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Lords ChamberThat 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.
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Lords ChamberTo 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.
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.
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?
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.
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.
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.
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?
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.
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?
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.
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?
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.
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?
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.
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.
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.
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Lords ChamberMy 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.
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?
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.
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?
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.
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?
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.
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.
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.
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?
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.
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?
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.
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.
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.
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?
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.
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Grand CommitteeThat the Grand Committee do consider the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2025.
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.
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.
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.
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?
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.
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Lords ChamberMy 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.
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.
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?
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.
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?
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.
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?
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.
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.
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.
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?
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.
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?
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.
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?
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.
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?
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.
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?
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.
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.
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.
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?
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.
(1 week, 4 days ago)
Grand CommitteeThat 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
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.
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.
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.
(2 weeks, 1 day ago)
Lords ChamberTo ask His Majesty’s Government whether they plan to publish a full version of NHS England’s report regarding Valdo Calocane.
My Lords, I offer my sincere condolences and, I am sure, those of all in your Lordships’ House, to the bereaved families of Barnaby Webber, Grace O’Malley-Kumar and Ian Coates. Our thoughts are also with the three survivors who sustained serious injuries in the horrendous attacks that took place in Nottingham. Yesterday, NHS England published in full the report of the independent investigation into the care and treatment provided to Valdo Calocane.
I thank the Minister for her reply and associate myself with her condolences to the families and the other injured persons. This is a thorough report of 300 pages. Short of naming any names, I do not think there is anything more to be said. However, I have three points. First, the report indicates the difference in the balance between patient rights and community safety, and I would like the department to take that point firmly on board. Secondly, it appears that some of the treatment decisions were taken by individuals but could probably have been better taken by multidisciplinary teams to test the individual judgment against a wider group of experts. Thirdly, the report mentions equality, diversity and inclusion factors and the extent to which they cut across medical decisions. Will the Minister come back to this House, perhaps in six months’ time, having asked her services to look at these three points and any others because there are far too many lessons-to-be-learned reports from which lessons never seem to be learned?
I assure the noble Lord that officials are working with NHS England and partners to set out the next steps regarding how future mental health homicide reports should be published and to ensure that we act as transparently as possible in line with our legal obligations and with engagement for families. That is very important for the future. The three points the noble Lord raises are very relevant and are being dealt with thoroughly in Committee as we take the Mental Health Bill through this House. I am confident that your Lordships’ House is on top of this matter, as are the department and all concerned. There has already been progress on the CQC report published previously, and all the recommendations in this report have been accepted in full.
My Lords, these Benches share in the condolences to all those affected by this tragedy. This is a watershed moment, but I am not sure whether the culture of the NHS has changed, given that yesterday a senior official said,
“the system got it wrong”.
No. Individuals in the system got it wrong. What extra mechanisms will the Government put in place to ensure that every individual is held accountable for this and future tragedies in each ICB area?
I understand the seriousness of the points the noble Lord makes. As he is aware, the report to which we are referring is concerned with the care and treatment provided by health services to Valdo Calocane rather than questions of culpability. More broadly, I remind your Lordships’ House that the Prime Minister has committed to establishing a judge-led inquiry into these attacks. We absolutely understand the importance of an inquiry. Having met the families myself, it is crucial to provide families with answers and ensure that this cannot happen in the future.
My Lords, the Calocane report is a devastating mix of horror at state failures. It echoes everything from the grooming gangs to Southport, and you just think, “How could this have happened?”. The Minister said that we are dealing with this in Committee on the Mental Health Bill. I query that because the report has only just come out, and it seems to me that the Mental Health Bill will need to change to reflect the lessons learned, as the noble Lord, Lord Balfe, said. Otherwise, we are ignoring it. Will the Minister reflect on how that is happening?
Secondly, did she notice the worrying detail that staff were nervous about forcing treatment because debates here in Westminster on racism in the mental health system meant that they stayed back—they were silent—because this patient was black? Can the Minister assure us that those kinds of politicised issues should now be swept away from all service provision and that we will tell staff that the ethnicity of the patient does not matter and that they have to act according to procedures?
