Nº38
NOVEMBER 21
2020
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MARIOLINA ELIANTONIO, EMILIA KORKEA-AHO AND STEVEN VAUGHAN
ENRICO BONADIO AND ANDREA BALDINI
ON THE ETHICAL FOUNDATION OF PROPRIETARY RIGHTS: COVID-19, PUBLIC HEALTH, AND THE LIMITS OF PATENTS IN THE EUROPEAN CONTEXT
COVID-19 AND SOFT LAW: IS SOFT LAW PANDEMIC-PROOF?
www.eulawlive.com 1 EU LAW LIVE 2020 © ALL RIGHTS RESERVED · ISSN: 2695-9585
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On the Ethical Foundation of Proprietary Rights: COVID-19, public health, and the limits of patents in the European context Enrico Bonadio and Andrea Baldini
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In collaboration with engineer Alessandro Romaioli, Isinnova reverse-engineered the valve, after Intersurgical apparently refused to share the schematics of this product (3). The release of the 3D printed version of the reverse-engineered valves started immediately after the rst positive trial. Time was in effect of the essence: many were already dying as a consequence of COVID-19 complications, which in Italy would claim 45,000 lives (4). “We’re trying to save lives,” Fracassi replied during an interview with BBC News, which was instrumental in bringing this case into the media spotlight for having highlighted a potential patent and public health issue.
1. Introduction In mid-March 2020, Nunzia Vallini – a journalist working for a local newspaper in Brescia, a city in northern Italy – got in touch with Cristian Fracassi, engineer and chief executive of Isinnova, a 3D printing start-up (2). The hospital in Brescia, which would sadly become famous as one of the European epicentres of the pandemic, saw a spike in hospital admissions due to COVID-19 infections in that period. The number of patients needing intensive care skyrocketed to 250 in just a few days, and the hospital was running out of respirator valves, with the ofcial supplier unable to meet the sudden demand. The valve, originally produced by UK manufacturing company Intersurgical which owns patent rights protecting such a technology, allows ICU patients to be connected to breathing machines. The design enables a maximum eight hours of use, therefore requiring frequent replacement.
In effect, early reports of the news suggested that Intersurgical was ready to go to court, threatening to sue Isinnova for patent infringement. Amidst public outcry, Charles Bellm – managing director of the UK company – later issued a statement claiming that his group had never considered a lawsuit.
1. Enrico Bonadio is Reader in Intellectual Property Law at City, University of London. He is interested in the intersection between intellectual property rights and public interests, amongst other areas. Andrea Baldini is Director of the NJU Center for Sino-Italian Cultural studies as well as Associate Professor. He is interested in philosophical issues about creativity, including ethical foundations of copyright. 2. ‘Coronavirus: 3D Printers Save Hospital with Valves’, BBC News, March 16, 2020, sec. Technology. 3. Jay Peters, ‘Volunteers Produce 3D-Printed Valves for Life-Saving Coronavirus Treatments’, The Verge, March 17, 2020. 4. Gianfranco Alicandro, Giuseppe Remuzzi, and Carlo La Vecchia, ‘Italy’s First Wave of the COVID-19 Pandemic Has Ended: No Excess Mortality in May, 2020’, The Lancet 396, no. 10253 (September 12, 2020): e27–28.
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“[W]e were contacted at the end of last week for manufacturing details of a valve accessory,” Bellm said, “but could not supply these due to medical manufacturing regulations, we have categorically not threatened to sue anyone involved” (5).
2. Patent protection in Europe and the ethics of pandemic litigation The Italian case was only one among the many similar controversies in intellectual property (IP) protection that emerged internationally (6). How things actually unfolded in this story (and other similar ones) is somewhat irrelevant here: what is important is a more general question about the ethics of IP that the story raises. If Intersurgical had decided to sue Isinnova, such a legal move would have been perfectly legal: but would have that been a morally justiable action? And, by bringing this doubt into the legal domain, should European laws accept or ignore claims of IP infringement in extreme circumstances such as a pandemic?
Should European laws accept or ignore claims of IP infringement in extreme circumstances such as a pandemic?
