The Court of Justice of the European Union (CJEU) has ruled that organisms created using modern gene editing tools – including CRISPR Cas-9 - should be subject to the same stiff regulation as genetically modified organisms (GMOs). This is an unexpected blow for anyone using these techniques in Europe to combat disease or develop hardier food crops. In January 2018, the court's Advocate General indicated that CRISPR-edited organisms should not be subject to GMO regulation.
The CJEU decision has been widely condemned by scientists and industry. They fear that Europe will become a backwater for gene editing whilst other countries are embracing these biological tools to realise significant advances in healthcare and food production. But not everyone is disappointed. As The Times reported, one Canadian professor commented: “Great news for Canadian and American farmers today. Hope all Europeans enjoy their future higher food prices".
Legal context
The EU has some of the strictest controls in the world on releases of GMOs into the environment (including genetically modified food and animal foodstuffs). The concern is that these organisms may replicate any unintended and potentially harmful modifications to their genomes. As a precautionary measure to protect humans and the environment, the GMO Directive (2001/18/EC) requires GMOs to undergo a risk assessment and public consultation before being placed on the market. They must also be registered and labelled as GMO products.
The CJEU has now ruled that organisms created by mutagenesis (using modern gene editing tools to make precise changes to an organism's own genome) should be regulated under the GMO Directive in the same way as transgenic organisms (which are created by introducing DNA from another organism). Mutagenesis techniques have been widely used for many years to develop seed varieties with herbicidal resistance and have an established safety record. The CJEU confirmed that these conventional mutagenesis techniques are exempt from the lengthy and expensive assessment and authorisation procedures under the Directive.
Background to the CJEU decision
The CJEU decision is a victory for the French small-scale farmers who were represented before the court by The French Agricultural Union (FAU). The FAU had challenged before the French courts domestic legislation exempting mutagenesis-derived organisms from the GMO Directive. The FAU argued that mutagenesis techniques have evolved since the GMO Directive came into force; mutagenesis no longer involves cultivating in vivo mutations on entire plants, but instead involves in vitro targeted genome mutations in order to obtain herbicidal resistance. The FAU argued that those varieties present a risk to human health and the environment in the same way as transgenic organisms which are subject to the GMO Directive, specifically:
"the release of genetic material of those varieties leading to the appearance of weeds which have acquired the herbicide-resistant gene, from the ensuing need to increase the quantities and vary the types of herbicides used and the resulting pollution of the environment, or from unintentional effects, such as undesired or off-target mutations on other parts of the genome and the accumulation of carcinogenic molecules or endocrine disruptors in cultivated plants intended for human or animal consumption".
Specific issues for the CJEU
The CJEU accepted the argument that modern mutagenesis methods are capable of creating organisms that pose a similar level of risk as transgenic organisms. It answered the specific questions referred to it as follows:
- Are organisms obtained by mutagenesis "GMOs" in the context of the GMO Directive?
Answer: Yes. All organisms obtained by any method of mutagenesis would be GMOs within the meaning of the GMO Directive. However, to the extent these organisms have been "conventionally been used in a number of applications and have a long safety record" they are exempt from the GMO Directive.
- Are member states free to subject such organisms to the obligations set down in the GMO-Directive anyway?
Answer: Yes. As long as member states comply with other aspects of EU law, member states have the option of defining their own regime in respect of those organisms.
- Is the GMO Directive applicable to organisms obtained by mutagenesis techniques that have emerged since it adoption?
Answer: Yes. Organisms obtained by these new mutagenesis techniques are not exempt from the GMO Directive. Since the new techniques are deemed to make it possible to obtain effects similar to those achieved by transgenesis, excluding organisms obtained by new mutagenesis techniques would compromise the purpose of the GMO Directive.
- In relation to a separate directive, does a GMO constitute a 'genetically modified variety', which may be accepted for inclusion in the ‘common catalogue of varieties of agricultural plant species the seed of which may be marketed’ only if all appropriate measures have been taken to avoid risks to human health and the environment?
Answer: Yes. A 'genetically modified variety’ must be construed as referring to the concept of a GMO in the GMO Directive. Organisms produced by new mutagenesis techniques must fulfil the conditions outlined above, whereas varieties obtained by conventional mutagenesis are exempt.
Comment
The world is changing. The CJEU, in attempting to update the concept of 'genetically modified organism' as used in the GMO Directive, has sliced up the definition of 'mutagenesis' without offering a coherent explanation as to why site specific, targeted mutations (through the CRISPR-Cas9 system, for example) may cause any greater risk to human health or the environment than traditional mutagenesis techniques. Those older techniques may now be the most cost-effective route to market leaving only the biggest multinationals to push the boundaries of gene-editing technologies in Europe. They are the only companies capable of footing the £30 million regulatory bill to obtain approval of a new GMO product in Europe. Smaller players, who are making great strides in the field, risk being side-lined or enticed overseas where the regulatory hurdles are lower.
Sarah Schmidt, Project Coordinator at the Institute for Molecular Physiology, University of Düsseldorf, has called the ruling a “deathblow for plant biotech in Europe” (as quoted in LISR). With Brexit looming, this could be a good time for the UK to reappraise its approach to GMOs. A different, UK-specific regulatory regime could allow UK scientists and businesses to side-step the EU's restrictive controls to develop much-needed new foods and medicines whilst preserving the UK's reputation as a leading light in the scientific world.
Meanwhile, we are working with colleagues and clients on strategies to mitigate the impact of the CJEU's decision on businesses and researchers. If you would like to join the discussion, please get in touch.