Lord Warner Portrait Lord Warner (CB)
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My Lords, I support all the amendments in this group, particularly Amendment 74, to which I have added my name. I was one of the successors to the noble Lord, Lord Hunt, as a Health Minister responsible for NICE. I pay tribute to his sterling work in establishing it. However, I encountered the same difficulties as he encountered with the NHS speedily taking up NICE recommendations and had to wrestle with this same problem.

I had a long and slightly exhausting chat with the chief executive and the chairman of NICE about what they could do to help the NHS implement their recommendations. We arrived at a concordat, and the NICE people went away and developed a rather helpful system for enabling the NHS to prepare for a NICE recommendation and to implement it. As far as I am aware, looking at the NICE website, it still has that system in place, so it is not as though NICE is simply putting its recommendations in the public arena and leaving the NHS to get on with it; it has done its level best to produce a way of helping the NHS to prepare to implement those recommendations.

What I do not understand is why we have not moved faster over time to recognise that more action needs to be taken with the laggards within the NHS to make this happen. I think that one method is captured in the amendment from the noble Baroness, Lady Finlay.

If NICE is so important and it is so important that the NHS implements its recommendations, that ought to figure in the regulator’s assessment of the performance of those NHS bodies. I can see no reason it should not, and I wonder whether the Minister could tell us a little more than I know—and more, I suspect, than the Committee knows—about the current position on the failures of NHS bodies to pursue NICE recommendations. Do the Government accept that the regulator of these bodies should take account of their ability and willingness to implement NICE recommendations? Perhaps the Minister could clarify some of those issues. If he cannot clarify them today, perhaps he could write to us.

Lord Stevens of Birmingham Portrait Lord Stevens of Birmingham (CB)
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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 Portrait Lord Lansley (Con)
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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?