National Institute for Clinical Excellence

HL Deb 23 January 2002 vol 630 cc1505-31

5.30 p.m.

Baroness Knight of Collingtree rose to call attention to the remit of the National Institute for Clinical Excellence; and to move for Papers.

The noble Baroness said: My Lords, with the benefit of hindsight, there are probably those in government who rather regret the name chosen for the body set up to review the clinical and cost effectiveness of NHS drugs and treatments. To look at drug effectiveness was fine, although I should have thought that the Medicines Commission could have done that. To look at value for money was perfectly reasonable, although to confine the search for savings to drugs and treatments, instead of searching more widely for other areas which could be run more cost-effectively—indeed, there are many such areas—was not very sensible.

And the name—the name "NICE" damned it from the start. Whether those responsible shuffled initials around and purposely used the word "excellence" so that such a cosy name with such glittering promise emerged, I cannot say. But it was tempting fate to set this body on its way with a name that promised far, far more than it could possibly deliver.

I do not blame the members of NICE. They were given an impossible task: first, to advise on what drugs and treatments are the most effective and whether they are cost-effective; and, secondly, to eliminate inequalities and postcode prescribing. But the two are incompatible. When you judge on evidence that a drug is good and effective—excellent, in fact—and then go on to say, "But it is very expensive and should be made available only to some sufferers", that is not very excellent for those who do not get it. It certainly does not eliminate inequalities of treatment. So far as I can see, NICE has no duty to say, "What is to happen to the unlucky ones for whom treatment is denied?".

The debate gives us an opportunity to ask the Minister for clarification on a number of points. According to one set of papers I read, health authorities must obey the diktats of NICE. If NICE says that a certain drug or treatment should be made available, then it must be. Is that right? I tend to feel that doubt is creeping in because another source of evidence states that if health authorities cannot afford the drugs arid treatments advocated by NICE, then they will not make them available. Which of those is correct? It must be one or the other; it really cannot be both. Do the Government have a statutory obligation, as was welcomed in an Early Day Motion put down in another place as recently as 13th December last, to fund all treatments recommended by Nice"? If that is so, why was there strong criticism only a week ago today that the drug approved by NICE for Alzheimer's was only very sparsely prescribed because of lack of funds? I thought that the position was clear when I read a speech made in July last year by Yvette Cooper, the Parliamentary Under-Secretary of State for Public Health in the other place, who stated: All health authorities must adhere to [NICE's] guidance". Later on in the same speech she said that: Health authorities need to fund the drugs and treatment recommended by NICE".—[Official Report, Commons, 417/01; col. 88W.] Right, so we know where we are. But oh, no, we do not. That is because many health authorities are refusing to fund new drugs—for instance, for lung cancer—despite NICE's backing for those drugs. Cancer Bacup states that under 15 per cent of authorities have set aside the necessary money for the purpose.

So much doubt has been cast on this—perhaps because of a number of warnings that such expenditure will lead to cuts in treatments for other patients; there are plenty of examples—that one Member of Parliament serving on the Health Select Committee, which noble Lords will he well aware is currently studying the work of NICE, said that he was "completely confused" about the matter. Expert witnesses were available in plenty, but they simply could not help him because they simply did not know. I wonder whether perhaps the Minister knows and whether he might help. It would he so good it-be could do so.

Points also need to be made about the formula used by NICE to decide who shall have drugs and treatments and who shall not. It is called QALY. Noble Lords may ask what is that; it is the initials by which the standard is known, representing the words: "quality adjusted life year". I really hate this. The notion of a group of people in an office, looking not at patients but at statistics. not at individuals but at calculated norms, not at family or circumstances, or achievements, or capabilities. but at pounds arid pence, is anathema to me.

Of course it is a huge and always increasing problem for the Exchequer. I certainly recognise that Modern drugs and treatments are unbelievably expensive. I made a few inquiries into this. Beta interferon, for example, costs around £10,000 per patient per year. Some treatments can cost even more. Incidentally, can the Minister say why this drug costs so much in Britain, but is available at half the price in America and southern Europe? Can he look into this? If that is the case, perhaps we could reach an arrangement with those two areas so that we are provided with cheaper drugs than we are using at the moment.

But my main point is that by adopting the principle that some patients should be left to suffer because they are judged not to be worth the cost of their treatment is simply not acceptable in a humane or Christian country. Once that principle is accepted, as it is by NICE and, apparently, by the Government, then it is only a short step—having decided that the patient really is not worth the cost of treatment—to wonder whether there is much point in keeping them alive at all.

Of course I am well aware that for many years doctors and midwives have had to reach decisions in their own practices with regard to their own patients on whether, say, the baby being born will have a normal life. They have done whatever they thought was right at the time. I am not happy about that situation, but I really do not think that it should be government policy to set out guidelines on which patients shall be treated and which shall not.

QALY may not be the only yardstick used to decide who should receive treatment, as is claimed by the chairman of NICE. But that it exists at all should give us cause for the gravest concern. There really are other ways in which money could be saved or spent better in the NHS. I should he more than happy to suggest a few, but tonight's debate gives neither the time nor the scope for that. I hope that perhaps we shall have a debate soon which would allow us such interesting opportunities.

But I must get back to QALY. I wonder whether age is a factor considered by NICE when it looks at and constructs this particular yardstick. I do not know—I wonder whether any noble Lords know—the precise details of this rather mysterious ruling. Only a short time ago the Government stated categorically that they would not touch ageism with a barge-pole and that age should not be a bar to receiving the drugs that patients need. I do not know whether that statement is accurate, but again that is something for the Minister to confirm.

The chairman of NICE said that patients' views are also considered when QALY is decided. Are they? The Macmillan Cancer Relief charity has said not. Only last week, at the Select Committee, it called upon NICE to review its procedures and to bring in patients' views more firmly. It said that NICE accords low priority to patients' inputs and is failing to listen to patients' views.

Was Macmillan Cancer Relief the only charity to claim that? No, it was not. The Consumers' Association made it clear that it held the same view, as did the National Cancer Alliance. There was also concern among these organisations that NICE was not open and worked too much in secrecy. The Multiple Sclerosis Society complained to the Select Committee that it never knew whether or not its input was worth while. It also said that the long delays in reaching decisions is tied up with this. I understand that with so much evidence to study delays are, to some extent, unavoidable, but sometimes there seem to be delays which are not excusable, many of which are on record.

The MS Society gave written information on its appraisal system for beta interferon and was told by NICE that there were gaps in its submission. The society asked what and where were the gaps and pledged to deal with them at a meeting to be held some three months later. NICE took until two days before that time to say what were the gaps. But surely it must have known what were the gaps before it complained. NICE not only gave too little time for planned discussion but, apparently, the facts of the alleged gaps were, according to the society, "very sketchy".

I feel that I should add my own comment about secrecy: there has never been a public debate on the adoption of QALY. Accountants may approve, but bishops will not. Well, I am not sure about that because, these days, I do not know what bishops will or will not agree. I am only certain that they will not all say one thing or the other. However, my point is that the subject should have been discussed.

I turn now to another important issue. We all understand that when NICE was set up its purpose was to take away from government the decision-making process of what drugs should be supplied and paid for by the NHS; that it should be an independent organisation scientifically to evaluate new drugs and advise independently whether or not drugs and treatments were effective. Now we have a situation which implies that this is not so. NICE has not so far reached its decision on beta interferon, but the Government are jumping in and having their own trials on it. It seems extraordinary that before NICE has said what it thinks, the Government, by their action, indicate that never mind what NICE decides, they will have their own look at that particular drug. Is the original understanding correct? If so, why are the Government stepping in?

