Moved by Baroness McIntosh of Pickering
54: Clause 16, page 14, line 47, at end insert—“3AA Duty of integrated care boards to commission approved treatments(1) This section applies where—(a) a treatment has been approved by the National Institute for Health and Care Excellence,(b) an integrated care board has not arranged for the provision of that treatment under section 3 or 3A, and(c) a clinician has recommended that treatment for a person for whom that integrated care board has responsibility.(2) The integrated care board must arrange for the provision of that treatment to the person for whom it has responsibility.(3) In subsection (1) “clinician” means a medical professional employed by or acting on behalf of an NHS Trust, NHS Foundation Trust or primary care service from whom the integrated care board has arranged for the provision of services.”Member’s explanatory statementThis amendment would require an integrated care board to arrange for the provision of a NICE-approved treatment to any patient whose NHS clinician has recommended it, even if that treatment is not otherwise available to patients in that ICB area.
My Lords, I will speak particularly to Amendments 54, 74 and 97 in this group. I warmly thank the noble Lords, Lord Patel and Lord Hunt, for lending their support to all three amendments, and the noble Lord, Lord Warner, for supporting Amendment 74. I pay particular tribute to the noble Lord, Lord Patel, and his historic work prior to the setting up of NICE; it was a great contribution that deserves to be recognised.
We are all aware of the procedure that, when a medicine is approved, it goes through two processes. First, it goes to the Medicines and Healthcare products Regulatory Agency, known as the MHRA, a body which checks whether a drug is safe and effectively does what it says on the tin. It then goes through a separate process run by the National Institute for Health and Care Excellence, known as NICE, which looks at cost-effectiveness and value for money. After those two hurdles have been passed, the medicines should, theoretically, be accessible to anyone. That is very clear in the NHS constitution, which explains that there is a legal right for people to have access to NHS NICE-approved drugs if it is right in their particular circumstances that they should. Indeed, the NICE guidelines say very clearly that there should be automatic adoption within 90 days of approval, if clinically appropriate and relevant.
For a drug then to be prescribed, it must not only have been approved by NICE but go on to the approved list of drugs in the local health authorities, called a formulary. The problem is that somebody must put the drug on the formulary and, currently, while in theory there is a system under the NHS NICE guidelines, this does not actually happen. Sadly, this results in a postcode lottery where some areas have the product on their formulary and others do not. Sometimes this is a process failure, but sometimes it is to avoid budget overspends. Therefore, I would say that it is at the patient’s expense that they are deprived of the drug.
To give an example of the problem, there is currently a drug for multiple sclerosis that patients are still waiting after 150 days to see go on to the formularies in around 25% of the local health systems across the country. There is a state-of-the-art flash monitor for type 1 diabetes, but the uptake across the country varies between 16% and 65%. What is most worrying is that those parts of the country with the greatest levels of deprivation have the lowest level of uptake.
I make a plea to the Minister: in my view, ICBs should be required to ensure that all NICE-approved medicines and devices are available and promoted to their population, because the cost of these drugs is covered by the VPAS reimbursement scheme agreed between the NHS and the pharmaceutical industry. If a treatment is unavailable in one ICB footprint, they should be required to commission the required treatment from another ICB. The Government should also promote uptake through the ICBs of NICE-approved medicines and report uptake of new medicines annually.
Amendment 54 would require an ICB to arrange for provision of a NICE-approved treatment to any patient whose NHS clinician has recommended it, even if that treatment is not otherwise available to patients in that ICB area. Amendment 74 would require ICBs to ensure that all NICE approvals are available and promoted to their population via a publicly accessible format, normally online, and to report on their uptake annually. Amendment 97 would mandate integrated care boards and healthcare providers, notably hospital trusts, to update their formularies to include all NICE-approved medicines or devices within 28 days of market authorisation, to ensure they are available for healthcare practitioners, through either their physician, for example, or prescribing pharmacist, to make available for suitable patients.
