NHS: Neurology Care

Lord Markham Excerpts

Monday 26th February 2024 Lords Chamber

[Lord Londesborough]

To ask His Majesty’s Government what assessment they have made of the NHS’s resourcing and capacity to provide specialist care, in line with that provided to cancer and cardiac patients, for those living with neurological conditions.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

My Lords, integrated care boards are responsible for commissioning most services for people with neurological conditions. NHS England has established the neuroscience transformation programme, a multi-year clinically led programme aimed at improving specialised adult neuroscience services in England. The programme has developed a new model of integrated care for neuroscience services to support ICBs to deliver the right service at the right time for all neurology patients, including providing care closer to home. A toolkit is being developed to support ICBs to understand and implement this new model.

[Lord Londesborough (CB)]

My Lords, there are 11 million people in the UK living with neurological conditions—the cause of more deaths than cancer and heart disease combined and the greatest cause of lifetime disability. The NHS is clearly not set up to provide the specialist care needed. France and Germany have more than four full-time consultant neurologists per 100,000 people; here, it is just over one. Across the UK, there are no full neuro units to be found in the majority of our counties. The consequential wastage of healthcare resource by non-specialist care, plus the social and economic burdens, is put at £96 billion by the Economist in a findings report released today. Can the Minister tell us: what are the plans to address this critical imbalance?

[Lord Markham (Con)]

I thank the noble Lord. I had the opportunity to join the Neurology Alliance forum today, which was quite timely. I think its approach is entirely right in looking at what we can do to help people get on with an active life and back into the workforce, understanding that the economic impact of that is key. We have set up the neuroscience transformation programme, which the Neurology Alliance is on board with, which we think will tackle many of the issues that the noble Lord mentions.

[Baroness Fraser of Craigmaddie (Con)]

My Lords, I declare an interest as chair of the Scottish Government’s advisory committee on neurological conditions and as chief executive of Cerebral Palsy Scotland. People with neurological conditions are faced with navigating a very complicated maze of services straddling primary care, secondary care and social care. Some conditions have well-defined pathways; many other conditions, such as cerebral palsy, do not. If the Government are not going to look at an overall neurological strategy such as the one that we have in Scotland, what practical steps will they take to help people with neurological conditions navigate these confusing services, so that they get the right support at the right time?

[Lord Markham (Con)]

My noble friend is correct. The important step towards this was our appointment of the first national clinical director of neurology over the last year. The task force put out a progressive neurological conditions toolkit which sets out the pathways exactly as my noble friend mentions. It shows the treatments for over 600 conditions. This is a complex area so it is vital that the pathways are understood in each area and patients can understand how to navigate them.

[Lord Allan of Hallam (LD)]

My Lords, the Government have created a new occupational health task force, which is welcome, but it will not help somebody to stay in their job or get back to work if they face a wait of many months to see a neurologist because that is what their condition requires. Can the Minister confirm that he will be working with his colleagues in DWP to ensure that the neurology capacity is there to see referrals from occupational health services more quickly?

[Lord Markham (Con)]

Yes, absolutely. Of course, this is what the CDCs are about as well in trying to get that diagnosis capacity. At the Neurological Alliance forum I was just at, the main thing was needing help with early diagnosis, because getting treatment is key to it all and, also, seeing whether we can sometimes refer people directly to the CDCs so that the GP is not always the bottleneck.

[Baroness Merron (Lab)]

My Lords, as Lord Cormack was a fellow of Lincoln, as I am, I pay tribute today to his considerable contribution to the City of Lincoln, as well as to this House and to the other place. May his memory be for a blessing.

The Neurological Alliance has expressed concern about the lack of clarity over whether new therapies for those affected by neurological conditions and their changing needs have been factored into the workforce plan. Can the Minister set out how the workforce plan will respond to these changing circumstances both for those with neurological conditions and those with other conditions?

[Lord Markham (Con)]

I echo the noble Baroness’s comments regarding Lord Cormack.

In terms of the long-term workforce plan, I was talking this morning to the national clinical lead in this area and to Professor Steve Powis. The next stage in terms of the detail is looking at the individual specialties and neuroscience experts are part of that. In the last five years, we have seen an increase of about 20% or so in this space but understanding that need going forward is the next stage in the long-term workforce plan.

[Baroness Blackwood of North Oxford (Con)]

My Lords, I echo the comments about Lord Cormack—we are all going to miss him dreadfully in this Chamber.

There are about 600,000 people in the UK living with epilepsy. An epileptic seizure can cause significant disability and, in the worst instances, death. Only half of those living with epilepsy are seizure free, but this could rise to 70% if all those with epilepsy were targeted to the right treatments. Can the Minister say what plans the department has to improve epileptic treatment in the UK with improved specialist care?

[Lord Markham (Con)]

I thank my noble friend, and I proudly wear the Epilepsy Action badge from the meeting I was just at. As my noble friend says, it is all about trying to get that early diagnosis. If you can get that and help people get the right treatments, that is exactly the right direction of travel because it can make a huge difference to outcomes. The progressive neurological condition toolkit I mentioned earlier sets out that pathway and the model of integrated care for all the ICBs, which they will all then be held to account on to make sure patients with all these conditions—and there are 600 of them including epilepsy—are getting the right treatment in their neighbourhood.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare my interests in palliative care. Do the Government recognise that many of the patients with neurological disease are living with palliative care symptoms such as pain, breathlessness, worry and fatigue, which could be managed in the community with good integration between palliative care services and neurological services? Therefore, have the Government given specific commissioning guidance to integrated care boards to ensure that they look to see how the integration is developing in their own areas to enable these patients to improve their quality of life and their ability to live actively for as long as possible?

[Lord Markham (Con)]

Yes, that is precisely what I was referring to: the progressive neurological condition toolkit is all about the pathways for that integrated approach to it all. Again, there are 15 million people affected—I think this statistic was mentioned earlier—and one in five deaths come from related conditions, so making sure we have that integration with palliative care as well as the other services is key.

[Baroness Barker (LD)]

My Lords, neurological conditions require diagnosis by a specialist. Thereafter, the individuals need the input of people from all the different disciplines of the NHS. At the moment, the expectation to manage that falls upon GPs, and they cannot manage it. The key people who can are specialist nurses, and we have a severe deficit of specialist nurses for several neurological conditions. Can the Minister say how that deficit is to be addressed by the workforce plan?

[Lord Markham (Con)]

I thank the noble Baroness. Yes, the point about epilepsy nurses was made very clear to me just half an hour ago, and I quizzed both the national clinical director of neurology and Professor Stephen Powis on that subject this morning. I was assured that the next stage of the long-term workforce plan goes into that level of detail. I have made a commitment to the House to share some of that data, so we can make sure that it really is covered properly.

[Lord Patel (CB)]

My Lords, as human beings we are one biological system. A disease in one system often impacts another: for instance, chronic cardiac failure often results in cognitive dysfunction and people with neurological conditions often have associated cancers. While this Question is about funding for neurological diseases—and in the last two weeks, we have had Questions about funding for cardiovascular disease, cancers and others—what the whole thing shows is that we have one system failure in the health service. The only way that might be addressed is to get some out-of-the-box thinking. Does the Minister agree?

[Lord Markham (Con)]

I hope the noble Lord knows me well enough to know that I am always up for some out-of-the-box thinking. We are putting a lot of resources into this space. When we talk about dementia, which is captured in this, the commitment I gave last week was to bring in the expert panel, so that we can start to really understand this because early diagnosis is absolutely key. There is some out-of-the-box thinking there. Again, just now I was caught by the spinal muscular atrophy people; they were saying that if we could add that to the baby pinprick test, for instance, we could make sure that babies never suffer those symptoms later in their life, in many cases. I am absolutely up for that out-of-the-box thinking.

NHS: Dementia Commission Report

Lord Markham Excerpts

Thursday 22nd February 2024 Lords Chamber

[Baroness Wheeler]

To ask His Majesty’s Government what actions they are taking in response to the NHS Innovation and Life Sciences Commission’s Dementia Commission: 2023 Report.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con) (Con)]

We welcome the Dementia Commission: 2023 Report and are taking steps to address each of the recommendations. The Government remain committed to improving dementia diagnosis rates and providing high-quality care and support following a diagnosis. The Government have committed to double funding for dementia research to £160 million per year by the end of 2024-25. We welcome all research that will help us to improve how we diagnose and care for people with living with dementia.

[Baroness Wheeler (Lab)]

My Lords, the commission’s wide-ranging and comprehensive report is very welcome, but it heavily reinforces the urgent need for radical change in the way we diagnose, treat and care for dementia patients and support their families and carers. To ensure timely, speeded-up diagnosis, the training of primary care practitioners in dementia-specific symptoms and diagnostic methods is crucial. What steps are the Government taking to strengthen general practice and community pharmacy in this regard so that individuals with dementia can receive appropriate care and support as early as possible?

[Lord Markham]

I thank the noble Baroness for this Question. As ever, I have found that one of the real strengths of being in this position is that the questioning here makes me explore an area. This has been another area which I have enjoyed and found fascinating. Early detection is absolutely key, and what I have been learning from that is that, yes, we need to arm primary care staff and a potentially vital front line in terms of primary care staff are opticians, because retinal scans are a really good way to early diagnose. Apparently, people more than ever will have a frequent eye check. I have pulled together a panel to understand this more, and I invite the noble Baroness and others so that we can look at the latest research and really understand this more.

[Baroness Manzoor (Con)]

My Lords, I welcome the additional sums of money that the Government are putting into this service, which is very important, but, as the Minister will be aware, and as he indicated in his response to the noble Baroness, Lady Wheeler, around 36% of those with this condition are undiagnosed, and that rises to around 50% in some authorities. The Minister will be aware that some exciting new drugs are coming on to the market that help to delay the onset of this terrible condition. What are the Government doing to raise awareness so that there is early diagnosis and those with the condition can access those services much sooner?

[Lord Markham (Con)]

My Lords, I thank my noble friend, who is absolutely right. This is where things such as the Barbara Windsor Dementia Mission have been successful in raising awareness, as she states. The challenge in all this, as I have learned, is that because it is such a slow-moving disease it is difficult to see how it progresses. Apparently, it has one of the lowest failure rates in terms of drugs because it is really hard to monitor the progress behind it. That is why work is being done, such as retina scans, where you can measure data objectively. There is real hope in all this, and it means that we need to make all primary care workers aware of the situation.

[Lord Allan of Hallam (LD)]

My Lords, the commission recommends the creation of dynamic care records for dementia patients and their carers. We know from experience that information projects such as this work best when they have a clear owner who wakes up every morning worrying about delivering them. Who in the NHS owns the delivery of dynamic care records for dementia patients? If that person turns out not to exist when he goes to look for them, would he consider appointing someone?

[Lord Markham (Con)]

Yes, that is a very good point. For me, as I have looked into this, the reason for assembling the panel that we can all interrogate is that we have the value of different noble Lords in this House who can add those points to it. What the noble Lord said sounds sensible. The honest answer is that I do not know whether there is such a person today, but let us use this as an opportunity to find out, because I think there should be.

