緊急情況下核准使用醫藥品與民事免責

Approval of Pharmaceutical for Reason of Emergency, and Immunity from Tort Liability

楊智傑(Chih-Chieh Yang) ； 張家維(Chia-Wei Chang)

《生物產業科技管理叢刊》 5卷2期 (2016/03) Pp. 35-58

https://doi.org/10.6170/2016.5(2).02

摘要

2005年，美國國會通過「公共緊急事態準備法」（the Public Readiness andEmergency Preparedness Act, PREPA），對醫療對抗措施提供侵權責任豁免。該法案之目的在於保護醫藥產業不受大量訴訟追訴，以確保緊急事態下，各式對抗疾病之對策能夠被採用，對抗各種疾病大流行之發生，且能讓藥品製造商願意隨時開生、生產、供應藥品與疫苗。我國傳染病防治法第51條規定：「中央主管機關於傳染病發生或有發生之虞時，得緊急專案採購藥品、器材，惟應於半年內補齊相關文件並完成檢驗（第1項）。無法辦理前項作業程序，又無其它藥品可替代者，中央主管機關得例外開放之，並向民眾說明相關風險（第2項）。」類似美國「公共緊急事態準備法」之制度，在緊急情況下，可以先通過藥品上市，但須向民眾說明風險。不過有一不同之處在於，傳染病防治法並沒有明確免除藥品供應商的民事賠償責任。

關鍵字

美國「公共緊急事態準備法」 ； 傳染病防治法 ； 救濟補償制度 ； 民事免責

並列摘要

In December 2005, U.S. Congress enacted the Public Readiness and Emergency Preparedness Act （PREPA）. PREPA provides immunity from tort liability to individuals and entities involved in the development, distribution, and administration of certain biodefense and pandemic countermeasures to ensure preparedness in the case of a public health emergency. PREPA extends well beyond the scope of emergency preparedness and provides unprecedented liability protection to pharmaceutical manufacturers and other covered entities. There is similar provision in Taiwan. Article 51 of Taiwan's Communicable Disease Control Act provided that: ＂When communicable diseases occur or are expected to occur, the central competent authority, for the reason of emergency, may procure pharmaceuticals and equipment...If the operating procedures in the preceding paragraph cannot be fulfilled or other alternative pharmaceuticals are unavailable, the central competent authority may make exceptions and explain the risks associated with the product to the general public.＂ But the difference is that there is no provision about liability immunity for pharmaceutical manufacturers.

並列關鍵字

Public Readiness and Emergency Preparedness Act (PREPA) ； Communicable Disease Control Act ； No-fault compensation scheme ； Immunity from Tort Liability