Weekend Edition Nº70 by eulawlive

Nº70

SEPTEMBER 11

2021

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MARY GUY

EUROPEAN HEALTH UNION ONE YEAR ON…

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European Health Union: One year on... Mary Guy

ment of the EU’s health competence and where a ention has previously been focused. It will then recall the initial calls for a European Health Union amid perceptions of disappointing EU-level responses to the COVID-19 pandemic in early 2020. ird, it will compare and contrasts two visions of a European Health Union – of the Commission and emerging from the aforementioned Manifesto. Fourth it will conclude with some nal remarks pending further discussion of EU-Member State interaction and the possibility of Treaty change.

On 16th September 2020, Commission President von der Leyen gave notable impetus to the EU-level response to the COVID-19 pandemic in her State of the Union address with the words “For me, it is crystal clear – we need to build a stronger European Health Union”. Concerns that the initial EU-level response to the pandemic was limited meant that calls for a European Health Union at national and EU levels can be traced back to around May 2020, and have continued since, developing to encompass not only the pandemic response, but wider health issues. November 2020 saw the Commission se ing out a vision of what a European Health Union can look like, and the publication of a Manifesto by the European Health Union initiative proposing wider parameters beyond pandemic responses. During the rst part of 2021, calls continued, and developed. Two prominent aspects to emerging visions of a European Health Union are the interaction between the EU and Member State-levels regarding healthcare, and whether the existing Treaty provisions on health need amendment to deliver the bene ts of a European Health Union.

1. Development of the EU’s health competence… It might be considered that the most obvious manifestation of the EU’s competence in health is set out in Article 168 Treaty on the Functioning of the European Union (TFEU). is combines both a public health aspect, and a ‘healthcare’ aspect relating to health policy, and healthcare system organisation. e two aspects combine to outline the interaction between the EU and national levels, with ‘public health’ being a ma er for ‘complementary’ action between the EU and Member States (2), and for ‘cooperation’ within and beyond the EU (3), with scope

In anticipation of the 2021 State of the Union address, this Long Read will rst outline the develop-

1. Mary Guy is Lecturer in Law at Lancaster University (UK), founder of the Health in Europe virtual seminar series, and a co-coordinator of the EU Health Governance Research Network. 2. Article 168 (1) and (2) TFEU. 3. Article 168 (2) and (3) TFEU.

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for the European Parliament and the Council to adopt measures to meet common safety concerns regarding, inter alia, organs, blood and medical devices (4). Closer cooperation between the EU and Member States regarding comba ing cross-border health scourges and serious threats to health, as well as protecting public health regarding tobacco and alcohol abuse is also provided for with the European Parliament and the Council’s scope to adopt incentive measures, with the stipulation that this does not extend to harmonisation of national provisions (5). In contrast, national health policies and healthcare system organisation are reserved exclusively to Member States (6).

‘ e European Parliament and the Council, acting in accordance with the ordinary legislative procedure and a er consulting the Economic and Social Commi ee and the Commi ee of the Regions, may also adopt incentive measures designed to protect and improve human health and in particular to combat the major cross-border health scourges, measures concerning monitoring, early warning of and combating serious cross-border threats to health, and measures which have as their direct objective the protection of public health regarding tobacco and the abuse of alcohol, excluding any harmonisation of the laws and regulations of the Member States.’

e Treaty provision on public health was initially inserted by the Maastricht Treaty (Article 129 EC) and expanded to incorporate the explicit delineation of Member States’ competence for national health policy and healthcare system organisation within the subsequent renumbering in the Amsterdam Treaty (Article 152 TEU). e shi to the current Article 168 TFEU has seen the incorporation of the ability to take ‘incentive measures’ under Article 168(5) TFEU, speci cally:

It has also provided for further clari cation of the Member States’ competence vis-à-vis national health policy and healthcare system organisation under Article 168(7) TFEU thus: ‘Union action shall respect the responsibilities of the Member States for the de nition of their health policy and for the organisation and delivery of health services and medical care. e responsibilities of the Member States shall include

