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National Health Service (General Medical Services) Amendment (No. 2) Regulations 1999

7.55 p.m.

Earl Howe rose to move, That a humble Address be presented to Her Majesty praying that the regulations, laid before the House on 10th June, be annulled (S.I. 1999/1627).

The noble Earl said: My Lords, I beg to move the Motion standing in my name on the Order Paper. The statutory instruments to which my two Prayers relate are of considerable significance for the National Health Service. Their effect is to limit the availability on the NHS of a number of drug treatments for male impotence or, as it is technically known, male erectile dysfunction, including perhaps the most widely publicised of such treatments, the drug Viagra.

I wish to make a number of points about these regulations; first, as regards their direct consequences; secondly, on some matters of detail; and thirdly, in relation to their wider context. Sildenafil, Viagra, is a drug that was licensed by the Medicines Control Agency in September 1998. At that time the Secretary of State for Health issued advice to all GPs, making it clear that Viagra, notwithstanding its licence, should not be prescribed on the NHS by reason of its cost. This de facto ban became the subject of a court action by the drug's manufacturers and it was declared by the High Court to be unlawful earlier this year, on the grounds that it contravened both the doctor's professional duty to treat patients according to his or her own judgment of clinical need and the requirements of EU law.

However, the court judgment was overtaken in a sense by events, in that the Government had in the meantime resolved to replace their interim guidance with regulations restricting the availability of Viagra and other anti-impotence drugs to patients falling within a

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number of carefully defined categories. These are the regulations that we are now debating. The categories of patients entitled to Viagra on the NHS are those men suffering from one or more of 12 clinical conditions, including diabetes, prostate cancer, and multiple sclerosis. Viagra may also be made available to men who were already receiving impotence treatment on the 14th September last year. The effect of these provisions is to limit drug treatment to about 20 per cent of patients suffering from impotence. The other 80 per cent may, where appropriate, seek a private prescription from their GP.

Several consequences ensue from this. The most obvious is that, for the very first time, we are seeing overt rationing of treatments taking place within the NHS. That fact should not, on its own, upset or alarm us. Rationing has been a feature of the NHS in one form or another since its inception. What should alarm us is the basis of this particular example of it. The Secretary of State has decided that there is "good" and "bad" impotence--that is to say, impotence that is deserving and impotence that is undeserving.

On what basis can there possibly be a justification for the NHS withholding Viagra from a man with a brain tumour whilst dispensing it to a man with prostate cancer? What can be the justification for denying it to a man with liver failure whilst allowing it to a man with kidney failure, regarding vascular disease differently from Parkinson's disease? Try as I may, I cannot find such a justification. And whose rules are these? The answer is that they are not clinicians' rules; they are the Secretary of State's rules. They are rules which drive a coach and horses through the ethos of the NHS, which has always been to allow clinical judgment to determine the appropriateness of medical treatment and to treat individuals equally according to their need, and not to discriminate on the basis of the underlying reasons for that need.

There is another bizarre feature of this set of rules. Any man who was already receiving impotence treatment on 14th September 1998 is automatically entitled to the drugs listed in the regulations, whatever the underlying cause of his condition. How can the Government justify rationing on the basis of a cut-off date? What would we have said about the fairness of a petrol rationing policy in September 1939 which stipulated that rationing would apply to everyone except those who were running a car on the day that war was declared?

The idea is absurd and the scope for anomaly is immense. A man with vascular disease who, let us say, had been receiving impotence treatment by injection until shortly before the 14th September but who had abandoned it because of the discomfort it was causing him would be denied Viagra, or any other impotence treatment on NHS. Yet that same man, if he had decided to give up his treatment on the 15th September, could have asked for and received Viagra without needing a private prescription. I would be grateful for the Minister's comments on why this feature of the regulations was considered by the Government to be fair and equitable to impotence patients in general.

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The Minister may tell me that the lists contained in these regulations do not represent the whole picture. The Government have said that it will still be open to a GP to refer to a specialist any patient who does not qualify under the standard headings but who is suffering from severe distress as a result of impotence.

That sounds reasonable as far as it goes, but if a GP is to follow that advice he has to know what it means. What is the definition of "severe distress"? How do you measure it? If a referral is made to a urologist, how is that urologist in a better position to make a judgment about a patient's degree of distress than the GP, who knows the patient very much better? It seems to me that this is simply a recipe for creating even longer waiting lists than there are at the moment for urology clinics.

