| 關 鍵 詞： |
正當使用；再生醫療製劑；徵收金；藥害救濟 |
| 中文摘要： |
再生醫療由自體使用之醫療技術層面，發展為供多數異體使用之藥品製劑層面，可以節省病人經濟負擔。但是因為細胞基因來自單一個體，如果用於異體，不確定之風險即會因個人差異而增高，對於可能產生不良反應之救濟，亦應相對重視。本文依據行政院提請立法院審議之再生醫療雙法草案條文，分析其適用藥害救濟或其他救濟方式之條文問題，發現對於藥害救濟有關正當使用之條件應予釐清，並建議依風險程度分級徵收救濟金，提供給醫界及法界參考。
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| 英文關鍵詞： |
proper usage；regenerative medicine preparations；imposition pay；drug injury relief |
| 英文摘要： |
Regenerative medicines have evolved from autologous uses as a medical technology to allogeneic uses as pharmaceutical preparations, which can reduce financial burdens for patients. However the risk for cells and genes used on allogeneic bodies would be raised due to the individual differences. Corresponding attention should be paid to the relief of possible adverse reactions. Based on the drafts of Regenerative Medicine Act and the Regenerative Medicine preparation regulations that were submitted to Legislative Yuan by Executive Yuan, we analyzed the issues which were applicable for drug relief or other relief methods in this article. The conditions for drug relief of proper use were clarified to grading the imposition pay based on the level of risks, and the results were provided for the medical and legal professions.
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| 目 次： |
壹、自體細胞治療之法制發展
貳、再生醫療製劑與風險控管
參、藥害救濟之法目的及要件
肆、再生醫療製劑之救濟補償
一、再生醫療製劑之類型及適用救濟補償之機制
（一）取得藥品許可證
（二）有附款許可
（三）恩慈（人道）治療使用（compassionate use）
二、再生醫療製劑所定「指定使用」，與藥害救濟法所定「正當使用」，應釐清其關係
伍、宜依風險程度分級徵收救濟金－代結論
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