The controversial decision by the European courts in 2018 to regulate gene-edited organisms as GMOs has had a damaging effect on biotech companies working in this area.
The current GMO regulations were established in Europe in 2001 and were designed to strictly regulate the introduction of DNA from other species into animals and plants. These regulations do not cover mutagenesis techniques, such as exposure to radiation, where mutations are artificially induced without inserting foreign DNA.
In the last few years, fast and precise gene editing techniques such as CRISPR-Cas9 have become available. This has triggered much debate about whether gene editing should count as genetic modification or simply as another version of mutagenesis.
In 2016, the French government requested the current GMO directive to be re-interpreted after the arrival of new gene editing techniques. The resulting decision in 2018 to apply stricter regulation to organisms that have undergone gene editing has had far-reaching outcomes and according to many has conclusively demonstrated that the EU’s GMO directive is “no longer fit for purpose.”
Following the request from the French government, Michal Bobek, Advocate General of the Court of Justice of the European Union, released a statement in early 2018 with the proposed changes to the regulations.
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Published on Wed, 11 Nov 2020 09:00:27 +0000 on behalf of nintex collection ends with value