Mental Health Bill [HL]

Lord Scriven Excerpts

Report stage
Monday 31st March 2025 Lords Chamber

[Lord Crisp (CB)]

My Lords, I have added my name to one of my noble friend Lady Hollins’s amendments on community services and to four of those on long-term seclusion. I will speak very briefly to each topic.

On community services—I also support my noble friend Lord Adebowale’s amendment on this issue—I understand the Government’s concerns about timing and, presumably, costs, but I believe nevertheless that the Bill should provide legislative pressure to deliver community services for autistic people and people with learning disabilities. There is little point in using the Bill to set out a new legislative framework for this group if this does not include some notion of a plan or timetable, and it is highly likely that the service will simply fall back into the established patterns of non-therapeutic containment if this is not included.

I fully endorse the point made by the noble Baroness, Lady Browning, about the Autism Act. As one of the witnesses to the autism committee recently said, this is a pretty good law, but where is the action? Where is the implementation? That is the point, and we need some reassurance on a plan being forthcoming within a reasonable timeframe.

On long-term seclusion, I suspect that most members of the public would be surprised to know that what amounts to, in some cases, solitary confinement—I use that pejorative phrase deliberately—is used for such long periods in our institutions. We are talking about 15 days at a time and potentially more than that, over the course of a month, if there is a break between the 15 days and the next 14 days, for example. We should be particularly concerned about what happens out of sight in these institutions, where what should be a very rare occurrence at best can become all too easily routine.

These amendments open this long-term seclusion to greater scrutiny and control. They may not prevent it happening altogether, but they will help to make it a rarer occurrence. I refer in particular to two amendments, neither of which I have my name against—that is my mistake rather than anything else. Amendments 3 and 53 both refer to the code of practice and require that if people are kept in long-term seclusion for 15 days, or indeed the majority of 30 days, there will be clear monitoring and subsequent active intervention to take account of that. They are entirely reasonable amendments and do not raise funding, timing or any other issues. They are about ensuring proper scrutiny of what is happening to vulnerable people in some of our institutions.

In saying that, I am reminded of reading the report from Blooming Change, a young people’s organisation. I quoted the report at Second Reading, and it describes problems with safety and quality. There are descriptions of being injured during restraint, being drugged and restrained, and being scared all the time. It includes the terribly sad quotation:

“‘hospital makes you worse’… going into hospital with one problem and then leaving with trauma, new behaviours, new diagnoses, assaults, PTSD – it’s awful.”

We ought to be able to ensure that the code of practice for long-term seclusion is adhered to and that where it is not, it is properly investigated.

[Lord Scriven (LD)]

My Lords, I rise to speak to a number of amendments that I have added my name to, particularly those in the name of the noble Baroness, Lady Hollins. In Committee, the whole issue of people with learning disabilities and autism caused a number of concerns. I note that the Minister has gone some way towards dealing with some of those concerns, and it is a tribute to her listening and enaction skills that progress has been made.

I think it would be fair to say that there are still some concerns on Benches across the House about potential unintended consequences for people with learning disabilities and autism if the Bill goes through in its present form. In some areas, I would describe the statement from the Minister as, “It’ll be all right on the night”—but we know that, sometimes, it is not all right on the night, and things will happen.

The noble Baroness, Lady Hollins, puts forward quite an important base for long-term segregation. There is no evidence that it has a long-term therapeutic benefit for people who have learning disabilities and autism, and so the provision for it still being there, without laser-focused monitoring and intervention, is a weakness. The Minister really has to convince the House that the Government have a plan to deal with this.

The worry about having too much faith in the code of practice, as we found out in Committee, is that simple words such as “should” and “must” have very different meanings for whether or not there is a statutory obligation on an organisation. It would be interesting to hear the Minister’s view on the focus in the code of practice and on strengthening the words used.

Amendment 4, to which I have added my name, is something that the House should focus on and understand. Throughout the history of implementation of improvements in mental health and other areas where community carers come in, they have always fallen down on implementation, due to a lack of either funding or resources. Amendment 4 focuses on implementation. As the noble Lord, Lord Crisp, has just said, in the Autism Act 2009 Committee, we heard from two witnesses who said there is a plethora of policy but it is always the plan on implementation that fails. The amendment in the name of the noble Baroness, Lady Hollins, focuses on that implementation and asks that the Government have a real plan to do that.

It was worrying as we went through Committee, particularly when issues were raised about the numbers in the impact assessment, that the Minister pointed out that they are indicative. The amendment in the name of the noble Baroness, Lady Hollins, is required because, if we take a look at the trend of the percentage of total healthcare spend that has been allocated to mental health, including the Government’s announcement last week, we find that there have now been two years in which the total spend will be reduced. That means that some of the good ideas that the Government have mentioned with regard to the implementation of this Bill and community services are potentially at risk.

I do not know whether the noble Baroness will press her amendment, but, if she does, she will have the support of these Benches. We think this is vital, and we are not quite convinced, unless the Minister says something to that effect from the Dispatch Box, that that crack—that real weakness—has been dealt with.

[Lord Kamall (Con)]

My Lords, before I begin my remarks, I express my gratitude to the Minister and to officials for their engagement with not only me but other noble Lords between Committee and now. I know I am not alone in appreciating the amount of time and work that the Minister and officials have put into meeting with us, addressing our concerns, and even having follow-up meetings; that was very much appreciated.

I will speak to Amendment 1, in the name of my noble friend Lady Browning, and briefly address some of the other amendments in this group. We supported my noble friend Lady Browning’s intention to retable this amendment, which seeks to address the loophole which could lead to the use of the Mental Capacity Act to detain patients with learning disabilities but without a recurring condition.

As noble Lords have acknowledged, both in Committee and today, once the legal basis for detention under the Mental Health Act is removed for these patients, there was always a profound risk of them falling under the deprivation of liberty safeguards. Nobody wishes to see extra safeguards introduced into the Mental Health Act for that to be simply replaced with detention by another Act. My noble friend said today that she has received further assurances from the Minister—we are grateful for those assurances—and that she is no longer minded to test the opinion of the House. Had she been minded to test the opinion of the House, she would have had our full support, but I am grateful for the assurances that the Minister has given to my noble friend.

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Moved by

[Lord Scriven]

11: Clause 6, page 12, line 40, at end insert—
“(2A) In section 17B (conditions) after subsection (7) insert—“(8) The responsible clinician must ensure that community treatment orders align with the code of practice as set out in section 118(2B).(9) A community treatment order shall have a maximum duration of 12 months, subject to the following provisions— (a) the responsible clinician may extend the duration of a community treatment order beyond 12 months only after— (i) consulting the patient, the patient’s nominated persons, and any relevant mental health care professional involved in the patient’s treatment or care planning;(ii) undertaking a review process to evaluate the ongoing necessity and therapeutic benefit of the community treatment order;(iii) consulting a General Medical Council registered psychiatrist regarding the conditions of the community treatment order and obtaining their written agreement that an extension is necessary and in accordance with the principles set out in section 118(2B);(b) community treatment orders with a duration of less than 12 months are not subject to the review process set out in subsection (9)(a)(ii);(c) a tribunal may recommend that the responsible clinician consider whether to extend, vary, or terminate the duration and conditions of a community treatment order.(10) Where a community treatment order is extended beyond a period of 12 months, the order shall be subject to review at intervals not exceeding six months, in accordance with the procedure set out in subsection 9(a).(11) At the conclusion of the default period or any extended period, the responsible clinician must undertake a review to assess the effectiveness of the community treatment order in aligning with the code of practice stipulated in section 118(2B).””Member’s explanatory statement
This amendment ensures that community treatment orders align with the code of practice, limits their default duration to 12 months, requires a structured review process for extensions, mandates six-monthly reviews for extended orders, and reinforces patient consultation and oversight by mental health professionals.

[Lord Scriven (LD)]

My Lords, I start this group on community treatment orders by thanking the Minister and her team of officials for dealing not just with this issue but with most issues in the Bill on a collaborative basis, which should be a blueprint for how Ministers should deal with people with different opinions to those of the Government. It is genuine thanks from these Benches.

I also thank my noble friend Lady Parminter for giving her lived experience of community treatment orders. In Committee, there was a huge divide in this House about whether they should continue rather than pragmatism on how we deal with the problem. My noble friend Lady Parminter focused our minds on that.

My amendment tries to deal with what I see as the major flaw of community treatment orders, whether or not we have a review of them, and that is their potentially indefinite nature. As for the way that these community treatment orders are implemented, whether they are effective or not, there seems to be a revolving door which some people find impossible to get out of. This has led to a number of issues about whether they have therapeutic benefit and whether the treatment is actually effective. There have also been huge issues to do with racial disparities in their use and the length of time that people are on a community treatment order.

