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The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis technologies such as CRISPR-Cas9, left the community in awe.

The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16

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<h4>Summary</h4><ul><li>The decision of the Court of Justice of the European Union (CJEU) in case <a target="_blank" href="https://curia.europa.eu/juris/document/document.jsf;jsessionid=E6A644720D7897129A0217D79B443A24?text=&docid=204387&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=3612390">C-528/16</a> essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis technologies such as CRISPR-Cas9, left the community in awe.</li><li>A <a target="_blank" href="https://ec.europa.eu/food/sites/food/files/plant/docs/gmo_mod-bio_ngt_eu-study.pdf">study</a> recently published by the European Commission (“Commission”) now calls for targeted policy action regarding plants derived from targeted cis- and mutagenesis, with an inception impact assessment expected in the third quarter of 2021, as the study revealed that:       
<ul><li>The current European legislation regarding genetically modified organisms (GMOs) is no longer fit for its purpose with respect to plants derived from targeted cis- and mutagenesis.</li><li>Scientific review did not uncover any new hazards linked to targeted cis- and mutagenesis compared to conventional breeding methods or random mutagenesis.</li><li>In particular, in the agri-food sector, use of NGTs is likely to result in plants more resilient to diseases and climate change effects that have the potential to contribute to a more sustainable agri-food system and thus benefit society.</li><li>Only 21% of EU consumers have ever heard of “gene-editing” but general perception of such technologies is still negative.</li><li>Disparities between public perception and limited public knowledge about NGTs could hamper NGTs market uptake. </li><li>Different regulatory oversight for NGTs in other countries could lead to trade limitations and disruptions, and put EU operators at a competitive disadvantage.</li></ul></li><li>A basic problem identified by the study is the lack of reliable methods to detect such NGT products. To ensure a level playing field for all stakeholders involved, such methods must be able to distinguish between regulated and unregulated products, which is, however, a challenge from a scientific point of view. Alternatively, the study suggests a document-based traceability system, which would, however, involve additional costs and could affect the international competitiveness of EU operators.</li><li>The study suggests that a more flexible approach to assessment of risk of NGTs should be undertaken on a case-by-case basis, rather than the restrictive regulatory framework that is currently in place.</li><li>With respect to other organisms than plants (microorganisms and animals) and other NGTs than cis- and mutagenesis (e.g., epigenetic editing), however, the study observes substantial knowledge gaps. While the Commission intends to build further knowledge, at this stage other organisms and other NGTs will remain subject to the current GMO legal framework.</li></ul><h4>INTRODUCTION</h4><p>At the request of the Council of the European Union (“Council”), the Commission recently published a study regarding the status of NGTs under EU law in light of the decision of the Court of Justice of the European Union (CJEU) in case C-528/16 (for a comprehensive overview of the decision please refer to our <a href="/resources/insights/180625-cjeu-crispr-europe-agribusiness.html">Client Alert</a>). The CJEU ruled, to the surprise of many, that organisms obtained through targeted mutagenesis are to be classified as GMOs and as such subject to the strict rules of the Directive 2001/18/EC (“GMO Directive”). While the decision focused specifically on new mutagenesis techniques, meaning the creation of a mutation or mutations without insertion of foreign genetic material, the request by the Council was broader and referred to NGTs in general. NGTs, for the purpose of the study, are defined as all techniques to alter the genome of an organism developed after 2001, the year the GMO Directive was adopted. Such techniques have advanced at a rapid pace in the last 20 years, with applications in the agri-food sector already being marketed in North America and hundreds of applications potentially reaching market stage in the next 10 years. The study aims to provide updated and comprehensive information on NGTs and to assist in deciding on any further action in this policy area. The study was carried out through targeted consultations with the competent authorities of the Member States and stakeholders at EU level. In addition, various expert opinions were incorporated in the study.</p><h4>KEY FINDINGS</h4><h5>NGTs under current GMO legislation</h5><p>The study concluded, based on clarifications provided by the CJEU, that not only organisms obtained from new mutagenesis techniques but also such obtained from cis- and intragenesis fall within the scope of GMO legislation. Cisgenesis techniques introduce foreign genetic material (e.g., a gene) into a recipient organism from a crossable donor, whereas with intragenesis techniques the inserted foreign genetic material is rearranged. Article 2(2) of the GMO Directive defines GMO as “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.” Both cis- and intragenesis techniques alter genetic material in such a way. Thus, resulting organisms are GMOs, even if similar ones can also be obtained naturally. Since neither cis- nor intragenesis techniques are listed in Annex IB to the GMO Directive, resulting organisms are subject to the requirements of the GMO legislation. The same applies for techniques that introduce alterations of the genetic material without changes in the nucleic acid sequence (e.g., epigenome editing). While the term “alteration” is not defined in the GMO Directive, the application of the precautionary principle warrants a restrictive interpretation, including alterations of the genetic material that leave the nucleic acid sequence untouched.