Prostate Cancer: National Screening Programme

Baroness Merron Excerpts

Thursday 27th February 2025 Lords Chamber

[The Lord Bishop of St Albans]

To ask His Majesty’s Government what plans they have to introduce a national screening programme for prostate cancer.

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

My Lords, we are investing £16 million in the Prostate Cancer UK-led TRANSFORM trial to look for better tests than we have currently. Evidence shows that the current best test available, the PSA test, is not accurate enough to use in men without symptoms. As noble Lords will appreciate, policies must be evidence-based, so the UK National Screening Committee is actively reviewing the evidence for prostate screening programmes and will complete its review this year, to be followed by consultation.

[The Lord Bishop of St Albans]

My Lords, I declare an interest, in that just a year ago I was unexpectedly and rapidly diagnosed with prostate cancer and received wonderful treatment from the NHS, to which I pay tribute today. Some 12,000 men die each year, many needlessly, because of late diagnosis. It is a postcode lottery. It is quite clear that in areas of socioeconomic deprivation, and among black men between the ages of 45 and 70, there is a much higher incidence. When can we expect to hear news about a national screening programme? What assessment is being made of the new tests that are being reported at the moment, which are much more successful in diagnosis?

[Baroness Merron (Lab)]

My Lords, I am glad to hear that the right reverend Prelate had such good care in the NHS. His comments are appreciated, and we are very pleased that things have out turned so well for him. The issue, as I know he will he understand, is that we cannot offer an inaccurate test to high-risk groups, not least because that increases the risk of adverse effects, unnecessary treatment and misdiagnosis. We are not yet in a scientifically and evidence-based position to offer the national screening programme, and that is why we are taking the action that I outlined in my Answer.

[Baroness Walmsley (LD)]

My Lords, while we wait for a more reliable screening tool, what are the Government doing to inform men about the very clear risk factors that are known about? To that I would add that maintaining a healthy weight reduces the risk. Additionally, what can the Minister do to reassure men that, if they are in any way worried about any symptom, they are not wasting their GP’s time if they go along and get it checked out?

[Baroness Merron (Lab)]

The noble Baroness is absolutely right. I encourage everyone, men and women, to be aware of any changes in their bodies. They are not wasting the time of their GP. That is exactly what they should do. As she says, men are disproportionately affected by a number of health conditions, including some cancers, heart disease and type 2 diabetes. As part of addressing this, the Secretary of State has announced that we are developing a men’s health strategy, not least because we know that men are less likely to come forward to deal with health matters.

[Baroness Manzoor (Con)]

My Lords, in the absence of a national screening programme and given the difficulty in getting access to GPs, particularly in deprived areas, how are the Government improving access to GPs? In some areas, it is two to three weeks before people can get an appointment.

[Baroness Merron (Lab)]

Again, I am sure that the noble Baroness would agree that the important thing is that people ensure that they do not ignore the situation. I agree that the situation that we inherited was hugely difficult, particularly in some areas, around GPs. In the 10-year plan, which will be published in the coming months, there will be a big focus on the move from sickness to prevention, from analogue to digital, and from hospital to community. In all three pillars, greater access to GP appointments will be included.

[Baroness Finlay of Llandaff (CB)]

My Lords, as the Minister rightly highlighted, there are detection gaps, and one in 50 people have aggressive disease at the time of diagnosis. When this proves to be hormone-therapy or chemotherapy resistant, how many centres can offer strontium, which can be very effective for metastatic bone pain, as that is how some people present?

[Baroness Merron (Lab)]

I was glad to have the opportunity to discuss this with the noble Baroness. Having looked into it, we do not currently hold this data. However, where strontium therapy is appropriate and preferred to improve patient outcomes, it will be offered. This is, of course, a clinical decision.

[Lord Kamall (Con)]

My Lords, when I worked in Belgium, a urologist told me that men over 45 years old should seek a test every year for this. When I came back and asked my GP, he was dismissive of that, saying that I should seek a PSA test. When I asked a nurse at my next blood test for a PSA test, she said, “Are you sure? They’re not very reliable”. Given that the last Government introduced trials, and that one of the tests seems to be 96% accurate, can the Minister say any more about that trial and its evaluation, and whether we are any closer to a definitive test? If not, what guidance is available to medical practitioners for the PSA test?

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[Baroness Merron (Lab)]

The advice and guidance is that GPs should counsel asymptomatic men about the potential benefits and harms of PSA testing, so that they can make an informed decision. However, the guidance is that GPs should not proactively offer a PSA test, for the reasons that we have covered. That is why we are investing in this trial, to find a better test so that we can address this. This is a complex area, as often it is, but we are making progress, as I have already outlined.

[Lord Brennan of Canton (Lab)]

My Lords, it is very welcome that new diagnostic tests are being investigated. However, can we be careful not to give out the wrong message? I was diagnosed with prostate cancer—and I was completely symptomless—thanks to the PSA test. In giving out that message, can we make it clear that GPs should not stop men getting a PSA test, even when they are symptomless, if they are at the right age and in the right bracket?

[Baroness Merron (Lab)]

I certainly agree with my noble friend. As he knows from his experience, tests are available. The point is that they should be used in the right situation. As he knows, one of the issues is people being asymptomatic, which is why it is very important that men take note of their health and report any change or concerns that they have.

[Lord Grayling (Con)]

My Lords, I am also here thanks to early diagnosis. I understand what the Minister is saying about the PSA test, but very many people are here today because they had such a test. It worries me that the message is that, because it is not reliable, it should not be at the forefront. I ask the Minister not to rule out using PSA tests more widely. If it is the best we have got, it may be the only thing we have got.

[Baroness Merron (Lab)]

I thank the noble Lord for sharing his personal experience. I am not suggesting that the PSA test should not be used, but we are talking about extending it and using it in a screening program. I thank him for giving me the opportunity to reassure your Lordships’ House that that is why we have the trial, which will report later this year, to find a better answer; the answer we have currently is not where we need it to be. Yes, there is a role for it, but we must strive for better than we have got currently.

[Lord Sentamu (CB)]

My Lords, 13 years ago, a PSA test saved my life. I had an operation in Leeds hospital and I now have no sign of that, and every year they test me by the same method. I encourage the Minister not to give mixed messages. We need a very clear message that, at the moment, the PSA test saves a lot of lives.

[Baroness Merron (Lab)]

I agree about the need for clear messages, and I hope the noble and right reverend Lord will agree on the need for striving to do rather better.

[Lord Bailey of Paddington (Con)]

My Lords, in many deprived communities, and in the black community in particular, there is a very high incidence of prostate cancer. Before they get to the PSA test, what work is being done to educate communities even to be involved with seeking out that test in order to protect their health?

[Baroness Merron (Lab)]

The noble Lord is quite right to raise this. I am glad to say that the TRANSFORM trial I referred to will help to address this by ensuring that a significant proportion of participants are black men, who suffer disproportionately in this regard. That is really important, because previous trials have not included enough black men. The trial will address those disparities, and therefore the results that we get from that will be really important. It is always the case that working with specific communities to get the right message out is key to what we do.

Musculoskeletal Health: Chiropractors

Baroness Merron Excerpts

Wednesday 26th February 2025 Lords Chamber

[Baroness Ritchie of Downpatrick]

To ask His Majesty’s Government whether they plan to incorporate a role for chiropractors in national musculoskeletal health prevention strategies.

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

My Lords, improving health outcomes for over 17 million people in England with musculoskeletal conditions forms a key part of this Government’s commitment to build an NHS for the future. Healthcare professionals play a vital prevention role in supporting people to self-manage their conditions. NHS England does not commission chiropractic care nationally. However, ICBs have their own clinical or commissioning policies and so may commission a limited amount of such treatment, based on the needs of the local population.

[Baroness Ritchie of Downpatrick (Lab)]

I thank my noble friend for her Answer. I say initially that I am someone who avails periodically of chiropractic services. Will my noble friend the Minister, along with her ministerial colleagues in the Department of Health and Social Care, review the allied health professions list to include chiropractors working within the NHS to deal with musculoskeletal conditions, which in turn could alleviate the burdens on an already overburdened NHS? Could this also be included in the national health plan, which I hope will be published shortly?

[Baroness Merron (Lab)]

I recognise the importance of mitigating the long-term burdens of MSK conditions, which are considerable, and the role that healthcare professionals, including allied healthcare professionals, can play in supporting not just prevention but early detection and the management of conditions. I know that chiropractic care is appreciated in a number of cases, including that of my noble friend. However, clinical evidence from systemic reviews does not support national commissioning of chiropractic treatment, as I mentioned, although ICBs can commission these services. To the point on the 10-year plan—a report on that is expected in the spring, as my noble friend referred to—I place on record that I am grateful to the British Chiropractic Association, the Arthritis and Musculoskeletal Alliance, Versus Arthritis and the Royal Osteoporosis Society for ensuring that the voices of the MSK community have been well heard in the consultation.

[Baroness Burt of Solihull (LD)]

My Lords, 30% of GP consultations are for people with musculoskeletal problems. As a previous back sufferer who has made use of chiropractors in the past, I know personally the transformation that chiropractic treatment can achieve. I can afford that treatment, but many NHS patients cannot, so why can chiropractors not practise across the NHS, when waiting lists for treatment on the NHS are causing the loss of over 6 million working days every year?

[Baroness Merron (Lab)]

The noble Baroness is absolutely right to highlight the extent of the impact of MSK conditions not just on individuals but on our economy and our health service. However, to extend my earlier comments, chiropractic care is regarded as being in the category of complementary and alternative medicines. Some treatments have an evidence base that is not recognised by the majority of independent scientists, whereas others have been proven to work for a limited number of conditions. I appreciate the point that the noble Baroness is making, but probably the simplest way I would wrap it up is in talking of sufficient and reliable evidence, because that is what NHS commissioning at a national level is based upon.

[Lord Lexden (Con)]

My Lords, is it not the case that chiropractic treatment is included in the World Health Organization’s guidance on MSK conditions? Will the Government keep that guidance clearly in mind as they work, as I am sure they will be working, to develop a better approach to helping people with these painful conditions?

[Baroness Merron (Lab)]

I am glad that the noble Lord acknowledges the ongoing work, because we are indeed exploring how best to support dealing with MSK conditions—not least to encourage and provide greater parity in the support that is given. That will be alongside the 10-year plan and the long-term workforce plan. Of course, we keep all evidence continually under review.

[Baroness Winterton of Doncaster (Lab)]

My Lords, I take the point my noble friend the Minister makes about national commissioning and the ability of integrated care boards to do some commissioning, but would not the answer be for the integrated care boards to get all preventative healthcare practitioners to sit down together and work out local strategies? It may well be that one condition can have an effect on another, and perhaps that would make the commissioning of chiropractors easier and fit in with a local preventative healthcare strategy.

[Baroness Merron (Lab)]

My noble friend helpfully emphasises the point about the need to provide for local populations, and ICBs are in the pole position to do that. I am sure that noble Lords will recall that we recently announced changes in the NHS operating model to move power from the centre to local leaders. I particularly refer to the NHS planning guidance, whereby we follow the recommendations of the noble Lord, Lord Darzi, to take a whole new approach and reduce the number of national targets from 32 to 18. The reason for that is to give the local systems my noble friend refers to greater control and flexibility on how local funding is deployed. Indeed, one such model could be the one my noble friend referred to.

[Lord Rogan (UUP)]

My Lords, an estimated 30% of the population of the UK are burdened with a painful and debilitating MSK condition. That is over 20 million people in the United Kingdom. Given the Government’s priority of shifting treatment into communities in the 10-year health plan, will the Minister meet again with representatives from the chiropractic profession to hear how they can increase capacity for community MSK treatments?

[Baroness Merron (Lab)]

I am certainly happy to have such discussions. Perhaps I could use this opportunity to say to noble Lords that part of the recently published elective reform plan sets out funding to boost bone density scanning—or DEXA—capacity, to provide an estimated 29,000 extra scans per year. The work goes on also to support workforce health. For example, we are commencing training so that over 200 doctors and nurses can undertake occupational health training and qualifications. The numbers of physios and OTs are increasing. This is very much work in progress. I certainly agree with what the noble Lord said about the impact and extent of this; it really does affect so many.

[The Lord Bishop of London]

My Lords, according to the Arthritis and Musculoskeletal Alliance report on health inequalities and deprivation, an important way to reduce health inequalities in these conditions, particularly in those groups of people who are underserved, is to help them to manage their own conditions. Often it is much harder because they often have more than one complex condition; often they are much more complex and are picked up much later. One of the recommendations was around moving NHS care into the community. Could the Minister tell us what the Government are doing to encourage the NHS to build partnerships with community groups, including faith groups, to seek to reduce inequalities in these conditions and communities?

