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Session 1999-2000
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Delegated Legislation Committee Debates

National Institute for Clinical Excellence (Amendment) Regulations 1999

Fourth Standing Committee on Delegated Legislation

Thursday 2 December 1999

[Mrs. Ray Michie in the Chair]

National Institute for Clinical Excellence (Amendment) Regulations 1999

National Institute for Clinical Excellence (Establishment and Constitution) Amendment Order 1999

9.55 am

The Chairman: Is it the wish of the Committee that both instruments be taken together?

Hon. Members: No.

The Chairman: As there is objection, they will be taken separately.

Dr. Peter Brand (Isle of Wight): I beg to move,

    That the Committee has considered the National Institute for Clinical Excellence (Amendment) Regulations 1999 (S.I. 1999, No. 2218).

Despite the muttering of dissent, it would be sensible for me to discuss both orders together--

The Chairman: Order. The hon. Gentleman must confine his remarks to the first statutory instrument.

Dr. Brand: I stand corrected, Mrs. Michie. However, I must admit that I have absolutely nothing to say about statutory instrument No. 2218. It would be more productive if the Committee concentrated on the matter that really concerns us all, which relates to statutory instrument No. 2219.

Question put and agreed to,


    That the Committee has considered the National Institute for Clinical Excellence (Amendment) Regulations 1999 (S.I. 1999, No. 2218).

9.57 am

Mr. Philip Hammond (Runnymede and Weybridge): I beg to move,

    That the Committee has considered the National Institute for Clinical Excellence (Establishment and Constitution) Amendment Order 1999 (S.I. 1999, No. 2219).

This is one of the most devious and deceitful manoeuvres that this devious and deceitful Government have sought to carry out. Having spent many hours in this Room, facing this Minister, and having received many assurances from him about the functions of the National Institute for Clinical Excellence, I feel personally affronted.

I shall set the context for this debate by quoting one or two important ministerial statements. The Minister said:

    "Ministers are accountable for setting overall priorities for the NHS. Ministers are and must remain accountable for those decisions."--[Official Report, 15 June 1999, Vol. 333, c.225]

On 15 December 1998, when my right hon. Friend the Member for Maidstone and The Weald (Miss Widdecombe) asked the then Minister for Public Health whether there was rationing in the NHS, she was told no.

The now Secretary of State for Health told the House:

    "No one will be denied the drugs they need. That is guaranteed."--[Official Report, 30 June 1998, Vol. 315, c.143]

In a letter to the chairman of the general practitioners committee of the British Medical Association, dated 17 June 1998, the Secretary of State wrote:

    "Patients will continue to be guaranteed the drugs, investigations and treatments they need. I guarantee that the freedom to refer and prescribe remains unchanged."

Again, the Minister for Public Health said:

    "I made it clear once again that the NHS will not apply blanket bans to clinically effective treatments."--[Official Report, 15 December 1998, Vol. 322, c.746]

The Minister is not listening, but he should take careful note of that last remark.

Every one of those ministerial statements, if they were true at the time, will be rendered demonstrably untrue if the order is passed. I should make it clear at the outset that the Opposition do not assert that there should be no resource constraints in the NHS. While we readily accept that there are such constraints, the Government consistently deny it while the evidence against them mounts. We have seen examples from around the country of cancer drugs being denied to patients who desperately need them to save or extend their lives. Getting beta interferon has become a postcode lottery around the United Kingdom. Atypical antipsychotics, drugs that are vital in the treatment of sometimes dangerous schizophrenic patients, are rationed at the point of use--53 per cent. of psychiatrists say that at some time they have been denied the opportunity to prescribe those drugs because of cost considerations.

The National Institute for Clinical Excellence was originally named the National Institute for Clinical Effectiveness, but was subsequently renamed by some Government spin doctor, who owed much to the wisdom of George Orwell. When the Government announced that it was to be established, we challenged its purpose in a world in which, according to Ministers, everyone will get the drugs that they need. On the basis of that viewpoint, if unqualified, there would be no need to assess the cost-effectiveness of drugs. NICE will have only a limited role in assessing the clinical effectiveness of drugs, because we can assume that any drug that is licensed on the market is clinically effective in its principal purpose. That is the function of the Medicines Control Agency.