Even if we agree Amendment 23, in the name of the noble Baroness, Lady Bennett, and Amendment 62, in the name of the noble Lord, Lord Kamall, to have a review of their effectiveness, something needs to be done now to ensure that the initial community treatment order is time-limited—I suggest 12 months—then if it is to be reviewed, it has to be reviewed by not just the consultant who is treating the individual but also by another GMC psychiatrist who has to agree in writing that there is therapeutic benefit for the community treatment order to continue. That review should take place every six months. That would not stop community treatment orders, but it gives an absolute, firm process, which needs to be in the Bill—not in the code of practice—to ensure that individuals who are on a community treatment order have certainty about the length of time and review. It would also require a second doctor’s written agreement about the therapeutic benefit of reviewing and continuing the treatment order.

I understand that the Minister will probably and quite rightly say that the Bill has moved forward and that there are certain elements which help with the review of treatment orders and the people being put on them. For example, the community doctor has to be consulted. However, there is a difference between being consulted and giving agreement. That is why my amendment talks about the agreement of a second doctor. Consultation in itself does not mean that community treatment orders cannot be indefinite, as they are in some cases. My amendment is practical and solves this problem. As my noble friend Lady Barker said, we tend to get legislation about the Mental Health Act once every 15 years, and we cannot wait another 15 years to deal with this anomaly.

I and others on these Benches would be supportive of a review of community treatment orders and of the evidence about whether they are effective in the grand sense. However, the practical pragmatism is that people will continue to be put on community treatment orders, that, even with the changes that the Government have put in the Bill, people would still be there indefinitely and that the second doctor’s opinion would not necessarily have to be taken into consideration if the order were to continue to ensure that there was therapeutic benefit.

I will not say much more, but I believe that my amendment is practical, needed and will get the correct balance both for service providers and for those who are on a community treatment order to deal with some of the unintended consequences we have found since they were introduced. It is a practical step to ensure that we get them right, if reviews take place. I beg to move.

[Baroness Bennett of Manor Castle (GP)]

My Lords, it is a pleasure to follow the noble Lord, Lord Scriven, and to agree, in essence, with everything he said. Amendment 11 is truly important; it would immediately affect the well-being of some very vulnerable people in our community. Should the noble Lord decide to divide the House, the Green Party will support his amendment.

I will chiefly speak to my Amendment 23, which also relates to community treatment orders and calls for a statutory periodic review of them. I can see quite a few noble Lords in the House, so it is worth very briefly going back a little over what we discussed in Committee. The Joint Committee on the draft Bill concluded that CTOs should be abolished for people under Part II, the civil sections. For people under Part III, the Joint Committee recommended a statutory review of CTOs with a provision to abolish them unless the Government legislated to keep them.

My amendment does not go that far, but it starts from the point that the noble Lord, Lord Scriven, mentioned, citing the noble Baroness, Lady Barker: it is likely to be at least 15 years before legislative attention returns to the Mental Health Act. That is a very long time—especially for the health of people who are going through certain experiences. I stress that it is not my own initiative that brought this amendment forward; the organisation Mind encouraged me to do so. I will quote from a couple of people who Mind has spoken to about CTOs, because we have to consider what the actual lived experience is like. One person said:

“Being on a CTO is like being cornered … It is good that you are out of hospital but only a little better because it is so intrusive”.


Another person who had been on a CTO said that it can feel like:

“A tag that nobody can see but you know it’s around your mind”.


Throughout the debate on this Bill, we have considered getting rid of CTOs entirely. As the noble Lord, Lord Scriven, said, the noble Baroness, Lady Parminter, made the very powerful case that there may be circumstances and conditions where they are indeed appropriate. However, my amendment simply calls for a statutory review, so that we do not wait 15 years and then say, as we have been saying about so many aspects of what we are trying to fix now, “This has been terrible for so long. We really need to do something about this”.

I say to the noble Lord, Lord Kamall, that I am still planning to arrange the Trieste meeting; I am afraid I have not got there yet. Looking at community alternatives has to be the way forward. There are models around the world where that is achieved. If we were to have a review, as my amendment would require, then everything in proposed new subsection (3)—which looks at

“the impact … on people from different ethnic minority backgrounds”,

preventing readmissions and whether CTOs provide “therapeutic benefits”—would be considered within a reasonable period. We could affect and improve people’s treatments within a foreseeable period and not sentence them to another 15 years.

It is not my intention to divide the House. I very much hope that the Bill will continue to work on this, and that the arguments for including a statutory review will become evident as the Bill progresses. On that basis, I urge noble Lords, particularly the Minister, to consider that, and I echo the points that the noble Lord, Lord Scriven, made. My engagement between different stages of the Bill tends to be limited by the fact that I am juggling a great many Bills at the same time. However, I have heard reports of how the Minister has been engaging with noble Lords, and I hope that she and the department will bring an open mind to the idea that we should not sentence people to another 15 years of CTOs without a statutory review, because there have been so many questions and concerns about them. On that basis, I hope that we can move forward as the Bill progresses.

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[Baroness Merron (Lab)]

I thank the noble Lord, Lord Scriven, for tabling and speaking to Amendment 11, along with the noble Baroness, Lady Tyler. At the outset, I can say that it is already the case that community treatment orders can be renewed only under specific conditions, which aligns with the intent and direct requests of the noble Lord, Lord Scriven.

Alignment with the code and the four principles is already achieved by new Section 118(2D) of the Mental Health Act, which requires clinicians, before placing someone on a community treatment order, to have regard to the statement of principles in the code. Clause 6 ensures that a patient can be put on a community treatment order only if there is a risk of serious harm without it and a reasonable prospect of it having therapeutic benefit for the patient.

I assure your Lordships’ House that a responsible clinician cannot extend a community treatment order beyond six months, unless the conditions, including therapeutic benefit, continue to be met. A community treatment order can be extended for a further six months and then a subsequent 12 months, but only if these conditions continue to be met.

The current code of practice states that, before renewal, the responsible clinician should consult with the multidisciplinary team, the patient, the nearest relative—which in future will be the nominated person—and an advocate. I put it to the House that we are going further than the request from the noble Lord, Lord Scriven, by introducing a new requirement for the patient’s community clinician—who must be an approved clinician, overseeing the patient’s care as a community patient—to be consulted before a community treatment order is renewed beyond six months.

I have heard the concerns of the noble Lord, Lord Scriven, that the Bill requires just the second-opinion appointed doctor to be consulted, whereas the amendment requires the extension to be agreed with them. In response to that, I assure the noble Lord that, in addition, the community clinician must provide a statement that it appears to them that the community treatment order criteria continue to be satisfied.

We are increasing the frequency of automatic referrals to the tribunal to ensure that patients can come off community treatment orders when they are no longer benefiting them. The tribunal will have a power to recommend that the responsible clinician reconsiders whether a CTO condition is necessary. To elaborate further in view of the points raised, this means that, following an initial tribunal referral at six months, another referral is required after a further six months, followed by a mandatory referral 12 months after that, if the patient has not made an appeal themselves. The tribunal will have to agree the CTO criteria, including the requirement that a therapeutic benefit continues to be met. We are therefore already meeting the requests that the noble Lord, Lord Scriven, has rightly made and, in some places, going further than we have been asked to do.

I turn to Amendment 23, tabled by the noble Baroness, Lady Bennett. As I said on the similar amendment tabled by noble Lords on the Opposition Front Bench in Committee, CTOs remain a valuable intervention, albeit they need reform—as I more than acknowledge and accept. We will review these changes as part of our ongoing monitoring of the implementation and impact of the reforms. A review after two years would be premature, as it would be based on data from before any reforms were commenced. I say to the noble Baroness and your Lordships’ House that we will instead commit to review the impact our reforms have as part of our wider monitoring and evaluation of the Bill as it is implemented.

Amendment 62 is in the name of the noble Lord, Lord Kamall, and the noble Earl, Lord Howe. We are, as the noble Lord acknowledged, committed to addressing racial disparities under the Act—something I know the noble Baroness, Lady Tyler, was concerned about. I was very pleased to host a session a couple of weeks ago with leading academics, a number of officials from the department and Members of this House. We discussed in detail what is known and what further evidence is required. I give the assurance that work—as the noble Lord, Lord Kamall, has kindly acknowledged—is already under way, and we will continue to explore this issue. I am therefore happy to commit to undertake further investigation into racial inequalities under the Act.

