Intended for healthcare professionals

Education And Debate

Rethinking transparency and accountability in medicines regulation in the United Kingdom

BMJ 1999; 318 doi: (Published 02 January 1999) Cite this as: BMJ 1999;318:46
  1. John Abraham, director science policy research (,
  2. Julie Sheppard, senior public affairs officerb,
  3. Tim Reed, research assistanta
  1. aDepartment of Sociology, University of Sussex, Brighton BN1 9QN
  2. bConsumers' Association, London NW1 4DF
  1. 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:

Open government is part of an effective democracy. Citizens must have adequate access to the information and analysis on which …

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