Secretive drug law ‘must go’

New Scientist Oct 1994

A LAW that bars public access to information about medicines should be scrapped, says Britain’s National Consumer Council. In a report launched last week, it urges the government to "lift the shroud of secrecy surrounding prescribed medicines". Even the Association of the British Pharmaceutical Industry which represents drugs manufacturers, agrees that the law is over secretive.

The main target of the NCC’s campaign is section 118 of the Medicines Act 1968. This makes it a criminal offence for the government’s advisers on drug safety to disclose any information they receive from drugs companies applying for licences to sell their drug in Britain. This applies to data on clinical trials of drugs in people, and toxicity experiments in animals.

Section 118, which was designed to protect commercial confidentiality, even forbids the advisers from explaining why a drug licence is withdrawn. This caused controversy when the sleeping pill Halcion was banned in 1991 after having been on sale for 13 years (This Week, 12 October 1991).

The NCC points out that from the end of this year companies seeking licences to sell drugs throughout Europe need no longer apply to the British licensing authority Instead, they can apply to the new European Medicines Evaluation Agency. Fernand Sauer, director of the EMEA, says the agency will be "totally transparent". For example, it will publish "summary assessment reports" for every drug it approves.

SARs will include summaries of clinical trials, toxicity tests and data on side effects, dosages and recommended uses. Sauer also says the EMEA will publish its reasons for withdrawing a licence where new evidence shows a drug to be more toxic than first thought.

Andrew Chetley, the author of the NCC’s report, foresees tensions ahead, because the European agency will soon begin disclosing information that is still secret in Britain. "I think section 118 will have to be repealed or amended at some point," he says.

Even the ABPI believes that more openness is desirable. "We accept that when there’s a new medicine approved, the regulatory authority should make available an SAR," says Peter Lumley of the ABPI. "And the authorities should be allowed to say why a licence has been altered or revoked."

The Department of Health appears to be unmoved by the NCC’s report. "We have no plans to change the Medicines Act," a spokesman said this week.


Andy Coghian