Weekend Edition Nº74 by eulawlive

Nº74

OCTOBER 9

2021

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SPECIAL ISSUE

COVID-19 VACCINATIONS AND EU LAW: BALANCING RIGHTS AND THE INTERNAL MARKET EDITED BY DOLORES UTRILLA AND JEFF KING WITH CONTRIBUTIONS BY

GAVIN BARRETT SABRINA RÖTTGER-WIRTZ DILETTA TEGA AND MICOL PIGNATARO JACQUELYN D. VERALDI AND DIMITRY V. KOCHENOV

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Contents

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Introduction Dolores Utrilla and Jeﬀ King

e Law of Covid-19 Vaccines as a test bed for European Public Law

Gavin Barrett

COVID-19 and EU Health Law Sabrina Röttger-Wirtz

COVID-19 Vaccines and Composite Administrative Procedures –Time for a Dose of Accountability in the EU’s Integrated Administration? Diletta Tega and Micol Pignataro

European Standards on Compulsory Vaccination: e Case Against No-vax Objections Jacquelyn D. Veraldi and Dimitry V. Kochenov

EU COVID-19 Certi cate: A Vehicle of Arbitrary Restrictions

Highlights

Week 4-8 October 2021

Insights, Analyses & Op-Eds

Book Review

by Willem A. Janssen

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Introduction The Law of Covid-19 Vaccines as a test bed for European Public Law i

Dolores Utrilla and Jeﬀ King

In this context, COVID-19 vaccines are signi cant because they meet the triple condition of being a key element of health policy, a marketable product (and not just any product, but one which is scarce and has profound safety and human rights implications), and the key to enabling a return to normality and a way out of the crisis. is explains why, within the European arena, the developments linked to the vaccination process are becoming a true test bed for the evolution of EU health law and, more generally, for EU constitutional and administrative law. Indeed, the asymmetries between the vaccinerelated legal framework existing until February 2020 and the urgent regulatory needs arising from the pandemic are impacting several key areas of EU law, such as the competences of the EU institutions, the design and implementation of administrative procedures, the powers of inspection of the EU agencies and bodies, free movement law, and fundamental rights protection.

e COVID-19 pandemic has led to signi cant legal experimentation and transformations, some innovations and some regress, around the world. Starting with arrangements to contain the spread of the virus and continuing with measures to mitigate the economic and social impact of the crisis, the pandemic would soon give rise to important legislative developments related to public health interventions in general and to the development, distribution and administration of vaccines in particular. ese developments exhibit similarities between many diﬀerent legal systems, but have had a distinctive signi cance at the European level due to the sui generis institutional and political structure of the EU. In all too common theme in its history, the EU has again been confronted with responding to a crossborder crisis in which most of the sector-speci c (in this case, health) competences still remain in the hands of Member States, but whose exercise profoundly aﬀects certain EU powers (e.g. the functioning of the internal market) and several crosscu ing principles of European constitutional law (solidarity, free movement, protection of fundamental rights, etc.).

is Special Issue explores some of the challenges and potential structural transformations arising from the legal treatment of COVID-19 vaccines under European law. It results from the joint work of a

i. Professor of Administrative Law at the University of Castilla-La Mancha, collaborating with EU Law Live as External Assistant Editor and with the ‘Lex-Atlas: Covid-19’ Project as Rapporteur for Spain. ii. Professor of Law at UCL and Co-Principal Investigator of the ‘Lex-Atlas: Covid-19’ Project, in which he also acts as General Editor, Area Editor for Legal Framework, Institutions, and Social Policy, and Rapporteur for the United Kingdom.

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tions and EU Law: Balancing Rights and the Internal Market’, which took place on Wednesday 30 June 2021. We expect these pages to add to the ongoing discussion around COVID-19 vaccines and to foster further re ection on the potential systemic legal eﬀects arising from the current crisis in Europe and beyond.

wide network of academics and practitioners, articulated around two structures: EU Law Live and the International Project ‘Lex-Atlas: Covid-19’. More speci cally, the re ections collected in this Special Issue are a summarised and updated version of some of the contributions presented in the joint EU Law Live – LAC19 Webinar ‘Covid-19 Vaccina-

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COVID-19 and EU Health Law Gavin Barrett

petition law and even the Common Agricultural Policy (CAP) were also used as bases for interventions in the health eld (for example, rules ensuring that e onset of the COVID-19 pandemic has had mamilk sold across borders was disease-free, and safety jor implications for EU health law, which has been rules for medicines and pharmaceuticals). Until de ned as a body of legal rules and policy provisions 1993, extensive reliance was also made on Article which mandate, incentivise or otherwise regulate 235 EEC (now Article 352 either certain actions or re aiTFEU) for reserve competenning from certain actions in ce wherever action proved neproviding human health care cessary to a ain Treaty objecHistorically, the EU had and protecting public health tives in the absence of Treaty(1). Historically, the EU had no formal legal basis conferred powers. no formal legal basis for adop-

I. Introduction

ting health legislation. Yet it has by now adopted a very large number of rules in the health law eld. A brief explanation follows as to how this could become the case (2).

for adopting health legislation

e Maastricht Treaty rst conferred explicit competence in the health eld: a new article was inserted in the EC Treaty enabling measures to be adopted in the eld of public health (although excluding harmonisation measures). Amended at Amsterdam, this provision was given its present, somewhat strengthened, form as Article 168 TFEU at Lisbon. It remains the main Treaty provision on health law and policy and governing the reaction of the EU to COVID-19.

Initially, at least, it involved the creative deployment of a number of Treaty articles. Article 2 EEC spoke of promoting ‘an accelerated raising of the standard of living’. Somewhat adventurously, this was deemed a suﬃcient basis for various training, research and information exchanges programmes. Treaty provisions on fundamental market freedoms, com-

i. Professor specialising in European Union law at the Sutherland School of Law, University College Dublin and sometime Jean Monnet Professor of European Constitutional and Economic Law. 1. A. de Ruijter,EU Health Law & Policy, Oxford University Press, Oxford, 2019. 2. See for examinations of the genesis of EU health law which are more extensive than the brief summary which is all that is possible here, T. Hervey and A. de Ruijter, e Dynamic Potential of European Union Health Law (Amsterdam Law School Legal Studies Research Paper No. 2020-44, Amsterdam Centre for European Law and Governance Research Paper No. 2020-06) and T. Hervey and J. McHale, European Union Health Law: emes and Implications (Cambridge University Press, 2015).

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Article 168 TFEU raised the requirement on the EU from ‘supporting’ a high level of health protection to ‘ensuring’ it. However, EU action is seen as merely complementing national policies: the Union must respect Member States’ responsibilities to de ne their health policies, and to organise and deliver health services and medical care. Re ecting this, Article 6 TFEU describes human health protection and improvement merely as an area in which the EU has supporting, coordinating or supplementing competence. Notwithstanding such restricted competence, much can nonetheless still be done when the political will exists. e EU may well lack competence to adopt measures with the primary objective of harmonising national health policies, or of organising and providing medical care, but the availability of single market legal bases gives the EU ‘power to adopt binding laws that have the eﬀect of improving health, so long as those measures remove obstacles to trade or prevent appreciable distortions of competition’ (3). Article 168 TFEU certainly imposes limits, but these limits have their limits. A limited power to legislate, though not to harmonise, is envisaged. Hence Article 168(4) TFEU provides that the ordinary legislative procedure may be used to adopt measures se ing high standards of quality and safety for medicinal products and medical devices. Article 168(5) TFEU allows the same procedure to be used to adopt incentive measures for protecting and improving human health and measures concerning monitoring, early warning of, and combating serious cross-border threats to health. e EU possesses very considerable means to incentivise Member State action, including the provision of funding, of pooled expertise and of knowledge. Under Article 168(6) TFEU, the Council can also adopt recommendations: considerable use has been made of these to in uence Member State behaviour during the pandemic. Two further aspects of Article 168 TFEU are striking. First, Article 168(1) obliges the EU to mainstream health protection (4). Secondly, Article 168(2) provides that Member States shall, liaising with the

3. T. Hervey and A de Ruijter, ‘ e Dynamic Potential of European Union Health Law’, Amsterdam Law School Legal Studies Research Paper No. 2020-44. 4. See also Article 9 TFEU and Article 35 of the Charter.

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Hence, overall, even with limited powers, the European Union has shown itself able to do much in the health policy eld.

Overall, even with limited powers, the European Union has shown itself able to do much in the health policy eld

II. EU Activity in the Health Field In practice, as Hervey has observed (7), EU law has been relevant to the health area in at least seven ways.

Commission, coordinate among themselves their policies and programmes in several health areas. is has provided the basis for successive Union public health programmes, including the March 2021 ‘EU4Health’ programme, establishing the 20212027 health programme with an annual nancial envelope of 0.5 billion euros.

First, it has established extensive rules concerning patient mobility via the Court of Justice’s case law on the freedom to receive cross-border medical services and associated legislation such as the 2011 Patients’ Rights Directive (8). Secondly, the EU has established rules concerning the free movement of health care professionals (workers, service providers and the self-employed) and sectoral and general rules on mutual recognition of professional quali cations.

Much of norm-se ing in the health eld actually involves so law. Notwithstanding its lack of binding force, so law can be highly signi cant. Documents such as the 2021 Commission Communication ‘A Common Path to Safe and Sustained Reopening’ are likely to be highly in uential, both in their own right and as possible harbingers of future hard law measures (5).

irdly, EU free movement and competition law rules have been applied to health care institutions. Fourthly - and this is something which became very relevant during the COVID-19 crisis - free movement of goods law applies to medical products and to pharmaceuticals. One feature of this is the dual marketing authorisation system. Under this, medicinal products for human use must be authorised either (a) by the competent Member State authorities,

A nal piece in the jigsaw of Treaty-level rules is the Court of Justice’s case law establishing a general principle that the protection of public health must take precedence over economic considerations (6).