I thank those who submitted briefings to me while I was preparing for today, notably JDRF, which makes a number of recommendations on this issue, particularly in regard to type 1 diabetes. These aim to reduce inequalities, remove the postcode lotteries to which I referred and make sure that treatments, such as those for type 1 diabetes, are uniformly available across the piece. I also thank EMIG, a pharmaceutical trade association for small and medium-sized companies, for its briefing. It says that the uptake of NICE-approved medicines is critical for NHS patients to benefit from the latest and most promising innovations. Finally, I am grateful to Vertex Pharmaceuticals, which submitted a briefing that again supports the conclusions reached. Among the proposals it highlights is the introduction of a modifier to take account of the severity of a disease and efforts to more fairly consider uncertainty in the evidence for highly innovative and complex treatments for rare and severe diseases, including through greater use of real-world evidence.
On this small group of amendments, I look forward to hearing what the noble Baroness, Lady Finlay, has to say in connection with her neat, simple amendment, which would strengthen what we are proposing to do here. I urge the Minister and the department to address these postcode lotteries and make sure that NICE does not just make the guidelines but ensures that treatments reach the formularies and ultimately the patient in question. I beg to move.
My Lords, I wish to speak in support of Amendments 54, 74 and 97, tabled by the noble Baroness, Lady McIntosh, and Amendment 163, tabled by the noble Baroness, Lady Finlay. I too pay tribute to the historic work of the noble Lord, Lord Patel, prior to the setting up of NICE.
While it is not an interest in the formal sense, I declare that I have autoimmune disease and have experience of being on the NICE rheumatoid arthritis care and treatment pathway for 19 years, which has been regularly updated by NICE over that time. Where it has been applied in full and from diagnosis, patients have found it very beneficial and, with new and more effective drugs being approved every few years, many are now in remission. I pay tribute to the consultants trying to do their best for their patients and the National Rheumatoid Arthritis Society and Versus Arthritis helplines which support RA patients in navigating their way through access to their NICE treatments when these have been blocked.
I thank the noble Baroness, Lady McIntosh, for her introduction to this group and for explaining the problem with the formulary list. She is right that this should be addressed formally. However, I want to focus on some of the commissioning practices on NICE-recommended treatments, including those on the formulary, in the current CCGs, because I believe these explain the need for the amendments in this group.
In May 2014, the High Court ruled that Thanet CCG could not disagree with NICE guidance merely because it disagreed with it, even when there is no statutory duty to provide that treatment. This specific case was about access to fertility treatments for a woman who was about to undergo bone marrow transplantation to put her severe form of Crohn’s disease into remission. NICE’s 2013 clinical guidance recommended that
“oocyte or embryo cryopreservation as appropriate” should be offered
“to women of reproductive age … who are preparing for medical treatment for cancer that is likely to make them infertile”.
This was not cancer, and the CCG’s own policy was to not grant funding unless there were exceptional circumstances.
One might think that, after the High Court ruling, CCGs would follow the High Court judgment, but many have found ways to delay the implementation of NICE treatment pathways recommended by consultants for their patients. A particularly unhelpful practice is that many CCGs have developed a committee for considering the initially more expensive NICE pathways. A nasty delaying tactic employed by some sub-committees, reported to me by consultants, is to meet only a limited number of times a year, meaning that there is an automatic minimum delay of some months before any request for a biologic drug can be approved for autoimmune disease. Worse still, one consultant told me that, when budgets are tight, some CCGs use bureaucracy to wait until the committee is due to meet, and at that point write back to the consultant to say that their proposal does not exactly meet the NICE pathway as they understand it and, like a game of snakes and ladders, the consultant must apply all over again. I am sure that this is because of budgetary means, but it makes a mockery of the principles behind the NICE pathway.
