药品缺陷概念研究

Research on Conception of Drug Defects

药品标准属于国家强制性标准,但药品没有国家或者行业的安全标准,故国家药品标准不是认定药品缺陷的充分和必要条件。药品缺陷分为研究缺陷、生产缺陷、警示缺陷、经营使用缺陷。药品缺陷具有可变性、普遍性。从医学伦理出发,应该减轻原告的举证责任,加强被告就所生产、经营、使用药品不存在缺陷的举证责任。

Drug standard should be state mandatory standard, but there is not drug safety standard in the level of administration and manufacturer in China. The state drug standard is not the sufficient and necessary condition to conclude drug defects. Drug defects consist of research defects, manufacture defects, warning defects and management defects. Drug defects possess changeability and universality. In terms of medicine ethics, it is appropriate to ease burden of proof for plaintiff and strengthen the responsibility for defendant in the cases relating with drug defects.