5. Communication from the Commission to the European Parliament, the European Council and the Council ‘A common path to safe and sustained reopening’, COM/2021/129 nal. 6. CasesArtegodan (C-221/10-P), ECLI:EU:C:2012:216 and Aﬃsh BV v Rijksdienst (C-183/95), ECLI:EU:C:1997:373. 7. See by that author, Chapter 20 of C. Barnard and S. Peers, European Union Law, third edition, OUP, Oxford, 2020. 8. Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare OJ L 88, 4.4.2011, p. 45.

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Sixthly, there has been public health legislation, in elds such as tobacco, alcohol consumption, and food law.

or else (b) centrally by the Commission, on the advice of the European Medicines Agency, under a procedure laid down in Regulation 726/2004 (9). is la er procedure was used for COVID-19 vaccines (10).

Finally, EU external policy law (including inter alia the common commercial policy, development cooperation and international agreements) also impacts on health law and policy, something unsurprisingly stressed by the Commission in a global pandemic and provided for under Article 168(3) TFEU.

EU free movement of goods law also a ained some prominence during the pandemic because of Commission objections to the bans and restrictions on exports of medicines and medical devices that featured heavily among Member States’ rst panicked reaction to the COVID-19 crisis.

III.

Fi hly, EU intellectual property law is also relevant in the health eld. Directive 98/44 on the legal protection of biotechnological inventions has been crucial to the Commission being able to vaunt the EU as the world’s top vaccine exporter (11). However, there is considerable room for controversy here in that protection of intellectual property rights has been criticised as enabling major corporations to pro t at the expense of poorer countries. e Commission has highlighted the EU’s commitment to Covax and possibilities regarding using TRIPS exibilities. But there is clearly more to be said on this subject.

e Pandemic

In responding to the challenges posed by the COVID-19 pandemic, Europe got oﬀ to a poor start. Initial national reactions showed a distinct lack of solidarity, generating negative reactions in turn. Gradually however, solidarity and European cooperation crystallised, and a mixture of Member State and EU actions in the health and economic spheres resulted. e problem was perhaps less an absence of capabilities than an unwillingness by political leaders to use existing cooperative powers. Perhaps inevitably,

9. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, p. 1. 10. On this, see the contribution to this Special Issue by Sabrina Rö ger-Wirtz. 11. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ L 213, 30.7.1998, p. 13.

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ma ers gradually changed: pandemics are inherently cross-border and thus the solutions were always likely to be as well.

2. Measures regarding port

erapeutics and Medical Sup-

Measures of this description have included Commission joint procurement to secure access to therapeutic treatments for COVID-19, as well as the common EU Strategy on erapeutics.

In addition, no other international organisation brought the kind of resources to the problems generated by COVID-19 as the EU did: the active participation of 27 diﬀerent Member States representing some 450 million inhabitants, a history of cooperation in the health eld, a variety of available legal instruments, the capacity to enter contracts, considerable nancial and resources, and institutions including not just formal EU institutions such as the Commission, Council and ECB but also a vast range of specialist commi ees, centres, agencies, steering groups and task forces.

3. Measures regarding Sectoral Re-opening Measures which may be classi ed under this rubric have included the downloadable app ‘Re-Open EU’, giving information about the epidemiological situation and rule in place across the EU; 2020 guidance provided to the transport and hospitality sectors; and the European Commi ee for Standardisation’s document on health and safety protocols for the hospitality sector.

By now, a wide range of EU-level pandemic-related initiatives has been adopted. eir sheer number and breadth are so vast, it can be diﬃcult to keep track of them all. However, we may mention at least the major categories of action and some of what the EU itself has identi ed as the most signi cant measures, namely: (1) measures regarding re-opening generally; (2) measures regarding therapeutics and medical support; (3) measures regarding sectoral re-opening; and (4) measures regarding the adoption of a global approach to the pandemic.

4. Measures regarding the Adoption of a Global Approach to the Pandemic Measures of this nature have either already included or will soon include the direct nancial help to States and to international partners; the EU participation in COVAX (a global initiative to facilitate greater access to vaccines); and the operation of the Union Civil Protection Mechanism.

1. Measures regarding Re-Opening Generally

One particularly prominent measure in this eld has been the centralisation of vaccine procurement: hence the EU’s Joint Procurement Agreement for medical countermeasures (provided for in Decision 1082/2013) was used to deploy the bargaining power of the EU in negotiations with vaccine manufacturers (12).

Measures of this kind have included inter alia the EU Digital Green Certi cate, its twin measure addressing the situation of third country nationals legally entitled to travel within the EU, and the European Centre for Disease Prevention and Control’s (ECDC) framework for re-opening (and the interactive digital tool it has developed in this connection).

12. Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC, OJ L 293, 5.11.2013, p. 1.

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it is hard to consider such a se lement a major win for the Commission. Commercially, it is hard to consider it much of a win for AstraZeneca, since the P zer BioNTech vaccine has now become the workhorse of EU immunisation eﬀorts.

Dissatisfaction with one supplier, AstraZeneca, led the European Commission to initiate litigation on 28 April 2021, a step backed by all 27 Member States even if some initially vacillated. e ruling of the Tribunal de première instance ancophone de Bruxelles, civil section (13), ultimately proved a subtle one (with, rather improbably, both parties claiming victory). While refusing to require AstraZeneca to meet a schedule as onerous as that demanded by the Commission or to pay punitive nes close to the level sought on the grounds that this would be premature, the court did demand a delivery schedule, imposed an astreinte (ongoing nancial penalty) at a more modest level, and held that AstraZeneca had commi ed a gross breach of contract and had also failed to make its ‘best reasonable eﬀorts’ to supply the contractually agreed 300 million doses to the EU, because it had not sent any doses from its UK manufacturing sites. It also ordered AstraZeneca to pay the bulk of (very modest) Court costs. is was originally to be only the rst of a series of legal skirmishes: the Commission action for damages was due to be heard in 2022, a er a hearing in Autumn 2021 to reconsider whether the UK plant should have been used to supply the EU. However, on 3 September 2021, the EU and AstraZeneca announced the se lement of the remaining litigation before the Brussels Court on terms securing the delivery of the remaining COVID-19 vaccine doses due to Member States under the terms of the Advance Purchase Agreement with a greatly extended deadline to the end of March 2022 (14). Legally,

IV. Pandemic-Related Trends in Health Law and Policy By way of conclusion, some tentative observations and predictions may be oﬀered. First, COVID-19 has changed and will continue to change the face of EU health law. Instead of largely consisting of an extension of (or addendum to) single market law, EU health law is now becoming a eld of EU law in its own right, with the development of the autonomy of this area of law being considerably accelerated and enhanced by the eﬀects of the pandemic. Secondly, the solutions which have been found to the COVID-19 crisis have frequently been temporary or ad hoc but in several cases are now crystallising into permanency. Turning emergency action into structural change is a deliberate strategy by the Commission, which has noted the need to learn from the example of the EU’s response to the 20072011 economic crisis (15). irdly, a process of regulatory strengthening is taking place. is is taking various forms. For exam-

13. Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC, OJ L 293, 5.11.2013, p. 1. 14. e text of this ruling is available online here. 15. See European Commission press release, 'Coronavirus: e EU and AstraZeneca agree on COVID-19 vaccine supply and on ending litigation' Brussels,3 September 2021. 16. See in this regard: Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Commi ee and the Commi ee of the Regions ‘Drawing the early lessons from the COVID-19 pandemic’, COM/2021/380 nal.

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Medicines Agency (EMA), including by se ing up the COVID-19 EMA Pandemic Task Force and by creating a permanent EMA Emergency Task Force.

ple, ma ers previously governed by decisions (such as Decision 1082/2013) will henceforth be governed by regulations. Furthermore, issues which had to be governed during the pandemic by mere ad hoc agreements (the exclusivity of the Commission negotiating and procurement role in joint procurement procedures being one prominent example) are now to be given a rmer foundation through the adaptation of the Joint Procurement Agreement to include an exclusivity clause.

Another development involves the Health Security Commi ee, which is now to have representation in its high-level working group at the level of Deputy Health Ministers, capable of triggering common EU-level responses, and to have an enhanced role in coordinating risk communication in addition to a strengthened mandate to enforce coordinated responses.

Fourthly, as a result of the COVID-19 crisis, the EU is at present in an intense process of institutionbuilding. A number of features of this are particularly prominent.

A further institutional innovation will be the creation of an entirely new authority – the European Health Emergency Preparedness and Response Authority (HE ), to provide a structure to deal with future pandemics.

One is the upgrading of the ECDC, with the ultimate objective of making it a real European Health Agency. Another is the upgrading of the European

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Lastly, in the future evolution of European health policy, it is clear that a number of overlapping challenges will have to be faced:

In the future evolution of European health policy, it is clear that a number of overlapping challenges will have to be faced

• ensuring democratic control is maintained over health policy; • avoiding unsystematised competence creep; - ensuring that the full spectrum of interests is properly represented at European level; • ensuring the EU will not become a ‘bull in a china shop’ in a sensitive policy area; • ensuring that the power of international corporations in the medical/pharmaceuticals eld is kept under control; • maintaining technocratic decision-making by commi ees, agencies, and expert groups under democratic control; and • ensuring success in safeguarding and promoting human health (17).

Fi hly, the EU will have changed by the time the crisis is over. While much pandemic-related legislation has been adopted in the usual way, involving the agreement of both Council and Parliament (albeit without impact assessments on grounds of urgency) and to this extent has democratic approval in the normal way, the overall vision for the EU Health Union’s future arguably needs democratic sanction in a stronger form. e Commission has argued that the upcoming Conference on the Future of Europe provides an optimal platform to ignite discussions and provide impetus for the evolution of the EU’s role in the health eld.

