Mental Health Services: Huntington’s Disease

Lord Allan of Hallam Excerpts

Monday 12th June 2023 Lords Chamber

[Lord Markham (Con)]

The research from the Huntington’s Disease Association, albeit with a small sample size of only 100, suggests there is an issue here. That is why I spoke to Minister Whately about this just this morning. She is being very firm in terms of tasking the NHS to come back with a plan to make sure we get that diagnosis. We will not know until we see the situation across a larger sample size, but clearly it is something we need to work more on.

[Lord Allan of Hallam (LD)]

My Lords, the Huntington’s Disease Association is pressing the Government for a number of actions in its campaign “Mindful of Huntington’s”. Could I press the Minister on one of these: that there should be a care co-ordinator in each area to help manage the various professionals? Do the Government agree in principle with this approach? What specifically are they doing to work with integrated care boards for situations such as this, in which you need primary, secondary, mental health and social care to all work together?

NHS GP Surgeries: Purchase by US Companies

Lord Allan of Hallam Excerpts

Monday 5th June 2023 Lords Chamber

[Lord Markham (Con)]

I think it was the noble Lord opposite who introduced patient choice. That looked to the independent sector to increase supply, which is what we care most about. I do not believe that anyone should be fundamentally against who owns a business. What they should care most about is the supply of good-quality services.

[Lord Allan of Hallam (LD)]

My Lords, further to the Minister’s answers around quality, does he agree that there is a significant public interest in understanding how well different general practice ownership models perform for patients? In this context, can he confirm whether his department is carrying out any research into patient satisfaction and outcomes by ownership type, using sources such as the general practice patient survey and the OpenSAFELY trusted research environment for GP data?

[Lord Markham (Con)]

I am not aware of any correlation between the type of ownership and the quality of the services from it. If there is one, then we can look at that, but we are focusing resources on the areas where they make most difference, and the focus is: what is the performance of that clinic? That is what we should all care about. How are the doctors there performing in terms of appointment times and everything else? I will not put a false target on who owns it and the structure of it, because that is not relevant. What is relevant is the quality.

Cancer Referral Targets

Lord Allan of Hallam Excerpts

Monday 5th June 2023 Lords Chamber

[Lord Markham (Con)]

I am not exactly familiar with the test that my noble friend might have taken but many of us will have heard about the early promise shown by the GRAIL programme. It is a simple blood test and, right now, has a two-thirds success rate for early detection. Those are early indicators, but early diagnosis and innovative approaches such as the GRAIL blood test are important.

[Lord Allan of Hallam (LD)]

My Lords—

[Lord Patel (CB)]

My Lords, I interrupt to say that, while the new test shows promise, it is nowhere near perfection. The sensitivity of the test is extremely low and false positive rates are high. This is cell-free DNA testing, including machine learning. It may be the promise of five years to come that we detect cancers at an early stage, which would be the holy grail, but we must not hype the test at this point and raise false hope.

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[Lord Markham (Con)]

The noble Lord is absolutely correct that we always need to keep these things in balance. What I was trying to express was that we have an opportunity to innovate in this space. We have another innovation in our targeted lung cancer programme, which has now been rolled out to 43 sites. In 2019, 50% of such cancers were not detected until stage 4. Now, through mobile delivery of services to these sites, we are detecting 60% of such cancers at stage 1. Those are the sort of innovations for which we have very solid data, and they do show promise for the future.

[Lord Allan of Hallam (LD)]

My Lords, national waiting times for cancer treatment have fallen way off target, as the noble Baroness, Lady Merron, set out in her Question, but these national numbers mask significant regional variations. In March, they ranged from 45% of referrals within the target time in Birmingham and Solihull to 80% within target in Kent and Medway. How does the Minister account for such significant variations and what are the Government doing to level up those integrated care board areas that are falling furthest below the targets?

[Lord Markham (Con)]

That is exactly the example I was giving when I mentioned lung cancer targets, where mobile devices are being used. Interestingly, the most deprived areas have been targeted because they are often areas of high smoking, and these are the areas where they have managed to get screening times down the most. We have the opportunity to put CDCs in the areas of most need. We all agree that there is unprecedented demand and that we have to expand supply; there is no other way to meet that demand but to expand supply.

National Health Service (Dental Charges) (Amendment) Regulations 2023

Lord Allan of Hallam Excerpts

Monday 5th June 2023 Lords Chamber

[Lord Allan of Hallam (LD)]

My Lords, I am very grateful to the noble Lord, Lord Hunt of Kings Heath, for giving us the opportunity to have this debate. I think he is having an even busier day than the Minister, given his contribution to the Illegal Migration Bill debate that we just had.

There are two real questions that people are asking about access to NHS dental services. The first is whether they can get an NHS dentist. That is something that we have debated in the context of other regulations along similar lines discussing the way in which the remuneration scheme works. The second question is about how much will it cost if they do get one—if they are the lucky few who can navigate through the system and find an NHS dentist, and that is what we are primarily discussing today.

It is also important to touch on dental deserts, particularly in rural and coastal areas. I hope that the Minister may also have some to say on availability. He has assured us in this House previously that the Government have ideas to try to improve the ability of NHS dentists generally, and I know he had some creative ideas about attracting dentists into under-served areas.

Having got through the barrier of finding an NHS dentist, we now need to think about the question of charges—a question that is entirely academic if you are unable to get one in the first place. The Government are proposing in these regulations an uplift—in common language, an increase, but they prefer to use “uplift”, which I think is supposed to sound a little softer— of 8.5%. I find that curious language. When I go to supermarkets they do not tell me that they are applying an uplift value to their prices; they apply an increase to their prices, but here we are told it is an uplift value.