In its submission to the Select Committee, the Consumers' Association identified serious shortcomings in NICE's appraisals of health technologies. The drugs and therapeutics bulletin reviewed all nine NICE guidance documents and found serious flaws in every single one of them. Is this the kind of thing which has led the Government to start their own investigations or what? No one denies for a moment that NICE has a complicated remit, but on the present evidence we must acknowledge that there is a worrying number of grave concerns about the way in which NICE works—concerns about whether its judgments are right, about secrecy, about undue delays, about the yardsticks used and about NICE's role versus the Government's role. I invite the Minister to think about all this and, at the end of the debate, to have a shot at clearing up all these problems. I beg to move for Papers.

5.44 p.m.

Lord Addington

My Lords, I have discovered—unusually for someone who is speaking only second in a debate—that the noble Baroness has covered many of the points which led me to get involved in this debate.

I first paid attention to NICE as a result of the great beta interferon and multiple sclerosis initiative, primarily because my main concern—disability—was drawn into it. Here was a drug treatment which may well prevent an illness which could cause someone to be permanently disabled. It seemed to me absurd that this treatment could be refused.

As to costing—and it has been said that this does happen—I have spent a considerable amount of time searching the NICE website and looking here, there and everywhere, but I could not find the costing formula for this. Presumably there is costing in every other area; presumably a formula is used. I shall not repeat every single acronym involved in this process, but there must be something going on here. How much in terms of disability living allowance and other benefits could be offset against the cost of these drugs? How much should the average wage be brought into the equation? Where is the equation given? In what areas does it work?

I believe that another debilitating condition—rheumatism—will be covered later in the debate by another noble Lord.

With any luck, drug treatments will get better—but this situation will arise again in all fields. It is to be hoped that all degenerative illnesses will one day have some kind of treatment which, even if it does not totally reverse them or stop them, will at least make life bearable, but, if this situation is on-going, we should surely have something built into the system which could kick in straightaway and dictate what we should do.

Unless we bring in a system to deal with it, the beta interferon situation will arise again and again and we will create a situation guaranteed to let people down every time. We are not bringing in a system to deal with it. We must build and structure into the situation a system which takes account of matters across the board.

Later today I shall be taking part in the Second Reading of the Disability Discrimination (Amendment) Bill. How far does the NICE situation spill over into another area where we are denying people their rights? I do not say that there are any limits to what is going on—I can ramble on for 15 minutes or I can stop very quickly—but it would seem that we have drawn our circle very tightly in dealing with the situation. All the internal talk is ultimately about the health service. Clearly, we are not looking wide enough.

I know that the Minister's job is to defend the current system, but please can he take on board and take back to the Government that we need to know whether consideration is being given to the problem. That is the least that we have a right to expect.

All the charities and organisations which are in the vanguard of these current struggles, and which will be in the vanguard of the struggles that will go on in the future, feel that the system is far too bureaucratic and that it is not user friendly. That theme ran through the evidence about which the noble Baroness has spoken. The organisations are not sure what is going on and feel that the system is not open enough. They feel that the lay person has no real chance of getting a handle on the issue.

We all know that the campaigning carried out in this area in this country is driven by the lay community associated with these causes. We have all dealt with such bodies, which provide us with briefings on a regular basis. Ultimately, unless we can open up the system, no matter what we do—even if the noble Lord takes my advice and does his calculations—we shall not know about it properly. We shall not understand it and we shall keep coming back to it. If the noble Lord can address these points, he will deal with many of the concerns that people have.

5.49 p.m.

Lord Colwyn

My Lords, I thank my noble friend Lady Knight for initiating the debate. She is a great campaigner and I thank her for giving me the opportunity to say a few words about the relationship between NICE and dental surgery. With that in mind, I declare an interest in that I am a practising dental surgeon.

The latest press release that I have received from NICE, dated 6th November 2001, informs me that, last year, it issued guidance that had the potential to affect the care of over 10 million users of the NHS and their families, and that it now expects to issue over 100 guidelines each year. It states that contact has been established with multi-professional partnerships to set up national collaborating centres to help with its authoritative guidance on healthcare for healthcare professionals and users of the service. NICE will create a new partnership between the Government, the National Health Service and clinical professionals. By establishing NICE the Government will take responsibility for helping to clarify, both for patients and for professionals, which treatments work best for which patients and those which do not.

This is a massive responsibility and commitment. I am sure that it is no coincidence that, on 23d November, the Health Select Committee announced that it would be holding an inquiry into NICE. I understand that the inquiry is ongoing and that the committee has been taking evidence today.

Until recently, the professional organisations were reluctant to give guidance on clinical techniques. However, we now have many different authorities telling professionals what they can and cannot do, and what materials they can and cannot use. I have debated this with the Minister on many occasions, largely in connection with the administration of general anaesthetics in the dental surgery, where the General Dental Council, which will soon have many more members who are not dentists, issues new guidelines on this particular clinical practice on a regular basis—seeming to many of us to be out of touch with the real world. To give a further example, the Department of Trade and Industry—for some reason that is not understood by the dental profession—has taken responsibility for the materials that can and cannot be used in bleaching techniques.

It is important that the healthcare professions understand who ultimately controls guidance for clinical techniques. The stakeholder organisations—of which the British Dental Association is one—must be concerned about the potential for a lack of independence in NICE's activities. This can be allayed only by close partnership between NICE and the stakeholders. The NICE key principles for NHS guidelines, together with recognition of the importance of taking account of existing guidelines and the best available evidence, are crucial.

The dental profession does not believe that NICE can, or should, aim to provide a single national focus for guideline setting. I know that the British Dental Association has expressed its concern about the need to avoid duplication and to ensure that all organisations involved in guideline setting are consulted and given the opportunity to participate in relevant activities. To this extent, the development of its commissioning process and the stakeholder involvement mechanisms that have been introduced have been welcomed. Guidelines must be credible and robust; and, if they are to be implemented as such, they must be developed by individuals with relevant practical experience and by organisations that have the confidence of the profession.

The first NICE guidelines for dentistry were on the removal—or not—of wisdom teeth, which were set out in its Technology Appraisal Guidance No. 1. This was generally welcomed by the profession, but was noted to be a re-hash of the existing guidelines from the Royal College of Surgeons, which were already followed in the NHS but did not take account of the most recent research.

It is rumoured that we are about to be advised on the relevance of the six-monthly check-up and the need for treatments for gums. I can assure the Minister that those in the dental profession advise their patients individually on the ideal intervals between check-ups and gum treatments. Some may need to be seen every three months, some annually and some every two or three years. It varies according to the individual's ability to look after himself or herself. It should also be remembered that the check-ups include an examination for oral cancers and are a vital link in the prevention of this debilitating disease.

Dental care has a high ratio of private provision. About half of the money spent in a year on dentistry outside hospital is paid by patients. NHS guidelines which concern cost-effectiveness must make very clear the context in which they are issued, and must recognise that NICE is unable to make recommendations concerning cost-effectiveness in private care. Once again, I thank my noble friend Lady Knight for introducing the debate.

5.55 p.m.

Lord Roberts of Conwy

My Lords, I, too, compliment my noble friend on securing this debate.

In this House NICE is not the most popular body, judging by questions that have been asked and by what has been said so far in the debate, and we all know why. NICE is regarded, rightly or wrongly, as the body which prevents certain types of patients from obtaining the drugs and treatments that they desperately need, and which would be prescribed for them by their doctors if those doctors were not convinced that their clinical judgment would be thwarted one way or another if NICE did not approve. That is the case in the beta interferon/MS saga.