17. See further regarding some of the foregoing, T. Hervey and A. de Ruijter, loc. cit..

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COVID-19 Vaccines and Composite Administrative Procedures – Time for a Dose of Accountability in the EU’s Integrated Administration? Sabrina Röttger-Wirtz

In this regard, the cornerstone of the EU’s pharmaceutical regulatory framework is the marketing authorisation requirement. A marketing authorisation for medicinal products may be obtained, depending on where the product will be marketed and also the kind of pharmaceutical in question, via four procedures: the national procedure of a Member State; the Mutual Recognition Procedure or the Decentralised Procedure; and the Centralised Procedure. With regard to vaccines, no specialised regulatory pathway is created, and generally vaccine authorisation takes place under the same legal requirements and procedural framework as other pharmaceuticals. e only exception to this are vaccines against pandemic in uenza, for which special procedures are in place.

While at the beginning of the COVID-19 pandemic in spring 2020 the Member States resorted to nonpharmaceutical responses like social distancing to protect public health, it was clear that pharmaceutical responses and especially vaccination would become the key remedy to overcome the spread of the virus and to establish a path back towards normality. In EU health law, the regulation of pharmaceuticals is one of the few areas where the EU’s powers reach beyond coordinating and supporting competence and allow for the adoption of harmonising measures to ensure the safety and quality of medicines on the internal market. Nowadays, essentially the whole pharmaceutical lifecycle, from development over clinical research to the marketing authorisation and post-marketing stages, are subject to detailed EU rules. Moreover, during the pandemic, while the vaccination policy in terms of how and to whom the vaccines will be administrated is determined by the individual Member States, the Commission also advised national authorities on potential vaccination strategies and points to be taken into account. us, the EU was not only supporting the COVID-19 vaccine purchase, but the responsibility for the regulatory safeguarding of quality, safety and eﬃcacy of the vaccines rested on EU level.

e four currently available COVID-19 vaccines were authorised via the Centralised Marketing Authorisation Procedure, which leads to a marketing authorisation issued by the European Commission based on a scienti c opinion by the European Medicines Agency (EMA), which is valid throughout the EU. Also under the pressure of the pandemic, the EU choose to still fully examine the vaccine authorisation applications under the regular requirements of quality, safety and eﬃcacy. As expressed by Commission President von der Leyen: ‘We have chosen

i. Assistant Professor of EU Law at the Maastricht Centre for European Law (Maastricht University), working on EU risk regulation in the elds of pharmaceuticals, foods and pesticides.

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EU pharmaceutical law is characterised by the integrated nature of its Administration and the use of composite procedures

res do not only occur at the authorisation stage, but permeate the pharmaceutical regulatory framework, also in terms of variations (namely changes to the authorisation such as the authorisation for use in children), authorisations of manufacturing sites or the detection and response to adverse drug reactions. ey are also present in the enforcement of pharmaceutical law in terms of inspections and penalties (3).

not to cut any corners as regards safety or eﬀectiveness. is is a choice that we stand by wholeheartedly’ (1). Yet, other tools were used in order to speed up the authorization process, like rolling review, conditional marketing authorisations or the derogation from the GMO deliberate release requirements. What is interesting about the marketing authorisation procedures from an EU law perspective is that EU pharmaceutical law – like many policy elds in the EU – is characterised by the integrated nature of its administration and the use of composite procedures. Composite procedures are de ned in the literature as ‘procedures entailing the input of administrative actors from diﬀerent jurisdictions, and in which the nal decision, issued by a Member State or a EU authority, is based on procedures involving the more or less formalized input of the various participating authorities’. (2) Such composite procedu-

While at rst sight the Centralised Procedure used for the COVID-19 vaccine authorisations might not look like a case of a composite procedure, given that it entails the scienti c opinion of an EU agency and a nal Commission decision, this impression does not hold true upon closer inspection. In fact, in forming its opinion the EMA relies heavily on Member State expertise, and has traditionally been characterised as central node in a network of national agencies (4). e Commi ee for Medicinal Pro-

1. Ursula von der Leyen, Speech at the European Parliament Plenary on the state of play of the EU's COVID-19 Vaccination Strategy, 10 February 2021. 2. Mariolina Eliantonio, ‘Judicial Review in an Integrated Administration: e Case of “Composite Procedures”’, Review of European Administrative Law 2014/2, December 2014, 65-102. 3. Merijn Chamon and Sabrina Wirtz, ‘Complex procedures as hurdle to accountability: verticalization of pharmaceutical enforcement’, in Miroslava Scholten and Michiel Luchtman (eds.), Law Enforcement by EU Authorities. Implications for Political and Judicial Accountability, Edward Elgar Publishing, 2017, 141–167. 4. Renaud Dehousse, ‘Regulation by networks in the European Community: the role of European agencies’, Journal of European Public Policy 4(2), 1997, 246261.

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butable to the EU requiring a full dossier, but some ducts for Human Use (CHMP), the EMA’s main voices also pointed out that the composite − as opscienti c commi ee for human medicinal proposed to truly centralized − nature of the procedure ducts, is formed of experts appointed by the Memand the need for agreement amongst the Member ber States, generally from the national competent State experts in the CHMP might have slowed authorities. For each new product to be assessed, down the process (6). Re ecting on the authorisathe CHMP appoints two Commi ee members as tion process, von der Leyen starapporteur and co-rapporteur to ted that following the EMA procarry out the detailed individual assessment, using the national Next to the harmonisation cedure might have taken some extra time, but pointed out that administrative structures and reof the legal requirements, that this is ‘an investment that is sources. e assessment reports crucial to trust and safety’ (7). dra ed by the rapporteur and the use of composite While it is diﬃcult to assess if the co-rapporteur are discussed in authorisation procedures EMA approval really cemented the CHMP, which although a mamore trust in the vaccine within jority voting option is foreseen, for medicines has been the population, it is clear that generally adopts its opinion by an important factor in from a more historical perspecticonsensus. us, an EMA opive, next to the harmonisation of nion – like those on the bene tbuilding trust amongst the legal requirements, the use of risk balance of the COVID-19 Member States composite authorisation procevaccines – is formed in a compodures for medicines has been an site procedure where the scientiimportant factor in building trust c data provided by the appliamongst Member States in the respective scienti c cants is assessed by national experts, and where the assessments of pharmaceuticals (8). opinion requires the buy-in of (at least the majority of) the national experts. Finally, the Commission’s One a more general note, the use of composite proauthorisation decision is subject to comitology, adcedures in the implementation and enforcement of ding another composite layer. EU law has received a lot of a ention especially in the EU administrative law scholarship, due to the With regard to the COVID-19 vaccines, it drew wifact that even in the face of these highly integrated despread a ention that in the EU the rst COVIDmulti-actor and multi-level procedures, accountabi19 vaccine (BioNTech/P zer) was approved on 21 lity mechanisms are still strictly separated between December 2020, while the UK already had issued the EU and the individual Member States. Political an approval on 2 December. Leading up to the EMA accountability towards parliaments or ombudsmen opinion, critical voices like the German health migenerally is limited to the actors within their respecnister Jens Spahn had called on the EMA to speed tive jurisdictions, which falls short of serving as a up (5). e approval timeline might have been a ri5. Ashleigh Furlong, ‘Germany pushes EU regulator on approving coronavirus vaccine before Christmas’, Politico, 15 December 2020. 6. Jillian Deutsch and Ashleigh Furlong, ‘Pressure mounts on EU regulator to approve coronavirus vaccine — and fast’, Politico, 12 December 2020. 7. Ursula von der Leyen, Speech at the European Parliament Plenary on the state of play of the EU's COVID-19 Vaccination Strategy, cit. 8. Sabrina Rö ger-Wirtz, ‘Mutual Recognition and the Ever-incomplete Internal Market for Pharmaceuticals’, Review of European Administrative Law 13(3), 2020, 61-87.

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As the EU does not have a pharmaceutical inspection unit of its own, it relies on inspections carried out by the competent authorities of the Member States, upon request of the Commission, the EMA or another Member States (Article 111 of Directive 2001/83) (13). In the context of the dispute surrounding the export to the UK of COVID-19 vaccines by AstraZeneca, the European Commission reportedly requested an inspection of an Italian AstraZeneca plant. As we argued in our Op-Ed, the very broad inspection mandate in combination with questionable access to judicial review raises concerns with regard to the accountability of the Commission for requesting the inspection and the protection of the rights of the inspected company. e inspection mandate based on the Directive and enshrined in national law is generally very broad and is bounded by li le procedural limits. Additionally, judicial accountability might be barred as the Commission’s inspection request to Italy is hardly directly reviewable under Article 263 TFEU. Moreover, review via preliminary question of validity under Article 267 TFEU will depend rst of all on the form in which the request for inspection was made – a formal measure or just an informal phone call or email – and also on the access to legal review for the inspection or inspection outcome under Italian law. Next to judicial accountability, also political accountability mechanisms are obstructed by the composite nature of the procedure: the European Parliament could concern itself with the proportionality

meaningful accountability mechanisms in procedures where several national and EU authorities take part (9). Additionally, gaps in the judicial reviewability of the procedural steps in various composite procedures have been highlighted (10). As discussed in more detail elsewhere, also pharmaceutical authorisation composite procedures raise problems with regard to access to judicial review, given that actions contributing to the nal decision take place in various jurisdictions and may not be recognized as formal legal acts (11). In the pharmaceutical remit, this is more pronounced in the Decentralised and Mutual Recognition Procedure, where the intermediate procedural steps, information exchanges and discussions amongst the Member States are hardly challengeable. In the Centralised Procedure, the main gap indenti ed with regard to judicial review is familiar to EU lawyers: the marketing authorisation applicant has access to judicial review of the Commission Implementing Decision – including the review of the preparatory step of the EMA’s opinion – but due to the well-known strict standing rules of the CJEU this will be barred for non-privileged applicants such as third parties. Accountability concerns can also be highlighted in COVID-19 vaccine-related administrative procedures, for example in the remit of inspections, which form an important element in the enforcement of EU pharmaceutical law, as was discussed in detail in a previous Op-Ed published on EU Law Live (12).