[Baroness Merron (Lab)]

Working with community-based organisations, including faith communities, has come up a number of times in the 10-year plan consultation, as I am sure the right reverend Prelate will find. I would certainly associate myself with the comments about the importance of getting healthcare provided in the community.

[Lord Kamall (Con)]

I thank the Minister for giving me the time to ask a question. Following the tragic death of Joanna Kowalczyk in October 2021, the coroner has recently raised concerns over the fact that chiropractors are not required to request their patients’ medical records before they begin treatment. While I recognise that there is scepticism from many in the NHS, and in fact physiotherapists, towards osteopaths and chiropractors, will the Government take on board the recommendations of the coroner to look at changing guidance to ensure that all healthcare treatments require consideration of a patient’s medical history, especially as we move toward a digital single patient record that could be shared across our system of health and care?

[Baroness Merron (Lab)]

The noble Lord raises an important point about what is required before healthcare is provided. I can certainly assure the noble Lord that, as I know he is aware, where there is a coroner’s report, we look at all of the lessons to be learned to consider how we might make it a safer and more effective environment for people. Certainly in the case to which he refers, that will happen.

Mental Health Bill [HL]

Baroness Merron Excerpts

Committee stage
Monday 24th February 2025 Lords Chamber

[Lord Kamall (Con)]

My Lords, I thank the noble Baroness, Lady Tyler, for introducing this amendment. It is quite clear that noble Lords across the Committee agree with the Government’s commitment to move the emphasis from sickness to prevention. This amendment is clearly aimed at that, as the noble Baroness has said.

During my time as a Health Minister and since, I have met a number of community and civil society projects, charities and mental health professionals who have shared the amazing work being done across the country to improve the well-being of local communities. I put on record my thanks to the late Baroness Greengross and the noble Lord, Lord Howarth, for introducing me to the wonderful world of creative health and to the National Centre for Creative Health. Its work addresses the theme of earlier amendments from the noble Baroness, Lady Hollins, and the noble Lord, Lord Crisp, on the overprescribing of antidepressants and looking at alternatives. We are not saying that medication is a bad thing necessarily. It is very appropriate in some cases, but there are alternatives, such as social prescribing.

The late Lady Greengross introduced me to a wonderful organisation called Intergenerational Music Making, and I put on record my thanks for its work. It invited me to take part in one of its intergenerational music hubs in Guildford last December and, despite being handed a guitar to play along, I found it inspiring to see the difference that music can make in improving well-being and bringing people of all ages together, including some children from a local learning disability charity.

Noble Lords will also know of the equally amazing work done by many social prescribing organisations, using music, art, drama and green spaces. A career in creative health also opens up new opportunities for budding actors and rock stars who can train as drama and music therapists while waiting for their big break. But many do not wish to be stars and actually find their work, combining their passion with improving mental well-being, fulfilling in its own right.

However, one criticism I hear is that, although there is amazing work on well-being in different primary care settings or in different trusts and integrated care systems across the country, the challenge is how we spread the best practice across our system of health and care, while recognising that what works in one area may not always be an off-the-shelf solution in another locality.

The amendment from the noble Baroness, Lady Tyler —which says that

“Local authorities and commissioning bodies must publish an annual report outlining the steps taken to discharge their duty”


to promote mental health and well-being—may be a way to address this concern. Given that, I hope it is an amendment that the Government will consider. If not, perhaps the Minister can tell your Lordships how the Government intend to encourage the sharing of best practice in improving mental well-being across our system of health and care, particularly across different communities with different needs and different constraints, in order to improve the mental well-being of the nation.

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

My Lords, I thank the noble Baroness, Lady Tyler, for tabling Amendment 160B. We recognise the importance of local organisations taking collective action to promote mental well-being and prevent mental ill-health. However, turning to the amendment very specifically, we do not feel that this amendment suggests the best approach, as there is potential for introducing unnecessary burdens on local authorities and commissioning bodies. It may also be duplicative of other existing duties, such as the Care Act duty, to promote individual well-being.

However, the noble Baroness, Lady Tyler, and the noble Lord, Lord Kamall—whom I also thank for his contribution—may be interested to note that the existing prevention concordat for better mental health, a voluntary agreement signed by local authorities and integrated care boards across the country, does involve, for those who sign it, a commitment to take

“evidence based preventive and promotional action to support”

population mental health and well-being.

Through the NHS 10-year plan, which the noble Baroness referred to, and as noble Lords are aware, we aim to encourage stronger partnership working between local government mental health services and the voluntary and community sector—which, as we know, plays a vital role, as the noble Lord, Lord Kamall, described—in order to galvanise that shift, which we all seek, from sickness to prevention. On the basis of the reasons outlined, I hope the noble Baroness will withdraw her amendment.

[Baroness Tyler of Enfield (LD)]

I thank the Minister for her remarks and the noble Lord, Lord Kamall, for his. I am interested to hear about the prevention concordat and hope to hear more about that; I think that could be a useful way forward. Overall, I remain of the view that having something about prevention in this Bill—we have not got it yet—sends out an incredibly important signal.

I am very happy to accept that the way it is currently worded may not be the best and that we could find other ways of doing it. But I would be really disappointed if, in the final piece of legislation, we do not, in some way or another, have something that underlines the importance of prevention. I am not going to go over all the arguments again. I can see us returning to this on Report and, on that basis, I withdraw my amendment.

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[Baroness Fox of Buckley (Non-Afl)]

My Lords, I was pleased to see these amendments as well. The noble Earl, Lord Howe, explained why they are important. He has conceded—I tried to imply the same in my own amendment—that it is not necessarily clear how best to raise these issues, but that we need to. If we are seen by the public discussing a mental health Bill, going through the whole thing and refusing to acknowledge one of the big controversies of recent times, which was a mental health issue, it will discredit the Bill when it becomes an Act.

In relation to the reluctance of the NHS trust to publish its investigation and the use of patient confidentiality, I note that the families of the victims saw this very much as an excuse and were very angry about that. It does not help us to have a discussion with the public about mental illness because it then seems as though murder was committed but, somehow, mental illness was used as an excuse. We have all heard that argument being used; that is why I referred to the fact that there was some dispute about whether Calocane should be sent to prison or to hospital. The more openness that we can give this, the less stigma and confusion there will be. We need to have this debate out in the open.

Finally, I have a question on the judge-led inquiry and what we now know from the investigation by the trust. How will that impact this Bill? How, practically, will we be able to incorporate what we have learned from that into our discussion on a whole new piece of legislation on mental health? It would seem that we need to be able to take on board some of the recommendations of the inquiry and what we now know from the investigation by the trust.

[Baroness Merron (Lab)]

My Lords, I thank the noble Earl, Lord Howe, for tabling Amendments 160BA and 160BB, supported by the noble Lord, Lord Kamall, and spoken to by the noble Baronesses, Lady Tyler and Lady Fox.

I say at the outset that I understand the deep concerns raised today by noble Lords. I would like to take this opportunity to express my sincere condolences, and I am sure those of the whole of your Lordships’ House, to the families of Grace O’Malley-Kumar, Barnaby Webber and Ian Coates. The Secretary of State and I have met the bereaved families following these horrific killings, and, rightly, important actions have been taken, which the noble Earl, Lord Howe, asked about. Indeed, we have to look at what improvements must be made, both at the trust and across the country.

To take this further, NHS England and the Nottinghamshire Healthcare NHS Foundation Trust have accepted all of the recommendations made following the Section 48 CQC review into this incident, and action has started on implementation. The recently published independent investigation into the care and treatment provided to Valdo Calocane makes a series of recommendations, which NHS England and the Nottinghamshire Healthcare NHS Foundation Trust have accepted. I reiterate that the Government expect to see swift action to ensure that the recommendations are implemented as soon as possible. As the Prime Minister has confirmed, and as the noble Earl, Lord Howe, acknowledged, there will be a judge-led, statutory public inquiry into this tragic incident.

I now turn specifically to the amendments, and first to Amendment 160BA. We recognise the importance of transparency when there are concerns around a patient’s care, to enable a full understanding of what went wrong and how learning can be applied as a result. The courts already have legal powers to request, and where appropriate compel, disclosure of relevant reports, ensuring judicial access to relevant information. In criminal and civil proceedings, courts can make orders that particular information be provided, or issue witness summonses, while coroners can obtain documents as part of an inquest. There is no clear evidence that courts face systemic barriers in accessing necessary information.

There are also existing mechanisms to provide robust oversight and transparency. NHS England’s patient safety incident response framework sets out clear guidelines for responding to serious incidents involving patients who are detained under the Mental Health Act. Additional scrutiny is provided through investigations by the Health Services Safety Investigations Body and oversight from the CQC.

If information is not disclosed, interested parties already have mechanisms to access information, including judicial review, freedom of information requests and the coronial process for deaths in detention. While courts have the powers set out in the amendment, we absolutely recognise the importance of openness in mental health services, which is why officials are working with NHS England to ensure that information from investigations is as transparent as possible—something that all noble Lords have rightly referred to.

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[Earl Howe (Con)]

My Lords, I will keep this brief since I can do no more than back the noble Baroness, Lady Tyler, in every word that she has said in support of these two amendments. We are dealing here with a Henry VIII clause that is surely far too permissive given the great sensitivity of the Bill’s entire subject matter and, as the noble Baroness said so well, its momentous significance for the health and well-being of very vulnerable people.

The absolute minimum that Parliament can expect is that Parliament be consulted in the exercise of these powers. The affirmative procedure is therefore entirely appropriate for any statutory instruments made under this clause and I hope the Minister will not disagree with what is proposed.

[Baroness Merron (Lab)]

My Lords, I thank the noble Lord, Lord Scriven, for tabling Amendments 160C and 160D, which were introduced by the noble Baroness, Lady Tyler, and spoken to by the noble Earl, Lord Howe.

The proposal in the amendment, as was referred to, was a recommendation in the report from the Delegated Powers and Regulatory Reform Committee. I hope that your Lordships’ Committee will welcome that we are actively considering this proposal and will publish our response to the committee’s recommendation ahead of Report.

[Baroness Tyler of Enfield (LD)]

My Lords, I very much welcome the statement we have just heard from the Minister. I think it is a good point on which to finish our deliberations tonight and I thank her very much. I also thank the noble Earl, Lord Howe, for his support. I beg leave to withdraw the amendment.

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Moved by

[Baroness Merron]

161: After Clause 51, insert the following new Clause—
“Power of Welsh Ministers to make consequential provision(1) The Welsh Ministers may by regulations made by statutory instrument make provision that is consequential on this Act.(2) The only provision that may be made by virtue of this section is provision that would be within the legislative competence of Senedd Cymru if contained in an Act of the Senedd.(3) Regulations under this section may amend, repeal or revoke provision made by or under primary legislation passed—(a) before this Act, or(b) later in the same session of Parliament as this Act.(4) In this section “primary legislation” means—(a) an Act, or(b) an Act or Measure of Senedd Cymru.(5) A statutory instrument containing regulations under this section is subject to annulment in pursuance of a resolution of Senedd Cymru.” Member's explanatory statement
This confers a regulation-making power on the Welsh Ministers to make consequential provision that is within devolved legislative competence. The Secretary of State has an equivalent power under Clause 51.

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Moved by

[Baroness Merron]

162: Clause 53, page 64, line 2, leave out “33, 34,” and insert “29(2), 31, 33, 34(1) and (3)(b),”
29(2)
34(1)
(3)(b)
Member's explanatory statement
This amendment would provide for certain provisions currently commenced by regulations to be commenced two months after Royal Assent (and vice versa).

Mental Health Bill [HL]

Baroness Merron Excerpts

Committee stage
Monday 24th February 2025 Lords Chamber

[Earl Howe (Con)]

My Lords, I am right behind the noble Lord, Lord Scriven, and the noble Baroness, Lady Tyler, in their Amendment 130. We know, and I believe that by and large we accept, that the Bill is not intended by the Government to hold out the prospect of instantaneous changes to the delivery of mental health care. It offers a series of measures that, over a period of years, should make a material difference to the well-being of a wide range of mentally ill people who require treatment, whether in a secure mental health setting or in the community.

