An ISDB survey to assess the degree of transparency of drug regulatory agencies

Issue title: Secrecy in Drug Regulation

Article type: Research Article

Authors: Bardelay, Danielle^;

Affiliations: La revue Prescrire, BP 459, 75527 Paris Cedex 11, France. Tel.: +33 01 4700 94 45; Fax: +33 01 48 0787 32

Note: [] ISDB: International Society of Drug Bulletins.

Abstract: Members and correspondents of the International Society of Drug Bulletins (ISDB) from 23 countries responded to a questionnaire assessing the degree of transparency of their national Drug Regulatory Agency (DRA). The access to unpublished data on drug efficacy, safety or utilisation appears to vary enormously among the selected countries. The majority of DRAs provide little information on new drugs (or on new therapeutic indications for older drugs) and less on drug side effects, even when this is specifically requested. In particular many agencies still do not explain or justify their decisions in these fields. There are however a few countries, such as the United States or Sweden, which have more transparent agencies which provide detailed on-line information. A number of countries are presently moving towards increased openness, either taking the opportunity of a new legal framework for drug regulation (as for example in South Africa or in a few Eastern European countries), or through the introduction of Freedom of Information legislation (as in Japan). A second stage of the survey is being developed in order to examine these developments more closely and to compare the legal situation in more detail. During this second stage the number of participants will be increased and this will help to minimise interpretation bias.

DOI: 10.3233/JRS-1996-9304

Journal: International Journal of Risk and Safety in Medicine, vol. 9, no. 3, pp. 151-155, 1996