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Mr. Hammond: I point out to the hon. Gentleman that any chagrin felt by Conservative Members is due entirely to the fact that the Government have allowed only one day for Report. We consider that to be wholly inadequate in view of the Bill's importance.
Mr. Deputy Speaker: Order. We need not go into those matters; we need only to worry about the group of new clauses before us.
Dr. Harris: The new clauses are about what the Government should and should not do in the rationing of treatment.
Dr. Harris: I should be grateful if the hon. Gentleman would be patient so that I can get into the substance of my speech. I shall then willingly give way to him. On this Bill, we have a spirit of giving way--liberally, if he will excuse the expression.
New clause 4 provides that the National Institute for Clinical Excellence
New clause 14 refers to the need for openness and accountability and for public participation in whatever decisions are appropriately made through NICE.
Mr. Bercow:
I welcome the fact that the hon. Gentleman is introducing this group of new clauses.
Mr. Deputy Speaker:
Order. I certainly do not want to hear a debate about the party make-up in the Chamber at present. We must discuss the new clauses.
Dr. Harris:
I was going to say that I am aware of the interest of the hon. Gentleman in rationing. As he has acknowledged, he is aware of the interest of at least two Liberal Democrat Members who have raised that matter in Adjournment debates. They will be following the proceedings carefully.
New clauses 16 and 17 consider rationing of the drug Viagra from two different approaches. We take the Government to task for what has happened, in a way that is analogous to that in which the courts and the Government, by their own admission, feel that the issue has been mishandled. We also want to help the Government by introducing a measure to ensure that those mistakes are not repeated and that such rationing decisions are made fairly and rationally, rather than irrationally.
As I did in Committee, and as is customary, I declare an interest. I have a non-declarable interest as a fellow elect to a pharmaceutical company, under the Industry and Parliament Trust scheme, which gives Members of Parliament experience of private sector companies. I am attached to Glaxo Wellcome plc for that purpose, although I receive no remuneration. In addition, my interest in rationing took me on a study trip to the United States with NHS commissioners and clinicians to study the details of the association with the American Society of Clinical Oncologists, and the trip was funded by a pharmaceutical company.
I hope that the Minister recognises that my approach to the National Institute for Clinical Effectiveness is not unreasonable.
Mr. Hammond:
Clinical Excellence.
Dr. Harris:
Sorry, the National Institute for Clinical Excellence. When I referred to the National Institute for Clinical Effectiveness, I was thinking of the Government's original press release on the special health
The Liberal Democrats accept that treatments should be used only when they are likely to be efficacious and when they are effective. We have no time for an NHS that wastes money on prescribing drug treatments or carrying out operations that are not of clinical benefit to the patient, or where the adverse effects of the medication are likely to outweigh any clinical benefit that the patient may receive. Clearly, there is a need for national standards, not only to get rid of what the Government rightly describe as unacceptable variations in the delivery of treatment, but to ensure that treatments that are a waste of money are not carried out through best practice not being disseminated sufficiently widely.
We would go further on the issue of cost-effectiveness. We recognise that the NHS has limited funds, although we would argue that it should be better funded than even the Government have managed over the past two years. Given that funds are limited and that there is a great need for services, it would be wrong for health authorities, trusts and clinicians to prescribe drugs or offer treatments that are more expensive than other treatments for the same condition or symptoms, but no more effective. It is sensible to consider the relative cost-effectiveness of treatments and to ensure, given the NHS's limited budget, that money is not spent needlessly. I hope that that is common ground between us.
We have two concerns, however, on which the Government have yet to reassure us. The first is whether the measure of cost-effectiveness will be wide enough and, if it is sufficiently wide, whether it will be fair, especially to pharmaceutical companies and in respect of drug treatments that are relatively new. Our second concern is that, even if the test of cost-effectiveness is met, the Government will use NICE to ration on the basis of affordability drugs that are highly effective, efficacious and relatively cost-effective, but whose widespread effective and cost-effective use would have implications for NHS budgets. We acknowledge that there is a need for tough decisions to be made on those issues, but the Government must publicly announce those decisions, not shelter behind NICE.
We are concerned that, so far, the Government have not ruled out NICE making its recommendations on the basis of affordability, even in respect of treatments that are effective and cost-effective. We are also concerned that the chairman of NICE, Professor Rawlins, in his evidence to the Select Committee on Health, did not rule out the possibility that he might be forced--against his will, I am sure--to make recommendations based on affordability in respect of treatments that would otherwise pass the effectiveness and relative cost-effectiveness tests. I see that the hon. Member for Runnymede and Weybridge shares my concern.
