CJEU rules that mutated organisms are covered by the GMO Directive
Last week, the CJEU ruled that organisms obtained by mutagenesis are genetically modified organisms (GMOs) and are, in principle, subject to the obligations laid down by the GMO Directive. The implication of this decision is that products produced by gene-editing techniques, such as CRISPR/Cas-9, will be subject to the same regulations as transgenic organisms. The Agritech industry has met the CJEU decision with dismay, arguing that it will further stifle agribiotech innovation in the EU.
Gene editing and transgenics
IPKat followers will be familiar with the on-going patent disputes on both sides of the Atlantic concerning CRISPR/Cas-9 (IPKat post here). Gene editing technologies such as CRISPR/Cas-9 can be used to efficiently mutate the genome of plants and animals. Before the development of gene editing technologies, new plant products were produced by insertion of large sections of foreign DNA into an organism's genome (transgenics). For example, a pesticide resistant crop may be produced by insertion of a pesticide resistance gene from a naturally resistant plant into the genome of the crop plant. Conventional genetic mutation techniques were not suited for performing large alterations to the genome, but were used to produce random mutations, followed by screening and selection for a desirable phenotype. By contrast, gene editing technologies enable researchers to precisely change the genetic sequence by targeted mutation.
Non-human genetically modified organisms (transgenic or mutated) may be patented under the European Patent Convention, in contrast to organisms produced by "essentially biological processes" such as natural breeding methods (IPKat post here). Until the latest CJEU decision, gene edited plants were excluded from the EU's restrictive legislation relating to GMO's, and therefore possessed a clear commercial advantage over transgenic products.
The GMO Directive
The purpose of Directive 2001/18/EC on the deliberate release of GMOs into the environment (the "GMO Directive"), and Implementing Regulation (EU) No 503/2013, was to control the risk from GMOs to human health and the environment within the EU. Under the Directive, parties wishing to cultivate and sell GMO's must apply for authorization (See here for a helpful flowchart: "EU decision-making process explained").
The GMO Directive regulates the use and sale of GMO's within the EU. Organisms falling within the Directive can only be released into the environment or placed on the market following an environmental risk assessment and public consultation. Registration of GMO organisms and labeling of GMO products is also compulsory.
The GMO Directive also includes a "safeguard clause" (Article 23) allowing Member States to restrict the use and sale of GMOs previously approved by the EU (in line with Article 191(2) of the Treaty on the Functioning of the European Union (TFEU). Article 191(2) requires that, under the "precautionary principle", preventive action should be taken to avoid environmental damage. Consequently, even if a GMO product is authorised, Member States can opt-out and restrict or ban a GMO product. This opt-out provision has been widely used (full list of opt-outs by Member States here).
The GMO Directive excludes organisms obtained by mutagenesis from the definition of a GMO (Annex I B). The reasoning behind this exclusion was to prevent the stringent requirements of the Directive being applied to organisms produced by traditional, non-targeted mutagenesis techniques that had long been widely available.
Impact of the GMO Directive
The EU GMO authorization procedure represents one of the most stringent regulations on the cultivation of GMO foods in the world. Whilst many GMO foods and products have been approved in the EU for import and sale (GMO Register), Directive 2001/18/EC allows Member States to restrict or ban cultivation of EU authorized GMO products in their territories. Where Member States choose to ban cultivation of a GMO product, it appears the decision is often based on political motives, particularly given that the European Food Safety Authority (EFSA) will have already given the green-light to the product in question. It is widely recognized that the EU legislation on GMO Products (and that of particular Member States) has had a significant dampening effect on the agribiotech industry within the Union.
National proceedings
In France, the agricultural union Confédération paysanne, in conjunction with 8 other parties, sought annulment of the provision of the French Code de l’environnement (Environmental Code) corresponding to the mutagenesis exclusion of the GMO Directive (Article D. 531-2). Confédération paysanne argued that:
The Conseil d’État stayed proceedings and referred to the CJEU the question of whether organisms obtained by mutagenesis are covered by the Directive despite the exemption of Annex I B. The French court also asked the CJEU whether, according to the precautionary principle of Article 191(2) of the TFEU, member states have discretion to define the regime to be applied to organisms obtained by mutagenesis, regardless of Annex IB exclusion of the GMO Directive.
Preliminary ruling
In a preliminary ruling earlier this year, the Advocate General Michal Bobek was of the opinion that mutagenesis techniques meeting the criteria laid down in Article 2(2) are exempt from the obligations of the GMO Directive, provided that they do not introduce foreign DNA (i.e. that they satisfy the criteria of Annex I B). The Advocate General was also of the opinion that the GMO Directive does not prevent member states from introducing their own ban on organisms obtained by mutatagenesis according to the precautionary principle, given that the intention of the GMO Directive was not to stipulate that all mutated organisms are safe.