In paragraphs 7.8 and 7.9 of the Explanatory Memorandum we get a lengthy and quite convoluted explanation of where that money goes, which makes it clear that patient charges make no direct contribution to the remuneration that the dentist receives. People out there may think that the payment they are making to the NHS goes to the dentist, but it does not. Again the Explanatory Memorandum makes it clear that there is intentionally no link between the contract price paid to the dentist and the contribution that the individual pays. Paragraph 7.8 states that the money is essential to improve access challenges, and that current and future work to improve NHS dentistry would be undermined by the risk of reduced funding if the patient charge revenue was lower. Yet, as we heard from the noble Lord, Lord Hunt, it is reported that there was a £400 million underspend in the NHS dentistry budget for last year, so I have a couple of questions for the Minister, a maths question and a logic question. The maths question is: will he confirm that £400 million is approximately five times as much as the £78 million in extra revenue that we are told that this 8.5% increase will achieve? In other words, if we were not to have the increase but were simply to roll the underspend into dentistry, we could cover five years of that additional revenue-raising from the underspend that already exists. The logic question is simply: how can we say logically in this paragraph that these charges are essential to improve NHS dentistry when we are not spending the money that is already available? Perhaps the Minister is going to make us all happy by confirming that that £400 million underspend is all going to be spent on NHS dentistry, in addition to the extra £78 million, but I suspect that is not going to be the case. Listening to the noble Lord, Lord Hunt, I wondered whether one of the solutions might be that the new charges should not be allowed to be levied unless and until all the existing budget has been spent. If there is going to be a £400 million underspend, perhaps the patient should benefit from that if the money is not going to be rolled back into NHS dentistry.

The overriding concern is one that the noble Lord, Lord Hunt, also referred to: that the long-term commitment from this Government to provide dentistry within the National Health Service just is not there. The right words are being spoken, but the actions are telling us a different story.

The Government’s own impact assessment notes, at paragraph 37, tell us:

“There remains uncertainty about whether higher patient dental charges would lead to lower levels of patient access”.


They say that, although the research is not clear,

“it is very likely that higher charges will reduce the number of patients seeking NHS dentistry services, relative to there being no patient charge uplift.”.

So, again, the Government’s own notes tell us that it is likely there will be reduced demand for NHS dentistry as a result of the charges that we are discussing today.

Paragraph 32 very tellingly talks about the relationship between NHS and private dentistry, which, of course, is an alternative in most parts of the country. It says:

“There is also a risk that increases in NHS charges could mean that the cost of NHS dental treatment becomes closer to prices of private dental care. Some patients may choose to receive private care if the cost differential is lower”.


It seems logical that, if a patient is confronted with real difficulty in getting an NHS dentist compared with getting a private dentist and if they understand that there is no real price differential, those two forces combined will act to steer people away from NHS dentistry towards private dentistry.

As I know the Minister and I have heard him speak on these issues before, I suspect he will say that this is not the Government’s intention—but we need more than words. We need evidence that we are not seeing a succession of measures leading inexorably in one direction: a direction in which dentistry ceases to be available on the NHS at a fair NHS price for people in large swathes of this country.

[Baroness Merron (Lab)]

My Lords, I am grateful to my noble friend Lord Hunt for tabling this regret Motion and speaking so clearly to it, describing for your Lordships’ House what this actually means for people by its effect on NHS dentistry.

I am glad to follow the noble Lord, Lord Allan, and I absolutely associate myself with his remarks about the word “uplift”. It is a very positive way of describing an increase in costs to those who need NHS dentistry. We should remind ourselves that this is why we are having this debate, not only about the costs but about the sorry reality of the state of NHS dentistry at present—and bearing in mind that all this takes place in the context of a cost of living crisis.

It is incumbent on us this evening to remind ourselves that poor oral health—which is where we end up when people do not look after their teeth because they cannot afford and/or cannot access NHS dentistry—does not just affect the teeth. It impacts on our general health and well-being; it affects what we can eat, how we communicate, and how and whether we can work, study and socialise with ease, and it affects our self-confidence. Yet it is right to say that tooth decay is largely preventable.

There is also a significant public health problem linked with considerable regional variation and inequality. A three year-old living in Yorkshire and the Humber is more than twice as likely to have dental decay as a three year-old who lives in the east of England; and one in three five year-olds in the north-west has experience of dental decay, compared to nearly one in five in the south-east of England. It would be helpful if the Minister could tell us: what is the Government’s aspiration in respect of NHS dentistry? That aspiration and the practical means to achieve it seem to have got rather lost on the way.

As we heard from my noble friend Lord Hunt, the last 13 years have seen dentists quitting in very considerable numbers. In 2021 alone, 2,000 quit the NHS, which represents almost 10% of all dentists employed in England. An estimated 4 million people cannot access NHS care, with some parts of the country now described as dental deserts, where remaining NHS dentists are not taking on new patients.

To secure a future, we need staff, which I will refer to later, and the equipment, technology and access to ensure that patients get the treatment they need. This raises a number of wider questions. We are spending less on dentistry per head of the population in the areas with the highest levels of deprivation. Statistics from the British Dental Association suggest, for example, that 1 million new or expectant mothers have lost access to dental care since the start of the pandemic. Could the Minister say what the Government are doing to prevent those on low incomes or in more vulnerable groups being disproportionately impacted?

Tooth extraction in hospital due to tooth decay remains the most common reason for hospital admissions in the six to 10 year-old age group, with an estimated cost of hospital admissions for children aged between nought and 19 for this intervention being some £33 million per year. What steps are being taken on early preventive action to reduce what has become a shameful situation?

