Mutual trust and independence of the judiciary after the CJEU judgment in LM – new era or business as usual?

Dr hab Agnieszka Frąckowiak-Adamska, Faculty of Law, University of Wroclaw

In case C-216/18 PPU LM the CJEU was asked by an Irish court to address one of the most serious current legal challenges of the EU: the consequences of restrictions imposed upon judicial independence in one Member State for other Member States of the Union. The sequence of laws adopted in 2015-2018 in Poland has been assessed commonly by various external and internal institutions as “enable(ing) the legislative and executive powers to interfere in a severe and extensive manner in the administration of justice and thereby pos(ing) a grave threat to the judicial independence as a key element of the rule of law” (quotation from the Venice Commission). Consequently, to protect the rule of law in Europe, the European Commission submitted for the first time in the history a reasoned proposal activating the Article 7 TEU mechanism. Two infringement procedures based on Article 258 TFEU against Poland are also ongoing (on the law on the ordinary courts organisation - C-192/18 and on the law on the Supreme Court). The Supreme Court itself has also asked the CJEU to rule on the latter issue (see discussion here).

Is the organisation of the judiciary in Member States the EU’s business?

The Polish reforms are problematic for the EU because national courts are to ensure “the full application of European Union law (…) and (…)  judicial protection of an individual’s rights under that law” (Opinion 1/09, § 68). If politicians can influence courts’ decisions, they can use this leverage to pursue sheer protectionism, instead of advancing the interests linked to the EU internal market and citizenship. In addition, deficiencies of judicial independence in one Member State entail problems for the courts in other Member States, as the latter are obliged by EU law to recognize and enforce judicial decisions coming from other EU Member States. Should the courts trust the judgments from the State in which the division of powers is blurred?

Many questions arise in this context. Member States and their legal orders differ as to the substance and procedures, ways and level of protection of fundamental rights, court organisation and the expediency of proceedings. These differences are treated as diversity and have not prevented the EU from establishing the European area of justice based on mutual trust and mutual recognition of judgments. How to find the limits of States’ freedom to organise their judiciary? How to differentiate between a “reorganisation” and a breach of the rule of law? Is the EU (and if yes, who exactly – Council, CJEU?) legitimized to make such a decision? And what consequences should be drawn if a breach of the rule of law is established?

These issues can be important for all 24 EU acts introducing mutual recognition of judgments (14 regulations on civil cases and 10 framework decisions and 2 directives on criminal cooperation). The LM case arose in the context of one of them – the European Arrest Warrant (EAW) Framework Decision.

The preliminary reference in the LM case

In the Irish case, in which the EAW was issued by a Polish judicial authority against a person prosecuted for a drug related crime, the defendant argued that, due to the reforms of the Polish judiciary, there is a risk of denial of justice if he is transferred to Poland. Consequently, the Irish court premised its preliminary question to the CJEU on the right to fair trial. As at this time Poland was already subject to the stage of a reasoned proposal by the Commission as referred to in Article 7(1) TEU (which would, if adopted by the Council, have established a risk of a threat to the rule of law in Poland), the Irish court asked whether in case of “cogent evidence that conditions in the issuing Member State are incompatible with the fundamental right to a fair trial because the system of justice itself in the issuing Member State is no longer operating under the rule of law” it should “make any further assessment, specific and precise, as to the exposure of the individual concerned to the risk of unfair trial”. Such a two-prong test (first - “systemic deficiencies in the state”, and second – “actual risk in an individual case”) was established by the CJEU in the Aranyosi judgment (discussed here), which also related to the protection of fundamental rights in the context of mutual recognition of judgments, in the context of detention conditions.

In the LM case the CJEU could answer the question in three different ways. First, it could refrain from assessing the impact of the restrictions of judicial independence on the EAW mechanism (following Poland’s argument that only the Council is empowered to do so, on the basis of Article 7 TEU). Second, it could follow the Aranyosi pattern, ie the two-step test. As the last alternative, it could allow to suspend the cooperation with a Member State which breaches the obligation to ensure the independence of its courts. This last possibility could seem all the more likely path towards deciding the LM case after the Court issued its recent decision in the case of Associação Sindical dos Juízes Portugueses (discussed here), in para 37 of which it stated that the obligation of judicial independence stems from the EU law.

Judgment in the LM case 

Maybe because of time constraints (as the due urgent procedure applied) or maybe due to an unwillingness of the CJEU to become dragged down into a political brawl, the Luxembourg institution took the safest path of applying to the case the already existing pattern (Aranyosi).

According to the judgment of 25 July 2018 in the LM case, national courts should apply both steps of the Aranyosi test when judicial independence in the issuing country is endangered. If the executing court possesses a strong evidence of systemic or generalised deficiencies in this respect, it should proceed to the second step – of individual case assessment. The CJEU indicated that suspending the mechanism of recognition is possible only if the decision on the basis of Art. 7 TEU is taken (§§ 71 -73 of LM).

Until this moment even if a Member State is subject to a reasoned proposal, as referred to in Article 7(1) TEU, “the executing judicial authority must refrain from giving effect to the European arrest warrant” only if there are substantial grounds for believing that that person will run a real risk of a breach of the fundamental right to a fair trial (§ 78 and 59). However, there is one important novelty (stemming from §§ 60 and 68 of LM) - the fact of starting the Article 7 TEU procedure rebuts the presumption of mutual trust as the individual assessment is required in every case in which the person subject to EAW pleads it.

By the same token, the Court found itself competent to tackle the issue of judicial independence, but only from the perspective of the protection of an individual. It did not determine any systemic consequences of limiting the judicial independence for judicial cooperation. The issue of judicial independence was thus treated as a part of a right to a fair trial protected by Article 47 of the Charter. The answer was based on the interpretation of Article 1 (3) of the EAW framework decision, which states that this act shall not modify “the obligation to respect fundamental rights and fundamental legal principles as enshrined in Article 6” [TEU] (nota bene interesting from the Freudian perspective is that the CJEU did see in this provision also the reference to Article 2 TEU (§ 45 of LM), which sets out the values of the EU enforced by the Article 7 process, even though Article 1(3) mentions only Article 6 TEU, which refers to the mechanisms for the protection of human rights within the EU legal system).

