從胚胎幹細胞研究到基因編輯技術的倫理法制省思

Rethinking the Ethical and Legal Implications for the Research of Embryonic Stem Cell Research Genome Editing

莊晏詞(Yen-Tzu Chuang) ； 顏上詠(Shang-Yung Yen)

《生物產業科技管理叢刊》 8卷 (2020/04) Pp. 57-73

https://doi.org/10.6170/BTMR.202004_8.0004

摘要

胚胎幹細胞的研究以及基因編輯技術所衍生的倫理與法律爭議始終不斷，諸多的討論亦難取得利益與風險之間的平衡。本文回顧相關發展提出兩部分探討說明，首先，胚胎幹細胞研究所涉及的最大倫理爭議仍在於人類胚胎使用所衍生的衝突，科學具備研究以及掌握人類發展的能力，建立中立性的準則應有助於未來生技的發展。其次，從法律規範觀點，我國如2007年「人類胚胎及胚胎幹細胞研究倫理政策指引」規範訂有胚胎取得與利用之範疇，惟當中的部分規定仍可能因為科技的變遷而有所影響；再者，從專利取得觀點，參照歐洲法院先後針對胚胎訴諸於不同的定義範疇，歐洲法院並非解決人類生命起源的問題，而是僅限於在生物科技的專利發明層面當中，判斷其道德標準應如何在商業的環境應用中達到一定的約束作用，而目前科學知識的概念將會影響法律的界線範疇應如何制定以達到安全性目的。

關鍵字

再生醫療 ； 胚胎幹細胞 ； 基因編輯

並列摘要

The research on embryonic stem cells and gene editing technology raise some ethical and legal disputes and challenges. However, it has always been difficult to achieve a real balance between risk and potential benefits, which involves the degree of openness of research, the degree of restrictions. This article reviews the past, present and future developments of embryonic stem cells and the recent controversial issues arising from gene editing technology. First, the human embryonic stem cell research is ethically and politically controversial because it involves the destruction of human embryos. Secondly, from a legal perspective, in Taiwan, the related guidelines call for special scrutiny on human embryonic stem cell research with rigorous ethical standard and define permissible and impermissible experiments. These also include the scope of embryo acquisition and utilization, but some of the provisions may still be affected by technological changes. For example, whether the research should comply with the 14-day principle. In addition, while applying to the patent application, the Court of Justice of the European Union (CJEU) has successively resorted to different definitions of embryos, it did not decide questions of ethical nature in very sensitive fields such as the definition of human embryo. Instead, it left it to the national court to determine in the light of knowledge which is sufficiently tried and tested by international medical science. In other words, it shall be conducted basing on current scientific knowledge to see whether it has the inherent capacity of developing into a human being.

並列關鍵字

Regenerative Medicine ； Embryonic Stem Cells ； Genome Editing