The scope is to be developed further, but may involve synthesising findings of existing research, conducting a review of recent literature, and exploration of potential evidence gaps that require future research with experts and academics. Further research will receive sufficiently high-quality research applications and will be subject to the outcome of the spending review. I hope noble Lords will understand that we therefore prefer not to commit to a timescale in primary legislation but to allow time to develop and deliver research to ensure the best-quality evidence in this extremely important area. I hope noble Lords will not press their amendments.

[Lord Scriven (LD)]

I thank the Minister for that helpful explanation and description of community treatment orders. Despite all the words, whenever independent research is done, whether by the CQC, the Joint Committee or mental health organisations, the same answer keeps coming back. Something is fundamentally flawed, maybe not with the policy but with the implementation of CTOs. I note the Minister quoted the rule in the code of practice but, as we know, the code of practice does not necessarily have the legal status of something in the Bill. Therefore, for that reason and because there is an issue with community treatment orders, I believe that putting this in the Bill will not just change the practice but get the correct safeguards for people who are put on them. I would like to test the opinion of the House.

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Further guidance will be provided in the code of practice and, as my noble friend the Minister announced, we are committed to establishing an expert task force to support the development of the statutory code of practice to provide clear guidance for professionals involved in the nominated persons appointment process for children and young people. This would include the witness process. For these reasons, I hope noble Lords will feel able to support these amendments.

[Lord Scriven (LD)]

My Lords, I thank the noble Baroness for detailing very clearly the Government’s amendments. I also thank the Minister, who I see in her place, for, again, a very collaborative approach and for, on this occasion, implementing exactly not just what was in my previous amendment, so ably moved by my noble friend Lady Tyler, but what came from the Delegated Powers and Regulatory Reform Committee.

On the use of ECT, the powers in the government amendments before the House mean that the balance is absolutely correct on not having the second doctor’s signature and consent, as well as on the need to save life and the use of ECT. I thank the Government sincerely for not just listening but acting on the concerns that were around.

[Earl Howe (Con)]

My Lords, the House will be grateful to the Minister for these government amendments, which, as the noble Baroness made clear, cover two principal policy issues. Accordingly, I have two sets of queries.

On the changes for the rules for authorising electroconvulsive therapy, I am sure it is not the Government’s intention in any way to water down the safeguards surrounding the administering of ECT. However, in relation to Amendments 16 and 17, taken together, can the Minister reassure me? The Bill, as modified by the proposed amendments, will posit that there could be circumstances in which a patient who has the capacity to consent to ECT but who has not consented to it could nevertheless find their refusal to treatment overridden by the decision of a single treating clinician. Even in a situation where the judgment of the clinician was that ECT was necessary to save the patient’s life, it seems to me a significant change from the current rule whereby the decision of a second opinion appointed doctor is required in all cases where it is proposed to administer ECT to a non-consenting patient who has the capacity to consent.

Amendment 17 makes it clear that the regulatory authority—the CQC, in other words—may give permission for ECT to be administered only on the say-so of a single doctor where a SOAD is not available and “exceptional circumstances” apply. I will not ask the Minister to define what “exceptional circumstances” might consist of, but it is to be assumed that a primary example of such circumstances might be when time was of the essence and no SOAD could be located soon enough to avoid exacerbating the risk of harm or death.

So my questions are, firstly, has this proposed change been prompted by a general awareness across the mental health sector that the availability of SOADs can frequently prove a problem in circumstances where urgent decisions are needed? In other words, to put it bluntly, are we being asked to change the law because of habitual shortcomings in NHS communication arrangements? I would be concerned if that were the case.

Secondly, what guidance, if any, will the CQC formulate for itself to ensure that, when its decision is sought to temporarily waive the requirement for a SOAD, it will not do so just on the basis of a SOAD being unavailable? Will it also commit itself to a standard procedure whereby it will seek at least some background detail from the treating clinician of the case before him or her, such as the reasons why they consider that administering ECT to that particular patient carries particular urgency? In other words, can we be reassured that the treating clinician’s opinion will be subject to at least a modicum of testing and cross-questioning before the CQC issues the go-ahead for ECT to be administered? I hope so, because anything short of that could turn into a tick-box exercise.

The other government amendment on which I would appreciate further clarity is Amendment 26, which

“changes the process for appointing a nominated person”.

One of the changes proposed is that the various statements and signatures required for appointing the nominated person no longer have to be contained in the same instrument. The other is that the nominated person’s signature no longer has to be witnessed. I was grateful for the Minister’s explanation, but it implies that the written instrument that appoints the nominated person and is signed by the patient in the presence of a witness can be executed without the nominated person themselves being in the room, or indeed anywhere near. At the moment, the Bill says:

“The instrument appointing the nominated person must … contain a statement, signed by the nominated person in the presence of”


the same person who witnesses the signature of the patient.

I previously assumed that the reason for that provision was the responsibility that the Bill places on the witness—quite a serious responsibility—to ensure, as far as possible, that the nominated person, whoever they are, is a fit and proper person to act in that capacity. It would appear now, with this amendment, that there is no need for the witness even to clap eyes on the individual who is nominated. How can that be right? Without at least meeting the nominated person, how can any self-respecting witness certify, hand on heart, that, in the words of the Bill, they have

“no reason to think that the nominated person lacks capacity or competence to act as a nominated person,”

or that they have

“no reason to think that the nominated person is unsuitable to act as a nominated person”.

Are they simply meant to take the patient’s word for it?

This alteration in the wording raises all sorts of question marks in my mind, given the concerns expressed by noble Lords in Committee about misplaced loyalty towards a particular individual, a naivety on the part of a child or young person, or even some degree of psychological manipulation of a young person—for example, someone who makes it their business to set a child against their own parents.

In Committee, the Minister herself emphasised the need for the law to prevent exploitation and manipulation. While I did not at the time think that her response was completely reassuring, I saw it at least as an acknowledgement that the role of the witness could not be fulfilled properly without some sort of contact with the nominated person. Was I right or wrong on that? It would be helpful if the Minister could explain how my misgivings in this area, about the way in which the nominated person procedure comes to be implemented in practice, might be allayed.

Pharmacy Opening Hours

Lord Scriven Excerpts

Thursday 20th March 2025 Lords Chamber

[Baroness Merron (Lab)]

The noble Lord makes some very constructive points and illustrates further the point that there are many ways to deliver pharmaceutical services. I can assure him that we are exploring how pharmacy can best be positioned—and indeed levered—to fit our ambition for a neighbourhood health service within the NHS 10-year plan. More will be heard about that soon.

The noble Lord will also be aware that one of the challenges that community pharmacies raised with us is about funding, which was cut or held flat between 2015-16 and 2023-24, representing a cut of some 28%. That is why we have concluded the consultation about funding; we will shortly announce the outcome, looking at how these private businesses can operate in the market. We are keen to ensure that they play their part and continue to work very constructively with them.

[Lord Scriven (LD)]

My Lords, the financial year ends in two weeks, and the ongoing delay in this year’s financial settlement for pharmacists has created a cash-flow problem and exacerbated the financial issues, which means that on average eight community pharmacies a week are closing. In December the chief executive of Community Pharmacy England wrote to Ministers asking for a remedial injection of cash to help cash flow and keep pharmacies open. I gently ask the Minister why Ministers have so far ignored that request.

[Baroness Merron (Lab)]

I feel that the most constructive response I can give to the noble Lord is the response of the Secretary of State, who has made it quite clear in Parliament that discussions will conclude shortly and an announcement will be made in the normal way. That will be via an open letter to contractors, which will be published on GOV.UK. I hope the noble Lord will understand that I cannot say more until our engagement with Community Pharmacy England, the representative body, comes to a conclusion. I can add for the benefit of noble Lords that NHS England commissioned an independent economic analysis of the cost of providing pharmaceutical services. It has informed the consultation with the sector and will be published in due course.

NHS England Update

Lord Scriven Excerpts

Wednesday 19th March 2025 Lords Chamber

[Lord Kamall (Con)]

My Lords, no one can really disagree with the intention to reduce unnecessary duplication between the NHS and the Department of Health and Social Care, so these Benches welcome these proposals where they ensure value for money for taxpayers and free up money from bureaucracy to spend on front-line services. One of the many things that many medical staff have complained about is the amount of paperwork. We hope that these reforms and better investment in technology will reduce the time spent on administration. Although administration can be tedious, it provides much-needed data to monitor the level of services and, we hope, to improve patient care. But these changes need to be judged on more than just money; they must make sure that the patient remains at the centre of the conversation when we talk about our system of health and care.