So there is some truth behind this harsh popular perception of NICE. However, it is not the whole truth, as I am sure the Minister will tell us in replying to the debate. The health service circular which set out NICE's initial work programme makes it clear that NHS bodies should, continue with local arrangements for the managed introduction of new technologies … where NICE's guidance is not available at the time the technology first becomes available". In theory, therefore, there is no let or hindrance to NHS bodies allowing the prescription of drugs and the giving of treatments referred to NICE for appraisal, or if the appraisal process is incomplete. One would have thought that in such circumstances local clinical judgment would prevail, but that has not always been the case—far from it: other factors such as the availability of funds and resources, and local priorities, have come into play.

I have a particular interest in the availability of anti-TNF alpha drugs for the treatment of rheumatoid arthritis. For those noble Lords who are interested in definitions, I turn to the definition of TNF in a paper prepared by a team some time ago, led by Bryan D Williams, professor of rheumatology at the University of Wales College of Medicine, of which I have the honour to be president. The paper states: Tumour Necrosis factor has emerged as a key molecular target for the treatment of rheumatoid arthritis. Two effective new therapies infliximab (Remicade) & etanercept (Enbrel), the first of their kind as biological response modifiers and disease controlling anti-rheumatic therapies, have become available … for the treatment of severe resistant rheumatoid arthritis". My interest in the subject began as a personal matter. My youngest son suffers from the disease and. initially, he could not obtain the appropriate drug. But I soon realised that there were many others in the same position. So it has become a matter of national interest. There are some 600,000 people who suffer from rheumatoid arthritis in the United Kingdom. There is no doubt that many of them—but by no means all—could have their suffering relieved by the used of these anti-inflammatory drugs, which are currently being appraised by NICE.

I am in touch with the leading medical authorities on rheumatoid arthritis throughout the UK and last year I helped form the National Rheumatoid Arthritis Society to raise the profile of the disease and its alleviation. There is no doubt about the efficacy of the drugs in appropriate cases. The Minister has acknowledged it in a letter to me dated 9th November last year. He said: There appears to be clinical evidence that these anti-TNF drugs can help a proportion of patients to achieve better control of their arthritis, with reduced pain and disability. when treatment with existing drugs has failed. Unless there are appeals, NICE expects to issue its guidance in March 2002". Last year, the British League Against Rheumatism and the British Society for Rheumatology carried out a survey of 185 of the UK's 215 NHS trusts. Their preliminary findings showed that postcode prescribing of the treatment was rife, with wide variations across regions, within health authorities and even within trusts. Rheumatologists in nearly one third of trusts are unable to prescribe the drugs. Nearly half of the remaining trusts' rheumatologists were able to prescribe the drugs to only a handful of people—fewer than 10. Only in around one sixth of the trusts covered in the survey did rheumatologists have adequate funding to meet the need.

Those findings, which are not yet verified, but which are borne out by experience, should send shivers down our spines. Postcode prescribing is a dreadful form of inequality and discrimination. It means that whether a patient suffers depends on where in the United Kingdom he happens to live. That is grossly unfair. I must make it clear that I want to end postcode prescribing not by prohibiting the use of such drugs when they are available, but by making the drugs generally available to all who need them and qualify for them. Of course they are expensive. They cost about £8,000 per annum per patient.

One must also consider the position of the rheumatologists under those findings. They are unable to prescribe according to their best clinical judgment because of a shortage of funds. The rheumatologists are in an intolerable position. I am not sure that they are not offending in some way against their Hippocratic oath. There are also implications for the United Kingdom as a whole. The drugs are available in the United States, where they are even given to children who are showing signs of rheumatoid arthritis. They are also available in a number of European countries. Where does that leave the NHS? It leaves us looking very backward and retarded compared with other countries.

I am sure that there are also implications for the future of the pharmaceutical industry, which contributes so much to medical research in the United Kingdom. It cannot be much encouraged by the fact that the market for the drugs is so weak that it cannot bear the cost.

Many of us are concerned, because we get the impression that NICE is being used as a delaying tactic, a rationing agency and a cover by the Government for a lack of adequate funding for the NHS. How can that be true when the Government say that they are pouring more money than ever before into the NHS? The latest news is that the NHS is only just about breaking even and some regions, such as the South East of England, are heading for a deficit.

Would not the use of funds to make those drugs available assist the Government to achieve their targets for the NHS? The current Secretary of State certainly believed so in 1998, when he told the other place: If drugs mean easier, better and quicker treatment for the patient instead of going to hospital, that is a good thing and if it means growth in the NHS drugs bill, we should welcome it.… we want a more rigorous assessment of what is cost effective and clinically effective, particularly when drugs come on to the market".—[Official Report, Commons, 28/7/98; col. 158.] I am not sure that those words are reflected in the Government's current policy. Things have changed since those words were uttered in 1998.

I am also greatly worried about whether NICE takes account of the cost of a disease in its appraisal. It is estimated that rheumatoid arthritis costs the country £1.2 billion a year in benefits, income tax lost because of inability to work and so on. I have been assured by the Minister that it can take such matters into account. In a Written Answer to me, he referred to the framework document for NICE, which states that, its task is to assess the evidence of all clinical and other health-related benefits of an intervention—taking this in a wide sense, to include impact on quality of life, relief of pain, or disability etc as well as any impact on likely length of life—to estimate the associated costs, and to reach a judgment on whether on balance this intervention can be recommended as a cost-effective use of NHS and PSS resources".—[Official Report, 11/12/01; col. WA 193.] I am grateful for that assurance, but I am not sure that it works in practice and that NICE takes the full costs of a disease such as rheumatoid arthritis into account.

I have concentrated on rheumatoid arthritis because I know something about it. There is also the saga of beta interferon and MS. The Government should take a firm grip on the whole area. So much suffering could be relieved and so much saving could be effected by the use of the most modern treatments available. NICE would be well advised to cultivate a more positive reputation than it has at present.

6.9 p.m.

Lord Astor of Hever

My Lords, I congratulate my noble friend Lady Knight on bringing before the House the important subject of NICE. She is a great and very successful campaigner, as my noble friend Lord Colwyn said.

Last week, the Government announced that NICE, the Commission for Health Improvement, the National Clinical Assessment Authority and the National Patient Safety Agency should work more closely together to establish a more coherent approach to standard setting, regulation, monitoring and inspection of healthcare. The Government also made a commitment to establish a new council for quality healthcare, encompassing the bodies I have mentioned, to facilitate co-operative working on the functions they jointly pursue.

We on these Benches are concerned about whether the new council, or anyone therein, will be given the very important and necessary role of overseeing quality and standards in public health services. The recent failure in public health is a very great concern. On 10th January, the Chief Medical Officer announced a new committee—the National Infection Control and Health Protection Agency—which will assess the threat of new and emerging infections and disease and implement vaccination. That is necessary simply because of the Government's lamentable failure in public health. We have decreasing immunisation rates and an increasing incidence of infectious diseases and sexually transmitted diseases. There is need for a body that can take concerted action across departments.

As I understand it, the council for quality health care will have overarching supervision of NICE, CHI, the NCAA and the NPSA . It will also ensure that, together, those constituent organisations work more closely with the Social Services Inspectorate, the National Care Standards Commission and the Audit Commission.

