§ Motion made, and Question proposed, That this House do now adjourn.—[Janet Anderson.]
11.32 pm§ Dr. Evan Harris (Oxford, West and Abingdon)I am pleased to be able to introduce a debate on the prescribing of Viagra, although not because I think that people need any information about what it does or why there has been concern about it. I should stress at the outset that this is a serious debate about a serious problem—the potential costs of a treatment for a significant condition.
Prescription of Viagra is a recognised drug treatment for male impotence, or male erectile dysfunction; but Viagra is a new drug, which causes concern about cost. At its recent conference, the British Medical Association passed a motion based on its worries about the introduction of the drug—
That this Meeting demands that the Government urgently reviews the mechanism for the introduction into clinical practice of newly licensed expensive drugs".There is clearly concern about the cost, but that applies to other drugs as well.The debate has attracted a degree of media attention. I suspect that we would not be able to get that attention if we discussed the prescribing of beta interferon, cholesterol-lowering statins or Taxol for ovarian cancer; however, the principles in regard to those drugs—as far as they go—are the same as those applying to Viagra.
However, four factors that are special to Viagra give us cause for greater interest. First, this drug has been well publicised, so, if and when it is introduced into the NHS, it will not be possible to do so quietly and without patients or those who feel they could benefit from it knowing about it. Secondly, there is potential for demand to be for a quasi-recreational use of the drug.
The third special factor is that some—perhaps the majority—of the people who feel that they could benefit from the drug are not already being treated by the NHS for the condition, as may be the case with the other drugs I mentioned. The fourth thing that is special about Viagra compared with the other drugs that cause concern because of the cost of introduction is that there are no immediately obvious down-the-line savings through the prevention of either in-patient admission or a worsening in health that would require more expensive treatment. There is also little in the way of savings from replacing existing treatment by this new drug.
Viagra is, in those senses, special, but I wanted to raise this issue because it allows us to discuss a specific example of NHS rationing probably for the first time. I should like to explore a number of false arguments about Viagra. I hope and expect that the Government will not disagree with me.
The first argument is that Viagra, if available on prescription from a GP, will blow a £1 billion hole in the NHS budget. That is certainly a fear, but although there will be an effect on drug cost pressures, a cost of £1 billion is unlikely, and it is not the figure that anyone I have spoken to who has thought about potential demand would put on it. Even if one in 10 men have a problem with erectile dysfunction, only a proportion would benefit from this treatment, and only a proportion of them would 318 come forward for treatment. Some men are already being treated, so there would be a small cost saving if they switched to Viagra.
The second argument—it is almost a knee-jerk reaction—is that there are good reasons why Viagra should not in fact be available on the NHS. People are persuaded otherwise, however, when they realise that male erectile dysfunction is a recognised medical condition that is already treated on the NHS by injection or by implant. Many patients suffer significant psychological or even psychiatric problems, and there are strong causal associations with alcoholism, suicide and marriage breakdown.
Some of the effects and associations that I have just mentioned have significant treatment and social costs. I hope that the Minister will agree that, in a philosophical sense, most definitions of health include reference to adequate function of all organs of the body, without discrimination, and the ability to perform most functions, without discrimination, that people and professional doctors would consider to be normal.
The third argument is that there are good clinical and cost reasons for prescribing this drug only through hospital consultants. Many people think that the Government are seriously considering that. It is right to give the matter serious consideration, but there are no strong arguments for doing so. Although some patients suffering from impotence see urologists, GPs are more than capable of treating male erectile dysfunction with existing treatments, and are also capable of establishing who needs the treatment as opposed to who demands it.
Unlike powerful cardioactive drugs, Viagra does not have a particularly complex pharmacology with particularly complex interactions. It does not have a difficult or unusual mode of delivery, unlike beta interferon by injection. It does not have difficult outcome measures, or difficult-to-measure outcome measures. Altogether, it seems suitable for primary care prescribing. It would be ludicrous to clog up hospitals with such patients in view of the high work load of urologists and the shortage of urologists to carry it out, including important waiting list procedures.
The cost of a hospital appointment is higher than a general practitioner consultation, and in some specialties secondary referral automatically brings expensive investigations. The only point of consultant-only prescription might be to reduce take-up for financial reasons, but that would be a distortion of the clinical gate-keeping role of primary care. Other hospital-only drugs are generally much more expensive per dose. They include beta interferon and are for patients, such as those with multiple sclerosis, who are already under the care of a consultant. Such patients would be expected to be under the care of, known to, or in touch with, a hospital neurologist.
