台灣藥害救濟制度與健康人權

Abstract

台灣於2000年訂定施行《藥害救濟法》，主要為正當使用合法藥物而受害者，提供及時救濟，維護病人用藥安全。健康權作為基本人權之一，本研究由國際健康人權法源中所提健康權的原則、國家報告等文獻，為探詢藥害救濟與健康人權關係之出發點，闡述與分析國際人權法、實施藥害救濟制度之國家報告，釐清藥害救濟制度是否為人權的核心保障範圍；其次，置於台灣時空背景，透過理解藥害救濟制度設計之初、立法變革、藥品風險管控、釋字第767號解釋等重要事件影響，分析藥害救濟制度是否符合國際法中關於健康人權保障之原則。 研究結果發現，本文由行政機關、立法者、大法官（司法）、藥害救濟審議委員會等與藥害救濟制度相關之角度，探析處於不同位置的利害關係人，對於藥害救濟於健康人權之定位，綜整發現行政機關主觀地將藥害救濟制度，視為國內保障人民健康權的人權政策及政績。而再由立法者、主管藥品機關、藥害救濟審議委員會等角度觀之，其精神與意旨與國際人權原則不謀而合，然並未提及「健康權」一詞。最後，從大法官意見書也發現有類似見解，且大部分大法官更直接認為《藥害救濟法》為「福利性立法」，可見不同利害關係人所詮釋之台灣藥害救濟制度定位，有不一致之處。 研究討論及未來政策建議，建議政府需要重新審慎評估，是否要繼續將藥害救濟制度當作「人權政績」來宣揚，或需定義健康權之性質、內涵及保障範圍後，再進一步確認藥害救濟制度於其中之定位，以避免產生不必要的誤解。另建議，政府未來可依社會情況適時調整藥害救濟之制度設計，並將就醫用藥識能延伸於健康權衛教的推廣。

In 2000, Taiwan enacted the Drug Relief Act to provide timely relief for individuals who suffered harm due to the legitimate use of drugs, aiming to safeguard patient medication safety. As the right to health constitutes a fundamental human right, this study explores the relationship between drug relief and the right to health. Drawing from principles outlined in international human rights law, this research collects and analyzes state reports on the implementation of drug relief systems. It also clarifies whether drug relief falls within the core scope of human rights protection. Subsequently, within the context of Taiwan''s temporal and spatial background, the study examines significant events such as the initial design of the drug relief system, legislative changes, pharmaceutical risk management, and the impact of Constitutional Interpretation No. 767. It assesses whether the drug relief system aligns with principles of ‘health and human rights’ under international law. Drawing on the perspectives of administrative agencies, the legislator, the judiciary, and the Drug Relief Review Committee, the findings reveal stakeholders of different positions. It explores their perspectives on the positioning of drug relief concerning the right to health. The study concludes that administrative agencies subjectively regard the drug relief system as a human rights policy and achievement in safeguarding the people''s right to health. However, from the perspectives of legislators, drug regulatory authorities, and the Drug Relief Review Committee, the spirit and intent of the system align with international human rights principles, albeit without explicitly mentioning the term “the right to health.” Finally, insights from the opinions of the grand justices also reveal similar views, with a majority directly considering the Drug Relief Act as a “welfare law,” indicating inconsistencies in the interpretation of the positioning of Taiwan''s drug relief system among different stakeholders. The discussion and the future policy recommendations suggest that the government aims for a unified stance among administrative, legislative, and judicial bodies. The government should reconsider whether to continue promoting the drug relief system as a “human rights achievement” or define the nature, content, and scope of protecting the right to health. Adjustments to the design of the drug relief system, considering societal circumstances, are also recommended. Additionally, extending health literacy to health rights education is proposed for future government initiatives.