药品不良反应的法律定性及其后果的救济

药品不良反应致人损害的救济是我国法律规制的盲区。药品不良反应类型包括药品常见且可预期的不良反应、常见且可预期之外的不良反应以及特异体质型药物过敏反应。其中,常见且可预期之外的不良反应对药品使用者而言应属不合理的危险,也即药品本身存在缺陷,消费者因此遭受损害理应得到法律救济。另外,对遭受特异体质型药物过敏反应的受害者则应从社会补偿的角度给予考虑,而不应让其独自承担不幸。

On the legal nature and remedy of drug side effects.

There is no lawful remedy in our country when drug side effects happen to users and cause body damage. The category of side effects includes frequent side effects, unexpected side effects and drug allergy response to idiosyncrasy. Among them, unexpected side effects of drug should belong to unreasonable danger, namely drug has defect. Consumers should get lawful remedy if they are damaged by taking defective drug. In addition, for idiosyncratic damage caused by drug allergic response, the victims should get relief from society, should not bear burden alone.