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.