We have had many reforms over the years, and whether these reforms are the right ones can be judged only on what comes next. My noble friend Lord Lansley, who has been much maligned recently, has written that the lesson he learned from the 2012 reforms is that his Government, and subsequent Governments, delivered only one part of the intended reforms—creating NHS England—but did not always intervene when NHS England sought to block other reforms, such as clinically led local commissioning, competition and choice, choice of large-scale commissioning support organisations, tariff reform, “any qualified provider”, and an annual mandate from the Government and Parliament to the NHS, with accountability through the NHS outcomes framework. This, he believes, is what led to the centralised, bureaucratic system that the Government are trying to reform.

Whether noble Lords agree with my noble friend or not, surely the lesson is to have an overall plan for reform and to intervene when a bureaucracy is a barrier to further reform. For this reason, noble Lords look forward to the publication of the 10-year plan. I wonder, at this stage, whether I can tempt the Minister to say whether she is any closer to giving us a date for that 10-year plan. I suspect that these reforms have to be seen in conjunction with the 10-year plan, and cannot be seen in isolation.

Given these lessons, where clinical leaders are calling for greater autonomy from centralised control in order to offer better care for patients at a local level, how do the Government intend to balance centralisation to the DHSC with empowering clinicians and giving them autonomy at a local level? They are better equipped to know what services are needed locally.

I know from my experience of organisational change that it is often not enough to change structures if the organisational culture does not also change. I will give your Lordships an example. I had an operation in Brussels a few years ago, and when I came back to the UK I wanted to have my annual check-up. I contacted a GP and eventually got a double appointment: an ECG at a local health centre, and a consultant phone call a week later. I thought that this was really good and modern. The ECG went smoothly and, a week later, I got a phone call from a junior doctor in the consultant’s office. It was clear that he had not seen the ECG, so I asked him, “Have you seen the ECG?” He said, “No”. I asked, “Can I tell you exactly what time, what day, and where it was, then you can call me back and we can discuss it?” He refused, and said, “I’ll just make a new appointment, including a new ECG”. I wonder what it is in the system that incentivises this sort of behaviour, rather than making that phone call and saving taxpayers an awful lot of money.

Although these changes will save money, which is welcome, can the Minister provide clarity to the House on how these reforms will drive efficiency and cultural change within the health service, and ensure that we improve care, with patients at the centre?

One of the key challenges your Lordships will be aware of when dealing with the NHS is the lack of willingness to own mistakes and accept responsibility. The NHS needs to be better at taking responsibility when targets are missed and things go wrong. Can the Minister assure your Lordships that the new structure the Government propose will have clear lines of responsibility, redress and transparency? Will it allow noble Lords, other politicians and people throughout the country to understand how the NHS is governed, who is responsible for what and how it operates? I look forward to hearing from the Minister, and I hope that we can work constructively, on a cross-party basis, to improve patient outcomes and our system of health and care.

[Lord Scriven (LD)]

My Lords, the Government, with their sovereign right, propose the abolition of NHS England. Although the method of delivery is a matter for the Secretary of State to propose, governance changes in themselves will not achieve better outcomes. These Benches will continue to point out that chronic operational issues in the NHS cannot and will not be dealt with effectively until the Government show the same speed and determination to deal with the social care crisis. The Minister must know that you cannot have 13,000 hospital beds full of people medically fit for discharge and pretend that a change of who sits in what chairs in the governance of the NHS will solve that issue. When will the Government commit to a timetable to restart the cross-party talks to deal with this important issue?

The paramount—indeed, the sole—objective of any organisational change to the NHS must be demonstrable improvement of patient experience and outcomes. The Government assert that this change will improve efficiency and streamline services. However, assertions alone are insufficient. We require rigorous evidence, not mere conjecture.

Therefore, I am going to ask the Minister five questions. First, and most importantly, what detailed analysis has been conducted on the projected impact of this abolition on patient outcomes? We require more than abstract pronouncements. For instance, how will it improve cancer treatment? What will these changes do to improve access to GP services? How will they improve local integration, particularly when 50% of funding for ICBs will be reduced across the board?

Secondly, what specific legislative changes are required to abolish NHS England and redistribute its functions? I note that the Secretary of State pointed out that the Government could predominantly go ahead with these changes but that legislation is required, so will the Minister explain to the House exactly what legislation will be required to bring about this change? Will she give a commitment that no redundancies will take place until legislation has been passed and these changes have been given the go-ahead by this House and the other House?

Talking of redundancies, my third question is: what are the estimated costs of redundancies associated with the abolition of NHS England, including not only financial implications but the potential loss of expertise and institutional knowledge? Furthermore, will the Minister indicate whether any departing executive has been offered a severance package exceeding statutory redundancy limits and, if so, how many? What justifications are there if such arrangements have been made?

Fourthly, how will the Government ensure continuity of service during the transition period? Any disruption to patient care is unacceptable, so when will there be a robust plan that outlines how essential services will be maintained, how staff will be supported and how the public will be kept informed?

Finally, in line with what the noble Lord, Lord Kamall, said, what mechanisms will be put in place to ensure ongoing accountability and transparency in the newly restructured healthcare system? How will the Government measure success—not just of the times in which people are seen but that these changes have contributed to improvements in patient care? The Government are the custodians of this vital public service and have a duty to ensure that any changes to NHS structures are driven by evidence, guided by principle and focused relentlessly on improving the lives of the people it serves. They must proceed not blindly but with clarity, so I look forward to the Minister’s answers.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)]

My Lords, I am grateful to both Front Benches for their reflections and their support for the direction of travel, in certain areas. I am pleased to see the noble Lord, Lord Scriven, in his place and I wish him a full recovery. I note that the noble Lord, Lord Kamall, welcomed the moves on value for money, freeing up from bureaucracy and the need to put the patient at the centre. I am glad that he did that, because that is exactly what this is about: better services and cutting duplication.

It is probably worth my reflecting on the sentiments expressed in the other place by my right honourable friend the Secretary of State for Health and Social Care when he referred to the question of why we are doing this. The independent investigation by the noble Lord, Lord Darzi, was called for by this Secretary of State not long after we came into government and discovered a situation beyond what I think anyone had anticipated. The noble Lord, Lord Darzi—this relates to the point that the noble Lord, Lord Scriven, made about evidence—traced the current crisis back to the 2012 top-down reorganisation of the NHS and the establishment of NHSE. He stated that it had

“imprisoned more than a million NHS staff in a broken system”.

There are twice as many staff working in NHS England and the Department of Health and Social Care today as there were in 2010. In 2010, the NHS was delivering the shortest waiting times and the highest patient satisfaction in history. When we came into government last year, it was the exact opposite: the longest waiting times and the lowest patient satisfaction in history.

You can add that up: taxpayers pay more, and they get less. We have been left with two very large organisations. I see that there are some former Ministers from the department in the Chamber today, which I am glad about. I will not speak for them, but they might also reflect that they will have noticed duplication and layers of bureaucracy that have stifled the progress and the patient treatment, patient focus and patient experience that we all seek to improve. The noble Lord, Lord Kamall, talked about the need for us all to coalesce around the interests of the patient, with which I certainly agree. Over the next two years, the intention is to bring NHS England into the department entirely. That will make significant savings of millions of pounds a year. To noble Lords who have raised some questions about whether the money will flow down to the front line, I say that it will cut waiting times faster and deliver our plan for change.

The matter of staff came up, and I will come back to that. I acknowledge that there are talented, committed public servants who work at every single level of the NHS and the Department of Health and Social Care, including NHS England, with whom I have had the privilege of working over the past eight months under this Government. I was previously a Minister in the department in the last Labour Government. This is about the system, not the people. I say that to reassure those who are employed both at the department and in NHS England.

The noble Lord, Lord Scriven, asked some important questions about staff reductions and when redundancies would potentially take place. There are currently 19,000 staff across NHS England and DHSC; across both, we are looking to reduce the overall headcount by 50%. Conversations have already begun with the trade unions on this change, and we will of course continue to engage with them throughout the process. As the noble Lord, Lord Scriven, rightly observes, abolishing NHSE—a non-departmental public body—will require primary legislation, so we are working with the usual channels to ensure that we have an appropriate legislative timetable to allow us to do things in a timely way, while safeguarding what is an ambitious legislative programme that has already been set out. We are already getting on with the job immediately, which also answers the point raised by the noble Lord, Lord Scriven, about bringing NHSE back into the department.

The noble Lord, Lord Kamall, raised a very good point about the need for better understanding, clear lines and transparency. One of my learnings since we announced the abolition of NHSE was that, unfortunately, some members of the public thought that meant we were abolishing the NHS. I would like to reassure anybody in this Chamber or outside it that we are not doing that at all: we are committed to the National Health Service, as we have always been throughout our history as a party, and we will continue to strengthen it. However, what that said to me relates to the point the noble Lord made. People do not care about structures, and why should they? What they are interested in—and I completely endorse this—is what it does for them. Can they get that appointment? Can they get that treatment? Can their child get access to dentistry, or whatever it is? That is what people want.

