Health and Social Care Bill

Lord Patel Excerpts

Monday 19th December 2011 Lords Chamber

[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.

[Lord Patel]

My Lords, I have added my name to Amendment 344 tabled by the noble Lord, Lord Warner. NICE should continue to do technology assessments or appraisals. It is not surprising that I should support the amendment, because I was closer to the establishment of NICE than most people may know, although I said so at Second Reading. It was a paper written when I was chairman of the Academy of Medical Royal Colleges, to establish a national institute of clinical effectiveness, which led to the establishment of NICE as an institute of clinical excellence. At the same time as Mike Rawlins, a good friend for many years, started with NICE, I was involved in a similar exercise with SMC, its sister organisation in Scotland.

The key thing about both organisations is that, despite their appraisals of drugs, neither of them has been taken to court about their advice. That says something about the scientific veracity with which examinations are carried out. Although I have views that are sometimes slightly different from NICE—for example, I think that we will have to adjust in due course the QALY from £30,000 a year because we will find with drugs that are more expensive and effective that that price is too low—I go further and say not only that NICE should not be stopped from doing these appraisals but that its remit should be extended to biochemical tests, which should not be used in the NHS unless they are proven to be useful. As genomic medicine advances, more molecular and genetic tests will come on the market. It is already happening in the United States. Tests are used which are not found to be scientifically appropriate and marketed at a ridiculous price. I give the example of a test that is used to predict whether a person with a myocardial infarction will develop chronic heart failure. We use a much simpler test. They charge £8,000 for a test which must be done twice a year; we use a stethoscope to listen to the chest to see whether there are any bubbles in it. If there are not, the person is not in cardiac failure. It is as easy as that and every medical student is taught it. It will become even more important that an organisation that is as respected as NICE is given the task of assessing biochemical, molecular and genetic tests before they are implemented in the NHS, otherwise their cost will be enormous. Every marketing company will come along and say, “This test should be used”, as is happening in the United States. I would therefore extend NICE’s technology appraisal remit beyond drugs. It offers proven, scientifically driven assessments and I cannot see why we should stop them. Besides, we would see one part of the United Kingdom continuing while another part did not. I know that if NICE says a drug produced by a British pharma, particularly a big pharma, is not effective based on QUAL, it might be difficult for that pharma to market the same drug internationally, but that is an issue that needs to be tackled separately. Value-based pricing of drugs may be an area that we need to look at again, but not the appraisals.

[Earl Howe]

My Lords, I know that NICE is held in very high regard by noble Lords in the Committee. The Government share that view. That is why we are putting NICE on a firmer statutory footing in the Bill, extending its role to cover social care as well as healthcare and public health, and putting NICE quality standards at the heart of quality improvement. NICE will continue to play a key role in helping to ensure that decision-making in the NHS is robust and evidence-based.

The noble Lord, Lord Owen, said that the Bill gave the impression that NICE would turn into a kind of annex of the Department of Health. I can assure him that that is not the intention of the Government. A special health authority, as NICE technically is at the moment, is much closer in technical terms to the Department of Health than the non-departmental public body that we will set up. He also said that he felt that the additional responsibilities we were placing on NICE were inappropriate. When I have spoken to Sir Michael Rawlins, the chair of NICE, he does not take that view. He regards what we are doing as a vote of confidence in NICE, which is what it is intended to be.

There has been some confusion throughout the passage of the Bill about the detail of NICE’s future role. This may underlie some of the discussion we have had in the debate around the incorporation of NICE’s technology appraisals into quality standards. First, I can confirm that NICE will continue to appraise new drugs and technologies at least until we implement our plans for value-based pricing from 2014. The Bill enables us to provide for NICE to continue this important work when it is re-established.

As we develop our plans for value-based pricing of new branded medicines, NICE’s role in appraising drugs will inevitably evolve. However, we have been clear that we expect NICE to have a central role in the value-based pricing system, including in undertaking an assessment of the costs and benefits of different medicines. That is highly analogous to its current role. I very much agree with the noble Lord, Lord Owen, that we do not wish to lose—and certainly not downplay—the skills and scientific and analytical expertise that NICE undoubtedly has. We will make announcements on the precise shape of the value-based pricing model in due course but suffice to say for now that we believe that NICE is very well placed to fulfil the role of performing the pharmacoeconomic evaluation that will underpin the value-based pricing assessment.

Alongside that, NICE may also need to continue to undertake some technology appraisal activity after 2014—for example, to review existing recommendations in the light of new evidence or to assess important new non-drug technologies. It is quite wrong to suggest that we will cease that activity within NICE.

I also take the opportunity to reassure noble Lords that we will use powers in the Bill to replicate the effect of the funding direction which ensures that the NHS in England continues to fund drugs that have been recommended by NICE’s technology appraisal guidance. However, it would not be appropriate to place in the Bill such a requirement on clinical commissioning groups—as Amendment 344ZA would seek to do. That would leave no flexibility to alter the requirement in the event that there were clear practical barriers to implementation within three months of the final guidance. Amendments to the existing funding direction have only been made on a small number of occasions but it is important to retain that flexibility and secondary legislation supports this better than putting a requirement in the Bill.

--- Later in debate ---

[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.

[Lord Owen]

I thank the Minister for his explanation earlier. I found much of it convincing, particularly his statement that Professor Mike Rawlins thought that this was a vote of confidence in his organisation. I have long had respect for Professor Rawlins—he was an adviser to the SDP many years ago, so I can hardly disavow his advice at this stage. I urge the Minister to consider for one moment that Amendment 342 would go a long way towards reassuring a lot of us. It would take out the word “direct” and put in the concept of agreeing, which would be much more beneficial if he wants to establish the relationship in reality.