NHS: Treatment of Children from Other Countries

Lord Lansley Excerpts

Thursday 21st November 2024 Lords Chamber

[Baroness Merron (Lab)]

I will certainly ensure that officials take up the suggestion of the noble Baroness to explore possibilities.

[Lord Lansley (Con)]

My Lords, one of the reasons why people are envious of the NHS is because we are able to do things through the NHS which are not necessarily able to be supported in other countries by private medical insurance, and we have the benefit here of some of the finest clinicians in the world. That is something I am sure the Minister will want to focus on when she meets Professor Jeelani. There will doubtless be very specific ways in which he and his team might be helped, but could she bear in mind the fundamental principle that only about one in three million babies is in this condition and they have no hope other than to be treated by his excellent team? That is a responsibility, regardless of residence and those definitions, that we probably take on board through the NHS.

[Baroness Merron (Lab)]

I understand the point that the noble Lord makes and am sympathetic to it. He will also understand the need to ensure not only that we have the expertise here and use it correctly, but that the payment is in place so that the areas of excellence can also meet the requirements of other demands on them, including the reduction of waiting lists. He knows that it is a very delicate balance and that is why it is right that this is a trust-based approach, but I will certainly bear that in mind when I meet the professor.

Cancer: Older People

Lord Lansley Excerpts

Tuesday 19th November 2024 Lords Chamber

[Baroness Merron (Lab)]

I thank my noble friend for her confidence, and I will do my best. Decisions on screening, including the age ranges at which they operate, are made by the UK National Screening Committee. They have an upper and a lower age limit, which are based on evidence and kept under review. Current evidence does not support making changes to these ages. For breast screening, for example, self-referral is available for those over the age of 71 and for bowel screening it is available for those over 75. I confirm to her that this is all evidence-based, and we always keep an eye on the continuing evidence.

[Lord Lansley (Con)]

My Lords, I declare an interest in that I am a happy statistic of having survived more than five years after cancer treatment. But I know that I am not alone and that many others of the near 2 million cancer survivors have chronic conditions resulting either from cancer or from its treatment. Will the cancer strategy recognise and offer support to the many cancer survivors who have continuing chronic conditions resulting from their cancer?

[Baroness Merron (Lab)]

I am glad that the noble Lord is, as he describes himself, a happy statistic. We are all grateful for that. I certainly share the view that there are a number of ongoing chronic conditions and impacts on other aspects, such as people’s mental health. The cancer strategy needs to look at this in its development, and I am grateful to him for highlighting it.

NHS: Independent Investigation

Lord Lansley Excerpts

Tuesday 8th October 2024 Lords Chamber

[Baroness Merron (Lab)]

I am sorry to hear of the circumstance that the noble Baroness raises. I agree with her about the pressure on GPs who, of course, are working harder than ever. We know, not just through the Darzi report but through much evidence, that discharge into the community has to take place at the right time and with the right support, and that is not the case at present. I will certainly take up the specific thing the noble Baroness asks for and look into it in far greater detail, because this is clearly a practice, as she described, that is not supporting patients or GPs but working against them.

[Lord Lansley (Con)]

A wholly different report could have been written based on the underpinning evidence. To that extent, the report may call itself independent but it was not objective. If the Minister subscribes to some of the hyperbolic criticisms of the 2012 Act, can she then explain how the NHS in Labour-run Wales—where the 2012 Act had no effect whatever—performed worse on almost every measure of performance? She said that output was what matters. Can she therefore confirm that productivity in the NHS rose after 2010, relative to the preceding period, up until the pandemic? Can she actually agree that it is outcomes that matter most? Will she say that the Government will maintain the progress that needs to be made in making the NHS accountable to the NHS outcomes framework that we established a decade ago?

Finally, to revert to what my noble friend and the noble Lord, Lord Scriven, rightly asked about, in the last decade the 10-year plan has been something that the NHS owned. There was the five-year forward view in 2014 and the 10-year plan in 2019, and now in 2024 the NHS should own the refresh of the 10-year plan, but I do not think that is going to be the case. Can the Minister explain why the Government are taking that earned autonomy away from the NHS?

