UK Companies To Provide Drug Data

The Association of the British Pharmaceutical Industry published a new voluntary scheme last week, under which, for the first time, companies will open up to the public summaries of licensing data supplied to the government as part of the drug approval process, including information on safety, side effects and the scientific basis on which it is approved. The scheme spells out what information drug companies should give to public inquirers from january 1, 1996.

The ABPI says its aim is to match information published by the European Medicines Evaluation Agency by providing public summary documents on new drugs when licensed through the UK system and whenever they are reviewed or changed by the UK licensing authority. When the EMEA was set up in February of this year, it said it would publish this information; the UK Medicines Control Agency does not make this information public.

UK consumer groups and opposition politicians have long sought public availability of such data under a US-style Freedom of Information Act, but the UK Medicines Information Bill, introduced two years ago by Labour Member of Parliament Giles Radice to liberalize the 1969 Medicines Act in this regard, failed at the report stage in the House of Commons. The government said the bill's defeat was mainly due to the industry's continuing unhappiness with its proposals, and also because it would place the UK licensing authority at a competitive disadvantage as companies would prefer to license their products in more secretive countries (Marketletter May 17, 1993).