9. Herwig C.H. Hofmann, ‘Decision-Making in EU Administrative Law – e Problem of Composite Procedures’, Administrative Law Review 61, 2009, 199221. 10. Mariolina Eliantonio, ‘Judicial Review in an Integrated Administration: the Case of “Composite Procedures”’, cit. 11. Sabrina Rö ger-Wirtz and Mariolina Eliantonio, ‘From Integration to Exclusion: EU Composite Administration and Gaps in Judicial Accountability in the Authorisation of Pharmaceuticals’, European Journal of Risk Regulation10(2), 2019, 393-411. 12. Sabrina Rö ger-Wirtz and Mariolina Eliantonio, ‘Hidden’ vaccines in Italian plant: EU composite procedures and hidden accountability paths’, EU Law Live, 5 April 2021. 13. Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council, OJ L 304, 22.11.2011, p. 64.

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of the Commission’s request to inspect, but not with the execution of the inspection itself; while the Italian Parliament is barred from questioning the inspection request. Such accountability gaps are especially problematic in unannounced inspections, which are a quite intrusive form of enforcement. Overall, the proliferation of composite procedures is a sign of the EU’s maturing and integrating administrative structures. However, it should raise concerns that the accountability frameworks do not follow suit. is is especially true in enforcement procedures where fundamental rights need to be safeguarded. e introduction and strengthening of more cooperative accountability structures like procedural cooperation of Parliaments and/or Ombudsmen or a procedure for horizontal preliminary questions (namely preliminary references between Member State courts) have been proposed in this regard. e search for increasing the accountability of composite procedures becomes all the more important also beyond pharmaceutical law, as many apparently quite technical composite procedures have become highly salient due to their connection to pressing societal issues, ranking high on the political agenda, such as the GMO (14) authorisation or the authorization of plant protection products like glyphosate (15).

e proliferation of composite procedures is a sign of the EU’s maturing and integrating administrative structures. However, it should raise concerns that the accountability frameworks do not follow suit

14. Rui Lanceiro and Mariolina Eliantonio, ‘ e Genetically Modi ed Organisms’ Regime: A Playground for Multi-Level Administration and a Nightmare for Eﬀective Judicial Protection?’, German Law Journal 22(3), 2021, 371-390. 15. Anjum Shabbir, ‘Glyphosate in Pesticides: Rocky Road or an improved process for renewed authorisation this time around?’, EU Law Live, 8 July 2021.

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European standards on compulsory vaccination: the case against no-vax objections i

Diletta Tega and Micol Pignataro

haps even for COVID-19 related disputes. We will advance the view that the judgement is particularly compelling as it contains insightful elements in terms of the multilevel protection of human rights and because it is an example of the constant interplay that runs between national and supranational courts, whose relationship is ever more interwoven.

e debate concerning compulsory vaccination is once again at the center of the stage as the only hope to overcome the COVID-19 pandemic seems to be a wide-spread vaccination campaign. Indeed, there is a general consensus that vaccination is one of the most successful and cost-eﬀective health interventions and that each State should aim to achieve the highest possible level of vaccination among its population. When it comes to the best means of protecting the interest at stake, however, there is no consensus over a single model. is is the case today as a wide spectrum of policies are being implemented, ranging from ones based wholly on recommendations to ones that are enforcing forms of compulsory vaccination.

I. e Dispute in Vavřička and Others v. the Czech Republic Compulsory vaccination has o en been challenged at a national level on several grounds, including the one whereby vaccination amounts to an unjusti able interference with the right to self-determination and the right to respect for private life. In the Vavřička judgment, delivered in April 2021, the ECtHR decided upon the compatibility with the European Convention on Human Rights (ECHR) of Czech legislation enforcing a general legal duty to vaccinate children against nine diseases. e law provides that parents who fail to comply, without good reason, can be ned, and that non-vaccinated children will not be accepted in nursery schools. e applicants submi ed that the main reason why they decided

As the debate receives increasing a ention, it is useful to understand what the European human rights standards on compulsory vaccinations are. To do so we will brie y retrace a recent judgment of the Court of Strasbourg, Vavřička and Others v. the Czech Republic (1), which, although it doesn’t concern COVID vaccination programs, sheds light on a type of reasoning that the European Court of Human Rights (ECtHR) could use in the future, per-

i. Professor of Constitutional Law at the University of Bologna, Bologna. ii. PhD candidate in Constitutional Law at the University of Bologna, Bologna. 1. ECtHR, judgment of 8 April 2021, Vavřička and Others v. the Czech Republic (applications nos. 47621/13 and 5 others), ECLI:CE:ECHR: 2021:0408JUD004762113.

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not to vaccinate their children was to protect the la er’s health and argued that such State interference was in violation of the ECHR, in particular Article 8 thereof. e applicants further invoked the protection of Article 9 for their critical stance towards vaccination.

II. A Multi-Layered System of Rights Protection In its reasoning, the ECtHR took into consideration the fertile legal terrain that evolves around compulsory vaccination and fundamental rights, giving substance to the entrenched multi-layered system of rights protection. In particular, the Court referred to the European Social Charter, the Oviedo Convention, Recommendation 1317 (1997) of the Parliamentary Assembly of the Council of Europe (‘Vaccination in Europe’), Resolution 1845 (2011) of the PACE (‘Fundamental rights and responsibilities’), Article 168 of TFEU, and Article 35 of the Charter of Fundamental Rights of the European Union (see paragraphs 129-151 of the judgment). e ECtHR further recalled the rich jurisprudence that national constitutional courts have developed over the past years, ultimately appealing to similar reasonings to clarify what the human rights stan-

e ECtHR held that there was no violation of Article 8 and it found that the complaints raised in relation to Article 9 were incompatible ratione materiae with the Article’s provisions. It’s already worth highlighting that the ECtHR revealed a very precise epistemic and political position by creating a sharp distinction between ‘opinions’ and ‘convictions’, as by nding that the applicants’ critical opinion on vaccination didn’t constitute ‘a conviction or belief of suﬃcient cogency, seriousness, cohesion and importance to a ract the guarantees of Article 9’ (paragraph 335), the ECtHR subtly minimized the weight of, ‘no-vax objections’.

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zed, on the other, the central government appeared partly discredited by the hesitation and uncertain political positions that ultimately led up to the statutory decree (5).

dards for compulsory vaccination programs are in relation to the ECHR. e clearest example of the la er is the extent to which the ECtHR recalled and adopted similar ndings and reasonings to the ones developed by the Italian Constitutional court (ItCC) in decision n. 5/2018 (2), ultimately showing an inclination towards a dialogue that is based on similar concerns and apprehensions. To grasp the similarities and to engage with the exogenous in uences that the la er national court had on the former supranational body, it’s worth retracing the Italian decision, which recently became both the explicit legal basis for introducing the mandatory vaccination requirement on healthcare practitioners and workers (3), and also the implicit support for the very recent extension of the green pass requirements to every public and private worker (4).

e Italian court considered the critically unsatisfactory level of vaccination in the country at the given time as well as the existing trends suggesting that the rate of vaccination was deteriorating, in relation to which it immediately pointed out that there was no scienti c basis for the existing trends which considered vaccination to be futile or dangerous. It found that the legislation was within the scope of discretion and political responsibility of the authorities, and that requiring a certi cate for school enrolment and imposing nes were both reasonable measures for the legislature to take, not least where it had provided for initial steps to be taken before the imposition of such sanctions. e court drew a ention to the requirement to strike a balance between the individual right to health (including freedom concerning treatment) and the coexistent and reciprocal rights of others and the interests of the community, as well as the interests of children, who require protection even vis-à-vis parents who do not ful l their duties of care. It ultimately found that a national law imposing a health-related treatment is not incompatible with the Italian Constitution provided that (cumulatively):

In this judgment, the ItCC considered the constitutional validity of a statutory decree introduced as a ma er of urgency to increase the number of compulsory vaccinations from four to ten. e decree made access to early childhood educational services conditional upon the receipt of all ten vaccines and the sanction for failure to comply was an administrative ne. is was challenged on several grounds, including that the obligation was an unjusti able interference with the constitutional guarantee of individual autonomy. e context within which the ItCC was called to deliver its decision was not an easy one: on the one hand, there was part of the public opinion that had been strongly instrumentali-

(i) the treatment is intended not only to improve or maintain the recipient’s health, but also to preserve the health of others;

2. ItCC, judgment no. 5/2018 of 22 November 2017, ECLI:IT:COST:2018:5. 3. Michele Massa, ‘ e Italian “No Jab, No Job” Law’, Verfassungsblog, 7 April 2021. 4. Stefano Ma eucci Civitarese and Micol Pignataro, ‘Italy: Back to school and work with the Green Covid-19 Certi cate’, Lex-Atlas: Covid-19 Blog, 4 October 2021. 5. Dile a Tega, ‘ e Italian Constitutional Court in its Context: A Narrative’, European Constitutional Law Review, 2021, 1-25.