[Baroness Merron (Lab)]

I do not recognise the description of taking autonomy away; I appreciate that that is the noble Lord’s opinion. The National Health Service is so key to not just our health and well-being but the economic health of this country. In my opinion, it is something of a backbone of the country. It is right that the Government have made this an absolute priority and have commissioned a very honest report—I hear his criticisms of the report; they are not ones that I share—and that the Government are held accountable. That does not mean taking away autonomy from the NHS. I accept the noble Lord’s point that it is outcomes that matter, and perhaps I should have put that better because by output I mean things not just being done but actually being effective. I thank him for that point.

On frameworks and meeting obligations, one of the points made not just in the Darzi report but elsewhere is on how many of the standards are not being met. We will return to a number of the standards to ensure that people can feel that they know what they are going to get and within what timeframe, and that that will be absolutely possible. We are interested only in what works. We are not interested in scoring points; we are interested in improving the health and well-being of the nation, and I hope noble Lords will want to join with that.

Covid-19 Inquiry

Lord Lansley Excerpts

Tuesday 3rd September 2024 Lords Chamber

[Lord Lansley (Con)]

My Lords, I am very pleased to contribute to this debate and to follow the noble Baroness, Lady Thornton. One should never underestimate the importance of the Official Opposition in securing the role of good government. I am slightly hoping that the noble Baroness, Lady Merron, will recall that I was the shadow Secretary of State for Health when she was Minister of State for Public Health during the swine flu pandemic. I give credit to her and to the then Secretary of State, Andy Burnham—and indeed to Alan Johnson previously—because they were always very open. She will know that it was one of the things I was very interested in before the 2010 election. I asked specifically for an evaluation by the Health Protection Agency of the containment phase of the response to the swine flu pandemic. Although people might imagine that we did not do this, we were looking carefully at what the potential for containment of an influenza epidemic looked like and how we might do more in that respect.

I should declare an interest: I was Secretary of State between 2010 and 2012. In that context I was, strictly speaking, the author of the 2011 pandemic influenza preparedness plan. I am not going to go on at length about it, but I have my personal criticisms of the way the inquiry has been conducted, which I hope can be remedied in part by the government response which the Minister said will be coming in the months ahead. It is very important for the Government to ensure that any flaws in the inquiry report are themselves challenged, because the inquiry may have been prone to groupthink as well, by imagining that there were certain conclusions that it was bound to reach and then aiming for them.

My problem with the process is that, as a number of noble Lords have said, there is criticism of flaws in the 2011 preparedness plan. The inquiry did not ask me for evidence. It did not invite me to give oral evidence or ask me for written evidence. Notwithstanding that, it then chose to send me a rule 13 letter, making what were not specific individual criticisms but generalised criticisms of Secretaries of State over a period that included me. I then had three weeks in which to send it what were pages and pages of corrections, some of which it took on board, and others it did not. Although I will not go through them in detail, there are things the report says about the period running up to the 2011 pandemic influenza preparedness plan and the use of it which are absolutely wrong. It is not fair for it to say that we should have looked at other emerging infectious diseases in the same way that we looked at avian influenza.

I was responding, and I knew it, to the national risk register. It said that H5N1 was going to have a very high mortality rate when it was transmitted to humans, and therefore was immensely dangerous. If it were to mutate to the point at which it would be readily transmissible between people, we would be facing a pandemic on at least the scale of Spanish flu. I was very focused on that, because that is what the risk assessments told me to do. Let us not leave aside the central importance of looking at risk and understanding the various components of the risks that we face. To be fair, the national risk register and the risk assessments took account of other emerging infectious diseases—hence the establishment of NERVTAG.

We should be much more aware of the risk of the next pandemic—we may be in it. The scale of the impact of antimicrobial resistance on global population and mortality could potentially be worse than the Covid-19 pandemic. We know that many emerging infectious diseases are zoonoses, and we may see in them characteristics that we do not recognise from either influenza or coronaviruses; it may be something completely different, and the vectors of transmission may be completely different.

I do not want to go on about it at length, but I want to talk about the idea that, in 2011, we should have had a pandemic plan that looked at other potential pandemics. It would not have changed the outcome in 2020. Why? Because when you look at the 2011 pandemic preparedness plan, you find that many of the potential countermeasures were either not considered or the evidence base we were presented with and on which Ministers were working said that they would not work.