The reasoning of the court unfolds in three parts.

Firstly (§§ 33-46) the CJEU reminds of the fundamental values and principles which are at stake in the case – Article 2 TEU, mutual trust, and mutual recognition principles. Then it confirms that the execution of the EAW constitutes a rule and can be refused only when one of the grounds of refusal exhaustively listed by the Framework Decision materialises. Additionally, the executing judicial authority has the power to bring the surrender procedure to an end ‘in exceptional circumstances’, when limitations are placed on the principles of mutual recognition and mutual trust.

In the second part (§§ 47-59) the CJEU verifies whether a risk of a breach of the fundamental right to an independent court can justify a limitation of the mutual trust and permit the executing judicial authority to refrain from giving effect to an EAW. This highlights the importance of judicial independence as a part of a right to fair trial and the rule of law. It repeats the statements made by the Court in Associação Sindical dos Juízes Portugueses i.a. that it is an obligation of Member States to ensure that their courts which “come within its judicial system in the fields covered by EU law” meet the requirements of effective judicial protection. Only if there is a real risk that the person will suffer a breach of his fundamental right to an independent tribunal and, therefore of the essence of the right to a fair trial, can the executing judicial authority to refrain, by way of an exception, from giving effect to the EAW (§ 59).

For national courts and individuals the most important part of the judgment are paras 60-78, which instruct the former on how to proceed if the person in respect of whom an EAW has been issued pleads that there are systemic or generalized deficiencies in the independence of courts in the issuing state. The procedure is not left to the discretion of the executing authority. In such a case the executing authority is required to make an assessment of the risk in the individual case (§ 60). The assessment consists of two steps – a systemic assessment (§ 61-68) and a specific one (§ 69-78).

The first step (a systemic assessment) should be done by the executing authority on the basis of “objective, reliable, specific and properly updated” information and according to the criteria of judicial independence set out by the CJEU in §§ 62-67 of the LM case. If this assessment implies the conclusion that there is a real risk of systemic or generalised deficiencies of judicial independence there, the court is obliged to pass to a specific assessment. The executing authority does not have to make its own assessment if the issuing state is subject to reasoned proposal as referred to in Article 7(1) TEU, and “the executing judicial authority considers that it possesses, on the basis, in particular, of such a proposal, material showing that there are systemic deficiencies, in the light of those values, at the level of that Member State’s judiciary” (§ 68). In such a case also the executing authority should pass to the second step.

The second step (specific assessment) aims to verify whether in the particular circumstances of the case there are substantial grounds for believing that, following the surrender to the issuing Member State, the requested person will run a real risk of a breach of the fundamental right to a fair trial (§ 69-78). The court should verify firstly “to what extent the systemic or generalised deficiencies are liable to have an impact at the level of that State’s courts with jurisdiction over the proceedings to which the requested person will be subject” (§ 74). In case of a positive answer, it should assess whether there is a real risk of a breach of his fundamental right to an independent tribunal, having regard to his or her personal situation, the nature of the offence for which he or she is prosecuted and the factual context that forms the basis of the European Arrest Warrant.

It can perform this assessment on the basis of (§§ 75-78): 1) specific concerns expressed by the individual concerned and any information provided by him or her; 2) any supplementary information obtained from the issuing judicial authority in the answer to the (mandatory) request made by the executing authority’; and 3) (optional) assistance from the central authority or one of the central authorities of the issuing Member State.

If the information obtained in such a way by the executing judicial authority “does not lead the latter to discount the existence of a real risk (…) (for the individual concerned) “the executing judicial authority must refrain from giving effect to the European arrest warrant” (§ 78).

Assessment of the LM judgment

It is difficult to assess the LM judgment in an unequivocal way (see the debate on Verfassungblog). The Luxembourg court is praised by some for confirming its competence to tackle the issue of the independence of judiciary and for its judicial prudence. It is criticized by others for not setting systemic consequences of the breach of independence but also for a definition of judicial independence which is too detailed and disconnected from the ECHR’s.

Certainly, the LM judgment did not halt the Polish “reforms”. Instead it allowed to rebut the presumption of mutual trust if a Member State is subject to a reasoned proposal provided by Article 7(1) TEU. In such a case the individual assessment is required in every case in which it is pleaded. But it means that the executing authorities would have to make embarrassing investigations about the substantial issues of the cases and of the division of powers in Poland. In my opinion (developed here), it can contravene the spirit of mutual trust between the courts and often will be impossible in practice. Arguably the CJEU should have focussed not only on the protection of individuals but also on the interests of other States and the EU at large. In the LM case the CJEU acted like the Court of Human Rights which is always very welcome. But it is not enough to stand up against the destruction of the rule of law in Europe. Maybe in next cases – either based on the Article 258 TFEU infringement procedure or following the preliminary reference from the Polish Supreme Court it will show also its other face – this of a constitutional court of the EU.

But the LM judgment can also be seen as an important development of the case law related to the protection of fundamental rights in the context of mutual recognition. At least some questions arising after the Aranyosi decision have been answered. It is now clear that not only an infringement of Article 4 of the Charter (on freedom from torture or other inhuman or degrading treatment, in the context of detention conditions) but also of the essence of Article 47 (which is always at stake when the judicial independence is limited) can justify refraining from the execution of the EAW. However, it is to clarify whether the EAW should not be executed also in case of the risk of the breach of further fundamental rights e.g. a right to a private and family life. The detailed analysis on the issue whether the right to the fair trial is capable of limiting the execution of EAW (§§ 47-59) suggests that it is not certain that every right protected by the Charter can have this effect.

Other aspects to be clarified in the future are what “refraining from giving effect to the EAW” exactly means and whether the systemic deficiencies are a prerequisite to apply the individual test. The Aranyosi and LM cases are related to systemic deficiencies, but their conclusion is that what is always required to be performed is the individual risk test. The development of the case law on another aspect of the Area of Freedom, Security and Justice – the common European asylum system – shows that the transfer of an asylum seeker to another Member State should be refused if there is a risk of the person concerned suffering inhuman or degrading treatment even if there are no systemic deficiencies (case C-578/16 PPU, C.K., discussed here). The open question is whether the same pattern will apply to the EAW and to other fundamental rights.

My final point is that the non-execution of EAWs based on an individual test is not capable to resolve the essence of the problems with fundamental rights and judicial independence. It often results in an impunity for the requested person, which constitutes a severe consequence for others (victims) and for the public interest. Moreover, it can save fundamental rights of individuals partly only. The parallel judgment in Case C-220/18 PPU ML confirms this conclusion, as it limits the meaning of the Aranyosi assessment of detention conditions in the issuing Member State to the first prisons in which the person concerned will be held immediately after the surrender. The CJEU admitted that “since a person who is the subject of a European arrest warrant can, as a general rule, be detained in any prison in the territory of that State. It is generally not possible at the stage of executing a European arrest warrant to identify all the prisons in which such a person will actually be detained” (§ 81 of ML). In reality, therefore, the individual is not wholly protected against inhuman treatment. The same limitation is seen already in LM judgment according to which the executing authority should verify “to what extent the systemic or generalised deficiencies (..) are liable to have an impact at the level of that State’s courts with jurisdiction over the proceedings to which the requested person will be subject.” (§ 74 of LM).

The non-execution of EAWs should be treated as a signal of serious problems and the EU should reflect how to solve their sources. Here there is a clear difference between prison conditions and the independence of the judiciary. In the case of a breach of fundamental rights (Aranyosi) the reason laying at the heart of the breach was a serious structural incapacity of some Member States to ensure the proper standard of detention conditions in prisons. Improving this capacity is a long, costly and complicated process, which the EU could only stimulate and support. In the case of independence of judges in Poland the source of the problem is the will of the governing party. The problem could be very easily and quickly resolved by withdrawing the reforms related to courts, according to the recommendations of the Venice Commission/European Commission. The only thing that the EU can (and should) do is to set clear limits as to the rule of law and the consequences of trespassing them. If the EU had done it earlier addressing Hungary, the Polish government would not have dared to follow the Hungarian path.

Barnard & Peers: chapter 9, chapter 24

JHA4: chapter II:3

Photo credit: CNBC.com

EU law and genetic mutations: does a recent CJEU ruling show an irrational fear of mutation?

A recent CJEU judgment has made it more complicated to develop plants which have been cross-bred by mutagenic breeding. Two contributions to the blog (from Kathleen Garnett and Felix Beck) examine the judgment from different angles.  

Confédération Paysanne & Others, Case C-528/16: GMO cabbage or plain old cabbage?

Kathleen Garnett, Consultant and writer on EU government and law

In September 2016 Stefan Jansson, professor in Plant Cell and Molecular Biology at Umeå University in Sweden sat down to a meal of cabbage and pasta, which he shared with a good friend. Prof Jansson had grown the cabbage successfully in the back of his garden in Sweden using conventional cottage-garden husbandry. He claimed it was a historic first – no one else on planet earth (to the best of his knowledge) had ever eaten a CRISPR Cas-9 cabbage. He obtained the mutagenic cabbage seed from a scientist abroad (who preferred to stay anonymous).

Two years on and Prof Jansson along with many of his colleagues in the scientific community are hugely disappointed with the European Court of Justice’s ruling on mutagenic plants, which came out on 25 July 2018. Commenting on his cabbage in Nature Jansson noted “I took a photo yesterday, and I took another after the ruling. It’s still the same plant. Yesterday it wasn’t a GMO, and now it’s a GMO. I’m a bit curious what I have to do. Do I have to remove it?”

The CJEU’s ruling in the Confédération Paysanne & Others case has led to derision within the scientific community. Some have called the decision “catastrophic”, others “absurd". In this piece I set out the exact legal reasoning of the judgment. Since this case concerns a very specific form of plant breeding technique called “mutagenesis”, I briefly explain what is meant by mutagenesis in order to place the case in context.

Background on transgenesis and mutagenesis

The two most common methods for scientist to change the DNA structure of plants through artificial means are transgenesis and mutagenesis.

Transgenesis occurs when scientists transfer a gene from one species into the genome of another species. This happens through highly sophisticated, scientific techniques, such as the use of a gene gun or through the use of soil bacteria.

Cross-breeding between species does not occur in nature. A dog cannot mate with a cat and produce off-spring because they are from a different species. Similarly, in nature an apple cannot cross-breed with a grass because of the species barrier. Species which are closely related can produce off-spring but the off-spring are infertile – as is the case with the mule.

Through transgenesis, however, bio-engineers have been able to cross the species barrier by inserting the DNA from one species into another species to produce crops with enhanced traits that are capable of replicating. Transgenic techniques (although not defined in the Directive as such) are described in Annex I A, Directive 2001/18 (the EU law on GM foods) as:

-          recombinant nucleic acid techniques involving the formation of new combination of genetic material by the insertion of nucleic acid molecules produced by whatever means outside of an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;

-          direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation;

-          cell fusion (including protoplast fusion) or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally. (emphasis added in all cases).

In the US many maize, soya-beans, corn and cotton seeds are grown using this technology. Over 40% of US agricultural land cultivates transgenesis crops. In the EU there is only one commercial variety of transgenesis crop – the Mon 819 – which was approved in 1998 before the 2001 GMO Directive. Although cultivation of GMO crops in the EU is low to non-existent the EU does, nevertheless, import huge amounts of GMO soya beans for animal feed from over-seas.

By contrast, mutagenesis does not require the transfer or insertion of foreign DNA but it can alter the genetic make-up of a living organism. Mutation is generally defined as, “a process by which the genetic information of an organism is changed in a stable manner, resulting in a mutation.” More simply put, “having the ability to cause a permanent change in an organism’s genes”.