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(ii) the treatment is not expected to have a negative impact on the recipient’s health, besides the usual and tolerable consequences that normally arise from its administration;

III.

e Vavřička and Others judgment

A similar approach surfaces as we read the ECtHR’s decision, as the fundamental standards of protection that the Court of Strasbourg identi es recall much of the reasoning and main ndings of the ItCC’s judgment. It’s also worth bearing in mind that the decision was probably borne out of the concerns and issues that were prominent at the time the judgment was delivered: in April 2021, Europe was still in the midst of the pandemic and the vaccination campaigns were just about picking up. Furthermore, the AstraZeneca case had just exploded throughout the continent (7). It’s inevitable, therefore, that the ECtHR had this background clear in mind when it laid out its arguments, probably developing the standards knowing that they will be bound to come in handy once disputes concerning COVID-19 vaccines will be brought before it.

(iii) and, in the event of further injury, the payment of just compensation to the injured party is provided for, separate and apart from any damages to which they might be entitled.

e ItCC also noted that the issue of vaccination involves many constitutional values (including selfdetermination), coexistence of which leaves room for legislative discretion in choosing the necessary means to ensure the eﬀective prevention of infectious diseases. at discretion must be exercised according to various health and epidemiological conditions, as ascertained by the responsible authorities and the constantly evolving discoveries of medical research, to which the legislature has to turn for guidance when making its choices. Besides being an example of the balancing of rights and interests in a constitutional order, judgment n. 5/2018 also exempli es how these principles may support a datadriven judicial review of epidemiological legislation; indeed, the opinions expressed by several scienti c and professional bodies and associations, including the WHO as well as national and regional health authorities, were held into account in the decision. Moreover, the comparative nature of the study that led up to the court’s decision re ects the fact that when constitutional judges decide on such sensitive ma ers they tend to observe and examine other experiences. is was de nitely the case as the Court’s Research Department published a comparative study on compulsory vaccinations in 2017, just a couple of months before the decision was published (6).

As mentioned earlier, the Court of Strasbourg creates a rm distinction between opinions and convictions, as it nds that a general critical opinion on vaccination does not constitute an expression of conviction or belief that is sufficient to get an exemption. To a ract the guarantees of Article 9 ECHR or the guarantees set by the Czech Constitution, the critical opinion has to be sufficiently cogent, serious, cohesive and important; in the case at hand, the ECtHR found that the reasons of conscience given by the applicants had been brought forward only at a late stage and that they had failed to advance any concrete argument concerning their beliefs and the intensity of the interference caused by vaccination. is is one of the most crucial passages of the decision as the ECtHR seems to reject no-vax objections. More generally, this view re ects diffe-

6. Servizio Studi della Corte Costituzionale Italiana, La disciplina degliobblighi di vaccinazione, October 2017. 7. Micol Pignataro, ‘Grey areas and uncertainties: the AstraZeneca case in Italy’, Lex-Atlas: Covid-19 Blog, 10 August 2021.

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of others, recognized by Article 8 ECHR as well as by constitutional provisions related to the right to health. is position partially echoes the considerations that the ItCC made about the preventive nature of vaccination and about the unsatisfactory levels of vaccination in the country at the time. In light of these factors, authorities have the political responsibility, not least the discretion, to intervene and enact the policies it deems necessary to pursue the objectives mentioned above. While exercising such discretion, however, the authorities must consider the scienti c data and advice that is available to guide its decision-making process, as well as the many constitutional values that are involved. Both points are underscored by the ECtHR as it directly evokes the ItCC’s 2018 decision.

In the Vavřička judgment, the ECtHR seems to reject no-vax objections rent elements of both the ItCC’s and the Czech constitutional court case-law, emphasizing again the inuence that judicial decisions have on each other. It appears that the ECtHR further extends the ItCC’s perspective on the feeble relevance of the popular belief that vaccines serve no purpose, or are even harmful, de ning opinions as something distinct from personal or religious beliefs and convictions. e ECtHR also considers that healthcare policy ma ers come within the margin of appreciation of national authorities, as they are best placed to assess priorities, social needs, and the use of recourses. Interestingly, the Strasbourg-based Court takes the view that the compulsory nature of child vaccination demands an even wider margin of appreciation. Furthermore, it asserts that States have an obligation to place the best interest of the child, and more generally of children as a group, at the center of all decisions aﬀecting their health and development. When it comes to immunization, the objective should thus be to ensure that every child is protected from serious diseases, and domestic authorities may reasonably introduce a compulsory vaccination program to achieve an appropriate level of protection. More generally, the goal to protect against diseases which may pose a serious risk to health refers both to those who receive the vaccinations as well as those who cannot be vaccinated and are thus in a state of vulnerability. is objective may be a ained through a high level of vaccination within society at large and it corresponds to the aims of the protection of health and the protection of the rights

e reasoning in Vavřička and Others and the inuence that the ItCC’s decision had on the la er supports the idea that national and supranational judicial bodies do not operate in a vacuum, but that they are deeply embedded in a legal, political, social, and economic context that necessarily shapes their reasonings and decisions. Both decisions oﬀer similar levels of protection, and they resonate the general idea that vaccinations remain one of the main tools for primary prevention of communicable diseases. More importantly, the ECtHR’s decision seems to

National and supranational judicial bodies are deeply embedded in a legal, political, social, and economic context that necessarily shapes their reasonings and decisions

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tional courts work with the European counterparts to de ne and strengthen health guarantees. A possible evolution in such direction will be particularly interesting and useful in relation to COVID-19 vaccinations, encouraging us to consider how the pandemic is in uencing the application of the European human rights standards clari ed in the Vavřička and Others decision, and to what extent, if any, they will have to be re-adjusted.

leave signi cant space for a productive dialogue and exchange of arguments among national constitutional courts (and their respective national legal systems) and the Court of Strasbourg. Indeed, the ECtHR builds its conclusions on the national ndings of national courts, suggesting that the protection of public health through vaccination is an example of a sort of pan-European constitutionalism, in which national legislations and national constitu-

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EU COVID Certiﬁcate: A Vehicle of Arbitrary Restrictions i

Jacquelyn D. Veraldi and Dimitry V. Kochenov

I. Introduction

But let us start at the beginning. Set against a background of debae EU has used the pretext of When a certi cate is te and doubt on the appropriatethe protection of public health in order to adopt and implement required to ‘move freely’, ness and eﬃcacy of vaccine passports for the purposes of crossoverreaching placebo measures someone has to put up border travel in limiting the to ‘restart’ free movement a er spread of COVID-19, Regulathe pandemic (1), which resulted a border to check tion 2021/953 on the EU Digital in a host of problems (2), from this certi cate COVID Certi cate (DCC) (7) ‘re-bordering’ (3), arbitrary disbecame applicable on 1 July 2021 crimination (4) and undermiwith a transitional phase until 12 ning of free movement rights (5), August 2021. e DCC (origiopening the door to abuse (6), and fragmenting the nally proposed as the Digital ‘Green’ Certi cate) internal market: when a certi cate is required to ‘mocon rms that its holder (i) has received a speci c ve freely’, someone has to put up a border to check COVID-19 vaccine in the issuing Member State or this certi cate. Since this border is closed for the vachas been veri ed to have received such a vaccine in a cinated who acquired immunity via ‘unrecognised’ third country (‘vaccination certi cate’), (ii) has revaccines, the emptiness of the ‘health’ reasons ceived a negative COVID-19 test result (‘test certi behind the EU’s regulation comes to the fore: geocate’), or (iii) has recovered from COVID-19 (‘cerpolitics of vaccine recognition has li le to do with ti cate of recovery’). health. e a ack on the internal market is thus very diﬃcult to justify. i. Trinity College, University of Cambridge. ii. CEU Democracy Institute, Budapest and CEU Legal Studies, Vienna. 1. Alberto Alemanno and Luiza Bialasiewicz, ‘Le passeport sanitaire européen : un placebo risqué’, Le Grand Continent, 14 July 2021. 2. Alberto Alemanno and Luiza Bialasiewicz, ‘Certifying Health: e Unequal Legal Geographies of COVID-19 Certi cates’, European Journal of Risk Regulation 12(2), 2021, 273-286. 3. Martina Tazzioli, ‘A “Passport to Freedom”? COVID-19 and the Re-bordering of the World’, European Journal of Risk Regulation 12(2), 2021, 355-361. 4. Sarah Ganty, ‘ e Veil of the COVID-19 Vaccination Certi cates: Ignorance of Poverty, Injustice towards the Poor’, European Journal of Risk Regulation 12(2), 343-354. 5. Dimitry V. Kochenov and Jacquelyn D. Veraldi, ‘ e Commission against the Internal Market and European Union Citizens’ Rights: Trying to Shoot Down Sputnik with the “Digital Green Certi cate”?’, European Journal of Risk Regulation 12(2), 404-414. 6. Iris Goldner Lang, ‘EU COVID-19 Certi cates: A Critical Analysis’, European Journal of Risk Regulation 12(2), 298-307. 7. Regulation (EU) 2021/953 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, veri cation and acceptance of interoperable COVID-19 vaccination, test and recovery certi cates (EU Digital COVID Certi cate) to facilitate free movement during the COVID-19 pandemic, PE/25/2021/REV/1, OJ L 211, 15.6.2021, p. 1.

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of residence, travel history, the Member State of destination and the type of the vaccine which has been administered. e analysis of the relevant legal documents immediately reveals that the restrictions in question are arbitrary, as they are unrelated to their proclaimed objective: the protection of public health.

e rollout of the DCC has varied widely across Member States: while Spain issued over 18 million certi cates by 12 August 2021, in late July individuals in Germany were facing difficulties accessing them and their rollout has been delayed due to technical security issues that have led to the creation of fraudulent certi cates. Rollout is also of course affected by the differing speeds at which vaccine distribution itself occurs.