During a debate in the other place on the National Health Service Reform and Health Care Professions Bill, which we shall very shortly be considering in this House, my honourable friend Oliver Heald suggested the urgent need for more management, co-ordination and provision of quality public health services in the NHS. He suggested that the role be given to a unified body. The newly announced council will unify NICE, CHI and the other bodies vested with ensuring quality in the health service. I wonder whether that body, with its collective role—NICE providing clinical guidance and perhaps taking on a new screening role, and CHI with its inspectorate responsibilities—might be an appropriate organisation to house within it a much needed public health role.

The BMA has expressed concern that the Bill's new arrangements may lead to some areas having no public health doctor advising either the primary care trust or the strategic health authority. Statistics on public health make gloomy reading. The number of BCG vaccinations decreased from 518,000 in 1997, to only 137,000 last year—a decrease of almost 400,000—yet the number of TB cases reached a 15-year high. According to the British Thoracic Society, the number of adults and children with the respiratory disease TB was at record levels. London is the TB capital of the western world.

In addition to the considerable risk of a TB outbreak, we are also at risk of a measles epidemic, as the levels for MMR have fallen to as low as 72 per cent in London, compared with a "safe" uptake level of 95 per cent. The most important task we have is to protect our children. To do that, we must have sufficient immunisation levels to prevent any possible epidemic. We have seen the tragic effects of failure to immunise in Ireland and the Netherlands, where children have died as a result of the disease.

I believe the evidence that suggests that MMR is safe, and I am not convinced that there is any link between MMR and autism. However, many of the public and some in the medical and nursing professions believe otherwise. That is resulting in considerable public health risk. It is a huge failure of the Government's public health policy neither to reassure the public effectively nor to provide an alternative. We simply cannot sit by and watch immunisation rates fall to levels that will virtually guarantee a measles epidemic.

The increase in sexually transmitted diseases also has been remarkable. Between 1999 and 2000, the incidence of syphilis increased by 5.1 per cent, gonorrhoea by 25 per cent and chlamydia by 12 per cent. We have seen similar pictures with other diseases.

The Government have a duty to protect the public's health, but currently they are failing. In his wind-up speech, can the Minister tell the House how the Government intend to ensure higher quality standards of public health provision?

6.15 p.m.

Baroness Howells of St Davids

My Lords, I am grateful for the opportunity to speak in the gap; I had some problems getting to the House today. I also thank the noble Baroness, Lady Knight, for introducing this debate. I shall concentrate on NICE itself.

In establishing the National Institute for Clinical Excellence, the Government have given all clinicians the opportunity to adhere to informed, sensible and, I believe, strictly scientific advice. NICE is here to ensure that patients receive better care, and the indicators are that it is already having that effect. To date, NICE has made significant progress in identifying effective medicines and treatments and spreading their use quickly throughout the NHS. We should be aware of that fact.

In less than three years, NICE has become established as an integral part of our National Health Service. Its work reaches into all aspects of the NHS, from wider judgments on whether a new treatment is clinically effective and cost effective to assessment of what care is best for the individual patient.

The NHS can no longer tolerate postcode prescribing whereby decisions on what care is best for a patient are made on the basis of widely varying funding policies. We need the institute so that, as we go forth towards the end of this century and new medicines become available, we have one body that establishes and helps us to decide what is best for the people of this country.

6.18 p.m.

Lord Clement-Jones

My Lords, we are all grateful to the noble Baroness, Lady Knight, who has raised some very important issues in an extremely trenchant and thought-provoking way.

On a number of occasions, Ministers—including the noble Lord, Lord Hunt—have promised a full review of the work of NICE. That review should have started half way through last year. Very regrettably, rather than establishing a full review, Ministers seem to be content to respond to the recommendations affecting NICE made by the Kennedy report on children's surgery at the Bristol Royal Infirmary. A full review would have been preferable. Evidence should have been taken, and a far wider range of recommendation should have been considered.

The Government's response to the Kennedy report was published last week. The original report made clear recommendations on a more independent role for NICE. The Government's response was half-hearted, to say the least. The dissemination of NICE guidance, we are told, will no longer need the approval of a Secretary of State for Health. What a big step! On the truly crucial issue—the selection of topics for appraisal—we are fobbed off with the promise of a consultation document. When will that he forthcoming? Should not NICE, subject to consultation with its stakeholders, be able of its own volition to choose its own topics for appraisal? Would it not raise the level of public and professional trust in NICE if it were seen as more than a creature of government? What real impact will yet another body that the Government propose to establish—the council for quality health care—make? It seems to be another body to co-ordinate a whole series of other bodies. I am afraid I do not share the presumed optimism of the noble Lord, Lord Astor, in that respect.

In the absence of a government review, the other mechanism for change, apart from the Kennedy report, is the current Health Select Committee inquiry into NICE, referred to by a number of noble Lords. I welcome the Select Committee's initiative. It has given rise to a number of very interesting contributions, most of them dealing with issues of common concern not dealt with in the Government's response to Kennedy.

NICE's evidence is also of great interest. Although sorry to see that it did not support the Kennedy report's recommendation that it should become a non-departmental public body, I welcomed its suggestion that its work programme be constructed in a more open and inclusive manner and that there should be an annual report to Parliament. Many of the areas of concern have been aired in debates in this House, not least in our debate last April.

The original remit of NICE included the important role of looking at the cost-effectiveness of treatments. It also had its remit extended at the last moment to look at the affordability of treatments in its appraisals. However, I have been assured that that latter role is only activated at the request of Ministers and that it has not been so activated to date. It is therefore, contrary to expectation, NICE's role and methodology in assessing cost-effectiveness which have given rise to many of the problems to date. It is that which has fed the belief that NICE is engaged in a rationing exercise and taking quasi-political decisions.

As I pointed out last April, one of the key problems is the scientific basis of the appraisals, highlighted in the Beta interferon and the glatiramer acetate appraisal. That was referred to not only by the noble Baroness, Lady Knight, but also by my noble friend Lord Addington. That appraisal raises fundamental questions about how NICE will accommodate access to drugs for rare diseases and the appropriateness of cost-economic evaluation—the QALY—in the treatment of low prevalence diseases. The superimposition of standard cost-effectiveness criteria on to the assessment of a drug for a rare disease is not always appropriate. How can existing treatments be compared when the orphan designation implies that there are no satisfactory methods of prevention or treatment of the condition?

As I pointed out, conventional health economics techniques are based on the availability of a wide range of comprehensive data needed for the appraisal. But in the case of rare disorders, often for practical, ethical and scientific reasons, it is impossible to provide equivalent comprehensive data. Innovative products which treat diseases are often by their nature unique and cannot therefore be assessed by the use of traditional cost-effective assessment methods—I am sorry that that is rather technical language.

Since that debate I have not heard or seen anything which persuades me that NICE has properly grasped this issue. Quite the contrary. Clearly we need changes to the system so there is proper recognition of the issues which surround rare diseases and orphan drugs. Like the EU, we need recognition of the specific nature of rare diseases and a different appraisal system for orphan drugs such as beta interferon and glatiramer acetate. The cost of the illness and the burden of the disease—a point made by my noble friend Lord Addington and the noble Lord, Lord Roberts—must be properly taken into account in relation to those orphan drugs.

A further cause for concern remains the lack of transparency of NICE—mentioned by a number of noble Lords. As mentioned by the noble Baroness, Lady Knight, in December last year the Consumers' Association published a report on NICE. It concluded that it needs to become much more open as to how it arrives at decisions. In its evidence to the Select Committee, the Consumers' Association goes further and claims that there were serious flaws in the nine NICE guidance documents it examined in detail. It compared Scotland favourably with England in that respect. It says it is difficult to see what impact evidence from voluntary organisations has. Is NICE relying too heavily on clinical trials data and overlooking quality of life information? Is it applying a crude, cost-effectiveness threshold, as many claim, of £30,000 per QALY? Perhaps the Minister can enlighten us.