We know that 91% of dental practices are not able to accept new adult patients in England and 80% are not able to accept new child patients. Millions are having to face the unpalatable options of waiting for months in agony, resorting to their own DIY dentistry, or stumping up for private dental fees they simply cannot afford. My question to the Minister is not just about what the Government are doing to tackle this crisis, but how did they allow it to get to this situation? From inadequate support for the prevention of oral ill health in childhood to dental deserts, net government spend on general dental practices in England has been cut by over one-third over the past decade. Again, perhaps the Minister could explain how the situation has been allowed to deteriorate to this extent.

We know that not enough is being done to recruit and retain dentists and dental care professionals. A recent British Dental Association member survey showed that more than nine in 10 owners of dental practices with a high NHS commitment found it difficult to recruit a dentist, with 43% of vacancies unfilled for more than six months.

On the workforce, there is a point I want to underline following the points raised by my noble friend Lord Hunt. In June last year the House of Commons Health and Social Care Committee reported the findings of its inquiry into the health and social care workforce. It found that the headcount—to underline this—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. While the register has the highest number of dentists, the number doing NHS work is decreasing. In 2021 alone there was a decrease of 951 dentists with NHS activity in England. That is the near equivalent of the whole intake target of dental students for the whole year. Perhaps the Minister could explain how this all stacks up.

On the matter of substance—we have heard much about this from the noble Lord, Lord Allan, as well as my noble friend Lord Hunt—at almost 500 practices across England the British Dental Association tells us that the amount paid by NHS patients was greater than the amount paid to that practice to provide NHS services. The analysis suggests that patients at those surgeries were topping up government funding by an estimated £2 million last year. It would be helpful to hear from the Minister how and in what way this makes sense.

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

My Lords, I am pleased to respond to this debate on these regulations and to address the concerns about their impact on patients and access to dental treatment. I thank the noble Lord, Lord Hunt of Kings Heath, for securing this debate on this important matter, and I thank noble Lords on all sides of the House for their contributions to the constructive debate.

Dentistry is an important part of the NHS and we acknowledge the gravity of the challenges that some people have faced in accessing these services—and the real impact on the health service and A&E, and on young children, that the noble Baroness, Lady Merron, mentioned. So, to answer clearly the point of the noble Lord, Lord Hunt, about this not being about decreasing access, I say that access challenges are at the top of our minds. Hopefully, this speech will show that we have an aspiration to increase access to dentistry, as the noble Baroness, Lady Merron, said.

In July 2022, we announced a package of dental system improvements, having fully engaged, via the NHS, with the dental profession and patient representatives. These initial changes were aimed at improving information for patients, improving incentives in the contract to deliver more complex care and enabling the NHS to better work with the sector to ensure that dental care is delivered.

Most importantly of all, I will address the underspend head on. I appreciate the noble Lord’s maths, but I will be absolutely clear that we do not want the underspend; it is caused by dental surgeries that are not delivering on their contract. In many cases, they declare a number of UDAs to underpin their business and then try to sell in the private sector, ending up with an underdelivery at the end of the year. The changes that we introduced on 18 May were all about being able to adjust those contracts so that, where dentists underperform, we can remove those UDAs from them and redistribute them to those who are performing. So, effectively, I can say categorically that we are not trying to bank that £400 million—which is not the final number, I should say—or to bank an underspend; rather, we are trying to find ways to prevent that happening, because we absolutely accept that we want access to increase in all of this.

The dental patient price increase—I will not say “charges uplift”—is very much about generating money which will be used around the system. This is not a case of saying, “Oh, we’re going to try to bank the underspend and generate some more for us”; this is about trying to get to where people can afford to pay. Let us remember that 50% of people, including those in the most need, receive their dentistry completely free, so this is for the 50% or so of people who are in a position to afford it. Of course, since dental charges were last increased, we have had an increase in inflation of 17.9%, so what we are doing here is increasing those prices by only half that amount. This is about making sure that the money is there to fund an expansion of dentistry.

We consider that the 8.5% is a proportionate increase; it is about £2 on the cost of an NHS check-up. I reiterate that it is being paid only by those people who are in the best position to be able to afford it; we are making sure that those who cannot afford it continue to receive it free at the point of care. We know how important it is to provide the courses of treatment. We provided 8 million courses, 5.6 million of which were to children. The noble Lord, Lord Hunt, will be pleased to know that 54% of those are for fluoride treatments. We understand that it is vital that we provide those preventive measures to children.

To answer the noble Lord, Lord Allan, we know that we need to go further; the creative thinking has continued, and there will be further, wider-reaching changes to improve access to NHS dental care that we hope to announce shortly. I can say, hand on heart, that we are actively looking at ways to fund these increases. This is not about trying to bank underspend; this is about trying to make sure that those underspends are delivered. If those we are contracted with are not delivering it, we will find others who will do it. That is also where some of the creative ideas will come in.

[Lord Allan of Hallam (LD)]

I am curious about the point the Minister made about the underspend resulting, in a sense, from accounting practices—or, as I understood it, that people are seeking additional contracted amounts to boost the financial health of their dental practices. It is first time I have heard that. I wonder whether he thinks that that is a temporary phenomenon that will somehow come out of the system, or whether it is something that is inherent in the way the system has been established so that private dentists are contracting for blocks of NHS work.

[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.

Medical Devices (Amendment) (Great Britain) Regulations 2023

Lord Allan of Hallam Excerpts

Monday 5th June 2023 Grand Committee

I hope that my noble friend will at least say that we have not abandoned the objective to arrive at mutual recognition of conformity assessments and that the transition will literally buy us time, and that we register the great advantage it would be if we used that time to arrive at mutual recognition in the future.

[Lord Allan of Hallam (LD)]

My Lords, these Benches also welcome the Minister’s introduction to this statutory instrument. I am starting to get used to being presented with a statutory instrument and told, “You can either support this or the sky could fall in on the heads of some part of British industry tomorrow”. It is a fairly straightforward choice: of course we support the statutory instrument going ahead to allow the medtech sector a little more breathing space.

