On 25th July 2018, the Court of Justice of the European Union (CJEU) ended a decade-long debate on whether organisms obtained by gene-editing techniques should be treated as genetically modified organisms (GMOs) within the meaning of the GMO Directive… and the answer is “yes”.
The upshot of this landmark ruling is that organisms obtained by modern gene-editing techniques, such as CRISPR/Cas9, must go through the same regulatory and approval process as organisms obtained using traditional transgenic methods. Craig Titmus, a Partner in our Life Sciences and Chemistry team, explains.
The GMO Directive (2001/18/EC) is the key legislation controlling cultivation and sale of GMOs within the EU. Organisms categorised as “GMO” fall within the scope of the GMO Directive, and must undergo a risk assessment, public consultation and labelling, prior to authorisation. Mechanisms also exist for individual EU member states to provisionally restrict or prohibit the use and/or sale of an authorised GMO. For organisms categorised as “GMO”, the route to market is far from straightforward.
Traditional transgenic methods for generating genetically modified organisms leave a genetic “fingerprint” which can readily distinguish such modified organisms from those existing in nature. Few would argue that organisms, modified using traditional transgenic techniques, do not qualify as “GMO”. At the other end of the scale, few would argue that naturally-occurring organisms are “GMOs” (even though random genetic mutations occur in nature and give rise to the biodiversity present in the natural environment).
Between these two extremes, there exists a grey area in which the delineation between “GMO” and “non-GMO” is not clear-cut.
One such example is the use of chemical mutagens and ionising radiation to introduce random genetic variations e.g. in conventional crop breeding techniques. At first blush, although these conventional mutagenic techniques often leave no genetic fingerprint, many would assume that the resulting organisms would be categorised as “GMO”, and would therefore fall within the scope of the GMO Directive.
This is not the case. As set out in the GMO Directive and confirmed in C-528/16, “organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record are exempt from [the obligations set out in the GMO Directive (subject to other EU provisions)]”.
The GMO Directive and gene-editing techniques
Several years after the GMO Directive was directed back in March 2001, modern gene-editing techniques (such as CRISPR/Cas-9) have been developed, enabling targeted modification of an organism’s genetic material, without leaving a genetic fingerprint. Absent a genetic fingerprint, one cannot readily distinguish organisms that were obtained using modern gene-editing techniques from organisms that were modified using conventional mutagenesis techniques (or, indeed, from organisms in which the same mutation occurred through a random natural event). Drawing parallels with conventional mutagenesis techniques, it was widely anticipated that the CJEU would rule that organisms obtained using modern gene-editing techniques would fall outside the scope of the GMO Directive.
On the contrary, C-528/16 held that “new techniques/methods of mutagenesis” which enable targeted modification of an organism’s genetic material, might carry the same risks as traditional transgenic organisms, and must therefore be subject to the requirements set out in the GMO Directive.
GMOs and Brexit
The cultivation and sale of GMOs in the UK is, of course, mainly regulated by EU law. At the time of writing, it is virtually-impossible to imagine what a Brexit deal might look like, but the Department for Environmental Food and Rural Affairs (DEFRA) has just issued a guidance notice entitled “Developing genetically modified organisms (GMOs) if there’s no Brexit deal”, which seeks to explain “how controls on the release of genetically modified organisms (GMOs) into the environment would be affected if the UK leaves the EU in March 2019 without a deal." The guidance notice may be summarised as follows: in the event of a no-deal scenario, the UK Government will maintain the status quo.
Craig Titmus is a Partner in our Life Sciences and Chemistry team and is based in our Cambridge office. Craig holds a bachelor’s degree in molecular biology and biochemistry and a PhD in biotechnology. His practice covers diverse biotechnological subject-matter, with a particular focus on vaccines, diagnostics, therapeutic antibodies and peptide conjugates and agri-tech. Craig has significant experience of European and international patent prosecution, and coordinates global IP strategies for a range of clients including start-ups, SMEs, universities, large corporations and the UK Government. The “Legal 500” notes that Craig is an “excellent” patent attorney with “strong a technical background and highly developed legal skills” (2017). For any questions related to GMOs, please contact Craig via CETitmus@mathys-squire.com.