It should be noted as a preliminary matter that patents are strongly protected in Europe. The European Patent Convention (EPC), which is not an EU instrument (7), provides a solid legal framework for the granting of European patents. Pharmaceutical companies from all over the world regularly obtain European patents to protect a wide range of new medicines – which they use to recoup the (often huge) investments necessary to develop them. Patent protection is therefore key to the pharmaceutical industry, also in Europe. This also clearly emerges from the recent European Parliament Resolution ‘The EU’s Public Health Strategy Post-Covid-19’ of 10 July 2020 (8). While the Resolution calls on the Commission and the Member States to allow maximum sharing of COVID-19
5. Peters, ‘Volunteers Produce 3D-Printed Valves for Life-Saving Coronavirus Treatments’. 6. For a discussion of international patent controversies during the pandemic, see for instance Enrico Bonadio and Andrea Baldini, ‘COVID-19, Patents and the Never-Ending Tension between Proprietary Rights and the Protection of Public Health’, European Journal of Risk Regulation 11, no. 2 (June 2020): pp. 390–95. 7. European Patent Convention (Convention on the Grant of European Patents) of 5 October 1973 as revised by the Act revising Article 63 EPC of 17 December 1991 and the Act revising the EPC of 29 November 2000. The EPC has been signed by 38 Contracting States, including countries which are not EU Member States. 8. European Parliament Resolution 2020/2691(RSP) ‘The EU’s Public Health Strategy Post-Covid-19’ of 10 July 2020.
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gent situations such as those produced by the COVID-19 crisis. And egoistic takes on IP justications clearly show their limits when major conicts between individual and societal well-being emerge. These months of global lockdown have been a powerful reminder of a simple truth about humans: we are a community of unity, whose collective well-being also makes individual selfsatisfaction possible.
health technology-related knowledge, IP and data to the benet of all countries and citizens (Paragraph 6), on the other hand it also reminds us that the EU must keep a robust European IP regime to incentivise research, development, and manufacturing, to make sure that Europe remains a world leader in innovation (Paragraph 23).
With that being said, one could argue that behaviours seemingly disregarding the imminent death of many individuals as well as 3. The relevance of collective wellthe concrete possibility of further spreading being of a dangerous virus appear morally disputable. Patents, one may After all, collective very well add, should (10)well-being was taken not make access to into consideration by the drugs or life-saving techGerman judiciary when a Collective well-being was nologies more difcult, compulsory licence over taken into consideration a patent owned by the Jaespecially during a pandemic. Should we allow by the German judiciary panese company Shionofor restrictions of circugi was granted to Merck lation of knowledge and in 2017. While controits outcome to increase versial, compulsory liprots in times of a cences allow eligible health crisis? The drugmakers to legally manufacture and sell COVID-19 pandemic has taught us many generic versions of patented drugs during nathings, but when looking at patent laws, pertional emergencies, public health crises, or haps its most important lesson has to do with in other instances of extreme need. In that cathe ethical justication of IP. Put in a nutsse the German Federal Patent Court granted hell, IP protection cannot be fully or effectiMerck the compulsory licence to continue vely vindicated by egoistic theories (9). In otselling the HIV drug Isentress, which conher words, personal gain – broadly understains the patented active ingredient raltegratood both as existential self-realisation (10) vir (12). The decision was also conrmed by or economic prot (11) – does not offer solid the German Federal Supreme Court shortly moral ground to justify IP in extreme and urafter (13).
9. For an instructive survey of philosophical justications of intellectual property, see Adam Moore and Ken Himma, ‘Intellectual Property’, in The Stanford Encyclopedia of Philosophy, ed. Edward N. Zalta, Winter 2018 (Metaphysics Research Lab, Stanford University, 2018), . 10. Georg Wilhelm Friedrich Hegel, Elements of the Philosophy of Right, ed. Allen Wood (Cambridge: Cambridge University Press, 1991). 11. John Locke, The Second Treatise of Government, ed. Peter Leslett (Cambridge: Cambridge University Press, 1988). 12. Decision of 11 July 2017; X ZB 2/17, GRUR 2017, 1017. 13. Decision of 21 November 2017; 3 Li 6/16, GRUR 2018, 803.
