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由2009年H1N1論因應公共衛生緊急情況行政管制架構─以風險管理理論與行政法原理原則為核心
Thesis

由2009年H1N1論因應公共衛生緊急情況行政管制架構─以風險管理理論與行政法原理原則為核心

曾方盈
Masters, 國立清華大學, 科技法律研究所
2010

Abstract

H1N1 風險管理 預防原則 EUA 法律保留 法律明確性 H1N1 Risk Management Precautionary Principal Emergency Use Authorization (EUA) Principle of Law Reservation Principle of Explicitness
The traditional regulation of public health has been changed due to globalization and the improvement of transportation systems. In the past, contagious diseases were more likely to be limited within a region, but now they can be spread widely around the world, shockingly fast. The H1N1 in 2009, for example, only took six weeks to become a global epidemic, since the first H1N1 case was discovered. Due to the high mortality rate of H1N1, governments took H1N1 seriously, including Taiwan. This paper aims to discuss the disputes about the process of preventing H1N1 in Taiwan. First, this paper framed the regulation of traditional theories by the risk management theory and the precautionary principal. By expanding the Precautionary Principal, policy makers can make temporary decisions in situations when extensive scientific knowledge on the measures and the damage of the risk is lacking. The EUA system in the U.S.A. proved that this new kind of precautionary principal not only can be implemented in practice, but also can be used in an emergency situation. . By issuing EUA, FDA can authorize the use of unapproved drugs during a declared emergency in order to subdue the epidemic. Second, this paper would examine whether the regulation of H1N1 in Taiwan in 2009 could correspond with the logic of risk management theory; by using the principle of law reservation and the principle of explicitness in administrative law, this paper would also examine the legitimacy and legality of the administrative means used by the competent authorities in Taiwan. In the concluding chapter, based on the analysis results of the risk management and the principal of administrative law, this paper would propose the amendment of current regulatory system in Taiwan.

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