A recent landmark decision of the Court of Justice of the European Union (CJEU) on the use of gene editing technologies to create new crops and livestock animals has sided with environmentalists and food safety groups, prompting outcry from the biotech industry.
To the dismay of the global biotech industry, the decision handed down on 25 July 2018 by the CJEU makes clear that organisms prepared using modern mutagenesis techniques, notably including CRISPR-Cas9 gene editing techniques, will be considered genetically modified organisms (GMOs) and subject to the strict EU rules on GMOs. This decision will make bringing new crops and livestock developed using CRISPR-Cas9 and other gene editing techniques to the EU market much more onerous and risky. Because the EU is such a large potential market for such organisms, and because third countries will wish to trade the food they grow with the EU, this ruling will have a global impact.
The biotech industry rightly fears that these uncertainties and their global reach will dramatically cool investment in the development of such organisms and stifle their adoption throughout much of the world, thereby depriving the world of improved crops and livestock which could address some the world’s most pressing problems. On the other hand, environmental NGOs are hailing the decision as a triumph for the cautious application of a potentially dangerous technology.
It seems right that the biotech industry’s use of gene editing to shape our agricultural future should come under some scrutiny, but as is often the case, the reasonable path is perhaps somewhere in the middle. Modern gene editing technology presents a wonderful opportunity to create innovative solutions to the world’s ever more serious food supply problems and create jobs and value, but society is right to be sceptical and cautious. Although gene editing can, in some instances, merely accelerate the natural selection process to arrive at new organisms which can still be considered “natural” and so no risk to the environment, the technology can also introduce heterologous traits or unintended “off target” changes and thus suffer from the same concerns as classical genetic modification.
The most satisfactory way forward would be to create new legislation that is designed with modern gene editing technologies in mind and which plots a fully considered and balanced path to harnessing the power of gene editing whilst exercising sufficient caution to mitigate the risk of environmental damage, or at least not throwing the baby out with the bathwater by using woefully out of date legislation to place all applications of such technology under existing GMO rules. Indeed, the US government seems to recognise this, at least in the context of plants, by indicating previously that it has no plans to regulate plants prepared using CRISPR-Cas9 gene editing techniques so long as such organisms could otherwise have been developed through traditional breeding techniques and as long as they are not plant pests or developed using plant pests.
The CJEU ruling is specific to crop and livestock GMOs and so there will be no impact on the medical uses of such technologies. These must, of course, plot a path through their own complex regulatory and ethical landscapes.
The debate concerning the application of gene editing across all aspects of our lives will, no doubt, rage on and on.
Gene-edited crops should be subject to the same stringent regulations as conventional genetically modified (GM) organisms, Europe’s highest court ruled on 25 July.