January 14, 2020 - Agtech, European Union, Regulatory

Silver lining? Genome-editing regulation following CRISPR ban in Europe’s Agribusiness

In its landmark decision of July 25 2018, the Court of Justice of the European Union (“CJEU”) essentially banned crops obtained by new genome editing techniques from the EU market. The decision left the European biotech industry in awe, as it came unexpectedly and caused its activities to come to a sudden halt. Now, a request by the Council of the European Union (“Council”) to the European Commission seems to have set the ball rolling again. So what happened?

A widely criticized decision

The CJEU decided that organisms obtained by cutting-edge genome editing techniques such as CRISPR/Cas9, Talen, or zinc finger are to be classified as genetically modified organisms (“GMO”). As such, these organisms are subject to the EU’s rigorous Directive 2001/18/EC (“GMO Directive”). The consequence is a de facto ban of the new technologies in the agricultural sector of the EU due to the established practice of rarely approving GMO crops on the market and leaving the Member States the option of banning GMO crops altogether on a national level.

The decision stirred up a fierce controversy. Firstly, it came as a surprise to many, as the opinion of the Attorney General was generally interpreted as considering such techniques permissive under the GMO Directive. Moreover, integrating the new mutagenesis techniques, dubbed the “printing press of the 21st century”, into the scientific toolbox is widely regarded as essential in order to develop solutions to the most pressing problems of the 21st century. The wide array of plant characteristics that can possibly be achieved includes higher yields, decreased chemical and water usage, and improved resistance to pathogens and drought, as well as increased nutritional value that could help tackle hunger crises, worldwide climate change, water scarcity, and a diminishing biodiversity.

In addition, apart from the EU risking its competitive edge in sustainable food production, scientists argue that the desired genome-edited crops are at least equally as safe as the ones stemming from “conventional” mutagenesis techniques with similar alterations, since those could also occur in nature, only on a random and therefore less cost-effective and precise basis. Not only does this fact contradict the decision’s implication of crops obtained by new mutagenesis techniques posing the same risks as traditional GMOs, but it also makes distinguishing how the alterations in question were originally achieved nearly impossible. Thus, an insurmountable hurdle for passing the authorization process is created, since today’s methods do not allow for definitively proving that none of the “new” genome editing techniques were applied in the breeding process of a crop.

A silver lining?

Despite the clear signal that the CJEU sent to European lawmakers to expressively regulate genome-editing techniques, no corresponding steps were taken for the past year and a half. However, there seems to be a silver lining on the horizon. On November 8, 2019 the Council issued a request to the European Commission to submit a study on the status of new genome-editing techniques in the light of the CJEU’s decision and, if needed, propose changes to the GMO Directive.

Although the request mainly focuses on the issue of distinguishability of products resulting from natural mutation from those stemming from new mutagenesis techniques, there is a chance that the request will kick off a fundamental debate about the future role of genetically modified plants and a comprehensive review of their regulation. In this regard, several Members of the European Parliament have already expressed their concerns with the currently missing distinction of new innovations and technologies from traditional GMOs under the GMO Directive, which is widely considered archaic.

Outlook

The Commission has not yet reacted to the request, but an answer is likely to be issued early February following paragraph 10 of the Interinstitutional Agreement on Better Law-Making.

While the use and commercialization of genome-editing tools is embraced by 13 members of the World Trade Organization, including the U.S., Canada, Australia, and Brazil, the EU risks losing its seat at the table of the major countries defining the future of agriculture and food production. Nevertheless, some European players seem willing to put high bets on a change of policy in a still unforeseeable future by signing the first gene-editing related deals.

We are going to keep you informed about any progress on this matter.

For further information, read our Client Alert of July 25, 2018, for a comprehensive overview of the decision.