A number of questions have already been touched on about where we are going. The first is a specific one. The MHRA has said that the start date for the new UK regime is 1 July 2025, after which, as I understand it, no new devices with CE marks will be recognised. The existing ones will roll over, as we are discussing today, but post 1 July 2025, any new devices coming onto the market will need the UKCA mark. I have had representations from people in the industry who think that that is what the collective information they have received means, but it would be helpful if the Minister could clarify that: that after 1 July 2025, the new UK regime is in place and new CE marks will not be recognised after that date.

The second question is one correctly raised by the noble Lord, Lord Hunt: where the capacity to carry out the assessment will come from. Of course, the will is there, but what if the staff are not? The Minister is used to discussing in this House staffing across all different aspects of the health sector. This is another aspect where specialist staff will be needed. I am particularly mindful of the Minister’s introduction, when he talked about the important role of software now in medical devices, many of which are software controlled. That is a specialist and high-value area, and it is important that we get some assurances that there will be the capacity, or the Government have a path to developing the capacity, to have people who can do the approvals, particularly of sophisticated software-controlled devices and—dare I say it—flavour of the month, artificial intelligence-controlled devices, which will be embedded in future. Again, that is a very high value, specialist function. MHRA will need to have the capacity to certify devices that use artificial intelligence and other sophisticated forms of software.

The third question is a very specific one about class 1 low-risk devices, which, as I understand it, are things such as wheelchairs and stethoscopes. Again, it would be helpful if the Minister clarified what is intended here and how they fit into the transitional scheme that is being extended today.

The fourth question is about labelling. It would be really helpful for people in our medtech industry who are seeking to export to understand how labelling will work, and specifically in the context of the Great Britain/Northern Ireland question. The Minister referred to medical devices for the Great British market. There is an issue of intonation here: is it the “great British” market or the “Great British” market? I think in this case it is the latter: the market of Great Britain, not Northern Ireland, because of the arrangements we have there. It is really important that people who are making devices understand how labelling will work, particularly if they are selling devices across the island of Ireland, where they are in the Northern Irish and Republic of Ireland markets, but also exporters more generally.

The final issue I think is interesting is information-sharing and government distributing information to the sector. Paragraph 12.4 of the Explanatory Memorandum says that there will be

“some costs for the industry associated with familiarisation with the regulations”.

I think it is much bigger than that, and the noble Lord, Lord Lansley, was quite right: the industry needs to understand the direction of travel, particularly around convergence/divergence. The sector, which, as the Minister rightly said, is an important one in the United Kingdom as a whole—not just in Great Britain, in this case—is in a very different place and needs the information now that will enable it to plan. For example, if a UK-based entity will in future be trying to conform to two very divergent regimes in the EU and Great Britain, it may well want to structure accordingly. It might want to have separate legal entities in the EU and the United Kingdom. The situation would be quite different if the message the Government are giving is that there will be the kind of convergence the noble Lord, Lord Lansley, talked about, whereby approvals might be transferable.

The sector needs to make those kinds of decisions quite quickly. We are talking about an extension of the CE mark to 2030 but, as I said in my opening question, we are talking about the new British regime kicking in in 2025. That is not far away in business terms, so it is extremely important that we get some clarity from the Government—to the extent that they can give it—about the future direction of travel and whether they hope for or aspire to a regime of mutual recognition or instead anticipate that it would be quite divergent.

We need information not just about the technical details of what these regulations mean today but about the direction of travel and how approval processes may be changing over time, which is important. As I said, we will not oppose a statutory instrument that needs to be in force by 1 July to stop the sky falling on people’s heads, but I hope the Minister will take this opportunity to answer some of the questions that people building businesses in the United Kingdom and elsewhere need answers to in order to get essential devices. That kind of information would help them to plan and be most effective in supporting patients.

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for introducing the SI and other noble Lords who have spoken today. Those of us involved in the somewhat tortuous passage of the Medicines and Medical Devices Act 2021, and subsequent SIs designed to bring about the transition from the previous, easily understood CE assessment under EU legislation to the UK conformity assessment marking system for medical devices, knew and predicted that the new and complex system needed much more time to develop the new arrangements and work out how they would work, and that the deadline set by the Government for transition would inevitably have to be extended. This last-minute SI fully recognises this, although many questions and issues remain unclear, as we have heard.

Given the complexity of the assessment marking system and what is proposed in this SI, I thank our Secondary Legislation Scrutiny Committee for setting out concise reasons, which were clearer than the SI’s Explanatory Memorandum, about the key points of what the SI seeks to do and why the seven-year extension for some medical devices is needed. On the reasons, the committee says:

“The extension is partly in response to a Europe-wide shortage of assessment capacity for these and other goods and also due to the Medicines and Healthcare products Regulatory Agency’s intention to strengthen the future regulatory framework for medical devices … in a way that both improves safety while also enabling innovation”.


I would be grateful if the Minister could comment on the Europe-wide shortage and the impact that it is currently having.

We have seen today that nobody is at all clear about what is going to happen, when the work and the timelines for MHRA’s new framework will be ready and when the extensive reform that will apply from 2025 will be published. I look forward to the Minister’s explanation of what paragraph 7.3 of the SI Explanatory Memorandum anticipates are the steps the MHRA will take

“to build approved body capacity to meet the demand for UKCA … marking”—

to which a number of noble Lords referred—in order to achieve the capacity when the transition periods after 2025 expire for the relevant medical devices. The capacity covers in particular the ability to assess higher-risk medical devices which we are not yet in a position to assess.