The Minister has spoken of the need to view these measures in the broader context of the NHS 10-year plan and, certainly from the Government’s point of view, that is a perfectly reasonable position to take. However, if that is the Government’s policy, it begs a whole mass of questions around implementation and funding. For example, what do the Government see as the immediate high-priority measures that they wish to introduce? Which measures do they propose to defer, and for how long? What are the costs associated with these changes, both to the NHS and, as the noble Baroness, Lady Tyler, pointed out, to the justice system and local government? Bearing in mind Treasury constraints, when realistically do they believe a clear timeline for change will emerge? We have the impact assessment, but how far can we rely on that?

If those questions for the time being have to remain hanging in the air, as I suspect they will, I share the view of the noble Baroness, Lady Tyler, that Parliament, in the not-too-distant future, needs to be given an account of what the longer-term future looks like in a way that reflects not only the Government’s current thinking but, as time goes on, how their thinking evolves, as it surely will. There is therefore a strong case for a report to Parliament sometime in the next few months and on an annual basis thereafter, making clear both the timeline of ambition and the timeline of what in reality is being delivered.

I am conscious that we all need to keep our remarks succinct and to the point, so I will comment only briefly on the other amendments in this group. I am afraid I cannot support Amendment 153 in the name of the noble Baroness, Lady Bennett. I have always believed that what matters most in healthcare is not whether a service is delivered by a public or a private organisation but rather the quality of care to patients and whether good outcomes are achieved at acceptable cost.

Finally, my noble friend Lord Kamall has added his name to Amendments 163 and 164. These amendments stand absolutely four-square with the theme of Amendment 130, and on my noble friend’s behalf I express my warm support for them. The noble Lord, Lord Stevens, has said it all.

Just as we accept that we will not get any instant changes arising from the Bill, by a corresponding token, the Government cannot take that as a free pass from Parliament to defer implementing its provisions sine die. We cannot have a situation in which, prior to implementing the provisions, the principle of parity of esteem is quietly put to one side. I hope the Minister will have reassuring words to say on those very important points of principle.

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

My Lords, I am most grateful to noble Lords for their contributions to this first debate today, and I start by saying how glad I am—I am sure other noble Lords will say this too—to see the noble Baroness, Lady Hollins, in her rightful place. I certainly heard her support for the amendments that we are discussing.

Before I turn to the amendments, it may be helpful to your Lordships’ Committee if I briefly set out some of the high-level plans for implementation of these reforms. I am grateful for the understanding—the noble Earl, Lord Howe, made this point—that time is required. I also understand the emphasis that noble Lords are putting on pace and, of course, we try to match those two things together, but I know we are all agreed on the need to get the Bill in the right place and the Act delivering.

The first priority after Royal Assent will be to draft and consult on the code of practice, and we will be engaging with people with lived experience and their families and carers, staff and professional groups, commissioners, providers and others to do this. The code will be laid before Parliament before final publication, and I am committed to working with noble Lords to ensure that we get this crucial piece of work absolutely right. We expect that this process will take at least a year.

Alongside the code, we will be developing secondary legislation, which will also be laid before Parliament, with more detail on areas such as statutory care and treatment plans. We will then need time to train the existing workforce on the new Act, the regulations and the code. This will likely be in 2026 and 2027, and we intend to commence the first major phase of reforms in 2027.

Of course, some reforms are going to take longer, as noble Lords will appreciate. The noble Baroness, Lady Neuberger, tempted me to go even further than five years, and I thank her for the temptation, but I know I will not be able to please her on this occasion. Of course, it takes time to train new second opinion appointed doctors, judges and approved clinicians, so, as set out in the impact assessment, we believe it will take 10 years to fully implement the reforms, but I emphasise that these timelines are indicative, and we will iterate these plans as we get more certainty on future funding and the wider workforce plans. Of course, I fully appreciate the importance of parliamentary scrutiny and accountability of this work, which is crucial, and I am committed to updating the House throughout the implementation period.

Turning to the amendments, I will start with Amendment 130 in the name of the noble Lord, Lord Scriven, kindly introduced by the noble Baroness, Lady Tyler. I say in response that any implementation plan, as proposed in the amendment, which would be published four months after Royal Assent, would be very unlikely to contain any more detail than is already in the impact assessment. It is important to prioritise drafting the new code and the secondary regulations after Royal Assent. I also confirm to your Lordships’ Committee that we will commission an independent evaluation of the reforms, alongside existing monitoring and reporting by the CQC.

As I have said, I fully expect to update the House during the planning and delivery of the reforms. However, a requirement in primary legislation to publish annually, and within four months of Royal Assent, would be premature.

Amendment 153, tabled by the noble Baroness, Lady Bennett, would prohibit for-profit companies from delivering provisions of the Act. I listened closely to the concerns raised by the noble Baroness, but I do not share the view that a ban on for-profit providers is the right approach, for the reasons that were set out by the noble Earl, Lord Howe, and the noble Baroness, Lady Fox. Our focus should indeed be on ensuring that we have high-quality and good value-for-money services. However, I assure the noble Baroness, Lady Bennett, that we are already investing in a significant quality transformation programme and piloting new models of care to ensure that care is focused on the individual, with maximum therapeutic benefit. That is where our priority lies and for that reason we are resisting this amendment.

Turning to Amendment 163, I am grateful to the noble Lords, Lord Stevens and Lord Kamall, and the noble Baronesses, Lady Tyler and Lady Neuberger, for bringing this issue before the Committee. As I said in my opening remarks, I too want to see the benefits of these reforms coming into play quickly and effectively. We intend to commence the reforms in phases, because some can be implemented more quickly than others, which need more time. This is not just about money but about building system and workforce capacity. For example, the impact assessment estimates that we need over 400 additional second opinion appointed doctors and over 300 additional approved clinicians. Many of these will be consultant psychiatrists, who would already need to have commenced training prior to the legislation for us to fully implement the Bill within five years, as required by this amendment. Rather than having a fixed deadline, as is proposed, we intend to monitor the impact of investment and test readiness to commence new powers on an ongoing basis, commencing each phase when we are confident that it is safe and effective to do so.

Finally, I turn to Amendment 164, tabled by the noble Lord, Lord Stevens, and supported by the noble Lord, Lord Kamall, and the noble Baronesses, Lady Tyler of Enfield and Lady Neuberger. I associate myself with the comments about the commitment to treating physical and mental health equally, in line with this Government’s manifesto commitments. The mental health investment standard requires ICB spending on mental health to grow at least in line with overall recurrent funding allocations. Based on total planned spend for 2024-25, we expect all ICBs to meet the standard in this financial year.

There are already mechanisms to ensure that spending on mental health is prioritised. I refer noble Lords to Section 12F of the NHS Act 2006, which requires the Secretary of State for Health and Social Care to lay before Parliament an annual document setting out whether they expect NHS England and ICB spending on mental health to increase in the next year. The Secretary of State will publish this statement before the end of this financial year.

As several noble Lords said, funding for mental health spend goes beyond the scope of the Mental Health Act, which aims to improve the care and treatment of individuals who have a mental illness and need to be detained in hospital or subject to restrictions in the community. Therefore, I respectfully suggest that the Act is not the appropriate mechanism for holding the Government to account on mental health spend. I ask the noble Baroness to withdraw the amendment.

[Baroness Tyler of Enfield (LD)]

My Lords, I thank the Minister for her very comprehensive response and all noble Lords who have spoken. It was very helpful that the Minister started by setting out some of what I think she called the “high-level” plans for implementation. It was good to hear about what is going to happen with the code of practice and about plans to bring forward secondary legislation. I hope I heard correctly that it will be 2027 when we see the first major stage of these reforms starting to happen on the ground. That is the good side of this debate; it is incredibly important, because this is one of those issues where the implementation is as important as the policy, and that is why it is right that we are having this discussion.

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[Lord Kamall (Con)]

My Lords, before I begin my remarks, I want to say how pleased my noble friend Lord Howe and I are to see the noble Baroness, Lady Hollins, back in her place; I am sure that many noble Lords would echo that sentiment.

I thank the noble Baroness, Lady Tyler of Enfield, for moving this amendment to establish a statutory mental health commissioner. One of the motivations behind some of the amendments in my name and that of my noble friend Lord Howe is to probe the Government on those recommendations from the pre-legislative Joint Committee that did not make it into this draft Bill. As noble Lords will be aware, and as the noble Lord, Lord Bradley, has said, this is one such recommendation of the Joint Committee that did not make the cut.

We did consider tabling a similar amendment ourselves, but I have to admit that the amendment from the noble Baroness, Lady Tyler, did the job very well; there was no need to duplicate that. Having spoken to the noble Baroness and to her noble friend Lord Scriven, I know this is an issue that they and many other noble Lords feel passionate about. The noble Baroness, Lady Tyler, has today made a very good case for a commissioner. The noble Lord, Lord Scriven, has also spoken of the need for central co-ordination to ensure implementation of the provisions of this Bill—something that was referred to in the last group of amendments.

I pay tribute to the noble Lord as I know that he has considerable experience in the NHS and is all too aware of the problems involved in trying to deliver at scale. However, I admit that I have some reservations about the idea of a mental health commissioner. While I understand the arguments in favour, I am, like the Minister, concerned about the creation of a new bureaucracy that could possibly duplicate functions.

In their response to the recommendations of the Joint Committee, the previous Government noted that

“the government does not believe that a statutory mental health commissioner would add significant value within the framework currently provided by existing bodies”.

The Joint Committee pointed out that a Mental Health Act Commission was established by the Mental Health Act 1983, which stood alongside the Healthcare Commission and the Commission for Social Care Inspection. In 2009, the then Labour Government took the decision to combine these three bodies into one integrated regulator with responsibility for all health and adult social care. I say that not as a political point but as an observation.

Since then, the CQC has undertaken the functions of the previous Mental Health Act Commission, and its remit extends to ensuring protections for those who are detained under the Act or subject to a community treatment order. To do this, the CQC has a number of Mental Health Act reviewers, who can visit patients in hospital and raise concerns about treatment or detention with managers, and then report back to the commission. The CQC also has a dedicated team that assesses complaints about the use of the Mental Health Act, including issues around detention and the use of CTOs.

I also understand that the CQC provides second-opinion appointed doctors for patients who do not have the capacity to consent to treatment under Part 4 of the Act. This Bill strengthens the safeguards around second-opinion appointed doctors, such as creating a clinical checklist that must be certified by the second-opinion doctor.

In addition to the functions of the CQC, local authorities and ICBs provide independent mental health advocates; we have debated those in earlier groups. The Department of Health and Social Care also gives funding to local authorities to commission Healthwatch services, of which I understand there are about 152 across the country. Healthwatch is another statutory organisation that gathers feedback from the users and ensures that NHS leaders listen to and, hopefully, incorporate that feedback.

As we have seen, the Parliamentary and Health Service Ombudsman, alongside the CQC, supports individuals to raise complaints against the private sector, the NHS and all public health authorities.

The point I am trying to make is that there appears to be a plethora of services and public bodies that work to oversee the function of the Mental Health Act and try to ensure that patients have a voice in their care and treatment. While I appreciate that some of the proposed duties of the commissioner would be unique to that role, there appear to be elements of duplication in that role and those of existing public bodies. However, I am also conscious of the point made by the noble Baroness, Lady Tyler, about being complementary.

So, while I hear the arguments on both sides, I am still slightly sceptical about whether we need a stand-alone mental health commissioner. To be fair, we have not completely made up our minds yet, and my noble friend Lord Howe and I are weighing up the arguments. For that reason, I ask the Minister to help these deliberations by clarifying a few points. First, will she confirm whether the CQC will take on the role of implementing the provisions of the Bill? Perhaps more importantly, how will it be able to fulfil that function effectively, given the concerns expressed by the noble Baroness, Lady Tyler, the noble Lord, Lord Bradley, and others and their strong feeling in favour of an independent mental health commissioner?

What action will the Department of Health and Social Care take to ensure oversight of the CQC’s role in the implementation of this legislation? If the Government remain opposed to the creation of a commissioner, can the Minister reassure your Lordships on how existing bodies will address the Bill’s implementation and accountability for its implementation, without the need for a stand-alone mental health commissioner?

I hope the Minister is able to give these assurances. Otherwise, given what was said today by other noble Lords, I am sure we will come back to this issue on Report.

