再生醫學應用相關法制之研究

再生醫療為目前全世界醫療科技趨勢，相關產業皆摩拳擦掌蓄勢待發，美國、歐洲、日本、中國等國家皆紛紛制定相關的法律來規制再生醫療。我國政策規劃上亦將其視為發展重點，但相關法規仍有缺漏，我國分別在2017年及2018年提出「細胞及基因治療產品管理法(草案)」及「再生醫療製劑管理條例(草案)」，但到現今仍未完成立法程序。再生醫療的法案，涉及醫療機構、相關產業及人民等等，影響甚深，行政機關在政策、立法規劃上應傾聽公民之意見，立法者在制定相關法案時應有通盤的考量，適時參考外國可行之法規，並將其轉化、歸化成我國可用之方式。另有鑑於各國對於生殖細胞施行基因編輯技術之禁止，因為如果對於生殖細胞進行基因編輯有極高機率會遺傳給後代，且具有高風險對於環境之影響亦有不確定性，我國在立法時亦應給予規範。

關鍵字

再生醫療；細胞治療；基因治療； CRISPR/Cas9 ；健康權；醫療權；基因隱私；基因歧視；細胞製劑；基因製劑；無過失責任

並列摘要

Regenerative medicine is the current global medical technology trend, related industries are gearing up ready to go, United States, Europe, Japan, China and other countries have all formulated relevant laws to regulate regenerative medicine. Our country’s policy planning also regards it as a development focus, but there are still gaps in relevant laws and regulations, and proposed the "Cell and Gene Therapy Product Management Law (Draft)" and "Regenerative Medical Preparations Management Regulation (Draft)" in 2017 and 2018, but the legislative process has not yet been completed. Regenerative medicine bill, involving medical institutions, related industries and the people and so on, deeply influenced, Administrative agencies should listen to citizens’ opinions on policies and legislative planning, and legislators should have overall considerations when formulating relevant bills, refer to feasible foreign laws and regulations in a timely manner, and transform and naturalize them into methods usable in our country. In addition, in view of the prohibition of gene editing technology on germ cells in various countries, there is a high probability that they will be passed on to future generations, and there is uncertainty about the impact of high risks on the environment. In our country should also regulate it when legislation.

並列關鍵字

Regenerative Medicine ； Cell therapy ； Gene therapy ； CRISPR/Cas9 ； Right to health ； Right to medical treatment ； Genetic privacy ； Genetic discrimination ； Cell therapy products ； Gene therapy medicinal products ； No-fault proposal