Children’s Health: Sugar
Lord Hunt of Kings Heath Excerpts(2 years, 5 months ago)
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Lord Markham (Con)
Yes, the noble Baroness is absolutely correct, and that is why in the major conditions survey we have an ambition to reduce sugar intake by 20%, working right across the board and especially with baby food manufacturers. As I set out earlier, there are a range of things that we have already done: the sugar tax reduced intake by 46%, and the movement of the so-called “pester power” has made a big impact. We are seeing companies reformulate food. But it is something we will keep under review, and we will do more if we need to.
Lord Hunt of Kings Heath (Lab)
My Lords, I declare my interest as the president of the British Fluoridation Society. Coming to oral health, is he alarmed at the number of intensive dental treatments that children need because of the rise in decay? Could he update the House on any speed up in fluoridation schemes?
Lord Markham (Con)
The noble Lord is absolutely correct. As many are aware, the most common reason for six to 10 year-olds to go into an A&E visit is tooth decay. The noble Lord will recall that we passed an SI quite recently expanding opportunities for water fluoridisation. I know that is now increasing and I will happily follow up with the detail in writing.
Respiratory Syncytial Virus
Lord Hunt of Kings Heath Excerpts(2 years, 6 months ago)
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Lord Markham (Con)
This is where nirsevimab is very promising, in that it gives six months’ protection. The problem with the previous jab is that it needed monthly injections and was only 50% effective. We are talking about 70%-plus effective now, which makes it more practical to have that sort of rollout. To date, we have been looking at the very targeted group of 75 year-olds only, particularly as each course costs £2,000 and has to be given monthly over the winter months. Now that we are opening up to this injection, which is much cheaper and lasts for six months, we can look at a broader range, and then there is a much more general education programme to go with it.
Lord Hunt of Kings Heath (Lab)
My Lords, will the Minister comment more generally on vaccine manufacturing in the UK, which comes into play here? During Covid, we learned that having our own vaccine manufacturing capacity was important. Is that the Government’s position going forward?
Lord Markham (Con)
The noble Lord is correct. I have two good examples of that, BioNTech and Moderna, where as part of commercial arrangements for us to buy large amounts of Covid vaccines from them they are making investments in UK plants. It will not always be practical, but those examples are billion pound-plus investments which I think we all agree are welcome news.
National Health Service (Performers Lists) (England) (Amendment) Regulations 2023
Lord Hunt of Kings Heath Excerpts(2 years, 7 months ago)
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Lord Hunt of Kings Heath
That this House regrets the lack of an impact assessment and a full consultation exercise being undertaken in relation to the changes made through the National Health Service (Performers Lists) (England) (Amendment) Regulations 2023 to the National Health Service (Performers Lists) (England) Regulations 2013, given the wide-ranging effect of those regulations on NHS primary care dentistry in England.
Lord Hunt of Kings Heath (Lab)
My Lords, it is a great pleasure once again to draw your Lordships’ attention to dentistry matters in relation to this statutory instrument. I declare an interest as president of the British Fluoridation Society and related bodies.
These regulations are important in themselves—more important than first meets the eye. They come within the context of wider issues around the problems that patients are having getting access to dentistry under the NHS. In our previous debate, a few weeks ago, I referred to the GP patient survey last year, in which 12.9% of those surveyed said that they had failed to get an NHS dental appointment in the last two years. If you count only those people who attempted to get an NHS appointment the first time, 24% failed to get an appointment in the last two years.
In the last few weeks, I have had urgent representation from the Shildon and Dene Valley branch of the Labour Party about the impact that the closure of BUPA Dental Care in Shildon and Bishop Auckland has had on providing NHS dental services. As the branch says, this is an area where only a minority of people can afford expensive private dental care. The closures will lead to an overall decline in dental health and to increases in related health problems. This is happening up and down the country.
When we debated this in June, the Minister referred to the July 2022 package of dental system improvements, which was aimed partly at improving patient information and at changes to the contract to provide some incentives. However, that is not sufficient to tackle the chronic access problems that patients have.
The announcement in the NHS workforce plan that the Government intend to
“Expand dentistry training places by 40%”
is, of course, very welcome indeed. However, the Minister will need to find some capital funds to help dentist schools expand, and I know the Minister will not be surprised if I mention that the
“tie-in period to encourage dentists to spend a minimum proportion of their time delivering NHS care”
has caused some eyebrows to be raised—although I actually sympathise with that proposition.