Some CCGs are interested only in the medication side—the noble Baroness, Lady McIntosh, talked principally about medication—and ignore the other elements of a NICE treatment pathway. In the RA pathway one key recommendation is that all newly diagnosed patients have access to specialist physiotherapy and occupational therapy, hand exercises, podiatry and psychological interventions, among others. Far too many patients are not offered any of these. The importance of this at diagnosis is that it helps to reduce symptoms, reduce bone damage and reduce future costs to the NHS.
My local CCG, among others, used to have specialist provision, but it now refers new patients to cheaper, non-specialist physios and occupational therapists, wasting valuable time to prevent damage to patients’ joints. I am horrified when talking to recently diagnosed patients to discover they have not been referred to any of the wider multidisciplinary teams, despite the clarity of the NICE guidelines.
NICE uses experts to develop the most effective and cost-effective treatment pathways. In the case of RA, this includes a ladder of medications that consultants and patients progress up, ensuring value for money as well as value for treatment. Providing a consultant uses the NICE guidelines and pathways, it should not be within the gift of any commissioning body to change or delay that.
These amendments place in the Bill the duty of ICBs to approve and deliver treatments as set out by NICE in full. We delude ourselves if we think that ICBs will not try to behave in a similar way to CCGs, not least because many of the staff who deal with the commissioning will have been TUPE-ed straight across from CCGs.
Amendment 54 tackles the problem of the patient in the High Court case I referred to, by proposing that if a clinician recommends a NICE-approved treatment, even if the treatment is not available to other patients in their area, the patient should receive that treatment. I agree.
Amendment 74 deals with the problems of poor practice in some of the CCGs, which I have outlined, and ensures that if NICE has an approved treatment pathway, ICBs should not be able to refuse it. The reporting mechanisms in Amendment 97 would hold ICBs to account publicly. I like the way that Amendment 163 links all this back to the NHS mandate, because of course the NHS is going to be providing the funding for CCGs.
To do anything less than accept these amendments is to demean the work and statutory role of NICE and its experts, to frustrate consultants trying to do their best under those guidelines for their patients, and to deny patients their fundamental right to access to treatment as approved by NICE. I look forward to hearing the Minister’s response and hope that it will be helpful.
My noble friend Lord Patel has had to leave because of pre-booked travel, but he has given me the honour—and it is an honour—of having his brief speaking notes, from which I would like to start, and then move on.
Before I get on to that, I think it is important for us to remember that NICE was set up to establish the evidence base behind what we do. Before NICE was established—and I have worked with Deirdre Hine, who was very involved in setting it up when she was Chief Medical Officer for Wales—people were doing things because they had always done them and because they liked doing them that way, with no evidence base, and often they were doing things that made situations worse, not better.
As Lord Patel wanted to stress, clinicians have a strong belief now in evidence-based healthcare, and guidelines are critical to ensure high and consistent levels of evidence-based clinical practice across the NHS. The guidelines developed by NICE can be adapted to the local situation, and they are also under review. I should declare that I have served for three years as vice-chair of the group looking at ME/CFS guidelines, and it was very instructive to see the depth to which everything was explored and the rigour of the processes; to the point that, when we were asked to review again some papers, we went back to the beginning and reviewed them all over again. Interestingly, in doing that, we slightly downgraded their scoring, rather than upgrading it, which is what had been expected. I was really impressed at the rigour of the process, including the health economics impact.
That experience has been behind the push to make sure that there is compliance. My proposed amendment would be a way of assessing compliance with the guidelines as predetermined and set out in the NHS mandate. The mandate could select a few that would act as proxy markers across the piece and include a date line, so that their implementation across the country could be benchmarked. It would not increase the workload, because it could draw on existing sources of data in the NHS. As the Minister has said, data is our key to understanding and unlocking things.
The noble Baroness, Lady McIntosh, in her comprehensive introduction to this group of amendments, spoke about type 1 diabetes and highlighted that, in some areas, the adoption of continuous glucose monitoring is as low as 0%, whereas in other areas it is up to 20%. There are a couple of other emerging areas; one is in atrial fibrillation, where direct oral anticoagulants have made warfarin a drug of the past. Yet the variation between clinical commissioning groups’ adoption of the guidance is quite horrifying. There is a threefold variation in prescribing, so there are areas of the country where a lot of patients are being denied an intervention that has been shown to be beneficial compared to what was done before.