The evidence base said that respirators and face masks were right for preventing transmission by a person but that they were probably not going to be effective in the population as a whole. We may now conclude that that was wrong, but that was the advice we were given at the time. The advice given at the time was that school closure should have been a limited measure, devoted to specific high-impact areas and events. That may have been wrong, but it was the advice given at the time. The advice given at the time was that we stood no chance of containing a pandemic by controlling access to airports.

If somebody had come along, by some mystery, and told us in 2011 that we were going to be presented with a coronavirus pandemic of the scale that we subsequently encountered, many of the measures that we deployed—including lockdowns, which were not recommended in relation to pandemic influenza—would not have been recommended. The pandemic plan may have been a pandemic plan for some other virus, but it would not necessarily have been any different from that which was prepared for pandemic influenza.

Therefore, there are two key points when it comes to what our preparedness should look like. The first is understanding at the earliest possible moment what a new virus or infectious disease actually looks like. How is it transmitted and by what means? What is the incubation period? What are the clinical characteristics? In 2011, the idea that we could be presented with something with a long incubation period and asymptomatic transmission was not contemplated, and so the idea that in 2011 we would have understood this and prepared for it is fanciful.

The point that the inquiry looks at but does not really focus on is the second key part of preparedness: making the country resilient by making people and our public health system more resilient. I put in parentheses that the public health White Paper of December 2010, establishing Public Health England, did so on the basis that its budget would increase at the same rate as the NHS budget. In 2015, this was trashed by the Treasury. Unfortunately, I think Secretary of State Hunt let that happen. You can look at the evidence to the inquiry from Duncan Selbie, former chief executive of Public Health England, to see the serious adverse consequences that resulted from the £200 million cut in that year and in subsequent years to the public health budget.

Not only that, but we must understand that, around the world, some populations were more resilient because they were less unequal. Equality matters. The coalition Government had this as an explicit objective of our policy, and I personally very much subscribe to it. Our public health needs us to be much more equal and for disadvantage to be actively challenged. That is why I supported Michael Marmot in the latter part of his further inquiries.

I encourage the Minister, in the work that will be done in government, not simply to respond to this module —and, as the noble Baroness, Lady Thornton, rightly said, to later modules—with what the present Labour Administration think or thought at the time but to challenge some of the things that the inquiry says if it is conducting itself on a basis which is not a reasonable one for us to have worked on in the past. To make conclusions that are unjustified seems to be a bad way of reviewing the evidence and thinking for the future.

Finally, when the inquiry moves on to later stages, I hope it will return to the question of what was done in 2016 on Exercise Cygnus and after it. If we are going to do better in future, having plans is critical. As von Clausewitz would have said, having plans will never stand contact with reality but having no plan gets you nowhere. It is important to have plans and to expose those plans to serious scrutiny, including by Ministers, as well as officials, and to follow up on those plans.

Everything tells me that the 2011 preparedness plan was not the problem. The problem, as Sally Davies said in evidence to the inquiry, was that it was not reviewed, updated and properly looked at in 2016 as it should have been. After Exercise Cygnus, there should have been a new and additional preparedness plan related to what we had then understood to be different threats from MERS and SARS. That did not happen. The follow-up to Exercise Cygnus did not happen as it should have. Having these exercises, preparing the scenarios and following up on them is absolutely critical to our overall preparedness, as is reforming our ability to influence the public health of this country.

Anaesthesia Associates and Physician Associates Order 2024

Lord Lansley Excerpts

Monday 26th February 2024 Lords Chamber

I ask the Minister to think very carefully whether or not we should be blurring the notion between those who are medically qualified and those who are not. By giving those who are not medically qualified some idea that they are, we are running the risk that this sort of accident can happen. These accidents are rare, but they are completely unexpected and unpredictable. An anaesthetist has to recognise the unexpected. That is not something that most individuals can do; I, as a different kind of doctor, could not do that. I had no idea what had happened to the young woman. I was prepared to do open-heart surgery while there was nobody else in the theatre, which would have been ridiculous. But my anaesthetist was there to hold my hand—metaphorically—and rescued the young woman. We must recognise this is a very serious issue: what you call the doctor or the assistant is extremely important.