If a man is prescribed Viagra treatment by a urologist, he must continue going back to that specialist if he wants a repeat prescription because his GP will not be allowed to continue the treatment. Is that really a cost-effective use of NHS resources? To what extent were urologists consulted over these procedures? I should be glad if the Minister would tell me when proper guidance on these questions will be issued by the Department of Health.

I should like now to turn briefly to the detail of these regulations. When I looked at these instruments I thought that the intention behind them was to group a therapeutic class of products within Schedule 11 of the National Health Service (General Medical Services) Regulations 1992; namely, all licensed pharmaceutical products for erectile dysfunction. However, it appears that not all such products have been included. I am advised that there is a product known as Viridal Duo which has been omitted. This is a product quite distinct from Viridal which is listed, with a separate product licence, different dosages, and a different NHS price. Why is it not on the list?

Secondly, the statutory instrument refers to products which have been withdrawn from use in the UK. Moxisylyte hydrochloride, known as Erecnos, and Thymoxamine Hydrochloride, also known by the same name, were withdrawn from the market in this country, I am told, in March 1999. Why, therefore, are they included in the list?

I move now to wider issues and, at the risk of overloading the Minister with questions, I should like to ask him about the use of Schedule 11 to restrict the availability of impotence treatments generally. What happened was that the Government panicked. They saw on the horizon an anti-impotence drug, Viagra, that they thought would prove extremely expensive for the NHS budget. So what did they do? They decided to ration not just that drug but all existing treatments for impotence as well. I put it to the Minister that this statutory instrument is outwith the spirit of the parent legislation set out by the National Health Service Act 1977 and that Schedule 11 was not intended for the purpose for which it is now being used.

Parliament was advised in 1985 that a Schedule 11 listing was a legitimate restriction on budgetary grounds where a medicinal product had more than one

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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 those indications for which treatment under the NHS is justified 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 such as nicotine replacement, or where misuse has arisen such as Temazepam capsules and clinical alternatives were available. Such circumstances do not apply here. The schedule is being used where there is no product otherwise available to meet a recognised clinical need. What is the Minister's comment on this?

For a variety of reasons, therefore, the Government have crossed a rubicon in introducing these regulations. That is perhaps the feature of them that worries me most. Today we are discussing treatments for impotence; tomorrow it may be something else. The new influenza drug, Relenza, is expected to be licensed before next winter. There are some who believe that its arrival will lead to GPs' surgeries being inundated by patients with early symptoms of a cold believing themselves to be suffering from 'flu. And that is only one possible example, of course.

What do the Government intend to do in such circumstances? Will they use Schedule 11 as a standard government response to what in their judgment are desirable but non-essential drugs? The case of Viagra and treatments for erectile dysfunction illustrates a number of severe problems that ensue from any attempt to ration treatments from the centre. I believe that the Government have got themselves into terrible difficulties on this issue. There is no easy way out for them by claiming that male impotence is a lifestyle issue and therefore automatically of low priority. On the contrary, male erectile dysfunction is, as the Secretary of State himself admitted, a distressing condition. It has serious medical consequences both for sufferers and their partners. Eighty-five per cent of cases result from underlying organic disease rather than psychological reasons. The outrage of doctors at the Secretary of State's decision to use Schedule 11 to limit the prescription of treatments for erectile dysfunction was highlighted by the British Medical Association which described it as arbitrary and one which would,

    "exclude people who have a genuine clinical need".

The BMA went on to say that the decision,

    "undervalues the position of GPs and will overload the hospital system".

The objection which I share with many clinicians is to the Government making rationing decisions on grounds of costs and then attempting to justify those decisions on grounds which authoritative medical opinion does not support. The result is unfair and divisive discrimination. I beg to move.

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Moved, That a humble Address be presented to Her Majesty praying that the regulations, laid before the House on 10th June, be annulled (S.I. 199/1627).--(Earl Howe.)

8 p.m.

Lord Clement-Jones: My Lords, on behalf of these Benches, I thank the noble Earl, Lord Howe, for praying against the regulations, not only because it gives this House a chance to look at the Government's actions but also to examine their intentions in future rationing decisions.

