Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)
My Lords, I am grateful to be here today to debate these important regulations. Before I begin, I draw the attention of noble Lords to my entry in the register of interests regarding my shareholding in a company which conducts private sector health screening.
To discuss this SI effectively, I must first set out some context. The provisions in the instrument concern in vitro diagnostic—IVD—devices. These are medical devices that test samples taken from the human body to monitor a person’s overall health or to treat and prevent diseases. Examples of IVD devices include blood tests to detect HIV or hepatitis, tests for cancer biomarkers and more commonly known tests such as pregnancy tests. The Medicines and Healthcare products Regulatory Agency—MHRA—is the UK regulator for medical devices, including IVD devices.
This SI is necessary first and foremost because it enables the MHRA effectively to enforce regulations in Northern Ireland, protecting patient safety. Without this SI, the MHRA will lack important powers equivalent to those in place across the rest of the UK.
Secondly, the SI is particularly beneficial given that life sciences and medical technology are major growth sectors in Northern Ireland, and this Government are committed to making Northern Ireland thrive. The SI will unblock UK-wide clinical studies of medical devices and IVD devices that include Northern Ireland locations. Northern Ireland has a unique regulatory position under the Windsor Framework, including access to the EU single market. By providing for a stable regulatory environment in Northern Ireland, this SI will further enable the whole of the UK to remain an attractive market for research and development of medical technologies.
In May 2022, the EU replaced its regulatory framework for IVD devices with a new regulation, the EU in vitro diagnostic regulation, which I will refer to as the EU IVDR. The EU IVDR has automatically applied in Northern Ireland since 2022 under the terms of the Windsor Framework. The Command Paper published last week reaffirms our commitment to unfettered access. This SI facilitates consistency in the operation of device regulations in Northern Ireland and GB, where beneficial to Northern Ireland, and reflects the unfettered access of Northern Ireland IVD devices to the GB market.
I will now take a moment to summarise the key provisions this instrument introduces. The SI lays down proportionate penalties and gives the MHRA powers to serve compliance notices for breaches of the EU IVDR in Northern Ireland. Although the MHRA previously had the necessary tools to respond to safety concerns, the statutory instrument further strengthens this toolkit. It gives the MHRA powers to designate and monitor notified bodies in relation to the EU IVDR and charge fees related to these activities. Notified bodies in the UK can carry out the technical conformity assessment of IVD devices for EU regulatory compliance, allowing the manufacturer to affix the “CE” and “UK(NI)” marks for placing their devices on the market across the UK.
Sponsors of performance studies for new IVD devices in Northern Ireland will need to apply to an ethics committee in the UK for an ethical review and hold sufficient insurance to meet any potential financial liability in the event of injury or death from participation in the study. The instrument also creates an arbitration procedure for refused performance study applications. It allows studies of IVD devices and clinical investigations of medical devices taking place in both Northern Ireland and Great Britain to require only a contact person to be established in Northern Ireland, rather than a legal representative, supported by a sponsor or legal representative established in Great Britain. This reduces the burden on businesses and makes it straightforward for studies and investigations to include sites across the whole of the UK. It will enable more studies and investigations to go ahead in Northern Ireland.
The SI allows a coronavirus test that complies with the EU IVDR and the new EU common specifications to be placed on the Northern Ireland market without needing to obtain separate approval from the MHRA, as is the current UK requirement. This will reduce burdens and avoid duplication of costs for Northern Ireland businesses wanting to place Covid tests on the market across the whole UK.
The SI includes specific provisions to ensure unfettered access of qualifying Northern Ireland IVD devices to the Great Britain market with no additional barriers or burdens to Northern Ireland traders. This product-specific legislation sits alongside general protections for Northern Ireland’s unfettered access to the rest of the UK under the United Kingdom Internal Market Act 2020.
These provisions allow us to honour our current commitments under the Windsor Framework and will strengthen the regulation of IVD devices in Northern Ireland, to the benefit of patients and businesses. For these reasons, I am content to bring forward this legislation today. I commend these regulations to the Committee.
Baroness Finlay of Llandaff (CB)
My Lords, I should declare that my son is a cardiologist and founder of Rhythm AI and Echopoint Medical—I think those medical devices do not completely fall within the scope of this, but I declare it anyway just in case.
