歐盟新興基因技術管理之發展趨勢──以基因編輯植物為中心

Trends in the Regulatory Development of New Gene Technologies in the EU: Focusing on Gene-Edited Plants

2018年7月25日歐盟法院（the Court of Justice of the European Union, CJEU）判決認為定向誘變仍屬於現行歐盟2001/18/EC指令所定基因改造生物的範圍，這個判決使歐盟科學家及研發單位與農業部門期盼落空，故而批評此判決並未顧及科技發展的現狀與未來，而且歐盟基因改造生物管理架構已不適用新興基因技術，因此要求歐盟應檢討適度調整現行基因改造生物管理制度，提供新興基因技術合適的發展空間，以維護歐盟的競爭力。
2023年執委會提出新基因技術法（new genomic techniques, NGTs）草案，將定向誘變（targeted mutagenesis）和同源基因（cisgenesis）轉殖技術且不含外源基因轉殖者視為新基因技術，並分為二類，經過驗證與傳統植物等效為第一類新基因技術，適用傳統植物管理規範，不屬於第一類新基因技術，則為第二類新基因技術，仍適用現行基因改造生物管理規範，但其風險評估與事先許可程序可緩減現行規定，並且訂定激勵措施，鼓勵研發第二類新基因技術。
執委會的提案試圖將特定新基因技術及產品賦予新的管理模式，以期能確保新基因技術產品與傳統同類產品一樣安全，同時不會帶來不必要的監管負擔。然而執委會的提案仍有許多疑慮，值得深入探討，未來歐盟對於新基因技術管理的發展趨勢，仍為國際間關注的焦點。

On July 25, 2018, the Court of Justice of the European Union (CJEU) held that Directive 2001/18/EC cannot be interpreted as excluding from its scope genetically modified organisms (GMOs) obtained by new techniques of mutagenesis which have appeared or have been mostly developed since that Directive was adopted. This judgment frustrated the expectations of EU scientists, R&D institution, and agricultural sector, they argued that it does not take into account the current status and future of scientific and technological development, and the Union GMO legislation is not suitable for regulating the deliberate release of plants obtained by certain new genomic techniques (NGTs). It calls for the EU to review and appropriately adjust the existing GMO regulatory system to provide adequate development space for new genetic technologies, thereby maintaining the competitiveness of EU.
In 2023, the European Commission proposed a regulation of NGTs, which would classify targeted mutagenesis and cisgenesis, which do not involve exogenous gene transfer, as new genetic technologies. These technologies are divided into two categories. If they are verified to be equivalent to conventionally bred plants, they fall into the first category of NGTs and are subject to any regulatory framework that applies to conventionally bred plants. All NGTs plants that are not the first category NGTs are classified as second-category NGTs, which should remain subject to the requirement of the Union GMOs legislation. However, the risk assessment and authorization procedures could be derogated, and incentives could be established to encourage the development of second-category NGTs.
The proposal of European Commission aims to establish a new regulatory model for NGTs and products, ensuring that these products are as safe as conventionally bred plants without imposing unnecessary regulatory burdens. Nevertheless, the proposal still raises many concerns and need more in-depth discussion. The future development of the EU’s NGTs regulation will continue to be a focal point of international attention.