Health and Care Bill

Lord Lansley Excerpts

Committee stage
Thursday 20th January 2022 Lords Chamber

[Lord Stevens of Birmingham (CB)]

My Lords, I had not intended to speak but, animated by the contributions of colleagues who, like me, were there at the conception of NICE, I thought I would offer a couple of contextual remarks to this group of amendments, supporting their underlying motivation, which is to ensure the spread of best practice as fast as possible across the National Health Service.

I was also motivated by the noble Baroness, Lady Watkins, who spoke earlier about the Crimean War, to recall that this is not a new problem. The world’s first controlled clinical trial took place in 1754 on board HMS “Salisbury”, when the Royal Navy was trying out the use of citric fruit—in lemons and limes—to combat scurvy. That experiment showed that scurvy could be tackled with lime juice, and it took the Navy 41 years to mandate its introduction more widely—fortunately, just in time for the Napoleonic Wars, which is why some argue that, contrary to Winston Churchill’s dictum that it was “rum, sodomy and the lash” that contributed to the Navy’s success, it was in fact lemon and lime juice.

The point is that this is not a new problem. We have been grappling with this but, despite that, we have seen the remarkably quick adoption of new clinical practices over the last two years during Covid, as new randomised control trials, following in the wake of the 1754 example, have shown the benefits of treatments such as dexamethasone. My point of context is that we need to be clear, if this group of amendments is to advance, about the terminology incorporated in the amendments. These will inevitably be, if they find their way into the Act, litigated against in the High Court and Court of Appeal.

In the drafting, there is reference to the marketing authorisations given by NICE, although I think it is the MHRA that provides marketing authorisations. There is a clear distinction to be made between the technology appraisals NICE undertakes and the development of guidelines. Although a number of noble Lords have referenced the importance of the guidelines, it is worth saying that a quick look at the NICE website reveals there are 1,591 guidelines, pieces of advice, quality standards and all the rest of it—most of which have not been subject to the full cost-effectiveness and affordability assessments that the gold standard technology appraisal performs. Before there could be a legal mandate for those guidelines, there would be some very significant methodological considerations for NICE. Without those, the risk is that mandating those guidelines would take resources away from other parts of needed care, such as mental health and community nursing—Cinderella services that have not been subject to those same processes.

We should also recognise that, vital though NICE is, the bigger contribution to the diffusion of best practice will probably be made in other ways. Certainly, reporting could help. Although one amendment makes the perfectly reasonable proposition of an annual report from integrated care boards on their adoption and uptake, that still feels a slightly 20th-century solution. If you go to Oxford University’s superb www.openprescribing.net, you can see your own GP practice and your own CCG’s prescribing patterns against the national norm, including, as the noble Baroness, Lady Finlay, said, for the DOACs, the anticoagulating medicines. Those technologies are already available, and the role that clinical pharmacists are now playing, including the thousands of new clinical pharmacists hired to work alongside GPs to improve their prescribing habits, is also likely to have an important influence.

Finally, there is this question of whether, just occasionally, conflicts of interest might arise on the part of prescribers or clinicians over the medicines or devices being used. The noble Baroness, Lady Cumberlege, has drawn attention to this in her important work, and that is perhaps something the House might return to at a later date.

[Lord Lansley (Con)]

My Lords, I want to intervene at not too much length. I welcome these amendments and am grateful to my noble friend Lady McIntosh of Pickering for bringing hers forward. It enables us to touch on a subject which those of us involved in the Medicines and Medical Devices Act will recognise. This is a short version of the debates we had then, but it gives us an opportunity to update a little on those and me an opportunity to ask my noble friend on the Front Bench a few questions arising from that. We are all grateful to the noble Lord, Lord Stevens of Birmingham, who clarified some of the terminology, which saves us going wrong. But I want to do a bit of clarification about some of the amendments as well.

The timing of this is terrific. We are discussing this today and NICE published the outcome of its methods review yesterday, so we can respond immediately. My starting point is to applaud NICE for having taken up and accepted the proposition that there should be a modifier in relation to its appraisals and assessments on severe diseases. We can argue about the precise detail, but it has taken that up.

Secondly, randomised control trials are terribly important but they are not the whole story. NICE has rightly accepted it should look at more real-world evidence and that, too, we can welcome, but it leads me directly to a question. Part of that real-world evidence, and one of the reasons it is not going directly to NICE, though NICE can use it, is the innovative medicines fund. NHS England published its proposal for the innovative medicines fund in July and said that it would consult on it, but it has not done so yet. My first question to my noble friend is therefore: when will NICE and NHS England consult on the innovative medicines fund?

The third point on NICE’s methods review is that it will take account of the wider impacts of the treatments it appraises. That is terribly important, especially given the present opportunities for personalised medicines and gene-based treatments, when one looks at how these can impact substantially on people’s lives from a relatively early stage and the contributions they can make to society and the economy. That is all good news.

The press release from NICE, however, did not draw specific attention to where it had proceeded in a way that its stakeholders did not support. It has maintained a reference-case discount rate of 3.5%, although NICE itself admitted that there was evidence that a lower discount rate would give significant benefits. It said that there would be wider implications for policy and fiscal complexities and interdependencies if it were to do this, which I think means “The Treasury said no”. We need to think very hard about whether a discount rate as high as 3.5% is appropriate for NICE’s application of its appraisals. I ask my noble friend, though he will not be able to give me the answer to this: who is telling NICE that it cannot adopt what it regards as the evidence-based discount rate for the appraisals it undertakes?

[Lord Hunt of Kings Heath (Lab)]

My Lords, on that basis, I have seen it said elsewhere that NICE has referred to its “national stakeholders.” I can only assume that they are Her Majesty’s Government.

[Lord Lansley (Con)]

Given NICE’s remit, it might be the Welsh Government as well, but the noble Lord may well be correct. We are all surmising, but I think we are probably not too far off the mark. It gave us an opportunity to respond to that.

So far as the amendments are concerned, the proposition that approved treatments should be adopted by the NHS is a proper one. What, of course, has not been brought into the debate is that the world has moved on, even in recent years. NHS England has taken what I think is an appropriately substantial interest in the approval of treatments, the uptake of treatments and their adoption by the NHS. When it started out, people said, “Oh dear, NICE is going to approve a treatment and then NHS England is going to tell people not to use it because it is going to cost them a lot of money.” In fact, we all agreed in the debates on the Medicines and Medical Devices Bill that there was everything to be said for NHS England, NICE and the pharmaceutical industry working together early, proactively, for the planned introduction of new medicines, including taking account of their cost. That is an NHS England role, not a NICE role. NICE does gold standard appraisals, but it does not take responsibility for the fiscal consequences of those appraisals, so all these things need to be put together. The pricing decision should not be something that comes out at the end.