It is notable that the medical devices road map from the MHRA, which set a future regulatory framework for devices and was published on 9 January, talks about four statutory instruments. Does this form part of those four? Are others due to come, and if so, when?
Despite the Government’s warm words about us being an attractive market, the problem is that the UK is becoming an increasingly less attractive market because our application-to-approval time has extended beyond that of other countries such as the US and Australia and, I think, Japan. Clinical trials in general are not being brought to the UK. During the pandemic, we showed that MHRA approval could allow us to be the fastest in the world with vaccine development and, more recently, with treatment of sickle cell disease. However, low numbers of patients are now enrolled in studies. For the life sciences to develop, trial and test new technologies, they need to be able to do so rapidly. How will the MHRA have adequate workforce to deal with an increased workload from Northern Ireland? Has that been factored in?
How will the risk assessment be set? It is important to recognise that some developments will fail and fall by the wayside. A realistic risk assessment recognises that a whole population needs to be studied. That is best done with post-market surveillance, which is key to evaluating the implementation of any new technology in the real world.
There is a view that our regulations have become tighter, making it too hard and burdensome for device development to be brought to the NHS; as the UK market is small, we need to make it particularly attractive for innovation. The eventual market, being small, would allow us to keep our innovations and market them abroad once they had gone through full approval processes. What steps are in place for mutual recognition agreements to be taken forward?
A paper from Birmingham Health Partners, Alternative Routes to Market for Medical Devices, suggests there are three routes. I gather that Switzerland has now undertaken to adopt the Food and Drug Administration approval systems from the US, registering the file—for us, it could be registered with the MHRA—with a post-market surveillance plan in place. Of course, the initial safety standards must be met, but it is in the real world that benefits and risks are revealed.
For our deficits and gaps in the NHS, there are problems that we need to solve by pulling new technology and diagnostics in. But the golden age of innovation will happen only if there is fast approval to evaluate, with good surveillance so that those innovations with problems are rapidly dropped and those with promise and better patient outcomes continue to be developed. This innovation has to happen across primary and community care as well as hospital specialty services. It requires the recognition of intrinsic risk by adjusting the risk threshold, including that not to innovate is also a risk.
The public understands the need to innovate. In the related areas of clinical trials, which I think is an important but salutary comparator, we have dropped from being fourth in the world to being 10th in the world, which is much to the loss of our NHS and our patients, as well as, obviously, innovation business. Our time for the regulatory review is greater, so we are slower than many other countries. How will these regulations strip out unnecessary processes and bureaucracy and speed up processes to make us attractive to innovators? Northern Ireland being in the unique position that it is now in could be a very important market for innovation, with its fast and easy access and attractions for those developing in vitro devices.
Lord Allan of Hallam (LD)
My Lords, I was grateful to the Minister for his description of in vitro devices, which is not necessarily obvious from the regulations. I hope that he can confirm that the “in vitro” bit is misleading; we are talking about lots of tests that are done in plastic and no longer glass, so it is a Latin hangover. I think that I am right in thinking that this applies to everything, whether it is a stick test or whatever device it is; it applies to any kind of diagnostic test.
On the regulations, I shall offer a one-sentence Brexit whinge, which is just to say: “Oven-ready, ha ha ha!” Looking at these regulations, we are now in legislative spaghetti territory, where to do something quite small and simple requires pages and pages of legislation to enact it. We are in a very messy regulatory situation, and it is only going to multiply over time. That was the first point that I wanted to raise.
It would be helpful if the Minister could say, for the health area for which he is responsible, the extent to which the Government have assessed how far there will now be divergence between Northern Ireland and Great Britain in the relevant health areas. There are two different scenarios. In one, the UK stands still, but the EU moves on, which is effectively what has happened here: the EU has updated its law, and we are now having to respond, because it will apply in Northern Ireland. So even if we do nothing, there will be change, and we should be reasonably capable of extrapolating that by looking at past behaviour and the EU’s legislative programme. Of course, the other scenario is where we actively diverge from the EU.
I hope that, in both scenarios, the Minister will be able to confirm that there is somebody—or a team somewhere in DHSC—who has all this mapped out. It may not have been possible before Brexit, when we were still living in la-la land—but, since we have had the experience of the retained EU law Bill, where the number of laws that we found tripled from the first exercise to the current iteration, it is important for businesses out there that we understand how much retained EU law there is in the health area, how much of it will be relevant and how much will require this kind of statutory instrument to ensure that we can respect both the Northern Ireland and the Great Britain settlement.