[Lord Patel (CB)]

My Lords, there are several important points in development that should allow us to better manage people with dementia. The first is early diagnosis, as has been mentioned, but we need greater input into research in developing biomarkers that detect early development of the disease. Having done so, we then need drugs that will be effective in early phases of the disease—so-called disease-modifying treatments. Some of those have recently been given accelerated approval in the United States and Japan, but they are very expensive drugs. As we discussed last week, one of the drugs for small-cell lung cancer failed at the final endpoint, so we have to be guarded. For instance, the drug lecanemab, which has been approved, would use up half the pharmaceutical costs of all the 27 countries of Europe. These two things are important, and I hope that the forum that is developing will address those issues of research.

[Lord Markham (Con)]

As ever, my colleague the noble Lord is correct. The blood biomarkers are central to this. We have set up the NIHR biomarker challenge to try to understand those, and my understanding is that a Swedish blood test is quite promising. NICE is bound to approve the two early-stage drugs that the noble Lord mentioned over the summer, in July and September, but then we need to look at scale-up issues. Often, we are talking about having to deliver them through drips, which means a whole workforce scale-up. So there are a lot of issues around this that the noble Lord rightly brings up, and I hope the panel can discuss them further.

[Lord Kamall (Con)]

My Lords, I would like to ask the Minister about the role of music therapy in helping dementia patients. It is well known that when someone listens to music, sometimes it takes them back to a place and time immediately. There has been research on the role of music therapy. I quickly skim-read the report but did not see music therapy mentioned in any way or in detail. If I am wrong, perhaps the Minister can correct me, but could he also tell me about the role that music therapy can play?

[Lord Markham (Con)]

My noble friend is correct; I did not see reference in my noble friend Lord O’Shaughnessy’s report to music therapy either. I am familiar with some of the principles behind it. My personal experience myself with the elderly dementia patient that I cared for was that bringing my five year-old son along took them out of their position and made them care for that child and forget about their own situation. Those sorts of therapies—and music is similar—have a vital role that we will look into further as part of this plan.

[Lord Scriven (LD)]

My Lords, the Alzheimer’s Society has a good report out called Dementia: What Every Commissioner Needs to Know, about Alzheimer’s care. What is the Government’s view on ensuring that ICBs across the country have a minimum standard of commissioning levels for people with dementia?

[Lord Markham (Con)]

We have set out a dementia good care planning guide to exactly those commissioners because, as ever, we need uniformity in these areas. Part of the strength of ICBs is that they have freedom to deliver local services, but we have to make sure that they are always achieving at least the minimum levels that the noble Lord referred to. That is what the guidelines are about, and we are setting monitoring against that to make sure that they are delivering on it.

[Baroness Watkins of Tavistock (CB)]

My Lords, I have two questions. First, I understand that NICE will review rather than approve the drugs in question. Secondly, it appears that they extend life but that the end of life is still very similar, so what do the Government intend to do to ensure that carers have sufficient respite and that there is a standard ratio of Admiral nurses to support families, certainly for the next decade until science gives us the answer?

[Lord Markham (Con)]

The noble Baroness is correct that the science is unfortunately not there yet. That is why we are investing £160 million a year in research, because more needs to be done. In the meantime, and I suspect for ever, we will need to make sure that support networks are around this space, and the voluntary care sector, for want of a better phrase, is a vital part of that. We are making moves towards it; we are giving respite care and making some payments. I freely admit that there is more we could be doing in this space, but we have done quite a bit as well.

[Baroness Seccombe (Con)]

My Lords, my husband, having had two strokes, was part of a project called OPTIMA, so he left his brain to that project. When the report was sent to me, OPTIMA assured me that my husband had had vascular dementia, not Alzheimer’s.

[Lord Markham (Con)]

Again, everything that can add to our knowledge has to be a good thing.

[Baroness Altmann (Con)]

My Lords, with an ageing population it is inevitable that this illness is going to increase in prevalence across the population. Do the Government have any intention of building into their strategy for caring for dementia the support, perhaps in the workplace, that might be needed, particularly for older women, who tend to be predominantly carers, maybe via insurance in the workplace for respite and for carer’s leave, in order to ensure that this is not such a strain on both the families and the public purse?

[Lord Markham (Con)]

There is recognition in all these things that the workplace has a role here. I have looked at treatments and outcomes in the G7 countries, and Japan is often a good example of having care in the workplace, as my noble friend is aware. As so often, it is about making people realise that this is everyone’s problem to deal with. I will do more work to understand what we are doing to arm employers for that, and I will come back to my noble friend.

NHS Dentistry

Lord Markham Excerpts

Monday 19th February 2024 Lords Chamber

[Lord Young of Cookham]

To ask His Majesty’s Government what assessment they have made of the availability of NHS dentistry.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

My Lords, since the pandemic this Government have taken decisive action to recover services. There are signs of recovery, with the amount of activity delivered and the number of patients seen increasing, but there is more to do. Our recently published plan to recover and reform NHS dentistry will make dental services faster, simpler and fairer for patients and will fund around 2.5 million additional appointments and more than 1.5 million additional courses of dental treatment.

[Lord Young of Cookham (Con)]

My Lords, I welcome the recent Statement but, with 80% of NHS dentists not accepting new patients and with 190 hospital operations every day removing rotten teeth from children, clearly a fresh initiative was needed. However, the dysfunctional, discredited 2006 dental contract, which is driving NHS dentists out of the business, and which was described by the Select Committee in another place as not fit for purpose, remains in place. When will it be reformed? Given that everyone has a right to register with a GP and if they cannot find one the ICB has to find one, why is there not an equivalent right to register with a dentist if dentistry is an integral part of the NHS?

[Lord Markham (Con)]

I thank my noble friend for raising this and declare my interest as my wife is a dentist, although she is not currently practising. It is accepted that we have made sensible improvements to the dental contract, but a fundamental longer-term overhaul is needed. In terms of the ability to get registered with a dentist, that is what the mobile trucks are all about. We realise that in certain areas it is difficult to get that registration. The idea is for mobile trucks to go into a neighbourhood where there is a particular shortage to resolve the problem.

[Lord Birt (CB)]

My Lords, while working at No. 10 in the early noughties, I was involved in a strategic review of the NHS and was shocked, at the time, to discover how poor the long-term workforce capacity planning was. The total number of dentists currently working in NHS England—around 25,000—has not changed by more than tens or hundreds over the last five years. In that period, more dentists have left than joined. At the same time, fewer than 1,000 dental students have been enrolled each year. Precisely how many dentists do we need to bring NHS capacity in line with demand? In what year, again precisely, will that point be reached?

[Lord Markham (Con)]

The noble Lord is correct in talking about the supply challenges. That is what the long-term workforce plan is all about, and why we are committing to a 40% increase in training places by 2030. The other issue that he rightly raises is the balance between the cost-effectiveness of providing private versus national health dentistry. The problem is that it is often seen as more lucrative for a dentist to go down the private sector route. That is why we are trying to rebalance that and have introduced an increase in the minimum charge to £28 for a unit of dental activity, and £50 for a new patient, to try to bring services back more in favour of the NHS.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I declare my interests as president of the British Fluoridation Society. The Academy of Medical Sciences reported very recently that nearly a quarter of five year-olds have tooth decay. Unless we deal with this there will be many more queues and great difficulties with access. The Minister will know that shortly there will be a consultation in the north-east to introduce fluoride. Surely the current situation demands that we extend this throughout the country.

[Lord Markham (Con)]

Yes, the noble Lord is correct that there is very good evidence of the effectiveness of water fluoridation, and the report as recently as 2022 showed there are no side-effects. The north-east will increase the number of recipients by about 1.6 million people, and there is a process that that needs to go through but I totally agree that we should expand it as far as we can.

[Lord Allan of Hallam (LD)]

My Lords, further to the question asked by the noble Lord, Lord Birt, I point out that we have very good data on the number of dentists engaged in NHS activity. It shows a pattern of falling numbers—down to 24,151 in the last financial year. Does the Minister agree that it is fair for us to judge the success or failure of the Government’s new plan on whether that number increases? Does he have a target for where the Government intend it to reach?

[Lord Markham (Con)]

The absolute measure that everyone cares about is output—the number of treatments—and this plan is all about increasing the number of appointments by 2.5 million. In the last year alone, we increased the number of treatments from 26 million to 33 million. There is more to do, granted, but the real measure of success is how many treatments we get done, which is a function not just of the number of dentists but of their productivity, and of the number of them we can persuade to provide NHS rather than private sector services.

[Lord Lansley (Con)]

Can the Minister confirm that it is nearly 13 years since the then Secretary of State, and his noble friend Lord Howe, initiated negotiations for a new dental contract? We still need that contract, because it would shift towards paying dentists for outcomes for their patients rather than for units of dental activity. It is when we have a shortage of dentists that we need to shift to outcomes and preventive work, to improve the balance of work that dentists must do and reduce demands on the total dental workforce.

[Lord Markham (Con)]

Yes, it is all about outcomes and output. As I mentioned, there have been sensible moves recently in terms of the contract—the £50 for new patients; increasing minimum levels; and ensuring that dentists get more payment for doing, for example, three fillings versus one. I also agree that some fundamental work needs to be done in this space.

[Baroness Merron (Lab)]

My Lords, the Minister has previously suggested that the 15 mobile dental vans would be able to address emergency situations as well as scheduled appointments. How will this work in practice, particularly in view of the size of the areas each van will cover? How will the Government meet the immediate need for thousands more appointments for emergency dental treatment?

[Lord Markham (Con)]

There will be a schedule of when the mobile vehicles will visit each area, with the ability to pre-book so, if someone calls up with an issue, they will know that a truck will come to their area in a week or two’s time. That is the idea, or people can queue to receive those services as well. I hope this will be successful. It has worked quite well in some areas already. The case will prove itself and the 14 will be just the start. We can do much more from that, because we all agree that we need to expand supply.

[Baroness Finlay of Llandaff (CB)]

Given that over 8,800 new oral cancers were diagnosed last year, and a fifth of those were in people under the age of 65, do the Government recognise that it is a false economy not to increase dentistry provision, dental hygienist screening for oral cancers and advice on prevention, such as by cutting down on smoking and so on? The cost of treating this, and of early morbidity to the country, is huge.

[Lord Markham (Con)]

Yes, absolutely. That goes back to my noble friend’s point about outcomes. I know that a lot of places, if they are fortunate enough to have an NHS dentist, give you check-ups every six months as a matter of course. In fact, NICE says that if you are in good oral health you will need that only every 24 months, with the idea being that you can create more space for other people to come in, because prevention and screening are vital in all this as well.

[Baroness Jolly (LD)]

My Lords, I live in Cornwall, where there are now very few NHS dentists and many people are resorting to do-it-yourself. What plan does the Department of Health have to ensure that all in Cornwall have access to a dentist as and when needed? A kit is available from the high street for less than £10, but this does not buy any expertise or guarantee of success.

