| 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. |