I am also curious: the Minister referred to the fact that the EU’s updated law was implemented as a regulation, which of course applies directly, rather than a directive, which needs transposition. He said that it applied from May 2022, but we are regulating only now. I am genuinely curious as to what happened in the intervening period. Is it the case that if somebody had been selling non-conforming devices, they would get away with it for that period because the law did not catch up? I am curious to hear what the Government’s intention is. Presumably, this scenario is going to be repeated: there will be new bits of EU law and we have to follow on and make sure that they are implemented for Northern Ireland. I am genuinely interested in the Minister’s comments on the Government’s strategy: are they concerned at all that there may be these gaps, or is it something we just have to live with now?
Lord Markham (Con)
Absolutely. Clearly, we would like it both ways, for obvious reasons. There are a number of areas where we are still being open about our rules—not just to the EU but to other countries as well, with the hope that there is some reciprocation down the line. That is definitely the intention. Talking to the regulators, I know that the situation is crazy. We know that the Australian, Canadian or Singapore regulators are top-notch, so we should be satisfied with their work in many cases. The feeling often is that stage one towards that recognition is that, while we might have slightly different standards, recognising that where they have conducted tests, rather than reconducting those tests, we should at least recognise that each other has done the tests correctly. We should take that data and that should speed things up.
In answer to the question of the noble Lord, Lord Allan, we are talking about any type of diagnostic test—
Baroness Finlay of Llandaff (CB)
May I intervene before the Minister moves off the subject of mutual recognition? Perhaps I may clarify whether he envisages this being similar to the Orbis project for drug approval recognition, particularly regarding oncology and cancer drugs, where FDA approval is recognised. There are different levels, so that things can come through to clinical application quickly. What is the position as regards us recognising FDA approval for development? Do the Government intend for that to be adopted by the MHRA, rather than devices having to go through all of our processes as well? Will we recognise the FDA system, with increased focus on post-marketing surveillance?
NHS: Fracture Liaison Services
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Lord Markham (Con)
Again, the use of hubs and their importance for getting people back to work is recognised. That is why in 2023, in the major conditions strategy, we announced the £400 million workforce programme to get 100,000 people with employee support back into work. It is absolutely recognised that what we can do with fracture liaison clinics is a major help. We are also looking at digital therapeutics—the app is close to my heart—that can help with MSK as well. There are a range of measures.
Baroness Finlay of Llandaff (CB)
My Lords, I declare my role as president of the Chartered Society of Physiotherapy. Will the Government undertake to work with the physios and Public Health England to look at prevention? This is a public health issue because people have trip hazards in their homes, and a decrease in exercise means that people’s balance generally is not as good, and therefore they are more likely to have a fall. When people do have a fall when they are older, they are more likely to sustain a fracture. Avoiding trip hazards and increasing people’s mobility can be a very important preventive measure.
Lord Markham (Con)
The noble Baroness is correct. As well as using a physio to strengthen people’s use of their limbs, there is a strong investment case behind home improvements because of the payback from them. This is all part of the prevention agenda, and we are looking to see if we can put a package of measures together because our feeling is that prevention is the best way to go.
Care of Critically Ill Children
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Lord Markham (Con)
First, I thank my noble friend and the noble Baroness, Lady Finlay, for their work in this field. Of course I will very happily meet to talk about progress. Minister Caulfield has agreed to chair the task force itself, and we have agreed the constituent parties; we are including the Ministry of Justice, the Royal College of Paediatrics and Child Health, the Royal College of Nursing and health qualification providers, which will all take part in the task force.
Baroness Finlay of Llandaff (CB)
My Lords, I am grateful for the compliment paid; it was a privilege to be involved. I declare my interests in palliative care. Given that the number of children with life-limiting and life-threatening conditions has more than doubled in the last 20 years, particularly in the nought-to-19 age group and especially in the under-ones, do the Government recognise the importance of early involvement of multiprofessional specialist palliative care teams, which can support families to come to terms with what they have to come to terms with, help other clinicians to understand the families’ perspectives and avoid some of these disputes happening in the first place? Can the Minister tell us how many of the integrated care boards have commissioned specialist palliative care services that work between hospitals, ICUs and wards, out into the community and into hospices?