Current processes and methodology concern patient organisations in particular. I declare an interest as a trustee of Cancer BACUP, the cancer information organisation. It has been heavily involved in submitting evidence to NICE appraisals for a range of cancer treatments since NICE started its work. In is evidence to the Select Committee it expressed concern about delays. It takes a year, on average, to carry out an appraisal, excluding appeals. Clearly, the process should be faster.

What is holding appraisals up? Is it a lack of resource? The Minister has consistently assured us that NICE does not lack adequate resources for its work. Can he repeat that assurance? NICE's evidence to the Select Committee seems to imply that that is not the case. With delay there comes the phenomenon known as "NICE blight". Physicians hold back from prescribing a treatment pending the outcome of the appraisal. In those circumstances, health authorities hold back from funding.

Cancer BACUP also expresses concern about the absence of adequate data on quality of life issues. It believes that issues relating to patient priorities and quality of life should be subject to separate research.

Now we come on to the even more difficult subject of implementation. That of course is not strictly within the remit of NICE. But there is little point in NICE appraisals unless they are implemented. The Minister assured us that the money is there. In fact the Secretary of State has now promised that there will be a statutory duty on health authorities from this month to fund NICE appraisals. That is welcome, with caveats, if indeed it is correct.

My honourable friend Sandra Gidley MP carried out a survey in May last year which demonstrated considerable divergence by health authorities in their funding of appraised treatments. One in five health authorities are not funding one or more approved drugs. There are clearly major geographical variations. In a recent Cancer BACUP survey—referred to in NICE's evidence to the Select Committee, so it must be respectable!—it was found that taxanes as treatment for breast and ovarian cancer were almost universally funded, but that only 15 per cent of respondents said that specific funds are available to implement NICE guidance on lung cancer treatment.

The postcode lottery is still with us. Yet in the NHS cancer plan launched in September 2000 there is a clear government pledge to ensure that NICE recommendations are fully funded. That is belied as we speak by the experience of many hospitals. Clearly, allocations are not being spent on what they were allocated for.

But it goes further than that. The systems for monitoring are not there. In the Cancer BACUP survey, it was found that fewer than half of all health authorities in England and Wales had a policy for monitoring local compliance with NICE guidance, although 80 per cent had a written policy for assessing the implications of NICE guidance. Do current performance assessment procedures contain any requirements in that respect? Perhaps the Minister can answer that question.

What assurance can the Minister give for the future? Will extra, identifiable and adequate funding be made available to implement past and present NICE guidance? Will monitoring systems be installed in each health authority or strategic health authority to ensure that a check on statutory implementation is kept? How will the statutory duty be enforced? Will the patient have a right to enforce the duty? Without that we shall simply be robbing Peter to pay Paul with the raiding of other budgets and distortion of clinical priorities. Some, such as Professor Alan Maynard, already believe that that is the case.

In conclusion, I recognise that NICE is to a high degree caught between the competing forces of government, patients and pharmaceutical companies. On balance, its impact has probably been positive. Although there are criticisms, we should recognise that it is performing a vital role and few of us would want to turn back to pre-NICE days. In this House we are all subject to entreaty about the outcome of NICE appraisals, not least in this House tonight. I believe a strong, independent but responsive NICE is of great importance.

It was always known that that would be a difficult role. But NICE seems to have been slow to respond to experience or criticism, and the quality of its communications has sometimes been enormously lacking. As a result there is already some clear sign of government embarrassment. The Government have already had to contemplate ways round their expected decisions on beta interferon and glateramer acetate, as with its risk-sharing discussions with the industry. The Minister protested when I raised that recently in a Starred Question and said that it does not demonstrate a lack of confidence in NICE. Time will tell.

It should be clear beyond peradventure that the Government have the responsibility of making political decisions about resources available to the NHS, not NICE. The sooner it steps out of that particular arena, the better. Yet that could be done at the same time as giving greater independence to NICE, along with more resources and a greater remit.

I am not yet convinced that NICE has demonstrated the transparency or sureness of touch that are necessary for its role, or indeed the flexibility of methodology needed. I hope that it will heed some of the points made today—and that Ministers will do likewise—and in evidence to the Select Committee and make the changes that are almost universally asked of it.

6.30 p.m.

Earl Howe

My Lords, I join other noble Lords in thanking my noble friend Lady Knight for bringing this important topic to our notice today and for speaking to it, if I may respectfully say so, in such a clear, concise and persuasive manner.

Nearly three years into its life, NICE and its work and way of working are ripe for review. That, coincidentally, is the view held by the Select Committee in another place which is currently in the midst of taking evidence. I hope, too, that it is the view of Ministers. I shall come back to that last point in a moment, but in the meantime I trust that the Minister will regard this as a good opportunity to listen to the observations of those of us who have followed the progress of NICE from its beginnings and who, despite perhaps understandable misgivings about it, wish it well.

For there can be no doubt that the rationale for N ICE, as originally presented by the Government, was a thoroughly worthy one. There was certainly a need to address and put right the grosser examples of so-called "postcode prescribing". There was much to be said for a body whose job it would be to evaluate treatments in a dispassionate, impartial way and to provide advice and recommendations on them to the health service. We all acknowledge the imperative to ensure rapid access for patients to new and innovative treatments. That was the good side of the rationale. But did it end there?

There were those of us three or four years ago who believed that the Government had darker motives. We believed that, despite the overtly respectable reasons for setting up NICE, the hidden agenda at the Department of Health was to put a brake on expensive treatments and thus save money for the health service. I am partially repentant of that suspicion, but only partially. If the Department of Health was at one time secretly hopeful that NICE would reach negative verdicts on expensive treatments, by and large those hopes have been confounded. Nevertheless, NICE has been an instrument for rationing, albeit a form of rationing that is indirect, and what I mean by that will become clear in a moment.

What surprised and disillusioned many of us shortly after NICE began its work was the augmentation of NICE's remit. When it first began, the task of NICE was to evaluate new and existing treatments for clinical effectiveness and cost effectiveness and to base its advice about best practice on those two bench-marks. In August 1999, safely into the summer Recess when most of us were by the sea, an order was laid which directed NICE to take a further factor into account; namely, the effective use of available resources. The reason that was a surprise was that up to that time the Government had insisted that decisions on the affordability of treatments, which is a question quite distinct from their cost effectiveness, would be a matter for Ministers. Those decisions require an "above the parapet" political judgment to be made—the kind of judgment that, to give him credit, Frank Dobson made on the contentious issue of Viagra. But the addition to NICE's remit suggested to many of us that questions of affordability were henceforth to be a matter for NICE itself and not for Ministers. Ministers would be able conveniently to shelter behind decisions of NICE, a supposedly independent body, and thus avoid being directly implicated in unpopular decisions where absolute cost played an important part.

I have had no reason whatever to change my opinion on that matter. If proof were needed, I refer the House to the Minister's answer to me in a Starred Question on 5th December last year when I asked him about the bench-mark to which we now understand NICE operates when reaching its determinations; namely, a cost of £30,000 per quality adjusted life year or QALY. I asked him who set the bench-mark. The Minister said that he could not respond specifically to me because, such matters are for NICE to consider in order to develop its own methodology".—[Official Report, 5/12/01; col. 830.] If NICE itself fixed the bench-mark of £30,000 per QALY, then that is indeed NICE making judgments on affordability. We do not know how that figure was arrived at. Ministers say that it has nothing to do with them. I find that disturbing.