In effect, as the noble Earl expressed so well, the Secretary of State in the Viagra case stumbled into a rationing debate resulting in a process which took far too long, could have been more coherently dealt with, and has had an extremely unfair outcome. On 15th September 1998, Sildenafil (Viagra) was licensed for use by the European Medicines Evaluation Agency and the Medicines Control Agency. The Secretary of State then acting on the interim advice of the Standing Medical Advisory Committee issued interim guidance by circular which prevented doctors from prescribing Viagra and caused a storm of protest; and indeed rebellion by individual GPs and their representatives. After a considerable delay, and despite receiving the advice of the Standing Medical Advisory Committee in November, he then issued draft guidance only in January which, although it allowed more latitude for prescription, and he agreed to consult with the profession over a six-week period, did not follow the advice of the Standing Medical Advisory Committee.

After a further delay the Secretary of State in May changed certain aspects of the original guidance in the light of consultations, to lengthen the list of eligible patients. Pfizer obtained a ruling later in May that the issuing of the original circular by itself was not in compliance with the EU transparency directive.

I welcome the fact that those consultations were genuine and produced changes in the eventual outcome and that the regulations will be reviewed after a year. However, there are considerable points of unhappiness with those regulations. The noble Earl, Lord Howe, has enumerated a number of the objections to the regulations and I do not propose to repeat them. Principally, above everything else, there is unhappiness in the medical profession that men whose impotence is causing them severe distress need to be referred first to a specialist before becoming entitled to treatment.

Yet there are many aspects in this whole affair which are not clear. Does the Secretary of State finally now admit that rationing is taking place within the NHS? Does he consider Viagra a precedent to be followed in other cases, or is it an exception? Is he convinced that the transparency directive is now being complied with? Does he propose to deal with all new treatments coming on stream in this way--for instance the new 'flu treatment referred to by the noble Earl, Lord Howe? How does he propose to deal with existing problems over chemotherapy drugs for cancer treatment, for example, which are subject to postcode prescribing because of cost constraints, along with Beta Interferon, Aricept and Clozapine?

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Does the Secretary of State believe in essence that the NHS is primarily for patients with life-threatening or painful conditions, as he seems to have implied in certain utterances? Will the Government now be explicit about what the NHS will or will not provide; or shall we simply proceed by testing every rationing decision, local or national, by means of judicial review? A senior executive of Pfizer recently wrote in the Royal Society of Arts Journal:

    "The Viagra phenomenon is a sign of a larger trend in the pharmaceutical industry. It signals a new era in using medication to enhance and prolong people's lives--entering areas of healthcare that once seemed outside medical parameters".

Is the department keeping pace with this type of change? Is it calculating the likely future cost implications of these advances in the pharmaceutical field, or is it simply hoping to keep the lid on the whole issue?

It is not enough for the Government to rely on evidence-based medicine and the setting up of NICE. After all, NICE will specifically not deal with the question of affordability, as Ministers have confirmed; it will deal only with clinical questions and cost-effectiveness. NICE may help eliminate some ineffective treatments currently in use, but as its new chairman recently said,

    "Anyone who believes that NICE will reduce NHS expenditure is whistling in the wind.".

What kind of assessment is being made of the future? Should not we treat drug expenditure in some cases as a kind of investment? It may be that there are savings that the Government as a whole can make in future if new drugs allow older people or those with mental health problems, for instance, to remain healthy and independent for longer and to stay out of institutions. If we deny access to some drugs, however, we may well not be reaping the healthcare economies that we could and should be making. In particular, will the Government introduce more transparency and accountability into the setting of priorities and the rationing process?

On these Benches, we do not argue that priority setting or rationing is bad--far from it. Indeed, the World Health Organisation in its recent report strongly backed publicly funded healthcare systems, but argued at the same time that rationing must be a feature of them. But in the process, we must keep public confidence in the NHS.

The recent interim report of the commission on representing the public interest in the health service stated:

    "No longer can doctors, clinicians, health managers and politicians decide what they consider to be the public interest in health behind closed doors with only nominal consultation".


    "This trend interacts with the growing insistence that healthcare must correspond to the best available practice".

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And further:

    "In short, a gap has opened up between government and citizen over health care that urgently needs to be closed".