The preliminary ruling of the Advocate General was greeted with cautious optimism by many within the agritech industry.
CJEU Decision
In a dramatic turn-around, on 25th July 2018, the CJEU ruled that organisms obtained by mutagenesis are GMOs and are subject to the obligations laid down by the GMO Directive. The CJEU also particularly ruled that GMO Directive applies to organisms obtained by mutagenesis techniques that have been developed since adoption of the GMO Directive, reasoning that these techniques can now be used to produce organisms similar, from a risk perspective, to those that can be produced using transgenic methods.
In answer to the specific referred question as to whether organisms obtained by mutagenesis are excluded from the GMO Directive by Annex IB, the CJEU first noted that, under EU law, the GMO Directive should be interpreted by consideration of not only its wording "but also the context in which it occurs and the objectives". The Court noted that the objective of the wording of Annex IB was to exclude organisms that are "obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record".
However, the CJEU reasoned, the GMO Directive should be interpreted as applying to organisms obtained by mutagenesis techniques that have been developed since adoption of the GMO Directive, given that these techniques can now be used to produce organisms similar (from a risk perspective) to those that can be produced using transgenic methods. The CJEU concluded that:
In view of its answer to the first question, the CJEU considered it unnecessary to answer whether Member States had the right to introduce their own ban on organisms obtained by mutagenesis according to the precautionary principle.
Perspective
Gene editing technologies are immensely valuable from a research perspective. The relatively permissive regulatory environment for the cultivation of gene edited organisms in the EU also provided a clear commercial advantage to the technologies over transgenics. The CJEU decision has been so far met with dismay by the industry, with the outcry that "classification of genome-edited organisms as falling under the GMO Directive could slam the door shut on this revolutionary technology" (source: Rothamsted Research). Are we likely to see a falling-off in European patent filings directed at gene edited organisms? At the very least, we may expect the urgency to specifically claim a gene edited form of GMO products to lessen.
Following the EPO decision last year in Tomatoes II G 2/12 and Broccoli-II G 2/13, together with the latest CJEU decision, the agritech industry faces ongoing challenges to the development of new plant products in the EU. On the one hand, plants and plant products produced by "natural" breeding methods cannot be protected under the patent system, whilst plants and plant products produced by transgenic, and now gene editing, techniques, are subject to crippling legislation. The EPO and EU must of course balance the promotion of innovation with ethical concerns regarding genetic modification, but has the right balance been struck?
Author: Rose Hughes
Gene editing and transgenics
IPKat followers will be familiar with the on-going patent disputes on both sides of the Atlantic concerning CRISPR/Cas-9 (IPKat post here). Gene editing technologies such as CRISPR/Cas-9 can be used to efficiently mutate the genome of plants and animals. Before the development of gene editing technologies, new plant products were produced by insertion of large sections of foreign DNA into an organism's genome (transgenics). For example, a pesticide resistant crop may be produced by insertion of a pesticide resistance gene from a naturally resistant plant into the genome of the crop plant. Conventional genetic mutation techniques were not suited for performing large alterations to the genome, but were used to produce random mutations, followed by screening and selection for a desirable phenotype. By contrast, gene editing technologies enable researchers to precisely change the genetic sequence by targeted mutation.
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| Transgenic Kat (Wongsrikeao et al.) |
The GMO Directive
The purpose of Directive 2001/18/EC on the deliberate release of GMOs into the environment (the "GMO Directive"), and Implementing Regulation (EU) No 503/2013, was to control the risk from GMOs to human health and the environment within the EU. Under the Directive, parties wishing to cultivate and sell GMO's must apply for authorization (See here for a helpful flowchart: "EU decision-making process explained").
The GMO Directive regulates the use and sale of GMO's within the EU. Organisms falling within the Directive can only be released into the environment or placed on the market following an environmental risk assessment and public consultation. Registration of GMO organisms and labeling of GMO products is also compulsory.
The GMO Directive also includes a "safeguard clause" (Article 23) allowing Member States to restrict the use and sale of GMOs previously approved by the EU (in line with Article 191(2) of the Treaty on the Functioning of the European Union (TFEU). Article 191(2) requires that, under the "precautionary principle", preventive action should be taken to avoid environmental damage. Consequently, even if a GMO product is authorised, Member States can opt-out and restrict or ban a GMO product. This opt-out provision has been widely used (full list of opt-outs by Member States here).
The GMO Directive excludes organisms obtained by mutagenesis from the definition of a GMO (Annex I B). The reasoning behind this exclusion was to prevent the stringent requirements of the Directive being applied to organisms produced by traditional, non-targeted mutagenesis techniques that had long been widely available.