One of the things I have been going on about for a decade or more—actually, 15 years—is that we should not end up in a position where there is an effective medicine that is properly approved by the MHRA and authorised for use; clinicians can use it and they know it is the right thing for their patient; but, because of the absence of an appropriate pricing decision, the answer to the patient is “no”. We should not arrive at that position. With NHS England and NICE working together with the pharmaceutical industry, we stand a better chance of the answer not being “no” in those circumstances as long as the resources are, indeed, available.

I do not think, on the face of it, that we should be legislating to change the medicines mandate from where it is now. My noble friend Lady McIntosh, in introducing her Amendment 54, referred to devices. The amendment does not refer to devices, but it should refer to devices. My further question to my noble friend the Minister is: when are we going to get a proper funding mandate on devices, which I think I was promised during our deliberations on the Medicines and Medical Devices Bill but we have not yet formally had it? Some good work has been done on some devices each year, but I am hoping that we will get a proper funding mandate on devices.

On formularies, my noble friend did not actually refer to the British National Formulary. Of course, NICE has had responsibility for the BNF for about seven or eight years, and even if it is not a legislative method, there is everything to be said for the NHS and clinicians looking to the BNF and NICE’s role in the BNF.

My noble friend and the noble Baroness, Lady Finlay of Llandaff, were quite right about the adoption of NICE guidance and standards on the use of them in clinical circumstances. However, via the regulator—the CQC—we already have a process by which the CQC looks at quality standards produced by NICE and incorporates what NICE itself isolates as the essential aspects of the standards that, in order to provide safe and effective care, must be reflected in the practice of a health provider.

My question to the noble Baroness, Lady Finlay of Llandaff, is: if she thinks that is not sufficient, how much further should the CQC actually go in adopting quality standards? At the moment, it has compromised and said, “We will take the essential steps, because those are a few, generally about five, specific things that we can look at to see whether they are being done, in which case, okay; or are they not being done, in which case it clearly needs improvement, or may not be meeting the standard.”

[Baroness Finlay of Llandaff (CB)]

The noble Lord asked me a question to which I feel obliged to try to respond, but I really want to answer the question with a question: does the CQC have enough powers to benchmark as it would want to do, and to publish those benchmarks? I hear the concerns of my noble friend Lord Stevens in relation to fear of litigation and how that is an objection to the amendments, but I am also quite worried that that is potentially a way of avoiding adopting the guidelines themselves, thereby inhibiting a change in practice and a move to best practice.

While there are sources of information that those who are very health-literate, IT-literate, and so on, can access to establish their own benchmarks about what is happening, many people, particularly those in the most deprived areas of the UK, do not have any knowledge of even where to begin looking for these things. That was the motivation behind the amendment: to try to make sure that in the poorest and most deprived areas, people would still be able to access this. That would drive up standards gently but would not create a mandated requirement that a NICE guideline is adopted, for the reasons I outlined previously.

[Lord Lansley (Con)]

I can see that my noble friend is eager to come in but I will conclude by answering the noble Baroness. I am not an expert, but I think the CQC has the powers—since it presently does it—to take account of the NICE quality standards and to incorporate specific indicators from those quality standards as part of its regulatory review. If the CQC was to attempt to introduce large-scale application of the guidance as a question in a regulatory review, I do not think the issue would be whether it had the power to do it, but whether it would make the headline conclusions it reaches in relation to healthcare providers increasingly difficult to interpret. At the moment, they are relatively straightforward to interpret. There is a small number of specific indicators in relation to services provided and they are either doing them or they are not. With guidance, it becomes much more complicated and many more value judgments have to be applied about the circumstances in which they are or are not complying. So, there is a real difficulty in going far beyond where we are now.

I will listen with great care when my noble friend the Minister responds to the questions I have asked.

[Lord Mackay of Clashfern (Con)]

My Lords, I support these amendments, subject to the economic difficulties. As I listened to the local Baroness, Lady Brinton, I wondered whether the amendments might be strengthened by some reference to the timescale in which they must be implemented. That might have some beneficial effect for many people who are waiting.

--- Later in debate ---

[Lord Hunt of Kings Heath (Lab)]

My Lords, the noble Lord has said that the Bill came because this is what the NHS wanted. But we must be clear who in the NHS wanted it, and it is obvious that it was the senior chief executives at the local level and NHS England. No wonder primary care has been completely squeezed out of it. Listening to this debate, it seems to me that the proposals from NHS England never had any scrutiny. Ministers just accepted this and, because NHS England does not engage externally, there has not been the testing that you would normally get, and we are having to do it now. Frankly, the wheels are falling off. It is tempting to invite the noble Lord, Lord Lansley, to come in, because clearly CCGs were all about putting primary care in the driving seat. This seems to be removing them altogether and it is worrying.

[Lord Lansley (Con)]

My Lords, in response to that, may I say that when I was shadow Secretary of State for several years, GPs consistently told me that if only they were given the responsibility, they could do it so much better than primary care trusts? So we gave them the responsibility in ways that were very like the locality commissioning that was the endpoint of the GP fundholding of the noble and learned Lord, Lord Clarke of Nottingham. To be fair to them, there was less money, but no sooner did they take this responsibility than NHS England said, “Hang on a minute, you’re not doing what we’ve told you to do.” It took about 18 months, perhaps slightly less, before NHS England effectively said, “You have no further autonomy. You’re going to be in the sustainability and transformation plans,” which are the forerunners of ICS. I do not think that the clinical commissioning groups ever got the chance to do what they were asked to.

We have now reached the point where, as the noble Lord, Lord Warner, rightly says, they are being written out of the script, but they are not complaining, which is very interesting. They are not complaining because they do not want to be responsible for the budgets; they want to be responsible for the patients. They always said that they wanted to decide how locality commissioning should be done and the good ones have put tremendous things in place in terms of population health management, patient pathways and commissioning linked to those patient pathways. That is why, if we can do something with this Bill, it is to retain all that locality commissioning with GP input. But be prepared for the ICS, the big battalions, to go away and fight with the barons in the big hospitals.

[Baroness Thornton (Lab)]

I wish you good luck.

Health and Care Bill

Lord Lansley Excerpts

Lords Hansard - Part 1 & Committee stage
Tuesday 18th January 2022 Lords Chamber

[Lord Kamall (Con)]

I hear the strength of feeling from the noble Lord. I will take this back to the department and discuss it with my right honourable friend the Secretary of State. I hope noble Lords are reassured by that. I may not get the perfect answer, but I will try. I understand the strength of feeling on this issue; no one can fail to do so. Let us put it this way: it was not subtle but direct. It is really important that, as the Minister here, I take this back and reflect the feeling of the House in my conversations with the Secretary of State, and his subsequent conversations with NHS England. I will take that back and look at the consultation process and the CCGs consulting all the relevant local authorities.

