Health and Social Care Bill

Lord Warner Excerpts

Monday 19th December 2011 Lords Chamber

[Lord Warner]

My Lords, Amendment 344 in this group, in my name and that of the noble Lord, Lord Patel, and the noble Baroness, Lady Thornton, has been prompted by the Government’s apparent wish to remove NICE from technology appraisals of new drugs to assess their cost-effectiveness.

I join my noble friend Lord Hunt in paying tribute to the work that NICE has done. These technology appraisals were the original purpose of NICE when it was set up, against the wishes of the pharmaceutical industry. It has done sterling work in this area which has provided it with an international reputation. One of the strange ironies of this is that the pharmaceutical industry has come almost to love NICE, because the commercial value and standing given to some of its new products when companies receive a positive appraisal by NICE has been considerable. When I went to America to make my peace with some in the pharmaceutical industry after cutting their prices, and after they sometimes broke down in tears over the drop in their profits, they would say that if the mean NHS was willing to pay for those drugs, they must be good things in themselves.

Value-based pricing still looks to be some way off and it seems premature to many to remove NICE from the sphere of technology appraisals—here, I should declare my interest, because I have been a Minister with responsibilities for NICE. I want to press the Minister to tell us more about the arguments for removing NICE from this work, particularly given the financial challenges faced by the NHS, and whether the Government will think again about technology appraisals and NICE’s responsibilities there. That is the purpose of the amendment; I look forward to hearing the Government’s views.

[Lord Owen]

My Lords, I wish to extol the merits of NICE after watching it from the other side, which is the pharmaceutical industry. It is certainly true that the United States pharmaceutical industry was appalled initially by the appointment of NICE and there are still a lot of people who dislike it intensely. Nevertheless, it has established a scientific credibility which is rare in regulatory activities and which it would be absurd to forgo.

I am worried about a lot of the language used about NICE in this legislation. I know that “direct” will be discussed in another context, but there is an overall intent effectively to bring the body into the Government and make it answerable to them. The important quality of NICE, which was established particularly when it first arose, is its measure of independence. If that measure of independence is lost, NICE’s authority and credibility will go with it. I see a lot of merit in ensuring that the appointment of the chair carries not just the imprimatur of the Secretary of State but the imprimatur of Parliament. The Select Committee on Health, which has shown itself over many years to take an informed and knowledgeable view of the National Health Service, is a credible check on NICE becoming not just another annexe to the Department of Health.

I am also concerned about the additional responsibilities being given to NICE. NICE’s quality came from the fact that it was highly focused. That focus was on the pharmaceutical industry but it was also on science and scientific appraisal. It is a great help to the department to have this authoritative, independent view. We all know how easy it is for so-called wonder drugs to get sponsored by newspapers, individuals or trends. What NICE did was to give an authoritative viewpoint, as far as possible objectively, and to take its time sometimes when there was great pressure for an early pronouncement. It was able to withstand that pressure and say, “Until we get more evidence, we will not be able to form a judgment”. We all know that it is very difficult for the department, for Ministers and for people who are in the front line to have that measure of detachment, but scientific evaluation requires it, as well authority that has been built up over a substantial period.

I hope that the Government will not only listen to the proposers of the amendments but take this issue away and ask themselves whether they are not scoring an own-goal. NICE is an organisation that has worked; not many of our organisations in this field work quite so successfully and build such a substantial reputation within the profession which was sceptical about it. I agree with the noble Lord, Lord Warner, that even the pharmaceutical industry has come to see its value. A lot of other countries are looking at NICE and want something similar to be established. A lot of the language in this part of the Bill goes against that trend. I will listen carefully to the Minister’s reply, but I hope that the Government will have a fresh look at this matter.

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[Lord Hunt of Kings Heath]

My Lords, I am grateful to the noble Earl. At heart, there are two key issues here. One is the independence of NICE—I am grateful for what the noble Earl said on that. I certainly support the change in status. The reason there is some anxiety about independence is that in two parts of the Bill the NHS Commissioning Board has powers of direction over NICE. We will come on to this in relation to Clause 231 on quality standards—it applies also to Clause 236 but this is where some of the concern comes from. I am very dubious about whether quangos, to put it kindly, should have power over NICE. That is where the concern comes from and why scrutiny by the Health Select Committee of the chair would be important.