4. Article 168 (4) TFEU. 5. Article 168 (5) TFEU. 6. Article 168 (7) TFEU.

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of the ‘Europeanisation’ of healthcare and concerns that the Directive eﬀectively ‘juridi es’ decisions about allocation of healthcare resources at a national level. e issuing of Country-Speci c Recommendations by the Commission within the context of the European Semester-annual scal assessment have similarly been framed as ‘incursion’, although the interaction between the national and EU levels within the assessment framework arguably suggests a more circular relationship. is circularity can also be found in questions of the extent of the applicability of the EU antitrust and State aid rules to national healthcare systems – and the varying recourse to the Services of General Interest exemption and Services of General Economic Interest exception (8). ese examples – from the internal market and scal policy – do, however, point to the potential for divergence between Member States, both in terms of the resources allocated at a national level and the organisation of healthcare system types. Quite apart from concerns about national sovereignty regarding healthcare, the very broad typology of insurancebased (Bismarck) systems and taxation-funded (Beveridge) systems help indicate in general terms where some of the tensions may lie when it comes to implementing EU-level initiatives at a national level.

the management of health services and medical care and the allocation of the resources assigned to them. […]’ is Treaty provision has enabled the EU institutions to raise the pro le of health, for example by dedicated Health Programmes since 2003 (7), and to take action with regard to other global health emergencies, such as BSE and bird u. However, EUlevel involvement in ma ers which may be deemed health-related can be traced chronologically, from initial involvement in social security and food safety, via pharmaceuticals and medical devices to medical quali cations and health and safety. e expansion of the EU’s interest in health has inevitably extended beyond the realm of public health to other aspects, notably the internal market and scal policy, which increasingly raise questions about the framing of national health policy and healthcare system organisation as an exclusively Member State-competence. e Patients’ Rights Directive is arguably the clearest example of how these concerns have been framed, given its basis on harmonisation (Articles 114 and 168 TFEU). e ability of EU citizens to travel and access healthcare in another Member State has prompted much academic discussion

e EU’s interest in health has inevitably extended beyond the realm of public health to other aspects, notably the internal market and scal policy

7. Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the eld of public health (2003-2008); Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007 establishing a second programme of Community action in the eld of health (2008-13); Regulation (EU) No 282/2014 of the European Parliament and of the Council of 11 March 2014 on the establishment of a third Programme for the Union's action in the eld of health (2014-2020). 8. Both a ma er for Member State determination under Protocol No. 26 on Services of General Interest.

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At the same point in time, the Socialists and Democrats party in the European Parliament outlined a vision for a European Health Union. is call aimed at increasing EU competence in health and proved wide-ranging, encompassing aspects as diverse as access to pharmaceuticals, health research and health and safety in the workplace, arguably consistent with the EU’s diversity of powers which might be considered related to health.

2. Initial EU responses to COVID-19 and the rst calls for a European Health Union… e EU’s initial response to the spread of the COVID-19 pandemic appeared fragmented and unsatisfactory, amid promises by Commission President von der Leyen that “Whatever is necessary, will be done…”, leading to criticisms such as “A union that speaks o en of solidarity between peoples initially saw li le solidarity”. e explanation oﬀered for this was the inhibiting factor of health policy and healthcare system-organisation being reserved as a national competence, and the limits to the EU’s legislative powers in the eld of public health (9). What emerged among the initial responses was that the EU’s ‘web of competence’ regarding health was not well understood.

While the Socialists and Democrats call may be considered to have been ‘built around’ the ‘core’ of the EU respecting Member State competence for national health policy and healthcare system organisation, there was already EU-level acknowledgement back in May 2020 by Commissioner Schinas that Treaty change may be possible. Developing in parallel alongside the calls for a European Health Union in May 2020 was the initial proposal for the EU’s current health programme, EU4Health, to run between 2021 and 2027. is provided for an ambitious health strategy, encompassing not only more coordinated COVID-19 responses, and key action areas for the improvement of the resilience of national healthcare systems, but also emphasised strong embedding in the ‘One Health’ approach recognising the interconnection between human health, animal health and the envi-

e EU’s initial response to the spread of the COVID-19 pandemic appeared fragmented and unsatisfactory e idea for a ‘European Health Union’ can be traced back to calls by Emmanuel Macron for a ‘Europe de la santé’ during a joint press conference with Angela Merkel in May 2020. is outlined a ‘health strategy’ for a strategically-positioned European healthcare industry which would upgrade the European dimension of healthcare and reduce EU dependency, while fully respecting Member States’ responsibility for healthcare systems.

e initial proposal for the EU4Health programme provided for an ambitious health strategy

9. See further this Long Read by Ulla Neergaard and Sybe de Vries from April 2020.

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ronment. e ambition of this programme may be considered to be recognised by the initial budget assigned to it in May 2020 – 9.4 billion euros. However, this was dramatically cut to 1.7 billion euros following the EU summit in July 2020 under pressure from the so-called frugal countries – Austria, Denmark, the Netherlands and Sweden.