[Lord Markham (Con)]

The noble Baroness is quite correct. Cornwall is one of the areas where we piloted the mobile services. It is probably not the number one area, but it is fair to say that it is one of the main areas where we are putting in more resources for precisely that reason.

[Baroness Bennett of Manor Castle (GP)]

My Lords, I shall switch sides of the country. The campaign group Toothless in England was founded in Suffolk and is calling for contracts for NHS dentists to cover the real costs. It says that this is the only way to solve the drought of dentists in places such as Waveney Valley, where one in three people has been unable to secure an appointment over two years.

[Lord Markham (Con)]

These plans were welcomed by Toothless in England, which was good to see, as well as by Healthwatch. I know personally that making it economic for dentists to work in the NHS rather than in the private sector, or getting that balance right, is fundamental. The changes are a good first step towards that but more probably needs to be done.

NHS Dentistry: Recovery and Reform

Lord Markham Excerpts

Wednesday 7th February 2024 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

My Lords, I start by declaring my interest that my wife, who is present today, is a dentist—although she is not currently practising. With the leave of the House, I shall now repeat a Statement made in another place by my right honourable friend the Secretary of State for Health and Social Care. The Statement is as follows:

“With your permission, Mr Speaker, I would like to make a Statement on our plan to recover and reform NHS dentistry. First, on behalf of the entire House and my department, I send our very best wishes to His Majesty the King. His decision to share his diagnosis will be welcomed by anyone whose life has been touched by cancer. I know that we are all very much looking forward to seeing him make a speedy recovery and resume his public duties.

Turning now to dentistry, thanks to a once-in-a-generation pandemic between 2020 and 2022, 7 million patients across England did not come forward for appointments with NHS dentists. Since then, we have taken decisive action to recover services. We have made reforms to the dental contract, so that practices are paid more fairly for caring for NHS patients with more complex needs. We have made sure that dentists update the NHS website regularly so that the public know that they are taking on new patients. This has delivered results, with 1 million more people seeing an NHS dentist last year than in the year before. However, we know that too many, particularly those living in rural or coastal communities, are still struggling to find appointments. This recovery plan will put that right by making NHS dental care faster, simpler and fairer for patients and staff. It is built on three key pillars, which I will address in turn.

First, we will help anyone who needs to see an NHS dentist to do so, wherever they live and whatever their background. To do this, we must incentivise dentists across the country to care for more NHS patients. That is why I am delighted to tell the House that for the coming year, we are offering dentists two new payments on top of their usual payments for care— £15 for every check-up they perform on NHS patients who have not been seen over the past two years, and £50 for every new NHS patient they treat who has not been seen over the same period—because we know that patients who do not have a relationship with a dentist find it harder to get care. That is not a long-term ambition: our new patient premium will be available from next month.

We are also increasing the minimum payment that dentists receive for delivering NHS treatments. This will support practices with the lowest unit of dental activity rates, or UDA, to provide more NHS care. However, we know that in many of our rural, remote and isolated communities, dentists themselves are in short supply. That is why, starting this year, up to 240 dentists will receive golden hello payments worth up to £20,000 when they commit themselves to working in one of those areas for at least three years. These dentists will give patients the care they need faster, make dental provision fairer and tackle health inequalities.

We are also delivering dentistry to our most remote regions without delay. This year, we will deploy dental vans to more isolated, rural and coastal areas. Staffed by NHS dentists, they will offer check-ups and simple treatments such as fillings. This model has been tried and tested successfully across many regions. For example, last year in Cornwall, a mobile van visited five harbours, treating more than 100 fishermen and their families. We will be rolling out up to 15 vans across Devon, Gloucestershire, Somerset, Norfolk, Suffolk, Lincolnshire, Cambridgeshire, Dorset, Cornwall, North Yorkshire and Northamptonshire. This move has been welcomed by Healthwatch, the Nuffield Trust and the College of General Dentistry. We will let patients know when vans will be in their area, so they can get the care they need faster.

These reforms will empower NHS dentists to treat more than 1 million more people and deliver 2.5 million more appointments. As the chief executive of National Voices, a group of major health and care charities, said:

‘This extra money … should help thousands of people who have been unable to see a dentist in the last two years to get the care they need’.


These reforms are just the beginning. This recovery plan will also drive forward reforms to make NHS dentistry sustainable for our children and our grandchildren.

That brings me to the second pillar: growing and upskilling our workforce for the long term. Our long-term workforce plan, the first in NHS history, gives us strong foundations on which to build. By 2031, training places for dentists will increase by 40% and places for dental hygienists and therapists, who can perform simple tasks such as fillings, will also rise by 40%. More dentists and more dental therapists will mean more care for NHS patients.

I am delighted to tell the House today that we are going further in three key ways. First, we will consult on a tie-in to NHS work for dentistry graduates, because right now too many are choosing to deliver private work over valuable NHS care. More than 35,000 dentists in England are registered with the General Dental Council, but last year almost one-third worked exclusively in the private sector. Training those dentists is a significant investment for taxpayers, and they rightly expect it to result in the strongest possible NHS care. That is why, this spring, we will launch a consultation on a tie-in for graduate dentists and how this could deliver more NHS care and better value for taxpayers.

Secondly, we will take full advantage of our dental professionals’ skills. Today, even though they have the right training, without written direction from a dentist, dental therapists cannot do things such as administer antibiotics. This year, we will change this, making life simpler for dentists and making care faster for patients. As the president of the College of General Dentistry has said, the

‘use of the full range of skills of all team members will enable the delivery of more care and make NHS dentistry more attractive to dental professionals’.

Thirdly, we will recruit more international dentists to the NHS. We have a plan to do this by working with the General Dental Council to get more international dentists taking exams and to get them on to the register sooner, and to explore the creation of a new provisional registration status so that, under the supervision of a dentist who is already on the register, highly skilled international dentists can start treating patients sooner, rather than working as hygienists while they are waiting to join the register.

I turn now to our plan’s third pillar, which is prioritising prevention and giving children a healthy smile for life. This begins by supporting parents to give their children the best possible start. That is why family hubs up and down the country will offer parents-to-be expert advice on looking after their baby’s teeth and gums. As those babies grow up, we will support parents and nurseries in making sure that, before every child starts primary school, brushing their teeth is part of their routine.

The evidence is clear: the earlier good habits are built, the longer they will last. Seeing a dentist regularly is vital for children’s health, but, since the pandemic, too many have been unable to do that. That is why this year we are taking care directly to children. We will deploy mobile dental teams to schools in areas with a shortage of NHS dentists. They will apply a preventive fluoride varnish to more than 165,000 reception-age children’s teeth, strengthening them early and preventing decay. Our Smile for Life programme has already been endorsed by the College of General Dentistry.

Six million people in England already benefit from water fluoridation. In order to go further in protecting children’s teeth, we will consult on strengthening more of our country’s water with fluoride. Again, the evidence is clear: in some of the most deprived parts of England, enhancing fluoride levels could reduce the number of teeth that are extracted because of decay by up to 56%. That is why, through the Health and Care Act, we made it simpler to add fluoride to more of our water supply. As a first step, this year we will launch a consultation on expanding water fluoridation across the north-east—an expansion that would give 1.6 million more people access to water that strengthens their teeth, preventing tooth decay and tackling inequality.

This is our Government’s plan to recover and reform dental care: dental training places up by 40%; 2.5 million more appointments; dental vans treating more patients; more dentists in remote areas; more dentists taking on NHS patients; better support for families and better care for children; patient access up and inequity coming down. It will make life simpler and treatment faster and fairer for patients and staff. We have taken the difficult decisions, and we have now delivered a long-term plan to make dental care faster, simpler, and fairer for people across the country”.

--- Later in debate ---

[Lord Allan of Hallam (LD)]

My Lords, from these Benches, I also echo our best wishes to His Majesty the King. We hope that he makes a speedy recovery.

In responding to this Statement, I also reach for that familiar phrase of it being a sticking plaster, before heading in the direction of dental metaphors. Rather than a scale and polish, it seems to me that this is something of a temporary filling when, as the noble Baroness, Lady Merron, says, NHS dentistry needs serious root canal work.

I feel for the Minister because I know he cares about dentistry and understands the scale of the problem. He has to sell the temporary filling hard in the hope that we will trust the Government to deliver on the more comprehensive course of treatment that is in the consulting on and exploring part of the document.

There are three elements in that long-term part of the plan on which I hope the Minister can comment further today or later in writing. First, we are told that the Government will ring-fence the £3 billion of NHS dentistry budgets from 2024-25 which have been underspent because of the lack of dentists willing to work at NHS rates. We cannot see this changing overnight, even with what is announced today. How will this ring-fencing work if an integrated care board has still not been able to get the take-up of the contracts that it wants? What kinds of things could they use these underspends for? Will these include additional local financial incentives on top of the ones we are discussing at a national level today?

Secondly, it is important to realise the benefits of people with dental qualifications moving to the UK. I know that the Minister would wholeheartedly agree. The policy document promotes the idea of a provisional registration of overseas qualified dentists while they are waiting for their full GDC registration. The phrasing in the Statement and in the document is quite hesitant. It talks about the Government working towards introducing legislation. Can the Minister give us more information about the complexity of the legislative changes that will be required and their likely timescale?

Thirdly, failures in emergency care both cause severe patient distress and additional work for NHS hospitals. The noble Baroness, Lady Merron, has already pointed out that many children are referred to hospital for emergency treatment. I looked at the description on the Smile Together website—a good service in Cornwall cited in the plan. It says that:

“Smile Together is commissioned by NHS England to provide urgent and emergency dental care to patients who would otherwise be unable to access treatment. Demand for this service is very high and the criteria set by our commissioners is very strict. We therefore offer emergency appointments that are independent of our NHS service”,


and people who call in who are unable to get an NHS appointment and do not wish to wait and try again the next day can basically go private. I am not sure we want to be in a situation where people needing emergency care are left hanging on the phone day in, day out, or face having to go for the private option. I hope the Minister can explain what the Government intend to do around emergency care. I hope he will agree that making sure people can get NHS emergency care will be better for both the patient and the NHS.

A temporary filling is designed to last a few weeks—or months at most—or perhaps until an election. We are grateful for the temporary relief it provides, but we know that more work is needed, and this has to be done urgently if we are to fix NHS for the long term.

[Lord Markham (Con)]

I thank noble Lords for their comments. First, the thing that brings us together is the desire on all sides to expand capacity. That is something that we are all behind. I hope that I can bring out the themes in this regard—the plans that we are talking about are designed to do exactly that.

The noble Baroness, Lady Merron, asked how the golden hellos will work. The idea is that it will be in the 12 most needy areas, and the ICBs will have the flexibility in how they attract people there. It might be existing dentists who they want to take from another area, or it might be private sector dentists or dentists who are just graduating. It is about making sure that they have the ability to bring those people into the areas of most need.