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rest in granting the licence exists. In this specic case, the licence was granted because the health of many people was at risk, including that of pregnant women, infants, young kids as well as newly infected and long-term patients (16). In particular, it was held that the public interest justied the compulsory licence, also taking into account the effects that an injunction against Merck would have created for HIV patients. The German Federal Supreme Court’s release claried as follows:
The grant of the compulsory licence was preceded by a patent infringement claim brought by Shionogi (owner of the European patent over the raltegravir) against Merck before the District Court of Duesseldorf in 2015 (14) after licence negotiations between the parties were unsuccessful. The Japanese company sought, inter alia, an injunction preventing Merck from using raltegravir in their drugs. The court stayed the suit pending the opposition proceedings against Shionogi’s European Patent initiated by Merck before the European Patent Ofce (15). In the meantime, Merck applied for the grant of a compulsory licence before the German Federal Patent Court. As Shionogi objected to the claim brought forward, Merck requested the Court to grant the compulsory licence by way of a preliminary order. The request was lodged pursuant to Section 85 of the German Patent Act. This provision allows compulsory licences to be granted as an interim measure where the applicant is able to furnish evidence that the prerequisites for granting a compulsory licence as outlined within Section 24(1)-(6) of the Patent Act are given and that an urgent public inte-
‘The Federal Court also shares the assessment of the Federal Patent Court that a public interest in the granting of a compulsory licence is credible. It is true that not every HIV or AIDS patient is required to be treated with raltegravir at any time. There are, however, patient groups that needed raltegravir to maintain the safety and quality of treatment. These include, in particular, infants, children under 12, pregnant women, people who need prophylactic treatment because of the risk of infection, and patients who are already treated with Isentress and who are threatened with signicant side effects and interactions when switching to another drug’ [translated from German by Google Translate]. (17)
14. Landgericht Düsseldorf (4c O 48/15). 15. The patent was subsequently revoked by the EPO Board of Appeals in 2017 - EPO, Technical Board of Appeal 3.3.01, T 1150/15, decision of October 11, 2017 – Merck & Co., Inc. v. SHIONOGI & CO., LTD. 16. Christof Hohne, Compulsory Licences in Germany: A Tool for Licensing Negotiations?, 8 March 2019, available here . 17. The Google translation has been taken from a blogpost by Andrew Goldman, German Federal Supreme Court Afrms Compulsory License on HIV Drug, 13 July 2017, published in the Knowledge Ecology International (KEI) website. See the webpage.
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This German case is certainly exceptional. There are no (recent) reported decisions in Europe where compulsory licences of pharmaceutical patents have been granted. Yet, this example shows us something important: the public need to access important lifesaving medicines may in some specic circumstances override the private interests of patent owners in restricting such access (indeed, as patents constitute monopolies, their owners are usually able to charge higher prices for their patented products and thus restrict availability). The collective good thus may supersede the nancial interests of specic companies.
There are no (recent) reported decisions in Europe where compulsory licences of pharmaceutical patents have been granted
whose consistent exercise appears to be instrumental in maximising social utility, which is the key principle of altruistic consequentialism.
4. Conclusion
But conventional altruistic consequentialism is inadequate insofar as it conceptualises innovators in terms of individual subjects, which could be either persons, institutions, or companies. And yet, at a time where scientic cooperation is at one of its historic peaks, we cannot fail to witness and acknowledge once again that the logic of discovery is of a distributive kind: innovators are likely to be collective rather than individual subjects, and laws should nd ways to protect the possibility of collaboration. This in turn seems at odds with commonsensical takes on IP, but it is certainly a welcome implication of altruistic understandings of patents.
In ethical theory, altruistic forms of consequentialism offer a suitable philosophical framework that could capture these exceptional cases, thus providing us with a more robust justication of IP that balances individual and collective needs and concerns (18). While recognising the ethical relevance of egoistic demands, altruistic consequentialism places those within a larger altruistic framework whose nal horizon is societal utility. Traditionally, altruistic consequentialism has offered justications based on the collective gain that follows from offering people incentive for innovation (19). By giving rewards to the efforts of certain ingenious individuals, IP protection has been considered a powerful stimulus to creativity,
18. In ethical theory, altruistic consequentialism is usually called utilitarianism. In this context, we opt for this alternative terminology (‘altruistic consequentialism’) to avoid a potential ambiguity with what is known as the ‘utilitarian theory’ of IP (i.e., IP rights represent an encouragement from the State for the production of inventions and cultural products useful to society). 19. Tom G. Palmer, ‘Are Patents and Copyrights Morally Justied - the Philosophy of Property Rights and Ideal Objects Symposium on Law and Philosophy’, Harvard Journal of Law & Public Policy 13, no. 3 (1990), pp. 817–66.
