| 關 鍵 詞： |
藥害救濟；藥品安全；經濟社會文化權利國際公約；不倒退；健康權 |
| 中文摘要： |
自 2000 年起，臺灣施行《藥害救濟法》，旨在為正當使用合法藥品而受害的病人提供即時救濟，並促進用藥安全。本研究從健康權視角出發，探討藥害救濟制度與人權保障之間的關係，透過檔案研究法分析臺灣制度發展脈絡，並系統性檢視瑞典、德國、日本及韓國等國國家報告與國際人權規範內涵。研究發現，不同利害關係人對臺灣藥害救濟制度的法律定位存有歧異。行政機關視之為保障健康權及補救權利受損之重要政策；立法機關與藥害救濟審議委員會雖未明言健康權，其制度實踐與國際人權原則相符；司法院則將其定位為社會福利立法的一環，可能侷限其在人權保障架構下的正當性與影響力。藥害救濟制度雖非屬健康權核心義務，但其制度設計與發展確實與健康權的逐步實現密切相關，並在藥品風險預防、衛教宣導與損害救濟方面展現功能。臺灣亦為目前唯一於國家人權報告中明文將藥害救濟視為健康權措施的國家，顯示其特殊的政策立場。為確保制度發展的正當性與政策一致性，政府應進一步釐清藥害救濟在人權保障體系中的法律定位，以避免健康權詮釋與制度設計之間的矛盾。
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| 英文關鍵詞： |
drug injury relief；drug safety；International Covenant on Economic；Social and Cultural Rights；non-retrogression；right to health |
| 英文摘要： |
Since 2000, Taiwan has implemented the Drug Injury Relief Act to provide timely redress for individuals harmed by the legitimate use of approved medications and to enhance drug safety. This study examines the relationship between drug injury relief and the right to health by adopting a documentary research approach, analysing Taiwan’s legislative background and risk management policies. It also systematically reviews periodic reports submitted by Sweden, Germany, Japan, and South Korea, in light of relevant international human rights standards. The findings reveal divergent interpretations of the legal status of Taiwan’s drug injury relief system among key stakeholders. While administrative authorities regard it as a vital policy for safeguarding both the right to health and the right to remedy, legislators, and the Drug Injury Relief Review Committee, though consistent with international human rights principles, have never explicitly invoked the right to health. The Constitutional Court, on the other hand, frames the system as social welfare, potentially narrowing its scope under the human rights framework. Although drug injury relief may not constitute a core obligation under the right to health as interpreted by the Committee on Economic, Social and Cultural Rights, it nonetheless plays a significant role in progressively realising this right. In particular, the system contributes to drug safety through risk prevention, health education, and compensatory mechanisms. Taiwan is also distinctive in being the only country to explicitly frame drug injury relief as part of its national human rights reporting. In this view, the government should clarify the normative positioning of the institution within its broader human rights commitments to strengthen its legitimacy and policy coherence.
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| 目 次： |
壹、前言
貳、關於我國藥害救濟制度之歷史與檔案研究
參、以經社文權利公約視角探討藥害救濟制度
一、瑞典
二、德國
三、日本
四、南韓
五、臺灣
肆、藥害救濟之政策目的：未直接保障健康權
一、2000 年：《藥害救濟法》完成立法
二、2011、2020 年：第 13 條及第 2 條修法
三、2023 年：依時勢調整給付金額上限
四、2024 年：預告修正合法藥物之定義
伍、藥害救濟制度發展：著重風險溝通及預防
一、風險控管：Carbamazepine
二、兼顧公衛目標：Ethambutol
三、轉向事前預防：Allopurinol
四、多元管道警示用藥風險訊息
陸、討論與建議：重新思考藥害救濟法律定位
附表 1：探討藥害救濟制度之學位論文
附表 2：本研究蒐集之檔案資料表
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