We have already alluded to another emerging area: the new biologics. On the face of it, they are very expensive, but they are often remarkably effective—they can revolutionise the management of some diseases. We have a budgetary problem here, because the NHS budgets are year-on-year, and the face-value cost of the new biologics is very high; but if you look at the whole lifetime cost of healthcare interventions then they come out much lower. Take the example alluded to, of Crohn’s disease, and consider the cost of someone having their bowel removed, who might then end up on total parenteral nutrition; it is not only the cost of that nutrition but the costs in all other domains in their life, and the lives of their family. In comparison, the new biologics can rapidly get this disease’s process under control and revolutionise things.
The proposal is to give the CQC the powers routinely to address the adherence to guidelines—that would be specified by the NHS mandate, so a national standard could be set—and introduce a reporting metric using current data sources as a starting point to establish a benchmark. I want to stress, as I know does my noble friend Lord Patel, that we are not advocating for guidelines to be mandatory—that would not be right, because each patient is different and individual—but we are asking for a system to be introduced that gives powers so that there can be scrutiny of whether the guidelines are being adopted, because their adoption would narrow the gap in inequalities. We both feel that we need to commit to address this in this important legislation, because it is a way of achieving tangible action to ensure equity in access to quality in healthcare.
My Lords, I have added my name to the three amendments that the noble Baroness, Lady McIntosh of Pickering, has referred to. I was the first Minister for NICE, going back to 1999. At that time, we were confronted with a paradox which continues to this day, which is that, although the NHS is full of innovation and we have an incredibly strong life sciences sector and industry, the NHS is also very slow to adopt those innovations. NICE was developed to speed up the introduction of effective new medicines and devices. Right from the start, we had a problem with the NHS being reluctant to implement its recommendations and, within a few months of it starting, a regulation had to be put through which required it to implement them within 90 days. That has been slightly modified since, but none the less, it is still in being. The NHS has become very adept at finding ways to get round this through the various blocks that have been put in at CCG level—the noble Baroness, Lady Brinton, explained clearly the kind of blocks, devices and bureaucratic machinations that are put into place.
The result is that we continue to be very slow to introduce proven new technologies and medicines. NHS patients are very disadvantaged compared to patients in most countries. It then impacts on pharma and the devices industry—I think that pharma is more reluctant now to introduce medicines and develop R&D in this country as a result.
The Minister knows that there is an agreement—it is called VPAS at the moment—whereby NHS expenditure on drugs is capped and industry pays rebates if the cost goes over that cap. Given what I have always thought to be an imaginative agreement and given that industry is essentially underwriting some of those additional costs, surely there must be a better way to approach this which would allow the NHS to implement NICE recommendations enthusiastically, rather than essentially putting into place blocks.
I doubt that we are going to spend two and a half hours on this group of amendments, but these are just as important as the last group, because they go to the heart of whether NHS patients get access to the drugs, devices and technologies that they should. At the moment, they do not. I hope that the Minister might be prepared to take the amendment away. Legislation is the only way that we can see of leveraging the kind of change we need.
My Lords, I support Amendment 163 in the name of the noble Baroness, Lady Finlay, to which I was delighted to add my name.
Perhaps I may remind the Minister of his very first session at the Dispatch Box. He confirmed to your Lordships that the Government had full confidence in the processes at NICE. In a follow-up letter to me he wrote:
“The National Institute for Health and Care Excellence (NICE) is the independent body that develops authoritative, evidence-based guidance for the health and care system to drive best practice. NICE is one of the few organisations with a remit spanning the NHS, public health and social care, meaning it is well placed to provide a system-wide perspective and support Government priorities for the health and care system.”