Lord Markham (Con)
The noble Baroness is correct: the number of young people with life-limiting conditions has gone up, from about 33,000 around 2001-02 to about 87,000 more recently. A lot of that is, conversely, good news in that we have more and more treatments that can keep these children alive for longer. Clearly, that requires the wraparound-type service that the noble Baroness is talking about. It is the responsibility of the ICBs to provide that; I will provide details of the progress of individual ones when we meet.
NHS Winter Update
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Lord Markham (Con)
The noble Lord is correct; London is always our most challenging place. I have found that across the board, funnily enough. He is right in terms of Covid and flu vaccinations, but it is also the case for the take-up of all sorts of different services. We see technology as a key enabler; in fact, the number of people who have booked their vaccinations and follow-up through the app has multiplied significantly. I do not have the precise figures in my head, but they really have gone up. A lot of that is through people seeing their reminder through the app as well. It is recognised that London in particular needs more targeted action—in fact, noble Lords will see an advertising campaign come out in the next couple of weeks or so. We are really trying to promote usage of the app, which is a tool for all these sorts of things as well.
Baroness Finlay of Llandaff (CB)
My Lords, I should declare that I am a registered doctor with the GMC. I live in Wales, but I do not want to get into data-hurling over Wales, but I do have a comment to make. I would like to follow up on the question from the noble Lord, Lord Allan of Hallam, about virtual wards. The Minister may be unable to tell us now, but how many of those patients were actually terminally ill; how many of the virtual wards were providing 24/7 effective cover for these patients; and what is happening across the whole country in relation to 24/7 palliative care cover? All the evidence that is emerging is that it really is grossly inadequate. Families are left unable to access the care and support they need.
Ten years ago, NICE recommended that every area in England should have a helpline so that families can phone if there is a crisis, 24/7, when they are looking after someone with palliative care needs at home; yet the Marie Curie report Mind the Gaps—I should declare that I am a vice-president of Marie Curie—which has been developed with the Cicely Saunders Institute—again, I should declare my interest there as an international adviser—has shown that only one in three areas has such a helpline available. Two-thirds of the country has nowhere for people to phone.
Is the Minister prepared to meet me and others from palliative care to mirror what is happening in Ireland now? From this February, the Irish Government will be funding 100% of hospice clinical services, because they have recognised the inadequacy of relying on voluntary sector funding. We know that good care costs less than poor care. We know that where there is good palliative care in place, with 24/7 support, the number of emergency admissions goes down, the pressure on acute beds goes down and inappropriate transfers drop. Although I am not expecting an answer today, I hope the Minister will seriously consider looking at that situation.
I shall just make a comment from Wales and point out that in Wales, paramedics are now being trained specifically in palliative care. Some consultant paramedics are now attached to palliative care teams and are able to administer palliative care drugs out of hours as required.
My other question for the Minister is on what discussions he has had with the GMC over retention. Those doctors who were temporarily registered have received notice that, as from March, for those who had retired, their temporary registration because of Covid will cease. I just wonder, with the figures we have seen come out today, whether it would be wise to negotiate with the GMC, first, for that to be deferred and, secondly, for all those doctors to be contacted and asked directly how they would like to contribute to improving some of the services. There is a lot of skill there which is currently being unused and underutilised. Again, I guess I should declare an interest because my husband is a dermatologist and has been in that position but has never been called up and would have been quite willing to go and help with clinics. Those are some of my questions for the Minister.
Lord Markham (Con)
I thank the noble Baroness for those points. Absolutely, I will need to come back on some of the detail on the virtual wards and how they are being used. One thing I will say about them, though, from my knowledge, is that the ability of people to communicate on a regular basis is one of the key advantages. On the point she makes about palliative care and the ability to have 24/7 communication, the beauty of the virtual wards is that they have that inbuilt, for want of a better word—they have that advantage. As noble Lords know, I am always eager to learn from practices all around the world, so I will very happily meet people and learn from them.
On retention, absolutely, we all know that the supply of doctors and medics is the key thing that we need, so I personally feel that we need to look at every avenue to make sure that we can maximise that supply. Again, it is something that I will inquire into as a result of that, and maybe when we have our meeting we can discuss that further.