3. Building a European Health Union: two visions … In November 2020, the Commission published a range of proposals to extend the mandate of the ECDC and the EMA, and for a Regulation on serious cross-border threats to health, as well as outlining a pharmaceutical strategy for Europe, and a Communication on Building a European Health Union – preparedness and resilience. e Communication con rmed that it proposed the rst building blocks for a European Health Union, and that these were envisaged within the current Treaty provisions, particularly Article 168(5) TFEU. In particular, ‘By upgrading the EU framework for crossborder health threats, these rst building blocks of the European Health Union will bring greater overall impact while fully respecting the Member States’ competence in the area of health’. is appears consistent with the initial calls for a European Health Union – as focused around an apparently immutable core of Member State competence in healthcare. However, the Communication can be seen as notable for its portrayal of EU-Member State interaction, in recognising the need to work together, and use the EU’s potential to improve the health response and to support Member States to ful l their responsibilities, and particularly with the concluding sentence: ‘ e European Health Union will be as strong as its Member States’ commitment to it.’

When Commission President von der Leyen gave her inaugural State of the Union address in September 2020, commitment to building a stronger European Health Union was evident, as was recognition of the need to ‘future proof ’ the EU4Health programme. e vision for a European Health Union focused on strengthening crisis preparedness and managing cross-border health threats througha three-fold approach: reinforcing and empowering the European Medicines Agency and the European Centre for Disease Control; building a European Biomedical Advanced Research and Development Agency; and discussing the question of health competences – con rmed by Commission President von de Leyen as a ‘noble and urgent task’ for the Conference on the Future of Europe. e concept of a European Health Union was given further impetus by Angela Merkel, who reiterated calls for this in December 2020, and her support for Treaty change in April 2021.

e Commission’s Communication can be seen as notable for its portrayal of EU-Member State interaction

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November 2020 also saw the launch of the European Health Union Initiative, facilitated by the European Health Forum Gastein and comprising a diverse group of academics and policymakers (10). e initiative’s independence means it has scope to outline a vision for a European Health Union which can be considered more ambitious than that proposed by the Commission, while stating its support for the Commission’s action and Commission President von der Leyen’s commitment to building a European Health Union. e European Health Union Manifesto is anchored around two aims: to call on the political leaders of Europe in the framework of the Conference on the Future of Europe to commit to creating a European Health Union, and to invite the people of Europe to engage in building a health policy that contributes to the EU’s long-term sustainable development. Signatories of the Manifesto comprise an impressive array of healthcare practitioners, politicians at national and international le-

e EU4Health programme was subsequently elaborated as paving the way to a European Health Union by investing in urgent health priorities, namely, responding to the COVID-19 crisis and improving EU-level resilience for cross-border threats, Europe’s Beating Cancer Plan, and the Pharmaceutical Strategy for Europe. Just as the scope for the EU4Health programme evolved, so too did the budget associated with it. In September 2020, Commission President von der Leyen had indicated support for the European Parliament’s ght for more funding following the cu ing of the budget to 1.7 billion euros in July 2020 by the European Council. In December 2020, the European Council and European Parliament agreed a budget of 5.1 billion euros for the EU4Health programme, a move acknowledged by Commissioner Schinas as a vote of con dence in making a European Health Union a reality, and by Commissioner Kyriakides as meeting EU citizens’ expectations of a European Health Union.

10. Including Vytenis Andriukaitis, former Commissioner for Health and Food Safety (2014-2019); and former President of the European Parliament, Klaus Hänsch.

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unmet medical needs, and strengthen the interoperability of their health systems’. While the rst amendment has echoes of a curious return to the original formulation of Member State competence (Article 152(5) TEU), the second indicates a decisive change in focus which could provide a useful reframing of the interaction between the EU and Member States regarding national healthcare, insofar as ‘health policy’ may be considered to be concerned with aspects such as health inequalities and responses to these.

vels, policymakers, civil society actors and academics from across the EU and beyond (11). Part of the Initiative’s ambition lies in its proposals for Treaty change, both with regard to Article 168 TFEU and elsewhere in the Treaty, for example, by stipulating the European Health Union as an instance of a shared competence between the EU and the Member States under Article 4 TFEU.