Lord Hunt of Kings Heath (Lab)
I am very grateful to the Minister, and to my noble friend and the noble Lord, Lord Allan, for their comments on the statutory instrument. As ever, I think we have had a very interesting debate.
It was interesting to hear the insights of the noble Lord, Lord Allan, on the website, which I have just tried out. It is easy to use and, as long as you know the name of the dentist, it finds it just like that. If you do not, I am not sure where you are. The other thing is its peculiar language. Why “performer”? That is a very odd name to use for a serious dental professional. What does “status: included” mean? Yes, they are included on the register, but I suggest it needs refreshing, and surely more information can be given. In the GMC, of which I am a member of the board, we too are looking at our registration details for the public. There is an appetite for the public to know more about the professionals—some of them specialise in certain techniques. Picking up the question of Scotland, Wales and Northern Ireland as a whole, I suggest that this is worth having a look at.
The noble Lord, Lord Allan, made a very good point on fees. I understand the issue about unfunded pay increases—we as Ministers have all had to go through some of those tensions—but that seems to be spiting yourself when, let us be honest, we are absolutely desperate for overseas recruitment. Using GMC figures, of the 20,000 or so extra registrants last year, 39% were homegrown, 11% came from the EEA and 51% came from overseas. We need to be very careful about dissuading overseas professionals from coming in, particularly when we know that the expansion in the workforce will take, I do not know, maybe a decade before we see its fruition—certainly with doctors and dentists—on the front line.
I thought my noble friend Lady Merron’s point about the cutback in NHS work post Covid was very interesting. Access issues are getting really worrying in some parts of the country where people do not have the wherewithal to go private. Somehow or other, we desperately need to do something more about access.
On the issue of impact assessment and consultation, I thank the Minister for the apologies about the tie-in statement, but there comes a time for a reset of relationships with the BDA. When the announcement about the extra training places was made, that might have been the time when a short consultation—although I think two weeks is too short—was tactically a good thing to do. Relationships between the department and the BDA are always full of interest—they are sometimes warm; they are sometimes not so great—but you cannot ignore the representative of the profession.
I accept the point the Minister made about sensible incremental changes. Small changes put together can lead to improvements. That is why the SI is welcome overall, as are the measures that we saw and debated recently.
Ultimately, we also need Governments to show more interest in dentistry. They need to understand that the access issues are very serious indeed and that we should not regard dentistry as a kind of marginal addition to the core issue of NHS services. I am sure the Minister will agree that dentists are an essential part of health promotion and healthcare provision in this country. Having said that, I am very grateful and beg leave to withdraw my Motion.
NHS Long-term Workforce Plan
Lord Hunt of Kings Heath Excerpts(2 years, 7 months ago)
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Lord Markham (Con)
That is absolutely my understanding. For it to be a living document, people clearly need to have input and to be able to debate it in exactly the way we are doing here today.
Lord Hunt of Kings Heath (Lab)
My Lords, I remind the House of my membership of the GMC Council. The GMC has warmly welcomed the plan and its role in the expansion of medical education, the development of physician and anaesthesia associates, and the apprenticeship programme. I want to follow on from the point made by the noble Baroness, Lady Brinton. The key point the GMC has made is that it is absolutely essential that there are sufficient clinical and educational supervisors, particularly for the F1 grade—newly qualified doctors going into postgraduate training. NHS trusts will have to release more of their doctors to provide this. Is the department in touch with and talking to the chief executives of NHS trusts to ensure that, as the pipeline develops, there will be sufficient clinical supervision? This is essential in order to get the quality of doctors that we need.
Lord Markham (Con)
The noble Lord is correct that it is essential. I emphasise that this is an NHS document, and the whole point is that it does not look to go “zoom” on recruitment. There is absolutely the understanding that this is a pipeline that has to be built brick by brick. There is no point front-loading the number of university places if, as the noble Lord mentions, there is no follow-up behind it in clinicians. The plan has been developed from the bottom up, including with clinicians and the trusts. There is an understanding that they need to build their own part of the pipeline towards this as well.
Mental Health In-patient Services: Improving Safety
Lord Hunt of Kings Heath Excerpts(2 years, 7 months ago)
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Lord Markham (Con)
We see that as being very much in the remit of the Health Services Safety Investigations Body. In fact, the first thing we are asking it to do is to consider how we can learn from those unfortunate deaths, where they have taken place, in terms of their care. The intention is that it will report back. It will start in October and will report back on that within a year, so that we can get some rapid findings.