The noble Earl has reassured us that the technology appraisals will continue and that, until value-based pricing is introduced, there will be a clear understanding that NHS bodies will implement the technology appraisals. He said that it would not be appropriate for those directions to the health service to be in the Bill, but can he clarify that the current order will be amended so that instead of directions to health authorities, primary care trusts and NHS trusts in England, clinical commissioning groups will appear in the title of the order? It is quite clear that although this will be done by secondary legislation, clinical commissioning groups will be required. I take his point about the need for discretion when it comes to primary legislation, but I would like to ask him about that point.

My third point to the noble Earl is about value-based pricing. One of the joys of talking about value-based pricing is that no one understands it, and, frankly, having read all the reports and the original OXERA report, I confess that I am still rather puzzled by it. It sounds good, but I caution the Government that the PPRS has served us reasonably well. It has allowed the Government to cap the profits of the pharmaceutical industry but has given them complete discretion about the price of individual drugs—the advantage being that prices set in the UK have then been influential throughout the rest of Europe. My concern about value-based pricing is that, combined with issues around the regulation of medical health research, it makes the UK a less attractive place for the industry to invest in R&D.

My noble friend Lord Warner toured the boardrooms of New York and New Jersey, and I followed him to sweep up—

[Lord Warner]

The mess.

[Lord Hunt of Kings Heath]

—not the mess, my Lords, but my noble friend’s vigorous discussions—because of the wish to ensure that those global companies continued to invest in the UK. The problem with the Department of Health is that while it sponsors the industry, its real concern, when it comes down to it, will always be the cost of drugs to the National Health Service—hence my concern that powers of direction by the NHS Commissioning Board will not be used in a way that is conducive both to the independence of NICE and to the continued R&D spend on pharmaceuticals in this country. I do not really want to institute a debate on value-based pricing at this point, but I hope that the Government will look very carefully at its introduction and all the consequences from it. Having said that, unless the noble Earl wishes to answer the point on direction, I certainly beg leave to withdraw.

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Moved by

[Lord Warner]

342: Clause 231, page 232, line 11, leave out “may direct NICE to prepare statements of standards” and insert “shall each year agree with NICE a programme of clinical quality standards to be completed or revised”

[Lord Warner]

My Lords, briefly, Amendment 342 is in my name and that of the noble Lord, Lord Patel, who will speak to Amendment 343, which I also support and to which I have added my name.

Amendment 342 was prompted by the rather slow progress that seems to have been made so far on developing clinical quality standards. I accept that these are very important, so there is nothing between me and the Government on the virtue and value of those standards. However, the rate of progress seems to be about five a year, on the information that I have managed to obtain, and at the present rate of progress it looks to be well over a decade before the exercise is completed—and then, I suspect, the whole process will have to start again because standards are likely to be out of date, and science and clinical practice will have changed. This exercise could become rather like painting the Forth Bridge.

I am all in favour of taking care in the preparation of clinical quality standards and of the need for proper consultation to ensure that a spectrum of expertise and discussion is brought to bear on each clinical quality standard. It is important to get clinical support for those standards, but in this area speed is also important if patient care is not to suffer. I wonder therefore whether the processes for preparing these standards do not need some review. It is possible that the resourcing of the work may need to receive some attention. In addition, I believe much work has been done in other jurisdictions—certainly, a lot has been done in the United States—and I wonder whether the Government and NICE could not draw on this work in an effort to speed things up.

To buck things up a bit, Amendment 342 requires the Secretary of State to “agree with NICE” an annual,

“programme of clinical quality standards to be completed or revised”,

in that year. This should ensure that the process and resourcing are kept under review and that faster progress is made. These clinical quality standards are critical to delivering improved quality and efficiency in the NHS at a time of great financial challenge and rapid clinical and scientific advance. We need to press on with their preparation and to ensure that the Secretary of State and NICE give proper priority to this issue. I hope the Minister can agree that an amendment of this kind will help to achieve this. I beg to move.