As noble Lords have outlined, and the Government have acknowledged, the process for publishing guidelines is authoritative, evidence-based and drives best practice. Why then would the Government not want to include a review of compliance with NICE guidelines to be stipulated in the mandate, which is all that Amendment 163 seeks?
I declare my interest as chief executive of Cerebral Palsy Scotland. I want to highlight the challenges faced by people with long-term conditions, particularly adults with cerebral palsy, who struggle to find co-ordinated, specialist services. The guidelines for adults with CP were published in January 2019. I can confirm that the process was indeed thorough and collaborative; Cerebral Palsy Scotland contributed as a registered stakeholder, even though NICE does not necessarily apply in Scotland. The process had wide cross-sector and specialty support. However, the guidelines are yet to be implemented.
In addition to the guideline, a year later, in January 2020, NICE published a quality standard on care and support for adults with cerebral palsy. This included a recommendation that adults with cerebral palsy be referred to a specialist multidisciplinary team. Adults with CP feel that they are second-class citizens. Their daily experience is of struggle to access any specialist services, in contrast to other lifelong conditions. For some reason, health services for people with CP are concentrated in paediatric services, and despite the fact that having CP does not in itself give you a reduced life expectancy, the NHS seems to believe that once you reach the magical age of 18, your cerebral palsy suddenly is not a problem any more.
The NICE guideline and quality standard both recognise the challenges that adults with CP face and that some people require access to specialist multidisciplinary teams, experienced in the management of neurological impairments, who can work to identify their needs, understand how they may change over time and refer on to specialist and local services as appropriate. Unfortunately, not enough of these services exist. The policy framework might be there, but we are doing absolutely nothing to ensure that it is implemented. People with cerebral palsy are asking, “What is the point of NICE?”
Since the Government clearly value the work of NICE, I urge the Minister to take the opportunity of these amendments to ensure that NICE guidelines are put into practice. Therefore, I look forward to the Government’s support for the amendments.
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.
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.
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?
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.”
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.
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.
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.
My Lords, I welcome these amendments, which relate to the National Institute for Clinical Excellence—NICE. I thank all noble Lords for tabling these amendments and for their contributions today, which certainly expanded my knowledge of the subject, as I am sure they did across the Committee. The debate has shown that there is a need for change, as I am sure the Minister has heard, to better equip the National Health Service to provide the patient what they need when they need it.
The noble Baroness, Lady McIntosh, spoke clearly about hurdles that must be overcome, whether they are bureaucratic, process, budgetary or administrative. All these hurdles get in the way of the end result: meeting the needs of patients. That, I believe, is what this debate is focused on.
NICE is well recognised as a partner to our NHS. Its objective approach and evidence-based analysis rightly gain respect. However, as my noble friend Lord Hunt said—he can now be called the first Minister for NICE—although the National Health Service is full of innovation, it is also slow to pick up on it; that point was emphasised by the noble Lord, Lord Warner. That begs the question: what kind of partner should NICE be to the NHS? Is it going to be an enabling partner, or will it frustrate at times? Of course, we all want to see NICE in that fully enabling capacity.
However, beyond what NICE approves in terms of treatments, pathways or otherwise, there must be procedures for it to implement and connect effectively to patients’ needs. We know that no system or set of procedures will ever be perfect; we have heard that today. Understandably, therefore, as the Minister has heard, pressure and a will for change—in a positive sense—is contained in these amendments. The noble Baroness, Lady Finlay, spoke about how important it is to have evidence-based healthcare and to have known guidelines and see them complied with, as is right and proper.
There are cautionary considerations to note in this debate; we have heard some of them. One is whether it is wise to put what in some cases appear to be operational requirements in the Bill. I am sure the Minister will address this. The new world is certainly paying a lot of attention to flexibilities. We want to make sure that anything contained in the Bill does not inadvertently work in another direction.
