accepted on to this trial. I must emphasise that no person will be guided towards it who should not be. We are seeking young people; there is no requirement.