论药品不良反应强制报告法律制度

我国目前在药品不良反应报告制度方面存在着药品不良反应报告的数量少、质量不高、有的单位不重视药品不良反应和监测工作以及严重药品不良反应事件频发等突出问题,危害人民群众的用药安全。其中重要的原因是我国未建立起药品不良反应强制报告法律制度。药品不良反应强制报告法律制度是指境内的药品生产企业、药品经营企业、医疗卫生机构及医务人员,必须向国家(食品)药品监督管理部门报告其所发现、发生的药品不良反应及事件,否则应负法律责任,国家支持和鼓励相关单位和个人报告药品不良反应。我国应当尽快建立药品不良反应强制报告法律制度,并改革和完善相应的法律规定和奖惩措施。

Discussion for the legal system of adverse reactions mandary reporting

At present,there are problems such as lack of reported cases and low quality of the reports,little importance attached by some organizations to the drug adverse reactions and their control,and frequent occurrences of severe drug adverse reactions,etc.in the drug adverse reactions reporting,and threaten the drug safety of people.The main cause of those problems was that no legal system of adverse reactions mandary reporting was established in our country.The legal system of adverse reactions mandary reporting means that the domestic pharmaceutical manufacturers,trade enterprises,medical organizations and the medical staff must report the drug adverse reactions they found to the food and drug administration authorities and otherwise take the legal resposibility of failure to report,and the government support and encourage the organizations and person to report the drug adverse reactions.The legal system of adverse reactions mandary reporting should be established in our country as soon as possible,and the related legal regulations and measures of reward and punishment should be reformed and improved.