Related questions arise from the Government's recent response to the Kennedy report. Paragraph 4.8 of the response announces the Government's intention to remove the requirement that the Secretary of State and the National Assembly should approve NICE guidance before it is disseminated. I am all for NICE being and appearing independent from Ministers in the way that it reaches its conclusions, but if NICE guidance is not to be approved by the Secretary of State, who will take ultimate responsibility for the decision about affordability? Who will be accountable to Parliament for such decisions? It is not clear.

That concern chimes in with another criticism of NICE which is its lack of transparency—a point that has been made by a number of noble Lords this evening. We do not know how topics for referral to NICE are selected. The Technologies Advisory Group makes recommendations to Ministers, but on what basis does it do so? We do not even know who the members of TAG are or how they are chosen. NICE itself is criticised by every pharmaceutical company that I have spoken to for its modus operandi Unlike its counterpart in Scotland (the HTBS), or the Medicines Control Agency, NICE is neither open nor consultative. The result of that is that it has failed to win hearts and minds. I have heard it said that because of its reluctance to consult and communicate, NICE tends to reach its conclusions in a fog of uncertainty, with little real understanding of the subject matter and hence a wide scope for error. One example of that was glatiramer acetate, or Copaxone, a treatment for MS. When Teva, the manufacturer, took the Copaxone decision to appeal, it was only at that late stage that it learned how NICE had interpreted the manufacturer's data and carried out the resultant economic modelling. Why could not Teva have been consulted on that process? What was to be lost?

It is that failure to win hearts and minds that worries me. If NICE has a role to play—and I believe it does—then it is essential that it carries credibility. But how can it be properly credible when other publicly funded bodies such as the Drug and Therapeutics Bulletin directly contradict what it says? That has happened more than once. How can it be properly credible when in the case of MS treatments it chose to rely on short-term data and to ignore extensive data collected from real patients over eight years of usage in the United States? What happened was that the short-term data were extrapolated by NICE and then subjected to economic modelling over 15 to 25 years—at best a highly uncertain procedure, but particularly so for a disease such as MS that develops over a long period of time.

In assessing a treatment for its cost effectiveness, there are worries that NICE takes too narrow a view of what constitutes cost effectiveness. Many, if not most, analyses are related purely to the costs and benefits within the National Health Service. As the Wanless report has shown, no attempt is made to demonstrate wider benefits to the Exchequer and society at large. This absence of what many would regard as a common-sense approach to evaluating cost-effectiveness undermines the merits of NICE's work.

There is another respect too in which NICE has lost credibility and is in danger of losing even more. Some of the technologies it has appraised have been well established ones, others have been less so. Unless there is a body of real life data available to NICE relating to the treatment it is considering, it is very hard to see how questions of clinical and cost effectiveness can be settled with any degree of confidence. It is certainly not enough for NICE to rely purely on data derived from clinical trials. There needs to be mature evidence. The suggestion that NICE should concentrate on assessing

products at or shortly after launch is in my opinion misconceived. Its conclusions will be based on assumptions rather than evidence and, as such, will either be tentative or carry a high risk of being wrong.

If one wants a perfect example of that point, there are few better than erythropoietin, or EPO, which is a treatment for patients with kidney failure. At the time of EPO's launch in 1990, the estimated cost per QALY was £103,000. That would have put it right out of court on the basis of NICE's current methodology. In the intervening period, the way in which EPO has been used to treat kidney failure has changed and much has been learnt from that. The cost per QALY for EPO is now estimated at between £3,000 and £9,000. If EPO had been rejected at launch, many kidney patients would have been denied a clinically effective and cost-effective treatment.

The probability that NICE guidance will be wrong under such circumstances is dangerous when one considers the Government's proposal that such guidance should in future be binding on health authorities and PCTs. In some ways I am sympathetic to that idea. One of the troubles with NICE guidance hitherto is that it has not been taken up across the NHS. The main reason that it has not been taken up is lack of money.

In the case of treatment for pancreatic cancer, only 34 per cent of health authorities indicated to Cancer BACUP that they had adequate funds to comply with NICE guidance. Many do not even know whether the patients in their area are being offered the approved treatment. The Government have allocated £250 million to health authorities and PCTs to support the implementation of NICE guidance. However, the way in which that money is spent is still a matter of discretion for those health service bodies. It is part of their unified allocation. In theory they can spend it in any way they like. As evidence of that, only a minority of health authorities actually have a written policy for monitoring implementation of NICE guidance, as the noble Lord, Lord Clement-Jones, mentioned. Without additional specific and earmarked funding, there can, I am afraid, be only one result from a binding direction from the Secretary of State on NICE guidance; that is, a distortion of local clinical priorities. I ask the Minister to respond particularly to that point when he replies.

After a reasonable period of time, it makes sense to look back at the purposes for which NICE was created and to measure its subsequent performance against those original aims. Has NICE eliminated postcode prescribing in the treatments it has examined? For the reasons that I have given, it is clear that it has not. In fact, with taxanes for breast and ovarian cancer, there are now wider variations in prescribing than there were before the NICE appraisal.

Has NICE's advice commanded a high degree of confidence in the NHS and among medical practitioners? I fear that the answer to that is, "Not high enough". Has NICE given patients faster access to proven treatments? If anything, it has hindered access. The determination process on MS treatments took more than two years and it is still not finished. The determination on the pancreatic cancer drug. Gemzar, took a year. A decision on atypical antipsychotics will have taken more than a year. In each case, by the end of the process, there will be patients who are beyond help from the treatment but who could have been helped if NICE had not intervened. Of course, in theory, doctors can prescribe licensed medicines while a NICE appraisal is going on. In practice, however—and all too often—health authorities call a halt to further prescribing, pending a NICE decision. That phenomenon is known as "NICE blight". I could quote a number of very disturbing examples of that. NICE blight is costing patients their lives.

The NICE process, looked at in that light, gives rise to rationing, albeit of an indirect kind. Something really has to be done to ensure that the fact of a NICE appraisal does not of itself inhibit speedy access for patients to effective new treatments. As it is, both the PICTF report and the Wanless report show that the UK compares unfavourably with other countries in providing fast access to medicines. Wanless states that the UK rate is only half that of Germany and one-third that of France.

Those are by any measure serious shortcomings in a body that in other respects performs valuable work and whose staff are, I have no doubt, committed and conscientious. I hope that the Government will have the courage to confront those issues fully. I hope that there will be an arm's length review of NICE that is both open and transparent. Reviews of that kind should be undertaken at regular intervals. Failure to do that will jeopardise the credibility that NICE must have if it is indeed to be the single authoritative voice for clinical best practice.

6.45 p.m.

The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath)

My Lords, I, too, join noble Lords in congratulating the noble Baroness on securing a debate on an interesting topic that is vital to the future health of our National Health Service.

In responding to the many points that have been made in the debate, it is important to start by putting the matter in context and in relation to our overall reforms of the NHS. In listening to the criticisms that have been made of NICE's performance, we should take ourselves back to 1997 and our inheritance. Our inheritance was of an NHS with an absence of national standards. There was no process for developing national guidance on the use of new treatments—I agree with the noble Earl, Lord Howe, on the importance of getting effective medicines introduced as quickly as possible—and no independent inspection of local services. Alongside the Government's determined effort to increase resources in the NHS, we have moved to put that right, to develop new standards, to introduce a new duty of quality, to have a system of clinical governance to drive up the quality of care and to have an independent inspectorate—the Commission for Health Improvement. Central to our modernisation programme is the National Institute for Clinical Excellence, which we established to give clear national guidance on the use of drugs and other treatments, as my noble friend Lady Howells aptly pointed out.