I thank the noble Baroness for the opportunity to clarify that my reference to the Mental Health Bill discussions was in relation to the three points raised by the noble Lord, Lord Balfe, rather than the detail of the report. As I said, the recommendations have been accepted in full, and there is a programme of work to take them forward and for full reporting back. In respect of the further comments the noble Baroness made, it is of course the care of the patient that matters and protection for both the patient—whoever they are—and the public.
My Lords, it is a tragedy that, on average, 120 people are killed every year in Britain by people suffering mental illness. As the noble Lord, Lord Hanson of Flint, flagged last night on a different but relevant topic, the risk of tragedy can never be zero, so mitigation of risk is key. I hope the Minister will commit, perhaps in the Mental Health Bill, that full and complete reports on crimes committed by those who have been treated under the Mental Health Act 1983 should always be published because that is the best way to decrease the likelihood of them happening again. I should flag that in 2006 the High Court refused a request to have a patient’s medical history deleted from a published report.
I am grateful for the reflections of the noble Earl. I said earlier and am happy to emphasise again that the department is working with NHS England and partners to set out the next steps regarding how we will do exactly what he is speaking of, which is how future independent mental health homicide reports should be published, because it is so important to be transparent. Transparency is key, not just for bereaved families but to ensure that it drives improvements to services to help prevent tragedies. I certainly share the intention of the points raised by the noble Earl.
The Minister will know from the Mental Health Bill discussions that there is quite a strong feeling about the abolition of community treatment orders, which were introduced into the 1983 Act by the 2007 amendments. I had reservations about them when I sat on that Bill in another place. I continue to have reservations about them, and this case is indicative of the difficulties and dangers of trying to administer strong medications to people in the community.
I am grateful to the noble Baroness and for all her contributions to the Mental Health Bill. Perhaps I could use this opportunity to say, in answer to her question but also to a previous question, that improving patient rights is not in conflict with public safety. That is something that I know we are very mindful of about the Bill. As the noble Baroness is well aware, and as we have debated many times in this Chamber, there is a case, when to protect people from themselves and to protect the public, action must be taken, and that should not be shied away from.
My Lords, as the terms of reference of the inquiry are developed, could the Minister outline whether they will cover the key questions that have been raised about the criminal justice system? Do we need to look, for instance, at renaming the offence “manslaughter on the grounds of diminished responsibility”, with the cry that he has got away with murder? Will it look at the sensitive issue of, when somebody is not culpable for getting as ill as he did, which is what the court found in the unduly lenient sentence judgment, whether we need to explain to the public why we do not send people to prison but only to hospital in those circumstances?
As the noble Baroness is aware and as I have already confirmed, the report is totally focused on the care and treatment of Valdo Calocane. The questions about sentencing are of course a matter for the courts, but I am sure that my colleagues in the Ministry of Justice will be interested in the noble Baroness’s comments.
(2 weeks, 2 days ago)
Lords ChamberTo ask His Majesty’s Government what assessment they have made of the remarks by Sir Julian Hartley, the new chief executive of the Care Quality Commission, that the public can no longer trust the safety ratings given to care homes.
My Lords, the CQC has assured the department that Sir Julian Hartley, the new chief executive, did not use the exact words attributed to him in the interview with the Sunday Times recently. However, the chief executive gave a very honest assessment of the Care Quality Commission’s operational failings as a regulator and the challenges that face it in regaining public confidence. We welcome his candour, as well as his actions.
My Lords, it seems that available reports about care homes, which are needed, may be four years out of date, which is a serious shortcoming. At a time when the pressure is on to discharge people who need social care, as opposed to medical care, does my noble friend agree that the serious problems in the inspection regime are a barrier to any kind of progress with hospital discharge, and that the aim must be to make the CQC the trusted organisation it once was, on which families can rely when arranging care for their loved ones?
My noble friend is quite right in her observations. Indeed, serious shortcomings are at play. As for the age of the assessments, to which she refers, that is of scant help to those who are seeking to make decisions for either themselves or those who they care for. The CQC, under its new leadership, is prioritising tackling the oldest assessments. The first order of priority is to reduce the registration backlog, which at present is over 10 weeks, and address issues with the registration portal. An independent review has been commissioned to look specifically at the technology that will help reduce the backlog and provide the very necessary up-to-date assessments.
