Rethinking transparency and accountability in medicines regulation in the United Kingdom

doi:10.1136/bmj.318.7175.46

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John Abraham, director science policy research (J.W.Abraham@sussex.ac.uk)a,
Julie Sheppard, senior public affairs officerb,
Tim Reed, research assistanta

^aDepartment of Sociology, University of Sussex, Brighton BN1 9QN
^bConsumers' Association, London NW1 4DF

Correspondence to: Dr Abraham

Accepted 10 July 1998

As the Labour government in the United Kingdom introduces its plans for British freedom of information legislation in a white paper, it is important to consider the issues raised by this for the regulation of medicines. In the United Kingdom, the regulation of medicines is governed currently by the 1911Official Secrets Act and 1968Medicines Act. These require all information on drug product licence applications to be treated with the utmost secrecy by the Department of Health's regulatory authority, the Medicines Control Agency, and all its expert advisory committees. Until May 1997,the official position of the British government was that confidentiality about regulation of medicines was needed to protect drug companies' commercially sensitive trade secrets so that the pharmaceutical industry continued to invest and to make medicines available in the United Kingdom.1

Summary points

Proposals for freedom of information legislation in the United Kingdom raise issues for regulation of medicines
Under current law all information on applications for licences of drug products is treated with utmost secrecy
Medicines regulators and their expert advisors are closely identified with the interests of the pharmaceutical industry in Britain
Existing secrecy may not protect public health
If legislation includes a “harm test” the commercial interests of pharmaceutical companies may take priority over providing the public with adequate information

Open government?

The existing secrecy sits uneasily with the rhetoric of the Conservative government's 1993white paper on open government, which espoused the following principles: