The European Court of Justice’s Decision on Genome Editing
摘要
This chapter discusses the decision of the Court of Justice of the European Union (‘CJEU’) in the case C-528/16 – Confédération paysanne et al. in which the CJEU classified organisms modified by targeted mutagenesis techniques as genetically modified organisms (‘GMOs’) under the GMO law of the European Union (‘EU’). The Court based its decision on the process-based interpretation of the GMO definition laid down in Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, highlighting that mutagenesis techniques result in genetic changes that do not occur naturally. The CJEU also ruled that targeted mutagenesis techniques do not fall under the mutagenesis exception in Annex I B of the Directive, thus falling within the Directive’s scope. This decision has sparked debate about the adequacy of the currently applicable EU GMO law, particularly in relation to genome edited organisms, and raised concerns about its potential impact on international trade and the compatibility of EU GMO law with the EU’s obligations under the law of the World Trade Organization and the Comprehensive Economic and Trade Agreement (‘CETA’) between Canada and the EU.