I understand the point made strongly by the noble Lord, Lord Scriven, that we have to be careful about prescribing in a top-down way how to work locally. I have always been a strong believer in localism and making sure that powers go down to a local level rather than being taken away. Let me again assure the noble Lords, Lord Scriven and Lord Hunt, and other noble Lords that I will take this back, because clearly there is concern. I had not appreciated the strength of that concern. At Second Reading the noble Lords, Lord Stevens and Lord Adebowale, said, “We are already doing this. It makes sense to go ahead and put it on a statutory footing”. But I have now heard the other side of the argument, and it suggests that I should go back and have a stronger conversation with, in effect, my boss—my right honourable friend the Secretary of State. I hope that gives some reassurance.

On Amendment 44, in the name of the noble Baroness, Lady Thornton, I assure your Lordships that we intend to provide as much stability of employment as possible while ICBs develop their new roles and functions. I hope that noble Lords are aware that there is already an existing commitment that staff transferring into ICBs will transfer across on their current terms and conditions in line with the NHS Terms and Conditions of Service Handbook. NHS pension rights will also be preserved. As a result, staff transferring into ICBs will not see any change to their existing conditions.

However, the Government are concerned about forcing ICBs to adopt conditions and practices that the ICBs do not believe work best for new staff. We believe that it is important to give ICBs flexibilities relating to staff terms and conditions; they are there for a reason. For example, when it is difficult to recruit and staff are going elsewhere, this would include allowing ICBs the flexibility to diverge from collectively agreed pay scales in order to attract staff from elsewhere or with unusual or valuable skills, or to reflect local circumstances. It will also give ICBs the flexibility to support joint working and bring in staff currently working in local authorities or foundation trusts, for example, supporting integration and the joint working approach that the Bill hopes to encourage.

I also note that ICBs having the independence and flexibility to choose whether to adopt collectively agreed pay conditions and pensions for new staff is not unique, as the noble Baroness, Lady Thornton, acknowledged. NHS foundation trusts, which are already free to exercise their discretion in adopting such conditions, overwhelmingly choose to honour and apply such terms to their staff unless there are good reasons to diverge.

On the proposals for very senior managers, existing procedures are in place to ensure that the most senior staff within the NHS are appointed with fair and equitable salaries. Proposals to pay very senior staff more than £150,000 must be similar to those for other equivalent roles or be subject to ministerial oversight.

The Government are in the process of finalising the procedures that will apply for ICBs. The specifics may differ but the effect and intention will be the same: to afford ICBs agency in setting pay at competitive rates so that we can continue to attract the most senior and experienced leaders, while putting adequate checks and balances in place to ensure appropriate use of taxpayers’ money and keep senior public sector salaries at an appropriate level. The Government believe that this amendment, which also asks for ICPs to approve annual salaries in excess of £161,000, is unnecessary. I am happy to have further conversations.

I now turn to the amendments on how the ICBs will function once established, starting with that in the name of the noble Lord, Lord Davies of Brixton, which relates to the question of treatment outside the ICB area. The new clause in question provides that NHS England must publish rules for determining the people for whom integrated care boards have responsibility. Importantly, this clause ensures that everyone in England is covered by an ICB.

We intend that the rules set by NHS England should replicate the current system for CCGs as closely as possible. This means that the ICB will be responsible for everyone who is provided with NHS primary medical services in the area—for example, anyone registered with a GP. It will also be responsible for those who are usually a resident in England and live in their area if they are not provided with NHS primary medical services in the area of another ICB.

It is important to remember that no one will be denied healthcare on the basis of where they live. We want to ensure that, under the new model, bodies that arrange NHS services—decision-making bodies—are required to protect, promote and facilitate the right of patients to make choices with respect to services or treatment. This means allowing patients to choose to be treated outside their ICB area. Choice is a long-standing right in the NHS and has been working well for some time. The Bill continues to protect and promote it. However, I am afraid that we have concerns about this amendment, as it places a requirement on providers rather than commissioners. It would not be reasonable to expect providers to provide services regardless of whether they were funded by an ICB to do so, and it is important that ICBs should be able to make decisions about with whom they contract and where they prioritise their resources.

On Amendment 53, in the name of the noble Baroness, Lady Walmsley, I hope I can assure the Committee that the Government are committed to ensuring continuous improvement in the quality of services provided to the public. As your Lordships will be aware, there is already a wider range of duties in relation to the continuous improvement of services. Clause 20 imposes on ICBs a duty as to the improvement in quality of services. Furthermore, the ICB must set out how it proposes to discharge that duty at the start of each year in its joint forward plan and explain how it discharged the duty at the end of each year in its annual report. I hope this goes some way to meeting the noble Baroness’s concerns.

Clause 16, which this amendment seeks to alter, recreates for ICBs the commissioning duties and powers currently conferred on CCGs in the NHS Act 2006. It ensures that ICBs have a legal duty to commission healthcare services for their population groups. It also recreates Section 3A of the 2006 Act, which provides the commissioning body with an additional power to commission supplementary healthcare services in addition to the services they are already required to commission. This power enables ICBs to arrange for the provision of discretionary services that may be appropriate to secure improvements in the health of the people for whom it is responsible—or improvements in the prevention, diagnosis and treatment of illness in those persons—so it is important that the clause remains as it is currently drafted.

The Bill will ensure that the existing local commissioning duties conferred by the NHS Act 2006 will transfer over to ICBs. This is set out in proposed new Section 3, which is also to be inserted by Clause 16 on page 13. I hope that the noble Baroness, Lady Walmsley, will be reassured that it rightly uses “must” rather than “may” when referring to the arranging of services. I can therefore assure the Committee that ICBs will continue to commission the services previously delivered by CCGs. That will ensure that service delivery for patients is not impacted.

Amendment 159 in the name of the noble Baroness, Lady Wheeler, touches on the important relationship between ICBs and ICPs. I remember that, when we had an earlier consultation, the Bill team had a diagram about how ICBs and ICPs would work together; It might be helpful if I ask for that to be sent to noble Lords so that all of us can have more informed conversations about the intentions of the amendments and the issues that noble Lords want to raise. I will make sure that that is done.

This amendment would add a requirement for the Secretary of State to make regulations to establish a dispute resolution procedure if an ICB fails to have regard to an assessment of needs, an integrated care strategy or a joint local health and well-being strategy in respect of the ICB’s area. The Bill was introduced to ensure that existing collaboration and partnership, working across the NHS, local authorities and other partners, is built on and strengthened; I recognise the concerns raised by the noble Lord, Lord Scriven.

We intend for these assessments and strategies to be a central part of the decision-making process of ICBs and local authorities. That is why we are extending an existing duty on ICBs and local authorities to have regard to relevant local assessments and strategies. The ICB and local authorities will be directly involved in the production of these strategies and assessments through their involvement with both the ICP and health and well-being boards at place—that is, at a more geographical level. As a result, they have a clear interest in the smooth working of the ICP.

More widely, there are several mechanisms to ensure that ICBs and local authorities will have regard and not intentionally disregard the assessments and strategies being developed at place in their areas. First, health and well-being boards have the right to be consulted.

