Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts

TLDR

Current EU directives, rooted in a transgenic versus conventionally bred distinction, inadequately regulate novel plant genome editing techniques that blur the line between genetic engineering and conventional breeding and are often interpreted as strictly process‑based despite containing product‑related terms. The authors argue that EU legislation should be interpreted product‑based rather than process‑based to accommodate emerging genome editing techniques, and call for urgent legal guidance to define such plants within existing directives. They outline the EU legislative development process for genome editing, compare it with international frameworks, and propose alternative regulatory approaches to address current hurdles.

Abstract

Novel plant genome editing techniques call for an updated legislation regulating the use of plants produced by genetic engineering or genome editing, especially in the European Union. Established more than 25 years ago and based on a clear distinction between transgenic and conventionally bred plants, the current EU Directives fail to accommodate the new continuum between genetic engineering and conventional breeding. Despite the fact that the Directive 2001/18/EC contains both process- and product-related terms, it is commonly interpreted as a strictly process-based legislation. In view of several new emerging techniques which are closer to the conventional breeding than common genetic engineering, we argue that it should be actually interpreted more in relation to the resulting product. A legal guidance on how to define plants produced by exploring novel genome editing techniques in relation to the decade-old legislation is urgently needed, as private companies and public researchers are waiting impatiently with products and projects in the pipeline. We here outline the process in the EU to develop a legislation that properly matches the scientific progress. As the process is facing several hurdles, we also compare with existing frameworks in other countries and discuss ideas for an alternative regulatory system.