The issue of efficacy is not all plain sailing, which is why it would be of great benefit to the House if we had a debate on NICE. However, I shall not take up time considering such matters in detail now. In respect of the efficacy of new treatments, it will be difficult for NICE to be fair to patients and to treatment providers. There are several new treatments whose efficacy dawned on the NHS rather late. For example, some of the new HIV treatments were never felt to be particularly effective on their own; but, a significant time after their introduction,
they were found to be highly effective and cost-effective if used in combination. If their use on the NHS had been prevented, NHS patients would never have benefited from that combination therapy and, in this country at least, doctors might never have found out that the drugs were so useful in combination. There are significant concerns about the way in which NICE will judge the efficacy of new drugs.
Dr. Nick Palmer (Broxtowe):
I, too, should declare an interest in that, from time to time, I advise Novartis, although I am not sure that that company would agree with the question that I am about to ask. Does the hon. Gentleman agree that the approach taken today, whereby such decisions are being made by dozens of individual units around the country, is not necessarily superior to having one body deciding centrally? Does he also agree that it is difficult to consider the question of cost-effectiveness completely separately from that of clinical effectiveness, because it is only one of several factors? It is rather artificial to expect NICE completely to ignore that aspect.
Dr. Harris:
I think that I have already covered the second part of the hon. Gentleman's question. As for his first point, it is not a question of centrally set guidelines versus the relatively quick or slow uptake of new treatments in various parts of the country. Clearly, having NICE lay down what should or not be prescribed and then insisting on its guidelines being followed--incidentally, the level of insistence is not clear--will mean that a treatment is either quickly introduced everywhere or not introduced anywhere. My concern is that the data on which that uniform, NHS-wide decision is based will not be complete and that the wrong decision will be made and its effect last for all time, or for a significant period of time until the decision is re-examined. Such an approach might well have held back the introduction and use of the HIV drugs to which I referred.
Although we support the idea that NICE should examine efficacy, costs and prescribing practices in respect of new drugs and treatments, we recognise the difficulties with data on efficacy. Another example of that is ACE--angiotension converting enzyme--inhibitors. They were felt to be of limited clinical use when they were first introduced, and certainly when I was a medical student, but were later found to be highly effective for conditions other than those for which they were originally used. That discovery would not have been made had they not been prescribable on the NHS on the basis of more limited evidence.
There is concern that the way in which NICE will consider cost-effectiveness will be too pure--that it will not consider "relative cost-effectiveness", which is the wording in the new clause, but will use some pure measure of cost-effectiveness without stating how that measure should be arrived at. There are many measures of cost-effectiveness, such as the numbers it is necessary to treat in order to achieve a valuable clinical effect in one patient, or the cost of a treatment, perhaps combined with the costs per life-year saved or per quality adjusted life-year. There is a series of such measures, but the NHS is not experienced in assessing them.
Patients, patient groups and the pharmaceutical industry are concerned that NICE will seek large amounts of data that are not readily available. The new clause makes it
clear that we should be considering "relative cost-effectiveness", where it is measurable, against existing treatments. When the data are poor, the new treatments should be given the benefit of the doubt.
An example is the drug erythropoetin, which is used to stimulate the production of red blood cells in patients who are anaemic and suffering from renal failure. That treatment was very expensive when it was first introduced. It was believed not to be cost-effective, and its availability was extremely limited. However, it proved to be relatively cost-effective in preventing hospital re-admissions and negated other costs associated with chronic renal failure. The early prevention of that drug's prescription may have hidden its relatively high cost-effectiveness.
Our main concern is which budgets NICE will examine when measuring cost and benefit. For example, the new anti-psychotics--the so-called atypical anti-psychotics--used to treat schizophrenia are much more expensive than the old reliables, such as haloperidol. There is no justification, on a purely cost basis, for prescribing the atypical anti-psychotics. However, it is now well recognised that the side-effects of the older drugs are so great that compliance is poor. Patients do not take them; they then suffer acute relapses and require hospitalisation, which generates more costs. The new drugs are tolerated better, and should therefore be prescribed.
"shall make its appraisals of different treatments and clinical interventions on the basis of clinical efficacy or relative cost-effectiveness compared with alternative treatments or clinical interventions for the same symptoms, but not on the basis of their affordability in relation to the funds available to the National Health Service."
That is a key point and the new clause states the matter clearly. It goes to the heart of rationing, priority setting or managing the resources of the health service--whichever term we use.
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