In less than three years, NICE has done its work well and with credibility and it has been established as an integral part of our modern National Health Service. Its work undoubtedly reaches into all aspects of the NHS, from the wider judgments on whether a new treatment is clinically effective and cost effective, through to the assessment of what care is best for an individual patient.

In listening to the criticisms that were made of NICE, it appears that some noble Lords were slow to recognise the situation in which the NHS existed before the institute was set up. The noble Lord, Lord Clement-Jones, said that few would wish to go back to pre-NICE days, and I certainly agree. The situation before NICE involved unfairness—one health authority could have a policy to fund a new treatment but a neighbouring health authority would not fund it. We had postcode prescribing—decisions about what care was best for a patient would be made on the basis of widely varying funding policies rather than on the basis of clinical need. We had a situation in which new drugs with clear evidence of clinical effectiveness and cost effectiveness were not being given to patients because it took so long for them to filter through into local prescribing policies.

NICE exists to deal with those issues. It has made significant progress in identifying effective medicines and treatments and spreading their use quickly throughout the NHS. I was interested in the comments of the noble Baroness, Lady Knight, who suggested that one of NICE's purposes was to make savings. The noble Lord, Lord Roberts, postulated that NICE involved a delaying tactic. The noble Earl, Lord Howe, spoke about his original thoughts of a hidden agenda, although he said that he had partially repented of that.

I want to make it absolutely clear that NICE's purpose never was, and never has been, to reduce the funding of treatments in the National Health Service. It was to speed up the introduction of clinically effective and cost-effective treatments and drugs. As the noble Earl, Lord Howe, suggested, from the figures that we have produced, we estimate that this year more than £250 million will be spent on treatments recommended by NICE. For example, NICE's appraisal of drugs to treat breast and ovarian cancer should benefit approximately 9,000 women at a cost to the NHS of £30 million. The noble Lord, Lord Clement-Jones, talked about cancer drugs. The recommendations on drugs to treat cancer of the pancreas, lungs and brain and leukaemia should benefit around 10,000 people this year at a cost to the NHS of £10 million; and so on.

It is all very well for NICE to issue guidance, but I fully recognise that the whole thing will fall apart if we cannot ensure that the National Health Service will implement that guidance. I have always understood that point, and I understand that it lies at the very heart of the credibility of what we seek to achieve.

At the annual conference of NICE last month, I announced that health authorities and primary care trusts have three months from the date of the issue of technology appraisal guidance to arrange for the funding of healthcare interventions recommended by the institute for patients for whom they are clinically recommended. I believe that that makes it absolutely clear that the Government expect the NHS to fund NICE guidance. I shall return to the issue of earmarking a little later. It is our belief that the extra resources put into the National Health Service both over the past few years and in the future are sufficient to ensure that locally the NHS has the funds to implement those decisions.

I listened with great interest to some of the concerns raised by noble Lords in relation to bureaucracy. The noble Lord, Lord Addington, said that user groups had reported finding the NICE processes to be somewhat unfriendly to user and patient groups. Of course, I am anxious to listen to the comments made and to discuss them with the national institute.

Perhaps I may make it clear that I expect NICE to have a central role in providing accessible information for patients. I believe that it has shown itself able to work with patients and their organisations: it consults patient groups at every stage; it involves patient representatives in its committees; and it actively seeks out the views of patients when developing its guidance. Of course, I am sure that it can always do better arid I certainly urge it to do so. But I could not respond to this debate without saying that I believe that NICE is exercised about ensuring that patient and user groups understand the processes and have full involvement in them.

I turn to the question of independence and openness. From its outset, I believe that NICE has enjoyed a large measure of independence from governments and, indeed, from other interests. That is why it is so important that NICE decides on its own processes for developing guidance. It is why the Department of Health has the same status as any other consultee within those processes. We contribute to the consultation process but our comments are either limited to detailed technical or clinical issues or they seek to clarify aspects of the draft guidance. It is because of its independence in making judgments that, very often, I cannot answer direct questions posed by noble Lords in this House while a NICE examination is taking place into, for example, a particular drug. The noble Lord, Lord Roberts, has raised the issue of drugs on a number of occasions in this House.

In our recently published response to the Kennedy report, we announced that we wish to build on the independence that NICE already has. We propose to remove the requirement for approval to be given by the Secretary of State for Health and the National Assembly for Wales for disseminating NICE guidance. We also intend to lay before Parliament changes to NICE's regulations in order to enable NICE to determine its own appraisal committee structure and to appoint members to that committee structure without reference to the Secretary of State or the National Assembly for Wales.

We also accept, and will be making clearer and more explicit, the ways in which NICE, other NHS professional and patient bodies, and individual professionals can contribute to developing NICE's agenda. I can assure noble Lords that we shall shortly issue a consultation paper suggesting a number of changes to the existing arrangements and seeking further comments.

One or two comments were made in relation to beta interferon. That drug is still the subject of a process within NICE. But the noble Baroness, Lady Knight, asked me about the discussion that the Department of Health has had, and is having, with manufacturers of the drug and other interested parties to see whether any of the four medicines can be secured for the NHS in a manner which could be considered cost-effective. That is not an attempt by the department to second-guess NICE or to interfere in the process. I refer to the view given by NICE in its provisional appraisal that those drugs did not represent a cost-effective use of NHS resources. At the same time, NICE recommended that discussions take place between the department and the manufacturers in order to secure supplies for the NHS on terms that could be regarded as cost-effective. That is why we are engaged in those discussions.

A number of very interesting points were made about the methodology of NICE. The noble Lord, Lord Clement-Jones, raised the issue of rare diseases and orphan drugs. In general, NICE has made it clear—this is its responsibility—that it is not tied to any particular methodology but will consider the special features of each appraisal on their merits. Obviously it must make complex judgments based on a number of different factors and then take into account all the available evidence.

We then moved on to the question of quality adjusted life years, or QALYs. I am disappointed that the right reverend Prelate is not here to respond to the noble Baroness and her criticisms, if I may say so, of a lack of consistency on the part of doctrine in the Church of England. I believe that when it comes to methodology in terms of judgments, it is clear that NICE will use different methodologies and seek always to find the best evidence available. QALYs are a method of taking a measure of health status which combines judgments about increased life expectancy and improved quality of life. The purpose of the QALY measure is to allow the health gain from different interventions to be compared. With information on the cost of interventions their value for money performance can then be compared using a common yardstick.

I do not seek to deny that there are criticisms of QALYs and that they are contentious. Indeed, I take on board the point which the noble Baroness, Lady Knight, has made about older people and the question whether QALYs might put older people at a disadvantage. I accept that there is a great deal of debate about QALYs and their use and that it is a methodology which is still under development. But it is a way in which to compare the health effects of different interventions which change life expectancy and the quality of life. It can be a useful mechanism to be used by NICE alongside other judgments.

The noble Earl, Lord Howe, raised the issue of whether it is right for NICE to have to take into account issues of cost effectiveness as well as clinical effectiveness. I believe it is right that it makes technical judgments on the clinical and cost effectiveness of drugs and treatments. I believe that from its perspective it is able to make those kinds of judgments. But I also believe that it is important that NICE guidance is issued direct to the NHS without being filtered or changed in any way.

Lord Roberts of Conwy

My Lords. I am most grateful to the noble Lord for giving way. Can he tell us whether NICE, in assessing the cost effectiveness of drugs and treatments, can take into account factors outside the NHS such as employment, the loss of it, benefit costs and so on?