[Lord Lansley (Con)]

I am very glad to follow the noble Lord, Lord Winston, because he directs us to the central issue, of how we seek to ensure the safety of patients in all circumstances. What he was describing illustrates the essence of the relationship of a physician associate—or, for that matter, an anaesthesia associate—to the supervising doctor. That is a central issue as well. In the circumstances that we were just hearing about, the responsibility of the doctor or the consultant in charge of the patient is the central responsibility. It would be wrong to think that the devolution of tasks to an associate removes the responsibility of the doctor in charge of that patient.

I hope we agree that proceeding with the order is necessary because we want to bring physician associates and anaesthesia associates within the scope of regulation. This process has been very useful, not least because my noble friend and his colleagues have given us considerable time and energy in discussing the order and how it is to be implemented.

I confess to the House that when I was Secretary of State back in 2010 to 2012, and as the noble Lord, Lord Markham, made clear, there were relatively few physician associates. I remember them as physician assistants. I remember the desire on the part of physicians to have additional resources available to support them in that role. It was never to replace doctors; it was always to enable physicians to focus on where their responsibilities lie. That is still the purpose and the point of physician associates. I am less familiar with anaesthesia associates, and in those days, I do not remember understanding that they were there in the form in which we now have a number.

None of this debate is about trying to criticise physician associates, anaesthesia associates or the profession as a whole. We are setting out to make sure that as they are brought into regulation, that regulation works most effectively. From my point of view, the simple fact of being brought under the regulation of the General Medical Council was not a problem, because the General Medical Council was clearly addressing all the issues very efficiently and professionally. However, because the GMC regulates doctors, I confess that there is a worry about the idea of another profession being regulated by it. If one says, “I am GMC registered”, what do people assume by that phrase? They assume that one is a doctor. The distinction that needs to be made between the medical register, the specialist registers and the register that is to be established for physician associates and anaesthesia associates is critical.

As for myself, I am perfectly clear in my mind and would have started out by assuming that PAs and AAs would be regulated by the Health and Care Professions Council. That clearly was not the route that was chosen. In my view, it is too late to revisit that. However, the distinction in the registers under the GMC must be very clear.

Equally, the scope of practice and what the noble Lord, Lord Hunt of Kings Heath, said about the governance of the trusts and the bodies responsible needs to be absolutely clear. In particular, the scope of practice is the essence of how we can ensure the safety of patients, so that the whole multidisciplinary team understands what their respective roles are. I am not sure that there is any merit in trying to understand which professions are responsible for which mistakes. Let us look at outcomes. The outcomes are the product of the multidisciplinary team and a group of professionals working together—they are not the results of individual professionals. Let us put that slightly to one side.

The only other thing that I feel very strongly about—which has been referred to in a number of respects—is that patients and the public need to understand who the professionals responsible for them or providing the service to them are. Let us be clear: we start from a point where I suspect that most patients in most circumstances where they are looked after by PAs or AAs do not know who they are and how they fit into the professional scene. It is not that we are looking to ensure that everybody needs to be educated about that—that is probably too hard a task—but I urge my noble friend the Minister, the regulators and the professionals involved to recognise that PAs or AAs do themselves and patients the greatest service by being absolutely clear at any moment—including proactively—that they are not the doctor in charge of that patient but that they are providing care under the supervision of the doctor for the given purpose. If anybody appears to be in any confusion whatever, it is important that that confusion is remedied. For patients, understanding who is doing what to them and why is an essential part of “no decision about me without me”.

While the order enables the regulation to proceed, I hope that our debates on it are not “fire and forget”. This is about a process that we should be looking at very carefully to understand whether the problems that we have referred to, and the difficulties and worries that we entertain while the order goes through, are dealt with in the subsequent regulation.

[Lord Harris of Haringey (Lab)]

My Lords, I declare my interest as the chair of the General Dental Council. It is not for me to comment extensively on matters affecting a fellow healthcare professional regulator, but I will say one thing directly in response to what the noble Lord, Lord Lansley, said about the substance of the order. Unlike the GMC, the GDC is responsible for all dental professionals, including dentists, dental nurses, dental technicians and so on in the four nations of the UK. I believe that it is helpful to the public to be assured that all the professionals they encounter when they enter a dental surgery will be registered as professionals by the same regulator and that they will have equal levels of assurance about the training and standards they can expect—and within a framework that indicates what the limits are of each of their professional responsibilities, what can and cannot be done, and how they are appropriately supervised.

