臺美醫藥緊急使用授權法制分析與比較

Emergency Use Authorization Regulations:A Comparative Study

我國二○一五年修正《藥事法》時增訂第48條之2，引進緊急使用授權（Emergency Use Authorization, EUA）機制，允許主管機關專案核准特定藥物之製造或輸入，利用未經批准或查驗登記許可的醫療產品或方法，診斷、治療或預防公共衛生緊急事件，且在二○ 二一年實施的《醫療器材管理法》第35條中同樣設有類似機制。然而，我國對緊急使用授權規範之縝密性和各類補充性指導及原則卻明顯匱乏，對於緊急使用授權之發動以及產品責任承擔等問題亦缺乏明確規範。本文擬透過比較法研究，對美國緊急使用授權制度進行分析及介紹，並與我國緊急使用授權規範比較後，對我國緊急使用授權制度規範提出剖析與建議，強化我國因應公共衛生緊急事件之法制建構。

During the COVID-19 pandemic, countries initiated the Emergency Use Authorization (EUA) to supply medical countermeasures (MCMs) onto the market without going through the complete FDA approval process. As a mechanism used in exceptional circumstances, EUA raises complex legal challenges among stakeholders over concerns such as issuance procedures, legal authority, product liability, etc. Like the U.S. EUA regulations under FDC&A, Taiwan’s pharmaceutical regulations also provide a EUA fast track procedures to supply necessary MCMs in response to the public health emergency under article 48-2 of the Pharmaceutical Affairs Act and article 35 of the Medical Devices Act. The Taiwanese government may also authorize the production, importation, and/or use of unapproved pharmaceuticals and medical products following the rules further supplemented by the ‘Regulations for Approval of Specific Medical Products’ Manufacturing or Importing as a Special Case.’ This article compares and assesses the EUA regulations in the U.S. and Taiwan through the lens of comparative study and shall address the normative lacunae in Taiwan’s EUA rules. Policy and legislative suggestions will also be provided to improve Taiwan EUA regulations.