[Baroness Merron (Lab)]

My Lords, I am grateful to the noble Baroness, Lady Tyler, for tabling Amendment 131, supported by the noble Baronesses, Lady Bennett and Lady Murphy, and my noble friend Lord Bradley. As noble Lords are aware, I understand the intent behind the amendment. We have carefully considered the proposed functions of the commissioner that it outlines, and we recognise that improvements are needed to ensure that the system works effectively. But as noble Lords are aware, we do not feel that a new body is the answer. As the noble Lord, Lord Kamall, said, it may only duplicate existing functions, rather than providing the clarity and leadership that I know everyone is seeking. I was particularly interested to hear the noble Lord give his reflections on the opinions of the previous Government about a proposed mental health commissioner.

Overseeing implementation of the reforms is the role of the Department of Health and Social Care, working with NHS England, the Ministry of Justice and the CQC in England, and, in Wales, with the Healthcare Inspectorate Wales.

On the interaction between this legislation and the Mental Capacity Act, we are committed to keeping that under close review to minimise challenges potentially faced by front-line professionals.

The annual report by the commissioner proposed in the amendment would overlap with the CQC’s annual Monitoring the Mental Health Act report. The CQC’s annual statutory reporting reflects the views of thousands of patients interviewed each year by the CQC. Many of the issues that the commissioner would assess and report on, such as the accessibility of advice and the quality of services, are already reported on by the CQC.

It is proposed that the commissioner would examine cases of people detained under the Act. This clearly overlaps with the functions of the CQC and Healthcare Inspectorate Wales, which have a statutory duty to monitor and, where appropriate, to investigate. The Act provides the regulator with similar powers—for example, to gather information to support it in exercising these powers.

The Health Services Safety Investigations Body is responsible for conducting independent investigations into patient safety concerns across England to identify ways to improve mental health care and patient safety. It has just concluded a series of investigations into in-patient mental health care and is currently undertaking further work.

With regard to the proposed commissioner’s general powers, it is the Government’s role, with NHS England, to ensure sufficient capacity and resources in the system. It is the role of NHSE’s national director for mental health and the medical director for mental health and neurodiversity, newly established last year, to oversee and take forward improvements to mental health services. It is already the role of the regulator to safeguard the rights and welfare of patients, while other organisations independently investigate complaints.

Minimising duplication with these organisations and functions would require significant remodelling of the system, interrupting ongoing programmes and responsibilities that are important to the smooth delivery of the Mental Health Act reforms. Having said that, we recognise that improvements need to be made in the quality of care and the patient safety landscape. We are committed to that goal and intend to overhaul the healthcare system to make it better for all patients.

The CQC has already begun to implement the recommendations made by Dr Penny Dash and Professor Sir Mike Richards: a new chief inspector for mental health will use their independent voice to amplify and respond to the experiences and outcomes of people who use services. Implementation of Mental Health Act reform will be at the top of their “to do” list.

On the wider landscape, we expect to hear soon from Dr Dash who, as noble Lords have said, is reviewing the broad range of organisations that impact on quality and safety, many of which I have mentioned today, and is due to report on whether greater value could be achieved through a different delivery model.

Reference was made in the debate to the role of the Children’s Commissioner, which the noble Baroness, Lady Tyler, particularly focused on. I want to place on record my gratitude to the Children’s Commissioner for the work done on children’s mental health. But, in reflecting on the debate earlier, I should say that the Children’s Commissioner is operating in a rather difference landscape. The proposed mental health commissioner would have a much narrower purview that, for the reasons I have stated, risks overlapping with existing organisations in a way that the Children’s Commissioner does not. I understand why the Children’s Commissioner is being looked to, but I cannot draw that direct comparison myself.

The challenges we have heard about in this debate have highlighted areas we need further to focus our efforts on. I look forward to speaking to the noble Baroness, Lady Tyler, about this topic this week, and I am sure that I will have further conversations about it. For all these reasons, I ask the noble Baroness to withdraw Amendment 131.

[Baroness Tyler of Enfield (LD)]

My Lords, I thank the Minister for her response and thank other noble Lords for their support: in some cases, strong support; in others, what I can only describe as support up to a point—if you know what I mean.

The noble Lord, Lord Kamall, was right to say that we on these Benches feel passionate about this. We think it has the potential to make a real difference and transform not just mental health services at the crisis end—the detention end—but how the whole mental health landscape works.

I would just say in response that I am slightly surprised that the Government consider the current arrangements to be satisfactory. The Joint Committee clearly did not. It spent an awful lot of time looking into this and made a recommendation for a reason.

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[Lord Kamall (Con)]

My Lords, I thank the noble Baroness, Lady Parminter, for moving this amendment. Unlike in the last group of amendments, where there was limited support, we fully support her on this one. We know that the noble Baroness has tirelessly campaigned for better support for those with eating disorders. At Second Reading, she shared the experience of living with such disorders, and we all became much more familiar with some of the concerns. I also agree with my noble friend Lady Browning that it is about time we stopped treating all people with mental ill-health the same; we know that we have to look at it in far more granular detail.

The amendment speaks to the problems around the adequacy of provision of care for patients suffering with eating disorders. As the noble Baroness said, Section 140 of the Mental Health Act provides for reception of patients in cases of special emergency and the provision of accommodation and facilities suitable for under-18s, but it applies only to hospitals. I agree that there is a reasonable case to extend this to specialist eating disorder units. With that in mind, I hope the Minister will be receptive to this amendment.

[Baroness Merron (Lab)]

My Lords, I am grateful to the noble Baroness, Lady Parminter, for bringing Amendment 132 to your Lordships’ Committee, for raising this important issue, for sharing at Second Reading, as the noble Lord, Lord Kamall, said, her personal experience of her daughter’s treatment and for sharing her overall experience of the provision of services today. The noble Baroness, Lady Browning, made the important point about different conditions needing different provision and support. That was amplified by the noble and learned Baroness, Lady Butler-Sloss, and the noble Lord.

Eating disorders are of course serious mental health challenges, and it is vital that those with them can access effective help quickly. We will continue to work closely with NHS England to improve access to the right and timely care and treatment for those with an eating disorder.

The purpose of Section 140 is to ensure that approved mental health professionals are aware of the services available to help them to locate hospital beds in special cases. The intention of the amendment is to extend the duty on health authorities to notify local authorities of arrangements for urgent cases and under-18s to include specialist eating disorder units.

Section 140 applies to arrangements for people who need in-patient treatment in a hospital. That includes specialist eating disorder units where they provide in-patient treatment in a hospital setting and are appropriate for someone to be detained in. Therefore, while I understand the points being made, it is not necessary to specify that Section 140 applies to specialist eating disorder units. I hope the noble Baroness will feel able to withdraw her amendment.

[Baroness Parminter (LD)]

My Lords, I am grateful to Members around the Committee who have shared my concerns about the need for proper provision for people with eating disorders. The noble Baroness, Lady Browning, rightly identified that there is a need for mental health provision to focus on the particular illnesses and to treat each appropriately.

I knew that my amendment would not be accepted; I was just desperate to find some way to raise this important issue, but I am grateful that my poor attempt has at least allowed for a debate in Committee and allowed me to share with Members a bit more about what it actually means if you are in a specialist eating disorder unit for a very long time. I would still love to see the words in the Bill, because every time ICBs and others think about provision for people with mental illnesses, including eating disorders, specialist eating disorder units should be in there, but I am not going to press the point either here or in the future. I am grateful for the support around the Committee, and I will keep trying to raise the issue whenever I can. With that, I beg leave to withdraw the amendment.

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[Lord Kamall (Con)]

My Lords, I will be brief on this one. I thank the noble Baroness, Lady Tyler, for this amendment and thank all noble Lords, who made very valid points.

Clearly, this is another sensible proposal, highlighting as it does the importance of making sure that the ICBs commission sufficient mental health services in the community to meet the demand for them. As the noble Baroness, Lady Barker, said, where will people go in the middle of the night? I know that we will come back to some of these issues when we discuss the group on mental well-being but I thought it was important that those points were raised now.

The Committee may remember that this was the subject of Amendment 139 in the name of my noble friend Lord Howe, who spoke to it on the second day in Committee. The main difference between those amendments is, I think, that the noble Baroness, Lady Tyler, wishes to get ICBs focused on this very important task as soon as the Bill becomes law—and I agree with her intention on that. My only fear around the wording as it is currently drafted—I recognise that it is a probing amendment—is that

“insofar as is reasonably practical”

may provide an excuse, or, as we say, the proverbial long grass into which this duty could be conveniently kicked. I look forward to the Minister’s response.

[Baroness Merron (Lab)]

My Lords, I thank noble Lords for their contributions on both these amendments. I turn first to Amendment 134 in the name of the noble Baroness, Lady Tyler, and spoken to by my noble friend Lady Ramsey and the noble Baroness, Lady Barker, both of whom shared real-life examples to illustrate what is being spoken about here.

This duty to consider mental health needs, as well as the needs of those with a learning disability and autistic people, in the community as well as in hospital is already covered by ICBs under the National Health Service Act 2006, as amended by the Health and Care Act 2022. An ICB must arrange for the provision of services to such extent as it considers necessary to meet the reasonable requirements of the people for whom it has responsibility.

ICBs and their mental health trusts are also required to prepare a joint forward plan that describes how the ICB will arrange for NHS services to meet its population’s physical and mental health needs, and the needs of those with a learning disability and autistic people.

On the general point with regard to the long-term workforce plan, which the noble Baroness, Lady Barker, mentioned, it will report in a few months’ time, later in the year, which I hope will give a lot more substance to answer the kinds of questions that are being raised. The noble Lord, Lord Stevens, asked about incremental requirements for psychiatrists on a year-by-year and whole-time-equivalent basis. I say to the noble Lord that the impact assessment sets out our best estimate at this point, but the plans need to be seen as somewhat iterative. With regard to further specific questions, including those raised by the noble Baroness, Lady Tyler, I will indeed be glad to write.

Turning now to Amendment 157, in the name of my noble friend Lord Davies and spoken to by the noble Lady Baroness, Lady Bennett, as we have already discussed in relation to Amendment 134, there is already a duty on ICBs to provide sufficient hospital and community services under the National Health Service Act 2006. Furthermore, chapter 16 of the Mental Health Act code of practice already states that local authorities, NHS commissioners, hospitals, police forces and ambulance services should have local partnership arrangements in place to deal with people experiencing crises in mental health.

We accept that there are issues with bed capacity and patient flow, as referred to by the noble Baroness, Lady Hollins. I will resist using the term “patient pathway”, but I certainly agree that they are part of what happens to a patient and they are indeed linked—whatever form of words we choose to use. That is why, in the recent NHS planning guidance, we have tasked local systems with reducing the length of stay in mental health wards and have committed £26 million to improve mental health crisis care, with a further £75 million to reduce inappropriate out-of-area placement. All this is already in train and does not suggest a requirement for primary legislation. So, for these reasons, I ask that the amendment be withdrawn.

[Baroness Tyler of Enfield (LD)]

My Lords, I thank the Minister yet again for her response. We have had a number of discussions so far this afternoon in this broad area, and indeed, as was alluded to, on previous Committee days. They are interrelated, so it is sometimes hard to separate the individual groups. I think at the very heart of all of our discussions is concern about two things: first, how we ensure that there is sufficient provision within the community to provide the sorts of services we all hope to see and which are fundamental to the successful implementation of the Bill; and, secondly—I think this came out very clearly—the need for really good workforce planning and understanding it on a year-by-year basis.

I was encouraged to hear from the Minister that we can expect to see the long-term workforce plan—I think she said—in a few months’ time. I very much look forward to that. I hope it includes some of the workforce planning and modelling of community provision that my noble friend Lady Barker referred to, and I hope, above all things, that it is slightly clearer than the impact assessment, which, I have to be honest—it may just be me; it might have been late at night when I was looking at it—I found somewhat on the opaque side. I am really hoping for greater clarity when we see the long-term workforce plan. This issue is not going to go away. In what form we return to it at Report, I am not quite sure, but, for the moment, on that basis, I beg leave to withdraw the amendment.

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[Baroness Merron (Lab)]

My Lords, I am grateful to my noble friend Lord Davies of Brixton for raising what is a very real issue, among many we are debating today in Committee. I thank him for Amendment 135, supported by the noble Baronesses, Lady Bennett, Lady Neuberger and Lady Tyler, and spoken to by the noble Baroness, Lady Watkins, and supported by the noble Lord, Lord Kamall. I certainly agree that breathing space can indeed be what could be described as a lifebelt for people in problem debt, especially where this is worsening or is indeed a trigger for their mental illness, as my noble friend Lord Davies spelled out and the noble Lord, Lord Kamall, endorsed.