NHS App: Medical Records
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Lord Markham (Con)
The noble Baroness is absolutely correct. While I think everybody would say that 90% digitisation is pretty good—it is not 100%, but it is pretty good—always making sure people are talking to each other is often the issue. I am sure we have all had examples of that. That is what the federated data platform helps to do, in terms of drawing it all in. For example, Chelsea and Westminster has put what was on 10 different spreadsheets and records into one place. We are getting a lot better at that, but is it perfect and seamless? No, there is still some work to be done.
Baroness Finlay of Llandaff (CB)
My Lords, given the importance of medical research, for the development of advances in knowledge and for inward investment into this country in research, what consideration is being given to ensuring that patients in different disease groups can be asked whether they would consent to being informed about clinical studies that may be relevant to their condition? This is so that pre-consent to being approached is being built into the system, because we know that one of the big delays in recruitment into clinical studies is the process of case finding and consent, particularly for less common conditions and when patients are living in more rural and remote areas.
Lord Markham (Con)
It is fair to say that we have made massive improvements. At the beginning of the year, we only had around 10% of patients with GP records available in the app but today it is 80%, which is a massive change. That allows us to do things like “Be Part of Research” which we have had hundreds of thousands of people volunteer for. We have not yet taken it to the next stage, so that you can get ahead of the curve for approvals for certain types, as the noble Baroness said, but the beauty of all this is that it gives all the opportunities for the future. As it is my last time standing up this year, I would like to finish by wishing everyone a happy Christmas.
National Health Service: 75th Anniversary
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Baroness Finlay of Llandaff (CB)
My Lords, I declare all my interests as listed in the register, including having worked throughout my life in the NHS. I congratulate the noble Lord, Lord Hunt of Kings Heath, both on securing this debate and, more so, on all the work he has done in his many years of service to the health of this nation.
Perhaps we should have called this debate “In Place of Fear”, the title of Bevans’s own short book. As Gordon Brown said:
“The astonishing fact is that Bevan’s vision has stood both the test of time and the test of change unimaginable in his day. At the centre of his vision was a National Health Service … a uniquely powerful engine of social justice”.
To know where you are going, you must know where you have come from. Bevan had seen directly how the mother in the average family suffers when there is an absence of a free health service and how financial distress excludes those with the greatest need from accessing even minimal care. Yet poverty still blights our health and care, particularly when serious illness hits and the main carer in the household is a child or young person. According to Bevan:
“The collective principle asserts that the resources of medical skill and the apparatus of healing shall be placed at the disposal of the patient, without charge, when he or she needs them; that medical treatment and care should be a communal responsibility; that they should be made available to rich and poor alike in accordance with medical need and by no other criteria”.
Seventy-five years ago, so many physically and mentally wounded were returning from war, penicillin had only just become available and, compared to today, there were relatively few interventions in medicine. The concepts of evaluating the efficacy of clinical audit and the frontiers of medical research that have revolutionised practice were just a dream for many. People now want to be cared for and know that they will get better care in research-active services.
My mother-in-law, as a young GP, gave penicillin injections to a critically ill woman with pneumonia; the response was miraculous. This recovered patient gave her a teapot as a wedding present, and we still have the “penicillin teapot” in the family today. Yet now we face huge threats of antimicrobial resistance, as these precious resources have been misused. Over-the-counter sales of antibiotics in some countries and their use in animal husbandry are threatening our survival from life-threatening infections. Drug-resistant TB is now a major threat.
Some of our failure to value adequately the importance of health to the country’s economy has resulted in too little effort being put into health promotion and public health, as others have said. Yet amazing advances have been made. The polio of my childhood has almost been consigned to history, diphtheria is rarely seen here, and other vaccines have transformed disease incidence, from measles to carcinogenic HPV, and many more. Yet we still see Dr Julian Hart’s inverse care law in play, that the availability of good medical or social care tends to vary inversely with the need of the population served.
With so much more that is treatable, and with social problems creating more avoidable disorders, we must tackle the social determinants of health if we are even to begin to tackle growing waiting lists. The NHS cannot be the final repository for all that is going wrong in society. Our collective responsibility is through care and well-being in communities, better nutrition, and through supporting people to look after their own health and to respect a health service that is not simply a demand service—it is not like online shopping.