Paragraph 6.9 of the memorandum refers to the MHRA’s intention to lay “further instruments” under the MMD Act and “significant amendments” to regulations. Can the Minister update the Committee on the proposed timetable for this? Is the consultation exercise undertaken last year still under consideration by the MHRA as part of its developing policy? Will a further consultation on the MHRA’s new framework proposals be undertaken and, if so, what is the timescale for this?

The SLSC points out that the MHRA’s plans for reform are extensive. My noble friend Lord Hunt referred to them: reclassifying products, gathering information at the point of registration, strengthening surveillance, better incident reporting and so on. The committee stressed that these are excellent aims, but how and when the MHRA will achieve them—or try to—remains unclear.

The SLSC also refers to the MHRA’s current slow progress: it still does not have estimates of the total number of registered medical devices that are UKCA rather than CE marked. Of the 789,581 new medical products that were registered with the MHRA between April 2021 and March 2022 only just over 9% were UKCA marked. Is the Minister confident that this rate of progress will enable the MHRA to have a proposed new scheme in place in 2025 for transition to 2030?

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[Lord Markham (Con)]

It is probably best if I write on those points. In terms of timing, the MHRA is planning a further consultation on its future regime from October, but I will come back on those other points.

[Lord Allan of Hallam (LD)]

On the labelling question, I wonder if I could helpfully suggest to the Minister something like an infographic, which shows what labels are needed in Great Britain and Northern Ireland and which labels would be helpful on which dates. Somebody who is making devices could just look at that and go, “I’ll need that kind of labelling at this stage of the transition process”. That would help.

[Lord Markham (Con)]

I absolutely agree. To clarify—I may have used the terms interchangeably—I am talking here about the Great Britain market. It is a great British market as well but we are talking particularly about Great Britain because we know that, under the Windsor Framework, Northern Ireland has separate CE arrangements.

I think I have answered as much as I can at this point. I will clarify further in writing. I thank noble Lords because this debate has been incredibly valuable in making sure that we are getting this right; it is non-trivial, to say the least. With that, I commend this instrument to the Committee.

Branded Health Service Medicines (Costs) (Amendment) Regulations 2023

Lord Allan of Hallam Excerpts

Thursday 25th May 2023 Lords Chamber

[Lord Warner (CB)]

My Lords, I support the regret Motion moved so ably by the noble Lord, Lord Hunt of Kings Heath. I agree with quite a lot of what the noble Lord, Lord Lansley, has said, but I am not going to be as wide-ranging as him. The Minister may be relieved to know that.

I speak from the perspective of having been a Pharmaceuticals Minister who negotiated a 7% reduction in the price of branded medicines, under the old PPRS, without damaging the UK’s life sciences industry and with the agreement of the Treasury. So it is possible to do these things and make such schemes work if, across government—we will come back to that—there is a willingness to engage properly with the industry. What we see here is that failure across government to deal with the industry.

Unfortunately, the regulations before us will, as has been said, significantly damage the UK life sciences sector. That was confirmed for me by the briefing received from the ABPI and some of the pharmaceutical companies that have also set out their views in relation to these regulations.

The regulations increase the repayments by pharmaceutical companies in the statutory price scheme to bring them into line with the already high levels in the voluntary price scheme, so we have a scheme which is catching up to an already unsatisfactory scheme. That is a wonderful achievement for government departments to have delivered. Government departments seem to have simply ignored the warnings they have been given about what will happen if they press on with the regulations as they stand. Instead, they have produced what I would regard as an unconvincing and wordy impact assessment, which has already been commented on. It totally downplays the warnings from the industry. The industry made its position very clear in the ABPI briefing for this debate. It points out that the proposed rebate of 27.5% of companies’ revenues

“is a rapid escalation from historical and international norms. Prior to this the average payment rate across the last four years was 10.6% and in 2022 the rate was 14.3%”.

That is almost a doubling of what the rate was a year or so ago.

When one looks at comparator countries, as has been mentioned, the UK rate is an extreme outlier within western Europe. Some countries do not even have comparable schemes, but in those that do, the rates are 12% in Germany and 7.5% in Spain and Ireland. The only comparable clawbacks to the UK’s are in Romania and Greece, two countries that, if I may say so, are hardly in the Premier League in terms of the life sciences. The ABPI brief goes on to state that

“the UK is already seeing worrying signs of decline in the UK life sciences industry including in R&D investment, access to clinical trials and medicines launches with companies making long-term decisions on the future of their UK footprint.”

The new proposed rate will accelerate this investment and jeopardise the availability of new medicines, which will lead to poorer NHS performance and patient outcomes. The ABPI contrasts the UK’s approach with incentives to new life sciences investments in France and Ireland, where Pfizer has recently announced big investments in both countries. AstraZeneca has followed suit in Ireland. The ABPI briefing is also supported by the briefing from AbbVie, a top-five, US-headquartered global biopharmaceutical company. It points out that the NHS already lags behind other countries in the take-up of new medicines. Branded medicines expenditure is reducing in the NHS, while the NHS budget is increasing. That is no mean achievement. I never got to that stage when I was the Pharmaceuticals Minister.

UK patient access to industry clinical trials is declining rapidly, and the average annual loss in the UK’s share of R&D spending is declining by about 3% a year. The briefing from Roche, another major company, is in a similar vein to that from AbbVie. This is not just the industry complaining about these regulations; these concerns are shared by patient groups. Gene People, which supports people with genetic conditions, has set out in its evidence the impact of these regulations for patients and on their access to the drugs that they will require over time.