II. Free movement restrictions in the COVID-19 era

Now that the DCC is here, what are its implications? We recently drew a ention to the potential consequences of the DCC in a Special Issue on COVID-19 Certi cates of the European Journal of Risk Regulation (8). Our warning of an increasingly fragmented internal market has effectively materialised with a mosaic of thus far unchallenged rules applying across the EU to different categories of EU citizens, family members, and resident third-country nationals being subject to differing restrictions when exercising their free movement rights. e panoply of supranational rules and bilateral agreements premised on the idea that the border is always there and the DCC is, in principle, checked, has destroyed Europe as a ‘single working-living space’, as the exercise of rights depends on the Member State 8. Dimitry V. Kochenov and Jacquelyn D. Veraldi, ‘ Sputnik with the “Digital Green Certi cate”?’, cit.

It did not take long for the EU internal market to dissolve into a patchwork of wildly divergent rules varying in their restrictiveness and requiring the investment of additional time and money to cross every border, which the Treaties solemnly promise to eliminate. Although the severity of the restrictions has eased in many Member States as an increasing number of people become fully vaccinated, some form of restrictions remains in all. However, while restrictions on cross-border movement might have become widespread and appear to be – a once unimaginable – ‘new normal’, the promise of the EU internal market remains, de ned as a space without internal borders (Articles 3 TEU and 26 TFEU), restric-

e Commission against the Internal Market and European Union Citizens’ Rights: Trying to Shoot Down

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imposed travel restrictions, holding them up against t h e l e ga l - a n a l y t i c a l t h re s h o l d s o f n o n discrimination and proportionality. Council Recommendation 2020/1475 lays down some criteria and thresholds in decisions on whether to restrict free movement for public health reasons (14), but such instruments cannot be used as a justi cation for cancelling the fundamental freedoms and core rights of Europeans set out in primary law.

tions on which have historically treated with suspicion and interpreted narrowly. Protection of the internal market is one of the main areas in which COVID-19-related legislation has been adopted by the EU, with other areas (also ultimately related to internal market protection) being inter alia recovery funding (9), COVID-19 clinical trials (10), or transport (11). Should the promise of the EU internal market stand, there can be no reason for the Member States travel restrictions to remain free from the strictest scrutiny, which has traditionally applied to such restrictions. Instead of scrutinising arbitrary restrictions and bringing the violators to court, however, the current Commission, most famous for its hesitation between procrastination and dereliction of duties also in other elds (12), has introduced legislation pu ing smooth functioning of the internal market to rest, at least from the lens of the mobility rights of EU citizens (as well as their family members and resident third country nationals (13)). e guardian of the Treaties has thus a acked the Treaties and our rights. Whatever the Commission’s reasons for such behaviour can be, the provisions of Part Two of the TFEU – in particular Articles 18 and 20-21 TFEU – must remain the starting point of the framework of scrutiny of Member State-

e executive’s seat has remained de facto vacant throughout at least the rst year of COVID-19: the EU Commission – with its power to institute infringement proceedings – failed to meaningfully address the range of barriers to free movement that have been erected by Member States on the declared grounds of public health in terms of their compatibility with the main criteria for derogating from these fundamental freedoms. Of course, certain restrictions would ful l these criteria. But there are other measures that have been questioned in terms of their ‘risk of arbitrariness or inequality’, pu ing the internal market at risk (15). A er the lethargy, the Commission took action that was either entirely inconsequential (if not unnoticed) or that involved siding with the Member States in their a ack on the free movement rights in the internal market – which is unusual in EU legal history.

9. Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility, DO L 57 de 18.2.2021, p. 17. 10. Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modi ed organisms intended to treat or prevent coronavirus disease (COVID-19), DO L 231 de 17.7.2020, p. 12. 11. Regulation (EU) 2021/267 of the European Parliament and of the Council of 16 February 2021 laying down speci c and temporary measures in view of the persistence of the COVID-19 crisis concerning the renewal or extension of certain certi cates, licences and authorisations, the postponement of certain periodic checks and periodic training in certain areas of transport legislation and the extension of certain periods referred to in Regulation (EU) 2020/698, DO L 60 de 22.2.2021, p. 1. 12. Laurent Pech, Patryk Wachowiec, and Dariusz Mazur, ‘Poland’s Rule of Law Breakdown: A Five-Year Assessment of EU’s (In)Action’, Hague Journal on the Rule of Law 13, 2021, 1-43. 13. Regulation (EU) 2021/954 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, veri cation and acceptance of interoperable COVID-19 vaccination, test and recovery certi cates (EU Digital COVID Certi cate) with regard to third-country nationals legally staying or residing in the territories of Member States during the COVID-19 pandemic, DO L 211 de 15.6.2021, p. 24. 14. Council Recommendation (EU) 2020/1475 of 13 October 2020 on a coordinated approach to the restriction of free movement in response to the COVID19 pandemic, OJ L 337, 14.10.2020, p. 3. 15. Mark Dawson and Pierre ielbörger, ‘EU law in the “First Wave”. e legality of national measures to tackle the COVID-19 crisis’, Report for e Greens/EFA in the European Parliament.

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e Commission formally wrote to several Member States – Belgium, Denmark, Finland, Germany, Hungary and Sweden in February 2021 (see this online press brie ng, at 10:45 to 13:50) and to Malta in July – to request justifying reasons for controls implemented throughout the COVID-19 period stricter than those recommended by the Council. In terms of the outcome, Belgium, Finland, and Germany (as a few examples) rejected the concerns of the Commission, while Malta opted for only a slight easing of the restrictions – going from a full prohibition on entry for adults not inoculated with particular vaccines ( agged by the Commission as discriminatory and disproportionate) to a 14-day hotel quarantine requirement, regardless of whether one has a negative test result or a certi cate of recovery from COVID-19 or immunity resulting from inoculation with a vaccine not recognised on Malta but recognised and used in other Member States. is appears to remain discriminatory and disproportionate on the face of it. e Commission’s le ers brought no results and no cases followed, while numerous borders remain de facto locked for plenty of Europeans in direct violation of their rights in the Treaties.

e EU’s ‘certi cate’ has become akin to a passport in its use by Member States to decide who can enter and under what conditions when used

16. Oskar Josef Gstrein, ‘ 2021, 370-381.

e ‘action’ phase of Commission’s belated awakening was worse than inconsequential, however, since it amounted to an arbitrary a ack on rights. e DCC’s official objective and hence legal basis is the facilitation of the free movement rights for EU citizens – Article 21(2) TFEU. Whereas the Commission did not undergo an impact assessment for their proposal (16) – the EU’s ‘certi cate’ has become akin to a passport in its use by Member States to decide who can enter and under what conditions when used. is is now what has effectively materialised within the almost three months of the DCC system’s entry into force, in that the DCC has become part and parcel of the systems of national checks for incoming travellers and hence free movement restrictions. Worse than that: in many countries the DCC is now necessary also beyond the border, from checking into a hotel to ge ing a coffee outdoors on a Parisian terrace. e border thus moved from the airport to the door of every theatre, bar and hotel. Scrutiny of the EU DCC Regulation is therefore absolutely crucial.

e EU Digital COVID Certi cate: A Preliminary Data Protection Impact Assessment’, European Journal of Risk Regulation 12(2),

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tion and vaccinated in a third country can now also be issued DCCs, though this is optional and applies with the limitation that ‘[A] Member State should not be required to issue a vaccination certi cate where the COVID-19 vaccine concerned is not authorised for use on its territory’ (recital 31). us, on the issuing side of the DCC, it now appears that the Regulation should be interpreted as meaning that an EU citizen that has received non-EMA vaccines in their Member State should nevertheless still be entitled to having this information recorded in the DCC, it remaining optional to issue DCC for vaccines from third countries not authorised in the relevant Member State.

III. e EU DCC: Facilitating or hampering free movement? As mentioned, under the EU DCC scheme a ‘vaccine’, ‘test’, or ‘recovery’ certi cate can be either issued or accepted for the purposes of waving cross-border travel restrictions, which remain the new norm. e DCC Regulation is limited to the criteria for issuing DCCs, their technical aspects, and establishing an obligation of mutual treatment towards travellers with DCC vaccination, test, and recovery certi cates. It does not require or prohibit any speci c crossborder restrictions so long as the destination Member State applies any exemptions that they have implemented for cross-border restrictions equally to those entering from other EU Member States that have certi cates a esting to having received particular vaccinations, negative tests, or recovery tests. While non-discrimination is promoted, the presence of restrictions is a starting point.

As for the eﬀects of the Regulation in terms of the DCC’s role in the receiving side of cross-border travel, Member States are only under an obligation to apply equal treatment to travellers with EMAapproved vaccines when it comes to applying waivers for travel restrictions, the la er emerging as the new norm. As for other vaccines, for the purposes of waiving travel restrictions national authorities ‘may also accept’ DCCs issued by other Member States for vaccines authorised or temporarily authorised via the MPD or which are on the WHO’s Emergency Use Listing (EUL). Under the EP’s initial suggested amendments which did not pass in the end and which we discussed elsewhere (17), it was only optional to waive restrictions for non-EMA vaccines if they were on the WHO EUL, ignoring the competence of Member States to authorise vaccines under the MPD and the interests of EU citizens that have received these vaccines. Note however that the equal treatment obligation when it comes to waiving restrictions for any non-EMA vaccine remains optional even a er the harmful EP amendments have been discarded.

From a free movement perspective, the eﬀects of DCCs can be understood from two sides: their issuance and their acceptance in cross-border travel. e DCC Regulation rules establishing which types of vaccines must or can be the subject of a DCC, as well as the rules on when Member States must or can accept a given vaccination DCC to waive free movement restrictions, both determine whether an EU citizen falls within the scope of the DCC Regulation when travelling from point A to point B. According to recital 29 of the Regulation, ‘Member States should issue vaccination certi cates to persons who have received COVID-19 vaccines that have been granted a marketing authorisation’ either under (i) Regulation 726/200, (ii) the MPD, or (iii) a temporary authorisation pursuant to Article 5(2) MPD. Persons covered by the Regula17. Mark Dawson and Pierre ielbörger, ‘EU law in the “First Wave”. Greens/EFA in the European Parliament.

e legality of national measures to tackle the COVID-19 crisis’, Report for

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since it is simply an ‘equivalent and interchangeable’ version of the EMA-approved AstraZeneca vaccine manufactured by and licenced to the Serum Institute of India; it is also on the WHO EUL. Under the DCC Regulation incoming travellers that have received these vaccines can still therefore be (and have been) subject to greater restrictions (such as testing, quarantine requirements, or complete exclusion) unless challenged under EU primary law.

