(1 year, 10 months ago)
Lords ChamberThis 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.
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.
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.
(1 year, 10 months ago)
Grand CommitteeMy 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.
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.
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.
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.
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.
(1 year, 11 months ago)
Lords ChamberMy 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.
(2 years, 3 months ago)
Lords ChamberFirst, 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.
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?
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.
(2 years, 4 months ago)
Lords ChamberI 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.
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.
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.
(2 years, 4 months ago)
Lords ChamberMy 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.
(2 years, 5 months ago)
Lords ChamberFirst, 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.
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?
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.
(2 years, 5 months ago)
Lords ChamberI 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.
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.
(2 years, 6 months ago)
Lords ChamberI 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.
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?
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.
(2 years, 11 months ago)
Lords ChamberNICE 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.
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?
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.