Mutations, as some of us may remember from our school biology classes, can occur spontaneously and randomly in nature every few generations or so. Mutations can also occur spontaneously as a result of background influences such as errors in DNA replication, environmental chemicals and radiation. Since the 1960s a number of scientists have been looking to induce rapid, unnatural mutation in plants in order to improve certain plant characteristics by, for example, making citrus fruit sweeter, with fewer seeds and thinner skins as with the KinnowLS.

I would like to stress at this stage that “mutant” plant is the scientific term for these particular novel plants. It is not an attempt to use alarmist terminology for the sake of a “click-bait” headline. It is the official term used for these novel plants by scientists themselves. Indeed, the international organisation responsible for cataloguing these novel plants (the FAO/IAEA) refers to its list of mutagenic plants as “The Mutant Variety Database” with applicants asked on the registration form to list their new “mutant” variety.

Conventional mutagenesis

In 2001 mutagenesis relied on two primary methods to induce rapid, forced, plant mutation: the use of mutagenic chemicals, or the application of ionizing radiation. For the purposes of this piece I shall refer to these two specific forms of technology as “conventional” mutagenesis.

When the GMO Directive was drafted the EU opted to exempt conventional plant mutagenesis from the Directive (2001/18/EC, Annex 1 B), presumably because it was a form of technology that has been “conventionally used” and has a “long safety record” (recital 17, Directive 2001/18/EC). As the Flemish Institute for Biotechnology states, conventional, in vito, mutagenesis creates thousands of mutant plants the vast majority of which are useless in that they either show undesirable product defects or are simply non-viable. Only a few new plants bred out of conventional mutagenesis show enhanced traits. It is the latter group of mutant plants which, in 2001 were exempted from the GMO Directive. For the past 17 years those working on classical mutagenesis have placed over 46 varieties of mutant herbicide resistant sunflower and six varieties of mutant herbicide resistant rape seeds on the EU catalogue of common plant varieties without having to undergo the stringent risk assessment procedures set out in the GMO Directive.

Novel mutagenesis

In the past decade, technological advances in mutagenesis have ensured that the technology no longer relies on either mutagenic chemicals or ionising radiation to affect artificial mutation in plants. A number of novel, directed and very precise technologies have emerged in the field of mutagenesis, which include:

-          site-directed nucleases (SDN) (including ZFN-1/2/3 and CRISPR systems);

-          oligonucleotide directed mutagenesis (ODM);

-          cisgenesis;

-          RNA-dependent DNA methylation (RdDM);

-          Grafting (non-GM scion on GM rootstock);

-          reverse breeding; and

-          agro-infiltration.

An amateur gardener’s shed may have a paint brush with which to brush the pollen from one plant onto the pistil of a sexually compatible plant, producing a hybrid that carries genes from both parents. In the case of novel, directed mutagenesis, however, this would be impossible. It requires highly sophisticated scientific technique to create a novel seed using these methods. No hobby, amateur gardener would have the sophisticated equipment needed to create a CRISPR Cas-9 cabbage seed. The eye alone is unable to distinguish the difference between a CRSIPR Cas-9 cabbage on the one hand and a natural, conventional cabbage on the other – only scientists using specialized DNA profiling would be able to identify the difference. Thus, although growing plants from mutagenic seeds can be done in a traditional, conventional manner (as Prof Jansson proves) the production of the seed is all but traditional or conventional.

Questions referred to the CJEU

In 2015 a small, not-for-profit organisation Confédération Paysanne together with eight other associations concerned with the protection of the environment and the dissemination of GMO information asked the then French Prime Minister to ban the cultivation and marketing of herbicide tolerant rape varieties created through the use of classical mutagenic techniques. Advocate General Bobek summarises the applicant’s concerns as follows:

“For the Applicants 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. The applicants refer, moreover, to the risks of unintentional effects, such as undesired or off-target mutations on other parts of the genome. They consider that this is the result of the techniques employed when modifications of the genome takes place in vitro and for the regeneration of plants from the cells thus modified.”

The French Prime Minister refused their request, so the applicants appealed to the French Conseil d’État. Feeling that this was a matter of EU interpretation the Conseil d’État referred the case to the CJEU asking, in summary, whether plants created as a result of novel, directed mutagenesis (i.e. those developed post 2001):

-          fall under the definition of a GMO as set out in Article 2, Directive 2001/18/EC, Article 2(2) Directive 2001/18 defines "genetically modified organism (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”;

-          are exempted from the impact assessment and traceability measures required of transgenic GMO’s in Directive 2001/18/EC; my review in this post focuses on these first two questions which have caused most controversy in the scientific community;

-          constitute GMO’s within the meaning of Article 4 of the Directive 2002/53/EC establishing a European common catalogue of agricultural plant species varieties;

-          constitute a harmonising measure prohibiting member states to all or some of the obligations laid in the GMO Directive – or do member states have some discretion to set the regime for organisms obtained by mutagenesis; and

-          fall under the precautionary principle guaranteed by Article 191 (2) [TFEU]?

Advocate General Bobek’s Opinion

In January of this year A.G. Bobek took a narrow interpretation of the GMO Directive. He agreed that novel, directed mutagenesis techniques fall under the definition of a GMO (Opinion at para 56) - but they are nevertheless exempted from the precautionary principle and the other stringent requirements set out in 2001 by virtue of the Annex I B exception (at para 56 and at para 81).

In Bobek’s opinion, the EU intended to exclude all forms of mutagenesis from the GMO Directive - past, present and future.  Bobek opined that in 2001 the EU understood that technology does not stand still and that its decision to exempt “mutagenesis” from the Directive’s obligations would apply to all future mutagenic technology regardless of novel techniques.

“The Applicants and several other interested parties have, to a great extent, relied on recital 17 to reach the conclusion that the EU legislature only intended to exempt safe mutagenesis techniques. I cannot agree. Neither the text, nor the historical context, nor the internal logic of the GMO Directive supports that proposition.” (at para 90 and at para 91).