Fragmentation of the internal market resulting from the DCC Regulation is the norm It is clear from the above that the fragmentation of the internal market resulting from the DCC Regulation is the norm. Diﬀerent criteria and rules for waiving restrictions in each Member State remain. First, any DCC holder, regardless of the certi cate they hold (vaccine, test, or recovery), faces a diﬀerent set of rules in each Member State of destination. Second, where a Member State applies restriction waivers to fully-vaccinated DCC holders, the EU citizens that have received non-EMA WHOapproved vaccines (such as Sinovac, Sinopharm, and Covishield), or neither EMA- nor WHOapproved vaccines (such as Sputnik V and EpiVakKorona) may nevertheless still be subject to these restrictions. us, ample scope is le for EU Member States to distinguish between EU citizens based on their medical status in order to determine for whom they deem safe enough to waive restrictions.

Hence, currently in Malta, to waive the 14-day hotel quarantine requirement only vaccine certi cates (rather than test or recovery certi cates) a esting to inoculation with an EMA-approved vaccine are accepted. Other travellers – including those with other vaccines, negative tests, and recovery certi cates – must be locked in a hotel and foot the bill, which certainly gives rise to doubts as regards discrimination and proportionality. e mosaic of rules across Member States varies from such extremes to regimes that accept a broader range of vaccines for the purposes of waiving travel restrictions, with for instance just over half of Member States (including France and Germany) apparently extending equal treatment to travellers with certi cates a esting to having had the Covishield vaccine; Croatia and Cyprus accepting the Sputnik and Sinopharm vaccines; or Greece also allowing Sinovac, Sputnik, and Sinopharm – to name a few.

is situation runs the risk of facilitating rather than reducing restrictions that are arbitrary or not based on the claimed objectives related to the protection of public health. e Member States who do so in principle remain liable for breaches of the Treaty provisions on the right to move freely throughout the EU, but the enactment of the DCC Regulation arguably sends the signal that the EU itself will not pursue it. Indeed, the Regulation seems to be a secondary law a empt to set primary law aside by providing a wrongful exception from the rule, which is unconnected from the stated objective to be achieved. Covishield is a particularly striking exclusion,

e Regulation seems to be a secondary law a empt to set primary law aside by providing a wrongful exception from the rule

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e underlying reason was implied in the EP’s 9 June 2021 amendments, in their emphasis upon the fact that EMA centralised authorisation procedure ‘ensur[es] that only high quality medicinal products are placed on the market’ and so EMA-approved vaccines should be mutually recognised’ (20). ey then however state that ‘…In order to support the work of WHO and to strive for be er global interoperability, Member States are in particular encouraged to accept vaccination certi cates issued for other COVID-19 vaccines that have completed the WHO emergency use listing procedure’ (19). is then casts doubt on the decision to explicitly ascribe the WHO EUL a lower status in the free movement context. is doubt is ampli ed by the equity concerns and uncertainty over whether vaccination prevents transmission highlighted by the WHO.

IV. Objectives of public health? In light of the above, one may observe that an instrument designed to facilitate freedom of movement in the internal market has simultaneously reinforced the fragmentation of the la er, with multiple layers of and diﬀering rules and instruments for in particular the acceptance of vaccine certi cates for the purposes of waiving restrictions on free movement rights. e EP’s initial amendments, which sought to prohibit the Member States to issue DCC to EU citizens vaccinated with non-EMA-approved vaccines, were particularly diﬃcult to reconcile with the requirements of propor tionalit y and nondiscrimination – the Parliament played a distasteful game. What objectives were pursued in the elimination of the possibility to even issue DCCs to those that had received other non-EMA-approved vaccines? While this oversight has been repaired, it is still quite unclear if the EU DCC – grounded in the Article 21(2) TFEU legal basis of protecting free movement rights – went far enough in protecting precisely these rights from disproportionate or discriminatory restrictions. Rather, the DCC arguably amounts to a legislative appeasement, if not encouragement, of the Member States willing to break EU free movement of persons law.

V. Dereliction of duties by the Commission facilitates the on-going assault on EU citizens’ rights In a world characterised by ‘vaccine apartheid’ (20), by becoming one of the few and rst jurisdictions to establish a vaccine passport the EU contributed to further entrenching a global system in which crossborder mobility of the world’s most excluded populations becomes increasingly diﬃcult. is is in addition to the long-established passport apartheid, which already blocks the majority of the travellers from the Global South at the boundaries of the aﬄuent ‘West’ (21). ere is one thing in common

Take the example of the according of WHO EUL vaccines a diﬀerent status under the Regulation, by making it merely optional to waive free movement restrictions for DCC-holders with these vaccines.

18. Position of the European Parliament adopted at rst reading on 9 June 2021 with a view to the adoption of Regulation (EU) 2021/… of the European Parliament and of the Council on a framework for the issuance, veri cation and acceptance of interoperable COVID-19 vaccination, test and recovery certi cates (EU Digital COVID Certi cate) to facilitate free movement during the COVID-19 pandemic, P9_TC1-COD(2021)0068, recital 34. 19. Ibid. 20. Sophie Harman, Parsa Erfani, Tinashe Goronga, et al, ‘Global vaccine equity demands reparative justice — not charity’, BMJ Global Health 6, 2021, 1-4. 21. Dimitry V. Kochenov, ‘Ending the passport apartheid. e alternative to citizenship is no citizenship—A reply’, International Journal of Constitutional Law 18(4), 2020, 1525–1530.

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new Regulation to harm these rights: seemingly a legislative carte blanche for arbitrariness and abuse of power. Doubt can also be shed on the public-health asserted grounds for excluding non-EMA vaccines from the mutual recognition obligation in the DCC. Member State restrictions on cross-border movement raising doubt on their compatibility with EU law have so far gone unchallenged, yet the DCC Regulation le broad scope for the implementation of arbitrary, discriminatory or disproportionate restrictions on cross-border movement. e longer such a situation – characterised by the nonenforcement (via infringement proceedings) and non-protection (via secondary legislation) of EU law – persists, the greater the threat to the foundations of the EU internal market and the rule of law itself.

among all the EMA-approved vaccines: none of them is designed or produced in the ‘non-Western’ countries – they come from China, India, Russia and the like. e blanket exclusion of all those who were inoculated with the ‘non-Western’ vaccines (even if they are licenced reproductions of AstraZeneca and whether they are EU citizens or not) which the Regulation gives a blessing to is done in the name of protecting the internal market. However, as argued above, doubt can be cast on the suitability of the DCC in facilitating freedom of movement; an extreme fragmentation remains when it comes to cross-border travel rules in the EU. is fragmentation, caused by the violations of the Treaties by numerous Member States, is not acted upon by the Commission. Instead of safeguarding EU citizens’ rights, it seems to rejoice in the ability of the

Doubt can be cast on the suitability of the DCC in facilitating freedom of movement; an extreme fragmentation remains when it comes to cross-border travel rules in the EU

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News Highlights Week 4 to 8 October 2021

ECA Special Report on the eﬀectiveness of Europol’s support in ghting migrant smuggling

Action lodged against Commission for denying access to nal report of an OLAF investigation

Monday 4 October

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In its latest Special Report, the European Court of Auditors found that Europol faces challenges in accessing all relevant available information necessary to combat organised migrant smuggling, and called for improvements to the way data exchange works.

An action for annulment (Vendrame v Commission, T379/21) against a decision of the European Commission rejecting a request for access to a nal report of an investigation of the European Anti-Fraud Oﬃce was oﬃcially published.

New public consultation on measures against abusive litigation against journalists and human rights defenders

Court of Justice to clarify whether special tax record-keeping obligations for cross-border related companies are contrary to freedom of establishment: action published

Monday 4 October

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e European Commission opened a public consultation on EU action against abusive litigation targeting journalists and human rights defenders. is consultation complements the upcoming initiative against Strategic Lawsuits against Public Participation.

Court of Justice to rule on whether presumption of innocence and ne bis in idem preclude suspension of tax warehouse-keeper authorisation Tuesday 5 October

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Oﬃcial publication was made of the requestfor a preliminary ruling in Dual Prod (C-412/21), in which the Court of Justice will rule on whether the presumption of innocence and the ne bis in idem principles, read in conjunction with the Excise Duty Directive 2008/118, preclude the administrative suspension of an authorisation as a tax warehouse-keeper.

Tuesday 5 October

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In X GmbH & Co. KG v Finanzamt Bremen (C-431/21), the Court of Justice will rule on whether the special recordkeeping obligations for cross-border business relations with related parties established by the German Tax Code are contrary to the freedom of establishment or, subsidiarily, the freedom to provide services.

Council greenlights negotiations for an agreement in respect of Gibraltar Tuesday 5 October

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e Council adopted a decision authorising the start of negotiations with the UK for an agreement in respect of Gibraltar, which comes a er the Commission had adopted a dra mandate for negotiations, following a political understanding between Spain and the UK on a possible framework for an agreement.

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Decision by which Commission asked Italy to remove unjusti ed corporate tax exemptions for ports published in the Oﬃcial Journal Wednesday 6 October

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e Commission Decision in the State aid case SA.38399 – Ports taxation in Italy, by which it was found that Italy provided incompatible corporate tax exemptions to its ports and Italy was ordered to abolish its tax scheme in order to align it with EU State aid rules, was published in the Oﬃcial Journal.