My understanding is that NICE guidance is mandated, in effect, with the guidelines somewhat less so. Amendment 54 contains a proposal to reinforce the intention that, once a treatment has been properly assessed and recommended, all patients should be able to gain the benefit. We know, and we have heard in this debate, that this does not always happen, and that clinical commissioning groups follow different policies. However, in considering the amendment at face value, it is important that we consider what impact this latitude might have. I am sure we are all keen not to accidentally invoke some kind of fallout, such as taking away all leeway from commissioners. At present, they can depart if they can set out an objective case for doing so; for example, with requests for certain drugs and therapies through individual funding requests.
Similarly, it would be unfair if a patient could cross an integrated care board border and receive a treatment that was not available in another ICB area. That would seem inadvertently to achieve what we do not want to achieve: the worst of a postcode lottery. Equally, if we have locally based approaches, the reality is that some localities will differ in their priorities and services. I know that we will return to this topic many times in our consideration of the Bill because the care that patients receive should certainly be equitable and fair and not based on where they live.
At this point I refer to the contribution of the noble Lord, Lord Stevens, who reminded your Lordships’ Committee that what we are dealing with is not a new problem but was considered over the matter of lime juice many years ago. It is right that the noble Lord, Lord Stevens, raised questions about the terminology in the amendments. If they are to advance, I am sure that your Lordships’ House would want to look at how the terminology is set out and what the wider impact of the amendments would be.
On Amendment 74, the intention for information to be promoted is sensible, as is a process to report on usage of online information sources. Again, I expect—I hope—that the Minister will at least find favour with this amendment, but he may question whether it is straying outside the legislative territory. That is a matter we should also consider about Amendment 97.
Amendment 97 is about a timeline for the updating of the systems of integrated care boards and healthcare providers to make NICE-approved medicines or devices available. I certainly support the intention here. However, if this is a direction to take, we need an examination as to whether a deadline of 28 days would actually provide for the intention of this amendment, and whether this is something of concern for primary legislation.
I had assumed when looking at Amendment 163 that the inspections referred to were by the Care Quality Commission. I am grateful to the noble Baroness, Lady Finlay, for confirming that. It makes sense for the CQC to look at many aspects of compliance and the amendment would ensure that focus is directed at ensuring equitable access to technologies and treatment.
In closing, I hope that the Minister will have felt the mood of this debate, which is supportive of NICE in all its excellence but also in a wish to see perhaps a nimbler and more responsive partner to the NHS so that we can see benefits for patients on a fair and equitable basis.
I thank all noble Lords who have spoken in this debate, both to the amendments and in making wider points about NICE. I take this opportunity to pay tribute to Gillian Leng, who recently stepped down as chief executive of NICE after a number of years.
I turn to Amendment 54. I am sure noble Lords will appreciate that we all want NHS patients to benefit from proven and cost-effective treatment; no one would want otherwise. That is why we see NICE as playing a vital role in supporting patient access to new treatments. I have heard the criticisms from previous Health Ministers, who were responsible for NICE. I sometimes feel in debates such as this, when I am with former Health Ministers, that it is like a special edition of “Doctor Who”, with previous regenerations. I hope we do not create a fracture in the space-time continuum. NICE recommends the vast majority of new medicines for use by the NHS. In fact, in 2020-21 100% of new medicines were recommended by NICE and many thousands of NHS patients have benefited from access to some of the most cost-effective treatments as the result of its work.
Another interesting thing is that when a decision is made and it is difficult to access medicines, patients will get frustrated—rightly so, given that they know it is available or maybe has been recommended. At the same time, on the global stage NICE has a well-earned reputation. It is one of my three priorities; I have mentioned technology, the second is life sciences and the third is international health diplomacy—how we use our position on health as part of UK soft power. One of the institutions people across the world look to and want to learn from is NICE. NICE is looking to be at the centre of a number of global networks on the issues where it has a reputation.