The GMO Directive referred to transgenic GMOs only through Annex I A and as such it is only that sort of plant breeding to which the Directive applies. Had the intention in 2001 been to include all new plant breeding techniques in the Directive’s stringent obligations and requirements, the legislature would not have created the Annex I B exemption referring specifically to mutagenesis. In short, all mutagenic plants – both conventional and novel are exempt from the stringent requirements set out in the 2001 GMO Directive. As a result, mutant plants could be placed on the European catalogue of common agricultural plant varieties without the need for applying the GMO requirements set out in the Directive establishing the catalogue. In answer to the harmonisation question Bobek stated that the 2001 GMO Directive does not preclude member states from adopting measures governing mutagenesis, provided that, “in so doing they respect the overarching obligations arising from EU law.” (para 108 ff; sufice to say the CJEU agreed with this part of the Opinion).

CJEU Findings

The CJEU judgment diverged significantly from that of Bobek’s opinion. 

The CJEU ruled:

“Article 2(2) of Directive 2001/18 must be interpreted as meaning that organisms obtained by means of techniques/methods of mutagenesis constitute GMO’s within the meaning of that provision.” CJEU, Judgment, 25 July 2018, C-528/16, (para 54).

To recall, the 2001 Directive on the deliberate release into the environment of GMO’s 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.” Article 2 (2) Definitions 2001/18/EC.

Applying this definition to both transgenic and mutagenic techniques the CJEU rules. “…those techniques/methods alter the genetic material of an organism in a way that does not occur naturally, within the meaning of that provision. It follows that organisms obtained by means of techniques/methods of mutagenesis must be considered to be GMOs within the meaning of Article 2 (2) of Directive 2001/18”  (CJEU, para 29-30). (Emphasis added).

The CJEU further decided that although mutagenesis is not listed as a GMO in Annex I A this does not mean that novel, directed mutagenic techniques should not fall under the definition of GMO’s. The use of the word “inter-alia” in Annex I A suggests “the list of genetic modification techniques in that part is not exhaustive. Consequently, the list cannot be regarded as excluding genetic modification techniques other than those to which it specifically refers.” (CJEU, para 35).

“…only 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 excluded from the scope of the directive.” (CJEU, para 54).

Here the CJEU turns to the Article 3(1) exemptions listed in Annex I B.

Firstly, the mutagenic exemption must be interpreted strictly. The Court here refers to its finding in Białowieża Forest (Commission v Poland) C-441/17, which itself builds upon a trail of precedent in the application of the Habitats Directive. Arguably the first in that line of authority, Case C-239/04 Commission v Portugal, at 35 simply observes the need for strict interpretation of exemptions from general protective regimes. However, it would not be far-fetched to say that the general principles of EU environmental law, in particular the principle of high level of environmental protection and the principles of prevention and precaution, play a role in that approach.

The need for strict interpretation having been established, the Court still required further guidance on how exactly that interpretation is to proceed. The wording of the provisions evidently serves as a first guidance principle. Here, the Directive is not of much help: at 43: the wording of Article 3(1) read in conjunction with the Annex does not on its own provide any conclusive guidance as to the types of techniques /methods that the EU legislature intended specifically to exclude from the scope of the Directive.

Consequently, the CJEU decides to examine the exemption contextually: ex multi: Pinckernelle, C-535/15. The context in which the exclusion is made is clarified in particular by recital 17 of the Directive, which states verbatim ‘this Directive should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record.’ It is not at all surprising therefore that the Court does not extend the exemption to those techniques which do not so qualify: at 47: ‘the referring court is called upon to rule, in particular, on the techniques /methods of directed mutagenesis involving the use of genetic engineering which have appeared or have been mostly developed since Directive 2001/18 was adopted and in respect of which the risks for the environment or for human health have not thus far been established with certainty.

The Court further notes at para 48 that what these techniques purport to do must be taken at face value:

‘…the direct modification of the genetic material of an organism through mutagenesis makes it possible to obtain the same effects as the introduction of a foreign gene into that organism and, secondly, that the development of those new techniques/methods makes it possible to produce genetically modified varieties at a rate and in quantities quite unlike those resulting from the application of conventional methods of random mutagenesis.’ (emphasis added)

This is then where the precautionary principle firmly kicks in, again with reference to the recitals of the Directive: at 49:

…living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers, thereby affecting other Member States. The effects of such releases on the environment may be irreversible. In the same vein, recital 5 of that directive states that the protection of human health and the environment requires that due attention be given to controlling risks from such releases.

At 50:

‘Furthermore, it has been emphasised, in recital 8 of that directive, that the precautionary principle was taken into account in the drafting of the directive and must also be taken into account in its implementation. Emphasis is also placed, in recital 55 of Directive 2001/18, on the need to follow closely the development and use of GMOs.’

The Court need not but repeats at 50 the perfectly logical chain of interpretation that leads to its conclusion: recital 17 explicitly justifies the exemption for mutagenesis by referring to the safety record of conventional mutagenesis. Article 4(1) emphasises the precautionary approach; such approach cannot support inclusion in the exception for new techniques/methods of mutagenesis which have appeared or have been mostly developed since Directive 2001/18 was adopted.

The impact of the Judgment

The ruling is significant for many reasons, primarily because the Directive is no longer restricted to the insertion of foreign DNA into the genome of a living species using the transgenesis technique. Any artificial modification of a plant using novel, directed mutagenesis must also apply the stringent obligations and requirements set out in Directive 2001/18.

Secondly, the terminology used in the ruling opens up the door to many unanswered legal questions. There is enough meat in this judgment to conclude that its reasoning extends not just to transgenic and mutagenic plants but to all forms of novel plant breeding techniques, which are likely to emerge in the foreseeable future.

