Lexchin J
Int J Health Serv. 1999;29(1):167-78. doi: 10.2190/RM7E-748K-K4XM-HHQP.
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.
加拿大药品监管机构——健康保护局运作缺乏透明度，这种系统性偏见严重损害了我们对该机构运作状况的了解。近年来，这种保密行为与放松管制、精简规模和私有化相结合，危及了安全性，并可能在药品使用方式上导致有害后果。最后，这些因素正威胁着健康保护局为整个药品监管体系设定优先事项的能力。本文提供了这些问题的具体实例。作者随后讨论了保密在监管审批体系中为何如此根深蒂固，并就如何解决这一问题提出了一些建议。