[Lord Patel]

My Lords, briefly, I support this amendment and Amendment 343, which has been tabled in my name. Although the amendments refer to “clinical quality standards”, I am well aware that the Bill itself refers to them as “quality standards”. It was I and the noble Lord, Lord Warner, who suggested in previous amendments that “clinical” should be introduced, but I recognise of course that these quality standards will concern not only clinical but social care, and there should therefore be a reference to clinical and social care.

I have also made the point before that these standards ought to cover the patient’s journey of care, which goes from diagnosis through primary, secondary and tertiary care and on to social care.

I believe that I know something about clinical quality standards, and while the noble Lord, Lord Warner, referred to standards written in the United States, closer to home there have also been hundreds of standards written over the past eight years. I bet your Lordships now that the methodology that will be used by NICE will be exactly identical, but that is an argument which I will have with the chairman or chief executive of NICE—no doubt over a dinner some time.

What is important about these standards is that they are evidence-based so that it is possible to defend them, just as technological appraisals are evidence based and therefore possible to defend. The evidence that we are looking for is that which will deliver the best outcome for the patient, in terms of safety of treatment, diagnosis, patient experience and outcomes in terms of diseases.

It is also important that they should stand the test of time—that they are written and based on evidence that is tested over time, so that they do not have to change every three months and have people complaining that treatment has moved on. Experience has taught us that it is possible to write those kinds of quality standards, which stand the test of time but, as the noble Lord, Lord Warner, said, they are time consuming to create and therefore they have to be resourced. If you are creating standards for over a patient’s journey of care, it will require several months and expertise to do so. If you intend to have more than five or six standards a year, you require to resource them fully.

Another important issue is that standards have to be tested before they are finalised so that, just as with the technological appraisal of drugs, you do not get complaints from clinicians or anyone else. I can tell noble Lords that doctors are very good at complaining afterwards if they are not consulted. There have to be consultations with both clinicians and the public so that they will feel happier that the standards are evidence-based and will deliver the outcomes that we expect.

A third important aspect is that the standards should be easily understood. I was clear when I did the job that every one of the standards written should get a crystal mark, so that they were written in a language that people could understand. If we are going to evolve and develop information standards, a further value is that each of the quality standards is an opportunity to inform the patient about what they should know about their disease and its treatment. There can be simply written questions that the patients or relatives can use to ask about the problem in question. That gives us an opportunity to use the standards not only to manage the care of the patient but to inform the public and the patients about their disease. That way, you make the public better informed and able to demand the kind of quality care that they should get, so the systems will be operating in a way that delivers care.

My Amendment 343 says that standards should also cover long-term conditions. To me, that deals with the problem of complex long-term diseases, which need to be managed in both the acute sector and the primary or community sector. The standards should therefore be written as a patient journey of care over a longer period of time. Those are the quality standards that we should be embarking on and the numbers that we should provide for.

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[Earl Howe]

The noble Baroness is quite right and no legislation can provide for that culture change, as she will appreciate. At the same time, we can put in some important building blocks to encourage a change of culture. One is to have maximum clinical input into how the quality standards are framed and formed and, indeed, input from patient representative groups. It is very important to see things from their perspective. We can create duties, as we have in the Bill.

The work that my department has done on accelerating the uptake of innovation is relevant here. The NICE implementation collaborative—the NIC—that was part of our announcement about the growth agenda some days ago is designed to bring together the relevant stakeholder groups to see how the uptake of innovation can be accelerated and how people can be made to look at working practices in rather a different way so that cultures shift. However, it is easy for me to stand here and say that; it is less easy to drive this forward. I would not pretend that the Government are necessarily in the best place to do that, although we are clear that this shift in approach, which largely underlines the QIPP agenda as well, has to take place. However, it will take a little time.

[Lord Warner]

My Lords, the total purpose of my Amendment 342 was to inject some momentum into the process of delivering these quality standards. I am much reassured by what the noble Earl has said. I think my noble friend’s point about directions for the national Commissioning Board is important. It can be misleading. I hope that the revelations of the noble Lord, Lord Owen, about the chairman of NICE’s past associations will do no damage to his reputation. I beg leave to withdraw the amendment.

Amendment 342 withdrawn.