我國緊急使用授權法制分析與再建構—以Covid-19疫苗為中心

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題名:	我國緊急使用授權法制分析與再建構—以Covid-19疫苗為中心 The Analysis and Reconsolidation of Emergency Use Authorization in Taiwan — Focus on Covid-19 Vaccine
作者:	何政龍 HE, CHENG-LUNG
貢獻者:	藥學系臨床藥學碩士在職專班張偉嶠吳全峰
關鍵詞:	緊急使用授權;藥品近用權;法律管制密度;藥事法第 48 條之 2;特定藥品專案核准製造及輸入辦法 emergency use authorization;right of access medicine;density of legal control;Pharmaceutical Affairs Act article 48-2;Regulations for Approval of Specific Medicinal Products' Manufacturing or Importing as a Special Case
日期:	2024-07-15
上傳時間:	2024-09-11 19:16:54 (UTC+8)
摘要:	研究背景:2019 年新冠疫情爆發，為因應此現象，藥廠除研發以治療為導向的藥品之外，更積極針對病原體進行以預防為目的之疫苗研發，而衛生單位也為此情況提供了更為簡易的行政流程，以達到快速合法使用藥品及疫苗的目的。然而在此過程中，因不同於以往正規的藥品許可證制度，快速的研發及簡易的行政流程，產生了些許爭議，包括緊急使用授權的法源、申請程序、評估標準、退場機制及資訊公開等。研究方法:本研究分析相關過往文獻，並比較美國、歐盟、日本及我國相關法律制度，主要討論三個區塊，分別為法源、實質要件以及程序要件，利用法律管制密度及藥品近用權保障為分析指標，分析後進行加總，並歸入所屬象限中。研究結果:我國法律管制密度為負向，藥品近用權為正向，為第二象限。美國法律管制密度為正向，藥品近用權為正向，為第一象限。歐盟法律管制密度為正向，藥品近用權為正向，為第一象限，日本(初)法律管制密度為負向，藥品近用權為負向，為第三象限。日本(後)法律管制密度為負向，藥品近用權為正向，為第二象限。研究結論:我國在法律管制密度及藥品近用權的保障，仍然有進步的空間，本研究提出修法建議，期待緊急使用授權制度能夠更加保障人民藥品近用權。 Background: The COVID-19 epidemic broke out in 2019. In response to this phenomenon, pharmaceutical companies, in addition to developing treatment-oriented drugs, are also actively developing vaccines for prevention against pathogens. Health units have also provided simpler methods for this situation. Administrative procedures to achieve rapid and legal use of medicines and vaccines. However, during this process, due to the rapid research and development and simple administrative procedures that were different from the previous formal drug licensing system, some disputes arose, including the legal source of emergency use authorization, application procedures, evaluation standards, exit mechanisms and information disclosure. Methods: This study analyzes relevant past literature and compares the relevant legal systems of the United States, the European Union, Japan and Republic of China. It mainly discusses three areas, legal sources, substantive elements and procedural elements. It uses the density of legal control and the right of drug access as the analysis Indicators are summed up after analysis and classified into their respective quadrants. Results: The density of legal control in our country is negative, and the right to access medicine is positive, which is the second quadrant. The density of legal control in the United States and EU are positive, and the right to access medicine are positive, which are the first quadrant. The density of legal control in Japan (initial) is negative, and the right to access medicine is negative, and it is the third quadrant. Japan's (later) legal control density is negative, and the right to access drugs is positive, which is the second quadrant. Conclusions: Our country still has room for improvement in legal control and the right of access medicine. This study puts forward suggestions for amending the law and hopes that the emergency use authorization system can better protect the people's access to medicines.
描述:	碩士指導教授：張偉嶠共同指導教授：吳全峰口試委員：賴嘉鎮口試委員：郭俊男口試委員：李伯璋口試委員：張偉嶠口試委員：吳全峰
資料類型:	thesis
顯示於類別:	[藥學系] 博碩士論文

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