The commission recommended that some form of organised independent public scrutiny of health services should be set up. We strongly agree with those sentiments and believe that the Government should act on them to set up an open system explicitly publicly to debate and confront the setting of priorities and the rationing of health treatment.

On these Benches we put forward numerous suggestions both in the debate last autumn initiated by the noble Baroness, Lady Cumberlege, on clinical futures and rationing and during the passage of the Health Bill on ways in which rationing decisions can be brought into the open. It is notable that one mechanism, citizen juries, was used extensively by Somerset Health Authority in its submission on Viagra to the Secretary of State. Despite all the ferment, we on these Benches are still waiting to see whether the Government are even willing to address the issue and instal mechanisms to deal with it. We look forward to the Minister's reply.

8.12 p.m.

Lord Hunt of Kings Heath: My Lords, I welcome the opportunity to debate erectile dysfunction with your Lordships tonight. Some important philosophical issues have been raised by both noble Lords and I gained the impression that both were taking the Government to task for the actions they have taken in relation to Viagra.

I say straightaway to the noble Earl, Lord Howe, that I reject the charge that the Government panicked in this area. The evidence shows that they came to a very sensible decision appropriate to the specific circumstances of Viagra. Careful consultation took place during that process. A balance had to be drawn between the need to protect NHS resources and to do what we could to provide treatment for impotence. Priority setting is a necessary part of any healthcare system--certainly in the case of the NHS. I believe that we came to a sensible decision which compares favourably with other European countries. Only in two other European countries is Viagra available to certain categories of patients free of charge.

As the House is aware, the regulations around which the debate is focused--the National Health Service (General Medical Services) Amendment (No. 2) Regulations 1999--came into effect on 1st July, as promised by my right honourable friend the Secretary of State for Health in his announcement of 7th May. I shall refer to the Scottish regulations in a moment.

The regulations introduce changes to Schedule 11 of the same regulations, the practical effect of which is to restrict the prescribing by GPs of treatments for impotence from 1st July. GPs may now prescribe these treatments on the NHS only for categories of men with specified underlying organic causes of impotence. Guidance has been issued to the NHS explaining in more detail the responsibilities of GPs and community pharmacists in prescribing and dispensing these prescriptions. That guidance also contains a

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recommendation, based on research evidence, that treatment be prescribed once a week. We are preparing some additional guidance on the identification and management within specialist services of those men suffering from severe distress as a result of their impotence. I cannot give the exact timescale, but we hope that it will be produced as soon as possible.

The overall context of these new arrangements is that the Secretary of State took the view that, with the introduction of Viagra, the cost of treating impotence should not be allowed to rise substantially, diverting resources from other health conditions and treatments. He undertook a public consultation to help us find a sensible balance between treating men with the distressing condition and protecting the resources of the NHS to deal with other patients. Current costs of treatment are around £10 million to £12 million a year, but without action by the Secretary of State these could have risen to a range starting at £37.5 million a year which could have risen as high as £81 million a year. During the recent legal action mentioned by both noble Lords, instituted by Pfizer, the judge acknowledged that Pfizer had rightly conceded that the Secretary of State is entitled to include medicines in Schedule 11 because of resource implications following the likely cost of allowing them to be freely prescribed. Indeed, the Honourable Mr Justice Collins in his judgment commented that:

    "It is clear that, for very understandable and proper reasons, the Secretary of State was concerned that Viagra would prove to have a significantly adverse effect on the resources of the NHS".

In the absence of his ability to use Schedule 11, my right honourable friend would have been faced with a stark choice. Either he would have had to risk an uncontrolled rise in expenditure, with all the potential of diverting resources away from other conditions, or he would have had to prevent GPs from prescribing treatments for impotence altogether. As it is, we have been able to introduce a regime which means that more men will be treated for their impotence than before, without a significant increase in costs, and which is more generous than in most of Europe.

In contrast to the suggestion that the Government panicked or did not act correctly, it is reassuring that many respondents to the public consultation supported the view that action needed to be taken. It is true that concern was expressed about distinguishing between patients on the grounds of their underlying condition. It is also true that the British Medical Association continues to express those concerns. But, no one, including the Standing Medical Advisory Committee and the BMA, proposed an alternative solution that would meet the concerns I have described.

