Medical Devices (Amendment) (Great Britain) Regulations 2023

Lord Lansley Excerpts

Monday 5th June 2023 Grand 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.

--- Later in debate ---

[Lord Markham (Con)]

I thank noble Lords for their valuable interventions; I will try to answer a lot of their points as far as is possible.

First, I completely agree that clarity is vital in this market. As ever, as well as trying as best as I can to reply now, I will follow up in writing so that there is absolute clarity there. A lot of this depends on the timing. I say this up front in answer to the question from the noble Lord, Lord Allan, on whether things will change for new products from 2025: no. In effect, we are saying that the deadline is the deadline and, as long as a product is approved during that period, it will run to 2028 or 2030. In fact, new products will now be largely under the new EU regulations so will generally run to 2030. Effectively, that 2025 deadline will apply to any new products even if they are approved and get their CE registration after 2025—say, in 2026. Generally, they will run up to the 2030 deadline.

I hope that what I have said clears up that point but, again, I will set all this out in writing; I am sure that I will be thumped by the team behind me if I misspoke. I think I proved the point very well in my explanation just now: this is non-trivial. As a businessperson by background, I know that, if you want people to invest in this market, they absolutely need to understand the rules.

Two major themes came through in all the points and questions. First, we want to maximise the supply of products. That has to be a good thing for us in making sure that we benefit as much as possible, and it goes to us recognising other quality—for want of a better word—regulators. You could say that approving the ceiling now up to 2028 and 2030 is a step along that way.

Similarly, we want to maximise capacity for our regulators. If you start to approve other quality regulators’ approvals, you are in effect pooling capacity and using their regulatory capacity as well. We know that that is an issue. In the last Budget, the MHRA was given a £10 million funding increase to make sure that it can recruit, but we recognise that it having that capacity is vital to all this.

On the point about mutual recognition, we can of course do it in only one way but, as in most free trade arguments, there is an understanding that it is generally to our benefit to recognise other quality regimes. That is to our benefit in terms of having a high supply of quality items here. Clearly, you want them to do the same in reverse. As ever in these things, there is a bit of trade-off in the negotiation: “Do I want to hold back so that I can maximise my leverage and get them to agree with it all?” Generally, as mentioned by the Chancellor, we are at the moment on the page of it being in our interests to recognise quality regulations from other countries because that can maximise our supply. We hope that they will recognise ours in a similar way, obviously, but that is in their power rather than ours.

I will try to answer some specific questions. There was a question from the noble Lord, Lord Allan, about class 1, low-risk products. Generally, the answer is yes, but this again goes to some of the confusion so I will definitely set this out in writing as well. It is not a blanket “yes”, which I appreciate does not help. Class 1, low-risk devices will benefit from the transitional periods in this instrument only where they are within the EU’s own transitional arrangements. I hope that that make sense.

[Lord Lansley (Con)]

My noble friend was talking about capacity. One aspect of it is the capacity of the regulators here and in the EU but, in some ways, I am equally concerned about the capacity in the approved bodies, or notified bodies as the EU has them. That is what has been delaying the EU’s regulations and its ability to implement them. It could equally be a problem here. We would both have less of a problem if the approved bodies in the European Union and the United Kingdom were all able to work on both sets of certificates.

[Lord Markham (Con)]

Yes; that is what I mean by pooling capacity, for want of a better phrase. My noble friend is saying that we can effectively use the EU’s capacity if we are willing to accept that it is doing proper scrutiny and measurement of products. By and large, we would all agree that that is a sensible approach, just as, similarly, there are situations in a lot of clinical research where, even if the regulators want a final sign-off, accepting each other’s data has to be sensible in terms of pooling capacity.

As ever with these things, it takes two to tango. We need to prove willingness on our side. I hope that the recent Windsor Framework agreement is a way to put things on a co-operative basis. Building trust on both sides takes a series of steps but we are trying to put our best foot forward and we hope that that is met in response.

This goes to the point about the EU-wide shortage of approved body capacity, which impacts us all. If, as we all agree, we want the best supply of products here, it must clearly be a concern if they cannot get through that way. If a company is finding that, through a lack of capacity, they cannot get through the EU route because there is no capacity there, it now has the opportunity to take the UKCA route if our capacity is in place, with the increases to the MHRA to which I referred.