Lord Hunt of Kings Heath (Lab)
My Lords, can the Minister return to the contribution from the noble Baroness, Lady Watkins? I note that the HSSIB has been asked to look at and develop a safe staffing model for in-patient services, but I re-emphasise the point made by the noble Baroness: you cannot look at in-patient services only; you have to look at the whole spectrum. Surely, he accepts that. For instance, with young people, the huge waiting times for CAMHS services, which eventually lead to some of them being out-of-area placements, is shocking. Surely, HSSIB should be looking at the whole picture. Can he also say how this will relate to the workforce plan? In other words, will the conclusions of HSSIB’s report go forward into the workforce plan, so that for the future we are developing enough people in the mental health field?
Lord Markham (Con)
As I am sure the noble Lord is aware, the second thing that the HSSIB is being asked to look at is exactly the point about how people are cared for as in-patients and how we can improve that approach. On staffing—again, we will debate this more tomorrow night following the Statement repeat—it is vital that there is a feedback loop in terms of the long-term workforce plan. That feedback loop, as I am sure noble Lords are aware, is built into it, so that when new data comes along, as will potentially be the case with the HSSIB, there is a way for that to feed back in again.
General Practitioners: Recruitment and Retention
Lord Hunt of Kings Heath Excerpts(2 years, 8 months ago)
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Lord Markham (Con)
I agree with my noble friend that recruitment and retention are key. To clear up the figures, the numbers I gave referred to all doctors working in GP surgeries, including people who have been qualified for five years and are just finishing off the GP element. Within that we absolutely need to increase training numbers. We already have 4,000 doctors in training, which is a record number, but we are looking to grow that. We are introducing specific actions on retention, such as the new changes to pensions.
Lord Hunt of Kings Heath (Lab)
My Lords, plugging the gap in relation to GPs will take many years. The noble Lord will know that in hospitals, specialist and associate specialist doctors have increased in number. Many would like to work in primary care but are prevented by bureaucratic barriers. Do the Government not think that one way to get an immediate injection of doctors into primary care is to get SAS doctors there and to lift the current barriers?
Lord Markham (Con)
I completely agree that we need to look creatively and flexibly. We are on target to deliver 50 million more appointments, which is 10% more each day. That is through recruiting more staff. We have about 29,000 more staff in the GP work space, and that is using them flexibly and creatively.
Mental Health Services: Huntington’s Disease
Lord Hunt of Kings Heath Excerpts(2 years, 8 months ago)
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Lord Hunt of Kings Heath
To ask His Majesty’s Government what assessment they have made of the number of people with Huntington’s disease displaying mental health symptoms who are being denied access to mental health services on the grounds that it is an organic brain disorder.
Lord Hunt of Kings Heath (Lab)
In begging leave to ask the Question standing in my name on the Order Paper, I apologise to the House as I should have declared my GMC board interest in the previous oral intervention.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)
NHS England has not made an assessment, as this is not data that is routinely collected or would be captured. Minister Whately has asked NHS England to look into reports that people with Huntington’s disease are being denied access to mental health services. NHS England is also in the process of developing a neuropsychiatry service specification, which will outline the approach to caring for patients with neurological conditions who require mental health support.
Lord Hunt of Kings Heath (Lab)
I am grateful to the Minister for that positive Answer. He may be aware that the Huntington’s Disease Association has research which shows, first, that many people with that disease suffer from severe mental health issues and, secondly, that in many parts of the country NHS mental health services refuse to give mental health treatment to those people. In addition to the work that his fellow Minister is requiring from NHS England, will the department look at the training of mental health staff so that they have the capability to support people with Huntingdon’s disease who have mental health issues?
Lord Markham (Con)
Yes. The noble Lord has heard me say many times that I have really come to appreciate the Questions format for looking into areas that might otherwise not be seen. I thank the noble Lord and the Huntington’s Disease Association for bringing this to our attention. We have the steps in place but that is a good point about the training.
National Health Service (Dental Charges) (Amendment) Regulations 2023
Lord Hunt of Kings Heath Excerpts(2 years, 8 months ago)
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Lord Hunt of Kings Heath
That this House regrets that the increase of 8.5 per cent to patient charges under the National Health Service (Dental Charges) (Amendment) Regulations 2023 (SI 2023/367) (1) will be a considerable burden on NHS patients, and (2) will not help to improve access for NHS patients, including children and young people.