Actually, this is a tremendous opportunity to be clearer and more straightforward about what those lines are, and I certainly look forward to doing so. The noble Lord, Lord Kamall, is right about the need for a change in culture, and I think that applies to a whole range of issues.

This measure has been considered and, as I explained, was born through experience and evidence. It will fit as part of the 10-year plan, to which the noble Lord, Lord Kamall, referred, and I thank him for that. On when that will be published, I will say only that I hope the noble Lord will not feel he is kept waiting for much longer. I am very grateful to everybody who gave input to the consultation—the biggest one ever in the history of the NHS.

The noble Lord, Lord Scriven, rightly asked for a number of details about impact; there will, of course, be a full impact assessment with the legislation. He asked particularly about improvements overall, which is what we seek. Currently we have two organisations, many layers and duplication. I cannot think of one organisation that can boast all that—I do not say boast in a positive way—and say it is at its most efficient in delivering for whoever the service users are.

All of it will translate to improvements on the front line, which is what we are talking about. As I mentioned, as I often do, earlier in Questions, we believe that decision-making locally—done in the interests of the local population, with their involvement and reflecting their nature—is crucial. Noble Lords will be aware that, on the advice of the report by the noble Lord, Lord Darzi, we reduced the numbers of targets in the planning guidance from 32 to 18, to free up local areas to better meet the local requirements. Again, we see the direction of travel.

The noble Lord, Lord Scriven, asked about senior management and severance packages. Of course, I cannot comment on individuals, but I emphasise that, in the cases of those who announced their resignation, it was just that, so all the normal arrangements would apply.

I hope we can continue to work together to improve the structure, support the staff and, most importantly, keep patients at the centre, so that they see improvements from this change and the recognition that two organisations are duplication and this needs to change.

Health Research

Lord Scriven Excerpts

Wednesday 12th February 2025 Lords Chamber

[Baroness Merron (Lab)]

My noble friend has made the point which I would emphasise: withdrawal from the World Health Organization is a matter for the United States to decide. The UK, however, will continue to work with all international partners and the WHO. It is a key factor in ensuring we have a healthier and safer world because disease does not respect borders. The UK Health Security Agency is carefully considering the impact of proposed changes in the United States, including its proposed withdrawal from the World Health Organization.

[Lord Scriven (LD)]

My Lords, the head of the UNAIDS agency has warned that global HIV infection could increase 600% by 2029 if the US continues its suspension of the UN HIV/AIDS programme. This means higher infection rates here in the UK, as communicable diseases do not recognise national borders. What specific steps will the Government take to support the UN and other nations in ensuring this programme’s effectiveness and efficiency?

[Baroness Merron (Lab)]

Our commitment in this country to supporting humanitarian aid and development across the world, including in this area, remains steadfast. It will not be affected by any external decisions. With respect to the US decision to pause foreign aid funding for three months pending a review, as I have said previously, this is a matter for the United States. We note that decision, but the experience of the Covid pandemic is writ large and shows us that disease respects no borders, so it is in the interest of all of us to do the kind of work the UK did, for example in developing vaccines at that time.

NHS: Electronic Patient Record Systems

Lord Scriven Excerpts

Wednesday 12th February 2025 Lords Chamber

[Baroness Merron (Lab)]

The noble and gallant Lord is right. Your Lordships’ House will be aware that, of the three main shifts that will be amplified in the 10-year plan, this plays very well into not only analogue to digital but the move from hospital to community, and sickness to prevention. The noble and gallant Lord is right that we need digital capability across aspects of not just the NHS but social care. We are developing various aspects, including the federated data platform and single patient records. We are engaging with the public and stakeholders to understand their views about the use of health data so that we can get it absolutely right.

[Lord Scriven (LD)]

My Lords, Oracle Cerner and Epic, the two electronic patient record systems that the NHS is purchasing, running to billions of pounds, were designed primarily for the US healthcare system and have not been significantly customised for the NHS. This is leading to a serious lack of alignment with the requirements of the British healthcare model. What assessment have the Government made of this issue and how confident are they that value for money and improved outcomes can be achieved, given that these systems have not been tailored specifically for the NHS?

[Baroness Merron (Lab)]

There are huge gains to be made in digitisation, which I know that the noble Lord shares my view on. It is crucial that we get it right. I assure him that procurement processes are carried out as we would always expect them to be and that we are satisfied that the right provision can be made.

Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2025

Lord Scriven Excerpts

Monday 10th February 2025 Grand Committee

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)]

My Lords, this SI amends the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, which are due to expire after 31 March this year. It removes that expiry date and amends the five-year period from which the regulations are required to be reviewed. Prior to laying this SI, the principal regulations required review every five years from 1 April 2015. The first post-implementation review was delayed until 2022 due to the pandemic. We therefore wish to conduct the next review in 2028.

This SI does not change any existing policy. The 2014 regulations set out the activities that are regulated by the CQC and the fundamental standards with which all health and social care providers registered with it need to comply. This is coming before your Lordships’ Committee because, if we do not amend the 2014 regulations, they will automatically expire and the CQC will have no powers to fulfil the requirements in the 2008 Act. Neither will there be an obligation on providers, which are currently required to register with the CQC, to comply with the fundamental standards set out in the 2014 regulations.

I am aware that there may have been an expectation to see further changes following the report by Dr Penny Dash into the CQC’s operational requirements, which uncovered significant failings in the CQC’s internal workings. However, dealing with those operational failings does not require changes to legislation; as we have debated in the Chamber on previous occasions, measures have been put in place by the CQC’s new chief executive, Sir Julian Hartley, to urgently address the failures, including the introduction of new governance at the board level.

Noble Lords may also have observed that this SI is silent on provisions relating to the use of restraint and the regulation of medical care at temporary cultural and sporting events, on which we also consulted last year. I can give an assurance that these sensitive areas have not been overlooked and that we are continuing to progress work on finalising these policies.

The consultation responses on the proposal to make restrictive practices notifiable to the CQC within 72 hours showed support for the measures but highlighted a number of practical concerns, primarily that the proposed timeline could place an additional burden on staff, with the potential risk of impacting patient care. As the Government said in their response to the consultation, further work is needed to ensure that we have the right definitions, systems and processes in place before proceeding with legislative changes.

I can tell the Committee that the Government will lay a statutory instrument to remove the exemption relating to regulation of medical care at temporary and cultural sporting events. With this change, providers of such care will be required to register with the CQC for the first time. I hope that will be helpful in setting out what this SI is, and is not, about. I beg to move.

[Lord Scriven (LD)]

My Lords, again I thank the Minister for clearly and aptly outlining what the statutory instrument is for. I am not going to go over the reasons for this but, broadly, these Benches support what is happening and understand why the streamlining is required. However, like all streamlining where common sense seems to take the central point, it is worth testing just how common and sensical the requirements are, and whether the Government have thought through some of the consequences—or unintended consequences—of what may happen. Although the intention to maintain regulatory oversight and uphold care standards is obviously commendable, several points warrant further investigation and probing. I hope that the Minister will answer in her normal way; she is usually quite thorough and detailed.

The Explanatory Memorandum notes that a post-implementation review conducted in July 2022 had limited responses, providing insufficient evidence to suggest that the 2014 regulations did not meet their original objectives. Could the Minister elaborate on the steps taken to engage stakeholders during this review? What measures will be implemented to ensure that, when statutory instruments are extended in future, more comprehensive stakeholder participation will be sought? The amendment mandates having a review every five years. Given the dynamic nature of health and social care, how will the Government ensure that the regulations are monitored and remain responsive to emerging challenges and innovations within the review period?

Removing the expiry date also extends the regulations indefinitely. Have the Government assessed the potential long-term impacts of this permanency on service providers and the CQC’s regulatory capacity? I think the noble Baroness knows why this question is being asked. Although I heard what she said about the operational issues that the CQC is undergoing at the moment, the regulatory changes that we are discussing may have some operational impact on the CQC.

In particular at the moment, when the CQC’s backlog is significant and its chief executive has said that it has no idea how it will deal with it—indeed, there are certain things stuck in the computer system that they do not know how to get out—how will the Government ensure in the interim that any application made to the CQC regarding this instrument is dealt with in a timely and safe manner?

Finally, on the policy areas that the Minister said were outwith these regulations due to further consultation and the sensitivity required, when will the statutory instrument be laid before Parliament? What is the timescale? Are any interim measures being put in place to ensure that any safety issues or regulatory issues with these sporting events are dealt with before the statutory instrument is laid before Parliament?

With those questions, we are, as I say, very supportive of this instrument in a broad sense, but the Minister’s normal detailed response would be welcome.