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

Lord Lansley Excerpts

Thursday 25th May 2023 Lords Chamber

I appeal to the Minister. We have had a number of debates in the past and, frankly, the line in the IA is the line the department has used for 20 years. The noble Lord, Lord Warner and I, are aware of the tensions within the Department of Health in managing the NHS budget on the one hand and, for much of that time, sponsoring the industry. I suspect that the noble Lord, Lord Lansley, faced similar issues. We are at a critical stage. The Minister will know that the UK economy is fragile. We desperately need to grow the life sciences sector, but the action the Government seem to be taking with the industry is guaranteed to ensure that this will not happen. I very much hope that the Government will listen and that this will inform their negotiations with industry on the new VPAS. I beg to move.

[Lord Lansley (Con)]

My Lords, I intervene in this short debate just to make a number of points that I feel strongly about and have done for quite a long time, because now is an important moment, when the Government are entering the process of negotiating the voluntary price access scheme starting at the beginning of next year.

I welcome the fact that the noble Lord, Lord Hunt of Kings Heath, has sought and secured this debate: it is really important. I do not disagree with any of the points he made, and he and I know that in past debates, together with the noble Lord, Lord Warner, we have often made these points—not least when we were debating the legislation which has given the Government the powers to secure whatever pricing outcome they are looking for, frankly. We do not actually have any pharmaceutical pricing freedom in this country; we effectively have government control of it.

The purpose of the regulations is not really in debate: to ensure that the statutory scheme and voluntary scheme align. We have been in a position where they did not align when we had the Gilead example, and that is not a place we want to go back to; we want to ensure that the schemes align, if we need two such schemes at all. That is my starting point. I have no registrable interests, although as a former Secretary of State I was very much involved in these issues, and as a Member of Parliament for South Cambridgeshire I probably had, in my time in the other place, a greater interest directly in the pharmaceutical industry, the life sciences sector and the R&D activity in this country than did Members for any other constituency.

I am sure the noble Lord, Lord Hunt of Kings Heath, is right that there is a relationship at this point between the scheme’s rebate level and the willingness or otherwise of internationally mobile investment and international pharmaceutical boards to consider the United Kingdom as a location for investment. The impact assessment does not sufficiently recognise that truth. It more or less works on the basis that this was the result of the old scheme, it is all for a few months and will all be replaced next year. I fear that is not how the world works. There will be discussions at international board level where people say, “We used to think the United Kingdom was the best place in Europe”—arguably, the best place in the world—“to conduct pharmaceutical research, but at the moment we are not sure that is the case because, if we were to launch in the United Kingdom, the level of pricing rebate being imposed on us makes the risks associated too great”.

From my point of view, clearly this can be remedied with a VPAS next year which re-establishes, from the industry’s point of view, a more predictable level of rebate. I have to say that the VPAS, the statutory scheme, is based on a serious fallacy that there is such a thing within the healthcare industry of a fixed drugs budget. I know of no healthcare system that thinks that is a logical way of approaching it. The drugs budget must be part of a health budget. We have budgets in order to deliver health outcomes. We do not have a drugs budget in order to secure a health outcome, we have a total health budget. The idea that the Government should intervene in order specifically to confine and restrict the amount that we spend on medicines in the healthcare system is wrong.

We should try to get away from that. I am not saying that we should not try to ensure that we get the best possible value for money for the medicines that we buy. The NHS in this country is effectively a monopsony, so we have every possibility of having extremely competitive medicine prices, but frankly we are being, as my mother would have said, penny wise and pound foolish. If we save a bit on NHS purchasing and parade to the rest of the world that we have the lowest medicine prices, the inevitable result—which we have seen—is a doubling of the number of pharmaceutical companies withdrawing their products from NICE evaluations. That is not a place where we want to be. We want those evaluations to take place.