Lord Hunt of Kings Heath (Lab)
My Lords, I know how eagerly noble Lords have anticipated our debate this evening. I should declare at the beginning my presidency of the Fluoridation Society and patronage of the National Water Fluoridation Alliance, so I can guarantee the House that I am not going to mention fluoridation again during tonight’s debate.
This is a critical time for NHS dentistry. The massive hike in charges of 8.5% in this SI seems to be a deliberate policy of discouraging patients who need care the most. Of course, it comes at a time when access to dentists has become increasingly difficult, with reports of patients resorting to DIY dentistry because they cannot get access to an NHS dentist. In August last year, the BBC reported that, based on a survey of 7,000 NHS practices, nine in 10 were not accepting new adult patients for treatment. The problem, of course, predates the pandemic, when enough dentistry was commissioned for only around half the population in England, and in many parts of the country access to NHS dental services was already very poor. It has now got worse.
Of course, the increasing cost burden on patients has been paired with a crisis of access. The General Dental Council found that the proportion of adults receiving dental care under the NHS fell from approximately half in 2013 to just over a third in 2021. The proportion of those over 15 years old receiving free NHS dental treatment fell from 31% in 2012 to 22% in 2017. According to the most recent GP Patient Survey, conducted in 2022, 12.9% of those surveyed said they had failed to get an NHS dental appointment in the last two years.
These access problems are obviously also linked to workforce challenges. In June 2022, the House of Commons Health and Social Care Committee reported that the headcount of primary care dentists in England providing NHS treatment or otherwise conducting NHS activity in 2020-21 was at its lowest level since 2013-14. The report said that although the GDC register has the largest number of dentists in its history, the number of dentists doing NHS work is decreasing. The BDA has told me that official data it secured shows that
“just 23,577 dentists performed NHS work in the 2022/23 financial year, down 695 on the previous year, and over 1,100 down on numbers pre-pandemic”,
which
“brings figures to levels not seen since 2012”.
The noble Lord referred to the NHS workforce plan in Oral Questions today. We certainly need a coherent long-term workforce plan for all dental professions, underpinned by data, starting with the regulator, the GDC, which counts dentists registered by full-time equivalent and not headcount. The basic fact is that we do not have enough dentists in this country willing to perform NHS treatments. At the moment, the shortfall can really only be met with overseas recruitment.
On that, I understand that the GDC has just announced that it is tripling the number of places on the first part of its overseas recruitment examination. However, there is no mention of part 2, which is the practical part of the process after candidates have passed part 1. Completely missing at the moment is anything being done to ease the blockages involved in getting an NHS number. Without that, newly registered dentists can work in the private sector immediately but not the NHS, making access to NHS dentistry even more problematic as private practices are more accessible to overseas recruits.
Dentistry has been subject to cuts unparalleled in the NHS. In real terms, net government spend on dentistry in England was cut by over a quarter between 2010 and 2020. The Prime Minister keeps making references to the £3 billion spent on dentistry, presumably implying that that is a growth figure. In fact, the budget was over £3 billion in 2015. In May 2022, the noble Lord, Lord Kamall, the Minister’s predecessor, told the House:
“The Government are working with NHS England and the British Dental Association to reform the current NHS dental system and to improve access for patients, tackling the challenges of the pandemic”—[Official Report, 24/5/22; col. 754.]
He also referred to an extra £50 million for additional activity and patient appointments. However, this is clearly not sufficient and a drop in the ocean. Actually, we have the remarkable situation whereby, as I understand it, we also have a likely £400 million underspend in the dental budget in the financial year just finished.
We then come to the issue of charges. In their Statement in March, the Government argued that this increase was necessary in order to continue to fund dental provision. They argued that the larger increase was necessary because dental patient charges had been frozen since December 2020. One contrasts that with the large underspending figure in the current dental budget. I simply do not see why the underspend figure could not be used to incentivise dentists to provide more NHS treatments. I understand that in the north-east there is a concept that follows the dental access centres, which we as a Government opened up and incentivised dentists to provide more NHS treatment. Some more imaginative leadership from the Government on this could use the money in a more effective way. We should not underestimate the real challenges for patients in finding access to a dentist where they are not eligible for financial support but do not have the resources to go private. For some people, this is a hugely disturbing and worrying challenge.