The mobile vans have proved quite successful already in areas such as Cornwall, where they have already been. They are designed to hit exactly those areas where it is hard to seed new dental practices, because there is a dental desert there, for want of a better word. Each of those vans alone should be able to do about 10,000 appointments a year, which is quite a sizeable number. Of course, what that does is put it in the areas of most need. The beauty of it—if beauty is the right word—is that, when you are talking about emergency-type situations, you will be able to tell exactly where they are.

The other thing that is important, with regard to all the payment mechanisms and how that will work, is that the dentists working in these vans are salaried. The idea is that we know that in those instances it is absolutely going to work in terms of the incentives. While we think that the patient premium absolutely will help in terms of access, and we know that the hardest one is getting them to see patients for the first time and that is what the additional £50 is all about, by bringing in these salaried people we can absolutely guarantee that those new people will be seen in those situations.

What I note from all this is that these are very concrete plans to create 2.5 million new treatments. I noticed that the noble Baroness, Lady Merron, mentioned the Labour plan of 700,000 extra, so I shall let noble Lords draw their own conclusions as to which one is more extensive. But to try to answer the question around ring-fencing, what this is all designed to do is to make sure that the contracted number of UDAs that we want to happen is delivered. Noble Lords will have heard me say before that the problem often is that it is not delivered because the dentists then go and try to sell to the private sector instead. So this is all designed to underpin that: first, by making it more attractive for those dentists to offer it to patients, in terms of the patient premium of £50, and the increase in the UDA price; and, secondly, by supplementing that with salaried staff, so you can absolutely make sure that it is being delivered in those circumstances. That is what we are trying to do—because we know that the UDAs are there in terms of the expansion, and we did see a large expansion last year. We increased the number of treatments from 26 million to 33 million, a 23% increase—so we have managed to do it. But we are talking here about wanting to do more of it, of course.

As for whether this is a temporary filling or a long-term fix, of course the long-term workforce plan is all about a long-term fix, making sure that we have the supply in place so we can supply the NHS services needed on a long-term basis. That is where we are talking about the 40% increase, and about making it easier to bring people in from overseas, to answer the question from the noble Lord, Lord Allan. As noble Lords know, I have a personal interest. I would not have a wife—or this particular wife—if she had not managed to become a dentist from overseas. But what I saw from all of that was that it is a two-stage process. It was one thing for her to be allowed to become a private dentist. I had to fill in the forms myself, and it was pretty hard. But it was an altogether new process then to become an NHS dentist. To be honest, the conclusion after all that was, “Why would I bother to do this? If I can already be a private sector dentist, why would I jump through a load more hoops to then become an NHS dentist?” It is designed to try to iron out those differences and not act as a disincentive in those situations.

To answer the question, those mobile vans, in terms of SMILE4LIFE, are there to make sure that they get people off on the right foot. The family hubs are for training would-be mothers about looking after gums and teeth. But also, crucially, it is about using those mobile services in the areas where they are most needed, putting in the fluoride varnish for 165,000 reception-age kids—so aged from four to five. That means really starting to get the right start to life in all this.

I hope that what we are seeing here is a comprehensive set of plans, expanding supply in terms of the golden hellos, mobile vans and increasing treatments, as well as the long-term workforce plan for increasing staffing. We are making it more attractive for dentists to provide NHS dental services in terms of the patient premiums. These will all start very quickly—in March, for instance. It is also about increasing the UDAs and making sure that our children get the right start to life, in terms of SMILE4LIFE, and making sure that their teeth are clean from a very young age.

There is a lot to do—I perfectly accept that—but I believe that what we have here is taking the right steps to achieve it.

[Lord Young of Cookham (Con)]

My Lords, I felt that today’s Statement deserved a slightly warmer welcome than it has received so far, particularly from the noble Baroness. At a time of enormous pressure on public expenditure, more resources have been found to target the people in the areas who need dental treatment.

I shall raise an issue that has not been raised in exchanges so far. The single most effective public health measure that the Government could take to reduce tooth decay, particularly among children, is to add fluoride to the water supply in those parts of the country where it does not occur naturally. The Health and Care Act 2022 transferred the responsibility from local authorities to my noble friend’s department. Since then, until today, nothing has happened. I welcome the announcement that there will be consultation on extending fluoride to the areas in the north-east where tooth decay happens to be at its highest. Can my noble friend give some idea of the timescale of that consultation and whether there are any plans to extend fluoride to other parts of the country where it is urgently needed as a public health measure?

[Lord Markham (Con)]

I thank my noble friend. He is absolutely correct that the benefits of water fluoridation are well proven. The consultation for the north-east of England, which will bring in 1.6 million people to this, is starting very shortly. The idea behind that is that we can really try to get moving quite quickly on that. I was surprised to learn that the level of water fluoridation in England today is only at about 6 million people. I know that a lot of people think that their water supply has fluoridation, but there is obviously a long way to go on that. The 1.6 million in the north-east is a good extension to that, but there is a lot more that we plan to do in this space.

[Lord Harris of Haringey (Lab)]

My Lords, I declare my interests as chair of the General Dental Council. I welcome the fact that this plan has now arrived—it has been a very long time coming. Of course, the council’s role is to maintain a register of dentists and ensure that all the dentists on that list are of an appropriate standard and fit to practise in this country. I am not going to comment on the level of investment, but I make the point that increasing the number of dentists on the register does not in itself increase the number of people who practise in the NHS. I think that the British Dental Association uses an analogy about a bucket with a hole in it. The point is that, if the situation is one in which dentists, whether they qualified here or abroad, feel that the rewards that they get from being an NHS dentist are insufficient, we will continue to see that drift away from NHS dentistry.

My specific point is about the question of overseas registration. The Statement highlighted the fact that 30% of those on the register are qualified from overseas. I should say that nearly 50% of those who joined the register in 2022 are from overseas, so that gives some idea of the direction of travel. To facilitate that, the GDC has trebled the number of places for people taking their ORE part 1 examinations. On the specific proposal about provisional registration, which the General Dental Council will welcome, I hope it is recognised that, if somebody is provisionally registered, they must be supervised. This will require a structure within both the NHS and private practice to make sure that there are adequate levels of supervision available and an adequate number of dentists to do that. Can the Minister tell us how that will happen?

[Lord Markham (Con)]

I thank the noble Lord, particularly for his great knowledge and work with the GDC. I absolutely accept the basic point about the leaky bucket, for want of a better phrase; we are losing a lot of dentists to private. At the end of the day it is about the economics, and clearly we need to make sure that doing NHS work pays. In part that is what the patient premium is designed to do, as is increasing the value of UDAs to £28. There is also an acceptance that we need to look at some of the more long-term measures to make sure that it is economic to do that. The salaried staff I mentioned earlier will help with that as well.

The noble Lord is absolutely correct—again, I have some personal experience of all this—about having that mentoring scheme. Even if a dentist has been operating overseas for a number of years, learning a lot of the techniques and methods here is very beneficial. It is absolutely recognised that such mentoring is required. On the detail of how that is being planned, I will set out in my letter to everyone how exactly that will be achieved.

[Lord Hacking (Lab)]

My Lords, I have been very reassured by the Minister’s Statement and by my noble friend speaking on behalf of my party. It is very good to hear that dentistry is at last being given much greater attention at National Health Service level. I welcome the type of detail that has been brought out in this short debate; for example, bringing more fluoride into our water supplies and the elementary thing of getting a child to clean his or her teeth with proper toothpaste as a morning act before going out to school or elsewhere.

Many years ago my wife, who is a qualified consultant, was in Pakistan with a team of English doctors and surgeons to demonstrate heart surgery. I, in a kind of parliamentary capacity, was asked to make a visit to a certain place, Murree. This involved going through a number of villages in Pakistan. Of all the infirmities among the villagers, and there were a lot, the most conspicuous were infirmities of the teeth. It was a nightmare to look at.

This is some reassurance. We are absolutely right to pay proper attention to dentistry, and I most welcome the Minister’s Statement and the words of my noble friend speaking on behalf of my party.

[Lord Markham (Con)]

I thank the noble Lord for his comments. I agree that we all too often see such circumstances. As many as half the children in A&E come in for reasons of problems with their teeth. That absolutely illustrates, in a similar way to the noble Lord’s experience in Pakistan, that it really is vital to get on top of these problems. The hope, and the plan, is very much that these are the first steps in making sure that we achieve that.

[Baroness Taylor of Stevenage (Lab)]

My Lords, I take the point from the noble Lord, Lord Young, about money being found for dentistry in straitened circumstances. However, in the past 14 years, a whole generation of younger children who are now around six to 10 years old have had almost no access to dental treatment, resulting in the poor health and dental health that we heard about from my noble friend Lady Merron and the noble Lord, Lord Allan. What efforts will the Government make to ensure that the backlog of dental treatment that those children need will be assessed properly, with the appropriate treatment given as quickly as possible? Otherwise, we will have further health problems in future as those children go into their teenage years.

[Lord Markham (Con)]

On the targeting and how we are using those mobile vans, the thinking is that they will be rolled out quite quickly—in about six months or so. We are absolutely looking to target those areas with backlogs, such as where we know that the distance to an NHS dentist is further than normal, where there is low access according to GP patient surveys or where there is a low number of dentists per patients. This is exactly set up to try to make sure that we are going into those areas where there is the biggest backlog. Turning up in those locations and allowing people to queue up and receive a service on that day allows access very quickly to the people who really need it. At the same time, when they are calling up because they might need dental services, we can tell them, “A mobile van will be in your areas in two weeks; we can book you an appointment now”. That is designed to really hit those backlog areas. I suspect—this is just me speculating—that such will be the success of these that this will a model that we will look to roll out more widely in future.

[Lord Young of Norwood Green (Lab)]

My Lords—

Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023

Lord Markham Excerpts

Wednesday 7th February 2024 Lords Chamber

Moved by

[Lord Markham]

That the draft Regulations laid before the House on 14 November 2023 be approved. Considered in Grand Committee on 6 February.

Motion agreed.

Pharmacy First

Lord Markham Excerpts

Tuesday 6th February 2024 Lords Chamber

[Lord Allan of Hallam (LD)]

My Lords, the holy grail for health policy is a change which improves the service for patients at the same time as reducing the cost of delivering that service. I think we can all see the potential for Pharmacy First to be such a move, if executed well. I have a few questions for the Minister and his answers will help us to understand whether he is on the right path in this grail quest.

First, I understand that there will be a payment per consultation, if the consultation meets criteria that the Government have set, but that there will be a cap on the total budget. Can the Minister explain how this cap will work? Is it per pharmacy or per integrated care board, and what happens if it is exceeded? I do not think that we want people going back to more costly channels simply because of an accounting feature. Secondly, can he explain how the Government will assess value for money in comparing the cost of the Pharmacy First consultations with the estimated savings on the GP and A&E side?

Thirdly, while we are discussing urgent care today, can the Minister also say whether the Government are looking at using pharmacies for approving repeat prescriptions—this was raised by the noble Baroness, Lady Merron—for drugs such as statins that people may be on for many years? The current protocol requires them to go back to their GP for regular reviews. Are there any plans afoot to move some of that medicine review process for long-term conditions also into the Pharmacy First programme?

