| 關 鍵 詞： |
新冠肺炎；BNT疫苗；原廠授權書；疫苗責任免責；公私協力模式 |
| 中文摘要： |
臺灣的新冠肺炎疫情於 2021 年 5 月中爆發，但疫苗採購現貨數量不足，引起人民焦慮，民間私部門希望能夠協助政府盡快採購國際認可之新冠肺炎疫苗。疫情指揮中心一開始要求企業必須委託藥商，備齊八項文件，特別是原廠授權書，但卻無法說清楚原廠授權書之內涵。
郭台銘先生代表鴻海集團／永齡基金會，於 6 月 1 日向政府申請採購，初期卡在「原廠授權書」的問題，而沒有進展。同時，國際疫苗廠必須獲得政府給予疫苗責任豁免之保證，在政府未給予保證下，疫苗廠也不肯與民間企業洽談。到 6 月 18 日後，行政院願意公開授權鴻海／永齡與台積電，對外代表政府採購並捐贈疫苗，採取公私協力模式。最後加上慈濟，總共成功地採購到 1500 萬劑 BNT 疫苗。整個過程，引發熱烈討論，到底什麼是原廠授權書？什麼是疫苗免責？民間企業到底能不能採購疫苗？本文將透過此案例，詳細說明民間企業採購疫苗緊急授權之法律問題。
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| 英文關鍵詞： |
COVID-19；BNT vaccine；Original authorization letter；Vaccine liability exemption；Public-private partnership model |
| 英文摘要： |
The COVID-19 outbreak broke out in Taiwan in mid-May 2021, but the shortage of available vaccines has caused great anxiety among people. Private sectors hope to assist the government in purchasing internationally recognized COVID-19 vaccines as soon as possible. The Epidemic Command Center initially required the company to entrust a drug dealer, prepare eight documents, especially the original factory authorization letter, but could not clearly explain the connotation of the original factory authorization letter.
Mr. Guo Taiming. on behalf of Hon-Hai Group/Yongling Foundation, applied to the government for procurement on June 1, but was initially stuck on the issue of "original factory authorization letter11 and made no progress. At the same time, the international vaccine factory must obtain a guarantee from the government to exempt vaccine liability. Without the guarantee from the government, the vaccine factory will not negotiate with private enterprises. After June 18. the Executive Yuan announced that they were willing to publicly authorize Hon-Hai/Yongling and TSMC to procure and donate vaccines on behalf of the government, adopting a public-private partnership model. Finally, with the Tzu-Chi Foundation, a total of 15 million doses of BNT vaccine have been successfully purchased. The whole process sparked heated discussions, what exactly is an original factory authorization letter? What is a vaccine liability exemption? Can private enterprises purchase vaccines? This article will use this case to explain in detail the legal issues of emergency authorization for private enterprises to purchase vaccines.
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| 目 次： |
壹、前言
貳、大陸疫苗進口限制與原廠授權書爭議
一、禁止進口大陸疫苗及理由
二、原廠授權書之爭議
三、「原廠製造、原廠標籤、直送台灣」三原則
四、小結
參、公私協力：民間採購緊急授權疫苗與政府協助
一、疫苗採購契約中的賠償約定
二、法律上的疫苗免責架構
三、民間廠商如何讓外國疫苗廠願意簽約
四、台灣作法可改進之處
肆、結論
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