As we push for more care in the community as people are moved out of hospital, we have to remember that the local family structure that previous generations depended on is just not there. Discharging people from hospital to loneliness does not aid recovery. Does the Minister acknowledge and value the excellent work undertaken by all those in the community, particularly district nurses and care staff, and the ever-increasing pressure on them?
We need to tackle public health more than ever, and the misinformation that blights its use and interventions. Prevention runs through everything, including preventing complications and care failures. Nye Bevan recognised that it is obviously preferable to prevent suffering than to alleviate it. We often know what to do but are just not doing it. We understand analgesics yet too few people with advanced disease are accessing the expertise they need, including in my own discipline—I declare an interest in specialist palliative care.
Our emergency departments are under such pressure that staff talk of leaving as we hit a downward spiral in access for those with greatest need. Disease does not respect the clock or the calendar. If we do not use our resources better—the greatest resource being our staff—we will never tackle increasing waits.
We live in a seven-day society so we need to make it easier for staff with children to work on different rotas, use term-time flexible hours and weekend childcare resources so that we can use our theatres with high-intensity teams, and use diagnostic scanners and so on much more efficiently. These are human resource issues. Staff at every level can care only if they feel cared for, supported in difficult decisions and valued for all they do, with meals available, on-call rooms, and private areas to have private conversations. Without the tools and the space they need to treat people and care for people, we cannot expect them to do well.
There are many apparently high-cost interventions now available that result in remarkable long-term savings. Failure to invest in these is short-termism at its worst. Investing in capital and training, as the noble Lord, Lord Hunt of Kings Heath, said, is essential. We need to rethink our health economics model to ensure that we meet need, in the short and long term. There are different ways of working. Technology can help but it is not the only answer to current issues. A healthy nation is a productive nation.
Children’s Hospices: Funding
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Baroness Finlay of Llandaff (CB)
My Lords, I declare my interest as having set up training in paediatric palliative medicine in the UK and internationally. Together for Short Lives data shows that about £15,000 per annum is spent on children and young people in the active caseload, which is probably almost 10,000 young people having care from hospices, some of them for many years. Given that there are service specifications and guidelines, can the Minister be a bit more explicit as to how those are monitored to ensure that service specifications really do meet the needs of the children and that hospice services are integrated with local paediatric services, given that such children often have multiple and complex needs?
Lord Markham (Con)
As I said, it is a responsibility for all of them, but I will happily give the noble Baroness a detailed reply so that it is very clear exactly what they are doing to make sure that happens.
Suicide Prevention Strategy
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Lord Markham (Con)
We are definitely always looking to improve, get access to better data and learn lessons from that. I will make sure that that is understood and follow up with DWP Ministers accordingly.
Baroness Finlay of Llandaff (CB)
My Lords, I declare my interests in medicine. The new suicide prevention strategy is most welcome, but do the Government recognise that the ONS data shows that the time of diagnosis and first treatment of those with severe health conditions can be a high-risk time when they feel devastated and often do not have adequate support? The way in which news is communicated and bad news is given to them alters their risk of suicide, particularly in those who have been bereaved by suicide previously. Will the Government therefore put pressure on NHS England and the GMC to ensure that communication skills are included in revalidation and appraisal processes so that patients get better support and are steered towards the new SR1 benefit, which is designed specifically for people with poor prognoses and can play a really important role in relieving financial pressures?
Lord Markham (Con)
I thank the noble Baroness for her support for the suicide prevention strategy. It tries to look at the themes behind this issue, of which working to give effective support, communication and training is absolutely key—as is making sure that that is followed up on. The other thing that I want to pull out from the report is the real feeling, in terms of the seven key themes, that suicide prevention is everyone’s business and is something that we all need to be aware of and could learn more about.
Adult Social Care (Adult Social Care Committee Report)
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Lord Polak (Con)
My Lords, it is a great honour to follow the right reverend Prelate. In the same way, it was a great honour to have been a member of the Adult Social Care Committee. I pay tribute to the noble Baroness, Lady Andrews, and the other members of the committee who took me along with them.
It was a learning experience for me, and there are one or two points that I would like to pick up. I notice that the noble Baroness, Lady Barker, is, sadly, not in her place. The thing I learned from her is something that we do not always think about: she talked a lot about the issue of ageing without children. I thank God that I have family and that we looked after my mother, who I will come on to in a minute. It is something that you do not appreciate until you hear it. The noble Baroness is a great champion for understanding that this will affect many, many people across the country. I was glad to learn that from her.
