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.
To explain what I mean by a technology-based approach to regulation, here’s an example from plant breeding. If you use x-rays or chemicals to change a plant’s DNA (known as mutation breeding or mutagenesis), you do not have to get regulatory approval before cultivating any products of this process. There are over 3000 varieties of plant in cultivation worldwide produced using these technologies, one of which is herbicide resistant oilseed rape that is grown in the UK.
However, if rather than using chemicals or radiation you had introduced a new piece of DNA that delivered the same property, then any plants produced would be categorised as a Genetically Modified Organism (GMO). GMOs have to go through an extensive regulatory process to demonstrate that they do not pose a risk to other plants, animals or people before they can be cultivated. So whether an organism is regulated or not depends on the technology used to make changes to that organism’s DNA.
The rationale underpinning this regulatory distinction is whether or not the changes could have occurred in that organism without any technological intervention. Random genetic changes between generations have always occurred and are the reason evolution exists – when these changes confer an advantage on the offspring, they go on to have more offspring and so the genetic change is inherited by subsequent generations. Mutation breeding is therefore seen as a way of accelerating a ‘natural’ process. GMOs are treated differently because you can introduce genes from another species (a process referred to as ‘transgenisis’), something that could never happen without technological intervention. Because of concerns at the time the regulations were drafted about unintended consequences from the process, even if you introduce a gene from the same species then this too would be treated as a GMO.
The challenge that genome editing presents to this philosophical basis for regulation is that you can use it both to make changes that could have occurred without technology and those that could only be made using technology. Hence the court case over whether it should be treated like one of the unregulated technologies for accelerating the process of ‘natural’ genetic variation or one of the regulated technologies for introducing new DNA. Contrary to the opinion of its advocate general that it depends on the change you are making, the court has decided that all genome editing applications should be regulated as GMOs.
Given that the EU’s GMO regulations have effectively prohibited the commercial use of technologies covered by these rules, this result will come as a disappointment to many European scientists whose work involves genome editing. Moreover, the fact that we have had two years of regulatory limbo during the court case and before that a further nine years of inconclusive deliberation by the European Commission demonstrates the challenge a technology-based approach to regulation has with keeping up with technological developments.
But beyond this, there is an open question as to whether a system in which some technologies go completely unregulated and some are regulated to the point of prohibition is what people want. During the recent public dialogue on genetic technologies commissioned by the Royal Society, many participants were unpleasantly surprised to learn that the products of mutation breeding technologies do not go through a regulatory process before being released into the environment. There was also a widespread view that genetic technologies should be strictly regulated but not so strictly that they are effectively prohibited.
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.
The Royal Society has responded to the European Court of Justice ruling that organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive.