台灣對於人類基因編輯的管理與法律規範研究

醫學與科學的進步，讓號稱神的領域-生命創造，逐一的揭密。其中基因與遺傳物質的研究更是漸漸興起。近幾年發展出的基因編輯，不但引發了人類治療絕症、強化身體的夢想。也帶來了無限商機。然而，基因編輯意味著用每個生物體可以讓DNA修復或具備有新的功能。但將基因片段取代也可能，創造出人類意料之外的可能性。這樣的科學新技術，將產生許多法律、人權、倫理，以及人類社會未曾有過的問題。尤其現在的法律對這些問題並未能充分解釋。而執法機關也需要專業知識與法源依據來面對這些挑戰。世界衛生組織也成立了一個基因編輯小組，用以審查人類基因編輯相關的科學、倫理與法律爭議，也建議每一個基因編輯研究必須進行登記，保持研究的透明度。然而無論怎麼管理，基因編輯都會引起倫理上的問題。除了涉及人類倫理，更包含了法律問題。以上的這一個新的領域，不再是管理自然群體中的問題，而是我們開始干預生命、創造與編輯物種，這將是我們成為法律研究人，新一代的挑戰。因此，在本研究中將試著探討國內外人類基因編輯的管理與法律規範。希望在未來的日子裡，能夠有機會貢獻一些粗淺的想法以供參考。

關鍵字

基因；基因編輯；基因治療；複製人；人造組織與器官；生物技術管制配合架構

並列摘要

Advances in medicine and science have opened up the realm of life called life creation, one by one. Among them, the study of genes and genetic materials is gradually emerging. The gene editing developed in recent years has not only triggered the human dream of treating terminal illness and strengthening the body. It also brings unlimited business opportunities. However, gene editing means that each organism can make DNA repair or have new functions. But replacing gene fragments is also possible, creating unexpected possibilities for humans. Such new science and technology will generate many laws, human rights, ethics, and problems that have never been encountered in human society. In particular, the current law does not fully explain these issues. Law enforcement agencies also need expertise and legal basis to face these challenges. The World Health Organization（WHO）has also set up a gene editing team to review scientific, ethical, and legal disputes related to human gene editing. It also recommends that every gene editing study be registered to maintain research transparency. Regardless of how it is managed, however, gene editing raises ethical issues. In addition to human ethics, it also includes legal issues. This new field above is no longer a problem of managing natural groups, but that we begin to interfere in life, create and edit species, and this will be a challenge for us to become a new generation of legal researchers. Therefore, in this study, we will try to explore the management and legal norms of human gene editing at home and abroad. I hope that in the future, I will have the opportunity to contribute some superficial ideas for reference.