[Lord Lansley (Con)]

I just had a flashback moment. I remember being asked, or volunteering, a decade ago to produce a chart of the various organisations under the 2012 Act. I think that the King’s Fund did a rather good job of doing it back then; perhaps it might do it again, although it will find that it is more complicated this time.

The noble Baroness, Lady Thornton, asked a perfectly reasonable question that might simplify the process. If health and well-being boards do the same job as integrated care partnerships, in large measure, why cannot integrated care partnerships and health and well-being boards be the same organisation?

[Lord Kamall (Con)]

I remember hearing in an earlier discussion on the Bill that nothing prevents that where they coincide. My noble friend and I have had conversations about health and well-being boards and where they sit. Given that, and given my noble friend’s experience of this issue, perhaps we could have a further conversation on this matter before the next stage to clarify some of the issues that he rightly raised in previous conversations.

At this moment, we believe there are mechanisms to ensure that ICBs and local authorities have regard to and do not disregard the assessments of the health and well-being boards. As my noble friend points out, that is for further conversations.

As noble Lords know, NHS England must also consult each health and well-being board on how the ICB has implemented its joint health and well-being strategies, so there is another level of reassurance there. The ICB must also include in its annual report a review of the steps it has taken to implement any relevant joint local health and well-being strategy and must consult the health and well-being board when undertaking that review. NHS England has formal powers of intervention if an ICB is not complying with its duty in any regard. That is sufficient to ensure that ICBs will have regard to both ICP and health and well-being board plans, but I understand the concerns raised.

Health and Care Bill

Lord Lansley Excerpts

Lords Hansard - Part 2 & Committee stage
Thursday 13th January 2022 Lords Chamber

I strongly welcome Amendment 17 and say “Please take notice of the devolved nations, even though the populations are smaller”, but there are, I am sorry to say, real problems with Amendments 301 and 205, and I hope the Government will come up with a solution and make sure that we have the health service that Aneurin Bevan wanted to instigate, which was for everybody at the point of need.

[Lord Lansley (Con)]

My Lords, I will intervene briefly, if I may, to support my noble friend in her Amendment 17. I am glad to follow the noble Baroness, Lady Finlay of Llandaff. I will not follow her in discussing the financial settlements between NHS England and NHS Wales; there is a lot to that. But I confess that I rather share her view that it would be a stretch too far for us to seek to legislate in this Bill for matters that are the subject of devolved powers for the parliaments in Wales and Scotland, even though the issues are very interesting and the points that were made, not least by my noble friend Lady Fraser, were perfectly sensible and rational objectives.

I will confine myself to Amendment 17 and say there are good reasons why my noble friend and the Government might adopt it. It seeks to amend what is presently Section 13O of the National Health Service Act. The differences are important. First, if one looks at Section 13O as it stands, it requires the board—NHS England for these purposes—to

“have regard to the likely impact of those decisions on the provision of health services to persons who reside in an area of Wales or Scotland that is close to the border with England.”

It is perfectly reasonable that it should do that, but that is not, as the debate has illustrated, the extent of the issue.

Speaking entirely personally, my late father-in-law was resident in Anglesey. He needed cancer services, so—perfectly sensibly—he went to Clatterbridge in the Wirral. My noble friend Lord Hunt is of course a former Secretary of State for Wales. He will be very familiar with the way in which services between north Wales and Cheshire, which he formerly represented, were provided. That is one straightforward example.

A number of noble Lords will recall the debate when I was Secretary of State about paediatric congenital heart services. In north Wales, they were provided in Liverpool, if I remember correctly. In south Wales, they were provided in Bristol. Those are one or two aspects of a necessary relationship for specialised services between different parts of the United Kingdom. At the border, there is a relationship in day-to-day healthcare services. There is an arrangement for that, and we do not need to interfere with it in this legislation. Shropshire CCG presently runs it on behalf of NHS England.

NHS England and NHS Wales have a statement of values and principles which, as far as I could see on looking it up, was last renewed in 2018. I think it is due for renewal. Basically, it relates to about 21,000 patients from England who are registered with Welsh GPs. About 15,000 patients resident in Wales are registered with English GPs. There is a transfer and a netting off of costs between them of about £6 million, and arrangements exist for referrals between the two countries. So we do not need to interfere with any of that, but the legislation needs to cover in particular this first point: that we are concerned not only with those who live in the areas bordering England and Wales; we are concerned with people in England and in Wales more generally, as well as with people elsewhere in Scotland and Northern Ireland.

The second point is that the present drafting excludes Northern Ireland. Clearly, there should be a role for NHS England. It should be prepared to consider its functions in relation to the provision of services—obviously where required and requested—by the Administration in Northern Ireland.

Finally, the drafting of Amendment 17 rather sensibly says not only that one should consider the impact on people living in Wales, Scotland and Northern Ireland but that one should think about the provision and delivery of additional services for people living in those areas. Amendment 17 makes this clear in 1(b):

“(b) services provided in England for the purposes of”

the health services in Wales, Northern Ireland and Scotland. In so far as any of those Administrations were to make a request or, under the concordat that exists, to look for support for services, that is something that NHS England would have the necessary legislative cover to support.

I appreciate drafting, if I may say so, and even at this stage my noble friend has drafted a very good amendment which I am rather hopeful that my noble friend on the Front Bench will also commend.

[Baroness Bennett of Manor Castle (GP)]

My Lords, in very clearly introducing these amendments, the noble Baroness, Lady Morgan, said that this group might not get feisty. I hope that we can manage to be very civil and calm in tone. None the less, there is a degree of disagreement—to which I am going to contribute.

In concluding her remarks, the noble Baroness said that this is a UK institution, embodying UK values. That seems to deny the reality of devolution. It is entirely possible that at least one of these countries could be an entirely separate nation very soon. That is the practical reality.

Once again, I was struck by the similarity with the climate change debate we had earlier. Sometimes people say, “Well, the scientists will tell us what to do about climate change”. Of course, this cannot be true, because how you get to 1.5 degrees involves a huge number of political choices around the allocation of resources. Similarly with health, many different routes and choices are involved in the effort to produce as healthy as society as we can. Whose health are you talking about? These are all political choices.

The noble Baroness, Lady Fraser, said that this was about data, not delivery. Of course, we know that very often what is delivered is what is measured, and if you choose to measure different things, maybe that is because you are seeking to deliver different things.

Like other speakers, I do not have any particular problem with Amendment 17, but I do with Amendment 205 and, in particular, Amendment 301, which says:

“The Secretary of State may … specify binding data interoperability”


and

“Scottish Ministers, Welsh Ministers and Northern Ireland Ministers must arrange for the information”.

I do not speak for the Scottish Government—albeit that they have some Green elements—but I would be surprised if they accepted that kind of wording. I do not wish to redraft on my feet but, if the Minister were looking to redraft, I suspect that something like a direction to the Secretary of State to “work with the Scottish, Welsh and Northern Ireland Ministers to agree” would definitely be preferable.