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that IP laws play a generally signicant role in promoting research with positive societal impact, but they are not awless, and we should not exclude a need for reform to meet these new challenges. The key is to lay out conditions for strengthening the mutual trust that international public health cooperation requires.
Balancing altruistic and egoistic motives in innovation is certainly difcult – and there is no exact science to that. Prudence and tact are essential requirements of effective management of IP protection. Especially when dealing with public health emergencies of a global scale such as the COVID-19 pandemic, prot may very well have to bow to ethical or moral concerns. There is no denying
Especially when dealing with public health emergencies of a global scale such as the COVID-19 pandemic, profit may very well have to bow to ethical or moral concerns
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COVID-19 and Soft Law: Is Soft Law Pandemic-Proof? Mariolina Eliantonio, Emilia Korkea-aho, and Steven Vaughan
1. Introduction
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To what extent have national governments and other (central or local) authorities used non-binding soft law guidance – in addition to or instead of binding rules – to stop or to slow down the spread of the virus? To what extent has soft law been used to restrict fundamental and human rights? How have courts, lawyers, and the public responded to regulation has soft law guidance?
COVID-19 has been an unprecedented challenge to many legal systems around the world. In attempting to mitigate the devastating social, economic and political effects of the virus, governments have closed national borders, schools, cinemas and restaurants, ordered lockdowns, Much of the strongly recommended that those over 70 years taken place through circulars, Reecting on these questions, a forthcoold stay indoors in quainstructions, guidance and ming Special Issue of rantine-like conditions, the European Journal other soft law norms banned social gatheof Risk Regulation rings, and encouraged compares and critisocial distancing and cally analyses the uses of soft law in dealing the use of face masks. with COVID-19 at the EU level, as well as at the national level in seven EU Member StaIn addition to ‘normal’ legislative measures tes (Finland, Germany, Greece, Hungary, (or, in some legal systems, administrative ruItaly, Spain, Sweden), China and England. le-making in the form of governmental or miWe have chosen to focus on these ten legal nisterial decrees), much of the regulation systems because of the various ways in has taken place through circulars, instrucwhich the pandemic has impacted them: whitions, guidance and other soft law norms, the le China was the rst country to be hit, it was legal status and effects of which are often unsoon followed in Europe by Italy and, within clear.
1. Mariolina Eliantonio is a Professor of European and Comparative Administrative Law at Maastricht University. Her research interests related to shared and transnational administrative law, soft law and technical standardization in the EU multi-level system of governance, and, in particular, the role of courts and judicial review in these regulatory mechanisms. Emilia Korkea-aho is Associate Professor of European Law and Legislative Studies at the University of Eastern Finland and Academy of Finland Research Fellow (2016–2021). Her research interests cover governance, in particular soft law, in the European Union and national contexts, as well as lobbying and its regulation. Steven Vaughan is a Professor of Law and Professional Ethics in the Faculty of Laws at University College London. His research spans various elds: environmental law; lawyers' ethics and regulation; legal education; diversity; and corporate governance.
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There was no consistency across the EU Member States, China or England in the use of soft law as a regulatory response to COVID-19
ments, agencies and others are still playing with their regulatory response mixes. Our temporary focus is the period of March 2020 - August 2020, which the research as well as media outlets generally refer to as ‘the rst wave’ (3).
only a few weeks, also by other European countries (2). Furthermore, these countries have followed very different approaches to the management of the pandemic, ranging from a full lockdown in China, Italy or Spain to very mild recommendations in Sweden. These differences have not only resulted from different legal and political traditions (such as federalism in Germany) but the countries’ specic approaches also reected the particular circumstances they were facing locally (such as the large number of migrants in Greece).