e Initiative’s vision for amending Article 168(7) TFEU sees the Member State–EU interaction regarding national health competence as being linked 4. Concluding remarks explicitly with the principle of subsidiarity. As the Initiative notes, this may create a rebalancing of the Ahead of Commission President von der Leyen’s seEU-Member State dynamic such that a counterincond State of the Union address, it is clear that fountuitive eﬀect of stronger EU dations have been put in plapower in health can be that ce since autumn 2020 for Ahead of Commission national health ministries the construction of a Euroand the a ached health pean Health Union. e President von der Leyen’s communities will have a Commission’s proposals second State of the Union more powerful role in defor legislation to facilitate termining whether or not EU-level responses by refoaddress, it is clear that EU legislation meets the cusing the remit of various test of subsidiarity. foundations have been agencies, the outlining of a European pharmaceutical put in place since autumn However, the amendments strategy and plans to adto Article 168(7) TFEU 2020 for the construction dress healthcare concerns are notable for two further outside of pandemic resof a European Health Union reasons. Firstly, they enviponses (via the Beating sage the removal of ‘health Cancer Plan) all demonspolicy’, such that Member trate notable commitment States would only be resand, combined with the signi cant budget evenponsible for the organisation and delivery of health tually agreed for the current EU4Health programservices and medical care. Secondly, they elaborate me (12), suggest that there now exists a relatively sothe EU’s role as ‘support[ing] the capabilities of lid base on which to build a European Health Member States to promote health equality, reduce Union. 11. As of 31 August 2021, there were 1,250 signatures. See here. 12.Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the eld of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014.

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What is surely becoming clearer as the COVID-19 pandemic evolves is not only the interaction of health with other policy areas, but also that it is impracticable (if not impossible) to completely separate health crisis responses from wider considerations of health policy and how healthcare systems operate. A European Health Union needs to recognise – and improve – where crisis responses at EU and national levels can be strengthened, certainly. However, it also needs to go beyond this: and both the Commission and European Health Union Initiative responses acknowledge this, albeit in diﬀerent ways. A possible weakness in the foundations of a European Health Union remains the interaction between the EU and Member State levels regarding national healthcare system organisation. Moving discussion of competence to the Conference on the Future of Europe is to be welcomed insofar as this discussion would bene t from wide audience involvement. How the discussion is managed will also be signi cant. e changes between Article 152 TEU and Article 168 TFEU can be framed as the Member States’ hands being strengthened vis-à-vis the EU, and the extension of EU scal policy into healthcare as a simple ‘power grab’. e upheavals wrought by COVID-19 oﬀer an opportunity to change the narrative – for a more widespread understanding of how the EU and Member State levels can interact regarding health.

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News Highlights Week 6 to 10 Sept 2021

Ryanair’s action for annulment against Commission State aid decision concerning Finnair: action published Monday 6 September

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Ryanair’s action for annulment against a Commission State aid Decision in favour of Finnair during the COVID-19 pandemic, on proportionality, discrimination, free movement and procedural grounds, was published: Ryanair v Commission (T-444/21).

e European Court of Auditors and the European Public Prosecutor’s Oﬃce entered into an arrangement to enhance cooperation and ght nancial crime Monday 6 September

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e European Court of Auditors and European Public Prosecutor’s Oﬃce signed a working arrangement to strengthen their cooperative relationship to combat fraud, corruption and threats to the EU’s nancial interests, which came into eﬀect on 3 September 2021.

Irish ne on Whatsapp: European Data Protection Board issues decision that requires it to be amended to make infringements clearer and recalculate ne Monday 6 September

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e European Data Protection Board issued a now published binding decision concerning the Irish supervisory’s authority dra decision on WhatsApp Ireland Ltd’s infringement of EU data protection law, asking it to clarify the speci c infringements breached and recalculate the ne.

Contractual agent dispute over pension rights following 2014 Staﬀ Regulations reform: appeal grounds before Court of Justice published Monday 6 September

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An appeal in a Staﬀ Regulations case concerning a contractual agent of the Commission’s pension rights against the General Court’s ruling Picard v Commission (T-769/16), lodged by Maxime Picard before the Court of Justice, was published (C366/21 P).

Review of the anti-dumping duty rate on certain imports from China Monday 6 September

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Commission Implementing Regulation 2021/1447 was published, concerning de nitive anti-dumping duty on imports of certain prepared or preserved citrus fruits originating in China, following an expiry review.

AG Bobek: group life assurance contracts linked to investment funds and the duty to disclose information under EU consumer law Monday 6 September

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Advocate General Bobek issued his Opinion concerning complaints over a lack of pre-contractual information on certain nancial risks, relating to the scope of Life Assurance and Unfair Commercial Practices Directive: A v O (C-143/20) and G.W., E.S. v A. Towarzystwo Ubezpieczeń Życie S.A. (C-213/20).