Individuals who are detained in hospital for assessment or treatment under the Mental Health Act are eligible for this scheme, as are those receiving crisis treatment in the community from a specialist mental health service. Approved mental health professionals can refer eligible individuals to protect them from debt enforcement. These professionals are often the first on the scene when a person is in crisis and are responsible for arranging assessment for treatment under the Act. Therefore, when a person is admitted to hospital, they may already have been enrolled in the scheme and, if not, NHS England guidance sets out the financial support, including referral to breathing space, that should be offered to patients receiving acute in-patient mental health care, whether detained or voluntary. I can say to your Lordships’ Committee that we do intend to make this an explicit requirement in the Mental Health Act code of practice.

I feel that is particularly important as my noble friend Lord Davies raised the point about uptake. Certainly, I recognise that uptake has been lower for the scheme than originally anticipated. While we do not believe this is a representation of the scheme significantly underperforming, I assure my noble friend that we will continue to keep the scheme under review to ensure that it is working effectively for those who need it, and needed indeed it is. It is for these reasons that I hope that my noble friend will withdraw the amendment.

[Lord Davies of Brixton (Lab)]

I thank everyone who has taken part in the debate; the case was made clearly by everyone. I thank particularly the noble Baroness, Lady Watkins, for the additional point about the pressure on clinical staff. This issue was, of course, raised in the earlier amendments about the code of practice and the treatment plan; they are all of a piece. I will consider carefully what my noble friend the Minister said, and perhaps we will have some discussions, and we will see where they go. In the meantime, I beg leave to withdraw my amendment.

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[Lord Berkeley of Knighton (CB)]

My Lords, I am only marginally less shocked than the noble and learned Baroness. The reason for that is that I regularly visited a friend in an adult ward, suffering, funnily enough, from eating disorders, among other things. So I support Amendment 144 most strongly. What shocked me was that, over several years, there were two children I saw. They were witnessing not only acts of violence but sexual acts too that were quite clear—I will not go into the details, but it was completely inappropriate for a child to be witnessing this.

The final point I want to make hinges on what we have also heard: that there is only so much we can do. Of course, the reason for that, and it is another reason why these experiences are seared into my mind, is the state of funding for mental health. No one can turn that switch on immediately, but the root problem here is that this is a sector that is somehow pushed to the side. Therein lies a fundamental reason why we have to take a completely different attitude to mental health, and I am sure that the Minister feels quite strongly about that herself.

[Baroness Merron (Lab)]

My Lords, I will turn first to Amendments 142, 143 and 144, in the name of the noble Earl, Lord Howe, supported by the noble Lord, Lord Kamall, and joined by the noble Baroness, Lady Tyler, on Amendment 143 and 144. I will also address Amendment 159 in the name of the noble Baroness, Lady Berridge.

I thank the noble Earl, Lord Howe, for the way in which he introduced this subject and for the understanding and shock shared by the noble Lord, Lord Berkeley, and the noble and learned Baroness, Lady Butler-Sloss. I am sure we all share the thoughts and views that they have expressed. I also thank the noble Earl, Lord Howe, for his reference to Blooming Change. I certainly recognise the important work that it does. The way he introduced its observations and experience really highlighted the reality of what we are here to deal with.

On Amendment 142, it is crucial that people with physical disabilities have equal access to mental health services. Under the Equality Act 2010, those providing mental health services, including under the Mental Health Act, must make reasonable adjustments to ensure that people with disabilities are not at a disadvantage. Therefore, the aims of this amendment are already covered by existing legislative requirements. I heard what the noble Lord said about an example of where this was not the case. I can only add my own comment to say that this is, of course, not acceptable and not at all how legislation would expect a provider to act.

We will review the guidance on how to support individuals with a physical disability, including children, when we consult on the revised code of practice and as part of NHS England’s new service specification, which will set out requirements for children and young people’s mental health services. I hope that will be helpful to meet the points raised in Amendment 142.

I turn now to Amendments 143, 144 and 159. The policy of NHS England is clear that children and young people should be able to access the right type of service, as close to home as possible and in the least restrictive environment. We do not want to see children and young people on adult wards or placed far from home. We are working to secure the necessary investment to expand community-based support and specialist beds to prevent this from happening. I am grateful to the noble Earl, Lord Howe, for referring to the need to deal with where we are rather than where we might like to be. That is what we intend to do.

There are already provisions in the Act that seek to limit inappropriate placements for children and young people. Under Section 131A, hospital managers must ensure that the patient’s environment is suitable, having regard to their age. We believe that the careful consideration and nuance involved in determining any circumstances where it is in a child’s best interest to be treated on an adult ward or in an out-of-area placement fits better in a revised code of practice rather than legislation, which would apply fixed rules that could not be adapted to individual circumstances or service provision.

We will provide additional guidance on the process to determine, and review throughout a child’s detention and treatment, that the environment in which they are accommodated continues to be in their interests. Such matters can be addressed through the new service specification for specialised children and young people’s mental health services.

I assure the Committee that there are already clear operational processes in place to identify and monitor children and young people in inappropriate placements. It is a statutory requirement for the CQC to be notified within 48 hours if a child or young person is placed on an adult ward. The CQC reports on the number of people under 18 admitted to adult wards as part of its Monitoring the Mental Health Act reports.

The CQC project on improving regulation for children inappropriately placed will identify what CQC can do to prevent children being cared for by providers who cannot meet their needs and to reduce their risks of being exposed to poor-quality care. I assure the Committee that we will review the process for who should be notified, and in what circumstances, in the new service specification for specialised children and young people’s mental health services, and in the revised Mental Health Act code of practice.

I turn to Amendment 160, tabled by the noble Baroness, Lady Berridge, on the extension of Section 17 of the Children Act 1989 to include children detained under the Mental Health Act. Section 17 places a duty on local authorities to provide support for children who are unlikely to reach or maintain a satisfactory level of health or development, or where their health or development would be significantly impaired without the provision of services—or where the child is disabled.

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[Baroness Barker (LD)]

My Lords, we on these Benches offer our support to the noble Baroness, Lady Hollins, for her two very thoughtful amendments and the way in which she introduced them. However, I want to turn our attention to Amendment 146, in the name of the noble Earl, Lord Howe.

I was a colleague of Norman Lamb, who was formerly a Minister in the department. He was one of the people who was, as a Minister, most active in addressing the issue of the overuse of force in mental health. This is a campaign that he has continued to develop in his chairmanship of South London and Maudsley NHS Foundation Trust. It is a subject that I am very glad we are focusing on again.

Anybody who has visited a mental health facility in which there are people who are having acute episodes will know that there are times when, for the safety of the person and the safety of others, it is necessary sometimes to use restraint. However, as I think the noble Earl was alluding to in his introduction, the overuse and frequent use of force is often an indicator of substandard care. Therefore, it is very important that incidences of use of force and the reasons for it, as in his carefully crafted amendment, are recorded.

There are two things that I want to pick up with the noble Earl. His amendment is very carefully crafted. In his introduction to it, he referred throughout to children, but his amendment relates not just to children but to all mental health patients. For that reason, I wish to concentrate on proposed new subsection (9). It says:

“In subsection (4)(k) the ‘relevant characteristics’ in relation to a patient mean—”,

and then lists all of the protected characteristics within the Equality Act, with one omission: gender reassignment. I therefore wish to ask him simply why people undergoing gender reassignment do not merit the same protection as everybody else.

[Baroness Merron (Lab)]

I thank noble Lords for their contributions. Let me first turn to Amendment 146, tabled by the noble Earl, Lord Howe, and supported by the noble Lord, Lord Kamall.

The amendment largely replicate duties under Section 6 of the Mental Health Units (Use of Force) Act 2018 for all patients in NHS mental health units. We recognise that the data suggests that the use of force for children and young people is still far too high, and we are working with NHS England to address this. Although the section I have referred to has not yet been commenced, the guidance is published and the data is already being recorded and reported, and we plan to commence the duty formally later this year. The amendment as drafted would capture a much broader range of patients than the use of force Act does—for example, all patients who are being treated for dementia or delirium in an acute hospital. Furthermore, it is not clear what use will be made of that data. Therefore, the volume of new data collection processes could be significant, but the benefits that would result from this are somewhat unclear.

I turn to Amendments 155 and 156, which have been put forward by the noble Baroness, Lady Hollins, regarding long-term segregation. The amendments are supported by the noble Lord, Lord Crisp, the noble Baroness, Lady Browning, and my noble friend Lady Ramsey, both of whom made important contributions to the debate.

Like other noble Lords, I thank the noble Baroness, Lady Hollins, for her work on this issue over many years, including her significant report, My Heart Breaks, which the noble Baroness, Lady Browning, rightly referenced. We are here today, I believe, in no small part due to the tenacity of the noble Baroness, Lady Hollins, and others who have fought for better outcomes for people under the Mental Health Act. I thank them all.

--- Later in debate ---

[Baroness Hollins (CB)]

There seemed to be an assumption that long-term segregation would continue and that perhaps ICETRs are not effective, but one thing that emerges from an independently chaired review is some learning about the barriers in place and the reasons why LTS is being used, rather than more therapeutic options. That is the reason for this kind of oversight being necessary. It is not necessarily that the ICETR itself will lead to recommendations being implemented; in my report, we found that the recommendations were not being followed—they were made and then not followed through. There needs to be much more effort to try to learn from what is happening and begin to change the culture of LTS as an okay response to somebody’s distress.

[Baroness Merron (Lab)]

I understand that point, and the noble Baroness makes it very well. I simply refer her to the points that I made about needing to look at evidence, the outcomes and the value of those reviews, and whether that is the right approach for everyone. I take on board her point, but my comments probably tell the Committee that we feel that there is more work to be done in this area.

[Earl Howe (Con)]

My Lords, once again, I express my appreciation to all noble Lords who have contributed to this debate. I highlight in particular the speech of the noble Baroness, Lady Hollins, which I found extremely powerful and persuasive, as did other noble Lords.

It strikes me that this is an especially appropriate grouping of amendments. The overuse of restraint in mental health settings and the use of completely untherapeutic long-term segregation are equally pressing and emotive concerns.

The noble Baroness, Lady Barker, pulled me up slightly on the issue of protection for those undergoing gender reassignment. The concern that I had in drafting the amendment was to cover protected characteristics across the piece, but she has drawn my attention to a lacuna, and I am very grateful.

I was somewhat disappointed with the Minister’s reply on the issue of restraint applied to mental health patients, which, as the noble Baroness, Lady Barker, pointed out, is an issue affecting adult patients as well as children. The amendment was drafted with precisely that in mind. The point that I sought to make was that, despite the statute law to which the Minister referred, the incidence of restraint on children in particular has rocketed, which raises questions about clinical practice, staffing and training around the code of practice. To my mind, it was a pity that the Minister had little to say about those possible areas for practical follow-up.

I shall read again what the Minister said about my amendment between now and Report. For now, I beg leave to withdraw the amendment.

--- Later in debate ---

I sometimes think that the law, like the Almighty, moves in a mysterious way and is all the more impressive for that. Having just reread the debate that took place on 7 May 2014, when I tabled that amendment, a debate which was both detailed and wide-ranging, including as it did, supportive contributions from the noble and learned Lord, Lord Hope of Craighead, as well as Lord Lester of Herne Hill and Lord Mackay of Clashfern, I can only plead for the Committee’s sympathetic understanding that, inadequate as my efforts clearly were on that occasion, I did my best.

[Baroness Merron (Lab)]

My Lords, I am grateful to the noble Earl, Lord Howe, for his reflection on both the Almighty and our legal friends, and I thank noble Lords for their contributions to the debate on these amendments.

I turn first to Amendment 149 and thank my noble friend Lady Keeley, supported by the noble Baroness, Lady Barker, not just for tabling the amendment but for the time and attention they and their expert advisers have given to this. It has been much appreciated. I take this opportunity to express my condolences to the family of Paul Sammut for the tragic loss of their loved one.

We recognise the concern around unequal coverage and rights to redress under the Human Rights Act. The Sammut judgment highlighted the need to clarify the position of private health and care providers under the Human Rights Act when providing care arranged and paid for by the NHS or local authorities, something that has come up a number of times in our debates. I am grateful to my noble friend Lady Chakrabarti, the noble Lord, Lord Pannick, and the noble and learned Baroness, Lady Butler-Sloss, for their good humour and their expert contributions on this matter. We are actively considering this matter and I look forward to engaging further with my noble friend Lady Keeley and the noble Baroness, Lady Barker, ahead of Report.