The BDA has said that the hike in charges
“won’t put a single penny into a struggling service”
or improve patient access to quality dental care. In essence, patients are being asked to pay more so that the Government can put less into the dental budget. We are talking about a huge differentiation between what happens in England and in the rest of the UK. A band 1 treatment, a check-up, will now cost £25.80 in England but just £14.70 in Wales. A band 3 treatment such as dentures will now cost £306.80 in England and just £203 in Wales. It is important to have some cohesion across the NHS in the United Kingdom and the differential in charges is really worrying.
The Government have described charges—no doubt the Minister will do so in his speech—as a patient’s contribution towards the cost of NHS care. However, it is clear that they are being used as a substitute for state investment, increasing as a proportion of total spend within a flat budget, thereby enabling Ministers to cut back government contributions. One wonders where this is all going to lead. Is this a signal that what the Government are doing is gradually withdrawing from any responsibility for NHS dentistry, leaving many members of the public desperately short of the ability to access a dentist?
The fact is that the UK now spends the lowest share of its health budget on dentistry of any European nation, according to OECD figures published in 2019. That is unsustainable and the dentistry service requires greater investment and leadership. I hope that this debate will provide some evidence to the Minister that the Government need to get a grip. I beg to move.
Lord Markham (Con)
I will try to unpack that point a bit more. A dentist can say, “Okay, I can provide so many UDAs over the course of the year”, and they will be contracted to do that. But there is then the situation whereby some of them—I am not saying all of them—having that banked in and knowing that they have the money to afford it, might go out to try to sell private healthcare, underpinned by that money. At the end of the year, if they have not delivered all the UDAs, then, in effect, the only reason that they have not delivered it is because they substituted that for private care work, resulting in that underspend, which we do not want.
That is what the changes we talked about in May were about: removing the UDAs from those persistent underdeliverers, for want of a better word, and having the capacity to give them to those who are persistent deliverers, so that we can increase their amounts by 110%. This is very much about taking away from those who are not delivering and giving to those who can, and also having money in the bank for some of the more creative ideas that Minister O’Brien is very focused on, and that we look forward to delivering. I can say, hand on heart, that is not about banking underspend; this is about making sure that we can redistribute it. These price increases—which, again, are half the rate of inflation—are for funding a dentistry plan through which we want to improve access; that is fundamental to all of this.
I hope that noble Lords understand a bit more where we are coming from and understand that it is an 8.5% increase versus 17% inflation. We are looking to recycle that increase and put it into more access for those who are not receiving it at the moment. I hope that noble Lords will see this in a better light and that it is all about increasing access.
In conclusion, as the noble Lord, Lord Hunt, mentions, it is important that patients can access NHS dental care and that it is affordable. No price increase is easy but we hope it is seen that this is a proportionate increase at less than half the rate of inflation and only for those 50% of people who are in a better position to pay. Most of all, this is part of a package of measures, of which more will be announced shortly, about expanding access to NHS dentistry—because I completely agree with the noble Baroness, Lady Merron, that it is vital to the health of our children, particularly, but to all the people in England.
Lord Hunt of Kings Heath (Lab)
My Lords, I am very grateful to the Minister and for him attempting to explain the mystery of the dental contract, which has defeated many Ministers over many years. Explaining it in the way he did lends support to those who think we need a fundamental rethink about the way we remunerate dentists. I took part in some of the discussions with the profession which led up to the last contract and before that there was the contract in the 1990s. Essentially, it seems to me, each time there is a revenue envelope agreed with the Treasury on how much can be afforded for a new contract. The profession will always exceed performance in general because it is always based on a payment for a procedure, although efforts have been made to bring in incentives to treat the oral health of a person as a whole, more like the way in which GPs are remunerated. But at the end of the day, we still await a change in contractual arrangements which will provide the right incentives.
I am grateful to my noble friend for her support. She is right to say that at the heart of this is needing to know the Government’s aspiration for NHS dentistry. The Minister said that dentistry is an important part of the NHS, that he recognises the access challenges faced by the public and that we can await further announcements. I welcome that and hope that we can reset NHS dentistry on a much more positive route for the future.
In relation to charges, the contrast between the difficulty so many patients are having in getting access on the one hand and the 8.5% increase on the other is very difficult to understand and to support. Many of the people who rely on the NHS but do not get benefit support from the state are really caught by high inflation in general and dentistry charges is one more burden they have to face. That ultimately is what makes the proposal before us really rather worrying.
