REFORMS MEAN GLOOM FOR INDUSTRY

Everything in US President Clinton's Health Security Act is negotiable, apart from its provision of universality of health insurance, says Richard Kingham, partner in the Washington law firm Covington & Birling. He told Management Forum's annual pharmaceutical conference in London last week that while the legislation will undoubtedly go through many changes before Congress passes it into law, the pharmaceutical industry can expect little to help it, given Senator David Pryor's success in building a case against drug companies. the industry's political base is small and getting smaller, Mr Kingham told the meeting, and, with few defenders on Capitol Hill, it is an easy target.

It is possible that the bill could pass by the end of next year, he said. Under its general insurance provision there will be no direct mandatory price controls on the industry, but pressure will be on to limit costs, accelerating the steps, such as tough formularies and therapeutic interchange, which are already being implemented by health insurers. And, of course, the Advisory Council on Breakthrough Drugs, to be established within the Department of Health and Human Services, will review launch prices of New Chemical Entities, making comparisons with other drugs in the same therapeutic class and overseas, and considering other relevant price-related information obtained from the manufacturer and elsewhere. The Council's findings may be made available to the general public.

Turning to other matters, Mr Kingham said the implementation of user fees at the Food and Drug Administration was very good news for the industry, as it meant the dedication of resources to the new drug approval process and placed the emphasis on action, although not necessarily approval. Nevertheless, it will be a very good thing for speed of review.