NHS England and clinical commissioning groups are already under a statutory obligation, under Regulations 7 and 8 of the snappily titled National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013, to fund any treatment recommended by NICE through its technology appraisal or highly specialised technologies programmes, usually within three months of guidance being issued. As the noble Lord, Lord Stevens, mentioned, NICE also operates a separate medical technologies programme, which supports faster and more consistent adoption of medical devices, diagnostics and digital products.
I assure noble Lords that these funding requirements will apply to the ICBs once established. Therefore, we do not see the amendment as necessary at this stage for clinicians to prescribe NICE-recommended treatments for their patients. I also thank the noble Baroness, Lady Merron, for pointing out some of the unintended consequences and scope of such amendments. I remind your Lordships that, since April 2021, NHS England’s medtech funding mandate has supported faster access to some of these innovative technologies recommended by NICE.
I know that I am going to try to reassure noble Lords on a number of things but, on Amendment 74, I hope they note that the funding requirement on ICBs for NICE-recommended treatments goes even further than the requirement to promote what the noble Lords propose in the first part of the amendment. This will ensure that clinicians will continue to be able to prescribe NICE-recommended treatments for their patients.
The second part of the amendment would replicate existing arrangements that are in place to measure uptake and use of NICE-recommended medicines. Since 2013, NHS Digital has published an innovation scorecard that reports uptake of medicines that NICE has recommended in the last five years at a national and local level. Data on the uptake of NICE-recommended medical devices is not currently reported in the innovation scorecard as it has been more complicated to collect. However, I assure noble Lords that work is under way, by both NHS Digital and the Accelerated Access Collaborative, to address this gap. The Government consider that it is more appropriate and proportionate that this information is collected and published by a single national body using an agreed methodology, not by multiple organisations that will each have different ways of measuring and presenting the data.
On Amendment 97, I can tell noble Lords that NICE works closely with the MHRA—I thank the noble Lord, Lord Stevens, for pointing out the distinction —which issues marketing authorisations to ensure that licensing and appraisal timescales are aligned wherever possible. The NHS in England usually funds any treatment recommended through NICE’s programmes within three months of positive final guidance. We believe that three months is a realistic framework for providers to prepare for and introduce a new technology, and I hope I can assure the Committee that NICE and NHS England already work closely to facilitate the adoption of recommended technologies as quickly as possible.
As the noble Lord, Lord Stevens, again alluded to, there is a high level of transparency in the operation of local formularies. Formularies have their own public websites, which list the selected medicines and associated guidance, and area prescribing committees publish the minutes of meetings, which identify the medicines added or removed from formularies. We believe that there is therefore no need to publish an annual list.
Although healthcare providers are encouraged to use local formularies when prescribing, they are not restricted to them. The decision as to what to prescribe lies with the prescriber, who will act in the best interests of the patient. Indeed, some of the correspondence I get as a Minister for Health often refers to when people cannot get access to a medicine that is not recommended, but the clinician has the authority to suggest that that medicine can be available to the local area.
I am sure the Minister is right about how this system is meant to work, but there are far too many examples of clinicians seeking to prescribe medicines that have gone through the technology appraisal and then finding that CCGs have set up the various devices that the noble Baroness, Lady Brinton, mentioned to delay or stop it. Does he recognise that CCGs are engaged in a process of seeking to delay implementation for as long as possible? Will this be accepted under ICBs or will it be tackled?
I thank the noble Lord, Lord Hunt, and the noble Baroness, Lady Brinton, for raising this issue. I should be honest; I was not aware of the suggestion that CCGs often delay and whether that situation will be transferred to ICBs. I ask noble Lords whether I can look into that situation further to understand it more. I simply say that I was not under that impression.
When the Minister is looking into that, will he also look at the issue of the usual suspects? The problem that the noble Lord, Lord Hunt, probably encountered—I certainly encountered it—was that many of these areas that are slow to implement NICE recommendations are the same areas where overall performance is pretty poor. There is an issue here about whether we can clearly identify the laggards and take action with them, rather than have a generalised look at the performance of particular areas.