I am genuinely puzzled by why the Department of Health and Social Care has simply ignored the evidence provided by the industry and patient groups on the damage that these regulations will do to UK life sciences and UK plc. The ABPI commissioned research which found that continued high payment rates in both the statutory and voluntary schemes would cost the UK £50 billion in GDP and £17.9 billion in tax revenue because of lost R&D investment of £5.7 billion by 2028. These are considerable losses to the UK economy. There is not a mention of them in the impact assessment. The ABPI company survey also suggests that repayment rates of around 24% across both the voluntary and statutory schemes

“would result in job losses in over 9 out of 10 companies”.

The savings to the NHS budget from these rebate schemes is modest compared to the economic damage that they do.

Despite all this evidence, Ministers from the Department of Health and Social Care are ploughing on with these regulations, seemingly unaware that the industry’s timescales for making R&D investment decisions are much closer than they realise. In the next year or so, these decisions will be taken in relation to 2030 onwards. Somewhat bizarrely, 2030 is the date the Prime Minister is talking about for cementing the UK’s place as a science and technology superpower.

It crossed my mind as I prepared for this debate whether the Prime Minister and No. 10 are aware of the contradictions between the Department of Health and Social Care and the Prime Minister’s aspirations for the UK economy. It is also strange that on the very day that we are debating this regret Motion on these regulations, the Chancellor is sitting with the industry at the Life Sciences Council, discussing the life sciences sector in this country. It seems an interesting coincidence.

I should like clarification from the Minister on one point and to ask him a question. The point of clarification is whether, as the usual convention requires, he is speaking fully on behalf of the Government in responding to the Motion tabled by the noble Lord, Lord Hunt. My question relates to the new discussions on the voluntary scheme, which are taking place or have begun. Can the Minister confirm that these discussions are indeed taking place? If so, what is the point of pursuing these regulations if, in these new discussions, there is the possibility of a more positive approach to rebates under both schemes, given the more sensible proposals put on the table by the ABPI—the Minister may be able to confirm this—which suggest that we should be talking about single-figure rebates if we want this country’s life sciences industry to be successful?

[Lord Allan of Hallam (LD)]

My Lords, I am very grateful to the noble Lord, Lord Hunt, for his Motion, and for giving us an opportunity to debate a series of questions raised by the statutory instrument about the life sciences sector more broadly.

I do not think that it is enough for us simply to say, “Look, Britain is great”, and expect that to act as a magnet for international pharmaceutical companies to invest in it. We certainly have a very strong sector and excellent skills, but the market is not sentimental: it reacts to financial signals. The noble Lord, Lord Lansley, was quite right to put us in the position of those people sitting in boardrooms, where soft signals such as the Prime Minister holding a summit are fine but the determinations will be based on hard numbers in spreadsheets. That is the way businesses work.

The concern that we should have in considering the statutory instrument is whether this settlement will be absorbed as simply the cost of doing business in the UK or whether it will change behaviour of businesses in a negative way. On all sides of the House, I think we hope that it will not do the latter. The ideal outcome is that businesses continue to invest in spite of taking a hit, but the risk that that will not be the case is genuine and deserves the debate that we are having today.

We have already seen some companies move from the voluntary to the statutory scheme. It would be helpful if the Minister could indicate how many. I understand that the rates are similar, but it is a pretty strong signal when a company says in that board discussion that it is important for them to say, “We are not taking this lying down. We are upset. Therefore, we will pay what we have to pay, but only if you make us do it. We are not willing to do it on a voluntary basis.” As I said, the numbers may look similar, but the signal seems pretty clear to me. I hope the Minister can indicate the scale of the trend and his views on whether we should be concerned that that is happening.

It is interesting to note from the Explanatory Notes to the legislation that the consultation responses were nearly uniformly negative. I was going to say that they were uniformly negative, but they were not: only 30 out of 33 were. I was fascinated by this comment in paragraph 10.3, which referred to having more responses than in previous years. It said:

“It is likely this rise in the number of responses reflects a stronger level of interest in the consultation from industry in advance of negotiations for a new voluntary scheme to succeed VPAS, which expires at the end of 2023.”


I suggest that the increased number of consultations reflects something else: it is a cry for help and a protest against the fact that the rate is now over 20% and seems to be rising inexorably. Businesses are not responding in greater numbers just because of something happening in the process but because of the substance. When the noble Lord, Lord Warner, made his 7% reduction some years ago, I suspect he would not have had the same number of responses, because the reduction was not at the levels we are seeing now. The fact that we are at over 20%, and that there seems no prospect that that will reduce, means that businesses want to engage.

Here is the question for the Government: what signal do they want to send to these major companies that produce medicines that our population depends on? Is it that the trend is going to improve over time, so that they are encouraged to invest in test facilities and research in the UK—that they can expect to have more free cash flow, as it were, from the sales that they are making in the UK, to invest back into the UK? Or will the trend stay the same, at a level that they have told us they already find unacceptable, or even worsen? As the Covid backlog is, hopefully, dealt with more expeditiously, there will be more dispensing of branded drugs, and there is a scenario in which things continue to get worse. If companies feel that they have less to invest, those signals will be negative.

New Hospitals

Lord Allan of Hallam Excerpts

Thursday 25th May 2023 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for reading out the Statement. It has been clear for the last year that we would have to come to this moment of the Government finally admitting that achieving their 2019 manifesto pledge for 40 new hospitals by 2030, under the new hospitals programme, was never on the cards, and that reality would have to take over. The Government must face the reality of the timescales and the scale of the money needed to address the NHS’s crumbling estate, and the reality of needing to prioritise and address the urgent rebuild and major maintenance problems of existing hospitals throughout the country, which are seriously endangering patient safety and the public.

This morning, it was reported that the announcement of the Government’s realisation of not being able to keep their promise was delayed

“because of fears about a backlash from Tory MPs”.

Was that vital information kept from the public because of such fears? Can the Minister tell the House when the target was abandoned internally?

