基因編輯產品管理法規之研究──兼論我國之因應策略

A Study on the Regulatory Framework for Gene Editing Products: Discussing the Feasible Strategies of Taiwan

近年來基因編輯技術的發展迅速，成為許多科學家及企業家關注的焦點，一躍成為炙手可熱的明日之星。基因編輯技術應用於農業技術上，有助於開發植物新性狀，可以因應生物及非生物壓力的挑戰，亦能提高農作物產量、營養成分及收穫後儲藏能力，解決氣候變遷與糧食危機的隱患，促進環境生態及生物多樣性的維護，有助達成永續發展的目標。
由於基因編輯產品可能與傳統作物或基因改造生物難以區別，因此如何管理基因編輯產品，給世界各國主管機關帶來新的考驗，不同的管理模式源自於不同的經濟、社會和政治先決條件，本文分析目前國際間已建立或正在建立的基因編輯產品管理的法規制度，借鏡其他國家的作法，探討最佳實踐的管理模式應有的要件，同時一併探討我國現行基因改造生物的管理制度是否適合管理基因編輯產品，以及分析我國應該採取何種措施以因應未來的挑戰。對於基因編輯產品管理的議題方興未艾，也是未來國際間最重要的新課題之一。

In recent years, gene editing technology has advanced rapidly, becoming a focal point for many scientists and entrepreneurs. It has quickly emerged as a hot topic and a promising area for the future. In agriculture, gene editing can be used to develop new plant traits that enhance resistance to biotic and abiotic stresses, improve crop yields, increase nutritional content, and extend post-harvest storage life. This technology offers potential solutions to the challenges posed by climate change and food insecurity, while also promoting environmental sustainability, ecological balance, and biodiversity conservation. Ultimately, it contributes to the achievement of the Sustainable Development Goals.
Due to the difficulty in distinguishing gene-edited products from conventional crops and genetically modified organisms, regulating such products presents new challenges for competent authorities worldwide. Different regulatory models have emerged in response to varying economic, social, and political contexts. This article analyzes the regulatory frameworks for gene-edited products that have been established or are currently under development in various countries. By examining from the strengths of different international approaches, we propose the essential elements of a best-practice regulatory model for gene-edited products. Furthermore, this article evaluates whether our country’s existing regulatory system for genetically modified foods is adequate for overseeing gene-edited products and explores the measures that should be adopted to address future challenges. As regulation in this area remains in its early stages, the governance of gene-edited products represents one of the most pressing and emerging global issues.