Can the Minister also explain how instructions will be given to NHS 111 services so that they can properly direct people, in light of Pharmacy First now being an available option? It could make a real difference to the pressure on A&E services if 111 moved appropriate cases over to pharmacies. There are concerns that 111 has a natural tendency to be risk averse and refer people to A&E. If we are going to ask it to refer people now to pharmacies, we need to understand how that shift in direction will take place.

Finally, I have a digital question. It is not the one about the joined-up records that we discussed earlier at Oral Questions, as I am confident that the Minister will tell us that the Government are on track for that. What I want to raise is, even when the pharmacy has issued a prescription and dispensed it, at present what happens is that it will then print it off and post it to the NHS Business Services Authority for payment. This happens with all the prescriptions in the pharmacy system at present. My understanding is that the business services authority will then scan them into its system to make the payments—which seems quite farcical in 2024. So I would be interested to hear from the Minister what plans the Government have to get rid of that piece of the equation or to make it more efficient, so that, when a prescribing process happens electronically, it happens all the way through, to the point at which the pharmacy is reimbursed for the work that it has done.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

I thank both noble Lords for their general welcome of what we are trying to do here. My thoughts on this are that anything that we can do to expand supply should be a good thing in this context.

I will pick up on specific questions. As mentioned, we have not managed to achieve 6,000 additional GPs. To specifically answer the question, we have achieved about 2,799. However, through the use of additional staff, we have managed to achieve 50 million additional appointments in GP settings since 2019, so we actually hit our target on that earlier. I think that demonstrates—this goes back to the Question we had earlier today—that we are trying to use people to the top of their professional skills and supplement that with other skilled people coming in. In terms of output, 50 million appointments are a good example.

We are hoping that this will be a boost to community pharmacies. They are, as I mentioned earlier today, seen as a very important asset. They are often the first line in terms of health in the local community. This is intended to not only enhance the health service in an area but give community pharmacies a necessary boost. I think these figures have been reported, but for the sake of completeness I will say that we have had about 10,000 pharmacies sign up—about 95% of them—so clearly it has been welcomed. In the first three days we have had about 3,000 consultations. In answer to the question about pharmacies being overwhelmed, the early indications are that it has been managed well. You could say that the more business they get is a good thing in terms of their viability. Right now, we feel that it is so far, so good.

On privacy—I will try to group the app and IT questions together a bit later—part of the conditions for being available for Pharmacy First is that a pharmacy has a private treatment area available, so that there will not be privacy issues.

My understanding—I will definitely need to write on this—in terms of UTIs is that it applies only up to the age of 64, as they are less complex in those cases. For instance, as you get older UTIs can be a sign of other comorbidities. I think that is the thinking behind the age of 64, but I will follow that up in writing.

The general point was made by both the noble Baroness, Lady Merron, and the noble Lord, Lord Allan, about trying to expand provision. I would say that this is the first step. We have tried to pick the areas that we think suit the situation well. This gives us the ability to expand as the capability increases. Repeat prescriptions is obviously a very good example, as is managing cases such as hypertension and other similar areas. The direction of travel is very much: let us make sure that this works well and then build on that.

I will answer the questions on IT asked by the noble Lord, Lord Allan, together. The overall thinking on the cap is that we are trying to make sure that this does not run out of control—for want of a better word—in some respects, and that goes back to the value for money question. If you can really prove that it is enhancing and substituting for GP appointments, which we all want to boost the availability of, that has to be a good thing. As ever, you need to try to set up budgets at the beginning to make sure that they are sensible in terms of that control.

To give a sense of direction, it is very much the intention that 111—I include the app and other digital approaches in this—will point a person to the right pathway for them. If we then know that they have one of these seven conditions, such as a simple UTI, sinusitis, or something of that ilk, they will be guided towards Pharmacy First. That is very much the intention. I hope that that in some way answers the question. It is intended that more and more volume is put that way.

In terms of trying to make sure that there is a slicker system with the IT generally, obviously it has to be sensible—for example, not printing things off, and that there is an electronic payment mechanism. My understanding is that that is already occurring in some of the digital areas. Noble Lords will be aware of some of the digital pharmacies, which are paperless the whole way. Those sorts of mechanisms are being set up and it is a matter of expanding them, so that there is a complete digital service. I will come back with more detail on that, but I understand that it is happening.

On the IT systems and the holy grail of making sure that they are all connecting—to give everyone the benefit of our conversation in the Corridor—the idea is that it has to be two-way. You want to make sure that pharmacies have access to doctors’ records. That is not ready today, but it will be in the next few months. Likewise, you want to make sure that whatever the pharmacies do gets updated to GP records. Right now, that will be done by a simple PDF. This is not ideal because it involves a rekeying, but in a matter of weeks, it will update the GP records automatically. The value of that is that, obviously, while Pharmacy First is the forerunner, there are all sorts of circumstances it could be replicated for, whether appointments with physios or any other physician relevant to the patient records. I think that will be a positive when it comes in.

I have tried to answer most of the questions about execution. I think we will all freely admit that, as ever with these things, there is a certain amount of bedding in—it is something that I am glad to see everyone welcomes in principle. I hope that in a few months’ time I will be able to update the House on it; I will be happy to do so. If it is executed well, and we believe that this is working well, we will be looking to extend it to further services.

[Baroness Wyld (Con)]

My Lords, I welcome the initiative. It is very good and has been very well thought out and communicated thus far. I would like to pick up the point made by the noble Baroness, Lady Merron, about women’s health. The point about older women was very well made. Equally, for younger women, on the subject of UTIs, I understand that there have been some very successful pilots, but my noble friend will be aware that for women persistent UTIs can be a symptom of something more serious. Symptoms of more sinister diseases can also mimic UTIs. While I have every faith in pharmacists to be able to refer on where possible, it is also important that women feel empowered to go to their GP if they feel something is not right. Women’s health has too often been pushed on to the back burner or ignored. I would like a bit of reassurance on that.

[Lord Markham (Con)]

My noble friend is absolutely correct to bring that up, and that is why it is quite specific on “simple” UTIs. The devil is in the detail, but the reason behind saying simple UTIs is that so the capacity is there, and you can have a referral to a GP.

In this space I speak from personal experience with my partner. It is much harder these days to get antibiotics for UTIs. We know that this is generally a good thing in terms of antimicrobial resistance, but in many cases, as my wife often says, she knows when she has a UTI—and boy does she need those antibiotics.

Some of the things I have started to see in terms of technology, which is relevant to the question of complexity, include point-of-care devices in surgeries or pharmacies that can detect a UTI very quickly, so that you then know you can give a prescription for antibiotics. That is what we see in terms of the direction of travel.

[Lord Hunt of Kings Heath (Lab)]

My Lords, when I had responsibility for community pharmacy more than 20 years ago, one of the schemes we instituted was incentivisation for private consulting rooms and spaces. I wholly endorse what my noble friend Lady Merron said about the importance of this, and the noble Baroness’s intervention reinforces this. It sounds as if most community pharmacies have some kind of private area, but they are not always as good, secure or private as they ought to be. So I very much hope that the incentive that I hear the noble Lord has built into the scheme will actually lead to ensuring that patients have confidentiality, which is really important here.

On the cap, I understand the need for probity and making sure that there are no perverse incentives to overcount, but it would be a bit of a disaster if, nine months into the financial year, a very good community pharmacy ran out of its allocated funding. What would happen? Will integrated care boards at the local level have some discretion to come in at that point to ensure that that service can continue?

On integrated care boards, some clinical commissioning groups were very poor at getting community pharmacy around the table. It always amazed me that, in their winter planning, they seemed to forget the need to have community pharmacies as equal partners. Can the Minister assure me that, when this programme is taken forward, integrated care boards will be clearly told that they are expected to treat community pharmacies as important partners in this and in planning for winter, which, as the noble Lord knows, continues for much of the year?

[Lord Markham (Con)]

I thank the noble Lord and will answer his questions in reverse. On getting the ICBs around the table, I absolutely agree. This is seen as a key part of those initiatives and handling those pressures. Generally, going back to privacy, I would expect to see, as ever with these things, some pharmacies that become very good and set up really nice areas, with a lot of expertise. I am sure they will push ahead. I am making this up, to be honest—this is not policy—but I would not be surprised if it started off with a base level of ones that can do only the seven, with others that are more skilled and show that they can manage more things, such as hypertension. There will be some very successful ones. On the cap, it would be perverse if those really successful ones suddenly hit the buffers, so to speak. As I understand it, the cap looks at this much more in terms of a global presence. In the department as a whole and the Treasury, we are going into this with a budget in mind and with the appropriate safeguards. But, going back to the value for money question, overspending is actually probably good news because it shows that it is working.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare my role as chair of the Bevan Commission in Wales. Through the Bevan exemplars, we have supported projects with extended roles for pharmacists. That included a project on urinary tract infection treatment in remote areas, which was very successful in a farming community.

My questions relate to the way in which this will be evaluated, because this project and the rollout sounds as if they are starting off well, but some difficulties may be encountered. One may be in appropriately diagnosing something such as a sore throat when it might be glandular fever. If you give the wrong antibiotics, there could be quite a nasty reaction. But equally important—in fact, often more important—are drug interactions overall. If the pharmacist does not have a list of the medications that a person is on, there is a real risk of drug interactions. Patients often cannot remember the names of things they are taking, particularly when they have multiple comorbidities. Drug interactions can be a really big problem to manage, so I would like to know how this will be evaluated and how adverse events, such as drug interactions that had not been picked up, will be collated centrally and notified.

My other question relates to the programme we developed in Wales. I declare that I am a vice-president of Marie Curie, which has the “Daffodil Standards” for community pharmacy. Our eight standards for community pharmacists have developed the concept of a pharmacy champion for palliative and end-of-life care, to make sure that medication is available and held in stock in a format that the patient can take. This is also linked to paramedics who are trained to administer medication at home, to families being trained to administer medication, and to pharmacists themselves undertaking individual medicines reviews to see what can be discontinued as well as what can be continued or how doses should be affected. Although we start off with this list, my interest in palliative and end-of-life care obviously means that I would like to see these Marie Curie “Daffodil Standards” adapted much more widely, because we know perfectly well that out-of-hours access to medication can be a real problem for families looking after people at home.

[Lord Markham (Con)]

I thank the noble Baroness. Key to her first point on drug use is obviously the functionality to be able to see the whole patient record— I talked about accessing that earlier. At the same time, the plan for the data flow is to look at what is being prescribed by the pharmacies—before the team gets on my back, I will say that “prescribe” is not quite the right word, because it is patient guidance and they are not formally prescribing. What is issued will go through the same data flow as for GP surgeries so that we can generally measure whether we think pharmacy X is overprescribing—or oversupplying—a certain type of drug versus a GP surgery. The idea is that that will be monitored in exactly the same way. Generally, on the overall experience of Pharmacy First, we commissioned the National Institute for Health and Care Research to review that to make sure it is done.

