by Penny Gilbert and William Hillson
Ever since the first demonstration of gene editing technologies, the scientific community has been abuzz with debate and speculation about their potential applications. But rather less well known may be the parallel legal battles over how these powerful new methods should be regulated, one of which recently found its way to the European Union’s highest court, the CJEU. Though courts and judges may appear remote from the daily reality of scientific research, scientists may want to pay close attention to these disputes (and not only those working in the private sector). As the CJEU’s recent decision on gene editing shows, they can have a powerful effect on the research environment.
The July 2018 judgement was known simply as case C-528/16. It put an end to a years-long legal battle between the French government and a coalition of anti-genetic engineering and environmentalist groups, who were arguing over a deceptively simple question – does gene editing count as “genetic modification”? From a scientific perspective this may seem a trivial distinction, but it is extremely important in EU law, which mandates such strict controls on the development and release of “GMOs”, such as genetically modified crops, that it has largely blocked their commercialisation within the EU. However, there is an exemption – organisms with genomes altered by random “mutagenesis” (e.g. exposure to radiation or mutagenic chemicals) are not considered “GMOs”. The justification was that such techniques were just a way of artificially accelerating the “natural” processes of mutation. They were therefore thought by the EU’s legislators to be inherently safer than “artificial” methods such as transgenesis and deemed not to require the same level of oversight.
C-528/16 started when a group of activist organisations sued the French government over its implementation of the EU’s GMO regulations into domestic law. In doing so, the French regulators had taken the view, not unreasonably, that gene editing technologies such as CRISPR were a form of (non-random) “mutagenesis”, as they involved introducing base additions, deletions and replacements into existing genes of the same type as those which occurred naturally. The activists disagreed, arguing that the immense precision and power of gene editing technologies meant they had more in common with older methods such as transgenesis than with traditional selective breeding. To the surprise of many, and acting against the recommendation of the EU’s own legal advisors, the CJEU agreed with the activists, finding that gene editing technologies were not yet sufficiently well established for their safety to be assessed, meaning that organisms edited by them should be classed as “GMOs”, with all the restrictions that entailed.
The CJEU’s reasoning has struck many scientists as deeply strange, even perverse. A newer, much more reliable and precise, technology is now to be severely restricted, precisely because it is more accurate and predictable than older, random methods! Many have expressed concern about what this will mean for biotechnology investment in the EU, or even Europe’s ability to feed itself in future. But unfortunately the prospects for reversing this judgment are not good – the CJEU is the final arbiter of EU law, and a reversal would require amending the underlying legislation – something that the European Commission has so far shown little interest in doing. In the meantime, researchers and companies working in the gene editing field will have to get used to the new regulations. If there is a lesson here for the scientific community, it is surely the importance of educating lawmakers early and often about new technical developments – otherwise they risk finding themselves entangled in flawed legislation which, overtaken by technological advances, may achieve the exact opposite of its intended effects.
Dr Penny Gilbert and Dr William Hillson are a Partner and an Associate at Powell Gilbert LLP, a London-based law firm which advises many clients in the biotechnology, pharmaceutical and medical device industries. If you would like to know more about how the law and scientific advancement interact, especially when it comes to patents, you may be interested in some of the firm’s other publications.
Dr Penny Gilbert, Partner and Dr William Hillson, Associate work at the IP law firm Powell Gilbert.
For more check out our article collection on Gene Editing