Callréus Torbjörn
Research Unit of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark, Odense, Denmark.
Drug Saf. 2005;28(6):465-71. doi: 10.2165/00002018-200528060-00001.
Although it is often vigorously contested and has several different formulations, the precautionary principle has in recent decades guided environmental policy making in the face of scientific uncertainty. Originating from a criticism of traditional risk assessment, the key element of the precautionary principle is the justification for acting in the face of uncertain knowledge about risks. In the light of its growing invocation in various areas that are related to public health and recently in relation to drug safety issues, this article presents an introductory review of the main elements of the precautionary principle and some arguments conveyed by its advocates and opponents. A comparison of the characteristics of pharmaceutical risk management and environmental policy making (i.e. the setting within which the precautionary principle evolved), indicates that several important differences exist. If believed to be of relevance, in order to avoid arbitrary and unpredictable decision making, both the interpretation and possible application of the precautionary principle need to be adapted to the conditions of pharmaceutical risk management.
尽管预防性原则常常备受激烈争议且有多种不同的表述形式，但在近几十年里，面对科学上的不确定性时，它一直指导着环境政策的制定。预防性原则源于对传统风险评估的批判，其关键要素是在对风险缺乏确定认知的情况下采取行动的正当理由。鉴于该原则在与公共卫生相关的各个领域以及近期在药物安全问题方面被越来越多地援引，本文对预防性原则的主要要素以及其支持者和反对者提出的一些观点进行了初步综述。对药品风险管理与环境政策制定（即预防性原则得以发展的背景）的特征进行比较后发现，存在若干重要差异。如果认为这些差异具有相关性，为避免任意和不可预测的决策，预防性原则的解释和可能的应用都需要根据药品风险管理的情况进行调整。