Consider, for example, the repeated references in Confédération Paysannes to “naturally occurring”, “conventional use”, “at a rate and in quantities quite unlike those resulting from the application of conventional methods” and “long safety record”. The CJEU is at pains to point out that these are not unimportant words to be dismissed as irrelevant when determining the Annex I B exemption. Rather, the judges rule that these terminologies have deliberately and intentionally been woven into the very fabric of the 2001 Directive in order to distinguish them from novel, artificial techniques.

Along these lines, some argue, not unreasonably, that the law should apply to conventional mutagenesis itself (the very technique the Directive and this judgment does exempt) given that the use of mutagenic chemicals and ionising radiation is hardly a “naturally occurring” technique albeit in 2001 it was considered “conventional”. All of this begs the question how much Confédération Paysannes will apply to other novel plant breeding techniques which are sure to emerge in the coming years? If yes, is it even possible to define what is meant by “conventional use”?  Does conventional use refer to ten years, twenty years or five months? If the law understands what “naturally occurring” means is it possible to deduce a definition of “artificial”, “induced” and “forced” technique? All of these considerations could have wider implications on the commercialisation of the EU’s biotechnology policy in the months and years ahead.

Further, unlike AG Bobek, who took a very narrow interpretation of the Annex I B exemption, the CJEU took a far broader approach to the questions referred to it by the Conseil d’Etat. They did so by placing greater emphasis on the Directive’s over-arching objective namely to protect human health and the environment. By focusing on the potentially “irreversible” effect of the release of a mutant plant in the environment the CJEU pulls the law on mutagenic plants – potentially all new plant breeding techniques – firmly back into the orbit of the Directive’s original intention and purpose namely to protect human health and the environment from the unforeseen effects of GMO technology through application of the precautionary principle.

Comments

It should be stressed that the ruling does not stop researchers from continuing to research new plant breeding techniques. They are, however, required to do so in a regulated, controlled environment. Nor, does the ruling end all scientific endeavour in new plant breeding techniques. The risk assessment obligations set out in the Directive are not about gut-feeling. They ensure objective, impartial and transparent scientific analysis. “The environmental risk assessment should be carried out in a scientifically sound and transparent manner based on available scientific and technical data.” (Annex II Principles for the Environmental Risk Assessment B, 2001/18/EC). Prof. Jansson’s Plant Cell and Molecular Biology Department at Umeå University in Sweden will still be able to conduct research into plant mutagenesis – but probably not in a Professor’s back garden.

What the ruling does impact on, however, is the ease with which industry can commercialise novel, mutagenic plants in the EU. I would like to re-emphasise at this point that this ruling does not block the cultivation of these plants on European Union soil. In practice however, very few GMO varieties are grown in the EU given that industry seemingly finds the obligations too stringent to invest the time, effort and money in wanting to do so. Even in cases where industry has had varieties go through the whole process, some of them have been subject to national moratoriums in application of the ‘safeguard measures’ set out in Directive 2001/18/EC.

Taking the CRISP Cas-9 cabbage grown in Prof. Jansson’s back garden as an example of the challenges facing the commercialisation of mutagenic plants in the Europe: any CRISPR Cas-9 cabbage will now be subject to notification to the national competent authority, using a standard authorisation procedure. Environmental risk assessment must be carried out, any risks must be managed, and any further growing must be subject to regular inspections from national competent authorities. Keeping the seed supplier anonymous, for instance, clearly will no longer be possible. Two days after the ruling Bayer and BASF announced that they would pursue gene-editing of plants outside of the EU.

For those wishing to commercialise novel plant breeding techniques unchecked, this ruling is indeed a set-back. For consumers in the EU, already enjoying a wide variety of fresh produce, the immediate effects of this judgment seem less pressing.

To be or not to be… a regulated GMO: The CJEU’s verdict on genome editing

Felix Beck, Doctoral candidate, University of Freiburg/Germany

The recent CJEU judgment on the regulation of genome-edited crops has been debated heatedly throughout the European Union. Many scientists and plant-breeders condemned the verdict as a “backward step” and “hostile to progress“, while GMO sceptics hail it as upholding the precautionary principle and protecting consumer choice between GMO and non-GMO products. However, the legal reasoning of the Court has so far only received little attention. While the Court was rather tight-lipped on the biggest legal issues, the ruling still yields some interesting observations.

To recall the facts of the case: On referral by the French Conseil d'Ètat, the CJEU had to decide whether crops modified with so-called “genome editing” techniques are covered by the EU’s Directive 2001/18/EC on the deliberate release of Genetically Modified Organisms (GMOs). The notion “genome editing” refers to recently-developed techniques, like CRISPR, that allow for targeted modification of the DNA of virtually any organism. This allows to activate or knock-out specific genes, for example to render a crop plant more resistant to certain herbicides or pathogens. In contrast to conventional genetic engineering, genome editing is much more precise and can be used without necessarily inserting foreign DNA into the organism. Whether organisms resulting from these techniques are subject to the protracted GMO regulation in the EU or not has been controversial for several years.

First, the Court assumed with much ado that genome edited organisms constitute GMOs in terms of Art. 2(2) of Directive 2001/18/EC. It even saw no reason to comment on the controversial question whether the notion “altered in a way that does not occur naturally”, which is used to define what constitutes a GMO, relates to the technique of genetic modification or its result. This question was not expressly presented by the referring court, which allowed the CJEU to avoid taking a clear stand. However, the Court indicated that it prefers a strictly process-oriented interpretation, which means that any technique where the genome is modified in vitro would lead to GMOs in terms of Directive 2001/18/EC.

The second and more difficult issue concerned the question whether genome edited organisms are exempted from regulation as organisms resulting from “mutagenesis”. Conventional mutagenesis techniques rely on exposing the organism to certain chemicals or ionizing radiation, which increases the occurrence of genetic mutations. Afterwards, a plant breeder has to select individuals carrying the desired traits from a large number of treated organisms. Pursuant to Art. 3 and Annex I B para. 1 of Directive 2001/18/EC, organisms bred with “mutagenesis” are perceived to constitute GMOs, but are exempted from the directive's scope. The term mutagenesis, however, is not further defined or qualified under EU law, which posed the question whether this term is to be interpreted dynamically (incorporating new mutagenesis techniques) or whether it only refers to those mutagenesis techniques that were known in 2001 when the Directive was adopted.

