Webinar organised by the European Parliament – January 26th, 2021
The Farm to Fork (F2F) strategy through its aim to contribute to a more sustainable food system, is crucial to the European Green Deal, highlighting the importance of innovative solutions across the entire food value chain in achieving the ambitious objectives of the plan.
In a ruling on July 25th 2018, the Court of Justice of the European Union (CJEU) concluded that organisms obtained using mutagenesis techniques constitute GMOs in the sense of Directive 2001/18: therefore, organisms obtained through directed mutagenesis are not excluded from the scope of the Directive.
The ruling of the CJEU raised concerns amongst many scientists that the uncertainty regarding the regulatory status of genome-edited organisms could be an obstacle to reaching the aims of the F2F strategy and more in general of the European Green Deal. Consequently, in October 2019, the Council of the European Union requested the European Commission to submit, in light of the CJEU ruling, a study regarding the status of novel genomic techniques under Union Law, that will focus on their technical status.
The webinar, hosted by Jessica Polfjärd MEP (EPP, Sweden) and Erik Bergkvist (S&D, Sweden), had the aim to discuss the potential of genome editing to contribute to the F2F objectives, the current regulatory landscape for GMOs, and eventual future options for governance.
Ever since Emmanuelle Charpentier and Jennifer Doudna won the Nobel Prize for the discovery of CRISPR-Cas9 techniques in 2020, the debate on the regulation of this technique, that in Europe is currently equated to genetic modification (at least from the legislative point of view), has left the sphere of the scientific community and has become a topic of public and political discussion.
During her opening remarks, Jessica Polfjärd highlighted that the European Parliament wants greater ambition in line with the European Green Deal and the Farm to Fork Strategy, to transform food systems, for example, and that embracing innovation is inevitable.
Erik Bergkvist focused more on the issues with the status quo in his remarks. He stated that the EP’s prevailing view is not balanced and that the current lack of clear rules and the EU’s particular position on the technology is bad for research. He concluded that the EU’s laws need to be harmonised with those of the rest of the world.
Professor Wendy Harwood, a Senior Scientist responsible for the Crop Transformation Group at the John Innes Centre, Norwich, gave the first presentation mentioning the “huge and growing” potential of the technology and providing several examples of how this potential could be practically applied to the needs of the Farm to Fork strategy.
Piet Van der Meer, professor of biotechnology regulation at the University of Ghent, then took the floor. After giving an overview of the history of biosafety regulations in Europe, he stated that establishing what exactly falls under mutagenesis is crucial. He went on explaining that for an organism to be a GMO, the technique used and the novelty of the resulting genetic alterations must be considered, then concluding that the ruling of the CJEU did not settle the question of the regulatory status of organisms obtained through new genomic techniques, something that he hoped the EC study would help to clarify.
The floor then passed to Tomasz Zimny (Institute of Law Studies, Polish Academy of Sciences) who gave a presentation on the future governance options for this subject, explaining that the deregulation could be based on the traits of the modified organisms and that pre-market approval or accelerated authorisation tracks could be of help in developing the potential of CRISPR/Cas9 without the burden of changing the European laws.
In her follow-up remarks, Jessica Polfjärd highlighted the importance of having an understandable and transparent regulation and stated that policymakers have a responsibility to listen to scientists. Erik Bergkvist was even more vocal in his comments, saying that it would be a disaster if genome-edited crops continue to be classed as GMOs, for example, due to a loss in competitiveness, and that the Farm to Fork Strategy consequently ‘wouldn’t be worth the paper it’s written on’.
Upon the webinar conclusions, Piet van der Meer intervened to stress that it is essential to differentiate between how something is currently regulated versus whether it should be regulated or not. He also expressed his view that other countries do not have “deregulation” in this area, but just a different interpretation. Therefore, more clarity on the implications of the law is also what Europe needs.