On Amendment 160BC in the name of the noble Earl, Lord Howe, supported by the noble Lord, Lord Kamall, deprivation of liberty for the treatment of a physical health disorder is always an important decision. We are concerned that this amendment would, in effect, remove the need for a separate authorisation where physical health treatment is needed. We do not think it is right to undermine the protections available under the Mental Health Act to patients who are already, as we have heard, in a vulnerable position.

Furthermore, the situation this amendment applies to is rare and, where it does arise, there are already frameworks in place to authorise a deprivation of liberty. These include: Section 17 leave under the Mental Health Act; deprivation of liberty safeguards under the Mental Capacity Act; and, in certain circumstances, the High Court. The safeguards provided by these frameworks are different, and decision-makers must use their professional judgment to decide which is most appropriate for the individual. We feel that retaining this flexibility is important.

While we recognise that there is, at times, confusion among clinical professionals around which legal framework to apply—it is a point well made—we do not believe that this amendment would bring the necessary clarity. We feel this is best clarified using the Mental Health Act code of practice. I say to the noble Earl, Lord Howe, that I will reflect on the detailed points that he raised and will be happy to write to him further on them. For all these reasons, I urge noble Lords not to press their amendments.

[Baroness Barker (LD)]

Before the Minister sits down, I thank her very much, but I wonder whether she could include some of the rest of us in her correspondence with the noble Earl? We are back to the same issue of the interface between the Mental Health Act and the Mental Capacity Act. We need to keep coming back to this to get more clarity on it, because nobody understands it now. Whatever the Minister comes up with will be only a sticking plaster until the point at which we recognise that these two pieces of legislation continue to rub up against each other and cause confusion. They need to be addressed together.

So, would the Minister please include more of us in the correspondence, including the noble Baroness, Lady Browning? A number of speeches she has made throughout our deliberations have indicated that this is exactly the sort of issue that she is concerned about, too.

[Baroness Merron (Lab)]

Yes indeed, I will be pleased to include the noble Lords referred to.

[Baroness Keeley (Lab)]

I am very grateful to all noble Lords who have spoken in the debate today, including the noble Baroness, Lady Barker, who has supported the work we have done on this, my noble friend Lady Chakrabarti and Justice, which I should have mentioned earlier. I am very thankful to the noble Lord, Lord Pannick, and the noble and learned Baroness, Lady Butler-Sloss, for bringing their expertise. I thank my noble friend the Minister for her positive response and I look forward to talking to her more about this and taking forward this amendment. But for now, I beg leave to withdraw.

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

Baroness Merron Excerpts

Wednesday 12th February 2025 Lords Chamber

Moved by

[Baroness Merron]

That the draft Regulations laid before the House on 12 December 2024 and 6 January be approved.

Relevant document: 13th Report from the Secondary Legislation Scrutiny Committee. Considered in Grand Committee on 10 February.

Motions agreed.

Health Research

Baroness Merron Excerpts

Wednesday 12th February 2025 Lords Chamber

[Lord Davies of Brixton]

To ask His Majesty’s Government what assessment they have made of the implications for health research in the United Kingdom of the funding cuts to the National Institutes of Health announced by the government of the United States of America.

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

My Lords, the United Kingdom’s world-class health research ecosystem makes us a natural partner for the United States’ research and life sciences communities. When UK health researchers collaborate internationally, it is most commonly with researchers in the United States. While it is too soon to make a full assessment of the impact of any changes in National Institutes of Health funding on health research in the UK, we continue to monitor and remain committed to strategic UK-US health research collaboration.

[Lord Davies of Brixton (Lab)]

I thank the Minister for her reply. It is part of the Government’s policy to emphasise health research to improve the health service and to power economic growth, which is why the announcements of arbitrary and material cuts to research in the US have potentially bad effects, given the extent of international collaboration in research and joint funding. Will the Minister give a clear commitment to do whatever it takes to protect health services research in this country from the madness being perpetrated in Washington?

[Baroness Merron (Lab)]

I note my noble friend’s observation. I certainly can give the assurance that the United Kingdom will continue to support and promote its research capability at home and, where we can, internationally. It might be helpful if I tell your Lordships’ House that, on 10 February, a United States district judge temporarily blocked the Administration’s cuts following a lawsuit which was led by attorneys from 22 US states. There is a further hearing scheduled for 21 February, so it is wait and see, and we continue to keep a close eye.

[Lord Patel (CB)]

My Lords, NIH is the world’s largest supporter of biomedical research. A long time ago, I was a part beneficiary of its funding. It is renowned for developing many technologies for medical care, the two latest being CRISPR technology for treating disease and messenger RNA for developing vaccines. The UK is the first country in the world to license using CRISPR technology to treat sickle cell anaemia and thalassemia. In view of the cuts in NIH funding, we have an opportunity to increase our recruitment process for talented scientists who will be now be looking for a new home. As the country with the second-largest research profile in biomedical research, we may be able to benefit from it, so I hope the Government will refocus their efforts in the life science strategy and remove the impediments to the recruitment of talented scientists.

[Baroness Merron (Lab)]

The noble Lord makes an important point. Decisions made by other countries, including the United States, are a matter for them. As the noble Lord said, if this goes ahead—I have made comments on a lawsuit, so I am limited in what I can say—while the US is indeed one of the UK’s closest partners in this area, we will seek every opportunity internationally and continue our commitment to see research at the heart of our NHS into the future.

[Baroness Blackwood of North Oxford (Con)]

My Lords, as my ally the noble Lord, Lord Patel, rightly says, uncertainties in the United States with health funding presents an opportunity for the United Kingdom. The research funded by the MRC alone led to spin-out companies which created value of more than £6.1 billion, 3,800 jobs and £10.2 billion of external investment. Will the Minister and her department commit to campaigning for ongoing research and investment through what will be an uncertain and difficult SR for health and medical research?

[Baroness Merron (Lab)]

As we move towards the 10-year plan, it will be key. Research, the contribution of life sciences and innovation will help us deliver an NHS that is fit for the future. I agree with the noble Baroness about the major contribution that is made to the UK economy. This is not just about healthcare, important though that is; it is also about growth. There are some 6,800 businesses generating more than £100 billion in turnover. Life sciences is one of the most dynamic and significant sectors. It drives economic growth, but it also provides a future in terms of the quality, availability and efficiency of the healthcare that we can provide in this country.

[Viscount Stansgate (Lab)]

My Lords, I hope the House will understand me when I say that I deeply regret the fact that my noble friend has had to ask this Question in the first place. The cuts to which it refers have been described as an apocalypse for American science, but that is a matter for them. What do the Government think the consequences might be of the United States’ withdrawal from the World Health Organization? And does the Minister not agree that, in the event of an emerging global health threat, we will be less well placed to deal with it, to contain it and to understand what may be done without the United States in the World Health Organization? Are the Government already beginning to plan for this very sad eventuality?

[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.

[Lord Kamall (Con)]

Can I take this opportunity to ask a question about the UK’s wider health research ecosystem? The Government have talked a lot about moving towards prevention. How is this translated across to the health research environment? And while it is right that we look at cures and get better cures, given that testing and diagnosis are an important part of prevention, have the Government thought how we could focus our research on ensuring that simple tests such as blood tests or breath tests can detect more conditions and diseases earlier—for example, cancers including less survivable cancers?

[Baroness Merron (Lab)]

Yes, very much so, because it is by doing so that we will improve prevention and make the move from sickness to prevention. I can tell your Lordships’ House that the Government are continuing to support commercial clinical research delivery, including through new NIHR commercial research delivery centres that work with industry and other research infrastructure. I was pleased to visit one of them in Leicester, meet patients and hear how they were very engaged in doing exactly what the noble Lord is referring to.

[Baroness Altmann (Non-Afl)]

My Lords—

--- Later in debate ---

[Baroness Altmann (Non-Afl)]

My Lords, will the Minister join me in acknowledging and applauding the work of charities in health research, particularly those such as Wellbeing of Women, Teenage Cancer Trust, many of the cancer research charities and Alzheimer’s Research UK? I declare my interest, but these are such a cost saver to the NHS.

[Baroness Merron (Lab)]

I certainly associate myself with the noble Baroness’s generous comments about the role of charities. Much of the work that we do in research and innovation is in partnership, including with the third sector, and I thank all those charities for the role that they play.

NHS: Electronic Patient Record Systems

Baroness Merron Excerpts

Wednesday 12th February 2025 Lords Chamber

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

My Lords, NHS England has supported over 160 trusts with digital transformation, including the implementation of electronic patient records. Currently, 91% rollout of electronic patient records has been achieved, with work under way to provide tailored support to the remaining 19 trusts that do not yet have an electronic patient record.

[Lord Kamall (Con)]

I thank the Minister for that informative Answer. As she will know, the rollout of electronic patient records is just the first step towards full digital maturity, which will allow systems to share data across the system, not only for patient care but for research data that can help with preventive care. Can the Minister tell us more about what specific, targeted assistance those trusts that have not yet reached digital maturity are being given to ensure that they are digitally mature, whether they have the technology but are not yet using it to full capability or they need better technology to achieve full EPRs?

[Baroness Merron (Lab)]

I first acknowledge the role that the noble Lord, and the noble Lord, Lord Markham, played when they were Health Ministers. They both drove this agenda forward. I am grateful for that. The tailored support includes a number of activities to install, upgrade and optimise electronic patient records to meet the standard that the noble Lord is aware that we need to meet. I am sure that he is aware of the What Good Looks Like digital framework. That is an assessment of how digitally mature a system is. It gives guidance but also highlights where intervention must take place to bring it up to the right standard, which we would all want to see.

[Lord Stirrup (CB)]

What progress is being made to improve the flow of patient information between trusts, which at the moment is poor, contributing to NHS inefficiency and hampering the timely treatment of patients?

[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.

[Baroness Pitkeathley (Lab)]

My Lords, does my noble friend agree that any reluctance to share records or data is very rarely on the part of the patients but instead is usually on the part of the systems and the professionals? Patients are always astonished that the records are not shared between their GP and the hospital, and less still with social care.

[Baroness Merron (Lab)]

My noble friend is quite correct. The report of the committee that my noble friend chaired said that one of carers’ greatest frustrations was repeatedly repeating information to all the various aspects. The point about ensuring that there is digital maturity, and that various parts of the NHS and social care can get up to that and beyond, is crucial. This is the way that we are going and it will produce far better outcomes, not just for patients but for those who care for them.

[Baroness Redfern (Con)]

My Lords, patient flow through a hospital is a critical factor in avoiding delayed discharges, which is a major issue. We know that electronic bed management systems can play a major part in helping to reduce bed-blocking. What steps are His Majesty’s Government taking to ensure that more hospitals have that technology and that timescales are set for achieving full rollout?

[Baroness Merron (Lab)]

The noble Baroness is quite right about the benefits. The electronic patient records programme provides a 4.5% reduction in length of stay, as well as a 13% lower cost in admitted patient spells, so there are great benefits as well as better productivity and outcomes for patients. Electronic patient record coverage is forecast to be at 96% of trusts by March 2026, and the remaining 4% of NHS trusts will be advanced in their plans for an electronic patient record. I emphasise that we are proactive in actively supporting hospitals and trusts to get to the right place.

[Lord Kakkar (CB)]

My Lords, I draw the House’s attention to my registered interests. Patients who are managed in research-active environments frequently have better clinical outcomes. For an environment, be it in the community or in the hospital, to be research active, it must be able to collect patient data; electronic records are therefore essential. Beyond that, there is a necessity to curate those data and present them in such a fashion that they can be used meaningfully and rapidly to drive our nation’s research effort and benefit all citizens. What plans do His Majesty’s Government have, as they move forward with the 10-year plan, to ensure that that area of development is properly funded?

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[Baroness Merron (Lab)]

Research and data are absolutely key to the 10-year plan and the shifts that I referred to earlier. I also draw the noble Lord’s attention to the data security and protection toolkit. It is an online assessment tool that allows organisations to measure their performance against the National Data Guardian’s 10 data security standards. I know there is a question among some members of the public about this, but perhaps I could, overall, reassure the noble Lord that we see data as key to research. I certainly agree with his comments about outcomes for patients being better.

[Lord Naseby (Con)]

My Lords, if the Minister is looking for a current successful case history, I recommend Bedford Hospital. I was referred to the external clinic on the 20th and tested for X, Y and Z. A bed was found for me at 2 am. I had four nights in Bedford Hospital, since when I have had three different departments, all of which had full details from my GP and the other departments involved. Not only that but I happened to go to the Moorfields clinic which is attached to it—it is external—which had them as well. So, there is a good case history.