2. The use of soft law as a tool to manage the COVID-19 pandemic: between different national cultures, shady procedures, and uncertain perceptions Perhaps unsurprisingly, there was no consistency across the EU Member States, China or England in the use of soft law as a regulatory response to COVID-19. We see regional variations on micro and macro scales. So, for example, the approach in Sweden differs from the approach adopted by its Nordic neighbours. We also see instances in which COVID-19 soft law was used widely (Swe-
There are always risks with this sort of action-research, as it is almost impossible to be ‘current’ and on top of things; that is, it is almost certain that a variety of the measures and tools that are described in the contributions to the Special Issue no longer exist (or look wildly different) because we are still in the throes of the pandemic, and govern-
2. For COVID-19 data (both past and up to date), see the European Centre for Disease Prevention and Control website. 3. See, e.g, Gianfranco Alicandro, Giuseppe Remuzzi, Carlo La Vecchia, 'Italy’s rst wave of the COVID-19 pandemic has ended: no excess mortality in May, 2020', The Lancet, September 03, 2020, DOI ; First and Second Waves of Coronavirus, ; Europe’s second wave is worse than the rst. What went so wrong, and what can it learn from countries like Vietnam?.
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den, Spain, England, the EU) and instances where it was hardly used at all (Greece) or used minimally (Germany). Of the former, in Spain there were more than 200 nonbinding measures adopted by the State and the 17 regional Autonomous Communities between March and July 2020. In England there are perhaps as many as 400 guidance documents (of various types) that have been created in response to the pandemic. The EU had also issued 197 soft law instruments linked to COVID-19 up to August 2020. By contrast, in Greece ‘COVID-19 hard law’ far outweighed the corresponding soft law instruments. Or consider China, which thanks to the legacy of the SARS epidemic in 2003 already has a relatively complete hard law-framework to combat infectious diseases. Yet it soon discovered that the hard law-framework was insufcient to cope with the challenge of the COVID-19 epidemic and thus opted to issue soft law to complement hard law. We also see the deployment of soft law with a temporal element: in Italy, for example, soft law was only really used in Phase II of the country’s COVID-19 response (from May 2020 onwards). As in other times and other ways, these papers show a wide variety of soft instruments being deployed: General Recommendations, Protocols, Guidance, Technical Recommendations, Circulars, FAQs, Pandemic Plans, Administrative Directions, Codes of Conduct and so on. The papers in the Special Issue also highlight differences in addressees: soft law instruments which are addressed to all citizens; those which impact only certain regions or places; and those which speak to certain sectors or industries. At the EU level for example, in sectors such as competition and State
aid, the consequences of the health crisis were dealt with exclusively through soft law. What the papers also show is a divergence in the hierarchy of norms used to respond to the current pandemic. Some countries already had legislation in place to respond to pandemics (and other emergencies) and used that legislation (Finland); in others, new hard laws were created (England, Italy, Greece) or specic states of emergency (or alarm or danger) were decreed under the relevant constitution (Spain, Hungary). In Germany and China, we see existing laws modied to specically account for the current crisis. Publication practices for COVID-19 soft law also vary. For example in Spain, COVID-19 soft law measures have been adopted in a rather informal way in the sense that many of them have not been subject to ofcial publication, but only published on the websites of the administrations that have created them. In various jurisdictions, access to soft law measures on governmental and agency websites is not always straightforward (England, Finland, Hungary), and our contributors had problems establishing what soft law rules were in force, when and where to nd them. In some cases, even the Wayback Machine, designed to dig out archived material from the world wide web, could not retrieve past soft law measures. A commonality in many of the legal systems we cover in the Special Issue is confusion on the part of the general public (and sometimes also on the part of the respective governments and their ofcials) as to how to view and/or respond to COVID-19 soft law and its relationship with COVID-19 hard law. On the former, in Sweden, for example,
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cols, Guidance, Technical Recommendations, Circulars, FAQs, Pandemic Plans, Administrative Directions and Codes of Conduct? Perhaps. There is no denying that COVID-19 soft law is soft law at its best: it is cheap, fast, exible, and therefore good for emergency situations. But COVID-19 soft law is also soft law at its worst: it lacks democratic credentials, poses – unlike nonemergency soft law – risks for fundamental rights, results in constitutional encroachments and confuses the general public.
the Director General of the Public Health Agency was quoted stating that General Recommendations are binding (when they are not; although the hard law onto which they are yoked is binding). Similarly in Finland, the Government’s inexperience with soft law resulted in much confusion among the public and in public apologies for the confusion by the ministry. A number of the papers contained in the Special Issue also discuss the extent to which soft law is being used to interfere with the exercise of fundamental rights, and the legality of such use. Of particular concern are restrictions on free movement (in Sweden and Finland), and the processing of personal data (via virus contact tracing and other means) (in Greece and Hungary).
