Gene Editing Regulatory Setback

July 27, 2018
Post by Heidi S. Nebel

The gene editing world was dealt a tremendous blow by the European Union (EU) in a decision issued July 25, 2018. The shock comes as the United Stated Department of Agriculture (USDA) recently announced that it would treat all gene edited crops with a deletion as outside of the regulations relating to “genetically modified” crops.    

Hopes that this acceptance of gene editing would open the floodgates for vast improvements in crops, were dashed yesterday as the EU announced that it will treat gene edited crops as “genetically modified”. The decision was handed down by the Court of Justice of the European Union, finding that these crops fall under the 2001 directive on genetically modified crops. The directive introduced the most restrictive GMO regulations in the world and was aimed at species into which entire heterologous genes had been inserted. Importantly, the directive exempts organisms whose genomes were modified using mutagenesis techniques, such as irradiation, which introduce changes to the DNA material, but does not insert foreign genetic material. 

The court had been asked to interpret the 2001 directive in light of newly emerging gene editing technology. It certainly seems that deletion gene editing is more akin to mutagenesis than insertion of foreign genes, however, the ruling held that mutagenesis techniques developed after 2001 did not have a sufficient record of safety to qualify for the exemption granted for mutation breeding. In a small glimmer of hope, the ruling leaves open the possibility that if gene editing techniques could prove as safe as mutagenesis then they too, could earn an exemption, but how long will that take? Nonetheless the immediate chilling effect on agricultural research cannot be denied.

Heidi S. Nebel is the Chair of the Biotechnology & Chemical Practice Group at MVS. She serves as the Managing Member of the Firm and has been assisting clients with intellectual property matters for over 25 years.

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