交大法學評論 (Sep 2021)
基因編輯技術對歐盟基因 改造生物管理之挑戰 The Challenge of Gene Editing Technology for EU Genetically Modified Organisms Regulation
Abstract
基因編輯技術（gene editing）是 21 世紀生物科技的重大進展，新育種技術即是運用基因編輯技術，精準誘發基因突變開發新品種，相較傳統的育種技術，更為快速且成本低廉，提升產量緩解糧食不足的危機，對於人類及環境永續發展帶來重大利益，然而，國際間對於基因編輯技術之管理仍未有定論，實則與基因改造生物（genetically modified organisms, GMOs）之管理策略有關，採產品導向模式的國家可能認為無須特別訂定相關管理的政策，而採製程導向模式的國家可能認為應以 GMOs 加以管制。對於 GMOs 一向採取嚴格管制的歐盟，在歐盟法院裁決利用基因編輯技術產生誘變的育種技術仍屬 GMOs，雖為基因編輯技術以及其產品屬性予以定位，卻造成新興科技發展與相關產業的衝擊，引發新一波的基因技術的爭論，歐盟理事會也要求執委會提出一份關於利用基因編輯技術與傳統技術產生誘變的評估報告。未來對於基因編輯技術及其產品之合理管理政策的發展，仍值得持續關注。 Gene editing is a major advancement of biotechnology in the 21st century. Compared with conventional breeding technologies, gene editing technology is more effective and precise. This new breeding technology not only improves the yield and nutritional value of crops, but also offer the resolutions for food security. However, many countries are struggling with the regulatory status of this new technology; one of major concerns is related with the strategies of genetically modified organisms. Some countries, represented by the United States, regulating GM crops on a product-basis, will think that there is no necessity to establish relevant regulation or policies for genome-edited crops; others, including EU member states, adopting process-based GM crop regulations, may regard the products obtained by using gene editing technology as GMOs, and these products should need a more rigorous risk assessment throughout the process of GM crop development. Recently, the Court of Justice of the European Union ruled that the organisms obtained by using gene editing technology to generate mutations are regarded as GMOs. The ruling marked the next round of the dispute around the genetic engineering in Europe. The European Council requested the European Committee to submit an evaluation report between the new breeding technologies and conventional breeding technologies in this year. In the future, we look forward to the development of reasonable regulation for gene editing technology and its products.
