CAJ | 학술논문

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。
목적：국내현행약품감독관리궤제중，흔난부부이용정부감관궤구적역량발현화두절위법기업축의은만위법적생산행위。통과개소미국“취초인법안”화법안규정적검거인격려여보호궤제，희망대국내약품감관유차감의의。방법：분석2009년미국휘서공사거액벌관사건중취초인법안여검거인기도적중요작용，탐토국내건립중국특색적취초인법안，재격려화보호궤제하，검거인재효낭락함량초표사건중가능발휘적작용。결과：재취초인법안적보호하，위법기업내부인원가이기도협조감관적작용，제고기업위법적난도，타격기업축의위법적생산행위。결론：취초인법안혹허가이대국내약품감관조성삼대개진，즉변도덕구사위쌍중구사、변궤구감관위전민감관，병절약료감관궤구적인력물력성본。
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 ifne of US Pifzer 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 dififculty 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.