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.

Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022

Lord Lansley Excerpts

Monday 14th March 2022 Grand Committee

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

My Lords, we are here this afternoon to debate two important statutory instruments which will amend provisions in the Human Medicines Regulations 2012 and support our work to ensure continued access to critical vaccines and medicines across the country. The first SI will maintain vital arrangements which have underpinned our vaccination campaigns against flu and Covid-19. The second SI will support our ambitions to ensure that patients with unmet clinical needs can access the innovative treatments they need. I am grateful to be able to debate such important provisions today.

The purpose of the provisions I have laid in the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations—which I will refer to as “the regulations”—is to amend the temporary provisions that cease to have effect on 1 April this year. They support the continued deployment of safe and effective Covid-19 and flu vaccinations at the pace and scale required both now and in the future as part of the pandemic response. This SI amends provisions in the Human Medicines Regulations 2012, SI 2012/1916, originally amended by the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020, SI 2020/1125, and the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020, SI 2020/1594, either to make permanent or extend by a further two years these key regulatory flexibilities.

There are five provisions before us today, three of which we are seeking to make permanent. The first will enable injectable prescription-only medicines, which includes vaccines, to be given under a patient group direction commissioned by the NHS or a local authority, which effectively expands the workforce of vaccinators. The second will enable pharmacy-led Covid and flu vaccination services to operate outside their registered premises. This has enabled, for example, “pop-up” vaccination clinics to be run by pharmacists at convenient locations for patients, and these have been very successful. The third will add several additional groups of healthcare professionals to those who can administer vaccines under occupational health schemes, thereby expanding the workforce to vaccinate health and care staff. The final two provisions relate to a further temporary extension of easements to licensing requirements for assembly and preparation of vaccines prior to use and sharing of vaccines between sites.

Why do we need this SI? The success of the mass vaccination rollout on the scale and pace that has been possible to date will not continue if the SI is not approved, and the Covid-19 and flu vaccination programmes will not be able to continue running as they currently do. Nor would they be able to be re-established at the pace and scale which has been so vital to our success—for example, in response to the emergence of a new variant, leading to recommendations for an urgent booster campaign.

Approval has been sought and agreed both in the other place and in the Northern Ireland Assembly, and I will now provide the rationale in support of these important provisions in this place. We are debating these provisions today against a completely different backdrop to that which was in place when the key regulatory flexibilities were first made in late 2020. We are now in a position that we should welcome, but we should also be aware that vaccines remain our best line of defence against the virus and to help us to live with Covid. This is the very reason why it is vital to make permanent or temporarily extend these provisions.

The provisions have already proved invaluable by enabling mass vaccination against both Covid-19 and flu to be done as quickly as possible while safeguarding patients and limiting disruption to other NHS services. Patient safety has to be at the heart of any vaccination programme, and it is at the forefront of these provisions.

To improve uptake in areas with low vaccination uptake we have used places of worship as vaccination centres, with many more acting as pop-up venues; provided £22.5 million to fund the community vaccine champions scheme, targeting the 60 local authorities with the lowest vaccine uptake and using local networks to promote accurate health advice; established an army of vaccine ambassadors, speaking 33 languages between them, promoting uptake across the country; and taken the vaccines into the hearts of local communities through initiatives such as vaccination buses and taxis. It is vital that we continue to protect and vaccinate those in our society who are hard to reach and it is really important that we continue to reduce health inequality in vaccine uptake. Making these provisions permanent will enable us to achieve this goal. Indeed, the National Audit Office’s recent report on the rollout of the vaccination programme in England highlighted the balance between central command and control structures and wider empowerment locally. It saw this as a success factor in achieving more than 139 million vaccinations in the 15 months since the programme began.

I turn to the second instrument before us today. We are committed to making sure that individuals suffering from life-threatening or serious debilitating conditions and facing unmet clinical need are able to access the therapies they need. The early access to medicines scheme is a vital tool in supporting such patients to receive innovative new medicines. EAMS, as it is commonly referred to, provides a route for patients to be prescribed medicines that either do not yet have a marketing authorisation or licence, or do not have a marketing authorisation for the medicine to be used for that particular illness. Since 2014, the scheme has benefited hundreds of patients across the country. In England alone, over 1,600 patients have received EAMS medicines since the scheme launched. Their lives have been transformed by the chance to receive vital therapeutics for conditions ranging from cancer to sickle cell disease or severe dermatitis. Putting the scheme on a statutory footing allows us to maximise the benefits it offers to patients, as well as supporting the early development of medicines by innovative manufacturers in the UK.