However, I agree with the noble Baroness, Lady Finlay, who gave us some very detailed and informed comment, that the best way to achieve this is by institutions at an operational level working together to find ways to link things up. If we take the example given by the noble Baroness, Lady Fraser, about her daughter’s situation, we can all be very annoyed that that apparently rather simple situation has not been sorted out. But I do not think drafting law in your Lordships’ Chamber is the way to sort that problem out. That needs to be at a very different level, and it needs to be sorted out as soon as possible.

Health and Care Bill

Lord Lansley Excerpts

Committee stage & Lords Hansard - Part 1
Tuesday 11th January 2022 Lords Chamber

Moved by

[Lord Lansley]

4: Clause 3, page 2, line 8, at end insert “and insert “, including in achieving improvements in the outcomes recorded in the NHS Outcomes Framework””

[Lord Lansley (Con)]

My Lords, I am very glad to have this opportunity to contribute to the Committee’s discussions. We turn to the mandate, which noble Lords will recall is the means by which the Secretary of State principally holds NHS England to account for the delivery of its functions and responsibilities in relation to the NHS.

This becomes more important as time goes on, for two reasons: first, because NHS England will incorporate within its own activities more of the functions pertaining to the NHS, particularly the powers and responsibilities of NHS Improvement; secondly, because in the past there was a sense in which some transparency was associated with the bodies across the NHS. NHS Improvement represented the interests of NHS service providers and NHS England represented the interests of the commissioning of services—that is, the public interest and the population health interest. These are to be incorporated in one organisation; that is the essence of the integration that NHS England and NHS bodies have sought to achieve, contrary to the structures of the 2012 legislation. I wish them success with it, but it does not enhance accountability, either to Parliament or the public. Therefore, the mechanisms for accountability must be as clear as we can make them.

As it happens, since 2013 I do not think Secretaries of State or Parliament have used the mandate in the way it was intended they should. On a number of occasions, the Secretary of State has not used the mandate on an annual basis but has run it on, and we therefore have before us—as we will see in many places in this legislation—an acceptance of how practice has developed and that the legislation should come into line with it.

On a number of occasions, I will simply throw up my hands and say, “Fine, if that is how the NHS wants to do things, let us put the legislation into that structure to enable the NHS to do its job in the way it wishes to.” Indeed, I suspect that those outside this House who are looking at the current situation in the NHS are saying, “What is the relevance of us engaging in all this legislative activity at this moment?” Part of the answer is that legislation impacts on the day-to-day activities of people in the NHS much less than they might imagine. Secondly, one of the things we can do sensibly is to say that, even before the pandemic and the additional extreme pressures that the NHS has had to face, it had developed its own way of working, it wants the legislation to fit with that and I think it is probably helpful to the NHS to do that.

There will be other places, and we will come to them later, some of which I mentioned in my Second Reading speech, where I think the Government are looking to go beyond and to change what the NHS has done by way of practical integration, practical implementation and practical decision-making. I think we should resist some of those. I do not think it helps the NHS, at a time of such extreme pressures, for there to be some of these innovations, and maybe we need to call a halt to some of them.

One of the things, however, that the Government are not intending to do is to dispense with the mandate. The mandate is, in my view, more important for the future, for reasons of the importance of the transparency of accountability for the NHS for the performance of its functions. Since we went into recess before Christmas, NHS England and NHS Improvement have published their operational guidance for 2022-23. I think they have actually set out a pretty admirable and comprehensive set of objectives, but only a minority of those objectives are outcomes related. Many of them are, quite understandably under current circumstances, very focused on the volume of activity and the targeting therewith—in particular, for example, that the level of elective activity should rise to 110% of the pre-pandemic level and that diagnostics should increase to 120% of the pre-pandemic level. This is absolutely instrumental if we are to deliver on or get back to remotely the kind of waiting time figures we experienced in the earlier part of the last decade—I might say back to 2012-13, when we reduced waiting times to their lowest level.

The point is that there is a great danger, which we have seen in the way Secretaries of State have structured the mandate in recent years to focus on process, on targets and on volume and to devote insufficient continuing attention to the outcomes that are achieved. I gladly make clear that, while I move this amendment, I do not think it is the way the legislation should be framed. What I am looking for from my noble friend is the Government’s acknowledgement that, even as they focus on waiting times, targets, productivity, volumes and the mechanisms by which the volumes of activity in the NHS can be increased in the years ahead, we must not lose sight of outcomes.

What I mean by that is that we have seen a number of examples in the past of how the pursuit of waiting time targets led to significant problems in terms of hospital-acquired infections, which really threw the NHS off course for more than one or two years. So, in the NHS outcomes framework there is a domain relating to safe care, which I think enables us to focus on things like hospital-acquired infections and continuously to measure the outcomes we are achieving in relation to that.

The same is true in relation to preventing premature mortality. This, happily, is an area where, by focusing on outcomes, we can demonstrate that we are meeting internationally comparative high levels of performance. Of course, that does not relate only to cancer, but it is one of the reasons why we do not have a separate debate for Clause 4. I was prompted to put this amendment forward partly because of Clause 4, however. I am glad that it is in the Bill—it was part of a debate we had more than 15 years ago, when John Baron was with me on the shadow health team in another place—but the point is that we were always focused on one and five-year survival rates for outcomes in relation to cancer. What Clause 4 does is enable us to focus on outcomes in that respect.

--- Later in debate ---

I hope I have been able to give your Lordships some reassurance of our intentions regarding the mandate. I therefore hope that my noble friend will feel comfortable withdrawing his amendment.

[Lord Lansley (Con)]

I am most grateful to my noble friend for that response and to all those who contributed to this short debate. It was a helpful opportunity to reinforce the desirability of the mandate itself being used positively as a mechanism for accountability, particularly where outcomes are concerned.

I entirely take my noble friend’s point that what we are looking for should not be confined to the parameters of the NHS outcomes framework. As time goes on, the possibility of developing what are effectively population health outcomes is exactly where we need to go. My worry is that, if the mandate shifts too much towards population health outcomes, we will be trying to express it in terms of outcomes which the NHS does not control the means of delivering. That goes back to the point the noble Lord, Lord Patel, made earlier about who is responsible for what. As my noble friend said, in essence, the NHS is responsible for delivering the outcomes in relation to healthcare, but the Government are responsible for delivering outcomes in relation to population health, so we cannot confine this to the NHS. The mandate certainly needs to extend into that territory but, in doing so, it should not lose track of continuous improvement in those things that are measured through the NHS outcomes framework, and its development as we go along.

I also take the point about the timeframe. We have learned that we need the NHS to be planning long term, and it is doing that—not least through its development of the 10-year long-term plan. That extends even beyond the Government’s funding commitment, which has a different timeframe. Neither of those are very easily reconciled directly with the annual funding settlement. The mandate could be developed as a very effective way to enable the NHS and the Government to show, in a way that is accountable to public and Parliament, how the plans of the NHS and the funding commitments from the Government can be reconciled into measurable changes, targets, objectives and outcomes in the lifetime of a Parliament, because that is what Ministers will inevitably be looking for. We want the NHS to feel that it has some degree of certainty for the longer term; we want Ministers to feel that they have some degree of accountability and control in the year ahead, or two or three years ahead. That is what the mandate should be used to enable them to do.