I am going to finish with this thought. Even at this stage, I hope they are looking at this not only in the pharmaceutical companies, not only in ABPI but inside the department and inside the Treasury. I think all of our experience is that at the end of the day these things were determined more in the Treasury and No. 10 than they were in the Department of Health. I did not actually see a PPRS negotiation completed in my time, but I know perfectly well that is what happens. When they read this, I hope they will say: “Why don’t we move away from this kind of system?” The idea of a rate of return regulation as a mechanism for industry control is so out of date, it is practically neolithic. We have the benefit in this country of the National Institute for Health and Care Excellence which has acknowledged expertise in health technology assessment. It should make assessments.

We have in NHS England an increased capacity and propensity to negotiate medicines prices regardless of what NICE says about evaluations anyway. Let us put those two together—we have argued this many times—and enter into negotiations on medicines pricing with the industry. Wherever we can, we should operate on the basis of a market. We have a market in generics and biosimilars. We are close to market on branded generics and biosimilars, but the branded medicines are inside this scheme. They should not be inside it; they should be the subject of negotiated pricing in what is effectively a market context. They should have to demonstrate where there is a benefit to a branded generic or a branded biosimilar relative to one which is not branded but is simply generic.

But for those where there is exclusivity, clearly there is going to be a negotiated price, and it is in our interests for that negotiation to take account not only of the incremental cost effectiveness, not only the quali-benefit, as it were, but also the societal benefits and the innovation benefit of new medicines. Let us say for the sake of argument that in the course of the next five years we were suddenly to find that we had a blockbuster new medicine that gave us immense advantages in terms of delaying the onset of dementia. It is not inconceivable that that could happen. As things stand, the scheme is designed for the pharmaceutical industry to derive no benefit from the fact that it has brought forward a new medicine of that scale and advantage. That cannot be right. If, in the context of healthcare, medicines occupy a stronger position, they should secure greater funding. If, relative to them, medicines do not do the job, they should have lesser funding, but this should be a healthcare and a health budget calculation, not a rate-of-return prior regulation. I hope that, even at this stage, the Government and the industry will think of whether there might be a better way of conducting negotiations on medicines pricing in this country.

NHS Winter Pressures

Lord Lansley Excerpts

Tuesday 10th January 2023 Lords Chamber

[Lord Markham (Con)]

First, I welcome the noble Baroness to the NHS England board, with high expectation of the value that she will add to it. I am very interested to understand her point further; I will speak to Minister Whately about that and respond to the noble Baroness in writing. Where people have knowledge of a patient at home, they can add that to their care when they come back out again.

[Lord Lansley (Con)]

My Lords, one of the lessons we learned, sometimes very painfully, during the earlier stages of the pandemic was the importance of working with, and often through, local government to tackle some of these issues. The same is true now. Would my noble friend explain how the NHS will use discharge funding and purchase social care provision? Will integrated care boards do that locally with local government, which has been managing social care purchasing for decades?

[Lord Markham (Con)]

I thank my noble friend. The best ICBs that I have seen have the local authority as part of their board and their decision-making on a day in, day out basis. One of the best control systems that I saw in an ICB actually had the local authority social care people in the room making the decisions with them, so they are a key element in all of this. On purchasing and funding, they are very much a strong player.

NHS Industrial Action: Government Preparations

Lord Lansley Excerpts

Tuesday 13th December 2022 Lords Chamber

[Lord Markham (Con)]

I do not have those figures to hand, but I believe there is a Question on this subject tomorrow, when we will be talking very much about the use of agency staff and bank staff. From memory—the right reverend Prelate will get the exact figures when I have done a bit more swotting up overnight—I think the cost of agency and bank staff work this year is around £3 billion. Clearly, the workforce strategy will be all about making sure we can recruit staff to minimise that.

[Lord Lansley (Con)]

My noble friend referred to the NHS Pay Review Body. As Secretary of State, I thought it was rather important that I did not determine the pay of nurses, for example; the pay review body made recommendations and I adhered to them. Will the Government continue to explain that they are not refusing to negotiate on pay with the trade unions but adhering to a long-established principle? The trade unions appear to be seeking somehow to overturn last April’s pay award, when they should be providing evidence to the pay review body on what the pay award should be next April, with the remit letter already published.