If I understood correctly, the question behind the palliative care point is, as we said about the other services: can we see them extending more, particularly in terms of out-of-hours use? The beauty of all this—there are things we can learn from the services that Wales and Scotland have introduced—is that, once the principle is established and there is a track record of it working well, there will be all sorts of opportunities such as these to extend it based on capability and, sometimes, convenience, with matters such as out-of-hours care.

[Viscount Waverley (CB)]

My Lords, as time is on our side, I will address, if I may, an issue which may or may not be totally relevant to the subject before us. I apologise to the House if it is not, but it does involve pharmacies. Before I venture forth, I offer the utmost fullest support for the principle of pharmacies playing a critical role in the whole system of patient care. My personal experience is absolutely excellent and that pharmacies provide a thoroughly professional service.

I will address a concern around the cost of purchasing non-medical equipment from pharmacies; it may also have relevance to the cost of living challenges. I went into a pharmacy recently and was charged £23.50 for a packet of four Gillette razor blades—shock horror. Of course, I needed them, and I paid, but I thought it was exorbitant, so I called the wholesaler to ask what was its cost of the same packet. It was £6 to £8. I recognise that pharmacies are a private sector set-up and can charge what they wish, but is there any aspect in this Statement that is relevant to the charges that pharmacies pay? I say this perhaps in support of the point of the noble Lord, Lord Hunt, about having facilities in pharmacies. Of course, they need funds, and pay rent and all the rest for all of the types of facilities that are required, but is there any relevance in relation to the costs that these people can charge? It is no wonder we have a cost of living crisis if people are having to pay those sorts of exorbitant prices.

[Lord Markham (Con)]

My understanding is that what we are really talking about here are the seven areas where they are allowed to supply treatments and courses of drugs. I do not think there is any read-across to other areas such as the pricing of medical instruments. I do not think that will help in this instance, but when I write round on the detail, I will make sure that this is clarified. Right now, I do not think that is envisaged by these measures.

[Viscount Waverley (CB)]

I never anticipated it was; I just thought it was relevant to the general circumstances of what people are being charged in purchasing from pharmacies.

[Lord Markham (Con)]

Again, it goes back to the point that, generally, we all agree that pharmacies offer an important service. Obviously, one would hope that they would be responsible; the vast majority of them are and there will not be such—predatory pricing probably is not the right word—hyper-pricing behaviour. Clearly, where those things do happen, I do not think any of us would support it. That is not the sort of thing we would want to be happening in any retail location, let alone one which is providing vital services.

Allied Health Professionals: Prescribing Responsibilities

Lord Markham Excerpts

Tuesday 6th February 2024 Lords Chamber

[Lord Bradley (Lab)]

I beg leave to ask the Question in my name on the Order Paper and declare my interests as listed in the register.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

In September 2023, we completed two consultations to amend the Human Medicines Regulations to enable dental therapists, dental hygienists and pharmacy technicians to supply and administer medicines without the need for a prescription. We aim to publish the consultation response in the next few weeks. In December 2023, the Misuse of Drugs Regulations 2001 were amended to enable independent prescriber paramedics and therapeutic radiographers to prescribe certain controlled drugs.

[Lord Bradley (Lab)]

I thank the Minister for that response, but primary and community health services, particularly general practice, are under great work- force pressure and waiting times for patients are unacceptably long. Although the plan to extend pharmacy prescribing is welcome, an important next step must be to extend appropriate independent prescribing and referral rights to a wide range of allied health professionals, including speech and language therapists, occupational therapists, diagnostic radiographers and many more similar professions.

As the Minister will know, the Lords Integration of Primary and Community Care Committee’s recent report supported this, and there was previously an unpublished NHS scoping report. Will the Minister now publish that report and act on the Lords committee’s recommendations to quickly implement the benefits for speedy and integrated patient care?

--- Later in debate ---

[Lord Markham (Con)]

I thank the noble Lord for his question and absolutely agree with the direction of travel. We are keen that every clinician should work at the top of their profession, and to bring in people with allied skills who can supplement that and prescribe as well. We need to be careful, because there is obviously a danger of overprescribing. But in general, we totally agree and want to extend this as far as possible.

[Lord Butler of Brockwell (CB)]

My Lords, I congratulate the Government on fulfilling their promise, made in reply to a Question for Short Debate in this House, to extend prescribing rights to paramedics by the end of last year. However, that was no fewer than four years after the extension had been approved by the Advisory Council on the Misuse of Drugs. Why did it take so long? Will the Minister undertake that future properly approved extensions will be implemented more quickly?

[Lord Markham (Con)]

Yes, because the noble Lord is correct: it should not take so long. We all agree with the approach. So noble Lords understand, there is a two-step process. First, the body to which we are trying to extend this needs to be agreed by a review of the Commission on Human Medicines; then, the Advisory Council on the Misuse of Drugs need to take a look at it. We are all aware of the dangers of anti-microbial resistance, which is why we need to be careful about things such as antibiotic prescribing. But in general, we want to do this as fast as possible.

[Lord Grade of Yarmouth (Non-Afl)]

My Lords, I am sure that most people will welcome the extension of prescribing facilities to pharmacies. Does the Minister understand that the rate of closure of independent pharmacies in the UK—these vital community facilities —is absolutely accelerating? Will he undertake to look at the rate of closure and understand why these small, independent businesses, which are the pillars of communities, are closing at such a rate? They are just financially unsustainable.

[Lord Markham (Con)]

I agree with my noble friend that not only are they the pillar of communities, but they are the front line in a lot of health services. This is about trying to put more business and activity their way to increase their viability, both in terms of paying for treatments such as these and increasing footfall generally. I completely agree with my noble friend that we want as many of these small businesses thriving in their own right, but also as a vital part of the health ecosystem.

[Lord Allan of Hallam (LD)]

My Lords, increasing the range of health professionals who can prescribe is welcome, but does the Minister agree that this makes it even more important that people are able to see their entire medical record in one place, as the Times Health Commission has proposed? What does the Minister make of that proposal, and what are the Government doing to ensure that, wherever you get a prescription, that record is located in one central point?

--- Later in debate ---

[Lord Markham (Con)]

It will not surprise noble Lords to know that I am totally in favour of the digital project and having this information available in one source. With Pharmacy First, in a matter of a few months we will have a system whereby everything it does will automatically update the GP records. That is important because once we have done it for pharmacies, we can do it for all other groups. We are absolutely moving in that direction.

[Baroness Whitaker (Lab)]

My Lords, to return to speech therapy, the Minister will be aware that the Royal College of Speech and Language Therapists wrote to the Secretary of State last November highlighting how independent prescribing responsibilities would help, for instance, patients with quite potent cases of head and neck cancer. Can the Minister be a little more specific and give a timeline for when speech and language therapists will be able to undertake independent prescribing training, so that these people can really have some help?

[Lord Markham (Con)]

I will need to get back to the noble Baroness on the precise timeline. We have an SI debate taking place shortly on physician associates, and a key step is that first, you have to be part of a legally regulated body. Once you are, the formal reviews can take place, along with the training. I will write giving the details, but we are keen to allow speech therapists and others to prescribe as well.

[Baroness Browning (Con)]

My Lords, people on the autistic spectrum who need prescribed drugs for their condition and associated reasons have to have a psychiatrist prescribe them because psychologists cannot do so. I am not for one minute suggesting that all psychologists should be allowed to prescribe, because they are quite a range of people. However, in parts of the country where there is no psychiatrist—I speak from personal experience—who can prescribe to autistic patients, can we see whether certain psychologists with a knowledge of autism could be trained to fill that gap?

[Lord Markham (Con)]

Yes, I will happily undertake to do that. There are a couple of mechanisms we can use. We can give them an independent prescribing ability, or we can give patient group directions on a certain number of items. That is what we are doing with Pharmacy First, for instance, in respect of the seven conditions. Clearly, we could look at doing that with the relevant autism drugs.

[Baroness Meacher (CB)]

My Lords, the steps so far taken by the Government to delegate prescribing to pharmacists seem pretty sensible. However, can the Minister assure the House that, bearing in mind that correct prescribing requires correct diagnosis, the Government will be extremely reluctant to delegate out the roles of doctors to healthcare professionals who do not have the benefit of a doctor’s training?

[Lord Markham (Con)]

I suspect that we are starting to get on to the debate we will have shortly on physician and anaesthetist associates. In both cases there is definitely a role for them, because we want to support doctors in the surgery and allow them to train and teach at the top of their profession. Clearly, however, we need to be sure of what such people can do and where they need extra supervision, and that is what we are setting out.

[Baroness Merron (Lab)]

My Lords, further to the Minister’s reply to my noble friend Lord Bradley, what is the Government’s plan to increase and integrate the number of independent prescribers being trained as part of the long-term workforce plan? Given that community pharmacists are already trained to vaccinate against Covid-19 and flu, will the Government be expanding the service to include the delivery of MMR jabs, in order to help address recent measles outbreaks?

[Lord Markham (Con)]

First, on the long-term workforce plan, yes, we want to increase the number of allied health professionals by 25% by 2030. We see a lot of that group—some 20%—coming through via apprenticeships. It has been proven just how well pharmacies managed to supplement MMR vaccinations in the Covid and flu space, so it is a good idea. I will need to take that idea back to the department, rather than agreeing to it on the hoof, but I will come back on it because it is an excellent one.

[Baroness Hoey (Non-Afl)]

My Lords, the Minister will know that the Health and Care Professions Council has suggested three times that sports therapists should be statutorily regulated and could also take part in prescribing. Can the Minister say when this might be likely to get legal agreement?

[Lord Markham (Con)]

I apologise: I am not quite sure what kind of therapists the noble Baroness is referring to.

[Baroness Hoey (Non-Afl)]

Sports.

[Lord Markham (Con)]

Yes, this very much applies to sports, and it goes to the whole social prescribing space and the role of physios. I know that physios are listed in the 15 professional groups we are looking to expand this out to. I will provide the details on the exact timing.

Premature Deaths: Heart and Circulatory Conditions

Lord Markham Excerpts

Tuesday 6th February 2024 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

The Government are committed to reducing premature deaths from cardiovascular disease. The NHS long-term plan aims to prevent 150,000 heart attacks, strokes and dementia cases by 2029, as well as preventing up to 23,000 premature deaths and 50,000 acute admissions over 10 years. The major conditions strategy will look at how best to tackle the key drivers of ill health and increase the healthy years of life for people with major conditions such as cardiovascular disease.

[Baroness Merron (Lab)]

My Lords, the Office for Health Improvement and Disparities reports a persistently high number of excess deaths involving cardiovascular disease since the beginning of the pandemic, avoidably cutting short more than 100,000 lives in England alone. What are the urgent plans for treating the thousands who are waiting for healthcare? How will the Government extend the roles and joined-up working of a range of healthcare professionals beyond GPs to support the millions who are living with an undiagnosed risk of high blood pressure, raised cholesterol, diabetes and obesity?

[Lord Markham (Con)]

I thank the noble Baroness and draw attention to my register of interests: I am a shareholder in a small health company that does high-end heart tests for the private sector.