For the Court, the decisive argument was recital 17, which provides that the Directive “should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record”. In the view of the Court, targeted mutagenesis techniques simply have no such long safety record and thus do not fall under the mutagenesis exemption.

In my view, this is a legitimate way of reasoning. There is a difference between the generic meaning of mutagenesis (i.e. any method that induces genetic mutations) and the legal meaning of the same term: recital 17 of Directive 2001/18/EC clearly indicates that only those techniques that were known and conventionally used when the Directive was adopted in 2001 should be exempted from its scope, i.e. conventional mutagenesis techniques relying on chemicals or radiation. Otherwise, changes in scientific nomenclature would be able to modify the scope of regulatory regimes, which would raise questions for the democratic legitimacy of such an interpretation.

Importantly, and this appears to remain difficult to grasp for non-lawyers, the Directive does not leave room for the question whether targeted mutagenesis is equally safe or even safer than conventional mutagenesis; it simply has no comparably "long" safety record. Therefore, it was reasonable for the CJEU to reject the idea of adopting a dynamic interpretation of the term mutagenesis, as Advocate General Bobek suggested in his opinion.

Unfortunately, the CJEU judges did not confine themselves to legal arguments, but also relied on very general (and unsubstantiated) allegations that the risks associated with genome editing were similar to those of conventional GM techniques (which is disputed by the vast majority of scientists), and that genome editing would lead to the development of modified organisms at higher rates and quantities (which is true, but not a risk per se). These misguided statements may make it very hard for scientists to accept that the CJEU's judgment may be okay from a purely legal viewpoint.

After all, the CJEU never was the appropriate organ to assess the risks or non-risks associated with genome editing techniques or to decide on their future regulation. This is fundamentally a matter of policy and must be dealt with by the European Union legislator. Hence, the Court should not be blamed for choosing one out of two controversial options for interpreting the Directive, but it should rather be asked why the European Union legislator has remained inactive for so long. When the European Commission proposed the first Deliberate Release Directive in 1988 and its revision that was adopted in 2001, it promised to regularly update the Directive in order to “keep pace with scientific and technological progress”. It is time for the European legislator to live up to this promise.

Art credit: John Byrne and Terry Austin, Marvel Comics

EU Closed Evidence by Stealth: Testing the Limits of Access to Justice and European Judicial Cooperation

Vigjilenca Abazi & Christina Eckes*

*Assistant professor of European law, Maastricht University and professor of European law, University of Amsterdam, respectively.

More than a ‘Procedural’ Revision

The European Union for the past few years has faced significant crises of political and economic nature. It has to deal for the first time in its 60-year history with a Member State wanting to exit from the Union; with hostility by and even trade wars with what used to be a solid transatlantic ally; and growing populist movements across Europe undermining the fundamentals of the EU construction, such as the rule of law. It is understandable that in the midst of these waves of uncertainties and challenging pressures, less attention is paid to the EU courts and the changes in how they deal with secrets, such as classified documents protecting national security.   

What prima facie may seem merely as a procedural change, introduced by a revision of the Rules of Procedure in 2015, in how EU courts should handle confidential information, has a severe impact on the right of access to justice, European judicial cooperation, and EU counter-terrorist measures – all of which have been largely out of public focus and debate.

For the first time in the history of the EU courts, the reliance on closed evidence, i.e. evidence that is not disclosed to the applicant, is allowed. This restricts the ability of the individual to defend herself to an extent that is contrary to established guarantees of the right of access to justice both under EU law and under the European Convention on Human Rights (ECHR).

This revision of procedural rules took place mostly behind closed doors. When attempts were made by human rights groups to express concerns for the revisions, they were met with a rejection letter by at the time President of the General Court for any ‘interference’.

Drawing from a recent publication on closed evidence, below we explain the implications of closed evidence for the right of access to justice and European judicial cooperation.

An Unlawful Limit of Access to Justice

The right of access to justice is protected under all constitutional orders of the Member States, the EU Charter of Fundamental Rights and the ECHR. Under all these legal orders, limitations to access to justice must be justified and can only be justified if they meet certain requirements. One essential requirement is that the gist of the secret information that is used against the individual must be disclosed to her, in order to allow the individual to defend herself and rebut the accusations brought by the other party. However, Article 105(8) of the Rules of Procedure of the General Court allows under certain circumstances full secrecy and complete lack of disclosure of the confidential material to the applicant. For example, if the Council relies on confidential information in its arguments and the Court is convinced about the sensitive nature of these files, the Court will base its assessment on these arguments without disclosing the information to the applicant. Not even a summary is disclosed to the applicant and this marks a clear departure from the Court’s previous case law.

Some constraints however apply to the Court when considering closed evidence: first, the Court may take into account the confidential information only if it is essential for the decision in the case; second, the Court must confine itself to information that is strictly necessary; and third, in its final judgment the Court must take into account that the applicant has not been able to make their views known on the closed evidence against them. Although these constraints are necessary they do not compensate for the fact that not even the gist of closed evidence was disclosed to the applicant, which is a requirement in the case law of the ECtHR.  

The fact that the EU procedure for closed evidence does not comply with the case law of the ECtHR may leave the Member States in a difficult legal position. Member States are bound by the ECHR under international law. If they followed the EU closed evidence procedure they would infringe their duty under ECtHR to disclose in all cases at least the gist of the incriminatory information. This would in turn negatively affect the relations and trust between the Strasbourg and Luxembourg courts. 

Trust and Judicial Cooperation

The EU closed evidence procedure may add to the tensions in European judicial cooperation, both in the relation between national courts and EU courts as well as between EU courts and the ECtHR.