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| Kat made from a plant product |
The EU GMO authorization procedure represents one of the most stringent regulations on the cultivation of GMO foods in the world. Whilst many GMO foods and products have been approved in the EU for import and sale (GMO Register), Directive 2001/18/EC allows Member States to restrict or ban cultivation of EU authorized GMO products in their territories. Where Member States choose to ban cultivation of a GMO product, it appears the decision is often based on political motives, particularly given that the European Food Safety Authority (EFSA) will have already given the green-light to the product in question. It is widely recognized that the EU legislation on GMO Products (and that of particular Member States) has had a significant dampening effect on the agribiotech industry within the Union.
National proceedings
In France, the agricultural union Confédération paysanne, in conjunction with 8 other parties, sought annulment of the provision of the French Code de l’environnement (Environmental Code) corresponding to the mutagenesis exclusion of the GMO Directive (Article D. 531-2). Confédération paysanne argued that:
"the use of herbicide resistant seed varieties obtained by mutagenesis carries a risk of significant harm to the environment and to human and animal health. It leads to an accumulation of carcinogenic molecules or endocrine disruptors in cultivated plants intended for human or animal consumption...moreover, to the risks of unintentional effects, such as undesired or off-target mutations on other parts of the genome".Confédération paysanne thus sought revocation of Article D. 531-2 and the ban of herbicide resistant seeds produced by mutagenesis. Confédération paysanne further argued that the mutagenesis exclusion was at odds with Article 2 of the GMO Directive, which defines a 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".
The Conseil d’État stayed proceedings and referred to the CJEU the question of whether organisms obtained by mutagenesis are covered by the Directive despite the exemption of Annex I B. The French court also asked the CJEU whether, according to the precautionary principle of Article 191(2) of the TFEU, member states have discretion to define the regime to be applied to organisms obtained by mutagenesis, regardless of Annex IB exclusion of the GMO Directive.
Preliminary ruling
In a preliminary ruling earlier this year, the Advocate General Michal Bobek was of the opinion that mutagenesis techniques meeting the criteria laid down in Article 2(2) are exempt from the obligations of the GMO Directive, provided that they do not introduce foreign DNA (i.e. that they satisfy the criteria of Annex I B). The Advocate General was also of the opinion that the GMO Directive does not prevent member states from introducing their own ban on organisms obtained by mutatagenesis according to the precautionary principle, given that the intention of the GMO Directive was not to stipulate that all mutated organisms are safe.
The preliminary ruling of the Advocate General was greeted with cautious optimism by many within the agritech industry.
CJEU Decision
In a dramatic turn-around, on 25th July 2018, the CJEU ruled that organisms obtained by mutagenesis are GMOs and are subject to the obligations laid down by the GMO Directive. The CJEU also particularly ruled that GMO Directive applies to organisms obtained by mutagenesis techniques that have been developed since adoption of the GMO Directive, reasoning that these techniques can now be used to produce organisms similar, from a risk perspective, to those that can be produced using transgenic methods.
In answer to the specific referred question as to whether organisms obtained by mutagenesis are excluded from the GMO Directive by Annex IB, the CJEU first noted that, under EU law, the GMO Directive should be interpreted by consideration of not only its wording "but also the context in which it occurs and the objectives". The Court noted that the objective of the wording of Annex IB was to exclude organisms that are "obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record".
However, the CJEU reasoned, the GMO Directive should be interpreted as applying to organisms obtained by mutagenesis techniques that have been developed since adoption of the GMO Directive, given that these techniques can now be used to produce organisms similar (from a risk perspective) to those that can be produced using transgenic methods. The CJEU concluded that:
"excluding organisms obtained by new mutagenesis techniques from the scope of the GMO Directive would compromise the objective pursued by that directive, which is to avoid adverse effects on human health and the environment, and would fail to respect the precautionary principle which that directive seeks to implement. "
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| Surveying the new regulatory landscape |
Perspective
Gene editing technologies are immensely valuable from a research perspective. The relatively permissive regulatory environment for the cultivation of gene edited organisms in the EU also provided a clear commercial advantage to the technologies over transgenics. The CJEU decision has been so far met with dismay by the industry, with the outcry that "classification of genome-edited organisms as falling under the GMO Directive could slam the door shut on this revolutionary technology" (source: Rothamsted Research). Are we likely to see a falling-off in European patent filings directed at gene edited organisms? At the very least, we may expect the urgency to specifically claim a gene edited form of GMO products to lessen.
Following the EPO decision last year in Tomatoes II G 2/12 and Broccoli-II G 2/13, together with the latest CJEU decision, the agritech industry faces ongoing challenges to the development of new plant products in the EU. On the one hand, plants and plant products produced by "natural" breeding methods cannot be protected under the patent system, whilst plants and plant products produced by transgenic, and now gene editing, techniques, are subject to crippling legislation. The EPO and EU must of course balance the promotion of innovation with ethical concerns regarding genetic modification, but has the right balance been struck?
Author: Rose Hughes
