EU/UK Dispute resolution post-Brexit in the light of the White Paper

Catherine Barnard and Emilija Leinarte*

*Professor of EU law, University of Cambridge and PhD student, University of Cambridge. This research has received support from the ESRC’s UK in a Changing Europe programme.

The recent report published by UK in a Changing Europe discussed different governance structures that could potentially regulate UK-EU relations post-Brexit. The now published White Paper provides insight into the sort of institutional framework the UK will seek from the EU upon its withdrawal. Is there merit in the UK’s proposals? Are there alternatives? We look into the options for the dispute resolution mechanism post-Brexit.

Institutional arrangements

The White Paper suggests that the governance of the UK-UK relations could be laid down in an association agreement (AA). The agreement would provide an overarching institutional structure which would cover the majority of the individual agreements for different elements of economic, security and cross-cutting cooperation. The form of economic cooperation is likely to be concluded in the form of a mixed free trade agreement (FTA).

The White Paper suggests governance through two main institutions:

-          a Governing Body which would set the general direction for the future relationship and,

-          a Joint Committee which would be directed by the Governing Body and would manage the implementation of the relationship.

Member States will be given authority through the Governing Body, which would consist of the heads of states and the presidents of the EU institutions and would meet at least biannually. Ad hoc meetings at ministerial level would also be held. The Joint Committee would consist of officials from the EU and the UK. In addition, the UK Parliament and the European Parliament would maintain a regular and formal dialogue.

The overall structure proposed in the White Paper is hybrid (see p. 21 of the report) because Member States of the EU as well as EU institutions would have authority in the governance of the relationship. This is different to other EU association agreements where Member States do not have a direct role in the supervision and implementation of the agreement. For example, under both the EU-Ukraine AA and the EU-Moldova AA the Association Council plays a role similar to that of the Governing Body. The Association Council consists, on the EU’s part, of members of the Council of the European Union and members of the European Commission. The structure of the EU’s AAs is commonly supranational because representatives from the EU institutions rather than member states are given the task of overseeing the implementation of the agreements.

Dispute resolution

The White Paper also proposes a framework for dispute resolution between the parties to the AA. The suggested mechanism would cover binding commitments between the parties, such as trade obligations. Protection of private rights is not covered and so British individuals or companies who consider their rights under the AA to have been infringed would only be able to enforce their rights in the UK through the UK courts and in the EU by the EU courts (para. 33 of the White Paper). This is typical of the EU’s AAs. For example, Article 402 of the EU-Moldova AA also excludes private rights from dispute resolution. The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), which replaced the Trans-Pacific Partnership (TPP) when the US withdrew from negotiations last year, also expressly excludes private action against the contracting parties (Article 28.22).

Private rights are also excluded from the dispute resolution mechanism under the Agreement on the European Economic Area (EEA Agreement) between the EU and members of the European Free Trade Area (EFTA) Norway, Liechtenstein and Iceland. To fill the gap, the European Commission, on the EU’s side, and the EFTA Surveillance, on the EFTA side, can receive complaints concerning the application of the EEA Agreement (Article 109(3) of the EEA Agreement) and may impose a fine on private persons if they breach the EEA Agreement (Article 110 of the EEA Agreement).

The EU’s recently concluded FTAs, such as the EU-Canada Comprehensive Economic and Trade Agreement (CETA), establishes a separate mechanism for investor claims and disputes arising in the financial services sector. Compensation awarded to investors is the primary remedy for such claims. The White Paper does not discuss this option. It is unclear whether the UK-EU FTA will contain an investment protection chapter.

Dispute resolution body

The White Paper says that disputes between the EU and the UK must be raised in the Joint Committee. Intermediation by an executive body is common to dispute resolution under the EU’s AAs. For example, under the EU-Moldova AA consultations are sought by sending a written request to the other party, copied to the Association Committee in Trade configuration (equivalent to a trade subcommittee of the Joint Committee). A similar arrangement for filing trade disputes is provided in the EU-Ukraine AA (Article 306).