[Lord Markham (Con)]

I thank my noble friend for his question. He is quite right. As mentioned before, this body was set up in 1984 and extended to other areas of the health service in 2007. Since then, Governments of all colours have followed its recommendations because, after all, it is the expert in this field. We have honoured that in full because it is right that the experts determine it. Working towards making sure that the next settlement in April—which, let us face it, is only three or four months away—covers the latest situation would be a good way ahead.

Health Promotion Bill [HL]

Lord Lansley Excerpts

2nd reading
Friday 2nd December 2022 Lords Chamber

[Lord Lansley (Con)]

My Lords, I am glad to follow the noble Lord and to welcome his Bill, not only because I agree with its content but because it affords us an important opportunity to discuss how we might improve public health through not only legislation but local, voluntary and community action. I declare an interest: I have a long-standing relationship with ukactive. In that context, I mention the recently retired chair of ukactive, our own noble Baroness, Lady Grey-Thompson, who participated in the debates about a national plan for sport and recreation to which the noble Lord referred. I thoroughly endorse what that committee had to say and the purposes of his Bill.

I will go a bit wider in the public health context and talk about the structure of support for the promotion of public health in this country. Noble Lords will recall that I was responsible for health in the coalition Government for two and a half years. We published the Healthy Lives, Healthy People White Paper in December 2010—exactly 12 years ago—and if anyone wants to see my prescription for public health, they still only have to look at that. It followed and reflected Sir Michael Marmot’s ground-breaking work on the social determinants of health and a “life course framework” for working on public health issues.

The Government have recently talked about the importance of preventive work through the NHS, which I thoroughly endorse. But, although preventive services are a key priority for the NHS, they are not a substitute for a government-wide and societal focus on improving public health. Inequality, poor housing, environmental quality—we discussed this on Third Reading of the clean air Bill—and, not least, economic disadvantage are the major social determinants of health. They require Governments to provide leadership, resources and structures to help us improve public health across society.

This was the originating purpose of Public Health England, which pursued both this agenda and the complementary tasks of combating the key risks associated with poor mental health: tobacco and smoking; obesity, both in terms of diet and activity; air quality; drug misuse; and sexual health. The then Government brought forward plans to address each of those causes of poor health. For example, my noble friend will, I hope, tell us that a tobacco control plan renewal will not be far off.

This was not done at the expense of the health security functions, in respect of which UK expertise was, and is, internationally recognised. For example, in the year following the White Paper, the pandemic flu preparedness plan was published. However, within two years of its establishment, Public Health England’s capacity to meet its responsibilities was progressively limited because of budget cuts and staffing limits. From 2015 onwards, local government’s public health grant was cut by £200 million, and Public Health England saw a 40% reduction in its real-terms funding, reducing its capacity by a quarter.

The classification of Public Health England as not part of the NHS was wrong at the time and a mistake in public policy terms, and in the pandemic we paid for the results of that mistake in lives and many billions of pounds. Public health policies should seek to address both communicable and non-communicable diseases. The pandemic demonstrated, not least in this country, the interaction between vulnerabilities to infection and the effects of chronic disease in the population, often as a result of smoking, poor diet or inactivity.

The resulting division of Public Health England into two organisations is therefore a mistake. The perceived reduction in the independence of the Office for Health Improvement and Disparities, compared with Public Health England—although both are in fact executive agencies directly accountable to the Secretary of State—is also a mistake and risks undermining future responses to public health challenges, not least by failing to engage and mobilise local government. During the pandemic, we saw how important this was and what might have been, had the Government engaged it more fully at an early stage.

The scapegoating of Public Health England, which in reality resulted from a lack of investment in it, should be called out in the coming public inquiry. Public health should, like tackling climate change, be a priority across government, with leadership from the top and dedicated funding. I believe that Public Health England was the right structural approach, as was the transferring of public health responsibilities to local government. We lose tens of thousands of lives prematurely every year because of smoking, alcohol abuse, poor diet and inactivity. During the pandemic, deaths in all of the older age groups were much exacerbated by obesity and diabetes.

