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11.46 pm
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
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
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. Harris:
I 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.
Mr. Milburn:
The 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.
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