There is thus a powerful case for treating Viagra, if and when it is licensed, in the same way as any other relatively safe or assumed-to-be-safe and effective oral medication for a recognised medical conditions. That would make it prescribable on the NHS in general practice. A decision not to do that would require the Government to justify the decision.
Nevertheless, a decision to allow GP prescribing of Viagra would have significant cost effects for some of the reasons that I have given, and there is also the cost 319 of the treatment itself. In addition, the cost effects will be even more apparent to professionals in the service, which is why the GP committee of the British Medical Association is particularly worried now that drug budgets for GPs are to be cash limited at practice or primary care group level. There is a thus a likelihood that the new treatment will make rationing decisions in the NHS more likely, more obvious to professionals and to patients and the public generally.
I call upon the Government to come clean about the word "rationing". It inevitably exists in the NHS because of a mismatch between resources and demand. I do not place any particular value on rationing: I use it to describe the mismatch. For example, long waits for elective treatment are a form of rationing. Curative treatment is delayed, and that means that some people will never have it because they may die or become inoperable. Treatments such as in vitro fertilisation, beta interferon for the treatment of multiple sclerosis, cholesterol lowering statin drugs to prevent heart disease, and taxol for ovarian cancer are available only on the NHS in some areas under what has been called post-code rationing.
Alternatively, they are cash-limited on a first-come, first-served basis. That means that known specific treatments may not be available, although in a population sense they were shown to be effective, and that is a form of deprivation of treatment. An even better example is the fact that NHS dentistry has effectively been rationed because it has been privatised away.
§ Mr. Deputy Speaker (Sir Alan Haselhurst)Order. I appreciate that this is the hon. Gentleman's Adjournment debate, but its title is "Prescribing Viagra", and he must relate his speech much more specifically to that. He is getting into the realms of NHS dentistry and rationing in general.
§ Dr. HarrisThank you for your guidance, Mr. Deputy Speaker. I was merely seeking, as I hope the Minister and you will understand, to show that Viagra causes problems in terms of rationing.
On the issue of prescribing Viagra, the Government will be forced to be explicit and to start a public debate. People will not understand that a treatment is not available on the NHS. It will mean that patients who cannot afford private treatment will not be able to obtain effective treatment for male erectile dysfunction, which is a recognised medical problem. That would be a return to pre-NHS days when the poor could not get the same treatment as other people.
Until recently, all Governments have refused to accept that for drugs such as Viagra rationing exists. As such drugs, of which Viagra is the best example, come on stream, people will ask for them and will expect a reason for their non-availability in their postcode area. Already the Minister has accepted, in answer to a Liberal Democrat question at oral questions, that there is a postcode lottery of some treatments. That is to be welcomed, as we need a public debate on the matter.
If the public who may need Viagra or other treatments are to make informed decisions about the resources that they want allocated to the NHS to allow those treatments to be prescribed, they must be told what they will get 320 from the NHS in return for the taxes that they pay. I would argue, and I believe that this was the fear of the BMA when it debated Viagra, that the amount of resources in the NHS—6.9 per cent. of gross national product—will not be sufficient to pay the full costs of prescribing such drugs, without something else having to give.
I hope that the Government will not—as they have done with other treatments, perhaps by default rather than by design—pass on the responsibility for denying patients on cost grounds treatments such as Viagra to doctors, nurses or even managers; just as doctors who do not prescribe a drug because it is clinically unnecessary would not seek to blame that clinical decision on the Government. The problems relating to the prescribing of Viagra give the Government an opportunity to set out to the public that what they get is what they pay for, and to make rationing on cost grounds much more explicit, for this drug and other treatments.
The minimum that I ask the Minister to do is to start a public debate on rationing, so that the public can recognise that what they put into the NHS is what they get out. The Liberal Democrats have for that reason proposed a standing conference to remove the party political element from debates about the prescribing of expensive new drugs. I hope that the Minister will take that into consideration in his response.
§ The Minister of State, Department of Health (Mr. Alan Milburn)I congratulate the hon. Member for Oxford, West and Abingdon (Dr. Harris) on securing this important debate. The subject that he has chosen, Viagra, has produced more comment than any other new drug in living memory, and probably more bad jokes as well. It is already a cause celebre and, as he rightly says, it raises some important issues, not least because Viagra has prompted a huge debate about its potential impact on the national health service. I shall take this opportunity to set out the Government's position on Viagra and, more generally, on the issues that it brings in its wake.