My last word on the mandate is: please could Parliament actually scrutinise it? It was always intended that there would be annual debates in this House and the other place on the mandate. There never were. I thought it was shocking that the Government did not devote a day in each House each year to looking at, understanding and scrutinising the mandate as a mechanism for us to look at our most important public service—you can always argue about that, but I think it is—and know what we are trying to achieve in the year ahead, even if the mandate extends further beyond that.

I thank my noble friend, not least for his point on Amendment 10 and his reassurance that Ministers will always explain their reasons for revisions to the mandate and, indeed, that such revisions, as we all agree, should not be too frequent or too detailed; they need to be strategic in their nature. I am glad for his reassurance on that point. With those thoughts, I beg leave to withdraw the amendment.

Amendment 4 withdrawn.

Health and Care Bill

Lord Lansley Excerpts

2nd reading
Tuesday 7th December 2021 Lords Chamber

[Lord Lansley (Con)]

My Lords, over the last two years, we have all had cause to be immensely grateful to the National Health Service. NHS staff have responded heroically to the demands of the pandemic, and the service has shown a capacity to innovate, adapt and collaborate. The noble Lord, Lord Stevens of Birmingham, has been at the heart of that, and so we much look forward to his maiden speech today. But we are not out of these woods. There is an immensity of effort yet required, and the Government are right to allocate unprecedented resources to the National Health Service to support the recovery programme.

This Bill enshrines in law an approach that is markedly different from that which has characterised virtually all health legislation in England since the 1980s. That earlier legislation progressively built an NHS based on key principles: autonomous NHS providers held to account by commissioners, who would pay them for the services they actually delivered; patients’ rights to choose a provider; money following the patient; clinical leadership; and, since 2013, an NHS that is operationally independent of politicians but with a series of checks and balances, including a mandated focus on improving clinical outcomes. In some ways, this Bill turns back the clock. Providers’ freedoms are to be limited; the purchaser/provider split is blurred; the NHS is being centralised; payment systems are being delinked from activity; and political direction is being reimposed. We should use debates on this Bill to ask whether this is really the right direction, particularly given the need now for a responsive, productive National Health Service.

One could argue that this Bill reflects a journey that, in truth, started soon after the 2012 Act was passed—and was never truly implemented. We see the Bill establishing integrated care systems, for example, but they have really been around, in one form or another, for six years already, albeit not in statute. Noble Lords considering this legislation should reflect that, much as we labour on the detail of legislation, as the House did a decade ago on my Bill, we should be aware that the NHS may choose simply to ignore it.

The Bill in fact goes beyond the NHS’s own long-term plan. The powers of direction and intervention put in the Bill by the former Secretary of State in Clauses 39 and 40 are not welcome—including to the National Health Service—are a potential political own goal and should be taken out.

Although I see the presentational appeal of repealing Section 75 of the 2012 Act, relating to procurement, virtually the same provisions are contained in Clause 70 of this Bill—highlighting the folly of trying to fix problems in secondary legislation through primary legislation. The slogan is “Collaboration not competition” —ironically, precisely the words that JP Morgan and Rockefeller used when creating vast monopolies.

My legislation was criticised for making the NHS too complex. This Bill takes complexity to a whole new level. We have ICS boards and ICS partnership boards—the latter sitting on top of health and well-being boards. Each ICS is large, so the workaround is to have places within them which map to local authority boundaries. That is just on the commissioner side. On the provider side, we have new provider collaboratives which, in fairness, is where the power in the NHS will lie. The Bill makes no provision for them in terms of transparency, openness or accountability.

The partnership with local government needs to be strengthened. Integration of NHS and social care demands joint planning, so why are the integrated care partnerships and health and well-being boards not made to be the same organisation? We must look also at Clause 54; I do not think hospital foundation trusts should lose their independence.

NHS staff will rightly say that none of this is any good without a clinical workforce, but Health Education England produced the first NHS workforce plan in 2017, and my noble friend referred to the People Plan in 2019. Why, at that time, was Health Education England’s budget cut when the NHS budget was not?

Finally, the Government put Clause 140 in at the last minute, which will mean that if someone has limited assets and must meet heavy care costs, they may end up losing virtually all of their lifetime assets before the cap is applied, but the well-off person would lose only a fraction of their assets. That is not the design of the scheme Andrew Dilnot’s commission recommended to me. I believe many Members in another place want to reconsider this. We should enable them to do so by leaving Clause 140 out of the Bill when we send it back.

As ever, it is our job to revise constructively. I hope that, in doing so, we shall sustain both the independence and accountability of the NHS.

Covid-19 Update

Lord Lansley Excerpts

Monday 29th November 2021 Lords Chamber

[Lord Kamall (Con)]

As the noble Baroness, Lady Watkins, will be aware, our scientific medical advice and the data are constantly reviewed. We are currently conducting thorough tests to review both LFT and PCR efficacy when it comes to the omicron variant. The advice that I have been given is that we must wait for the data and take a cautious, proportionate approach as scientists work urgently to better understand the variant. In terms of the question on more restrictions in terms of where face masks should be worn, the advice at the moment is still on public transport and in shops, and to continue to encourage people to work either from home or in offices, as appropriate.

[Lord Lansley (Con)]

My Lords, in my noble friend’s repeat of the Statement, he said that

“our strategy is to buy ourselves time and strengthen our defences”.

May I ask him about our border controls? Given our testing capacity, would it not make sense for us, for example, to test everybody who comes into our airports at the airport itself so that we have certainty that, where they are positive, we know who they are and are able to conduct the contact tracing required?

[Lord Kamall (Con)]

I thank my noble friend for giving me notice of the question; I appreciate it. The answer that I have been given in response is that we have built a thriving private diagnostic market to meet the demand of the international travellers and day 2 PCR testing for travellers is provided by these private providers. Based on forecast modelling, we are confident that the market has sufficient capacity to meet the rise in demand that omicron may pose.

Public Health England (Dissolution) (Consequential Amendments) Regulations 2021

Lord Lansley Excerpts

Tuesday 9th November 2021 Lords Chamber

[Lord Lansley (Con)]

My Lords, it was not my intention to speak in this debate—I wanted to come and listen to it—but I am prompted by a number of contributions just to say one or two things in response to the debate and before my noble friend has a chance to reply. I share with my noble friend Lord Cormack his support for my noble friend in taking on these responsibilities, and nothing I have to say reflects on his role in this. Indeed, I think it has been handed on to the Secretary of State as well, so in a sense we have a new team and I hope they will think about things sometimes in new ways.

