Systemic bias in the form of a lack of transparency in the operation of the Canadian drug regulatory agency, the Health Protection Branch, seriously undermines our knowledge of how well the agency is functioning. In recent years this secrecy has combined with deregulation, downsizing, and privatization to compromise safety and could lead to deleterious consequences in the way that drugs are being used. Finally, these forces are threatening the ability of the Health Protection Branch to set priorities for the overall system of drug regulation. This article provides concrete examples of each of these problems. The author then discusses why secrecy is so firmly entrenched in the regulatory approval system, and offers some suggestions on how to tackle this issue.
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