[Baroness Merron (Lab)]

The noble Lord is an exemplar when he describes the quality of care and the joined-up approach of the data and information relating to him. I am delighted to hear that Bedford Hospital was so good to him. I am sure it will appreciate him sharing that with your Lordships’ House, and I add my thanks too.

[Baroness Finlay of Llandaff (CB)]

My Lords, as part of the tailored support that the Minister spoke about earlier, can she explain about the cybersecurity provisions? The ransomware attack on Synnovis last June meant patients’ blood groups were unable to be matched, so there was a call-out for O-negative blood. Patients transfer between the devolved nations of the UK, between Wales and England, and across the border, to a lesser extent, between Scotland and England. Is she having discussions about United Kingdom-tailored cybersecurity support for these rollout systems?

[Baroness Merron (Lab)]

We regularly liaise and work closely with the devolved Governments. More than £338 million has been invested in cyber resilience to date. In March 2023, the department published the cybersecurity strategy for health and social care, which runs until 2030. This is an area of huge importance, as the noble Baroness identifies, and one we continue to press.

National Cancer Plan

Baroness Merron Excerpts

Monday 10th February 2025 Lords Chamber

[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.

[Lord Kakkar (CB)]

My Lords, I thank the Minister for bringing this Statement to the House today. I remind noble Lords of my interests as chairman of the Office for Strategic Coordination of Health Research and King’s Health Partners.

The Minister will recognise well that one of the most important determinants of achieving improved outcomes for cancer patients is access to innovative therapies. It has recently been suggested by the major pharma industry that there are fiscal and regulatory matters that impede the adoption of such innovative therapies across the NHS in England. Can the Minister confirm that, when His Majesty’s Government start to develop the cancer plan, they will look at matters of regulation and fiscal intervention to ensure not only the opportunity for broader support for clinical research but that a continued enthusiasm will be provided for those who have developed innovations to bring them to the UK and make them available to our fellow citizens?

[Baroness Merron (Lab)]

The noble Lord makes an important point about what I would call unnecessary obstacles to innovation and technology—something which the noble Lord, Lord Kamall, also raised. I assure the noble Lord, Lord Kakkar, that engagement with industry is extensive. We seek to identify blocks to improving healthcare provision in this country so that we can take the necessary steps. I agree that there are obstacles. We will continue to identify them—working with industry, which is crucial—and to seek to fix them.

[Lord Winston (Lab)]

My Lords, the Minister mentions the amount of money being spent on cancer research, but it is a small proportion compared with what the life sciences actually earn in Britain through patent and basic research. As UKRI recently pointed out, £3.7 billion has been raised as a result. Does the Minister agree that the Government should perhaps consider reinvesting some more of that money into much-needed basic research, which is currently regarded as being underfunded, with very many projects not being funded as they should be?

[Baroness Merron (Lab)]

As my noble friend is aware, the NIHR very much welcomes funding applications for research into any aspect of human health, including all cancers. As with other government funders of health research, it does not allocate funding for specific disease areas. My noble friend is well aware that applications are subject to peer review and judged in open competition—in other words, to make awards on the basis of the importance of the research to patients and on value for money. I appreciate his observation about investment. It is an area to which we are committed and will continue to be.

[The Lord Bishop of St Albans]

My Lords, a year ago this very afternoon, this very moment, I was in a surgery having a radical prostatectomy. I pay tribute to Professor Vasdev and his amazing team at Lister Hospital for the exceptional treatment I received. He is one of many fabulous people working in our NHS. The discrepancies, though, of diagnosis and treatment are stark in different parts of the country. Having worked in some of the more disadvantaged areas in the past, I am acutely aware of those. What are His Majesty’s Government’s going to do, as the plan is developed, to ensure that we look at the religious, social and ethnic barriers which are stopping groups coming forward to receive diagnosis and treatment? Will they particularly focus on how we can address these to try to support those in the most disadvantaged parts of our country?

[Baroness Merron (Lab)]

This is an extremely important point which will very much feature in the cancer plan. I am sure all noble Lords will join me in being glad to see the right reverend Prelate in rude health. I share his comments about the quality of care that is offered. I was fortunate enough to visit the Royal Marsden NHS Foundation Trust and Institute of Cancer Research on the day of the launch of the national cancer plan and the AI-assisted trial for women to tackle breast cancer. I assure the right reverend Prelate that that is crucial. I say from the Dispatch Box that I would expect any plan and work to take account of inequalities. I mentioned earlier targeting lung cancer; that is exactly what it does, and we need to see more of that.

[Lord Patel (CB)]

My Lords, the fact is that our best cancer services deliver as good a result as any in the world; they are second to none. We do not need to focus on what might happen in the future, with the promise of AI, etcetera. It may promise utopia, but we need the same degree of care as our best delivery provided universally to every cancer patient in our health service. That is what I hope the cancer plan will focus on, and not get carried away by a future that may look promising and bright but which may not deliver. I am delighted that there will be a separate children’s cancer plan, because that is needed. I hope that, in the meantime, it will stop any discussion about shutting down about our best children’s cancer hospital, for whatever reasons—which I think might be political.

[Baroness Merron (Lab)]

I want to clarify that while the cancer plan is not specifically aimed at children and young people, such evidence will be welcomed. Also, the taskforce will be relaunched this year, alongside the national cancer plan. As we do with adults, equally, we want to identify ways to improve outcomes and patient experience.

I hear the noble Lord’s point about AI. It is not a utopia, but it is a tool in the box that we would absolutely be right to look at. I am also struck by how AI is not something separate from human beings; it is human beings who guide it, and it has great potential. On the noble Lord’s point about tackling inequalities in access, which was also made by the right reverend Prelate, he is absolutely right. It is not acceptable that some people, because of where they live or who they are, are not accessing care. This is a constant issue for us, and we continue to tackle it.

[Lord Trefgarne (Con)]

My Lords, I have to start by declaring an interest. I lost my wife of 55 years in April last year due to breast cancer. I have a simple question for the Minister: when, oh when, are we going to find a cure for this dreadful disease?

[Baroness Merron (Lab)]

My condolences to the noble Lord; I am sorry to hear of the loss of his dear wife. I am afraid I cannot say when there will be a cure, but I can reassure him, as I have said previously, about the importance of research and research expenditure. We continue to make great strides, and we will continue on that trajectory.

[Lord Beamish (Lab)]

My Lords, I begin by declaring an interest as someone who is going through cancer treatment; I add my thanks to the doctors and our wonderful NHS workers. I agree with the noble Lord, Lord Scriven, who said that early detection is the main thing affecting whether someone survives cancer or not. I urge the Government to look at prostate cancer, particularly the PSA test, which we have to ask for now. Clearly, there is inequality throughout the country: in middle-class communities, where people ask for it, they get it; in poorer communities—certainly in Afro-Caribbean communities, which the right reverend Prelate referred to—detection is later and survival rates are poorer. If we cannot have a national screening plan straight away, can we not have a pilot to start with?

[Baroness Merron (Lab)]

I wish my noble friend well with his treatment. Screening for prostate cancer is not currently recommended in the UK because of the inaccuracy of the current best test available, which is the PSA. The advice we are given is that the PSA-based screening programme could harm men, as some could be diagnosed with a cancer that would not have caused them problems during their life; equally, some cancers may be missed. That is why we are investing £16 million towards the Prostate Cancer UK-led TRANSFORM programme, which is the name of the screening trial. On health inequalities, as I mentioned earlier, the trial is seeking to find better ways to detect prostate cancer, which is necessary, and to address the health inequalities.

[Baroness Laing of Elderslie (Con)]

My Lords, the Minister mentioned screening for lung cancer, and I am sure the whole House will welcome the progress made in recent years. Can she confirm whether the Government now commit to taking forward the plans for earlier screening of lung cancer, as recommended by the Roy Castle Lung Cancer Foundation?

[Baroness Merron (Lab)]

The Roy Castle Lung Cancer Foundation does excellent work and keeps our minds very focused. The point raised by the noble Baroness will be considered as part of the cancer plan.

[Baroness Watkins of Tavistock (CB)]

My Lords, the Cancer Research UK website clearly says:

“Drinking less alcohol can prevent”


at least seven types of cancer. The Statement refers to the Tobacco and Vapes Bill. Will the Government seriously consider a minimum unit price for alcohol to further reduce cancers across the board, particularly throat and bowel cancers?

[Baroness Merron (Lab)]

I cannot give that specific commitment to the noble Baroness. However, as I know your Lordships’ House is aware, one of the three major shifts we seek through the 10-year plan—this is very relevant to the noble Baroness’s point—is from sickness to prevention. Improved health absolutely is preventive for a number of conditions, including cancer. We need to get that message across, as well as supporting people to make improvements to their health.

[Baroness Tyler of Enfield (LD)]

My Lords, I pay tribute to all the staff at the Whittington Hospital and the Royal Free Hospital for the excellent treatment and ongoing care I have received for my own skin cancer. I will return to the question of early detection. What additional steps are being taken to try to counter the reluctance people sometimes feel to participate in screening programmes? I am thinking of bowel cancer screening and the embarrassment some people still feel, and cervical cancer screening, which many women find a very painful procedure. There is evidence that some younger women are no longer having this screening because they find it too painful. What steps are being taken to try to alleviate that?

[Baroness Merron (Lab)]

I am glad to hear the noble Baroness making statements about the quality of care she continues to receive, and I wish her well. She makes a good point about screening; some 15 million people are invited to screenings and about 10 million take them up. For bowel cancer screening, we have reduced the age to 50 to incorporate more people. That is very welcome, but I take on board exactly what the noble Baroness said: the tests that are painful or embarrassing all have to be dealt with. As part of the review of screening programmes, there is a constant, repeated look at how communications can be improved to target those who need the screening, and to try to be more creative. I refer again to the community diagnostic centres, which are where people need them to be and are less worrying than, for example, going to a hospital. I take the point about painful screenings, but, for us, it is also important to talk about the alternative, because without that screening I am afraid that the outcomes will be far worse.

[Lord Brooke of Alverthorpe (Lab)]

My Lords, I am grateful to the health service for saving me. Come this Friday, it will be six months since I was in the Royal Marsden—last summer, on my holiday—having my bladder and prostate removed. Here I am now, surviving. I had to struggle today to get into Parliament; farmers are protesting about money that needs to be raised to fund the NHS.

I return to the point about honesty that the noble Lord, Lord Kamall, raised at the beginning. You can have all the plans under the sun, but if you do not have the money or the will—and the plans to raise the money—you will not deliver them. I believe there is a question missing at the end of this invitation on the consultation: “Could you please suggest some ideas on how to raise the additional funds required to deliver these plans?” There are alternatives to those that we currently use. It is beholden on both the Conservative Party and the Liberal Democrats to be giving some attention to suggestions—which they would support—whereby we would raise additional money to fund the NHS, as our Government are endeavouring to do at the moment.

I would like the Minister to consider exploring a variety of options: how we might be more flexible in raising funds for the NHS, get the private sector more involved in new experimentation that needs to take place, and get the wider public more involved—perhaps by share interest in PPPs to fund particular operations and exercises; say, for a hospital such as the Chelsea and Westminster. Ask all the hospitals around the country what they would like to have. Could they involve their people? Could they involve the private sector? Could we explore a new model? It will not be done overnight but it needs to be done.

--- Later in debate ---

[Baroness Merron (Lab)]

I am glad that my noble friend is in the health that he is. I am sure that those who have supported him will appreciate his thanks and ours.

The considerations my noble friend raises are very much part of the considerations of the national cancer plan and the 10-year plan. With respect to funding, the allocation to healthcare in the recent Budget has allowed us to take steps to arrest a continuing decline and to fix the foundations. The fact is we are spending more and we are getting less. We have to do things differently. That will mean not just looking at money but reforming care, using solutions such as technology and AI to go further still.

[Baroness McIntosh of Pickering (Con)]

My Lords, I refer to my interests in the register. I warmly welcome the national cancer plan. The Minister will be aware that there still is an unacceptable wait time of 62 days. Will she use her good offices to ensure that there is early referral from GPs and that more funding is made available—for this purpose and longer appointments with GPs—if that is needed to make the case for earlier diagnosis and referral?