</p><h5>The promising benefits of NGTs</h5><p>Regarding the agri-food sector, a <a target="_blank" href="https://doi.org/10.2760/02472">review on current and future market applications of NGTs</a> conducted by the Commission’s Joint Research Centre (JRC) identified various NGT plant products that have the potential to contribute to sustainable food systems and therefore to the objectives of the <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52019DC0640&from=EN">European Green Deal</a>, more specifically to those of the “<a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52020DC0381&from=EN">farm to fork</a>” and <a target="_blank" href="https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal/actions-being-taken-eu/eu-biodiversity-strategy-2030_en">biodiversity strategies</a>.</p><p>NGT products, such as plants with better water and nutrient use efficiency that are more resistant to diseases (and thus reduce pesticides use), can lead to more sustainable food production with less environmental impact. Better nutritional values, lack of allergens, and reduced breeding costs can promote the shift to a healthier, nutritious, and more affordable diet, while plants more resistant to climate conditions are better equipped to deal with climate change effects. NGTs can also contribute to the objectives of the biodiversity strategy by enhancing the performance of underutilized plants, potentially providing for more diverse use.</p><p>The study also confirmed that there is still a strong interest in research on NGTs in the EU, albeit with most of development actually taking place outside the EU. After the CJEU decision, some stakeholders reported a negative impact on public and private research on NGTs due to the current GMO regulation, as well as a competitive disadvantage compared to non-EU countries and the risk of a brain and technology drain.</p><p>The organic/GMO-free premium market sector raised concerns, as stakeholders fear that any consideration of NGT products outside the scope of the current GMO legislation would deal a severe blow to their value chain and potentially damage consumer trust. However, the organic sector already uses seeds that may result from conventional mutagenesis and therefore are technically considered GMOs.</p><h5>Safety is key!</h5><p>The study highlighted the safety of NGTs as an important prerequisite when considering their potential role in a sustainable agricultural and food system. To that end, the Commission asked the European Food Safety Authority (EFSA) to provide an <a target="_blank" href="https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6314">overview of the risk assessment of plants developed with NGTs</a>. The overview covered various forms of NGTs, with new mutagenesis techniques being most prominently featured. Additionally, the study took account of expert <a target="_blank" href="https://ec.europa.eu/info/research-and-innovation/strategy/support-policy-making/scientific-support-eu-policies/group-chief-scientific-advisors/new-techniques-agricultural-biotechnology_en">opinions from the Group of Chief Scientific Advisors</a> (“SAM HLG”) and the <a target="_blank" href="https://data.europa.eu/doi/10.2760/710056">JRC</a>.</p><p>The EFSA assessment suggests that NGTs that do not introduce exogenous, non-host DNA (transgenesis) or recombinant DNA (intragenesis) are of similar risk as conventional breeding and established genome techniques (EGTs). Especially in terms of their specificity, such NGTs represent a significant improvement over random genetic modifications. Furthermore, based on recent experimental evidence, EFSA concluded that off-target mutations potentially induced by targeted mutagenesis are of the same type as, and fewer than, those in conventional breeding and random mutagenesis. The SAM HLG and the JRC made similar observations. EFSA and other Member States also noted similarities between cisgenesis and conventional plant breeding, with the introduction of undesirable traits and hazards being more easily avoidable when using cisgenesis. On the other hand, intragenesis introduces new combinations of genetic material that, as with transgenic plants, may pose new hazards.</p><p>Since most of the available expert opinions and views on safety and risk assessment relate to mutagenesis techniques used in plants, the study could not provide a similar assessment for other NGTs, e.g., epigenome editing, or microorganism and animal applications.</p><h5>Enforcement issues</h5><p>Since the CJEU’s ruling, most Member States have not adapted their GMO enforcement systems to cover NGT products, the primary reason being a lack of reliable detection methods. A report by the European Network of GMO Laboratories (ENGL) on the <a target="_blank" href="https://gmo-crl.jrc.ec.europa.eu/doc/JRC116289-GE-report-ENGL.pdf">detection of food and feed plant products obtained by NGTs</a> revealed that, at least for plants that do not contain inserted recombinant DNA, it is very unlikely for control laboratories to be able to detect unauthorized genome-edited plants. Current screening methods commonly used to detect conventional GMOs target common sequences generally present in transgenic organisms that do not occur in targeted mutagenesis. While DNA sequencing may be able to detect specific DNA alterations in a product, this would not necessarily confirm NGT genome editing, as the same alteration could have been obtained by conventional breeding or random mutagenesis techniques. Products of the latter would be exempted from the GMO Directive. These findings might explain why some Member States have been dissuaded from investing large sums of money, given the low chances of successfully developing a reliable detection method, the analytical results of which would stand up in court.</p><p>Furthermore, the study found that the lack of viable detection methods poses challenges not only for the Member States but also for stakeholders. GMO market authorization in the EU requires the applicant to submit a reliable detection method as part of the application. The ENGL report deemed it questionable whether such methods can be developed for all genome-edited plant products, especially for plant products bearing a non-unique DNA alteration. This makes it virtually impossible under the current GMO legislation to successfully apply for marketing authorization with regard to certain plant products.