It is fitting that February is Heart Month. The concern that the noble Baroness raises is exactly the one that noble Lords will have heard me speak about. This is precisely the concern that Chris Whitty, our Chief Medical Officer, was worried about during Covid, with missed appointments because people stopped going to see their doctor meaning that we missed things such as high blood pressure and high cholesterol. To tackle the problem urgently, as the noble Baroness suggests, we have put 7,500 blood pressure checkers in pharmacies. They have done 2 million checks to date. We have sent 270,000 blood pressure monitors to houses and have instigated mid-life NHS health checks to look specifically at early heart indicators so that we can try to tackle the problem that the pandemic caused.

[Lord Patel (CB)]

My Lords, we have had lots of plans and initiatives for reducing deaths from heart disease. Despite that, variation in both preventive care and outcomes have persisted for years now. They are exaggerated by deprivation and ethnicity.

Let me give two examples. First, 40% of people with high blood pressure have failed to be diagnosed— I know that the Government have an initiative for pharmacies checking blood pressure—and, even when they are diagnosed, 10% of them do not get the appropriate medication. Secondly, there are examples of people suffering from atrial fibrillation not getting the appropriate anti-coagulation treatment; we then find that 60% of the strokes that occur in these patients are because they have not been properly medicated.

It is these variations in care and prevention that we need to tackle. It is disappointing to see that some of the ICB plans do not take on the need to reduce this variation, particularly in deprived areas.

--- Later in debate ---

[Lord Markham (Con)]

I agree with the noble Lord. We violently agree that it is all about early detection. That is why we have not just put it in pharmacies but have had mobile units going to leisure centres and high streets: so that we can catch people early, whatever their background or ethnicity, because that is the key starting point.

Digital is the way of the future in this. We are introducing digital health checks from the spring. Again, these will open it up to a wider bunch of people. Early detection is key.

[Lord Allan of Hallam (LD)]

My Lords, the relationship between cardiovascular disease and poverty is clear and well documented. What specific steps are the Government taking to encourage take-up of the new screening programmes, which the Minister talked about, in poorer communities where people are at higher risk? Will the Minister commit to publishing data so that we can understand whether the screening programmes are reaching everyone or just people in wealthier communities?

[Lord Markham (Con)]

First, I am happy to commit on the data front, because data and giving results always shine a light and will always help in these situations. On outreach to all these communities, the noble Lord might be aware that, on top of the pharmacies and leisure centres, we have been incentivising GPs. As an example, being in the right age group I have numerous texts and messages from my GP about getting those check-ups done. It is those sorts of measures that we are trying to use.

[Earl Attlee (Con)]

My Lords, is the Minister aware that many of us strongly support his efforts to deter youngsters from starting to smoke because of the adverse effect it has on the circulatory system?

[Lord Markham (Con)]

Yes. I thank my noble friend. Prevention is absolutely key, as is tackling things such as smoking—the smoke-free legislation will do this for a new generation—obesity, and high levels of sugar and fat in foods. These are all key parts of our armoury.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare that I was a member of the Times Health Commission, which today published a report in which we highlight that a large proportion of disease is lived with silently, long before it presents. Therefore, prevention for cardio- vascular problems needs to start right from school age; simply screening people later in life is already too late. When people have an out-of-hospital cardiac arrest—I think there are about 30,000 a year—they have only a one in 10 chance of surviving. Will the Government undertake to work much earlier with schools and universities and young people to help them identify whether they are at particular risk through smoking, inappropriate alcohol use, living with obesity, inappropriate diets and so on, which will stack up problems into the future?

[Lord Markham (Con)]

Yes. Those are all key measures that we need to take and, I like to think, are making progress on. I thank the noble Baroness for her work and all the noble Lords who have been working on the Times Health Commission, which is a valuable contribution to this debate. I mentioned digital health checks. I have seen technology where holding your phone up in front of you can test your blood pressure and your heart rate. We need to verify that, but I think that is definitely the way of the future as well.

[Lord Brooke of Alverthorpe (Lab)]

Can the Minister say why the Government are refusing to review the regulations governing children’s meals? We know that the sugar content in them is too high and that our children are eating too much sugar. This needs to change, yet the Government refuse to look at the regulations and enforce them properly.

[Lord Markham (Con)]

I am not quite sure that I agree with the word “refuse”, but I agree with the noble Lord that healthy food in all environments is a good thing. I know that the delay happened because it was originally planned for 2020 or 2021, I think, and then the pandemic got in the way. I freely accept that the review now needs to take place. We are not refusing to do it, because it is an important part of the armoury.

[Baroness Bull (CB)]

My Lords, many noble Lords have mentioned the importance of early years interventions, not smoking, diet and so on. Does the Minister agree about the importance of exercise and of cultivating the habit of exercise, not just in early years but ongoing throughout later years?

[Lord Markham (Con)]

Absolutely. These are all key parts of a good, healthy lifestyle for mind and body—for mental health as well. Social prescribing is important for all this as well.

[Lord Bethell (Con)]

My Lords, following the appointment last year of Professor John Deanfield as the champion for personalised care, can my noble friend the Minister please update the House on the progress of his report on radical approaches to prevent life-threatening cardio- vascular disease?

[Lord Markham (Con)]

I will need to come back in writing to my noble friend on this. I take this opportunity to thank him for his work on the Times Health Commission and for generally pushing forward the whole prevention agenda.

[Baroness Boycott (CB)]

My Lords, following on from the Times Health Commission today, the Food Foundation has also produced a report on childhood obesity. The single biggest factor for preventing childhood obesity and thus adult obesity is breastfeeding. It reduces it by a figure of 25%, as the WHO has found from a worldwide study. To put that into context, all the reformulation of soft drinks has achieved only an 8.3% reduction in obesity in 11 year-olds. This is massive, yet as a country we have the lowest breastfeeding rate because we give the lowest amount of support to women when they have given birth. Not only do we get not that much time off work but there is very little support. My daughter has recently had twins, and the comparison between now and when I had her 40 years ago is really shocking.

[Lord Markham (Con)]

I agree with the noble Baroness. I am sure we all agree that breastfeeding is a really healthy start to life. I think the family hubs are trying to address these sorts of matters. Clearly, this is a point for education as well.

Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023

Lord Markham Excerpts

Tuesday 6th February 2024 Grand Committee

Moved by

[Lord Markham]

That the Grand Committee do consider the Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023.

[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.

--- Later in debate ---

[Baroness Merron (Lab)]

My Lords, I also thank the Minister for setting out the provisions in the regulations and for trying to unravel the many pages before us. This seems to be one of those innocuous measures that are needed just because that is where we are, but I very much take on board the comments of the noble Lord, Lord Allan, which are worth wider government consideration.

Clearly, these regulations are needed to support the implementation of new EU regulations that came into operation in Northern Ireland in May last year. They are important in that we have to secure continuity of supply and trade in medical devices within the UK and the EU, and the draft regulations affect a diverse range of equipment and systems to examine specimens in vitro, including items such as blood grouping reagents, pregnancy test kits and hepatitis B test kits, to give just a few examples.

As the noble Baroness, Lady Finlay, said, it is important that we support innovation. The medtech sector provides a huge contribution to our health service and our vibrant life sciences sector, from catching killer diseases early all the way through to preventing infections. The products we are talking about are found in doctors’ surgeries, hospitals and our own homes. They are part of our daily lives. We certainly know from the pandemic how difficult it can be to replace them if supply is disrupted, so we are here to ensure that supply disruption does not happen.

As has been said, the Explanatory Memorandum sets out that these regulations should affect only some 19 businesses in Northern Ireland and cost less than £5 million to implement, but it is important to acknowledge and put on record that they are a valuable part of the UK medtech ecosystem. On these Benches, we certainly support the regulations, which we believe will secure unfettered access to the British market for Northern Ireland businesses and ensure continuity of supply.

I also have a few questions that I hope will be helpful for the Minister. It is welcome that the previous fee structure is being retained to reduce disruption for Northern Ireland operators, but could he say what assessment has been made of any impact on the MHRA’s responsibilities as a regulator? Could he also confirm that it will be resourced to fulfil those responsibilities?

Previously, Ministers have talked about future realignment of regulations on medical devices following our departure from the EU, including consideration of alternate routes to the British market. Can the Minister say a bit more about what opportunities there might be in this area? What is the timeline for the future regulatory regime that the Government want to bring into force? As the Government have not yet set out their proposals, is there a timeline for doing so?

I note that medical devices did not receive attention in the Windsor deal, which was understandably disappointing to some suppliers, which cited the complexity of navigating the current system. Is the Minister considering adding other product classes, such as other devices, to its scope? Will he also clarify the status of devices on which a conformity assessment has been performed by a UK notified body? Following on from the questions from the noble Lord, Lord Allan, in this regard, will it be possible to place devices bearing a “CE” conformity mark, as well as the EU Northern Ireland mark, on to the EU market? Is it the case that no UK notified body has been appointed? If that is the case, when will this be dealt with and what is the delay down to?

In summary, we are pleased to support these amendments to the regulations to secure continuity of supply for the critical medtech sector. I look forward to hearing the Minister’s response.

[Lord Markham (Con)]

I thank noble Lords for their contributions and the spirit in which they were made in terms of helpfulness and trying to make the market as open and productive as possible.

I shall try to answer the questions in turn. To the noble Baroness, Lady Finlay, I say, yes, this is part of the four SIs.

On the noble Baroness’s whole question about making the UK market attractive to innovation, that is exactly what this is all about. On her point about clinical trials, my understanding is that there was a period when we slipped down the league on timings. I am told that a lot of that was because we were trying to prioritise Covid issues but, as I understand it today, we are now back within the timeframes. While we slipped down to 10th place in the league, the understanding from recent business coming in is that we think that we are making our way back up into the champions league spots, for want of a better phrase. I am assured that we have seen quite an improvement in the time taken in clinical trials.

On the noble Baroness’s question about what this means for the MHRA—the noble Baroness, Lady Merron, asked a similar question—we do not believe that this should have a significant impact. At the same time, I am totally with the sentiment that we do not want the MHRA to be a bottleneck, not just in this area but generally because speed to market is important here. In the last Budget, we agreed quite an increase in the MHRA’s budget, exactly so that it is able to pass such things through more quickly.

On the points about mutual recognition, it is absolutely our direction of travel. We are looking to do that with other authorities. Again—this also goes to the question of the noble Lord, Lord Allan—we are recognising the “CE” marks until 2030. That is probably a good example of mutual recognition.

[Lord Allan of Hallam (LD)]

The “CE” mark recognition is an example of one-way recognition, not mutual recognition, because it does not go the other way.

[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?

[Lord Markham (Con)]

I am probably not qualified to speak specifically about the Orbis project read-across but, at the general level, that is definitely the direction of travel, if you speak to the MHRA. As I said, there are almost two levels to it. The complete level is where you just take it lock, stock and barrel. That is the slightly harder one, but at least the preliminary step towards that is recognising when they have done a batch of tests. I know from a previous life—during Covid, for instance, when a lot of tests were about—that you have to do a number of samples, test them against a control group and see where they come out against that. Those were internationally recognised tests, so if the US, Canada or Australia have done tests on those devices, rather than doing our own tests, let us at least accept them. Those are the two stages of that.