My Lords, can the Minister say what urgent steps are being taken to restore public confidence in the CQC’s ratings, and, in particular, what measures are being taken to ensure that the voice of both the patient and their families is given far greater weight in the way that these judgments and ratings are made by the regulator?
I agree that public confidence is absolutely crucial. That is why honesty is very important and why the Secretary of State accepted in full the recommendations of Dr Dash’s review into the CQC, which was published in October. In addition to new executive leadership, a recruitment process is under way for new non-executive leadership, including the chair, which is very important. I agree with the noble Baroness on the importance of the patient voice, because that will lead to greater confidence. There is a long road to go down, but I am absolutely confident that we are well on the way.
My Lords, organisations such as the Medical Defence Union report that new healthcare providers are facing severe delays registering with the Care Quality Commission. These delays are slowing down the process of registering new patients to access services. Can my noble friend the Minister outline what discussions the Government have had, or will have, with the Care Quality Commission to resolve this issue?
I assure my noble friend that the department has discussions with the CQC at fortnightly meetings. Those discussions are about performance, including clearing the backlog of registration of new providers, and this will continue in order to make the necessary improvements that my noble friend seeks.
My Lords, does the Minister agree that a lot of the problems in care homes would be alleviated if becoming a carer in a care home required certified training, supervision and a defined career path, rather than it being a job of last resort for itinerant job seekers, as it seems to be in many homes at the moment?
I certainly agree with the noble Baroness that the workforce is absolutely crucial, and I very much value the contribution that is made by those who work in care homes. Perhaps it would be helpful to say that, just last month, we announced that the care workforce pathway, a new national career structure for adult social care, will be expanding to support opportunities for career progression and development. This is the direction of travel that we want to take.
My Lords, whether or not the newspapers were correct in reporting what the CEO said, I am sure we would agree that the Care Quality Commission has been found deficient in its performance. With particular reference to the reports on maternity services, which are now in crisis, what are the Government going to do about properly evaluating maternity services?
I absolutely agree that the CQC has been deficient in its performance. We can look back to 2023 for the roots of that, when a new single assessment framework for assessing providers, coupled with a new IT system and changes in the CQC’s staffing model, were all brought into play. That produced a stark reduction in its inspection activity, as well as causing huge problems in the time taken to carry out re-inspections. In all of the ways that I have already mentioned, in addition to discussions on reducing the backlog and looking at the technology, staffing structure and improving governance within the CQC, this will be a root-and-branch change and will greatly improve inspection for maternity units and others.
My Lords, Sir Julian Hartley, in the Health and Social Care Committee hearing, said that the new IT system introduced by the regulator had been a complete failure. What steps will His Majesty’s Government take to ensure that public bodies, not just the CQC, have adequate and effective rollouts of digital systems, so that they can deliver on their performance targets? On 6 January, the Secretary of State announced that the Government were launching an independent commission on social care reform, with the intention of forming a national care service. Can the Minister please update the House on the progress made towards this commission?
To take the second question first, the commission will start its work in April. The noble Baroness, Lady Casey, has agreed to lead that review. The terms of reference will be published, and the first report will be with us next year. On the important point about IT, as I mentioned in response to the noble Lord, Lord Patel, that problem arose in 2023. The CQC has acknowledged, as we have, that there have been huge challenges with the provider portal and the regulatory platform. The Dash review talked about poorly performing systems hampering ability. This is not how the system should work. As we move towards the 10-year plan, and from analogue to digital, we will have that front and centre in how we work.
My Lords, the Secretary of State in July said that
“the CQC is not fit for purpose”.
Given the systematic failings still within that organisation, what timescale have the Government given the CQC to become fit for purpose?
The Secretary of State did indeed say that, and he was right to do so, in the spirit of transparency. The fortnightly meetings which I mentioned will be a constant assessment until we have met the necessary timeframes that are only reasonable to assist people in making decisions. All of that—how might I put it?—deep focus on the CQC will continue. I do not think this will be quick, but it will be thorough.