</p><p class="MoFoLevel2Subhead">To counter analytical limitations, a document-based traceability system could be considered. However, this would involve additional costs and potentially affect the competitiveness of EU operators. Furthermore, Member States have highlighted that a valid traceability system would need the support of valid analytical tools.</p><h5>Reduced competitiveness</h5><p>For the purposes of the study, 31 legal frameworks of Non-EU countries were screened for regulations relating to GMOs and specifically NGTs. Around a third of those countries, including major agricultural trade partners in North and South America, do not or will not regulate certain NGT products, such as those derived from targeted mutagenesis. Such regulatory differences could, in certain cases, lead to trade disruptions with economic losses and a lack of access to resources outside the EU. As an example, the study mentioned the reliance of the EU feed sector on imports of genetically modified plant proteins.</p><p>At the same time, diverging requirements could also raise technical barriers to trade that could lead to disputes between the EU and its trading partners in international fora such as the World Trade Organization. In addition, many stakeholders voiced that burdensome regulation, in particular, costly EU authorization requirements, foster an uneven playing field that affects the international competitiveness of the EU’s agri-food, industrial, and pharmaceutical sectors. This holds especially true for small and medium-sized enterprises and small-scale operators, who generally see opportunities to access the NGT and NGT-product market, due to lower costs and ease of use of NGTs compared to EGTs. As they have fewer resources, these enterprises are particularly affected by regulatory barriers, specifically high costs relating to authorization.</p><h4>OUTLOOK</h4><p>The evident enforcement challenges, as well as the need for contentious legal interpretation while addressing NGTs, have revealed the current GMO legislation’s inability to keep up with rapid changes in biotechnology. It is therefore commendable that the Commission, at least for plants derived from targeted cis- and mutagenesis, is tackling these challenges by intending to initiate a targeted policy action.</p><p>The Commission has emphasized that it aims at a proportionate regulatory oversight of the relevant plant products by adapting existing risk assessment and approval procedures, as well as labeling and traceability requirements. However, the biggest issue remaining is still the lack of viable detection methods for certain gene-edited plants. It would therefore be welcome if the EU would catch up with some of its trading partners and exempt from the strict GMO legislation organisms obtained from certain NGTs that can be deemed safe. The screening of non-EU legislative frameworks has shown that such exemptions could either be product-based (e.g., absence of recombinant DNA) or process-based (e.g., certain types of mutagenesis). This would not only enable the use of safe NGTs to tackle some of the most pressing political objectives of the EU, but also prevent potential trade barriers and strengthen the overall competitiveness of the EU. In that vein, the Commission has noted that products similar to those derived from targeted cis- and mutagenesis with similar risk profiles can also be obtained using conventional breeding techniques or EGTs that fall outside the scope of the GMO Directive. The Commission indicated that it may not be justified to apply different levels of oversight to products bearing the same risk and suggests a flexible approach to assessment of risk will be required on a case-by-case basis, rather than the more restrictive regulatory framework currently in place.</p><p>It is to be hoped that the adaptation of the legal framework will also help to remove existing legal uncertainties arising from developments in biotechnology by clarifying certain undefined terms of the GMO legislation. An inception impact assessment, expected to be published in the third quarter of 2021, will likely shed more light on the matter. Further policy action should also focus on the disparity between public perception and public knowledge about NGTs. Member States and stakeholders agree that the current perception is negative, while a <a target="_blank" href="https://www.efsa.europa.eu/sites/default/files/corporate_publications/files/Eurobarometer2019_Food-safety-in-the-EU_Full-report.pdf">2019 Eurobarometer</a> on NGTs reported that only 21% of EU consumers had heard of gene-editing. Public perception of new biotechnologies is key to market uptake and thus of great importance for realizing the potential benefits of NGTs.</p><p>France will take over the presidency of the Council in the first half of 2022. The fact that the French Minister of Agriculture, Julien Denormandie, purportedly is a supporter of NGTs suggests that the intended policy action will move forward quickly under the French precedency.</p><p>In regards to other NGTs or applications in microorganisms and animals, however, the study found that safety data are mainly available for genome editing in plants. While the study emphasized the need to build up relevant data in these areas too, for the time being legislation is likely not going to change. Considerations related to the use of NGTs in medicinal products will be addressed in the context of the <a target="_blank" href="https://lifesciences.mofo.com/topics/The-European-Commissions-New-Pharmaceutical-Strategy-for-Europe.html">Commission’s Pharmaceutical Strategy</a>.</p><p>We are going to keep you informed about any progress on this matter.</p><p><em>Kilian Popov</em>, <em>Berlin Associate, and Jin Ito, Berlin Trainee Solicitor, contributed to the writing of this article.</em></p>

<p>The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16</p>