ECJ Gene Editing Ruling Stirs Criticism

Association: More Restrictive Rules could “Lock out the Benefits of Genome Editing from Europe.”

02.08.2018 -

Agrochemical and biotech companies based in the EU are assessing a ruling last week by the European Court of Justice (ECJ) that could potentially make work with genetically edited organisms, including crops, fall under GMO regulation.

The ruling came in response to a legal challenge brought by nine NGOs, including the agricultural union Confédération Paysanne, against France’s existing legislation that excludes organisms obtained through mutagenesis from GMO regulations. At present, the judgment applies only to France but could well have wider repercussions for companies.

Up to now, Europe’s GMO laws have governed only organisms obtained through transgenesis techniques, which insert DNA from a different species into an organism, Mutagenesis techniques manipulate the organism’s own DNA without introducing foreign DNA.

While the ECJ said that organisms obtained through conventional mutagenesis techniques with a long safety record should continue to be exempt, technologies developed after the GMO law was passed should be regulated.

The European Association for Bioindustries said it believes the ruling contradicts a previous document issued this past January, saying that precise gene editing technology may not need to be as strictly regulated as GMOs.

The association said it fears that more restrictive rules could “lock out the benefits of genome editing from Europe.” Not only genetically-modified crops could be affected, but also therapies for HIV or biological methods for the renewable production of fuel and plastics.

In a statement, Ricardo Gent, general manager of the German biotech industry association Deutsche Industrievereinigung Biotech (DIB), called the ECJ decision “very bad news for crop growers, drug developers and manufacturers of bio-based chemical products. Highly innovative methods such as Crispr/Cas are overregulated without any scientific justification,” he said.

Gent added that DIB does not support the position that modern mutagenesis techniques such as gene editing carry more risks than older transgenesis procedures. If European companies’ hands are tied, they will be disadvantaged in competition with the US and China, he said, while stressing that gene editing can produce genetic mutations but doesn’t necessarily have to.

Agrochemicals and seeds industry analysts speaking to the news agency Reuters noted that few, if any, commercial ventures based on gene editing have been launched so far in Europe. This would make sense for only very large companies, as overhead costs for market access costs would be “near-prohibitive” for smaller firms. 

Germany’s Bayer, the largest player in crop protection and seeds following the acquisition of Monsanto, would not be affected, a spokesperson told Reuters, as it has pledged not to develop genetically modified crops for commercial use in Europe.

For BASF, the ruling would not have a great impact, either, as the German group is not currently using gene editing instruments in Europe; however, CEO Martin Brudermüller told analysts in an a Q2 earnings call that for him as a European, the decision is worrying.

German seeds producer KWS Saat, the world’s largest supplier of sugar beet seeds, said it would study the ruling before making any changes to its strategy. The group has research centers in the US as well as Germany.

The European Seed Association said that much of the potential of innovative gene editing methods would likely be lost for Europe if these are subject to restriction.