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AG Rantos: Member States cannot subject the exemption from excise duty to payments made through non-cash means Monday 6 September

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Advocate General Rantos delivered his Opinion in MONO (C-326/20), a case on the margin of discretion that Member States have when regulating the exemption from excise duty of goods intended to be used in the context of diplomatic or consular relations, speci cally in relation to the method of payment.

AG Bobek: Financial penalty imposed in a Member State must be enforced in another if full assessment shows suﬃcient information provided in a language the individual can understand Monday 6 September

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For the pending case before the Court of Justice, Prokuratura Rejonowa Łódź-Bałuty (C-338/20) on the interpretation of the EU’s Framework Decision (2005/214/JHA) on the mutual recognition by a Member State of nancial penalties imposed in one Member State to be enforced in another, Advocate General gave his advice in an Opinion.

Rules on information given to private investors purchasing investment products simpli ed Tuesday 7 September

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Simpli ed rules on information that private investors should receive when purchasing certain investment products were adopted by the Commission, in the form of a Delegated Regulation se ing out that information on ‘Packaged Retail and Investment and Insurance Products’ in a single document (the Key Information Document).

ECB decisions on the delegation of certain decision-making powers to the heads of work units now published Monday 6 September

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A set of Decisions of the European Central Bank amending several previous Decisions on the delegation of certain decision-making powers to the heads of work units of the ECB were published.

AG Pitruzzella advises Court of Justice to dismiss anti-dumping appeal against General Court’s ruling in Eurofer v Commission Monday 6 September

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Advocate General Pitruzzella advised the Court of Justice to dismiss the anti-dumping appeal case Eurofer, European Steel Association, AISBL v European Commission (C-226/20 P), concerning an investigation into imports of hot-rolled at metal products originating in Serbia.

Commission requests Court of Justice to impose nancial penalties on Poland a er continued infringements of EU law Tuesday 7 September

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e Commission requested that the Court of Justice impose nancial penalties on Poland for failure to comply with the interim measures it ordered on 14 July to immediately suspend the application of national provisions on the competences of the Disciplinary Chamber of the Polish Supreme Court.

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Preliminary ruling request on the refund of travel packages in the context of COVID-19 Tuesday 7 September

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Commission approves German State aid scheme to support the acquisition of alternatively fuelled buses for passenger transport

A request for a preliminary ruling lodged by the French Council of State in Union fédérale des consommateurs v Premier ministre (C-407/21) was published, with questions on the obligation of travel organisers to refund travel package-payments a er termination of the contract, following the COVID-19 crisis.

Tuesday 7 September

EU-UK post-Brexit relations: Commission reiterates that it rules out renegotiation of how to implement Northern Ireland/Ireland Protocol

e Commission’s approval of the dra VBER and dra guidelines published in Oﬃcial Journal

Tuesday 7 September

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e Commission issued a statement that both the EU and UK are ‘legally bound to ful l’ the obligations that they have agreed under the Withdrawal Agreement, as an international agreement, and that for the issues currently faced, solutions concerning the implementation of the Northern Ireland/Ireland Protocol must be found.

Preliminary ruling request on the direct eﬀect of the Public Procurement Directive Tuesday 7 September

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Two requests for a preliminary ruling lodged by the Council of State of Belgium in Société de Logement de Service Public v Société wallonne du logement (C-383/21) and Municipality of Farciennes v Société wallonne du logement (C-384/21), were published on whether Articles 12(3) and 12(4) of Public Procurement Directive 2014/24 have direct eﬀect.

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A German scheme in the amount of 1.75 billion euros to support the acquisition of alternatively fuelled buses and related infrastructure for public passenger transport in Germany was approved by the European Commission.

Tuesday 7 September

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Commission Communications approving the content of the dra Vertical Block Exemption Regulation (VBER) and dra Vertical Guidelines were published in the Oﬃcial Journal, both of which are still available for public consultation on the Commission’s website.

Court of Justice: Grand Chamber claries interaction between transparency and protection of con dential information in procurement procedures Tuesday 7 September

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e Grand Chamber of the Court of Justice ruled in Klaipėdos regiono atliekų tvarkymo centras (C-927/19) on the interpretation of the public procurement Directives 89/665, 2014/24, and 2016/943 regarding the disclosure of documentation provided to contracting authorities by tenderers in public procurement procedures.

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ECtHR: lack of criminal conviction of ex-husband for disclosure in civil proceedings of applicant’s private emails does not breach privacy rights Tuesday 7 September

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AG Pitruzzella: Member States have wide discretion in regulating length of night-work for workers Tuesday 7 September

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e European Court of Human Rights in M.P. v. Portugal (application no. 27516/14), unanimously ruled that Article 8 ECHR was not breached by the acceptance as evidence, by domestic civil courts, of a number of the applicant’s emails that had been accessed by her ex-husband without her consent.

Advocate General Pitruzzella advised the Court of Justice in VB v Glavna direktsia ‘Pozharna bezopasnost i zashtita na naselenieto’ kam Ministerstvo na vatreshnite raboti (C-262/20) on how Member States may regulate the length of night work in compliance with the Working Time Directive 2003/88 to ensure its objective of full and eﬀective health and safety.

Luxleaks case: Grand Chamber of the ECtHR to re-examine standards for protection of whistleblowers

Newly appointed Advocates-General and Judges to the Court of Justice of the European Union

Wednesday 8 September

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e Grand Chamber panel of the European Court of Human Rights decided to refer to the ECtHR’s Grand Chamber the case Halet v. Luxembourg (application no. 21884/18), concerning the applicant’s criminal conviction in the so-called ‘Luxleaks’ case for disclosing tax documents concerning some of his employer’s clients.

Two new Advocates-General – Anthony Collins (Ireland) and Laila Medina (Latvia) – and one Judge – Mr Pēteris Zilgalvis (Latvia) – were appointed to the Court of Justice of the European Union, by the representatives of the Governments of the Member States.

ECtHR: limits on restoration of former properties of Bulgarian royal family breach human rights

Commission adopts Green Bond Framework to contribute to the EU’s environmental and sustainability strategy

Wednesday 8 September

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e European Court of Human Rights ruled in Sakskoburggotski and Chrobok v. Bulgaria (application no. 38948/10) that the moratorium imposed by the Bulgarian authorities on the transfer and on the commercial exploitation of forestland

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In line with its goal of strengthening the EU’s role in the sustainable nance markets, the European Commission adopted the Green Bond Framework, se ing an issuance of up to 250 billion euros worth of green bonds between now and 2026, the proceeds of which will be used for green investments.

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ESAs: cyber risks and risks in phasing out crisis measures Wednesday 8 September

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e European Supervisory Authorities (EBA, EIOPA and ESMA – ESAs)’s second joint risk assessment report for 2021 pointed out increasing risks in the nancial sector relating to the phasing out of exceptional crisis measures and cyber risks

General Court does not nd fault with Commission Decision agreeing that pinse er machines should be taken oﬀmarket for health and safety reasons: annulment action dismissed Wednesday 8 September

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e General Court dismissed the applicant’s request in Brunswick Bowling Products LLC v European Commission (T152/19) for annulment of Commission Implementing Decision 2018/1960, which approved a Swedish decision to prevent the placing of the applicant’s products on the market.

Conditions for clearing service providers regarding OTC derivative contracts: Delegated Regulation published

ECtHR’s Grand Chamber to rule on publisher’s warning that pro-LGBT children’s book is harmful

Wednesday 8 September

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Commission Delegated Regulation 2021/1456, that species conditions under which commercial terms for clearing services for OTC derivatives are fair, reasonable, nondiscriminatory and transparent (‘F NDT’ commercial terms), was published.

e Grand Chamber of the European Court of Human Rights will hear the case of Macatė v. Lithuania (application no. 61435/19), concerning the compatibility with the ECHR of the decision by a private publisher to label a book as ‘harmful to children’ because it contained a positive depiction of same-sex relationships.

Commission registers European Citizens’ Initiative concerning the Common Commercial Policy

General Court annuls Commission Decision declaring Lithuanian State aid compatible with EU law

Wednesday 8 September

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e European Commission registered a European Citizens’ Initiative calling on the Commission to present a proposal under the Common Commercial Policy to prevent EU legal entities from importing products originating in illegal se lements in occupied territories and exporting to such territories.

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e General Court upheld the action for annulment against the 2018 Commission Decision in State aid case SA.44678 (Decision), which declared the modi cation of the aid for the LNG terminal in Lithuania compatible with EU law.