My Lords, 30% to 40% of public money given to corporate-owned care homes vanishes in profits, leaving little for front-line services. Almost all care homes forcibly closed between 2011 and 2023 were operated by for-profit companies. The Government’s promised crackdown on care home profiteering probably will not even be as effective as that on water companies. What will it take for the Government to recognise that profit and care cannot easily be combined?
The independent sector, which is not just the private sector but the charitable sector, is an important part of the provider framework. We will continue to work with it to provide the right quality of services for those who need them.
(2 weeks, 3 days ago)
Lords ChamberMy Lords, nearly 600,000 women are waiting for treatment on a gynaecological waiting list in England. Labour’s 2024 general election manifesto made a commitment that:
“Never again will women’s health be neglected. Labour will prioritise women’s health as we reform the NHS”.
Why, then, are the Government removing the requirement on integrated care boards to implement women’s health hubs? The Answer given to this Urgent Question by the Minister in the other place stated that at least 90% of ICBs already have women’s health hubs, which is terrific. If they have been rolled out so effectively, why not complete the job and follow through to reach 100%? Perhaps the Minister could tell us what exciting plans she has to do this.
I would be glad to give information to the noble Baroness, whom I thank for reminding your Lordships’ House of the situation that we inherited—600,000 women on gynaecological waiting lists—and the challenge before us. My honourable friend in the other place was quite right about the planning guidance, but I commend the effort of the noble Baroness’s Government for pump-priming the introduction of women’s health hubs to the point where there are some 80 across the country—in nine out of 10 areas, there is at least one. It was never a long-term planning situation. The noble Baroness will also be aware of the informed observation from the noble Lord, Lord Darzi, that planning guidance has too many specifics. We therefore needed a new approach, which is what we have done. The planning guidance is not the catalogue of all the levers, nor of all that happens, in the NHS.
My Lords, women’s health hubs have proved enormously popular with practitioners, who are able to give multiple treatments in one session, and with women, who no longer have to take time off on different days to go to different clinics for different procedures. Given this, why are the Government not backing this cost-effective strategy, not least because it prevents women showing up at A&E, which is far more expensive?
We are not closing women’s health hubs—it is important to put that on record. I have already said how successful the pilot has been; it therefore does not require a further target. I hope that noble Lords have seen that the changes to the planning guidance move away from the old centralised operating model to give more control and direction locally. As I said, the decision not to mandate women’s health hubs reflects a new approach to the guidance: fewer national directives and more empowerment of local leaders. Women’s health hubs are also described in the elective reform plan, which is one example of another area where their importance is recognised and boosted.
My Lords, the Minister will know that women’s health hubs are vital in reducing gynaecological waiting lists. We have seen that through their success in areas such as Birmingham, Tower Hamlets and Liverpool. I hear what the Minister has been saying, but there is strong concern from the sector that many of the existing hubs are in their infancy or are not yet operational. They will not progress unless there is operational guidance for the NHS or formal commitment to them from the Government. With their removal from the planning guidance, what actions is the Minister taking to ensure that every ICB has a women’s hub? Given what she said about local decision-making, what steps are being taken to make sure that we learn from the success of the highest-performing hubs and share it with others?
We continue to learn from the best. I am committed to speaking with the leadership of ICBs about the importance of women’s health hubs, not least because it is about improving women’s healthcare. Having visited a women’s health hub myself, I can testify to the points that the noble Baronesses have made. However, I gently repeat that we need to look not just in the planning guidance but in the elective reform plan, which states about the NHS that:
“In gynaecology we will support … innovative models offering patients care closer to home”.
That is exemplified by the women’s health hub. The Neighbourhood Health Guidelines, published just last week, include women’s health hubs as an example of a neighbourhood health model.
My Lords, the history of health policy through successive Governments has been one of too many priorities and targets which are not delivered, so I support the Government in this analysis. It has also been one of poorer outcomes for women and minorities. Given the shift in leadership from the Department of Health and others, how will the Government ensure better outcomes for women and minorities? How will those be monitored? Will they intervene early if they do not see that direction of travel?