Lord Hunt of Kings Heath

My Lords, in broad terms it can. I was going to respond to the noble Lord later on that point. The point I am trying to make here, in answering the noble Earl, Lord Howe, is that I believe it is right that NICE makes judgments about cost effectiveness alongside clinical effectiveness, but Ministers are ultimately responsible for the affordability of NICE guidance. It is our responsibility to ensure that the National Health Service has the resources for that guidance. I believe that we are providing the level of resources to enable that to happen. I do not agree with the noble Earl that we should earmark those resources. In fact, I am always influenced by the noble Earl's strictures about too much central direction. In this case it is within the general allocations.

Lord Clement-Jones

My Lords, since this is such a crucial question and there are different interpretations of NICE'S remit, can the Minister absolutely and categorically say that no NICE appraisal has taken into account affordability?

Lord Hunt of Kings Heath

My Lords, the issue for NICE is judgments on cost and clinical effectiveness. The issue for Ministers is affordability. I believe that I have made it abundantly clear that there are respective responsibilities and it is quite clear as to who is responsible for what.

The noble Earl, Lord Howe, asked about criticisms of individual judgments and errors. I believe that it is unrealistic to believe that all expert opinions will always agree with NICE guidance because, at the end of the day, NICE will often have to make a fine judgment weighing up a range of evidence and opinions. But I believe that the experience so far has been that overall its judgments are robust because it seeks out all the available evidence and draws on the top experts in the field as well as on patient and carer evidence.

The noble Lord, Lord Roberts, and the noble Lord, Lord Addington, asked about the considerations that NICE can take into account. The appraisals that it carries out are done in accordance with its framework document. That document states that its task is to assess the evidence of all the clinical and health-related benefits of an intervention, taking this in a wide sense, to include impact on quality of life, relief of pain or disability as well as any impact on likely length of life; to estimate the associated costs and to reach a judgment on whether on balance this intervention can be recommended as a cost effective use of NHS and personal social service resources. I hope that answers the question and makes clear that NICE can take into account those wider considerations.

Lord Addington

My Lords, the only real point in raising the matter is that we hear about joined-up government and we have heard today about how the health department is borrowing from one part of it to meet a deficit in another. I was merely suggesting that we expand the suggestion so that another department helps in the National Health Service because such drug treatment may help people to stay in employment and keep off benefits.

Lord Hunt of Kings Heath

My Lords, I am always anxious to grab more resources from other government departments. I am unlikely to get much support for that across Whitehall. Of course I understand the point that the noble Lord raises. I believe that at the moment we have a sensible balance, which essentially allows NICE to take into account the wider considerations. But the balance on cost effectiveness is based on the use of NHS and PSS resources.

Obviously, these matters will continue to be debated. That brings me to the point made by the noble Lord, Lord Clement-Jones, about a review of NICE. We consider that the effect of our response to the Kennedy report, the publication shortly of a consultation document which will cover the detail of the process of topic selection, and our consideration of the inquiry by the Health Select Committee into NICE will provide a very helpful and comprehensive look at many of the current issues that face the national institute.

Indeed, considering our response to the Kennedy report brings me to another point raised by the noble Lord, Lord Colwyn, who always has many interesting insights into dentistry. He knows of my own keenness to ensure that the dental profession further develops its excellent quality and expands its services to the public.

He raised a concern that in a sense NICE might be given a monopoly for setting all national clinical standards. It was the recommendation of the Kennedy inquiry that NICE should be responsible for co-ordinating all action relating to the setting, issuing and keeping under review of national clinical standards. We rejected that view because while we believe that NICE is the foremost body to provide authoritative clinical guidelines and appraisals, there are many other bodies which are best placed to set standards in their fields. We would not wish to inhibit their excellent role in doing so.

The noble Lord, Lord Astor of Hever, asked a number of questions and in particular about the establishment of a council for quality. Its role would he to facilitate co-operative working between constituent organisations including NICE, CHI, the Clinical Assessment Agency and the National Patients Safety Agency. It would also help those bodies to work closely together with the Social Services Inspectorate, the Audit Commission and others. I accept that there is a need to co-ordinate. We want to avoid duplication and too much inspection in relation to individual organisations where a co-ordinated approach is likely to be much more effective.

As regards the other points raised by the noble Lord about public health, I do not believe that the Government are failing in those areas. I believe that our public health strategy, our strategy to tackle health inequalities, the consultative paper on sexual health strategy and the recent CMO's report on public health surveillance show that we are taking these matters very seriously. Of course, I share the noble Lord's concern about the low uptake of MMR, particularly in London, but also in other parts of the country. I believe that we have a massive job to do to restore public confidence in these vaccines.

I also believe that at the local level it is important to have a strong public health function. In response to the worries in relation to the BMA, we have made it abundantly clear that every primary care trust will appoint a director of public health. There will be a senior public health doctor at the strategic health authority level. I believe that making the primary care trust the primary public health body at local level will help to ensure a much closer relationship between public health and primary care. I believe that that is where we can tackle the issue of the low uptake of vaccination in a more effective way in the future.

The noble Lord, Lord Roberts, will know that the particular drugs that he mentioned are the subject of work being carried out by NICE at the moment. Taken as a whole, it is much better to have a situation where such drugs are properly assessed rather than leaving that to the ravages of postcode prescribing, which he so aptly described.

I also listened to the remarks about "NICE blight". I want to make it abundantly clear that it is unacceptable that health authorities should decide that a treatment should he prescribed while awaiting an appraisal of that treatment. I believe that Health Service Circular 1999/176 is clear about that. If health authorities are seen to make arbitrary judgments outwith the terms of that circular, I have made it clear that any complaint that is received will be investigated.

I have spoken at length but I believe that it is important to answer many of the points that have been raised in this important debate. I can reassure the noble Earl, Lord Howe, that of course we listen to comments made. They are taken into account in regular discussions with the National Institute for

Clinical Excellence. However, at the end of the day I believe that NICE has established robust mechanisms and that it is helping to ensure quicker update of new treatments, new technologies and new drugs. I also believe that that is the way forward. It will enable the NHS to ensure that, overall, patients will receive effective treatments quickly, and that is the NHS that we wish to achieve for the future.

7.12 p.m.

Baroness Knight of Collingtree

My Lords, we have had an interesting and well-informed debate. I warmly thank noble Lords who have taken part, particularly my noble friend Lord Colwyn. It is always a great pleasure to hear from experts who speak about their own field of expertise. I listened to him with enormous interest.

My noble friend Lord Roberts told of his experience from a more personal angle, but his speech was also important. We have heard clear expressions of concern. The noble Lord, Lord Clement-Jones, gave a trenchant speech, pointing out many areas of concern, and my noble friend Lord Howe made some important points that must be borne in mind all the time.

I am grateful that the Minister took on board the fact that unless NICE is respected, and unless the public feel that it is a body that is of real service, it will not be of much use. The noble Baroness, Lady Howells, for whom I have a warm regard, gave a statutory few moments of support for NICE, which we were all pleased to hear.

I wish I could feel more gratitude to the Minister, but questions were raised in the debate that he has not answered. Perhaps he would kindly read the speeches made and answer directly some of the clear questions that were put. He tried to answer one or two. Having said that the point was not to make savings, later he said much about being cost-effective. To me being cost-effective is allied to making savings. I listened carefully to what the Minister said, but when he said that the Government will fund the recommendations of NICE, did he mean that there will be other areas of treatment that will suffer because the money will go to the treatments that have been recommended by NICE? We do not know. We have had an interesting and helpful debate. I beg leave to withdraw the Motion for Papers.

Motion for Papers, by leave, withdrawn.