I hope this is an opportunity to reset our whole concept of NHS dentistry. I am very grateful to noble Lords who have supported the debate tonight and beg leave to withdraw my Motion.
NHS GP Surgeries: Purchase by US Companies
Lord Hunt of Kings Heath Excerpts(2 years, 8 months ago)
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Lord Markham (Con)
The noble Lord is absolutely correct that it is all about supply and the quality of that supply. That is why, again, I am pleased to say that we have a record number of GPs in training. We can learn from innovative measures. I have been looking at an advanced draft of the workforce plan. The number of doctors in the most advanced medical systems in the world—those of Japan and the US—is lower per head of population than here, but the number of nurses is higher. They have altered their staff mix to get the optimum performance, and we should be open to these innovative approaches to get the best output.
Lord Hunt of Kings Heath (Lab)
My Lords, the noble Lord referred to the workforce plan. Can he assure me that, when published, it will be fully funded?
Lord Markham (Con)
This is absolutely the work that the Treasury is doing at the moment. Noble Lords have asked, many a time, when it is coming out. I think people will understand that part of the delay is making sure that, when the plan does come out, it really does work.
Medical Devices (Amendment) (Great Britain) Regulations 2023
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)
My Lords, I am grateful to be here to debate these important regulations. Plasters for a scraped knee, blood tests that detect cancer, pacemakers, pregnancy tests and software that calculates insulin doses for people with diabetes—medical devices are used by millions every day.
The MHRA regulates medical devices in the UK, helping to ensure that these products are safe and perform as intended. Today, almost 2 million different medical products are registered with the MHRA for use in the UK, of which an estimated 500,000 different product types are regularly used in the NHS. The past few years have been a time of great change for medical devices. The Covid-19 pandemic saw big advances in the life sciences and diagnostics sectors.
This instrument is intended to give the medtech sector additional time to transition to our post-EU exit regime for medical devices. It extends the time during which manufacturers and importers can place CE-marked medical devices on the Great British market.
Since January 2021, manufacturers wishing to place a medical device on the GB market have been able to follow either the post-Brexit UK route and use a UKCA mark or the EU legislation and use a CE mark. Without this SI, this flexibility would cease on 30 June this year, with only the UKCA route available. This will impact an estimated 11,000 businesses that have registered medical devices with the MHRA with a CE mark only. These regulations will allow industry the flexibility to use either mark on medical devices for longer.
Continuity of supply is key and we recognise that the industry needs more time to prepare to transition. Without it, manufacturers of medical devices without a UKCA mark would have to stop supplying their products in GB from this July. This could mean some patients losing access to the devices that they need. I make it clear that this instrument has no impact on medical devices already on the market with a UKCA mark.
I will now take a moment to summarise the key changes. First, the instrument provides that medical devices compliant with the EU medical devices directive or EU active implantable medical devices directive with a valid declaration of conformity and CE mark can be placed on the GB market up until the expiry of the device certificate or 30 June 2028, whichever is sooner. Secondly, in vitro diagnostic medical devices, or IVDs, that are compliant with the EU IVD directive can be placed on the GB market up until the expiry of the device certificate or 30 June 2030, whichever is sooner. Thirdly, medical devices and IVDs, including custom-made devices, that are compliant with the EU medical devices regulation or the EU IVD regulation can be placed on the GB market up until 30 June 2030. This is in keeping with the Government’s response to the consultation on the future regulation of medical devices, which ran from September to November 2021.
I thank the SLSC for its thorough review of this instrument. The committee raised with the MHRA the important practical concern of whether firms will be incentivised to seek UKCA certification at an additional cost if CE certification is still accepted. Since January 2021, it has been possible to use a UKCA mark on medical devices. In the year ending March 2023, an estimated 9% of new medical products—around 71,000—were registered with the MHRA with UKCA marking, despite CE marking being an option.
Manufacturers will be prompted to consider shifting to using the UKCA mark through the transition period, including as their CE certificates expire. To transition to the UKCA mark, many manufacturers will need to use a conformity assessment body approved by the MHRA. The capacity of these approved bodies is currently limited. The MHRA is working proactively to build approved body capacity to allow a smooth transition to the UKCA mark. The agency engages regularly with the medtech sector and will continue to do so as it develops a future regime.