[Baroness Merron (Lab)]

I say to the noble Baroness that the overall trend for cancer performance is improving but it still needs to improve further. We will take all the necessary steps. The planning guidance set stretching targets for cancer, which will see around 100,000 more people every year having cancer confirmed—or ruled out—within 28 days, and about 17,000 more people beginning treatment within two months of diagnosis. The key to all of this has to be early diagnosis and treatment and ensuring that people do not get missed out, as we have discussed earlier. The trajectory is in the right direction, but they are small steps and we need to ratchet it up.

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

Baroness Merron Excerpts

Monday 10th February 2025 Grand Committee

Moved by

[Baroness Merron]

That the Grand Committee do consider the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024.

Relevant document: 13th Report from the Secondary Legislation Scrutiny Committee

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

My Lords, I am grateful for the opportunity to debate these amendments, which represent the most substantial reform of UK clinical trials regulation in over two decades.

Clinical trials are vital for developing safe and effective medicines, especially for those with limited treatment options, such as the estimated 3 million people living with cancer in the UK and the 17.5 million people managing long-term conditions. Last week, I saw for myself how innovative UK researchers are transforming cancer diagnosis and treatment. I joined the Science Minister, my noble friend Lord Vallance, at the Royal Marsden to learn about a research initiative that is using cutting-edge AI tools to improve breast cancer detection.

To support innovation, our regulations need to be flexible and proportionate. This legislation will do just that by delivering streamlined and efficient regulations, removing barriers to innovation and creating a patient-focused research environment—something that noble Lords called for during Questions on the Statement repeat that we just dealt with in the Chamber. These reforms will support the development of new life-changing treatments for those in need and strengthen the UK’s position as a global leader in clinical trials.

I turn briefly to why this change is necessary and timely. The reason is that the current legislation is based on the now-repealed EU clinical trials directive, so it therefore no longer aligns with the rapid advancements in medicine and technology. We have the opportunity to create a world-class regulatory environment for clinical trials, if we can deliver a modernised framework that supports the safe development of innovative treatments.

I will outline, for the benefit of the Committee, the key aspects of the reforms. First, on risk-proportionate regulation, regulatory requirements will align with the risk level of a clinical trial. Low-risk trials will receive faster approval through automatic authorisation, without compromising patient safety. The second aspect is that of future-proofing. We have removed duplicative and granular legal requirements in favour of tailored guidance, ensuring flexibility for future innovations and moving beyond a one-size-fits-all approach. On international alignment, the UK will remain aligned to global standards, ensuring that trial data is recognised internationally and strengthening its position as a preferred site for multinational clinical trials. Then there is the important point of cementing the UK as a destination for international clinical trials. Streamlined processes will simplify applications and deliver globally competitive approval timelines. The final change that these regulations deliver is increased transparency. We want to ensure that trusted information about clinical trials is publicly available for the benefit of all.

New legal requirements will thus be introduced to register a clinical trial, and publish a summary of results, including an easy-to-read summary for participants. These changes will build public trust in research by improving access to information about ongoing research and enabling informed decisions.

Of course, these reforms will also bring benefits to the National Health Service. Evidence shows that hospitals that undertake research have better patient care outcomes and improved staff retention. Improved efficiency in conducting clinical trials will therefore enhance research efforts and foster innovation in prevention, diagnosis and treatment across various conditions. Those conducting clinical trials will also benefit from a streamlined and risk-proportionate regulatory framework, reducing delays and admin burdens. These reforms, I am glad to say, will stimulate growth in the UK’s life sciences sector and position the UK as a global hub for clinical trials.

I beg the Committee’s indulgence as I correct an administrative error made in the Explanatory Memorandum. It incorrectly stated that an impact assessment was produced. However, since the projected costs and benefits to business were below £5 million annually, a de minimis assessment was conducted and published instead.

Before I conclude, I re-emphasise that participant safety remains absolutely paramount. While this legislation streamlines processes and removes barriers to innovation, what it does is to prioritise robust oversight of all clinical trials, ensuring that the safety of trial participants is never compromised. By modernising our approach, I believe we can strengthen the UK’s position as that global leader, as well as fostering innovation and having the highest safety standards. These reformed regulations accelerate the delivery of tomorrow’s emerging medicines into today’s reality for patients. I beg to move.

[Baroness Bennett of Manor Castle (GP)]

I thank the noble Baroness, Lady Merron, for her clear introduction to this statutory instrument, which I broadly welcome. There are some important factors here. I particularly welcome the requirement to register clinical trials and publish a summary of the results within 12 months. It has been widely and long acknowledged, in the research community broadly, that there is an issue where less successful or failed trials, or those that are not seen to have interesting results, are not published. They can be as important, or more important, than the successful ones. The failure to publish them is driven by academic, publishing and promotion imperatives—and, I am afraid, by the profit motive in healthcare, where companies have very much sought to find the successful stories and bury the less successful ones. That is really positive and, if I would say one thing, it would be to encourage the Government to speak more about that, because it is important that people understand it. Given the issues that we have with trust across the board at the moment, I encourage them to highlight that we are actually strengthening and improving regulation.

--- Later in debate ---

Overall, we welcome these regulations. We see them as a crucial step towards modernising the UK’s clinical trials framework. How we need to improve our clinical trials is one of the things that I hear about from industry all the time. We have great potential here, but we get slowed down by this bottleneck. We agree with the aims to improve efficiency, to foster innovation and to enhance transparency, but at the same time we must be mindful of the concerns that have been raised by others. Do we have the proper resources? Have we looked carefully at the unintended consequences? How do we make sure that the focus is on lower risk, with the appropriate focus on higher risk, so that we can all agree with the Government’s position on clinical research? This is about maintaining essential protections for patients and data integrity, making sure that the UK is at the forefront of clinical trials and encouraging more companies to do them here while, at the same time, reassuring the public about safety. I look forward to the Minister’s response.

[Baroness Merron (Lab)]

My Lords, I am most grateful to noble Lords for their time and their constructive contributions. I feel that we are all moving in the same direction, and I appreciate the welcome for these regulations. I also appreciate the understanding that I am not firing on all cylinders, but be warned: I will be at some point.

Noble Lords have heard the details of the amendments, which, as I said in my opening speech, represent the most significant reform of UK clinical trials regulation in more than 20 years. As I said in my opening comments, I am conscious of the fact that I have just come from the Chamber, where we heard questions about this very area. So these regulations do seem very timely. If I miss anything in response, I will of course be very pleased to write to noble Lords.

In delivering a more efficient and adaptable regulatory framework, and in accelerating life-saving treatment through streamlined and future-proof processes, the reforms will put patients at the heart of clinical trial processes, as we well as strengthening the UK’s position.

I turn to some of the key points that noble Lords have raised. On the matter of safety clinical trials of course carry varying levels of risk. No clinical trial is entirely without risk, but the MHRA maintains a rigorous regulatory oversight to safeguard patient safety in all clinical trials, and this legislation does not change that. There will be no compromise on the protection of participants. However, we are removing requirements from the current legislation that simply offer duplication or no additional value when it comes to identifying safety risks. As I and other noble Lords have acknowledged, this is about removing obstacles but ensuring that safety is paramount to ensure that regulators, researchers and participants are all aware of potential risks and can take action to deal with them as appropriate.

I very much welcome the removal of unnecessary administrative burdens; I am sure that all noble Lords do. By increasing the opportunities in the UK to access innovative medicines at an earlier stage, we will expand patient access to new therapies and reinforce the reputation of the NHS as a world-leading platform for health and life sciences.

The noble Lord, Lord Kamall, and the noble Baroness, Lady Bennett rightly highlighted the matters of transparency and public trust. I am very glad to see the new transparency requirements because, for the first time, there will be a legal requirement for sponsors to register a clinical trial, publish a summary of results and offer to provide participants with an easy-to-understand summary of what the research has found. Clear guidance is being produced to ensure that the summary for participants is accurate, tailored and appropriate for the audience, which includes translation into different languages and an awareness of suitable formats, as highlighted by the noble Baroness, Lady Bennett.

A recent study commissioned by the HRA highlighted the importance of transparency, with 69% of respondents stating that they would have greater confidence in research if participants were informed of the outcomes. These measures will therefore foster greater trust and engagement with clinical research, and I certainly welcome that.

The noble Lord, Lord Kamall, asked about the protection of pharmaceutical companies’ legitimate interests in protecting commercially sensitive information, and asked what safeguards are in place. I can assure him that we absolutely respect and understand the need for commercial confidentiality. The new regulations will permit research sponsors to request deferrals for registration and the publication of results, including offering to share these with participants where this is necessary to protect commercially confidential information. Deferrals could be granted for up to 30 months, with the possibility of further deferrals, where justified, up to a maximum of 10 years. I hope that these provisions will safeguard the very legitimate interests of companies, while also maintaining the overall goal of transparency, to which we are all committed.

We recognise the scale and the vibrancy of the UK’s life sciences industry, particularly those conducting clinical trials. Throughout the development of the reforms, we have engaged with the clinical trial community and received widespread support across key stakeholders, including businesses, academics and charities. The public consultation generated over 2,000 responses and demonstrated a strong appetite from the research community for updating and improving clinical trial regulations. We will continue working closely with the research community to produce guidance that supports the smooth implementation of these new regulations.

Noble Lords were very helpful in raising a number of considerations. The noble Lord, Lord Kamall, asked about the criteria for automatic authorisation and for information about low-risk trials. The criteria have been designed to ensure that sufficient scientific evidence already exists regarding the safety of the product and the methodology that has been used in the clinical trial—essentially, that we can be assured that the medicine is safe. The evidence must have been reviewed previously and approved by the MHRA or, where applicable, by regulatory authorities in the EU, the EEA or the USA. Additionally, the legislation defines the criteria for a clinical trial to be eligible for automatic authorisation. I hope that this is helpful to the noble Lord, as his point is very valid.

On the matter of implementation, raised by the noble Lord, Lord Scriven, particularly regarding guidance on risk proportionality, guidance will be published in advance of the regulations coming into force. This will ensure that researchers and those undertaking clinical trials understand the changes and have time to prepare. We are working with stakeholders across the sector and taking views into account to ensure that the guidance is as clear and helpful as possible. The guidance will be promoted by a wide range of channels to ensure that it reaches stakeholders across the research and clinical trial participant community. This is vital as we bring in this legislation.

The noble Lord, Lord Scriven, also raised a point relating to the performance of the MHRA. Since September 2023, all regulatory assessments for clinical trial initial applications and substantial amendments to protocols have been completed within the current statutory timescales of 30 days and 35 days, respectively. The latest performance information about the MHRA regarding clinical trials assessment shows strong consistency and, I am glad to say, no backlogs. The updated legislation will introduce key measures to make it easier and faster for applicants to gain approval. Noble Lords have acknowledged the need to ensure that the UK remains a prime destination for clinical trials.

The noble Baroness, Lady Bennett, raised questions about automatic authorisation. I understand why noble Lords are raising these matters. This is new territory and noble Lords need to be reassured. There are clear criteria embedded in the legislation to ensure that only appropriate clinical trials can use this automatic authorisation route. The criteria are based upon the MHRA stakeholders who were consulted on their extensive experience of clinical trials and the participant safety risks associated with them. I can give the reassurance that, where there is a significant safety concern with the product, clinical trials will not be eligible for automatic authorisation and must undergo full regulatory assessment.

The noble Lord, Lord Scriven, mentioned stakeholder engagement. Following the public consultation, a number of policies were adapted to ensure that the regulations did not have any unintended consequences, as the noble Lord, Lord Kamall, said. Let me give one example. The feedback indicated that patient and public involvement would be best addressed in guidance rather than in legal requirements, in order to give that flexibility and to enable it to be kept up to date.

The noble Baroness, Lady Bennett, mentioned the environmental impact at the stage of clinical trials. I will be pleased to write to her on that point.

As I believe this debate has shown, we are in agreement that, by improving the clinical trial regulatory framework, these changes will expand patient access to cutting-edge therapies, boost the UK’s life sciences sector and reinforce the reputation of the NHS as a leader in health research. On this basis, I hope that noble Lords will feel able to support these vital regulatory changes.

Motion agreed.

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

Baroness Merron Excerpts

Monday 10th February 2025 Grand Committee

Moved by

[Baroness Merron]

That the Grand Committee do consider the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2025.

[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.

--- Later in debate ---

On the whole, we welcome this instrument, but we want to understand whether there is flexibility within the five years and whether there have been any unintended consequences from the removal of the regulations. This is an important step towards ensuring the continuity of the regulatory framework, but we want to get the right balance between flexibility and being innovative and nimble to respond to changes in the landscape. I look forward to the Minister’s response.

[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.

Motion agreed.