Similarly, I was very much a supporter of the suggestion, as mentioned by the noble Lord, Lord Bradley, that we ought to have a commissioner for care and support. Just as the noble Baroness, Lady Barker, is a champion for her issue, we need a champion who can help my noble friend the Minister and other members of the Government to focus on this. Otherwise, it gets trodden down and nobody really takes responsibility; it is too big and, in the end, nothing really happens.
I made a plea last time I spoke on this subject and I make no apologies for repeating it. Looking around the House, I say to everybody: the one thing I learned is that it is important to take politics out of social care. Let us get politics out of it and let us try to help.
In the end, for me, it was an experience that suddenly became practical. During the time that we were sitting as a committee, my mother took ill in Liverpool; she sadly passed a few months ago. What is overridingly important is to have something that we missed—we did not understand what to do as a family; I have just made a note to call it a “guide for the ignorant”. We need a guide so that, when people find themselves in a situation like this, they know what to do, who to ring, where to go, who to ask. Currently, it is a lottery.
As it happens, I am from Liverpool and the organisation there was pretty impressive. There was a STARS scheme, which the Marie Curie centre had put on, and they came in to see my mum four times a day while she needed help. Without that, I do not know what we would have done. I live here, my sister lives in London and my mum was in a flat in Liverpool.
The experiences we had throughout were horrendous. As I have said once before here in the House, we experienced the best and the worst. The worst was when a nurse was assessing my mum—who could not speak any more—to see what the next stage of care would be. The nurse was in Maidenhead, or somewhere in Kent, and she was in Liverpool, unable to speak, and they did it on Zoom. It was a relic of Covid, of course, but it was no help to my mum at all. It took weeks before they had to pass on their report, from Margate, to a panel of three people who had never met my mother, to decide what sort of care she would get. It is mad. I repeat: we need a guide for the ignorant. The Government need to provide something like this so that people know where to go.
To conclude that story, the Marie Curie hospice in Liverpool was amazing; the people there were amazing. They cared for my mum for three and half months, which is pretty unusual in a hospice. They could not have been nicer. I remember after she passed, I thanked them for everything they had done and then I said, “But where is the gold watch? She has been in a hospice for three and half months”. They were amazing and I shout out to them.
In conclusion, it was a deep honour to have been a member of the committee chaired by the noble Baroness, Lady Andrews, and I learned so much. Following the point made by the noble Baroness, Lady Fraser, I ask the Minister to explain the role of data and patient records, and how we can use technology to support people to stay in their homes as long as possible.
Baroness Finlay of Llandaff (CB)
My Lords, I apologise to the noble Lord, Lord Davies, that in my keenness to follow the noble Lord, Lord Polak, I jumped up too early. I was very glad to hear about the experience of the noble Lord, Lord Polak, with Marie Curie. I must declare that I am a vice-president of Marie Curie; I should also declare my co-chairing of the Bevan Commission, an independent think tank on health and social care in Wales, and my experiences in palliative care.
The noble Baroness, Lady Andrews, is to be commended for a gloriously inspiring report on adult social care which spotlights how much could be achieved by co-production with those in receipt of services and those on whom they depend. The government response has pointed out that additional funding of “up to £2.8 billion” is available in 2023-24 and “up to £4.7 billion” in 2024-25. Can the Minister explain how this funding will be distributed, whether it is ring-fenced for local authorities and how it will be allocated? Palliative care patients often need both social care and specialist palliative care involving the voluntary sector. Will they be able to draw on this funding for their integrated services, which we have already heard about this evening from the noble Lord, Lord Polak?
“We all want to live in the place we call home with the people and things we love, in the communities where we look out for one another, doing what matters to us”.
This definition, as in the report from #SocialCareFuture, explains how social care is not only about services; it is about having a life. For those with progressive disease, this desire to live to the full becomes pressing and urgent. Palliative care works to restore quality of life and a sense of personal worth. This core aim should be the same across the whole of social care: to add life to years, rather than focusing only on years to life. To achieve it, the workforce must be empowered to use their initiative to meet need and with time enough to go at the pace of the person.
