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August 3rd, 2018 / The royal Society

When is modifying genetics not genetic modification? Strange question but it’s one that the European Court of Justice has spent two years deliberating. The court’s decision determines whether the latest generation of tools for making changes to the DNA of plants, animals and microorganisms come under the same regulations as previous generations. As these regulations shape what scientists try to use these tools for, whether businesses use them at all and whether products made with them appear in our shops, there was a lot riding on this verdict.

The new technologies in question enable a process called genome editing. They are used to make changes at a precise location in DNA. The most often discussed genome editing technology is CRISPR/Cas9, which has gained renown for being faster, cheaper and easier to use than all other methods for making changes to DNA. Genome editing ended up in court because EU policymakers, alongside regulators around the world, are grappling with how these technologies fit into their technology based-system to regulating genetic modification.

A way forward

The solution to these problems is to move away from a technology-based approach to regulation and towards a product-based approach that focuses on the genetic change that has been made. This is the system used in Canada. By not focusing on the technology used to introduce the change, this approach anticipates new technologies. And by focusing on the change made, it can meet public expectations by ensuring that no product with an entirely new genetic characteristic can be released in Canada without going through a regulatory approval process. So rather than spending two years asking whether genome editing should be treated as genetic modification, perhaps the European Court of Justice’s time would have been better spent asking whether the technology-based approach to regulation is fit for purpose. Read more