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Court of Justice: Loan agreements which contain incorrect or incomplete mandatory information may be revoked by a consumer at any time Wednesday 8 September

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Procedural rules to grant and withdraw international protection: Court of Justice’s ruling on newly raised facts and evidence ursday 9 September

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e Court of Justice rule in joined cases C-33/20, C-155/20 and C-187/20, Volkswagen Bank, Volkswagen Bank and Skoda Bank, and BMW Bank and Volkswagen Bank, that when a loan agreement contains incorrect or incomplete mandatory information required under the Consumer Credit Agreements Directive 2008/48 (Directive), the consumer may at any time revoke the conclusion of the contract and have the installments made to the bank reimbursed.

e Court of Justice delivered its judgment in Bundesamt für Fremdenwesen und Asyl (C-18/20), a preliminary ruling request made by the Supreme Administrative Court of Austria (Verwaltungsgerichtshof) on the interpretation of Procedural Directive 2013/32, concerning the common procedures for granting and withdrawing international protection.

AG Pikamäe: UK’s control of certain imports from China breached the TFEU and secondary legislation on customs, traditional own resources and VAT

Court of Justice clari es that on-call duty breaks are classi ed as ‘working time’

ursday 9 September

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Advocate General Pikamäe delivered his Opinion in the Grand Chamber case Commission v United Kingdom (C213/19), advising the Court of Justice on how to develop its case law on the scope of the obligations to counter fraud and protect the nancial interests of the EU.

AG Hogan’s Opinion on the procedural limits on the interaction between national supreme courts in EU law-related cases ursday 9 September

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Advocate General Hogan delivered his Opinion in Grand Chamber case Randstad Italia (C-497/20), advising the Court of Justice on preliminary questions submi ed by the Italian Court of Cassation on whether a Member State must provide a further right of appeal where an appellate court has misinterpreted or misapplied EU law, and other available remedies.

ursday 9 September

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In Dopravní podnik hl. m. Prahy (C-107/19), the Court of Justice held that a break taken by an employee when he or she must remain on-call duty should be classi ed as ‘working time’.

Rights of parent a ached to child who has subsidiary protection under EU asylum law: Court of Justice’s ruling in Bundesrepublik Deutschland ursday 9 September

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e Court of Justice ruled in Bundesrepublik Deutschland v SE (C-768/19) on the interpretation of Article 2(j) of Quali cation Directive 2011/95 in the context of a dispute over the refusal to grant an Afghan national refugee status or subsidiary protection for the purpose of family reuni cation with their child.

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Court of Justice clari es procedural requirements for the imposition of administrative penalties by national authorities in the nancial sector ursday 9 September

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e Court of Justice issued two separate judgments in Adler Real Estate and Others (cases C-546/18 and C-605/18), providing crucial clari cations on the competence and the procedure for the imposition of nancial administrative penalties by national supervisory authorities under Article 47 of the Charter, Directive 2004/25 and Directive 2004/19.

e bene t of EU’s protected designation of origin rules extends to signs used for services as well as products, Court of Justice rules ursday 9 September

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Comité Interprofessionnel du Vin de Champagne (C-783/19) was decided by the Court of Justice, which ruled that agricultural products can bene t from protected designation of origin-rules under Article 103(b) of Regulation 1308/2013 in respect of products as well as services.

ECtHR adopts interim measures in respect of Afghan nationals stranded at the Lithuania/Belarus border ursday 9 September

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e European Court of Human Rights adopted an interim measure in the pending case Sadeed and Others v. Lithuania (application no. 44205/21), indicating to the Government of Lithuania that the applicants, ve Afghan nationals who seek international protection, should not be removed to Belarus, provided that they are already on Lithuanian territory.

Court of Justice: taxpayers are entitled to the payment of interest on the amount of electricity tax wrongly levied Friday 10 September

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In Hauptzollamt B (Réduction scale facultative) (C-100/20), the Court of Justice held that a taxpayer is entitled to the payment of interest on the amount of electricity tax which was wrongly levied and therefore overpaid.

Uruguay added and six countries removed from the list of countries for which COVID-19 travel restrictions into the EU should be li ed

Payments owed to bank in cross-border domicile case: AG Campos SánchezBordona’s advice on application of Lugano Convention

Friday 10 September

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e Council of the EU revised the list of countries for which travel restrictions should gradually be li ed as of 9 September 2021 issuing a new recommendation that was published in the Oﬃcial Journal (Recommendation 2021/1459), updating Recommendation 2020/912.

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Advocate General Campos Sánchez-Bordona advised the Court of Justice in Commerzbank AG v E.O. (C-296/20) on how to interpret the Lugano Convention in order to determine which court has jurisdiction over a dispute raised by a banking institution to recover payment of the debit balance on a customer’s current account.

