基因编辑技术对欧盟基因改造生物管理之挑战

Abstract

基因编辑技术（ gene editing）是 21 世纪生物科技的重大进展，新育种技术即是运用基因编辑技术，精准诱发基因突变开发新品种，相较传统的育种技术，更为快速且成本低廉，提升产量缓解粮食不足的危机，对于人类及环境永续发展带来重大利益，然而，国际间对于基因编辑技术之管理仍未有定论，实则与基因改造生物（ genetically modified organisms, GMOs）之管理策略有关，采产品导向模式的国家可能认为无须特别订定相关管理的政策，而采制程导向模式的国家可能认为应以 GMOs 加以管制。对于 GMOs 一向采取严格管制的欧盟，在欧盟法院裁决利用基因编辑技术产生诱变的育种技术仍属 GMOs，虽为基因编辑技术以及其产品属性予以定位，却造成新兴科技发展与相关产业的冲击，引发新一波的基因技术的争论，欧盟理事会也要求执委会提出一份关于利用基因编辑技术与传统技术产生诱变的评估报告。未来对于基因编辑技术及其产品之合理管理政策的发展，仍值得持续关注。

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.