I thank the noble Baroness for her welcome for the new approach in the planning guidance. As she commented, and as noble Lords opposite will know, just because something is in the guidance does not mean that it will happen. For example, despite targets for A&E performance or ambulance response times being written into planning, they were not delivered. This is not where we want to be. We will continue to work with NHS England; for example, to ensure that women’s health is key. I should also emphasise that, as we move towards the 10-year health plan, women’s health will feature not as an adjunct but run throughout.
My Lords, I welcome the Minister’s comments. We know that black women are three to four times more likely to die during childbirth and that the rate of maternal deaths in the UK has risen during the past 10 years, which I am sure she will agree is a national disgrace. Does she therefore accept that women—and especially women of colour—have been ill served for many years? How will the Government reverse this trend?
I agree with the noble Baroness. It is a disgrace that there is such a huge inequality in maternity care. Maternal mortality rates are some 2.3 times higher for black women and 1.4 times higher for Asian women, while those living in the most deprived areas have a maternal mortality rate nearly twice as high as that for those who live in the least deprived areas. That cannot be acceptable in 2025. I am glad that we have taken a number of actions to ensure that trusts who fail on maternity care are robustly supported. We will set an explicit target to close black and Asian maternal mortality gaps. Trusts are also required to publish a suitable plan to tackle this and to put it into action. It is a challenge, but not one that we shy away from.
My Lords, I declare my interest as set out in the register. What is the Government’s timetable for a revised or updated version of the women’s health strategy? Can the Minister also assure the House that there will be adequate funding for its implementation when it is brought in?
Let me assure my noble friend and other noble Lords that there are no plans to cancel the women’s health strategy. I know my noble friend did not say that, but it is very important to put that on record. We continue to implement it; for example, since I have been in post, through measures such as supporting pregnancy loss through a full rollout of baby loss certificates, introducing menopause support in the workplace, and boosting women’s participation in research and clinical trials. As I said, our priorities for delivering the strategy will be through the 10-year plan. Funding decisions will be announced in due course.
My Lords, given that one-third of all new breast cancer cases occur in women over the age of 70, will the Minister consider extending automatic screening for those women? At the moment, it stops at that age.
Women over 70 can request an assessment if they feel it is appropriate for them. We act on and apply the scientific advice and evidence that we are given. On World Cancer Day, perhaps it would be appropriate to say to the noble Baroness that some 700,000 women across the country will take part in a world-leading trial to test our cutting-edge AI tools, which will be used to catch breast cancer cases earlier. This morning, I was at the Royal Marsden Hospital in Sutton with Minister Vallance to see the incredible contribution that AI is making to improved cancer services, including for women.
(2 weeks, 4 days ago)
Lords ChamberTo ask His Majesty’s Government what plans they have to reduce the waiting time for access to mental health treatment.
My Lords, I am pleased to be answering this Question during Children’s Mental Health Week. To ensure that high-quality support can be accessed in a timely manner, among other actions we are committed to recruiting 8,500 more mental health workers to cut waiting times, introducing access to specialist mental health professionals in every school and rolling out young futures hubs in every community.
My Lords, I thank the Minister for that helpful reply. There has been a 33% rise in mental health referrals since 2019 and it is particularly severe for children and young people, with an increase from 12% to 20% for those experiencing mental health conditions. This has not been matched by an increase in investment in services or additional staff to enable early intervention and speedy help. Many children have been forced to wait till their conditions escalate, putting a lot more pressure and exceptional demand on school counsellors and on community care. Can the Minister say exactly what the Government are doing to address these pressures, particularly on young people? How will she ensure that funding at local level will focus on their needs?
I agree with my noble friend’s assessment of the impact of what is a totally unacceptable situation, particularly for children and young people. On the point about ensuring delivery locally, I refer your Lordships’ House to the NHS planning guidance, published last week, which not only confirms our commitment to the mental health investment standard but sets out an objective to increase the numbers of children and young people under 25 accessing services in the forthcoming year compared to 2019.
Does the Minister agree that the long delays experienced by released prisoners in accessing necessary mental health care simply oil the revolving door of their return to prison? Will the Government give high priority to dealing with that problem?
We are extremely aware of the point the noble Lord helpfully makes. The matter of severe mental illness in prisoners has come up repeatedly in Committee on the Mental Health Bill, and we will continue to work to address the points he raised.