The National Institute for Clinical Excellence, as it was presented by the Government, could have fitted into the view of the world that is shared by all the Opposition parties, all the medical professional bodies and 99 per cent. of the responsible media--that is, that we have a rationed system and that what we need is a tool to assist in the rational application of such rationing. Ironically, 5 6 however, it could not fit into the Government's scheme of things, in which its advice would be completely unnecessary because, according to Ministers, the only criterion that was needed to determine whether a drug was available was an assessment of the patient's clinical need for that drug.

It soon became apparent to me and other hon. Members that the Government proposed to square that circle by applying pressure on doctors, through the Commission for Health Improvement, to ensure that prescribing and referral practice changed to reflect NICE's conclusions on cost-effectiveness. In effect, that would mean defining clinical need as what the doctor orders, and then using clinical guidelines in order to control doctors' behaviour. That would allow Ministers to go on making disingenuous claims such as those that I quoted earlier. It would amount to a 180-deg change of course--but not, apparently, a U-turn.

By the time Parliament rose for the summer recess, NICE had been established. Ministers had given repeated assurances during the debates on NICE and the wider debates on the Health Act 1999 that it would not be used as a tool for rationing. Despite what Ministers said, we all understood that it would be used to recommend for non-approval under the NHS drugs the cost of which would outweigh the benefit to the patient.

Mr. Patrick McLoughlin (West Derbyshire): Will my hon. Friend confirm that if someone were to go to a private doctor, they would be able to get their medicine through private practice? We are told that the Government do not believe in making drugs available to only one section of people, but the order will make it more attractive for people to take up private medicine, although the Government publicly set their face against it.

Mr. Hammond: That is right. Not only will the Government's action today encourage a two-tier system in the country as a whole, we have already seen a two-tier system developing within the national health service. NHS patients are being asked to pay for expensive drugs that are vital to their treatment.

Mr. Oliver Heald (North-East Hertfordshire): Does my hon. Friend agree that the Prime Minister seems to have overruled his Ministers? They gave a guarantee that drugs would not be excluded because of price, but the Prime Minister said yesterday that it was absurd not to take account of cost-effectiveness. The Prime Minister is at fault.

Mr. Hammond: I am afraid that the Prime Minister failed to grasp the issue when he answered my question in the House yesterday. He is at odds with his Ministers in the Department of Health and overrules what experts have decreed.

I shall return to the distinction between the cost-effectiveness of a drug and the overall resource constraint on the system, because that distinction is important, as hon. Members--I see that the hon. Member for Oxford, West and Abingdon (Dr. Harris) has now joined us--who were involved in our debate earlier this year will understand. We understood that the Government intended to use NICE to examine not only the clinical effectiveness of drugs and treatments, but their cost-effectiveness. We were not happy about that, but we understood the Government's intention to examine the cost-effectiveness of individual drugs and they were reasonably explicit about that. The term remained undefined, but we understood what it meant at the extremes.

A drug costing 10,000 with a one in 20 chance of extending a patient's life by a week would not be cost-effective. In the grey area in the middle, it is more difficult to understand without specific guidance what cost-effectiveness means. The Government have carefully not issued explicit guidance to NICE. They have not suggested what economic value the institute should place on an additional month or year of life or improvement in the quality of life so that the institute can undertake a proper cost-benefit analysis.

It is important that the Committee understands the point. The position at the summer recess was that NICE could recommend a drug on the basis of its clinical effectiveness, which could be in question only when the application was different from that for which the drug was originally approved, and its cost-effectiveness--defined as I have just described--but that the recommendation would be on a stand-alone analysis of the costs and benefits of that drug for the patient without reference to the wider resource constraints in the system.

Mr. Geoffrey Clifton-Brown (Cotswold): Does my hon. Friend recall that he and I discussed the original order that brought NICE into existence and that we warned the Minister about that precise issue at the time? We said that it was a device to force doctors to prescribe only a certain class of drugs. Combined with primary care groups and the budgetary constraints on individual GPs, it will greatly curtail their power to prescribe the drugs that their patients need.


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