If negotiations fail after a reasonable period of time, either of the parties may refer the dispute to an independent arbitration panel. Dispute resolution by independent arbitration panels is also typical in the EU’s AAs, including the EU-Moldova AA (Article 385) and the EU-Ukraine AA (Article 306). State-to-state dispute resolution under the EEA Agreement is different in this respect as it does not provide for the establishment of independent arbitration and instead gives the judicial function to an executive body (Article 111(2)).

The composition and process for appointment of an arbitration panel are not laid down in the White Paper, nor are the criteria for access to it, nor whether its findings will be published. All that is known so far is that the panel would include members from both parties. To this end, Article 28.9 of the CPTPP may serve as a template as it provides detailed rules on the composition of panels.

Remedies

The White Paper provides that in case of non-compliance, a complaining party may take measures to mitigate harm caused by the breach. These measures may include financial penalties or suspension of specific obligations (i.e. retaliation). As is common with trade regimes such as the WTO and CETA, such measures must be temporary and proportionate. Compensation and suspension of obligations for violations of trade obligations is typical to the EU’s AAs and are provided in both the EU-Moldova AA (Article 393) and the EU-Ukraine AA (Article 315).

In relation to suspension of obligations, WTO law allows a complaining party to cross-retaliate against any economic sector of the non-compliant state. In case of non-compliance by the EU, the so-called ‘carousel’ principle applies – goods and member states which are targeted by cross-retaliation rotate so that consequences are not concentrated in one member state and with respect to one product. The White Paper does not consider whether the same principle should apply to the UK-EU relationship. It only notes that suspension of obligations should be localised to the extent possible to the area of the future relationship that the dispute concerned (para. 46 of the White Paper). This is likely to be interpreted as meaning that in case of breach of trade obligations, suspension of obligations should be limited to trade.

In sum, the dispute resolution mechanism outlined in the White Paper is a mix of common features found in other EU association agreements as well as some innovative features. The proposal is up for negotiation with the EU, but it is Westminster rather than Brussels that will likely subject the proposal to most intense scrutiny and criticism.

The role of the CJEU

The influence of the Court of Justice of the European Union (CJEU) over the judicial system of the United Kingdom was, according to the Prime Minister, one of the key reasons which led to the Brexit vote. The Government has repeated time and time again that leaving the EU means leaving the jurisdiction of the EU Court. This has been a government red line. Yet, both in her Florence speech delivered on 22 September 2017 as well as in her Mansion House speech of 2 March, Theresa May suggested that judgments of the CJEU could be taken into account by the UK courts to ensure consistent interpretation of relevant EU law. This particular red line has already shown a pinkish hue.

So what exactly does it mean to leave the jurisdiction of a court but take its judgments into account?

Perhaps intentionally, the White Paper does not provide a straightforward answer to such a fundamental question. The document does suggest that the CJEU could have a dual role post-Brexit: (1) in relation to the UK courts when enforcing private rights stemming from the future relationship, and (2) in relation to the state-to-state dispute resolution mechanism. This is different to the EU’s recently negotiated FTAs, such as CETA where the CJEU has no role whatsoever. It is, however, typical in the EU’s AAs, perhaps because the aim of AAs is to lead to membership in the EU (this is not the case for economic cooperation under the FTAs). What the White Paper does demonstrate is that the sloughing of the CJEU skin is considerably more difficult than many Brexiters liked to think.

Let us address the dual role of the CJEU suggested in the White Paper.

The role of the CJEU in domestic cases

An obligation for the UK courts to follow the CJEU’s case-law differs depending on whether the dispute concerns the ‘common rulebook’ or other binding commitments under the future agreements. A ‘common rulebook’ is a customs arrangement proposed in the White Paper which effectively means that the UK would maintain the same rules for trade in goods as those of the EU in order to maintain frictionless trade and avoid Ireland/Northern Ireland border. It is not clear whether the UK intends to update its rules in line with changes in EU law.

The White Paper also suggests that when the UK courts enforce private rights stemming from commitments other than those related to the common rulebook, they ‘could’ take into account the relevant case law of the CJEU. This broadly confirms the language of s.6(2) of the recently adopted EU (Withdrawal) Act 2018 which provides ‘a court or tribunal may have regard to anything done on or after exit day by the European Court … so far as it is relevant to any matter before the court or tribunal.’