My Lords, I welcome the fact that the new NHS operational planning guidance, which the Minister just referred to, includes targets for improving mental health care, learning disabilities and autism. What assurances can the Minister give that these targets will be properly reflected in the forthcoming spending review, the NHS 10-year plan and the updated NHS workforce plan to ensure we really do see parity of esteem between physical and mental health?
I can confirm the commitment of the Government to parity of esteem between mental and physical health services, as was outlined in our first programme of legislation confirmed in the King’s Speech. It will have absolute regard in all the areas the noble Baroness refers to. I know she is aware that I cannot comment specifically on spending reviews, but all that will be announced publicly in due course.
My Lords, ADHD affects lots of children and, though treatable, it is often not treated. Can the Minister assure the House that treatment for ADHD will increase substantially to ensure children can get back to school and get on with their studies?
It is important that children with ADHD receive the right education and the right support. We are working with the Department for Education to make sure that happens.
I welcome my noble friend the Minister’s replies to the questions asked. I know she is personally committed to improving the services provided to people suffering from problems with their mental health. However, is she aware of the concern that has been expressed by the Royal College of Psychiatrists that the increased autonomy allowed to local health authorities will, without clear guidance, lead to inadequate investment in mental health services? Can she provide some reassurance for the royal college?
I am grateful to my noble friend for raising this. There are whole areas in which we are seeking to turn this round, and I know my noble friend is aware of the challenges we face. To highlight just one, I refer him to the fact that the Government have chosen to prioritise funding for talking therapies and to deliver that expansion. That is really important because, in all of this, we have to make the move from dealing with sickness to prevention, and I believe this is a very strong example of how we can do that.
My Lords, does the Minister agree that, in mental health services, the gap between referral and treatment is getting longer and longer, and that delay is leading to a marked deterioration in the patient’s experience? So far as young people are concerned, the delay has become incredibly long. Can the Minister assure the House that thought is being given to reducing the gap between referral and treatment?
The noble Lord makes a very important point. This is one of the many areas where long waiting lists and delays in people receiving the necessary service are creating additional pressures on the individual, communities and the NHS. We are doing work in a number of areas, such as ensuring that NHS 111 can provide for those in crisis, or those concerned about a family member or loved one, so they can speak to a trained mental health professional. We are constantly looking at and providing new ways for people to get more instant access.
My Lords, do the Government see a role for employers in promoting the mental health of their respective workforces?
I certainly do, and with the NHS being such a large employer, that is one of the areas that we will be attending to. The long-term workforce plan will provide its report around the summer of this year and there will be much detail on how the workforce will be but also on the ways that we can improve its health and retention as well as recruitment.
My Lords, my noble friend Lady Warwick spoke particularly about young people and provision in schools. Does my noble friend the Minister agree that there is a key role for educational psychologists and school nurses in ensuring that diagnosis can take place early? Does she believe there could be a greater role for academies and schools working together at local level to provide that type of provision?
I agree with my noble friend’s suggestions. Of course it is a team that provides the mental health support that is necessary, but I am particularly pleased that we are working to deliver a mental health professional in every school. That is a starting point, not necessarily the end point, so my noble friend makes some very helpful suggestions.
I appreciate from my own time as Health Minister how difficult it is to meet the expanding demand, so I wonder if we are still looking at other methods to expand capacity, particularly digitally, both in terms of early diagnosis but also some of the digital mental health treatments which are quite impressive?
I am glad for the understanding of the noble Lord. NHS England is encouraging the local use of digital tools, for example digitally enabled therapies, and it is an extremely helpful way also of managing waiting lists so people are not just left waiting but they are held and supported, often through digital means.
My Lords, I declare my interest as set out in the register. A policy of the police not attending mental health incidents, called “right care, right person”, was developed by Humberside Police and adopted by the Metropolitan Police. What assessment has been made of the impact of this policy on those suffering from mental health issues?
I thank the noble Lord. Again, this is an area which has been explored in Committee on the Mental Health Bill and we are looking at the results of how that is working out, because we have to get the balance right between supporting people in crisis and also ensuring that the right professionals are in place.