[Lord Kamall (Con)]

My Lords, I once again thank the Minister for the statutory instrument before us. We understand the reason for it: making sure, in particular, that this continues to be in effect after March this year, and setting the next review for 2028. Maybe that is where some of the questions arise—the noble Lord, Lord Scriven, alluded to some of these concerns.

We have just finished debating an SI on adapting for innovation—particularly in relation to speeding up clinical trials, which is to be welcomed. It showed that we need to be flexible with the emergence of new technology, knowledge and capabilities in health and social care. But, like the noble Lord, Lord Scriven, we wonder about a five-year review cycle, which may not allow for sufficient flexibility, given some of the fast-paced developments in healthcare. We have seen massive strides in digital health and mental health services. In our debate earlier in the Chamber, we asked about the use of AI in analysing data that the NHS already has. Will five years be too long to wait? Could it slow down the adoption or reviews, if you like, of some of these new technologies? Could the delay in reviewing regulations lead to some important issues being unaddressed for far too long? There may be new awareness of some emerging patient safety risks, for example. I just wonder: how do we get the right balance? I understand why the Government have extended this for five years, but we want to make sure that, within those five years, the Government, the NHS, the regulations and the CQC are flexible enough to take account of innovations.

The absence of interim mechanisms for addressing pressing issues during this review period could also foster a sense of regulatory stagnation. There may well be a case where providers and stakeholders feel that concerns are not being acted on quickly enough, especially as challenges arise before that next review. Although we understand the need for a stable framework, we want to understand how to get the balance between stability and responsiveness right. Could that delay necessary regulatory adjustments?

The other point here is extending the scope of the regulations to all patients being assessed or treated for a mental health disorder in a mental health unit. Obviously, this coincides with the debate that noble Lords are having on the Mental Health Bill. In this case, it extends beyond only those with learning disabilities and autism. This expansion is generally welcomed, but, once again, it raises questions—which were raised on the last SI—about resources and capacity. I know that the Minister has heard this a number of times, particularly during the passage of the Mental Health Bill. Will there be sufficient support for providers so that they can meet these expanded requirements? How will the Government monitor and address any challenges that may arise from this broader scope?

Fortunately, the Minister pre-empted one of the questions that I was going to ask about the regulations’ provisions on temporary healthcare settings, particularly at large sporting and cultural events. We understand the need to remove those regulations, but what thought has been given to the unintended consequences of doing so? I am generally supportive of removing regulations, but I understand why we need them: to make sure that enough account is taken of safety but also that someone is held responsible and there is some accountability when things go wrong.

--- Later in debate ---

[Baroness Merron (Lab)]

I thank noble Lords for their thoughtful contributions and questions. The summary of the noble Lord, Lord Kamall, of what we are looking for is exactly right. It is all about balance: we need efficiency and speed, but it has to be right. I certainly share that view. As I set out in my opening remarks, the dual purpose of this SI is to remove the expiry date of the 2014 regs and to amend the five-year period from which they should be reviewed. As I mentioned, this is to ensure that health and care providers will continue to be required to register with the CQC and comply with the fundamental standards set out in the 2014 regulations after 31 March this year, and also, as we all agree, to ensure that services will continue to be required to provide a safe and high-quality standard of care.

I turn to the points raised by noble Lords. If I find, on review, that I have not adequately answered or have inadvertently missed any questions, I will of course write with the requisite information.

The noble Lord, Lord Scriven, referred to the post-implementation review of the 2014 regs. That review ran from May to July 2022, and there were 86 responses. Interestingly, there was insufficient evidence in the responses to suggest whether the objectives of the 2014 regulations remain appropriate and whether there is an alternative system of regulation that would impose less regulation on the health and social care sector. I think we can safely say that it was not conclusive in pointing us in a particular direction.

The noble Lord, Lord Scriven, also asked when the statutory instrument to remove the exemption relating to the regulation of medical care at temporary cultural and sporting events will be laid. I can say to him that it will be in the summer.

The noble Lord, Lord Scriven, also raised the question of the performance of the CQC, which I completely understand. He asked what is happening, how we are dealing with the backlog of registrations and what is our assessment of its long-term impact on regulatory capacity. I understand that. I re-emphasise that the chief executive of the CQC has commissioned an independent review to look specifically at the CQC’s technology. That will help reduce the backlog, which can be tracked back to 2023, when there were a number of difficulties that now need to be resolved. I absolutely agree that the backlog in registrations is a problem particularly for small providers trying to set up a new care home or service. That problem can mean lost revenues and investment, and that has a knock-on impact on capacity, which we very much need to expand.

[Lord Scriven (LD)]

It is really helpful that the Minister says that, but a review in itself does not solve the problem. Have the Government given the CQC a timescale, not just regarding a review but for when they expect the operational difficulties to have been addressed? It is important for those who are registering to understand that. What is the timescale, not for the review but for dealing with the consequences of the backlog?

[Baroness Merron (Lab)]

The noble Lord has raised this with me in the Chamber and in a Parliamentary Question, if I am not mistaken. While I cannot be specific, as I have mentioned before, the fortnightly meetings with CQC—after which a report also goes to the Secretary of State—are an example of focus which, I hope, give some sense of the pace and intensity in putting this right. The CQC not being fit for purpose is an unsustainable situation which is causing great difficulty. When I can update your Lordships’ House about timelines, I will be very pleased to do so.

The noble Lord, Lord Kamall, asked about interim plans being in place. This is kept under review. We are working with the CQC on its recovery and will review whether further changes are needed. There is nothing to stop us from reviewing regulations in the interim. Five years is the statutory requirement, but it does not mean that we cannot act sooner. It is a point well made about time. Similarly, the noble Lord asked whether the reviews being every five years would slow down the adoption of technology. The intention is that it would absolutely not. The reason for keeping the regulations under review is that that would not be regarded as getting the right balance which we all seek.

Regarding capacity issues to meet the expanding requirement, we are very conscious of the consequences. The Government will work with the CQC, NHSE and its partners on a workable mechanism for notifying restraint within 72 hours, which was the point raised.

With that, I thank noble Lords for their contributions. Perhaps I can assure them that, in some ways, this is for me a work in progress, on many sides. We will continue to do that.

Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024

Lord Scriven Excerpts

Monday 10th February 2025 Grand Committee

[Lord Scriven (LD)]

My Lords, I start by congratulating the Minister; I hear her sniffles. She has been a champion of her brief in having to deal with two statutory instruments, as well as a Statement in the House. I thank her for being here.

As the Minister said, the reforms proposed in this statutory instrument aim to create a more streamlined and flexible regulatory environment for clinical trials in the United Kingdom, while balancing safeguarding the interests of trial participants. The amendments seek to uphold the paramount importance of participant safety, ensuring that their rights and well-being remain central to the regulatory framework. By refining the evaluation and development process for new or improved medicines, these changes aim to expedite the delivery of therapeutic benefits to patients and society at large, and we on these Benches recognise that.

The instrument will formalise the combined review process, which has been piloted since 2018 and become the exclusive route for clinical trial applications. This process offers a single application pathway and co-ordinated regulatory and ethics committee review, ending in a unified UK decision for clinical trials. That would be helpful for practitioners and those seeking to innovate, but there are still points that require clarification, and while the objectives of these amendments are commendable, I seek clarification from the Minister on several aspects.

What measures are in place to ensure that the Medicines and Healthcare products Regulatory Agency and the ethics committees will be adequately resourced to manage the anticipated increase in workload resulting from the streamlined process? If no impact assessment has been made, what working assumptions are the department and NHS England working to regarding the workload that this new process will bring?

Can the Minister provide detailed guidance on how the risk-based approach will be operationalised to ensure consistency across different types of trials? I note that she talked about international alignment, but how do the Government plan to align these regulatory changes with international standards to facilitate seamless multinational trials? What frameworks will be established to monitor the impact of these regulatory changes on trial efficacy and patient safety, which is really important? How will these findings be reported locally within the NHS? Will they be reported to Parliament at any point?

Finally, can the Minister explain and elaborate on the consultation process undertaken with key stakeholders regarding these changes, including patient groups, industry representatives and academic researchers, in the development of these amendments? Were there any differences that emerged from the stakeholders and how have the Government dealt with them?

In conclusion, while we on these Benches support the intention behind these regulations, it is imperative to ensure that the implementation is robust and effective. I look forward to the Minister’s responses on the matters I have raised—less croaky responses, I hope.

[Lord Kamall (Con)]

My Lords, I thank the Minister for the laying of this statutory instrument. Like the noble Lord, Lord Scriven, I commend her on her valour and robustness, as well as the speed at which she managed to transport herself from the Chamber to here after the Statement repeat, having prepared for that and having been briefed by her officials.