We all recognise that the NHS operates within financial constraints and that it is the Government's role to address concerns about the use of NHS resources. As I have said, some concern was expressed about distinguishing between patients on the grounds of their underlying condition. But no one proposed an alternative solution which would be consistent with the objective of containing expenditure to approximately the present level so as not to divert resources from other health conditions and treatments, and the general view

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that drug treatments should be made as widely available as possible for prescription by GPs on the NHS. We decided therefore to proceed with the proposals but in an amended form which took into account comments so far as possible within the available resources. We extended the list of eligible patients to encompass all men treated for prostate cancer--not just those who have had a prostatectomy, as originally proposed--men being treated for renal failure and men with polio.

Other concerns were raised in consultation, particularly about men receiving drug treatment before Viagra was licensed having their treatment withdrawn.

We took account of that in deciding that men who were receiving drug treatment for impotence on 14th September 1998 should be able to continue to receive treatment from their GP notwithstanding that they may not suffer from one of the named conditions. The noble Earl, Lord Howe, described that as an absurd position. However, it seems to me that that was a fair decision given that the people concerned were receiving a drug treatment before Viagra was available.

The provision of one treatment per week is considered to be reasonable by most people, but I must emphasise that this is advice. It is made clear in the guidance issued to doctors that if the GP in exercising his or her clinical judgment considers that more than one treatment is appropriate, that amount should be prescribed on the NHS.

In making these regulations the Secretary of State has consulted interested parties and complied with his obligations under European legislation, specifically with what is known as the "transparency directive", which was raised by the noble Lord, Lord Clement-Jones. He has done that by making the decision on the basis of a criterion that had been notified to the European Commission. The decision-making process was open and above board. For example, it was following consultation that the Secretary of State decided to extend the list of eligible patients and to enable men who were being treated for impotence before treatment became available in tablet form to be eligible for continuing treatment from their GP.

I turn to some of the specific points made. The noble Earl, Lord Howe, raised the issue of severe distress. I have mentioned already that we are in the process of preparing that guidance. It will be issued shortly. Perhaps I could further say to the noble Earl that identification and assessment of patients will be by doctors exercising their clinical judgment. It is likely that such patients will be suffering severe disruption to their occupational and social activity.

The noble Earl also raised the issue of inclusion in the regulations of products that have been withdrawn. It is my understanding that all the drug treatments for impotence included in Schedule 11 are presently available and listed in the British National Formulary. However, that is a matter I am prepared to check and clarify.

I come now to the point about whether a precedent has been set for dealing with desirable but non-essential drugs. I have to say, first, that it is unwise to foretell the future based on the way in which Viagra has been dealt

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with. Clearly, each condition has to be dealt with on its merits, subject to mature judgment. However, I believe that the potential pressure on NHS resources from calls to prescribe Viagra for the treatment of impotence gave rise to an almost unique set of circumstances. Ministers were required to make a decision, and I believe that a sensible and wise decision was made.

The noble Earl, Lord Howe, raised the issue of Viradal Duo not being included. I understand that they are included under the listing of Alprostadil. In relation to the misuse of Schedule 11 suggested by the noble Earl, I believe that I have covered that in relation to the judgment given by His Honour Judge Collins who, as I have said, acknowledged that the Secretary of State is entitled to include medicines in Schedule 11 because of the resource implications following the likely cost of allowing them to be freely prescribed.

The noble Lord, Lord Clement-Jones, asked about the issue of forecasting the future in relation to drugs. That is not without its challenge, as we have discovered in the National Health Service over many years. The overall aim of the Government continues to be to encourage the wider uptake of clinical and cost-effective medicines. I believe, despite some doubts suggested by the noble Lord, that NICE can help in securing that objective.

I turn briefly to the question of Scotland. It might be helpful to the House if I said that the Scottish regulations made on 8th June and laid before Parliament on 10th June, again came into force on 1st July. Nothing in the devolution legislation prevents those procedures being followed through. Therefore, it is appropriate for this House to debate those regulations. However, any subsequent amendments for Scotland or Wales will, of course, fall to the Scottish Parliament or the Welsh Assembly, as appropriate.

In conclusion, perhaps I may make it clear that the policy underlying the new arrangements will be reviewed after they have operated for a year. That will happen, but in the mean time, I commend the measures contained in the statutory instrument and the associated guidance--

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