生物科技已經革命性地改變現代人的生活。其中，基因治療與基因疫苗相較於傳統醫療之效果，雖然其技術仍處於起始階段，在醫療行為之實行與影響上，尚須待吾人學習與了解。然而就基因治療在治療效果難為人理解，與可能帶來不可預知之結果並且對人體有無法回復之作用角度觀之，確實釐清醫療施用者與受術者關係與應遵守之相關程序及責任有其重要性。本文試以規範之角度探討何謂基因治療與基因疫苗？醫療行為施用者與受術者問之法律關係？現行法規、命令等，包括民法契約、侵權行為規定與消費者保護法、醫療法及衛生署公布之「基因治療人體試驗申請與操作規範」業己對基因治療定義作調整後適用之問題，特別係已於九十二年一月二十二日修正之消費者保護法，及九十三年四月二十八日修正之醫療法等，後者是否為特別規定，將排除消保法如何之適用內容，本文亦將自立法及文義、體系分別討論。 　　法律上，祇要是利用基因或含有基因之細胞，輸入人體之內，不論其於人體之作用或表現於技術層面方式為何，均應適用操作規範之治療原則、安全確認及申請程序，以保障受術者之權益。並落實醫療人員之告知義務、充實告知內容及延續至實施治療之過程o而基因疫苗為製劑亦應適用藥物相關規定為適當，有民法第一百九十一條之一、消保法及藥害救濟法之責任。

　　Biotechnology has revolutionized modem life. Gene therapy and genetic vaccine are two of the major medical achievements with the effect that traditional medical treatment may not perform. However, the operation of gene therapy and genetic vaccine is still in its infancy, and much has to be learned about its performance and effectiveness. It is hard to comprehend the gene therapy, because we do not know how it really be used and effects? And may it carry unforeseeable consequences, which may have serve and unrecoverable physical impacts to human body. This article is struggling to understand what Gene therapy and genetic vaccine are? What kind of relationships betweem the medical treatment providers and acceptors? The applicable legislation, regulation, including Contract Law, Torts, Consumer Protection Law, Medical Treatment Law and relevant legal statements will also be identified and highlights of the results for Gene Therapy.