May I make one thing clear from the outset? The NHS is a national health service, not a national happiness service, to borrow a phrase from a recent article in The Sunday Telegraph. If Viagra is to be available on prescription, it will be so as a potentially serious drug addressing a genuine clinical condition for some patients. That is the context in which I propose to address the issues this evening.
I should also make it clear that the debate is in danger of running ahead of actual developments. Viagra has not even yet been licensed for use in the United Kingdom, or indeed anywhere else in Europe. At present, it is an unlicensed medicinal product in the UK. Apart from its being prescribed on a named-patient basis by a doctor, any form of retail sale or supply of Viagra is a criminal offence under the Medicines Act 1968. The Medicines Control Agency is currently investigating illegal trading and advertising activities, and will take action against traders. The MCA has also advised patients against buying Viagra through mail order, or through the internet, on health grounds.
It is true that the manufacturer of Viagra has applied to the European Medicines Evaluation Agency for a European marketing authorisation, which, if granted, would be binding on the United Kingdom. The agency 321 refers such applications to an expert committee that is responsible for the evaluation of medicines for human use—the Committee for Proprietary Medicinal Products. I understand that Viagra has now received a favourable opinion from that committee. The final decision on whether to grant marketing authorisation will now be taken by the European Commission after consultation with the competent authorities of the member states. The timetable for that decision is approximately one to three months.
If licensed, Viagra would, in the first instance, be available only on a doctor's prescription. It is possible that, after a period of further experience—assuming that reveals no unexpected safety problems—it could then be deregulated and made available for sale over the counter. That is not an immediate option, and would need to be subject to the most stringent safety tests, particularly bearing in mind the reports we have had from America on a number of people who have died as a result of taking Viagra.
Naturally, we have been giving serious thought to how Viagra should best be introduced into the NHS, if and when it becomes licensed for use. We have been analysing the potential number of patients and the potential costs, and we have commissioned an appraisal of the strength of evidence for clinical and cost-effectiveness.
We have also invited the Standing Medical Advisory Committee to develop guidance for the NHS on the appropriate use of Viagra. The committee, which includes the presidents of the medical royal colleges, is well placed to give such advice, and has, for instance, recently issued guidance on the use of lipid-lowering drugs.
In all this, three things need to be kept in mind. First, it is vital that any prescribing should be closely targeted on patients with genuine clinical need. As the hon. Member for Oxford, West and Abingdon was hinting, Viagra is unusual, if not unique, in the scope for patients who are seeking it to use it as a recreational drug rather than for real health need. I am determined to ensure that NHS resources are not frittered away in that fashion.
Secondly, erectile dysfunction has a variety of clinical causes, and treatment is not just a question of taking a pill. It must involve a full and expert assessment and consideration of alternative or complementary forms of treatment. Indeed, the NHS currently provides a range of treatment for men with erectile dysfunction, and it is important that the introduction of Viagra—if and when that happens—does not lead to the presumption that it is a miracle cure for all impotence problems
Thirdly, the NHS—even after today's historic increase in NHS funding—does not have infinite resources, and we must ensure that funding is devoted to health needs of the greatest priority. For some patients, there is no doubt that impotence is a serious and devastating condition. However, in making our decisions on how we offer NHS treatment to them, we need to keep in mind that it is not a life-threatening condition. Many might therefore conclude that, overall, it should have a relatively modest priority for NHS funding.
Weighing up all those factors—the evidence on clinical and cost effectiveness and the needs of individual patients while keeping a reasonable view on priorities—is a complex affair, involving a range of competing judgments. At the moment, decisions on how new treatments are introduced into the NHS, whether they be 322 drugs, interventions or new devices, are taken more or less on an ad hoc basis, usually at local rather than national level.
The result is twofold. First, we have the worst of all possible worlds with some proven treatments being introduced too slowly into the NHS and others, that are unproven—either on clinical or cost grounds—being introduced too quickly. Secondly, local decision-making about access to treatments can be extremely variable. The result is what many describe as a lottery in care, with unacceptable variations in access within what is supposed to be a national health service.
