New Genomic Techniques in Europe: Perspectives on the European Commission’s Policy Initiative Concerning the Regulation of NGTs in the EU

The European Union has long been known for its strict rules on Genetically Modified Organisms (GMOs). With an extensive regulatory framework in place that covers authorisation procedures, traceability rules, labelling requirements and other legal obligations, the EU arguably has one of the most stringent GMO regimes in the world. In recent years, this scientific field has progressed extensively, which has led to the rise of New Genomic Techniques. These technologies allow for increasingly precise genetic changes – in some cases without the need to introduce foreign DNA – and have opened up a new debate on the regulation of these technologies in the EU. In 2018 the Court of Justice of the European Union ruled that certain New Genomic Techniques were to fall under the scope of the EU’s regulatory framework for Genetically Modified Organisms (GMOs). Since then, the European Commission has started a policy initiative to pursue new regulations for NGTs such as cisgenesis and directed mutagenesis, which is the focus of this study. This paper focuses on different perceptions of the European Commission’s main motivations for pursuing regulatory change through documentary analysis and a number of interviews with organisations and individuals in this field. By combining these research methods with thematic analysis and a theoretical framework based on private and public interest theories of regulation, this paper identifies several overarching themes which offer insights into Commission’s actions in this field. The findings indicate that there are several conflicting perspectives on the Commission’s policy initiative, which each support different theoretical perceptions of these regulatory developments. This paper, therefore, provides preliminary insights into the perspectives on the drivers behind this policy initiative and paves the way for further research into this rapidly developing field.