从胶囊壳铬含量超标事件看“吹哨人法案”对药品监管的启示  

Enlightenment of US Whistleblower Protection Act for Chinese Drug Administration in Context of Chromium-Tainted Capsule Incident

作　　者：钱琛[1] 陈佳[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国药事》2015年第6期563-567,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:国内现行药品监督管理机制中,很难仅仅利用政府监管机构的力量发现和杜绝违法企业蓄意隐瞒违法的生产行为。通过介绍美国"吹哨人法案"和法案规定的检举人激励与保护机制,希望对国内药品监管有借鉴意义。方法:分析2009年美国辉瑞公司巨额罚款事件中吹哨人法案与检举人起到的重要作用,探讨国内建立中国特色的吹哨人法案,在激励和保护机制下,检举人在胶囊铬含量超标事件中可能发挥的作用。结果:在吹哨人法案的保护下,违法企业内部人员可以起到协助监管的作用,提高企业违法的难度,打击企业蓄意违法的生产行为。结论:吹哨人法案或许可以对国内药品监管造成三大改进,即变道德驱使为双重驱使、变机构监管为全民监管,并节约了监管机构的人力物力成本。Objective： In the current Chinese drug administration system, it is difficult to discover and prevent manufacturers＇ frauds in illegal manufacturing activities if only using the power of governmental administrative organizations. In this article, the US Whistleblower Protection Act and the encouragement and protection regulations for whistleblowers were introduced in the hope of providing references for Chinese drug administration. Methods： By analyzing the important effect of the Whistleblower Protection Act and whistleblowers in the case of huge fine of US Pfizer in 2009, the possible role of whistleblowers was discussed in the chromium-tainted capsule incident under the system of encouragement and protection if an whistleblower protection act with Chinese characteristics was established in China. Results： With the protection of the Whistleblower Protection Act, insiders in fraud manufacturers could assist drug administration, which may raise the difficulty for the manufacturers to conduct illegal activities and crack down illegal manufacturing activities.Conclusion： The Whistleblower Protection Act may bring three improvements to Chinese drug administrative system, i.e., the transformation from moral impulse into double impulse, the transformation of organization-based administration into public-based administration, and the cost saving of manpower and material resources.

关 键 词：吹哨人法案 药品监管 铬超标胶囊 举报人激励与保护机制 违法生产行为 

分 类 号：R951[医药卫生—药学]