Fifth Standing Committee on Delegated Legislation
Tuesday 27 July 1999
[Mr. Bill O'Brien in the Chair]
National Health Service (General Medical Services) Amendment (No. 2) Regulations 1999
10.30 am
Dr. Evan Harris (Oxford, West and Abingdon): I beg to move, That the Committee has considered the National Health Service (General Medical Services) Amendment (No. 2) Regulations 1999 (S.I. 1999, No. 1627).
The Chairman: With this it will be convenient to consider the National Health Service (General Medical Services) (Scotland) Amendment (No. 3) Regulations 1999 (S.I. 1999, No. 1620).
Dr. Harris: The statutory instruments will insert into schedule 11 of the National Health Service General Medical Services) Regulations 1992 specific drugs for treating the condition of male erectile dysfunction), in England, Scotland and Wales. They will ensure that such drugs are availabl e only to male erectile dysfunction patients whose illnesses fall into specific categories of pathological conditions. The Liberal Democrats contend that the Committee should not agree to the regulations because they are flawed in principle and in detail.
I shall concentrate initially on the principle. Our debate of the regulations will not concern only rationing, or whatever other term hon. Members would like to use. We shall also discuss the way in which treatments are rationed and discrimination in the national health service, which may affect the provision of NHS services. Hon. Members in all parties feel strongly about that issue, and we shall no doubt treat the matter with extra caution in the light of recent incidents involving NHS discriminat ion. It is incumbent upon us as Members of Parliament not to promulgate primary or secondary legislation that causes discrimination that cannot be justified on clinical grounds. Hon. Members will know that those sentiment s have been expressed on both sides of the House in the past, and that unjustifiable discrimination could relate to racial origin, age, gender, sexuality or disability. We must ask ourselves whether any aspect of the regulations discriminates against people with specific disabilities on grounds that are not clinically justifiable for reasons of cost.
In the spirit of constructive opposition, I shall also welcome some aspects of the statutory instrument and of the debate that it provokes. The first point that we welcome is the Government's admission in the statutor y instruments and in announcements concerning viagra—the drug that has led the debate on impotence treatments that is central to the regulations —that the NHS cannot afford necessary investment with current funding. That is an important admission, as it was not made clearly to the electorate at election time by every party represented in the Room today.
The idea that the NHS is safe and that no big increases in public expenditure or in NHS funding from general taxation will be necessary is a cruel myth to spread among the population. We recognise and welcome the Government's admission that the NHS cannot afford everything that it needs with current funding. It is important that admissions about affordab ility, about whether the NHS can afford to provide required services and about whether specific treatments can be afforded should come from the Government. The Liberal Democrats do not blame them for the fact that specific drugs, treatments and health needs cannot be met from the current budget, and we welcome their admission in respect of the relatively small aspect of health care covered by the regulations.
What we regret about the statutory instrument and the broader debate is the Government's refusal formally to admit that, in areas other than the treatment of male erectile dysfunction, there is a discrepancy between need and provision—between the demand for real health services for real health needs and the ability of the NHS to provide those services. It is important that the Government recognise that that mismatch exists, because we will then be able to have a sensible debate about what can and cannot be afforded.
What would have happened if people had seen this statutory instrument coming down the line before the last election? Those who hoped to use the NHS if they got into a position of real medical need—I hope that there will be no debate about the fact that male erectile dysfunction is a recognised condition and represents a clinical need—might have wanted the opportunity to vote for a party that did not pretend that rationin g and the restriction of treatment were not round the corner. They might have wanted to vote for a party that said that the NHS was so underfunded that it could no longer meet the demands that were made on it in a reasonable time scale or at all.
The second thing that we regret is the panicky way in which the Governmen t reacted to the spectre—as they saw it—of a new, effective treatment coming down the line. They reacted with interim guidance, which the High Court has since declared illegal. That guidance is not the subject of this debate, and I shall not go into it in detail. However, the political panic that the media and, it must be said, some in the medical profession and the British Medical Association stoked up was responsible for the speed and nature of the guidance. As a result, the recognition that the Government should have given to doctors' primary duty—a medical duty of care to their patients, rather than a duty to obey political diktat based on political panic—was overridden.
I and my party are prepared to let bygones be bygones as regards the interim guidance. We are dealing with the statutory instrument and not the interim guidance, which called on doctors not to prescribe a drug even though their terms and conditions stated that they should do so where they felt that it met their patients' medical needs. The press reported threats of employment action by the employers of certain GPs who had prescrib ed a drug that they felt would be of use. Those GPs might have been exposed to action for breach of their terms and conditions if they had not prescribed the drug.
The third thing that we regret—indeed, we deplore it—is the discriminatory way in which rationing has been carried out. That bring us to the core of the issue, and I shall come back to that to discuss it in more detail.
The fourth thing that we deplore is the use of schedule 11 of the National Health Service (General Medical Services) Regulations 1992 to carry out rationing. If the rationing of treatment on the basis of affordabil ity is necessary where there is clear health need and no clinical justificati on for restricting treatment, a mechanism should have been set up in the Health Bill, whether or not that involved secondary legislation. The Health Bill provided the Government with an excellent opportunity honestly to accept the fact that current NHS resources, sadly, could not meet current health need and that rationing on the basis of affordability was round the corner. At the same time that the Health Bill was going through Parliamen t, the Government recognised that the NHS could not afford treatment for male erectile dysfunction, even in cases of clinical need. None the less, they turned down the many opportunities offered by Liberal Democrat amendment s to use primary legislation, which could have been debated and voted on, to set up the necessary mechanisms. It is a misuse of schedule 11 to ration on the basis of affordability, because, for certain conditions, there is no clinical justification for using schedule 11 drugs at all or in preference to other drugs. I do not believe that the Minister will be able to justify rationing, but he will have to justify using regulations that were never meant for the purpose of rationing.
Some specific concerns about the regulations have been raised. Members of the Committee have been given a briefing from Pfizer, the pharmaceutical company that manufactures Viagra, which is one of the relevant drugs in this context. I should declare an interest at this point. I received funding from a pharmaceutical company to go to the United States on an NHS study tour in oncology, and, through another pharmaceutical company, I am a member of the Industry and Parliament Trust training scheme for Members of Parliament. As far as I know, neither of those companies make any of the medicines that we are discussing in relation to the statutory instruments .
I strongly agree with the argument that is set out in Pfizer's document, which states:
``the Statutory Instrument is outwith the spirit of the parent legislati on set out by the 1977 National Health Act˙.˙.˙.˙Parliame nt was advised in 1985 that a Schedule 11 listing was a legitimate restrictio n on budgetary grounds where a medicinal product had more than one distinct therapeutic use and met the criterion of having clinical advantages over other cheaper medicinal products for at least one of those uses, but did not meet the criterion for all of them. The conditions set out in Schedule 11, therefore made clear the indications for which the prescription was justified under the NHS as being the most economic option to meet the recognised clinical need for all or particular categories of patients. On similar grounds, Schedule 11 has been used to cover circumstances where a product such as a food supplement might have a medicinal purpose for some patients, but could not be treated as having a medicinal indication for all. In isolated cases it has been used where products were already available without prescription (nicotine replacement) or where misuse has arisen (Temazopam capsules) and clinical alternatives were available.''
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Clearly, none of those circumstances apply in this case. The Government will have to admit that the reason why these drugs have been placed under schedule 11 is so as to control the cost of the treatment of male erectile dysfunction. The statutory instrument states that a man who is suffering from the following conditions can continue to receive treatment on the NHS:
``diabetes multiple sclerosis Parkinson's disease poliomyelitis prostate cancer severe pelvic injury''—
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