Like many other noble Lords, we welcome these regulations, which are grounded in the review by my noble friend Lord O’Shaughnessy and the subsequent consultation with stakeholders, including the Medicines and Healthcare products Regulatory Agency and Health Research Authority, aimed at modernising the regulatory framework that governs clinical trials in the UK. We know that the landscape for clinical research in the UK faced significant disruption during the Covid-19 pandemic, but we also know that we learned quite a lot from trying to get vaccines out very quickly in terms of ways to speed up trials and to make sure that we get the right balance between efficiency and processes, as well as making sure that people are safe. We need to make sure that we can boost the volume of clinical trials and boost patient recruitment.

The O’Shaughnessy review identified the need for a more flexible and risk-proportionate approach to clinical trials. One very important point is that, while we cannot eliminate risk altogether, we can manage it. Where there is low risk, we should maybe not be placing so much emphasis on processes as compared with when there is high risk, but I also know that there may always be unintended consequences.

Stakeholders such as the Association of the British Pharmaceutical Industry were vocal in their support for these reforms and had in fact been calling for them. The ABPI 2024 report, The Road to Recovery for UK Industry Clinical Trials, highlighted that the number of pharmaceutical industry trials initiated in the UK increased—it was just over 400—between 2022 and 2023, although that still remained 36% below the 2017 level. We therefore understand the need to bring forward these regulations to make sure that we improve the regulatory environment to further increase clinical trial activity.

I turn to the detail of the regulations. One major change that noble Lords have already alluded to is the consolidation of the regulatory and ethics review process, enabling researchers to submit a single application for both regulatory approval and ethics review. While this change is aimed at improving efficiency—which we completely accept and welcome—there is a concern that any changes from consolidating these processes may put additional pressure on the regulators and ethics committees. The noble Lord, Lord Scriven, referred to that. If the single application process becomes overloaded, we risk delays in review times rather than the acceleration that was intended by these measures in the first place. It is essential that we have the resources and infrastructure in place to handle the increased workload effectively. Can the Minister therefore say how the Government will make sure to avoid that sort of overload? We completely understand why they want to consolidate the processes, but will it add extra pressure and will the resource be there to make sure that they are not overloaded and we do not just end up going back to square one, or even make things worse?

In addition, for low-risk trials, automatic regulatory authorisation will be granted, which will further streamline the approval process and free up resources for the more complex, higher-risk trials. Once again, while this makes sense, we have to be aware of possible unintended consequences or concerns that will be raised. The automatic approval of low-risk trials could, for example, raise concerns over oversight and monitoring. The intention to expedite the approval process for those with lower-risk profiles is laudable, but will there be clear criteria in place to ensure that the appropriate level of scrutiny is maintained, particularly in ensuring patient safety? As I said, while we support the intention, particularly for low-risk trials, we must always be aware of unintended consequences or unforeseen complications. Nevertheless, we completely understand why this is being done, and it is something to be welcomed.

National Cancer Plan

Lord Scriven Excerpts

Monday 10th February 2025 Lords Chamber

[Lord Kamall (Con)]

My Lords, I thank all those who work tirelessly to treat and help others who are suffering from cancer—not only the wonderful clinicians and medical professionals but also the many cancer charities, some of which I have met, which support people living with cancer and fund the important research that has led to significant increases in survival rates for some cancers and will lead to the future breakthroughs that we all want to see. Their dedication is an example to us all. We owe them a great deal of gratitude; it is something that we can all be proud of.

Cancer will affect us all in some way or another. Almost everyone knows someone who has been diagnosed with it or may have had to live with the big C themselves, so it is vital that we do everything we can to beat this disease. It is highly reassuring that cancer care and treatment are constantly improving. Over the past 50 years, the survival rates for all cancers have doubled. The one-year survival rates for cancer increased by almost 6% between 2010 and 2020, while the five-year survival rate has increased by more than 4%. However, we know that more can and must be done. Despite these improvements, we are not in the place we all want to be in. We should be honest about that.

These Benches welcome the fact that the Government are taking steps to try to improve cancer care and research. It is welcome that there will be a greater focus on prevention and early diagnosis, which we know to be one of the best ways of improving quality of care. We are also grateful to this Government for continuing the rollout of community diagnostic centres started by the last Government.

When I was a Health Minister, I was advised by officials that 80% of those on the waiting list were waiting for diagnosis. That statistic may no longer be true but more community diagnostic centres are clearly needed, not just for early diagnosis but because their being placed in local communities might help reluctant patients who are scared or worried about going to hospital or who suffer from white coat syndrome to seek a diagnosis—at a more friendly place such as their local sports centre or shopping centre, so it does not become a daunting task. We welcome the fact that the Government will continue to roll these centres out.

Technology will be an accelerator for cancer treatment. Coupled with innovative methods of utilising data, machine learning and AI, there are real opportunities to drive better outcomes. If we can identify those who are more at risk or likely to be at risk from certain types of cancer and streamline them into treatment pathways using the best data available, then we could increase our survival rates further. Can the Minister reassure your Lordships that there will be a strong focus on harnessing new technologies in the cancer plan when it is published and will the Department of Health and Social Care engage with the many innovative companies—start-ups and others, and rollouts and spin-outs from many research places—that produce such technologies and can help the NHS synthesise and restratify the available data?

While we welcome the Government’s commitment to cancer care, we have questions about the timescale. I appreciate that the Minister has been honest that some announcements by the Government are aspirations while others are firm commitments. I note that this announcement launches the call for evidence for the national cancer plan, but we have already heard that the Government have launched a number of other reviews and plans. We have the NHS 10-year plan, the elective reform plan, the commission on building the national care service and the review of the new hospital programme. I believe noble Lords would like to know when we will see action from these plans, and today in particular from the cancer plan. If the Minister cannot give further details now, can she give an indication of when we can expect them? That would be greatly appreciated when it comes to understanding the Government’s commitment to this plan.

Finally, while we have made great progress in tackling certain types of cancer, what more could be done to speed up treatment of the hard-to-treat or less survivable cancers? I recently met Pancreatic Cancer UK, which told me that one of the reasons for lower survivability is that, by the time the cancer is spotted, it has often reached a late stage: stage 3 or 4. It also told me about a breath test being trialled that captures vapours and gases which can be analysed to detect the presence of biomarkers of certain cancers. To be clear, I appreciate that this is being trialled, but I wonder what changes to processes the Government and the NHS may be looking at to speed up the rollout of such innovations, especially relatively low-cost tests. I appreciate that there might be unintended consequences, false negatives or false positives, but could the Minister write to noble Lords with more details of such forthcoming breakthroughs and trials in England? I look forward to her response.

[Lord Scriven (LD)]

My Lords, I thank the Minister for the Statement. Like the noble Lord, Lord Kamall, I thank those individuals who work day in, day out with people who have been diagnosed with cancer, and with their families, for the great work they do. This cancer plan represents an opportunity to make significant progress in the country’s fight against this terrible disease. The Statement and the plan, while containing some promising elements, require careful scrutiny. In the view of these Benches, further action is required if we are truly to make the necessary strides in the fight against this devastating disease.

Cancer, as we all know, touches every family in the country. It is a relentless adversary and our response must be equally determined. The plan before us rightly acknowledges the importance of early diagnosis and I commend the focus on initiatives such as the expansion of screening programmes and the innovative use of technology to detect cancers earlier. Early detection is, without question, the single most powerful tool we have to improve patient outcomes.

However, we have some concerns. While the rhetoric around early diagnosis is welcome, the plan lacks sufficient detail on how we will address the very real workforce shortages that plague the NHS. We cannot diagnose cancers early if we do not have the radiologists, pathologists and oncologists to interpret results and deliver timely treatment. The Government need a concrete plan for recruitment and retention of these vital professionals. I urge them to address these critical gaps and ask the Minister exactly how these gaps will be plugged.

Furthermore, the plan’s ambition for personalised medicine is laudable, but it seems somewhat detached from the realities on the ground. Access to cross-cutting treatments and clinical trials remains uneven across the country. We must ensure that one’s postcode does not determine a patient’s access to the most innovative therapies. This requires not only increased funding for research and development but a streamlined process for bringing new treatments to patients as quickly and safely as possible. What plans do the Government have to ensure that these treatments are brought forward quickly across the country?

Another area of concern is the plan’s approach to palliative care. While the focus on early diagnosis is crucial, we must not forget those for whom a cure is no longer possible. Palliative care is not simply about end-of-life care; it is also about maximising quality of life for patients and their families throughout their cancer journey. What are the Government doing to ensure a renewed focus on funding and resourcing for palliative care services, ensuring that every patient receives the compassion and holistic care they deserve?