Nº70 · SEPTEMBER 11 2021

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Insights, Analyses & Op-Eds e European Commission has the capacity to reject a social partners’ proposal for a Directive under Article 155 TFEU by José María Miranda Boto

e State aid and tax rulings saga: e General Court annuls a third Commission decision concerning tax rulings (Amazon) but also con rms the Commission’s approach (Engie)

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Op-Ed on the dismissal of the appeal EPSU v European Commission (C-928/19 P) by the Court of Justice against the General Court’s ruling that the Commission is not bound to give eﬀect to a joint request under Articles 154 and 155 TFEU, which ‘puts the procedure under Article 155 TFEU at a serious crossroads’.

by Adolfo Martín Jiménez and Juan Jorge Piernas López

AG Tanchev’s Opinions on the eﬀectiveness principle in EU consumer protection law

Migrants’ Social Rights in the Dialogue between the CJEU and the Italian Constitutional Court: Long Live Article 267 TFEU!

by Francisco Pertíñez

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Op-Ed on the General Court’s judgments in Amazon (T816/17 and T-318/18) and Engie) (T-516/18 and T525/18) concerning Commission State aid decisions, which ‘con rm (with some nuances) previous case law of the GC on the application of the EU’s State aid rules to tax rulings’, and ‘shed light on the interaction between Article 107(1) TFEU and rules prohibiting the abuse of tax law’.

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by Daniele Gallo

Op-Ed on Advocate General Tanchev’s Opinions in Unicaja Banco (C-869/19), SPV Project 1503 (C-693/19 and C831/19), Impuls Leasing România (C-725/19), and Ibercaja Banco (C-600/19), which if the Court were to follow would mean ‘the diffuse limits of the effectiveness principle in the eld of consumer protection against the use of unfair terms will be widened, and in correlation some basic national procedural principles of civil jurisdiction’ will be affected.

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Op-Ed on the Court of Justice’s Grand Chamber O.D. and Others v Istituto nazionale della previdenza sociale (INPS) (C350/20) by which it has recognised the rights of thirdcountry nationals who hold single permits to receive a childbirth allowance and a maternity allowance as provided for by the Italian legislation.

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Procedure ma ers – some preliminary thoughts on the Russian Inter-State Application against Ukraine before the European Court of Human Rights by Isabella Risini

e Komstroy case: common market philosophy, the ECT and intra-EU ISDS by Edoardo Stoppioni

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Op-Ed on Russia’s inter-State application against Ukraine under Article 33 ECHR - ‘a remarkable new development’, in the context of Ukraine’s nine (and other) such applications against Russia, focusing on those relationships between the applications.

Op-Ed on the solution of the Court of Justice’s Grand Chamber in the Komstroy case (C-741/19) which ‘does not come as a surprise for the readers of the evolution of the relations between EU law and international investment arbitration, as the evolution of the European jurisprudence points towards the prohibition of any intra-EU investment arbitration’.

Cases beget cases. A comment on the legal basis-litigation in light of Commission v Council (Accord avec l’Arménie)

To disclose or not to disclose – Klaipėdos regiono atliekų tvarkymo centras (C927/19)

by Andrés Delgado

by Piotr Bogdanowicz

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Op-Ed on the Court of Justice’s ruling in Commission v Council (Accord avec l’Arménie) (C-180/20), ‘one more case in the long saga of legal basis litigation on EU External Relations’ but which ‘continues to slightly modify the centre of gravity test that it applies to determine the correct legal basis’, and which ‘examines in detail the aims of the Agreement’ between the EU and Armenia.

Analysis of the Court of Justice’s case Klaipėdos regiono atliekų tvarkymo centras (C-927/19), a rare Grand Chamber case in the eld of public procurement, in which the Court ‘tried to nd a proper balance between the protection of the con dential information provided by a tenderer and the eﬀectiveness of the rights of defence of other tenderers’ and which focuses ‘on the con dentiality issues’.

Private standards, EU law and access – source.Org

e General Court’s ruling in Public.Re-

by Maurizia De Bellis

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Op-Ed on the General Court’s ruling in the case Public.Resource.Org and Right to Know v Commission (T-185/19, ‘Public.Resource.Org’) which ‘discloses the contradictions in the increasing public endorsement of private standards under EU law’. e Op-Ed considers the juridi cation of standards set by private bodies, another challenge to the de nition of so law, and the restrictive interpretation of the right of access.

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Library - Book Review

By Luca Lionello

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Stefan Griller and Elisabeth Lentsch (Eds.)

EMU Integration and Member States’ Constitutions Review of a ‘collective study by more than 30 contributors, which explains the main implications posed by the ongoing transformation of the EMU to constitutional law’.