药品说明缺陷的法律分析

Legal analysis of Drug Instruction Defects

文章根据产品责任法理论阐述了药品缺陷的含义以及我国对药品说明的有关规定;并根据药品的特殊性,深入分析了药品说明缺陷的判断因素,以及认定药品说明缺陷的注意问题,有助于药品生产者、经营者、医师、药师等在产品和医疗服务中规范行事。提出在司法实践中,要确认生产者、销售者或医师是否存在说明缺陷,应对药品的说明对象、说明方式以及说明时间、说明的充分性以及对明显或众所周知的危险进行警告等方面进行综合考虑评估。

In accordance with the theories of products liability law, the author clarify the definition of drug defect and relevant stipulations on drug instruction in China. Taking the medical particularity into consideration, the author penetrates into the factors to judge the drug instruction defects and some matters for attention while cognising the drug instruction defects, in order to help drug manufacturers, drug operators, physicians and apothecaries to standardize their products and medical service. It is advocated that, in judicial practice, comprehensive appraisal shall be carried out in many aspects, e.g. who to instruct, how and when, sufficiency, warning the obvious and well-known dangers, etc. in this way, to confirm the instruction defects by drug manufacturers, distributors or physicians.