緊急的倫理：新型冠狀肺炎疫苗之臨床試驗及緊急授權的法制與倫理分析

Ethics of Emergency: An Anatomy of Legal and Ethical Issues of Clinical Research and Emergency Use Authorization of COVID-19 Vaccines

張兆恬(Chao-Tien Chang)

《臺大法學論叢》 50卷S期 (2021/11) Pp. 1073-1165

https://doi.org/10.6199/NTULJ.202111/SP_50.0001

摘要

新冠疫苗以前所未見的速度成為抗疫措施之一，然而其研發與審查過程也帶來管制與倫理的挑戰，本文以緊急狀態下的公衛倫理為立基加以檢視。緊急狀態下的公衛倫理，以減少傷害和保障公共衛生為目標，且容許公衛措施非必然符合最小侵害原則，但同時亦須強化決策的透明、包容、責信，以及符合平等與正義原則，並以回復常態為目標。就新冠疫苗的臨床試驗而言，雖有出現為了促進研發而容許倫理爭議的試驗方式，然而在國際實踐上，最終仍以受試者保護為優先。又就緊急授權的審查上，美國政府採取較嚴格的審查標準及程序，以回應公眾對於新冠疫苗研發縮時的疑慮。可見在疫情的緊急狀態下，個人健康與生命權的保護、程序正當性、責信更形重要，此亦與緊急公衛倫理相呼應。我國防疫法制中，向來傾向仰賴醫療與公衛專業，而以立法概括授權行政機關。惟我國國產疫苗的研發與審核，不僅涉及科學證據，更須進行政治判斷，故依據緊急的公衛倫理，應該加強決策程序的透明性、政府的責信。雖然新冠疫情可能帶來公衛與管制的新常態，但緊急的公衛倫理亦揭示須堅守核心的倫理價值。

關鍵字

新冠病毒 ； 疫苗 ； 公衛倫理 ； 公衛緊急狀態 ； 臨床試驗倫理 ； 人體研究倫理 ； 緊急授權 ； 司法院釋字第690號解釋 ； 藥事法

並列摘要

Serving as one of the major pandemic prevention measures, the COVID-19 vaccines create a new paradigm of an unprecedently efficient research and development (R&D) and review process. However, the new paradigm also brings new regulatory and ethical issues. This article examines the regulatory and ethical challenges through the lens of public health ethics in emergency (PHEE). PHEE sets alleviating harms and protecting public health as the primary concerns, while it tolerates governmental interventions not necessarily least restrictive. PHEE also highlights the decision-making process to be transparent, inclusive and accountable. In addition, equity, justice, and preparation for returning to normalcy are also the core PHEE principles. PHEE coincides with legal and ethical practices in the COVID-19 R&D and review process. In terms of the clinical research of COVID-19 vaccines, international practices remain to consider human subjects protection as the priority, regardless of calls for a loosened ethical standard for the purpose of speeding up research during the pandemic. With regards to emergency use authorization (EUA), the US government took an ＂EUA plus＂ standard, in response to public doubts about safeness and effectiveness of the vaccines invented within a condensed timeline. Echoing with PHEE, the abovementioned issues concerning COVID-19 vaccine research and EUA indicate that the protection of individual health and life, due process, and accountability are irreparable even under public health emergency. The pandemic law of Taiwan has been deferential to medical and public health expertise, that is, the legislation grants blanket authorization to the executive branch. However, the R&D and EUA of domestic vaccines of Taiwan are not simple decisions based on scientific evidence, but involve complicated political judgements. The legal and policy suggestion based on PHEE is to strengthen transparency and accountability in the decision-making process. To conclude, while COVID-19 is likely to bring a new normal to public health and regulation, PHEE urges the obligation to adhere to the core of ethics.

並列關鍵字

COVID-19 ； vaccine ； public health ethics ； public health emergency ； clinical research ethics ； human subjects ethics ； emergency use authorization ； J.Y. Interpretation No. 690 ； Pharmaceutical Affairs Act

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