山东济南非法经营疫苗系列案件解析及启示

The analysis and enlightenment on the series cases of illegal supply of vaccine in Ji'nan of Shandong

目的深入分析我国第二类疫苗经营和使用监管的现状及存在的问题,为加强第二类疫苗监管提供建议。方法采用文献研究的方法,全面回顾山东非法疫苗案的整个过程及调查结果。结果与结论我国疫苗监管体系总体上是安全可信的,但是第二类疫苗购销渠道复杂、监管任务艰巨、监管力量缺乏,加之监管责任不落实和个别监管官员不履职等原因,导致第二类疫苗经营秩序的混乱。可采取简化疫苗购销渠道的方法加强部门间的沟通合作;加强基层药监队伍建设,落实疫苗监管责任、督促官员履职;加大对违法行为的处罚力度;加强诚信建设与监管,正确发挥新闻媒体的舆论监督与指导作用等措施,有效解决上述问题,确保公众健康,恢复公众对中国疫苗监管体系的信任。

Objective This paper analyzed the current supervision situation and problems in the process of supply and use of vaccines,then provided useful suggestions to strengthen the supervision of vaccines.Methods Literature research was used to comprehensive reviewthe process and results of the series cases of illegal supply of vaccines in Shandong. Results and Conclusions The vaccine regulatory system in China is generally safe and reliable. Due to the complexity of the marketing channels of second types of vaccines,the arduous regulatory tasks,the lack of supervisor and other factors,coupled with the regulatory responsibility was not implemented and some regulators did not fulfill their duties,the chaotic business order of the second type of vaccines was formed. The following measures should be used to solve these problems,such as simplify vaccine purchasing and marketing channels,strengthen communication and cooperation between the relevant departments,strengthen the construction of the basic drug regulatory team,implementation of vaccine regulatory responsibility,urge officials to perform their duties,increase penalties for violations of law,strengthen the construction and supervision of the integrity,correctly play the role of news media supervision and guidance of public opinion,and so on. to ensure the public health and restore public confidence on the Chinese vaccine regulatory system.