緊急使用授權之「緊急」──從美國法上觀察我國法制之修正建議

Interpretation of“Emergency”in EUA—Proposed Amendments to Relevant Taiwan Laws Based on an Observation of the U.S. FD&C Act

緊急使用授權之「緊急」應如何解釋及適用，於此次嚴重特殊傳染性肺炎疫情衍生諸多問題。本文由常態法制下之緊急情況立法所面臨之問題及解決方式切入，詳論緊急使用授權法理依據應係基本權保護義務，詳述基本權保護義務之保護範圍於緊急使用授權之特殊性，及其與保護規範目的理論之關係，並對我國實務見解予以評析。其次，整理美國法與我國學說對於緊急使用授權之定義、範圍，同時提出本文之見解。
末者，將進一步探究藥事法第48條之2及醫療器材管理法第35條「因應緊急公共衛生情事」此一要件之解釋，並輔以美國法上緊急使用授權（Emergency Use Authorization）之緊急宣告（EUA Declaraion）制度觀察，檢視我國法上之要件規範是否符合法律明確性的基本要求，並借鏡美國法上相關規定，分別就緊急事由及其內涵、緊急公共衛生情事程序控制等事項的規範再細緻化，以作為我國法制日後精進之依歸。

The interpretation and applicability of“emergency”in Emergency Use Authorization (EUA) have given rise to a number of issues during the still-raging COVID pandemic. Targeted at issues arising from emergency legislation in a normal legal system and solutions thereto, this paper elaborates on the protection obligation function of fundamental rights as legal basis of EUA, the particularity of its protection scope when being applicable to EUA, and its relations with the theory of protection norms. Based thereon, this paper provides an analysis of varying“emergency”related opinions in practice in Taiwan. The opinions in this paper are derived from a comparison of EUA in Taiwan and the U.S. in terms of its definition and scope.
This paper further explores interpretations of the element“the necessity of responding to emergency public health circumstances”set out in Article 48.2 of the Pharmaceutical Affairs Act and Article 35 of the Medical Devices Act, and then looks into whether EUA-related laws/regulations in Taiwan comply with the intelligible principle based on the aforesaid interpretations in combination with an observation of EUA Declarations required for issuance of an EUA in the U.S. Additionally, by referencing pertinent provisions in the U.S. laws, the author provides detailed analysis and comments on regulations governing emergencies and definitions thereof as well as process control of emergency public health circumstances, so as to serve as basis for improvements of Taiwan’s legal system in the future.