Court of Justice: Article 101(1) TFEU precludes national rules restricting liability of subsidiary companies to cases where they are controlled by parent companies Wednesday 6 October

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In Sumal (C-882/19), the Court of Justice set out the conditions under which victims of an anticompetitive practice by a company punished by the Commission are entitled to bring an action for damages before the national courts against the punished company’s subsidiary companies that are not addressed in the Commission decision.

Criteria on procedure and legal bases to conclude the Istanbul Convention clari ed by the Court of Justice Wednesday 6 October

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e Court of Justice in its Avis 1/19 Opinion, on the procedure and EU legal bases to conclude part of the Istanbul Convention, ruled that the Treaties do not prohibit the Council from waiting, before adopting the decision concluding the Istanbul Convention, for the ‘common accord’ of the Member States, but that they preclude it from altering the procedure by making the conclusion contingent on the prior establishment of such a ‘common accord’.

Court of Justice’s ruling on forced transfers and appointments of Polish judges Wednesday 6 October

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In the Grand Chamber case W. Ż. (Chambre de contrôle extraordinaire de la Cour suprême – Nomination) (C-487/19), the Court of Justice ruled that transfers without consent of a judge from one court to another or between two divisions of the same court are liable to undermine the principles of the irremovability of judges and judicial independence enshrined by EU law.

Grand Chamber of the Court of Justice con rms and clari es its CILFIT case law Wednesday 6 October

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e Grand Chamber of the Court of Justice handed down its judgment in Consorzio Italian Management e Catania Multiservizi (C-561/19), concerning inter alia the scope of the duty to make references for preliminary rulings on the interpretation of EU law.

Court of Justice dismisses actions against Commission Decisions declaring Spanish tax rules on the amortisation of nancial goodwill as incompatible State aid Wednesday 6 October

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e Court of Justice dismissed all the appeals against the judgments of the General Court which upheld the classi cation of the Spanish tax rules on the amortisation of nancial goodwill as incompatible State aid, and clari ed the case-law on the ‘selectivity’ criteria.

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Court of Justice: lawful purchasers of computer programs may decompile them if necessary to correct errors aﬀecting operation Wednesday 6 October

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In its in Top System judgment (C-13/20), the Court of Justice ruled that under Article 5(1) of the Computer Programs Directive lawful purchasers of a computer program are entitled to fully or partially decompile it in order to correct errors aﬀecting its operation, and that such decompiling is not subject to the requirements laid down in Article 6 of the Directive.

Commission withdraws referral of UK to the Court of Justice for failure to recover illegal State aid in Gibraltar Wednesday 6 October

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Commission adopts EU Strategy on combating antisemitism and fostering Jewish life Wednesday 6 October

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e Commission presented its rst-ever EU Strategy on combating antisemitism and fostering Jewish life, which aims to respond to a signi cant increase of antisemitism incidents during the last decades and foster Jewish life in Europe in all its diversity.

General Court dismisses request to give full access to ECB documents on Banco Popular’s assessment ursday 7 October

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e Commission withdrewthe referral of the United Kingdom to the Court of Justice pursuant to Article 108(2) TFEU for an alleged failure to recover illegal State aid granted as a tax exemption for passive interest and royalties in Gibraltar, following the con rmation that the full recovery of the illegal State aid has been nalised.

In Aeris v ECB (T-827/17), the General Court partially dismissed an action for annulment against several decisions of the European Central Bank denying access to a number of documents concerning its assessment of Banco Popular S.A. as a bank that was likely to be in serious diﬃculties.

Council adopts EU’s position for COP26 climate summit

Court of Justice: Member States can impose additional criteria on economic operators participating in reserved public procurement procedures

ursday 7 October

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e Council of the EU adopted conclusions on the EU’s position for the United Nations Climate Change Conference (COP26), which will take place from 31 October to 12 November in Glasgow.

ursday 7 October

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In Conacee (C-598/19), the Court of Justice ruled that Member States can impose additional criteria beyond those laid down by Article 20 of the Public Procurement Directive 2014/24, thereby excluding from reserved public procurement procedures operators which otherwise would satisfy the criteria in Article 20, provided that the principles of equal treatment and proportionality are complied with.

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EU and Western Balkans leaders sign Brdo declaration

AG Bobek: Nord Stream 2 can challenge Gas Directive before EU Courts ursday 7 October

ursday 7 October

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In his Opinion in Nord Stream 2 AG v Parliament and Council (C-348/20 P), Advocate General Bobek considered Nord Stream 2 AG to be both directly and individually concerned by the amended Gas Directive (2019/692) and therefore able to challenge its validity.

On 6 October 2021, the EU-Western Balkans summit took place in Brdo pri Kranju (Slovenia), in which EU leaders agreed on the Brdo declaration, with which six Western Balkans partners aligned themselves.

AG Bobek’s Opinion on the competence of supervisory authorities to monitor courts in their compliance with GDPR

Court of Justice clari es conditions of medical reimbursement when there are diverging medical opinions

ursday 7 October

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In its judgment in Casa Naţională de Asigurări de Sănătate and Casa de Asigurări de Sănătate Constanţa (C-538/19), the Court of justice ruled that insured persons are entitled to full reimbursement of treatment costs where they had not been able to obtain the required prior authorisation in their Member State of residence because national law did not provide for consideration of a second medical opinion given in the Member State where treatment was given.

In his Opinion in Autoriteit Persoonsgegevens (C-245/20), Advocate General Bobek considered that the national courts’ practice of disclosing procedural documents to a journalist for the purpose of be er covering a public hearing is carried out by courts ‘acting in their judicial capacity’ and thus supervisory authorities are not competent to monitor such processing operations.

Court of Justice con rms interim measures against Poland in case concerning judicial independence ursday 7 October

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Council adopts Blue Card Directive to a ract highly-quali ed workers Friday 8 October

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e Vice-President of the Court of Justice rejected Poland’s appeal against the order imposing interim measures and ordering it to immediately suspend the application of national provisions on the competences of the Disciplinary Chamber of its Supreme Court in Commission v Poland (C-204/21 R), until the nal judgment in the case is delivered.

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e Council of the EU adopted the so-called Blue Card Directive, which provides for new rules and conditions for the entry and residence of highly skilled non-EU nationals, rst proposed in 2016 to a ract workers to the EU.

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Partial renewal of the Court of Justice and reelection of President and election of Vice-President Friday 8 October

Amendment to Aarhus Regulation oﬃcially published Friday 8 October

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Oﬃcial publication was made of the amended version of the Aarhus Regulation, which aims to bring the Aarhus Regulation in line with the Aarhus Convention that guarantees access to information, public participation in decision-making and access to justice in environmental ma ers.

e Court of Justice was partially renewed on 7 October 2021 with the departure of nine Judges and Advocates General and the arrival of nine new members of the Court, while Mr. Koen Lenaerts was reelected as the President of the Court and Mr. Lars Bay Larsen as the Vice-President.

General Court dismisses action challenging ECB decision which was later replaced Friday 8 October

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In Ukrselhosprom PCF and Versobank v ECB (Cases T-351/18 and T-584/18), the General Court dismissed an action for annulment by the second applicant challenging a decision by the European Central Bank withdrawing authorisation to operate as a credit institution.

Insights, Analyses & Op-Eds Court of Auditors v Karel Pinxten (C130/19): a series of unfortunate events

Celebrating CILFIT while changing course, albeit slightly and subtly

by Enrique Arnaldos

by Jasper Krommendijk

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Op-Ed on the judgment of the Court of Justice in Consorzio Italian Management e Catania Multiservizi (C-561/19), which ‘reasserted’ the CILFIT criteria on the obligation of national courts to refer questions for a preliminary ruling to the Court of Justice, but slightly so ened them.

Op-Ed on the recent case Karel Pinxten (C-130/19), in which the Court of Justice found that a member of the European Court of Auditors had breached the obligations arising from his or her oﬃce.

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Sumal (C-882/19): Solving one problem, while creating many others? by Miguel Sousa Ferro

Opinion 1/19, the practice of ‘common accord’, and incomplete mixity: paving a way for concluding the Istanbul Convention?

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Op-Ed on the recent judgment of the Court of Justice in Sumal (C-882/19), which established the conditions under which subsidiaries can be liable for the competition law infringements of their parents.

by Gesa Kübek

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Analysis of the Court of Justice Avis 1/19 Opinion, on the procedure and EU legal bases to conclude part of the Istanbul Convention, which paved a way for the EU to conclude the Istanbul Convention in the absence of a ‘common accord’ of the Member States.

Perseverare diabolicum − Spanish law on State liability for breaches of EU law by Gabriel Doménech-Pascual

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Op-Ed on the compatibility of Spanish law governing State liability with EU law, in light of the recent hearing before the Court of Justice in Commission v Spain (C-278/20), in which Spain is accused of failing to ful ll its obligations when lying down the conditions governing State liability for damages caused to individuals by acts of the legislature in breach of EU law.

Library - Book Review

By Willem A. Janssen READ ON EU LAW LIVE

Pedro Cerqueira Gomes

EU Public Procurement and Innovation: e Innovation Partnership Procedure and Harmonization Challenges Review of a ‘compact and to-the-point book’ by Pedro Cerqueira Gomes which ‘adds signi cantly to the understanding of how EU public procurement law in uences the discretionary power of public authorities that aim to procure innovative goods, services and works on the market’ and is the rst to coherently explore the stages and main features of the innovation partnership procedure in an in-depth manner. According to the reviewer it is a recommended read for all of those who are involved with public procurement (law), innovation and the question of how EU law in uences our ability to overcome societal challenges.