I want to make a few, very simple points. The noble Lord, Lord Hunt of Kings Heath, is absolutely right: Public Health England was an executive agency. It worked for the department. In so far as it had operational autonomy, that was not in the legislation; it was a choice made by Ministers. At any stage, as was the case during the Covid crisis, Ministers had all the powers they required in relation both to Public Health England and to the NHS under the emergency legislation.

Let us remember that this House went through the 2012 Act in scrupulous—I might almost say excruciating —detail. It arrived at a conclusion that NHS England should be independent and Public Health England an executive agency. Notwithstanding certain measures put into the legislation to make sure that Public Health England would be more transparent and accountable, that balance was struck not least because I and my colleagues on behalf of the Government said, “We want the NHS to be seen to be independent. We want Ministers to take personal responsibility for public health.”

The noble Lord, Lord Howarth of Newport, referred to one or two things that happened afterwards. I want to share in thanking Duncan Selbie for what he achieved. I want to make it absolutely clear that I understand that Ministers subsequent to the establishment of Public Health England did not give to public health the resources, either for PHE itself or for local government with its responsibilities, that were intended back in 2010-12 under the coalition Government. That did not happen.

Let us remember that, at the beginning of 2020, the King’s Fund produced a report saying that it thought that the public health reforms had worked but they had not been sufficiently funded. Internationally, Public Health England was regarded as being as prepared for a pandemic as virtually any other country in the world. That things fell down needs to be thoroughly examined by an inquiry. An inquiry has not even begun, yet we are already at the point where people have made judgments, reached conclusions and found scapegoats. Heads and deputy heads have rolled.

We are not going about this in the right way. I want Ministers in due course to think again in the light of the report of that inquiry about what constitutes the right mechanism for managing their public health responsibilities. They need an organisation that understands public health in its entirety. How many of us think that the pandemic was unrelated to the extent of non-communicable diseases in this country, to the extent of disparities in this country and to extent of the obesity epidemic that we suffered?

We have so many interconnections between inequalities and public health problems, and our resilience against communicable diseases, that we should never think of managing public health in separate, siloed organisations again, but that is exactly what the Government are doing, without, frankly, having thoroughly understood what happened in in 2020 and 2021. I hope that they will go back and say, “Prevention is not the job of the NHS. Prevention is the job of the Government.” Public Health England was the organisation whose job it was to do that. If it was not strong enough in 2020 to do it, Ministers might look at what they did in the preceding years that might have undermined that role and think carefully about how they should take on the responsibility of building an integrated and fully functioning public health organisation for this country in the future, certainly not simply fragment it.

[Baroness Brinton (LD) [V]]

My Lords, I declare my interest as a vice-president of the Local Government Association.

From the Liberal Democrat Benches, we support the Motion of Regret in the name of the noble Baroness, Lady Merron, and the noble Lord, Lord Cormack and the noble Viscount, Lord Stansgate, are absolutely correct that this House does not like the fact that once again the Government have chosen to use secondary legislation to make major changes to the way the Government manage their business—in this case, public health.

The noble Baroness, Lady Merron, has set out the chaos of a series of announcements from August last year, followed by a variety of procedures and changes when the Government kept getting things wrong. I absolutely support her concerns, and, as have many other speakers, I start from the position that major reorganisations during a global pandemic are unsound and unhelpful, not just to dealing with the pandemic but to the performance of any successor bodies, including the UK Health Security Agency and the Office for Health Promotion and Disparities, with disparity work continuing in NHS England. I echo the comments of the noble Lord, Lord Howarth, and others on the work of all the PHE staff, and Duncan Selbie in particular.

NHS Update

Lord Lansley Excerpts

Thursday 22nd July 2021 Lords Chamber

[Lord Lansley (Con)]

My Lords, following our debates on the Medicines and Medical Devices Act earlier this year on an innovative medicines fund, the announcement in this Statement of a ring-fenced £340 million budget for innovative medicines is very welcome. When will those become available, so that clinicians and patients can access this funding? Given that it now takes us beyond cancer drugs and innovations, will there be a focus on those diseases for which there has been no effective treatment?

[Lord Bethell (Con) [V]]

My Lords, I am grateful to my noble friend for highlighting this important development. The cancer drugs fund was a great success, and we are building on it with a substantial investment. The new fund will support patients with any conditions, including those with rare and genetic diseases. Dementia is one area where we are extremely interested in looking at investing further, and I hope that this would be captured, but we are waiting for recommendations from NICE and the data that it will provide before we set the right prioritisations. In terms of the date, I do not have that at my fingertips, but I would be glad to write to my noble friend with the details.

Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021

Lord Lansley Excerpts

Tuesday 20th July 2021 Lords Chamber

[Baroness Tyler of Enfield (LD) [V]]

My Lords, this is an extremely tricky issue, and I find myself deeply conflicted. On the one hand, I strongly support the principle of mandatory vaccination of care home workers, for reasons I will explain. On the other hand, I think the Government have gone about it in entirely the wrong way. As so often in this pandemic, we are trying to reconcile forces that pull in entirely opposite directions—in this case, the public health need to safeguard some of our most vulnerable citizens, which in my view is overwhelming, pitched against the individual liberties of care home workers.

For me this is deeply personal. My mother is a long-term care home resident and in the first wave of the pandemic, when hospital patients were being transferred to the home without proper testing, there was a significant number of deaths. I need hardly say that this was deeply distressing for my whole family and, I know, many other families up and down the country.

Care homes have a duty of care to their residents, which in my view they are not fulfilling if they do not require care workers who perform close-contact and intimate tasks to be fully vaccinated, unless they have a medical exemption. In my view, anything else would be negligent. Let us never forget the human tragedy this cruel pandemic has wreaked in care homes. Some 20,000 care home residents died in the first wave, accounting for 44% of all excess deaths for that period in England and Wales. We surely owe it to all who died and their families to ensure that care home residents receive every possible protection at a time when cases are rising again with a far more transmissible variant. Today we learn from the latest ONS figures that care home deaths are on the rise too.

Months ago, Professor Chris Whitty expressed the view that front-line health and care workers have what he termed a “professional responsibility” to get vaccinated, to reduce the risk that Covid poses to patients and care home residents. It seems odd that the mandatory hepatitis vaccination for some front-line health workers is hardly, if ever, queried.

I regret that today we are not looking at both NHS and social care workers together. According to the evidence provided to the Secondary Legislation Scrutiny Committee, published only yesterday, take-up of the first dose in the care home workforce stands at 85.6% but with significant variation, as the Minister set out.

It is clear from the two reports of the Secondary Legislation Scrutiny Committee and the debate in the other place on 13 July that this SI is deficient in many respects. The confusing data provided in the Explanatory Memorandum, the lack of an impact assessment—particularly on the workforce implications—and detailed operational guidance not being available until the end of the month are inexcusable. Frankly, I also found it peculiar that the regulations cover a range of tradespeople and other service providers who are unlikely to have close contact with residents. In reality, proper parliamentary scrutiny was pretty much impossible. I totally get that.