So improving our public health, including by enhancing our environments, reducing inequalities, increasing physical activity and reducing average calorie intake—with less alcohol abuse and drug misuse, and stopping smoking—would be central to our future health security every bit as much as the investment in surveillance and the response to infectious diseases. There is a case not only for the changes proposed in the Bill, but to go further and reintegrate the public health function in an agency that leads for this purpose both across government and in society.

Tobacco Control Plan

Lord Lansley Excerpts

Wednesday 23rd November 2022 Lords Chamber

[Lord Markham (Con)]

First, I thank the noble Lord for all his work to reduce smoking; I am grateful for it every time I walk into a smoke-free environment in the evening. As he said, a cross-party approach has achieved many great things. As the noble Lord knows, there are some quite radical things in the Khan review, such as increasing the smoking age every year, which would in effect ban smoking altogether. There are many pros and cons to the prohibition argument, but it is something we take very seriously and we will publish our response. I assure noble Lords that we are going to tackle this issue.

[Lord Lansley (Con)]

My Lords, does my noble friend recall that in the former coalition Government, we made considerable progress in reducing smoking in this country, not least by focusing on the level of initiation of smoking among young people? We banned vending machines, for example. Will the Government consider raising from 18 the age at which young people can buy cigarettes?

[Lord Markham (Con)]

I agree with my noble friend. The key age group to attack, so to speak, is 16 to 18-year-olds, which is often when the smoking habit begins. We must look seriously at every step we can take to reduce smoking in that age group. I am also aware that 18 is the age of consent, of being able to do lots of things, and changing that for smoking would obviously be quite a radical step, but everything is on the table as we review the best way forward.

Childhood Obesity

Lord Lansley Excerpts

Thursday 17th November 2022 Lords Chamber

[Lord Markham (Con)]

I agree with the noble Lord that a healthy lifestyle in terms of exercise gets only you so far and that the amount we eat is critical to that. We have played a very active role on sugar reduction—of course, I say this in the context of this being Sugar Awareness Week. Obviously, the sugary drinks levy has reduced sugar in soft drinks by 44% by using artificial sweeteners, so this is something we will look to continue to research and to add to, if the evidence backs it up.

[Lord Lansley (Con)]

My Lords, I draw attention to my registered relationship with ukactive. I ask my noble friend whether he would agree that there is, on this occasion, as the noble Lord, Lord Stevens of Birmingham, said once, a silver bullet: it is called physical activity. This is in line with the question from the noble Baroness, Lady Hoey. In supporting physical activity, my experience was that the Department of Health needed to work with DCMS and the Department for Education to promote school sport partnerships. In my former constituency, 51 primary schools benefit from the school sport partnerships. It is a really important priority that every youngster, not just those who are really good at sport, gets the chance for that physical activity.

Maternity and Neonatal Services

Lord Lansley Excerpts

Tuesday 25th October 2022 Lords Chamber

[Lord Markham (Con)]

I agree about wanting to implement the recommendations. My colleague Dr Johnson, the Minister in the other House, already met with Dr Kirkup this week. We also undertook to come back in the next four to six months with where we are on each of the recommendations. I will bring that back to the House then.

[Lord Lansley (Con)]

My noble friend referred to the first recommendation for the prompt establishment of a taskforce to develop maternity and neonatal outcome measures. It is over a decade since we introduced the NHS outcomes framework but, far too often, it is not used as the basis for accountability inside the National Health Service. Will he say whether that first recommendation will be acted on immediately?

[Lord Markham (Con)]

As I mentioned before, we have already put this in place with the maternity quality surveillance framework. At the same time, if we feel that more needs to be done, it will be included in my review of the recommendations and report back to the House in four to six months.

National Institute for Health and Care Excellence

Lord Lansley Excerpts

Monday 23rd May 2022 Lords Chamber

[Lord Kamall (Con)]

NICE has recently concluded a comprehensive review of its methods. It wants to introduce greater flexibility in the appraisal of medicines for more severe diseases but is also reviewing the criteria for highly specialised technologies, to make them clearer and more specific. We hope this will benefit medicines for patients with rare diseases and improve equitable access to new and innovative treatment. On the exact detail, I am afraid I am going to have to write to the noble Lord.