We know that NHS maintenance costs have more than doubled, from £4.7 billion in 2011-12 to £10.2 billion in 2021-22, and about the dire condition that many hospital buildings are in. For example, Leeds Teaching Hospitals saw over 100 raw sewage leaks last year, including faeces leaking into wards and patient rooms; Hampshire Hospitals NHS Foundation Trust was forced to suspend some services because of a rat infestation; and the hospital in King’s Lynn, Norfolk, is one of the most prominent hospitals that has had to be propped up with steel and timber supports to stop its dilapidated roof caving in.

Do the Government have an estimate of how much they expect NHS maintenance costs to continue to rise until 2030? Is there a full overall strategic plan for this and the now-reprioritised 40 new hospitals programme? If so, when will it be published? After government announcements on the programme, only in February described by the Minister opposite as “world-class” and capable of being exported “around the world”, we have become familiar with the idea that the hospitals were not new, that many were not even hospitals and that “new” could include repairs and redecoration.

The Nuffield Trust put the number of new hospitals in the Government’s original programme—meaning those that we would all recognise as new—as three, not 40. The National Audit Office called the programme unachievable, and NHS Providers estimated the real costs of building new hospitals as £20 billion, not the £3.7 billion allocated by the Government. Can the Minister commit to publishing the latest estimate that his department has made of the cost of the now-revised programme? Can he now say specifically which of the new hospitals in today’s Statement are being kicked into the long grass beyond 2030?

The slow progress being made was clearly evident last February when it emerged that only 10 of the projects even had planning permission. Just last week the BBC reported that building work is yet to start for 33 of the 40 projects promised. Will the Minister commit to coming back to the House with detailed implementation, timescales, costs and scope of what is now proposed? The fact is that the programme has been hit with delays and uncertainty for years, and the longer this goes on, the higher the costs soar and the less likely it becomes that they will ever be built. Most of the hospitals in the programme are still waiting to hear what their final budget will be, and none of the six that were supposed to be ready for 2025 has full planning permission or funding yet.

On the seven hospitals built with reinforced autoclaved aerated concrete—RAAC—the Government acknowledged in December the enormous concerns and safety implications and committed to eradicating this from the NHS estate. The Government have now officially recognised what we all knew—that these hospitals are not safe to operate beyond 2030. We welcome the news that they will all be completely rebuilt and the promise that this will be fully funded. Can the Minister tell the House the specific funding that is to be committed to the seven hospitals? Can he also tell the House when we are to receive the full details of the new, reprioritised plan so that it can be properly scrutinised and assessed by this House?

[Lord Allan of Hallam (LD)]

My Lords, when I worked in business we had a maxim that we should always try to undercommit and overdeliver as a way of pleasing clients. It feels like the opposite is applying here, with the Government scrambling to show that they are not underdelivering on their overcommitment. Of course, 40 hospitals was a classic election promise, oversimplifying a much more complex need, with the reinforced autoclaved aerated concrete hospitals being one of those such complications that emerged once they had turned over the aerated concrete block.

I do not expect the Minister to comment on the election promise, but I hope he can comment further on three aspects of the Government’s programme that he has set out. The first is the modular hospital design approach, which certainly seems a very smart way to proceed if it can provide more and better-quality hospital capacity at lower cost. Of course, any negative impact of failures in design will be multiplied if you are using a similar, consistent design. We should remember that RAAC was the future once, and public buildings were built according to that specification because it was seen to be cheaper and better back in the 1950s and 1960s. What assurances can Ministers give us that they will get it right this time and that the modular approach being used everywhere is the right one? By the way, on branding, 2.0 is now very 1.0, and it might be more appropriate to call it “the metahospital” or “Hospital.AI” these days.

The second is the planning process, which the noble Baroness, Lady Wheeler, raised. It does not matter if the modular design allows much quicker construction if everything is held up in seeking the relevant permissions to build the hospital in the first place. I would be interested to hear how many of the schemes have been given planning permission already and the extent to which the Government see planning as potentially a disruptor to their plans.

Finally, on the risks, if there are delays or cost overruns, which we hope there will not be—but inevitably one sees those with schemes of this kind—I look for assurances from the Minister that the contracts are written in such a way that any additional bills will not fall back on the taxpayer and, crucially, that if some schemes overrun or get into difficulties and incur extra costs, it will not mean that other schemes in the programme have to be cancelled as the overall budget runs short.

[Lord Markham (Con)]

I thank noble Lords for their comments. On a personal front, this is a project I have been working on directly. It is very close to my heart and is something that I am delighted to be able to put forward. I would like to mention a couple of hospitals that probably did not get quite the prominence they deserved in the earlier Statement, which happen to be quite close to my heart as well: the North Manchester General Hospital, which is one of the Cohort 3 hospitals. I have worked closely with Manchester City Council in the past on the redevelopments around Manchester Mayfield, and that is very much part of the plans. Also, being an ex-deputy leader of Westminster Council, I am excited by the plans around St Mary’s, where we are looking at a couple of alternative sites. That will be in conjunction with the plans for the refurbishments of Charing Cross and Hammersmith so we have got three hospitals in one. Just to clarify an earlier statement: the surgical hub is planned for Chorley and South Ribble Hospital rather than the Royal Preston Hospital.

I am not quite sure on the point from the noble Baroness, Lady Wheeler, about the target being abandoned. What we were saying before was not that at all. We were saying we are positive about how it is progressing. To the point from the noble Lord, Lord Allan, about overpromising and underdelivering, I am sorry for the branding of the hospital 2.0 approach, and I take the blame for that. In terms of MMC, I was at one of the plants the other day, and it really is amazing the way its builds them and the speed with which they will go up. Many buildings have built like that for a long time. When I was up there, I saw them constructing the new Everton stadium, which is just one example. I believe that they will give the necessary speed we need for them all.