I have argued from the outset that far more support was needed to improve vaccine take-up rates among care workers. In early days, slow vaccine take-up was partly due to practical problems, such as vaccinators coming to homes with enough vaccine only for residents, staff being expected to travel to vaccination centres but not given time off or money to get there, and those staff not on duty when vaccinators came missing out. Despite all the efforts made locally to encourage staff to have the vaccine, crucially, the Government should take more proactive steps for carers to be paid for time spent on getting vaccinated, especially if they have to come in when they are not on shift and if they have to take time off because of any short-term reaction to the jab. These things are critically important to low-paid staff, some of whom are on zero-hours contracts.

GPs spending time in care homes talking to staff who are vaccine hesitant has proved highly effective. On top of this, I feel the Government should step in to help with the costs of redeployment and retraining for staff who still refuse to have the vaccine. Without seeing the operational guidance, we do not know whether this will happen.

It is with a heavy heart and after much thought that I am unable to support the amendment in the name of the noble Baroness, Lady Wheeler. I am sympathetic to its intent and broadly support the first three elements, but I cannot support the final element, which says that stronger supporting evidence for requiring staff to be vaccinated is required. The case is clear, and we need to see both more action and more support to ensure that more lives are not lost. However, we need to see the right action.

I plead with the Government, even at this late stage, to think again and to provide the help and support I have outlined above. I also feel that it sends out the wrong message to the public, who will not be following the minutiae of parliamentary procedures and impact assessments and the like. The message will simply be that we do not support the principle of mandatory vaccine for care workers other than those with the medical exemption, which I do, and strongly. This is the right policy but, sadly, the Government have gone about it in entirely the wrong way. It should also apply to NHS workers and it was wrong to exclude them. However, two wrongs emphatically do not make a right.

[Lord Lansley (Con)]

My Lords, I am very glad to follow the noble Baroness, Lady Tyler of Enfield. Like her, I would not be in a position to be able to support the amendment to the Motion. I support this statutory instrument but, I have to say, with some reluctance—and it is not simply because of the procedural issues. It is a step we should take only in a health emergency. I will come back to that point before I conclude.

I am grateful to my noble friend, who explained the SI with his customary clarity, but we are especially grateful to the Secondary Legislation Scrutiny Committee, whose painstaking work has illustrated many of the issues, including those I want briefly to refer to. I am looking for my noble friend in responding to this debate to give one explanation and two sets of assurances.

The explanation is because I simply do not understand why care homes have been brought forward and legislated for in this way where other settings have not been. I cannot understand the difference between a care worker going into a domiciliary care setting with a vulnerable person and how that differs from a care worker in a residential care home. I cannot understand how the vaccination of a residential care worker is different from the vaccination of a healthcare worker in a geriatric ward in a hospital. Why are these things different? If the Government are going to move forward on this, they should have moved forward on all these settings together and should have had the clear argument presented rather than what appears to be a piecemeal argument. I hope that my noble friend will explain why the Government have proceeded in this piecemeal fashion with a further consultation to come, which may lead to different conclusions even at the margin for other settings and for care homes, which will create unnecessary confusion.

Secondly, I am looking for an assurance about support for the care home sector. My noble friend said that the statement of impact—which I found on the government website but of course not published alongside the legislation—says that the Government’s central estimate is 40,000 potential losses of staff. This is in a sector where Skills for Care reported 112,000 staff vacancies in the autumn of last year and where we know that there is a dependence on workers from overseas, some of whom have gone back home and not returned. The sector needs help. The impact statement says that recruitment on average costs £2,500, which is £100 million for the sector in consequence of this measure. That is before you begin to look for the other support it needs from the healthcare system, its general practice colleagues, and in dealing with the insurance sector and others. I hope my noble friend will be able to say that the Government will add significantly—at least that £100 million—to the infection control fund, which is £1.1 billion, and do so in close consultation with the care home sector to give it the support that it needs.

Thirdly, and finally, the point of reassurance I am looking for is that I expected, having discussed this with Ministers, that this statutory instrument would be brought forward with a sunset clause. That is transparently something that should apply during the emergency. It would be reasonable if the Government had said, “This time next year, we should be deciding whether legislation of this kind should be renewed, and a sunset clause would enable that to happen.” I have no confidence that a review, as Regulation 7 says, means that if the review concluded that legislation in this form was not needed, it would not be retained. I am sorry, but I am afraid that from the parliamentary point of view, that is unacceptable. Therefore I am looking for my noble friend to make it absolutely clear that if Ministers conclude next year that the review says that this legislation is no longer needed, they will ensure that it is repealed.

Medical Devices (Northern Ireland Protocol) Regulations 2021

Lord Lansley Excerpts

Monday 12th July 2021 Grand Committee

[Lord Lansley (Con)]

My Lords, I am grateful to my noble friend the Minister for his clear introduction to these regulations. I want to take the opportunity to comment on just one aspect of these arrangements: the processes for a conformity assessment on medical devices placed on the market in Northern Ireland.

A European conformity assessment, a CE mark, is to continue to be recognised in the Great Britain market until 30 June 2023. Likewise, the certificates issued by EU notified bodies will continue to be recognised until that date. It seems to me that, if one is a Northern Ireland-based manufacturer of a medical device—the Explanatory Memorandum estimates that there are some 300 such businesses—for the next two years the CE mark should be a sufficient basis for placing a product on the market, whether in the EU, Northern Ireland or Great Britain. I would be grateful if my noble friend were in a position to confirm what I say or correct me.

If a Great Britain manufacturer is meeting EU requirements then, from 2023, it will require a UK conformity assessment, but this in itself will not enable its product to be placed on the market in Northern Ireland—hence the references in these regulations to the “UK(NI) indication”, which appears to become of greater significance after 1 July 2023. From that time onwards, British manufacturers will be required to adopt dual marking and conformity assessment through two systems, with the attendant cost and complexity. Obviously, the same is true for non-EU third-country suppliers.

At the heart of this problem is the failure of the trade and co-operation agreement to provide for mutual recognition of conformity assessments, given the simple fact that, as my noble friend Lord Empey adverted to, our MHRA undertook 40% of the most significant assessments in the EU. We do not have divergent technical standards; what we have, unfortunately, are divergent political priorities. I personally do not blame Theresa May’s negotiators for our failure to secure that mutual recognition.

One option now would be to roll forward our recognition of European conformity assessments—the CE marking—beyond 2023. Frankly, I do not expect that to happen, because it would undermine the role of the MHRA and British notified bodies, but can my noble friend explain what the position will be for Northern Ireland manufacturers post 1 July 2023? Given the principle of unfettered access to the UK market, will they be able to sell in Britain on the basis of their CE mark or will they require dual marking? This regulation makes provision for the UK(NI) indication, which is useful for UK manufacturers using a previous EU approval and for British devices to access the Northern Ireland market, but it seems to me no more than a face-saving approach to cover the harsh reality that we are going to put our highly successful medical devices sector through significant additional cost, disruption and bureaucracy.