In addition, the White Paper opens a backdoor to the CJEU’s case law. In case of ‘significant’ divergence between the interpretation of the agreements by the EU and UK courts, the Joint Committee (the governing body for the future relationship) ‘could be empowered to act to preserve the consistent interpretation’ (para. 34 of the White paper). The practicalities of indirectly giving such unprecedented power over domestic courts to an executive body are not detailed.

An obligation for the UK courts to follow the CJEU’s case-law is stronger in relation to the common rulebook: the UK ‘would’ commit to its courts paying due regard to the CJEU’s case law. This effectively means that the CJEU’s interpretation of rules governing trade in goods would be binding on UK courts. Neither the EU-Moldova, nor the EU-Ukraine AAs set such obligation, perhaps because the EU does not have a common rulebook with them. Instead, they commit themselves to progressive legislative approximation, that is making their laws similar to those of the EU. In the process of legislative approximation, due regard must be given the case-law of the CJEU (e.g. Article 153 of the EU-Ukraine AA on the approximation of public procurement rules) but that is different from directly binding domestic courts to follow the CJEU’s case-law.

On the other hand, the implementation of rights and obligations stemming from the EU-Turkey Customs Union, in so far as they are identical to corresponding provisions of EU Treaties, must be interpreted in conformity to CJEU’s case-law (Article 66 of Decision No 1/95 of the EC-Turkey Association Council). Unlike association with Moldova and Ukraine which do not have a customs union with the EU, Turkey must ensure that its trade policies are compatible with those of the EU in order to maintain frictionless trade.

The UK courts would not, however, be able to make a preliminary ruling to the CJEU to ask for the CJEU’s interpretation on a certain aspect of EU law (para. 35 of the White Paper). However, the draft Withdrawal Agreement, which governs the UK’s exiting from the EU as well as matters related to the transitional relationship (i.e. post 29 March 2019 until 31 December 2020), does allow EU citizens to ask UK courts to make a reference to the Court of Justice. Article 151(1) of the Withdrawal Agreement states that when dealing with cases concerning citizens’ rights which were commenced within 8 years from the end of the transition period, the UK courts will be able to request the preliminary ruling (i.e. decision on interpretation) from the CJEU (without the presence of a British judge). The time-limits of the transition period are not (yet) known, but it may be extended for some years.

So, in answer to the question, has the UK been set free from the CJEU, the answer must be: not as much as many might like.

The role of the CJEU in dispute resolution between the parties

The White Paper also discusses resolution of disputes between the UK and the EU, as opposed to cases in the UK courts enforcing private rights.

Disagreements between the UK and the EU over the common rulebook for trade in goods would have to be resolved consistently with the CJEU’s case law. The Joint Committee (by mutual consent) or the arbitration panel would be able to make a preliminary reference to the CJEU. The CJEU’s interpretation of points of EU law would be binding on the Joint Committee and the arbitration panel (para. 42 of the White Paper).

This is not novel. Article 403 of the EU-Moldova AA provides that the CJEU’s rulings are binding on matters of EU law in disputes between the EU and Moldova (this would cover the common rulebook). Similarly, Article 322 of the EU-Ukraine AA provides that where a dispute raises a question of EU law, the arbitration panel must request the CJEU’s ruling which would be binding on the arbitration panel.

The approach adopted under the EEA Agreement is different. Reference to the CJEU is neither mandatory nor automatic – only if the dispute has not been settled within three months after it has been brought before the EEA Joint Committee, the parties ‘may’ agree to request the CJEU to give a ruling on interpretation of relevant points of EU law (Article 111(3) of the EEA Agreement).

In sum, the degree of influence of the EU Court over the UK’s judiciary will to a large extent depend on how much EU law will be let into the domestic system: the deeper the relationship, the bigger the role for the EU Court. A full stop to the jurisdiction of the CJEU would be a reality in case of a ‘no deal’ Brexit, and even in this situation the Withdrawal Act makes clear that the British courts may still take account of the case law of the Court of Justice because given the volume of EU law which is incorporated into UK law, the case law of the Court will have influence for decades to come.

Barnard & Peers: chapter 27

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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

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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