By supporting these regulations, we can help ensure that patients and the wider public benefit from continued access to quality, safe medical devices; that the UK remains an attractive market for manufacturers of medical devices; and that the wider medtech industry has adequate time to prepare for the transition to the future regulatory framework for medical devices. I commend these regulations to the Committee.
Lord Hunt of Kings Heath (Lab)
My Lords, I thank the Minister for his explanation of the statutory instrument. I do not oppose it at all, although the fact that the Government are doing it seems to reflect the serious lack of preparation and planning for the post-Brexit world in which we now exist.
I have two points to put to the Minister. The first is in relation to the 30 June 2030 cut-off date for the sole use of UK conformity assessments for medical devices placed on the market in Great Britain. My understanding is that the transition timelines to 2030 are causing significant confusion for companies, especially SMEs in the health tech and medical devices sector. I refer noble Lords to paragraphs 7.6 and 7.7 of the Explanatory Memorandum in particular, which begin to explore some of the complexities. I say this to the Minister: a clear timeline would be very helpful in giving clarity and certainty to companies.
My second point picks up the point that the Minister made right at the end of his opening speech about the MHRA’s capacity and its plans to reform the current regulatory system. I pay tribute to the MHRA’s work and am sure that it will rise to the challenge but the plan includes proposals
“to reclassify products, to increase information gathered at the point of devices’ registration, to strengthen post-market surveillance requirements to ensure better incident monitoring reporting and vigilance, and to introduce alternative routes to market”.
I can see the reasons for this, of course, but additional regulatory burdens for industry to supply the UK may mean that manufacturers will not bother and will focus on the EU and other larger, certainly more valuable, markets. The number of products made just for the NHS is very small indeed.
The Minister will be aware that the Chancellor talked in the Budget about the rapid, almost automatic approval of devices approved in markets such as the US. Is the MHRA signed up to this? It seems essential to build on current product recognition routes from the EU and rapidly explore building a UK product regulation equivalence route for the approval of medical devices to include other trusted jurisdictions, such as the US, for a greater proportion of products. I would be grateful if the Minister could comment on this.
I now come to the very serious capacity and capability constraints. Clearly, the MHRA has suffered from the reduction in its funding, especially on the devices front. I hope that the Minister will be able to say what is being done to improve it. Also, what philosophy will the MHRA adopt in future? Will it continue to oversee the regulatory process in relation to devices or will it take a more expansive, more centralised and certainly more expensive FDA-style approach, with the attendant recruitment challenges that that brings? It has been announced that one of the MHRA’s senior executives, Dr Laura Squire, will focus on devices and that there is a recognition of skill shortages but I cannot begin to overestimate the problem for UK companies if, in meeting the target that the SI now sets, they find that one of the major problems is a lack of capacity in the MHRA to provide the necessary speedy regulatory assurance that is required.
This comment can generally be made about the post-Brexit arrangements as a whole. If, by “taking back control”, the Government mean that they are serious about developing a new regulatory regime that serves the public interest and is effective in attracting industry to this country, they really must ensure that the regulatory system is both fast and effective. This is the major issue that must lie behind this SI.
Lord Lansley (Con)
My Lords, I will speak about the medical devices issues in these regulations. I thank my noble friend the Minister for introducing them. To some extent, I share some of the concerns expressed by the noble Lord, Lord Hunt of Kings Heath. He and I will recall our debates on what is now the Medicines and Medical Devices Act 2021, which provides the power under which these regulations are being made. When the new medical device regulations are laid, we will look very carefully at the extent to which they reflect the considerations put into Section 15 of the 2021 Act, which are about not just the quality, safety and availability of medicines but the ability to support both clinical research and the supply and manufacture of medical devices in this country.
That latter point bears directly on this statutory instrument, which is helpful in that respect because it extends the transitional period. This will create an opportunity for manufacturers based in or exporting to the United Kingdom to supply medical devices here. They will be able to adapt to the changes in the regulations that are yet to come—we do not know when. My noble friend might like to tell us a bit more about that timing since, in a sense, extending the transitional period is all very well but you have to kick the transition off. We need our regulations to be in place in order to see how significant the differences between the existing regulations and the future ones are and how different our regulations are from those that apply in the European Union.
I will make a general point, on which I know my noble friend can say little at this stage. When we debated medical devices regulation and initially agreed that we would accept the UK CE marking for a period of time, there was always a question as to whether it made much sense to disapply the UK CE marking and when to do so.