The provisions we are debating today will deliver three key benefits. First, they will reaffirm in legislation the importance of patient safety within the scheme, putting specific provisions on safety monitoring and risk management on a statutory footing. Secondly, they will reduce the regulatory burden on manufacturers supplying EAMS medicines, making the scheme more visible and easier to use. Thirdly, they will help ensure that information on the real-world use of EAMS medicines can be collected. This will help provide more evidence and more data that can support future decisions about patient access to novel medicines. To summarise, we have the opportunity before us to deliver greater access to safe medicines, as well as supporting the innovation of our life sciences industry for the benefits of patients.

I am bringing forward the first instruments using the powers in the Medicines and Medical Devices Act, allowing us to use effective regulation to provide patients and the public with timely access to critical medicines and vaccines. The provisions in these instruments are incredibly important. They will be in force if mass vaccination campaigns against Covid-19 and flu are necessary again to protect the public and our freedoms. They will also ensure that patients with serious conditions and unmet clinical needs can be offered new, life-changing treatment options.

[Lord Lansley (Con)]

My Lords, I am glad to have the opportunity of contributing to this debate. If I may, I shall say something about each of the two regulations we are looking at. Before I go down that path, I should declare an interest as vice-chair of the All-Party Parliamentary Group on Vulnerable Groups to Pandemics.

The first regulation is, in a sense, the product of success: we have made a great step forward in the vaccination programme. For the very first time, I tested positive for Covid 10 or 11 days ago—I am negative now, I promise—but it was not remotely worrying and had no serious impact on my health because I had had two vaccinations and a booster. The process in this country, not least the use of pop-up locations, has been rightly envied in many countries around the world. I got my second vaccination in Poets Corner in Westminster Abbey, a particularly pleasant experience.

The point is, however, that we have now arrived at a position where we are living with Covid, which is a tricky thing to do because the numbers of cases are not small. I was just one of them last week, and not in the least bit surprised when the Office for National Statistics said that there was an increasing number of cases because so many people who I knew of were going down with a case of it. Living with Covid is going to be tricky and I suspect we will, from time to time, find ourselves having to resort to a booster programme—perhaps not for everybody, but certainly among the most vulnerable.

The point I make to the Committee today is that, as we move into this very significant new phase of living with Covid, I do not want us to leave behind—or leave out—the small proportion of people who, by reason of being severely immunocompromised, cannot live with Covid. They cannot access or tolerate the vaccines, as they cannot produce the necessary antibodies. If we do nothing about that we will end up with a very small but significant number of people, maybe somewhere between 100,000 or 150,000, for whom the severity of their lack of immune system means that they literally cannot go out and expose themselves to Covid.

I have been asking questions of my noble friend the Minister and I fear there is a bit of confusion here. The Government are in the process of promoting clinical trials for post-exposure prophylaxis as treatments so that, if somebody has the symptoms of Covid, there are antiviral treatments available for them which have significant efficacy. But the trials are all on the basis that their symptoms are detected within three to five days; if they are not, there is a serious risk of severe harm, hospitalisation or even death for this small group of people.

The case I want to put is that the Government should, as other Governments are doing, look at the emergency-use authorisation of pre-exposure prophylaxis. In this instance, it is a drug with the brand name Evusheld. This is an AstraZeneca combination of monoclonal antibodies, the purpose of which is to give protection to people who are severely immunocompromised. I hope it will be apparent to noble Lords that there is the world of difference between pre-exposure and post-exposure prophylactic treatments. The difference is that a sense of confidence is created in the people to whom the pre-exposure prophylaxis has been provided, such that they too stand some chance of living with Covid and of no longer being subject to the isolation and shielding which has otherwise been their unfortunate experience now for two years.

In the data presently available, the efficacy of Evusheld results in an 83% reduced risk of symptomatic disease over a six-month period. That is a very good potential level of efficacy. If we do not do this in the position we are in, many of these people will not feel confident about leaving isolation and not being shielded. They will not rely on the assumption that they would get access to treatments within the time required.

I am hoping that the Medicines and Healthcare products Regulatory Agency is just about to produce a positive, emergency-use authorisation assessment for Evusheld. If my noble friend has any information, that would be very welcome. While I entirely accept that the Government need to have that in place, why are they not negotiating with AstraZeneca to get access to it in a contract that depends, of course, on the availability of the authorisation?

Many countries are doing this. For example, the United States has ordered 1.7 million doses. The French have around 150,000, which is broadly comparable to us and the number we would expect to need; indeed, in France, they have administered 15,000 doses of Evusheld. I notice other countries entering into these contracts almost every day. On Friday, it was Switzerland. As we move into living with Covid, which these regulations support, can we have some confidence that we can supply Evusheld and pre-exposure prophylaxis for this very vulnerable group? That is my first point.