In terms of the funding, the estimate, as mentioned, is more than £20 billion. Each hospital has an indicative allocation. They are fully funded. We are not publishing them for obvious reasons: when you go out to tender, you do not want to tell the marketplace what you are expecting to pay. I hope noble Lords understand the reason for that. I am confident that the funding is in place. The hope in all of these things, as we have seen in the prison space and the schools space, is that if the first hospital costs £100 to build, the next one costs £95, the next one £90, the next one £85 as you get the economies of scale. So, you should be seeing 20% to 25% reductions, as you do a large production line. The benefit of all this is that there is such a mass volume of them all that you get the economies of scale. I genuinely hope that this will become the way we build hospitals for generations to come. It is very much cross-party, something that we all believe is a good way forward.

Some hospitals, as mentioned—as part of the timing and to try to make sure it all works in terms of the funding envelope—have been pushed into the 2030-35 bracket. They were mentioned in the Statement, and we have been speaking to them about that. They include Eastbourne, the Royal Berkshire, all the ones around St Mary’s with the complications there, Lancashire and Charing Cross to name just a few. In all those cases, they understand the reasons, and I think most people understand the need to prioritise the RAAC hospitals as a matter of absolute urgency.

On the questions about the planning process, we are on target. Obviously, you do not want to get planning permission too early, given the time it takes. In all the programmes I have seen, we do not yet have planning permission because we do not yet need it. I am confident that we are on track. We know that there are always X factors in these types of projects but, when you have so many, you want the flexibility to move some forward and some back, in a portfolio-type approach. That is well known when you are running as many projects as this.

At this stage, in all honesty I can say that we are as confident as we can be that we are on target to build them. Undoubtedly, there will be bumps in the road, and we are grown up enough to know that there are challenges, but I can say with a high degree of confidence that this really is the best approach. We will have world-class hospitals that will be state of the art, not only in their design but in their use of digital technology. A hospital today that is fully digitised costs 10% less per patient. With these hospitals, we should be looking at savings of 20% or more. That will really make a material difference to how we treat patients, increase productivity and be seen as the real way forward. I am very hopeful that the economics will become so compelling that this programme will not stop at 40 hospitals—in fact, 45, because of the extra ones we have brought in—and will become a rolling programme across the whole estate.

I am sure that we will have many more questions on this. As I say, it is my pet subject, as the priority lead, so I would be happy to talk about it in greater detail at a suitable juncture.

Pharmacies: Medicines at Home

Lord Allan of Hallam Excerpts

Wednesday 17th May 2023 Lords Chamber

[Lord Markham (Con)]

Yes. There are occasions when it is absolutely appropriate that medicines are packaged in that way; I am sure we all have plenty examples of friends and relatives for whom that is very useful. The whole point is that the blanket application of blister packs is not the right approach.

[Lord Allan of Hallam (LD)]

My Lords, the Government’s welcome plans for pharmacists to play a broader role in primary healthcare depend on there being pharmacies present in every area of the country, yet we have seen hundreds of community pharmacies close over recent years. If this trend is not reversed and there are even fewer community pharmacies in a year’s time, would it be reasonable for us to see this as a failure of government policies?

[Lord Markham (Con)]

No. What I want to be tested on is how many people are using their pharmacies for primary appointments—that is the real measure. I think we will see a marked change, and we will see it as a real convenience. The fact that this will drive more footfall to pharmacies will mean that more pharmacies will probably gain extra business and stay open. We have 24,000 more pharmacy workers than in 2010—there has been an increase in that number since then.

Life Expectancy: Pensions, Health and Insurance

Lord Allan of Hallam Excerpts

Wednesday 26th April 2023 Lords Chamber

[Lord Markham (Con)]

I am aware that there has been a similar phenomenon across all the G7 western nations. Life expectancy has been plateauing for the last few years, and the only country to buck that trend is Japan. A lot of this is to do with obesity, which I know noble Lords regard as a very important issue. While we are improving issues such as alcohol intake, the impact of obesity on healthy lifestyles is an important factor that we will need to tackle.

[Lord Allan of Hallam (LD)]

My Lords, as well as falls in overall life expectancy, there have been significant falls in disability-free life expectancy, as shown in the recent ONS figures. Can the Minister describe the steps his department is taking to understand why more people are acquiring long-term conditions earlier in their lives, and to ensure that health and social care services are geared up to meet that extra demand?

Long Covid

Lord Allan of Hallam Excerpts

Tuesday 25th April 2023 Lords Chamber

[Lord Markham (Con)]

I thank the noble Lord and applaud the research work that has been done. As I said, we have invested £50 million on top of the £118 million for Covid research. Just as we were one of the front-runners in developing the Covid vaccine, with AstraZeneca, it is very much our ambition to be a front-runner in developing cures for long Covid.

[Lord Allan of Hallam (LD)]

My Lords—

[Lord Dobbs (Con)]

It is this side. Thank you for giving way; I appreciate it. So far, 223,738 people have died from Covid and it has cost this country between £310 billion and £410 billion. Last month, in a Written Question, I asked the Government what they thought were the origins of Covid. The Answer that came back, which was not a reply at all, was that they fully supported the World Health Organization’s study into its origins. But that is an organisation that once speculated that Covid might have come into China on a package of frozen food. The World Health Organization has achieved very little since, and Nature magazine has just revealed that it has “quietly shelved” its second scientific investigation into Covid’s origins. Why do the Government appear so uninterested in the origins of a disease that has cost us so much? Why did it happen, where is it going and how are we going to prevent a second epidemic causing the same sort of chaos that came from Covid?