Advice in a circular sent last year to GPs by the health secretary, Frank Dobson, urging them not to prescribe the impotence drug Viagra (sildenafil) was unlawful, the High Court in London ruled last week. The successful challenge by the manufacturers, Pfizer, could prove to be just the opening salvo by the pharmaceutical industry as new drugs come on to the market and the government seeks ways of containing the NHS budget.
Mr Dobson issued the circular as an interim measure last September, just after sildenafil was approved for marketing, amid fears that unrestricted prescribing could cost the NHS £50m ($80m) a year. It was intended to hold the line until a decision was taken on how the drug should be restricted.
Mr Justice Collins ruled that the guidance was unlawful under both English and European law. Under English law it was unlawful because it deterred doctors from exercising their duty to use their clinical judgment. Under European law, the judge said, the circular contravened the so called transparency directive on medicines, which lays down the principle that any decision to blacklist a medicine from a member state’s national health system must state reasons “based upon objective and verifiable criteria.” The Department of Health was given leave to appeal.
Last month (May) Mr Dobson announced that from 1 July sildenafil would be available on the NHS only for men with erectile dysfunction stemming from one of a range of specified physical causes. Apart from these, men who suffer “severe distress” through impotence may be prescribed the drug in exceptional circumstances but only after assessment by a specialist. The result is that only about 17%of men with impotence will be allowed to have the drug. Sildenafil will be added to schedule 11 of the National Health Service Act from 1 July, subject to parliamentary approval. Schedule 11 lists drugs which are allowed to be used for some conditions but not for others in cases in which cheaper and equally good alternatives exist.
The addition of sildenafil is an unprecedented use of the schedule to limit prescribing on the basis of the underlying cause of the illness.
As we went to press, Pfizer was considering whether to mount a challenge to the new restrictions and whether to launch an action for damages over profits lost as a result of the circular.
Some 55%of doctors have prescribed the drug regardless of the circular after the BMA received independent legal advice that the guidance was unlawful.