Perhaps I may suggest, following the interventions of both noble Lords and their experience of being Health Ministers and of NICE, arranging a follow-up meeting with them to discuss this matter in more detail so that I can understand the situation more. As I am sure noble Lords will appreciate, I have been in this job for only four months and am still learning an awful lot. In fact, I am learning far more in this Committee than I have in my first four months. That shows that sometimes there is no substitute for learning on the job.
NICE has a suite of more than 300 guidelines and, as the noble Lord, Lord Stevens, said, more than about 1,900 medicines, spanning the whole of health and social care. It makes dozens of recommendations that can be complicated. We do not think it proportionate or feasible to require compliance with NICE guidelines but, given what I have just mentioned, I should like to consult previous Health Ministers with experience in this area and perhaps have further discussions to see what is relevant in the future.
I shall end with the CQC reviews of ICSs. We will look more broadly at the entire system of how the ICS areas are performing. A requirement for the CQC to specifically consider compliance with NICE guidelines as part of these reviews risks adding a considerable burden to this process. I can, however, assure the Committee that the Government expect the healthcare system to take NICE’s recommendations fully into account, subject to what noble Lords have told me about the performance of some CCGs. I am also aware that NICE works closely with system partners to support implementation where possible. It is probably best henceforth for me to have those conversations with the two noble Lords and any others with experience of this matter. There are more than two former Health Ministers in this House and we should have those conversations.
Let me see if I can answer some of the specific questions. As regards VPS—how do I put this in the most diplomatic way?—I have been asked to look at that issue. The industry has complained, for example, because we also have therapeutic tendering at the same time as expecting this. I am grateful to my right honourable friend the Secretary of State for asking me to look into this issue in further detail. I have asked what would happen, for example, when some of the life sciences companies ask whether it makes the UK less attractive in some ways. I am assured that it does not but I am looking into this issue as part of the life sciences aspect of my portfolio.
I think that I have covered all the questions but all that I ask at the moment is to let me have further conversations. That is probably best. In that spirit, I ask noble Lords to consider withdrawing or not moving their amendments.
My Lords, I am grateful to all who have contributed to this debate and for the number of issues that have been raised.
At the outset, the noble Baroness, Lady Brinton, highlighted and a number of us focused on the hurdles—as the noble Baroness, Lady Merron, described them—to be overcome. However, there has been a lot of focus on the problems of the budgetary challenge. It would be incumbent on my noble friend the Minister to meet not just with the two noble Lords he highlighted but the drafters of the amendments: myself, the noble Baroness, Lady Finlay, the noble Lords, Lord Hunt and Lord Warner, and the noble Lord, Lord Patel, who sat so patiently through the whole of today’s proceedings and had to leave before this discussion was reached. As he had such success in the mental health meeting, I hope that we replicate that and take up a number of the issues raised here.
I was very taken by what the noble and learned Lord, Lord Mackay, mentioned about strengthening the amendments by reference to timescales. I think that is very important indeed.
I am disappointed that my noble friend was not aware of, and has not fully answered the questions on, budgetary challenges, how to get on to and off the famous formularies and the process to be completed at that stage. Rather than pursue this now—I do not think we can take it any further at this stage—I hope my noble friend will use his good offices, so we can meet around the table on Zoom and take this further before Report. With those few remarks, I beg leave to withdraw the amendment at this stage.
Amendment 54 withdrawn.
Clause 16 agreed.
Clause 17 agreed.
Schedule 3: Conferral of primary care functions on integrated care boards etc
Amendments 55 and 56 not moved.
I call the noble Lord, Lord Low of Dalston, to move Amendment 56A—or the noble Baroness, Lady Hollins. Is the noble Baroness, Lady Finlay, moving Amendment 56A?
My Lords, perhaps I might put in a slight plea to the Committee on behalf of the noble Lord, Lord Low. He has sat patiently through this debate for a long time. He was expecting that the other amendment would be moved and, on realising that it was not, has made every attempt to return to his place as fast as possible.