The European Commission's Take On Novel Genomic Techniques (NGTs) In Light Of CJEU's Ruling In Case C-528/16

• Published date: 31 May 2021
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Morrison & Foerster LLP
• Author: Mr Wolfgang Sch'nig

Summary

• The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis technologies such as CRISPR-Cas9, left the community in awe.
• A study recently published by the European Commission ("Commission") now calls for targeted policy action regarding plants derived from targeted cis- and mutagenesis with an inception impact assessment expected in the third quarter of 2021, as the study revealed that
  • The current European legislation regarding genetically modified organisms (GMOs) is no longer fit for its purpose with respect to plants derived from targeted cis- and mutagenesis.
  • Scientific review did not uncover any new hazards linked to targeted cis- and mutagenesis compared to conventional breeding methods or random mutagenesis.
  • In particular, in the agri-food sector, use of NGTs is likely to result in plants more resilient to diseases and climate change effects that have the potential to contribute to a more sustainable agri-food system and thus benefit society.
  • Only 21% of EU consumers have ever heard of "gene-editing" but general perception of such technologies is still negative;
  • Disparities between public perception and limited public knowledge about NGTs could hamper NGTs market uptake.
  • Different regulatory oversight for NGTs in other countries could lead to trade limitations and disruptions, and put EU operators at a competitive disadvantage.
• A basic problem identified by the study is the lack of reliable methods to detect such NGT products. To ensure a level playing field for all stakeholders involved, such methods must be able to distinguish between regulated and unregulated products, which is however, a challenge from a scientific point of view Alternatively, the study suggests a document-based traceability system, which would, however, involve additional costs and could affect the international competitiveness of EU operators.
• The study suggests that a more flexible approach to assessment of risk of NGTs should be undertaken on a case-by-case basis rather than the restrictive regulatory framework that is currently in place.
• With respect to other organisms than plants (microorganisms and animals) and other NGTs than cis- and mutagenesis (e.g., epigenetic editing), however, the study observes substantial knowledge gaps. While the Commission intends to build further knowledge, at this stage other organisms and other NGTs will remain subject to the current GMO legal framework.

INTRODUCTION

At the request of the Council of the European Union ("Council"), the Commission recently published a study regarding the status of NGTs under EU law in light of the decision of the Court of Justice of the European Union (CJEU) in case C-528/16 (for a comprehensive overview of the decision please refer to our Client Alert). The CJEU ruled, to the surprise of many, that organisms obtained through targeted mutagenesis are to be classified as GMOs and as such subject to the strict rules of the Directive 2001/18/EC ("GMO Directive"). While the decision focused specifically on new mutagenesis techniques, meaning the creation of a mutation or mutations without insertion of foreign genetic material, the request by the Council was broader and referred to NGTs in general. NGTs, for the purpose of the study, are defined as all techniques to alter the genome of an organism developed after 2001, the year the GMO Directive was adopted. Such techniques have...