[Lord Lansley (Con)]

My Lords, would my noble friend agree with me that the publication by NICE last month, about its work on evaluating new treatments for severe drug-resistant infection, was really valuable, in that it looked at the benefits across the health system as a whole as the basis for an assessment of what an annual subscription for such drugs might be? Can my noble friend say how the Government are taking this work—which is a world first—and working with other countries to try to ensure that, collectively, that kind of subscription can incentivise the drugs industry to bring new treatments for antimicrobial resistance to the market?

[Lord Kamall (Con)]

I thank my noble friend for the question but also for highlighting the fact that NICE is trying to change the way it works to be more flexible and responsive. The new subscription-style payment model that the NHS is developing has been designed to try to address the lack of new antimicrobials being developed and the growing threat posed by antimicrobial resistance, or AMR. The recent guidance from NICE on the two new AMRs is a world first and an important step forward. What NHS England has now got to do is enter into negotiations with the manufacturer, with a view to making them available to NHS patients.

Health and Care Bill

Lord Lansley Excerpts

Consideration of Commons amendments
Tuesday 5th April 2022 Lords Chamber

[Baroness Pitkeathley (Lab)]

My Lords, I rise to express support for the Motion in the name of my noble friend on the Front Bench but principally to comment on Motion E. I know that the Minister and his officials listened carefully and took note of the strength of feeling about unpaid carers expressed on all sides of your Lordships’ House in Committee and on Report. I am most grateful for that strength of feeling and the wise advice given by this House, which has resulted in what I would describe as a satisfactory outcome in the form of a new amendment.

The other place has replaced the amendment passed by a large majority in your Lordships’ House and put forward its own, which was accepted there and brought to us today. I am most grateful to the Minister and all his officials for the work that they have put into drafting this amendment, and for the understanding shown for the position of unpaid carers and the importance of involving patients and carers in discharge planning, as soon as is feasible in that process.

I seek the Minister’s further assurance on a couple of other points. The first is that parent carers are not excluded when a disabled child is discharged from hospital. This is referred to in the guidance when their own discharge is happening but not when the child they care for is being discharged. We need to ensure that services across different disciplines are married up. I know that other Lords and colleagues will be seeking assurances about this and about young carers.

My second point is that the guidance contains references to checking that a carer is willing and able to care. I hope that the Minister may be able to enlarge on this a bit. There will be occasions when the carer’s own situation makes caring impossible: they may simply be too ill to take on the responsibility, for example, however willing they may be. We need to ensure that no pressure is brought to bear in such a situation and that no assumptions are made in the discharge process about the carer’s ability. We have all seen too many examples of where this was not acknowledged, inevitably leading to the readmission of the patient.

We all seek to make hospital discharges as safe and efficient as possible, while not exerting undue pressure on the most important components: the patient and their carers. Of course, we shall need to monitor carefully how the guidance is applied, and we have to be sure too that carers are informed about their rights. I hope that the Minister’s department will promote suitable publicity as the reforms are implemented. I assure him that I, Carers UK and, I am sure, other Peers will be constantly on the case to ensure that carers and patients can trust the discharge system to support them.

[Lord Lansley (Con)]

My Lords, I want to contribute to this group and speak to Motions G1, G2 and H. As context, I say that my noble friend, the Front Bench team and their Bill team have gone to enormous efforts to try to reach a number of compromises; at this stage it is incumbent on us to recognise that. If we were to send further amendments to the other place, we should confine ourselves to doing so only in circumstances where we believe that there is a realistic prospect of reaching a compromise on them.

I was a signatory to Amendment 80. There was a compelling reason to send that to the other place and ask it to consider again the question of excluding local authority contributions from the calculation of the social care cap. The reason was, very straightforwardly, that it was introduced in the Commons at a late stage in the passage of the Bill. At that point—on Report—MPs themselves complained vociferously that they had not had an opportunity to consider it for any period of time, so it has gone back. In sending it back, we have done our job, but I am afraid I see no evidence that the Government, given their majority in the Commons, are going to reconsider the central question of excluding local authority contributions from the cap. I think they are wrong but, particularly given the substantial financial consequences it would entail, it would be wrong for us to think that we could insist—and if we cannot insist, we should not send it back.