We need to do more to tackle what is happening. I will ask two further questions and give the Minister a suggestion that may be taken forward. First, it is pleasing to see that radiotherapy is in the Statement, which is a step forward. However, evidence shows that currently the United Kingdom allocates only 5% of its cancer budget to radiotherapy, compared with the OECD average of 9%. This discrepancy is a contributing factor to the UK’s low cancer survival rates, particularly in cancers such as lung and colorectal. Countries such as Australia and Canada, which allocate a higher percentage of their cancer budgets to radiotherapy, have seen improvements in survival outcomes. Will the Minister commit to addressing this funding gap and set specific targets for cancer budget allocation for radiotherapy to ensure better survival rates for patients in the UK?

Secondly, with over 500,000 people waiting more than two weeks for vital cancer treatment, how do the Government intend to tackle these extensive delays in the immediate term? What concrete measures will be taken to ensure that the national cancer plan leads to real improvements, rather than remaining a set of unmet promises?

I wish to give the Minister a suggestion, which I hope she will take forward. Many of us in this House understand the significant difference in outcomes between early and late-stage diagnosis of cancers. On these Benches, we are strong advocates of utilising AI in early detection. The UK, with its unique history of the National Health Service, benefits from a collection of historical tissue samples. Given this, would the Government implement a programme in which AI performs a retrospective analysis of these samples in order to identify patterns that would improve the speed and accuracy of cancer diagnosis in the future?

I urge the Government to listen to the concerns raised by healthcare professionals and, most importantly, by patients and their families during the consultation period. These insights will strengthen this plan and ensure that it delivers real and lasting improvements to the lives of those affected by cancer.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)]

My Lords, I am most grateful to both Front Benches for welcoming the plan and coming forward with very constructive points to strengthen our hand. I am sure we all agree that the prevalence of cancer and the way it touches everybody’s lives, either directly or indirectly, are considerable; cancer affects one in two people in this country. I also thank the staff, volunteers, researchers and everybody who is involved, including carers—paid and unpaid—for their work in this area.

The Statement was made on World Cancer Day. There were two aspects to it; both have been raised, but the one on which I want to focus is the national cancer plan. We have opened a call for evidence to gather views from the public, health partners and parliamentarians on what should go in the national cancer plan, because it seeks to improve every aspect of cancer care and to improve the experience and outcomes for people with cancer, including key goals and actions. The call for evidence is open until 29 April and, to the question raised by the noble Lord, Lord Kamall, it will report in the second half of this year, which, as I hope the noble Lord will agree, in government terms is quite prompt. It will follow the publication of the 10-year plan. In the Front-Bench questions, there was reference to various plans. They all chime in with and build on each other, but we feel that, as noble Lords have said, cancer is absolutely something on which we have to focus.

On radiotherapy access—an important point raised by the noble Lord, Lord Scriven—this is a priority, which is why this year we will spend £70 million in investment to replace older radiotherapy machines with newer and more efficient models. This will mean at least 27 machines to trusts across England, because we are keen that improvement is made.

It has come up in previous debates that NHS England and integrated care boards are responsible for ensuring that the healthcare needs of local communities are met. I take on board the point raised by the noble Lord, Lord Scriven, about concerns over differences of availability of care. In my view it is a good thing to move to give more decision-making and powers locally to meet the needs of local communities, rather than be instructed from the centre. Responsibilities for local provision include considering adequate healthcare provision, such as radiotherapy treatment, care and wider support, including in remote and rural areas. Of course, addressing healthcare inequity is a core focus of the 10-year health plan. We have established working groups focused on how care should be designed and delivered to improve equity and make sure that services are effective and responsive.

Cancer survival is indeed an area in which this country lags behind. That is a consequence of a number of issues, including diagnosis not being where it should be. Improving early diagnosis of cancer is integral for improving survival rates, and it is a priority both for the Government and for the cancer plan. The noble Lord, Lord Kamall, talked about recent successes, including the CDCs, but there is also, for example, the targeted lung cancer screening programme, which has been a tremendous boost to survival rates and to diagnosing cancer earlier in the groups and individuals who are more at risk and yet were not coming forward. We will continue to work from that.

The noble Lords, Lord Kamall and Lord Scriven, both raised rare cancers and research. There will be careful consideration of how the plan is going to deal with rare cancers so that they are not left behind. We absolutely recognise the importance of research and harnessing the powers of new technology to improve outcomes. That is why we invest more than £1.5 billion per year through the National Institute for Health and Care Research, which will help that prevention and detection.

The noble Lord, Lord Scriven, raised the important matter of AI. Your Lordships’ House will be pleased to hear that the other part of the cancer plan was to launch a world-leading artificial intelligence trial, involving nearly 700,000 women and using the latest AI technologies to catch breast cancer earlier. The noble Lord asked a specific question about the use of AI retrospectively, which I would be pleased to look into and get back to him on.

With regard to shortages in the workforce, we have already announced plans for a revised NHS Long Term Workforce Plan for the summer of this year, to make sure that the NHS has the right people in place.

To go back to the point raised by the noble Lord, Lord Scriven, on clinical trials, I should add that the TRANSFORM trial will look for better ways to detect prostate cancer and address the health inequalities that we know are there by ensuring that one in every 10 of the participants are black men.

The noble Lord, Lord Scriven, raised the important matter of palliative care. We will consider palliative care and other care for people living with and beyond cancer as a part of the cancer plan. We would very much welcome responses to our call for evidence on this.

On waiting lists, on 6 January 2025, a new elective reform plan was published to set out a whole-system approach to reaching and meeting the 18-week referral to treatment target by the end of this Parliament.

The noble Lord, Lord Kamall, asked about harnessing data, which is very important. As I mentioned, we have launched a world-leading AI trial, which will provide us with the kind of data we need to improve women’s health screening.

I am grateful to noble Lords for their support and suggestions. I look forward to this cancer plan making significant changes for so many in this country.

Valdo Calocane: NHS England Report

Lord Scriven Excerpts

Thursday 6th February 2025 Lords Chamber

[Baroness Merron (Lab)]

I assure the noble Lord that officials are working with NHS England and partners to set out the next steps regarding how future mental health homicide reports should be published and to ensure that we act as transparently as possible in line with our legal obligations and with engagement for families. That is very important for the future. The three points the noble Lord raises are very relevant and are being dealt with thoroughly in Committee as we take the Mental Health Bill through this House. I am confident that your Lordships’ House is on top of this matter, as are the department and all concerned. There has already been progress on the CQC report published previously, and all the recommendations in this report have been accepted in full.

[Lord Scriven (LD)]

My Lords, these Benches share in the condolences to all those affected by this tragedy. This is a watershed moment, but I am not sure whether the culture of the NHS has changed, given that yesterday a senior official said,

“the system got it wrong”.

No. Individuals in the system got it wrong. What extra mechanisms will the Government put in place to ensure that every individual is held accountable for this and future tragedies in each ICB area?

[Baroness Merron (Lab)]

I understand the seriousness of the points the noble Lord makes. As he is aware, the report to which we are referring is concerned with the care and treatment provided by health services to Valdo Calocane rather than questions of culpability. More broadly, I remind your Lordships’ House that the Prime Minister has committed to establishing a judge-led inquiry into these attacks. We absolutely understand the importance of an inquiry. Having met the families myself, it is crucial to provide families with answers and ensure that this cannot happen in the future.

Care Homes: Safety Ratings

Lord Scriven Excerpts

Wednesday 5th February 2025 Lords Chamber

[Baroness Merron (Lab)]

To take the second question first, the commission will start its work in April. The noble Baroness, Lady Casey, has agreed to lead that review. The terms of reference will be published, and the first report will be with us next year. On the important point about IT, as I mentioned in response to the noble Lord, Lord Patel, that problem arose in 2023. The CQC has acknowledged, as we have, that there have been huge challenges with the provider portal and the regulatory platform. The Dash review talked about poorly performing systems hampering ability. This is not how the system should work. As we move towards the 10-year plan, and from analogue to digital, we will have that front and centre in how we work.

[Lord Scriven (LD)]

My Lords, the Secretary of State in July said that

“the CQC is not fit for purpose”.

Given the systematic failings still within that organisation, what timescale have the Government given the CQC to become fit for purpose?

[Baroness Merron (Lab)]

The Secretary of State did indeed say that, and he was right to do so, in the spirit of transparency. The fortnightly meetings which I mentioned will be a constant assessment until we have met the necessary timeframes that are only reasonable to assist people in making decisions. All of that—how might I put it?—deep focus on the CQC will continue. I do not think this will be quick, but it will be thorough.