Gene Editing box reopened in Europe
Picture credits: Science I Business Goda Naujokaityte
Yesterday, the European Commission published a new study concluding that the current legal framework governing gene editing is insufficient and indicated that new policy instruments should be considered to reap the benefits of this technology. The much-awaited study, was requested one year ago by the EU Council to clarify the situation following a controversial European Court of Justice ruling in 2018 that organisms obtained by new genomic techniques should, in principle, fall under the GMO Directive.
Last October, the European Federation of Academies of Sciences and Humanities (ALLEA) published a report that presented the state of the art of scientific evidence in the field and explored paths to harmonise EU legislation with recent scientific developments, while particularly considering relevant ethical and societal considerations. Based on the ALLEA report and the outcome of other studies, the Commission concluded that there is sufficient evidence and scientific basis to initiate a targeted policy action on plants derived from targeted mutagenesis and cisgenesis. Furthermore, the Commission intends to carry out an impact assessment with a view to new proposals targeting selected gene editing technologies.
While the Commission’s study does not question the legal ruling, it does conclude that developments in biotechnology, combined with a lack of definitions of key terms, are still giving rise to ambiguity in the interpretation of some concepts, potentially leading to regulatory uncertainty. In particular, the study states that there are strong indications the current legislation is not fit for purpose for some new genomic techniques and their products, and that it needs to be adapted to scientific and technological progress.
The EC report confirms also that gene editing has the potential to contribute to sustainable agri-food systems in line with the objectives of the European Green Deal and Farm to Fork Strategy. However, it also mentioned that some stakeholders consider that these benefits are hypothetical and that many of these benefits can be achieved through other approaches such as conventional breeding. In particular, the organic farming sector shared their concerns and indicated that an adjusted legislation might damage consumer trust. The study ends then nicely by concluding that more effort should be made to inform and engage with different stakeholders and the public and assess their views.