Today, I was fortunate enough to meet a group of mothers who have children and young adults with multiple complex conditions. They were stressing the financial problem: they are unpaid carers who are getting burned out, and there is a huge lost opportunity. They realise that their children must be somehow prepared for independence because, as they get older and die, their children are likely to outlive them. However, the current system does not encourage that. It is simply about providing a response to the most pressing needs, rather than taking a long-term preventive approach, particularly when these young people are still able to develop.
The report highlights the ageist and disability-phobic attitudes that impede the ability of those with disability and who are older to function to their maximal ability in society. Such attitudes exist widely, sadly, including in health. Will the Government work with the voluntary sector to change attitudes and ensure that people are free to state what they need? The question “What matters to you?”, followed by sensitive listening, can guide the provision of services that empower, rather than a menu of services just given to people.
As the noble Lord, Lord Davies of Brixton, pointed out, we cannot expect the social care workforce to achieve the level of personalised care needed unless there is parity of esteem for them and without attention to their own welfare. Many have a wealth of valuable experience: the NHS could co-produce education and training with the social care workforce and with those with experience of receiving care. That would break down some barriers and improve integration.
In their response, the Government refer to the grant funding to Think Local Act Personal. Can the Minister tell us how that is being evaluated to ensure that holistic approaches reach the people on the receiving end of social care? Staff with skills need to be paid at an appropriate banding, with their managers also carrying a caseload so that they understand what is going on. Perhaps colleagues in health and management will then recognise the important job being done.
One thing I want to touch on in my closing moments is timely equipment. It can be essential to maintaining independence and decreasing the calls on hands-on care. What do the Government plan to do to decrease waste by recycling equipment such as mobility aids and so on? If equipment is not being recycled, could it then be sent to countries abroad as part of our aid programme? How much is wasted simply because things are not being used again and recycled in a timely manner?
Countess of Chester Hospital Inquiry
Baroness Finlay of Llandaff Excerpts(2 years, 6 months ago)
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Baroness Finlay of Llandaff (CB)
My Lords, I declare that I am registered with the General Medical Council. I am a doctor and I have been involved in providing some support to the Nuffield review into disagreements in care of critically ill children, which is about to report. As the noble Baroness, Lady Merron, pointed out, this is unbearably and unbelievably terrible. I watched the whole story unfold almost with a sense of disbelief, except the awful thing is that one can believe it happened as it did, with the suppression of the whistleblowers.
That is what I want to pick up from the point made by the noble Lord, Lord Allan: we do not have a senior doctor on every board. The training of a doctor is different from the training of a nurse, a manager or an HR manager. That understanding of statistics is different. When a doctor tries to raise a concern but hits a brick wall, they need to be able to go directly to another doctor on the board to explore what they want to raise and because that other doctor is also subject to the GMC’s requirements. I quote from the GMC’s duties of a doctor:
“You must take prompt action if you think patient safety, dignity or comfort is being compromised”—
“must” being the key word. It was easier for staff to raise issues in the days when there was a senior doctor on the board. It did not always work, but I hope the Government will look at that as an action that could be taken much more rapidly. The GMC also says that doctors must contribute to adverse event recognition.
Again, as has been pointed out, these things have happened before: we had the Robert Francis report into Mid Staffs and the Bristol inquiry into heart surgery. Those people who have been whistleblowers have been traumatised, but nobody has been as completely destroyed as the parents when they know that their child has been killed. Child bereavement is overwhelmingly terrible, but when you know that it was from the action of another person it is even more impossible to come to terms with it.
I hope the Government really will look at whether some urgent intermediate action can be taken, and whether they can have discussions with the GMC so that doctors who are reported to the GMC as being difficult because they are raising concerns are not treated with some of the problems that have arisen, where we have seen doctor suicides and so on when they have been inappropriately referred. I hope the Government will seriously consider whether there needs to be a senior doctor on every board, both in hospital and a provision in the community. Even the appraisal systems that are in place do not seem to be working adequately to protect whistleblowers.
Lord Markham (Con)
I thank the noble Baroness for bringing her knowledge and skills to this. Bringing senior doctors very much goes along with the sentiment that we were all trying to express about equipping boards in the right way to be the first line of defence in bringing such things up. I know that many boards have doctors on them, but the noble Baroness raised a very good point; it is something that we should take back. From my point of view, I absolutely see the sense in making sure we do that.