On the point about divergence, this SI tries to make sure that the GB and Northern Ireland markets are as similar as possible. My understanding of how we used to regulate EU “CE” devices was that we would take the “CE” marks and then often tweak them slightly to make them relevant for the domestic market. Apparently, France, Germany and all the countries do that. With this SI, as I mentioned, we are recognising “CE” marks generally until 2030 on a voluntary basis—so, obviously, we can tweak them as much as we like. Northern Ireland generally has to accept those devices because of the Windsor agreement, but it still has that tweaking ability, for want of a better word, that we always used to have when we were in the EU. The idea behind this SI is to allow us to tweak it from both ends—the GB end and the Northern Ireland end—so that it is common, and we have read-across so that the product will work under the “CE” mark in both Northern Ireland and across in GB.

This was explained to me this morning, so my officials can tell me later whether I have been a decent student. For general clarity, as ever, I will happily write this all down, but I hope that makes sense.

[Lord Allan of Hallam (LD)]

It does; that was a helpful and clear explanation. However, if somebody has tweaked their test for Northern Ireland and they also want to sell to the EU, are they able to do so? For example, can they send it south of the border into the EU? Or would that require an untweaked “CE” mark, and, if so, who gives them that? That is really the heart of it.

[Lord Markham (Con)]

My understanding of all this—again, I will tell the noble Lord to the best of my knowledge and correct it if I am wrong—is that we always used to tweak it when we were part of the EU. It was generally accepted that we would tweak a bit, and so would France and Germany. That did not stop products being sold across, so I do not believe that they will need to untweak it, for want of a better word. Again, if I am wrong about any of that, I will clarify it.

On the question of what happens between March 2022 and now, I will let the noble Lord know in writing about what happens during that period.

My understanding is that the MHRA is neither a notified body nor an approved body. It does not set “CE” marks or “UKCA” marks itself; it tests them and looks at the conformity, but it does not establish any, for want of a better word.

On the questions raised by the noble Baroness, Lady Merron, that I did not pick up on before, we do not think the fee structure will have much impact on the MHRA.

The noble Baroness also asked what the opportunities are and what kinds of visions will come from this. I freely admit that this is a complicated space. However, one area where I have seen an opportunity is around the precision medicine space. For example, for the next set of cancer treatments, it will be possible to take a sample of the malignant tissue or cells and adjust the messenger RNA to, effectively, get your own body to attack those cells. The problem is that each one of those medicines you produce is individual to you, so it becomes difficult to regulate each individual medicine under the regulatory framework, as it would take ages and destroy the point of the exercise. The MHRA, however, has developed an umbrella mechanism, allowing it to treat all the individual medicines as regulated and approved. That is a major opportunity. My understanding is that the EU has not managed to be quite as fleet of foot, so it is not there yet. That is just one example I have seen; it is very important, as it allows us to charge ahead in terms of the precision medicine space. Moving forward, that will help us establish ourselves in the clinical trials and life sciences fields. I understand the points the noble Lord makes about all the complications due to some of these post-Brexit situations, but, actually, this is one area that is very positive. It will be a huge benefit for us going forward.

On the question asked by the noble Baroness, Lady Merron, about the future vision, I think it is sensible to agree a baseline based upon what we see in reputable countries with standards—such as Canada and Australia —making it as easy as possible to regulate. It would not be ideal if that meant we had to do it just one way, as we would prefer to do it both ways. However, it would still make us attractive as it would be possible to do clinical trials for our products here and know that it will work. However, where we can forge ahead in areas such as precision medicine, where you need tailored and expert help, let us really try and do that. So I think there are some really exciting possibilities.

I hope that gives a flavour of our vision and how we are trying to progress matters in this space. I realise I have not answered every question, but it has been quite a useful debate. I have definitely found it useful to tease out the details. If I may, I will go back to my notes.

I trust that I have provided sufficient answers to the questions and, as I said, I will write to follow up. I hope and trust that I have demonstrated the necessity of these regulations to honour our current commitments under the Windsor Framework agreement. With that, I commend this instrument to the Committee.

Motion agreed.

NHS: Fracture Liaison Services

Lord Markham Excerpts

Monday 5th February 2024 Lords Chamber

[Lord Black of Brentwood (Con)]

My Lords, I beg leave to ask the Question standing in my name on the Order Paper, and I declare my interest as co-chairman of the APPG on Osteoporosis.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

The Government recognise the value of the quality-assured secondary fracture prevention services, including the fracture liaison services, or FLS. More than 500,000 fragility fractures occur annually in the UK, and up to 40% of fracture patients will suffer from another. FLS are commissioned by integrated care boards, which are well placed to make decisions according to local need. The Major Conditions Strategy: A Case for Change and Strategic Framework outlines that, with NHS England, we will explore supporting the additional provision of FLS.

[Lord Black of Brentwood (Con)]

My Lords, I thank my noble friend for that Answer, but all we ever seem to get are warm words and then broken promises. We were promised money for FLS in the elective recovery plan by the Chancellor himself, with announcements on FLS before the end of last year. A package of measures was promised in the Autumn Statement, as well as a national specialty adviser on osteoporosis. None of those promises has been kept.

To go back to basics, can my noble friend tell me whether he accepts that the 90,000 people who need anti-osteoporosis medication are missing out on it because of no access to FLS; that universal coverage of FLS in England could prevent 31,000 hip fractures over five years; and that investment in FLS would pay for itself in just 18 months? If he does accept those points, can he tell us why on earth these promises have not been honoured, and why the needless suffering of tens of thousands of people has not been brought to an end? When will words finally become deeds?

[Lord Markham (Con)]

First, I thank my noble friend for his tireless campaigning in this space. I agree that there is a very good case to be made. Many of us will know the advantage of the fracture liaison services. A lot of studies show that you are at least 10% less likely to suffer from another fracture, so it is a vital part of the prevention programme. There is a very strong case behind it, and my noble friend can rest assured that it is something that we are really looking to progress.

[Baroness Donaghy (Lab)]

My Lords, would the Government agree to a temporary transformation fund to pump-prime the fracture liaison services? If everyone over 50 had access to a quality fracture liaison service, it would prevent 74,000 fractures, which would help people to stay in work and help to take pressure off hospital beds. Would the Minister agree that this would be investing to save?

[Lord Markham (Con)]

As I mentioned, I agree with the noble Baroness that the FLS has shown many cases of prevention. There is a good argument in terms of investment and the return on it all. That is something that we are working towards and, as the noble Baroness will know, it is part of the major conditions strategy for musculoskeletal. So it is something that we are looking to expand.

[Lord Lexden (Con)]

My Lords, do the Government regret dropping the commitment that they gave in a debate in this House in September to expand financial provision for fracture liaison services? Is the health department considering the introduction of a best-practice tariff to reward those trusts that establish and maintain these vital services?

[Lord Markham (Con)]

I think that the statement made previously has been corrected on this, but, as I mentioned, we accept that these services are very effective in what they do. That is why we have musculoskeletal as part of the major conditions strategy. It was something that we put £400 million behind last year, in terms of a workforce package. We are looking at the effectiveness of FLS and, in ICBs that are not doing it, whether there is a case to expand them further.

[The Lord Bishop of Bristol]

My Lords, I thank the noble Lord, Lord Black, for his dedicated work in bringing this important topic to the attention of the House. Around this time a year ago, the noble Lord asked another Question on the early detection of osteoporosis, which is the leading cause of fractures in those aged over 50, particularly women. In his answer, the Minister, who is answering the Question again today, noted that

“a fractured femur is the second biggest reason for intake into hospitals, in terms of beds”—[Official Report, 19/1/23; col. 1926]

and that he would be happy to report on progress on this to the House. Will he tell us whether any progress has been made since he gave that answer one year ago?

[Lord Markham (Con)]

Yes. Again, I did more research into this and, similar to the point just made, for women over 45 more hospital days are spent with osteoporosis than with conditions such as diabetes, heart problems or breast cancer, so it is recognised that FLS have a very strong part to play. We are trying to pursue a prevention agenda; there is a good cost-benefit argument around it, so we are making a strong case for their expansion.

[Lord Allan of Hallam (LD)]

My Lords, the noble Lord, Lord Black, and the Better Bones campaign have done an excellent job in raising the public profile of fracture liaison services, so I was a little surprised that searching for them on the NHS website returned some general articles about fractures and advice about the Patient Advice and Liaison Service but nothing about fracture liaison services as such. Will the Minister look into this to ensure that people trying to find information about FLSs are given it and directed to their local service?

[Lord Markham (Con)]

I thank the noble Lord. His interventions around the communications side are always welcome, because we recognise that it is one thing having a service and another thing making sure that the world knows about it. I will go and find out more and write to the noble Lord.

[Lord Patel (CB)]

My Lords, the fracture liaison service originally started in Glasgow, with the particular intention of identifying mostly women who had a higher risk of fractures from osteoporosis. In England and Wales, a fracture liaison service audit has been established now for several years. How do the Government receive the learning from those audits and how do they implement the learning that they receive?

[Lord Markham (Con)]

The noble Lord is correct; there has been some good evidence gained. As I mentioned previously, it shows that the probability of suffering from a fracture if you have been in a clinic is 10%—some studies have shown as much as 30% to 40%. It also shows, as my noble friend Lord Black was saying, that there is actually a good cost saving: it is thought that £65 million per annum will give a return of more than £100 million. There are some very good statistics around this, and I assure noble Lords that we are making a strong case for their expansion.

[Baroness Merron (Lab)]

My Lords, the Minister has previously confirmed in your Lordships’ House that just 51% of ICBs have a fracture liaison service, and that the rest of the country has what he described as “different versions of it”. Will he explain what is meant by this, so that it can be understood whether this means a full fracture liaison service or not in the remaining 49%? When will Minister Caulfield’s promise to establish more fracture liaison services actually be delivered?

[Lord Markham (Con)]

I believe that the latest number is 57%, but the general point stands that that leaves 43% which are making other types of provision. The work we are doing right now is trying to understand the success of those versus what we see as prudent with that 57%. That is the case we are making and the case that Minister Caulfield was referring to as well. I believe personally that it is a strong case, so it is something that, as I say, we are looking to work further on.

[Baroness Altmann (Con)]

My Lords, I apologise for adding to the pressure on my noble friend, but half of all over-50s women will suffer fractures due to osteoporosis, and this affects 50,000 working-age women each year, yet too often this disease is just stereotyped as affecting old women. The menopause increases fracture risks for women in their 50s, when many are in the prime of their life. Might such mistaken stereotyping about old women explain the near total absence of osteoporosis from the Government’s laudable women’s health strategy? Will we perhaps see women’s health hubs referring women to fracture liaison services, with further progress in the forthcoming Budget?

[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.