Free-for-all Viagra after court ruling

THE DEPARTMENT of Health said last night that men should not expect a Viagra free-for-all during the next five weeks, even though a High Court judge ruled yesterday that the Government had acted illegally in trying to restrict access to the anti-impotence drug.

The ruling means that almost two million impotent men have the right to NHS prescriptions for Viagra until 1 July. But a spokeswoman for the Department of Health said: "We would expect GPs to follow the prescribing advice as if the July guidelines were already in force."

Mr Justice Collins ruled that interim advice to doctors by Frank Dobson, the Secretary of State for Health, in a circular last September had been unlawful. The circular, issued as the drug received its UK licence, urged doctors not to prescribe Viagra on the NHS other than in "exceptional circumstances" until guidance on its use had been agreed by the Department of Health.

That guidance, announced on 7 May, will restrict the prescribing of Viagra to a narrowly defined group amounting to 17 per cent of the 1.8 million men estimated to be suffering from impotence. It is due to come into force on 1 July.

In the meantime, yesterday's judgment leaves GPs free to prescribe the drug on the NHS to any man who, in their professional judgement, has a clinical need. It was because the interim advice appeared to overrule the professional wisdom of doctors that the judge found against the Government.

GPs are obliged under their terms of service to provide the best available treatment to each patient on the basis of their clinical need. Department of Health officials estimate that 55 per cent of GPs have prescribed the drug.

The judgment does not affect the Government's ability to ration new drugs nor does it challenge the new restrictions on Viagra, which are being introduced, legally, on 1 July. But it does remind ministers that they must follow correct legal steps for decisions of this kind.

The British Medical Association said yesterday that the judgment was in line with its own legal advice, which led it to advise GPs that they had a right and a duty to prescribe the drug to patients in clinical need.

Ian Bogle, chairman of the BMA, said: "This should ensure that rationing decisions aren't taken like this again. What the Government did was illegal." Dr Bogle does not expect a rush for Viagra in the next five weeks.

"GPs will need to explain to their patients that even if they may be eligible for the drug now they will have to pay for it after 1 July [unless they are in the eligible group]. I don't think the floodgates will open," he said.

Pfizer, the drug's manufacturer, is considering whether to sue the Government over alleged lost sales. The company estimates that the market for Viagra would grow to pounds 50m after five years if prescribing were allowed to all in clinical need. This is far lower than predictions by some doctors of over pounds 100m in the first year. The guidelines taking effect in July will limit total spending on all impotence treatments to pounds 14m, pounds 2m more than at present.

Pfizer accepted in court that the Government had a legal right to restrict prescribing of the drug by using the formal procedure of allocating it to Schedule 11 of the drugs list. Schedule 11 drugs may only be prescribed to certain groups of patients or in certain circumstances. However, a Pfizer spokesman said the company was also considering whether to seek a judicial review of this ruling.

"We do believe that the Schedule 11 restrictions are unfair and discriminatory and that the drug should be available to all men with a clinical need for it. We are considering all avenues open to us to achieve that," he said.

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