My reason for intervening, however, is separate. The DHSC has made it clear that this order is the first step in the reform of the way that all the healthcare professionals are to be regulated. Indeed, it told the Secondary Legislation Scrutiny Committee that the intent is to provide all regulators with “broadly equivalent powers”. While the GDC is some way down the queue—it is after the NMC, the Health and Care Professions Council and so on; although it is still helpful to get in early—this is potentially a template that will apply to all the regulated professions.

I make it clear that regulatory reform is welcome and long overdue. The GDC’s framework was set out in the Dentists Act 1984—that legislation is 40 years old, with only limited updating since then; somehow, the GMC is slightly more prominent and gets more updating than some of the other professions. The Government first consulted about the scope of reform in 2017, following Law Commission recommendations three years earlier. It has taken a decade to get even to this stage, and we are still a very long way off from orders being prepared to cover the dental professions. By the time the orders for all the other professionals are agreed, the model in today’s order may be outdated.

The GDC welcomes the intention to give the regulatory bodies more authority to update their procedures and processes without recourse to Privy Council approval and the delays inherent in waiting for the DHSC to draft regulations and lay them before Parliament. Such updating would of course be subject to full consultation in each case by the regulators concerned and would be only in the framework laid out in orders such as the one we are debating. We need such reforms to enable regulators to operate as effectively as possible to protect the public better in the light of changes in the way the professions deliver their services.

NHS Dentistry

Lord Lansley Excerpts

Monday 19th February 2024 Lords Chamber

[Lord Markham (Con)]

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

[Lord Lansley (Con)]

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

[Lord Markham (Con)]

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

Food: Two-For-One Offers

Lord Lansley Excerpts

Wednesday 19th July 2023 Lords Chamber

[Lord Lansley (Con)]

Does my noble friend the Minister recall, on that exact point about access to fresh fruit and vegetables, the very successful scheme that we pioneered about 12 years ago with the Association of Convenience Stores so that corner shops would carry fresh fruit and vegetables close to the till and make them accessible, with us carrying the risk of wastage? That led to a significant increase in corner shops selling fresh fruit and vegetables.

[Lord Markham (Con)]

To me, that is a great example of how working in co-operation to allow people to make the right choices is the best way. For instance, 78% of shoppers have said that they are in favour of not having unhealthy items at the till because they know that they give in to pester power. That is why this has been focus of what we have done.

NHS Procurement: Palantir Contract

Lord Lansley Excerpts

Thursday 22nd June 2023 Lords Chamber

[Lord Markham (Con)]

This went through the long-term plan in 2019, and the idea behind it all—it was debated a lot as the Health and Care Act went through—was to provide an approach which allows the flexibility in place here. What we are doing here is very good: I do not think anyone would want to see hospitals left in the lurch and the impact that would have on waiting lists. This makes sure that we have a robust situation in place so that we have an open tender, which we are going through the process of right now to get the best solution for the NHS—something which I think we all want.

[Lord Lansley (Con)]

My Lords, my noble friend will recall that the review led by the noble Lord, Lord Carter of Coles, and followed up by Professor Briggs with the Getting it Right First Time programme, has made significant improvements in how the NHS procures its services. During the debates on the Procurement Bill—I hope my noble friend will say that this will indeed be taken up in the NHS—we talked about the promotion of innovation through public procurement. I wonder whether the Getting it Right First Time programme could be a mechanism for that, by bringing evidence-based innovation to the attention of procurement managers across the NHS.

[Lord Markham (Con)]

I thank my noble friend. This is absolutely about enabling innovation: the data platform is there so that providers can use it to innovate. We all hear about AI, and AI depends on data. This puts in place a data platform that AI can use. It can also be used for scheduling appointments—currently done in 32 hospitals—and for the dynamic discharge of waiting lists. All those applications can work in place only if we have an open tender process, which is exactly what we are doing here, while making sure that transitions are in place so that no hospital is left in the lurch in the meantime.

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.