Sharing official secrets requires a high level of trust. Especially in issues of national security, sharing secrets among Member States or between them and the EU institutions has been a challenge, to say the least. In fact, this lack of trust and lack of sharing of information by national authorities with the Court, was what led to the revision of the procedural rules in the first place. The Court was continuously annulling EU restrictive measures against terrorist suspects (EU counter-terrorist sanctions) by the Council when it was not receiving access to the confidential or even classified information on the basis of which the sanctions were (presumably) adopted.

Whilst the General Court may gain (a bit of) Member States’ trust by having security procedures in place, the EU closed evidence procedure could strain trust relations between national courts and EU courts. The use of closed evidence is not permitted in most Member States. If the EU courts use the closed evidence procedure in a manner that does not comply with the ECtHR, it would not be a surprise if national constitutional courts stepped in to ensure fundamental rights, resulting in even greater tensions and power struggles.  

Furthermore, whereas the ECtHR would not be able to rule directly on an EU’s act as the EU is not a party to the ECHR, it could still send a strong message to the EU courts to reconsider the EU closed evidence procedure by ordering Member States to comply with the gist requirement. How the EU courts would respond to such a message could be a new test to the limits of judicial cooperation in Europe, but also the legitimacy of the EU closed evidence procedure, as well as ultimately the EU itself.     

Public Debate about Security & Secrecy 

With the increased EU involvement with security issues, including the military, classic tensions between the rule-of-law demands for transparency and accountability on the one hand and the need for confidentiality on the other will only grow in the EU. How should the EU resolve this tension?    

EU courts carry out important checks on (national) executive power. The case law on the sanctions regime illustrates that EU courts can – to some extent – constrain executive power, including in an area in which judicial review traditionally allows for great discretion of executive actors. It is hence of outmost importance that the EU courts continue to conduct a rigorous review of the exercise of executive powers in matters of security. The EU closed evidence procedure is not a step in that direction and should be reconsidered. Whatever precise way is chosen to resolve the tension between confidentiality and transparency, it must comply with the ECHR as interpreted by the ECtHR.

Moreover, the EU should not continue to treat these salient discussions on security and secrecy as a mere matter of ‘procedure’. Rather, the EU must establish an open debate and have public deliberations on how to reconcile openness and secrecy, especially when EU fundamental rights are directly affected in order to accommodate security rationales. Ultimately, the most important legitimating factor for the EU as a security and human rights actor is the trust of EU citizens in how the EU defends human rights and their security interests. Procedural talks behind closed doors are hardly the way to gain public trust.   

Barnard & Peers: chapter 10

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The CJEU and the rule of law in Poland: Note on the Polish Supreme Court preliminary ruling request of 2 August 2018

Alicja Sikora, Chair EU Law, Jagiellonian University

As Eugene Ionesco put it, you can only predict things after they have happened (Rhinoceros, 1959).

On Thursday the Polish Supreme Court submitted to the European Court of Justice a preliminary ruling request under Article 267 TFEU. While doing so it also suspended the application of a Polish law forcing the early retirement of Supreme Court justices who are above 65 years old, including the President of the Supreme Court whose mandate is guaranteed by the Polish Constitution. This is a challenge to the Polish government’s changes to the judiciary, on the grounds that it violates the rule of law.

There were many preliminary ruling requests in the course of the history of EU law from van Gend den Loos, Costa/Enel, Nold, Francovich, Defrenne, Akerberg Fransson, Melloni, Pringle, Gauweiler and many others which shaped a ‘constitutional order of States’. Judicial dialogue established under Article 267 TFEU has been a cornerstone for the development of the EU legal order.

Thursday’s request might, however, not constitute just a major doctrinal novelty. The Polish Supreme Court stepped into the path of active claim for rule of law, which is not only a common principle to Member States, but also expression of the axiology on which EU is founded as expressed in Article 2 TEU. Polish judges seek advice which will in a way sans precedent engage the Court of Justice in the legal and political battle for independent justice in Poland. It is a symbolic proof of how much Europe is needed and how crucial and fragile the enforcement of common values turns to be.

The Court of Justice has already prepared the foundations of such action in recent cases such as C-64/16, Associação Sindical dos Juízes Portugueses (on the independence of Portuguese judges in the context of austerity, discussed here) and C‑216/18 PPU, LM (on the recognition of Polish European Arrest Warrants in light of rule of law concerns), where Article 19 TEU (which sets out the basics of the CJEU’s role) was linked to the protection of the rule of law. Consequently, it is, according to the Court, for the national courts and tribunals and the Court of Justice to ensure the full application of EU law in all Member States and judicial protection of the rights of individuals under that law. It follows that every Member State must ensure that the bodies which, as ‘courts or tribunals’ within the meaning of EU law, meet the requirements of effective judicial protection, which include, in particular, the independence and impartiality of those courts.

In the present case, the Polish Supreme Court referred to the Court of Justice five questions which relate mostly to the interpretation of the principle of judicial independence in the light of EU primary law (Articles 2, 4(3), 19 (1) TEU as well as Article 47 of the Charter of Fundamental Rights). Other questions focus on the interpretation of Directive 2000/78, which includes the principle of non-discrimination based on age. The referring judges also applied for the application of the expedited treatment of the case under Article 105 of the Rules of Procedure of the Court of Justice.

Unsurprisingly, it is the suspension of the application of the national law which caused fierce criticism of the highest Polish authorities. Yet, Polish Court acted in perfect conformity with the classic case-law of the Court concerning interim measures (Factortame, Zukerfabrick, Atlanta) whereby national courts suspend application of a national measure which represents a risk of breach of EU law, pending the decision of the CJEU clarifying whether there is a conflict between national law and EU law (or, in some cases, on whether an EU law being challenged in the national courts is invalid).

The underlying question is whether the CJEU is willing to address the rule of law dispute in Poland directly, via use of the preliminary ruling procedure, or leave the issue to the EU’s political authorities, which are considering warning or sanctioning Poland under the process set out in Article 7 TEU. The Polish Supreme Court is potentially opening a new chapter in the enforcement of EU law and values.

Barnard & Peers: chapter 6, chapter 9

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