That is why the Government have decided to set up the National Institute for Clinical Excellence, to produce clear, authoritative guidance to the NHS on which treatments work best for which patients and which do not. The result will be greater national consistency, based on better informed clinical judgments.
The national institute will bring together the work currently scattered over many disparate bodies to benefit patients in two ways. First, treatments with good evidence of clinical and cost-effectiveness will be actively promoted, so that patients will have faster access to treatments that are known to work. Secondly, and conversely, treatments that are supported by inadequate evidence will not be widely disseminated unless further research shows that, on balance, they are an effective use of resources.
For a drug such as Viagra, the national institute would need also to advise on how such treatments should best be targeted to ensure that the most appropriate patients are selected for treatment, and that NHS resources overall are used in the most effective possible way.
Decisions on Viagra, however, will not be able to wait for establishment of the National Institute of Clinical Excellence. As I said, the Standing Medical Advisory Committee has been asked to develop guidance for the NHS on the role of Viagra. Clear guidance, properly monitored, will ensure that the availability of Viagra on the NHS is consistent across the whole country—should it be licensed.
I should expect guidance to emphasise the need for a full and expert clinical assessment before patients are prescribed Viagra, especially when there is no previous history of related disease or diagnosis of impotence. I should expect also that such assessments will take place under the auspices of expert hospital clinicians rather than through family doctors. Clearly the implications for specialist hospital services will have to be properly assessed before final decisions are taken, but I think that it is right to make it clear now that the Government do not want GPs to be burdened with the weight of expectations that have been built up around the drug.
§ Dr. HarrisI should be grateful if the Minister will return to an earlier point, and explain how, if the drug is licensed and available, general practitioners—regardless of whether their decisions are checked by a hospital consultant—should deal with the problem of having to tell some patients that the drug budget is insufficient to provide them with the treatment that they need. Such a problem currently exists, and it may well be exacerbated. 323 Does he not believe, as I asked him earlier, that the Government have a duty to be explicit about those matters?
§ Mr. MilburnThe hon. Gentleman could have made a good point, but he has made a bad one—as he did in his speech, when he said that drug budgets would be cash-limited. As we have repeatedly made it clear—he should understand this point; to be fair to him, he understands health issues—no part of the new unified budgets being made available to primary care groups is to be artificially capped. Indeed, we are removing the cap.
It will be for GPs, community nurses and others to decide how best to use available resources as a totality for the benefit of the individual patient. GPs have not previously had that ability, and they will welcome it. It will be a boon. It may well lead to increased GP expenditure on drugs, or on hospital referrals or other investigations. It will be for general practitioners to make those choices. It is simply wrong to suggest that GPs will be placed in the position of having to turn away patients because of an artificially capped drugs budget. The hon. Gentleman knows that that is wrong.
§ Dr. HarrisI am grateful to the Minister for that clarification. The point that I was attempting to make—I shall try to make it differently this time—was that health authorities are already faced with prioritisation, or deprioritisation, issues relating to expensive drugs. They have to decide which drug treatments they can or cannot support.
Under the new system, responsibility for many services that are decided at primary care group level will—just as health authorities are struggling with the issue of the 324 totality of available resources—be transferred to general practitioners. Therefore, the question that the British Medical Association and commentators such as the King's Fund still require the Minister to answer is how they should deal with the problem of expectations exceeding demand when the Government imply that the resources are available.
§ Mr. MilburnIf the King's Fund cannot read the White Paper or the quality consultation document paper that we have issued in the past few days, I wonder where all its money goes. What we are proposing is perfectly clear: the Government, in conjunction with the clinical professions, will take more responsibility than ever before to ensure greater consistency across the national health service and will, for the first time, do what no Government—Labour or Tory—have ever done, which is to ensure proper national standards across the NHS. I should have thought that the hon. Gentleman would recognise and welcome that.
As I have already said, Viagra has not yet been licensed, and the Government are keeping the issue under review. I conclude by saying four things. First, the Government accept that, for some patients, impotence is a significant clinical condition, for which effective treatment may legitimately be provided on the national health service. Secondly, depending on the decisions in the European licensing process, Viagra may be confirmed as an effective treatment for some patients, but, thirdly, treatment should be prescribed only following a full clinical assessment and as part of an integrated plan of clinical management.
Fourthly, and finally, I am determined, as are the Government as a whole, to ensure that NHS resources are safeguarded for those with real clinical need.
§ Question put and agreed to.
§ Adjourned accordingly at Twelve midnight.