Where Motion H is concerned, I am grateful to the noble Lord, Lord Warner, who kindly moved my amendment—which was entirely in my name— as at that point I was down with Covid for the first time. I would not now insist on that provision, not least because it entails financial privilege. From my point of view, it was to say, “Would you please get on with it?” My noble friend said in his introduction that the Government are getting on with it. I can promise him that, if they do not get on with it by the latter part of next year, we will be complaining and will be right to do so.

I turn to Motion G. Why have I tabled Motion G2? I confess that I have done it not in the expectation that we will send it to the other place because, as my noble friend said, that would be to intervene with quite a significant argument at this very late stage. However, I think the development of these arguments on the part of the Government has been quite interesting. First, they said, “Well, we are doing something and something is better than nothing.” Indeed, something is better than nothing, but it is not necessarily the best thing. So we said, “Hang on a minute. You said you would do this last September and introduce the cap.” We thought they were doing something that was very much in line with the Dilnot recommendations, even if the cap was set at a higher level, but it then turned out that they were not and that they were excluding local authority contributions.

On the financial implications of that, as the noble Baroness, Lady Wheeler, set out very well, if it saves £900 million, from whom principally is that saving to be derived? It is from those who are otherwise the beneficiaries of local authority contributions and who, as a consequence, are not asked to pay towards the cap. As the noble Baroness said, particularly if they have dementia and long-term care needs, over the years their assets will be substantially more depleted than would otherwise have been the case. I do not think we should kid ourselves: the Government are planning to do something which, in my view, exacerbates significantly the inequitable characteristics of the way the cap works. It is regressive in its effects.

Curiously, when they were debating this at the other end, they looked at the risk that incorporating local authority contributions would mean that, in different places across the country, different local authorities would provide different levels of contributions and therefore people would end up with some inequity in the amount they had to pay. This is no doubt true, but it feels like the Government shrieked at the mouse of inequity that would result from that and ignored the elephant of inequity that is in the removal of the local authority contribution to the cap.

I am always rather amused when the Minister is briefed—this happened at the other end as well—to tell us about what happened in 2012 or 2014 on the Care Act. Yes, Andrew Dilnot looked at whether the cap should be expressed as a percentage of people’s assets and did not recommend it, but that is not what is proposed in Motion G2. The model that was rejected was that there would not be a cap figure and that the cap would simply be expressed as a percentage—the so-called limited liability model. We did not support it, but the Dilnot model also had a lower cap and its structure, with the changes in the means test, would have had the effect that nobody would have lost more than about 45% of their assets. The structure the Government are now bringing in will mean that people with relatively few assets will continue to lose, in effect, 100% of their assets. As the noble Baroness, Lady Wheeler, correctly said, people who have substantial assets will only ever lose a modest proportion of those. It is not fair.

I am going to retreat, but I tell my noble friend that I think the Government should say, and I hope he will say in response, that if this turns out to be inequitable, which I believe it will, and the Government want to find the money to do something about it, they have the means to do so. I think that using the concept of a percentage of one’s assets is a legitimate way of doing it. Finally, just to put this on the record, my noble friend said that we cannot do that and that it is unworkable because people’s assets are constantly changing. No: if you do it in the context of the cap, people whose assets are significantly in excess of the requisite calculation of the amount of relevant assets would never have to be checked again. It is therefore perfectly possible to do it in relation only to those people whose financial means have to be regularly assessed for the purposes of the local authority means test in any case.

It is entirely workable; it could be done. Frankly, I think that with the passage of time the Government will realise that it is a better way of managing the cap; saying, for example, that 50% or 60% of one’s assets may be required to meet the cap but never as much as 100%. So I am retreating, and I encourage noble Lords not to insist on something that has substantial financial implications and on which the other place—as was quite clear from the debate—is not willing to shift. I hope my noble friend will say that, if this or indeed any future Government were to decide that they wanted to ameliorate the regressive effects of the exclusion of local authority contributions, there are other routes to doing so. Setting a percentage of the assets of people who are subjected to the means test as their contribution to the cap would be an effective way.