There is much more work that could be done in this space and we are struck by the lack of empirical work on soft law; particularly on how the general public perceives soft law and the norms it creates. What is not clear, in particular, is whether the general public follows soft law because they have faith in the government or whether they follow soft law because they think it imposes hard obligations on them (with sanctions for noncompliance). Similarly unclear is what drives national authorities to follow EU soft law or lower level national authorities to follow soft law guidance adopted by hierarchically higher authorities.
3. Conclusions Is soft law pandemic-proof, suited to regulating risks? If we were to face another unknown deadly virus in a decade from now – something which we hope will not happen would we also then turn to regulatory cocktails of General Recommendations, Proto-
COVID-19 soft law is soft law at its best: it is cheap, fast, flexible, and therefore good for emergency situations
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News Highlights Week 16 November to 20 November 2020
New Trade and Sustainability complaints system launched by Commission
Decision appointing new President of the EUIPO’s Boards of Appeal published
Monday 16 November
Monday 16 November
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The European Commission launched a new complaints system so that market access barriers and breaches of Trade and Sustainable Development commitments in the EU’s trade agreements, and under the Generalised Scheme of Preferences, can be reported.
The Council of the European Union’s Decision to appoint Mr João Negrão as President of the Boards of Appeal of the European Union Intellectual Property was published.
COVID-19 and aid to countries where EU sanctions apply: Commission Guidance
Single Resolution Board’s action against EDPS’s data protection decision published
Monday 16 November
Tuesday 17 November
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A chapter on Nicaragua was added by the European Commission to its Guidance Note on providing COVID-19 related humanitarian aid to countries that are subject to EU sanctions, in response to questions asked by NGOs, banks and other humanitarian actors.
Ofcial publication was made of an annulment action brought by the Single Resolution Board against the European Data Protection Supervisor (T-557/20) concerning the latter’s decision of 24 June 2020 that the SRB infringed Article 15 of the EU Institutions’ Data Protection Regulation 2018/1725.
Obligation to register imports of aluminium extrusions from China challenged before the General Court
EFTA Court dismisses action for annulment against an ESA State aid decision on Norwegian digital health infrastructure
Tuesday 17 November
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Ofcial publication was made of an annulment action (T-604/20) brought against the European Commission by the Chinese companies Guangdong Haomei New Materials and Guangdong King Metal Light Alloy Technology challenging Commission Implementing Regulation 2020/1215 that requires registration of imports of aluminium extrusions originating in China.
Tuesday 17 November
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The EFTA Court delivered its judgment in Abelia v EFTA Surveillance Authority (E-9/19), dismissing as unfounded an action for annulment against an EFTA Surveillance Authority (ESA) Decision. The Decision found that public nancing of digital health infrastructure did not constitute State aid without opening a formal investigation procedure.
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Agriculture and fisheries ministers’ meeting: main takeaways Tuesday 17 November
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Main takeaways were published of the EU agriculture and sheries ministers meeting on Monday to discuss, inter alia, food waste, the Farm to Fork Strategy, the EU Forest Strategy and the agricultural market situation, including the implications of the EU-Mercosur Association Agreement.
Using the COVID-19 recovery to make the EU competitive, green, digital and for strategic autonomy: Council adopts conclusions Tuesday 17 November
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Junqueras litigates against the European Parliament (again) for being replaced as MEP Tuesday 17 November
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A further action for annulment (T-613/20) brought before the General Court by Oriol Junqueras I Vies against the European Parliament was published. Mr Junqueras challenges the European Parliament’s Decision announcing that his seat as MEP will be given to Mr Jordi Solé i Ferrando.
ECtHR: ban of inhuman or degrading treatment breached by deportation order to Gambia in the absence of assessment of risks for the gay person concerned
The Council of the EU adopted conclusions on how the COVID-19 recovery can be used as ‘leverage’ for a more ‘dynamic, resilient and competitive European industry’, referring to the importance of achieving ‘strategic autonomy’.
Tuesday 17 November
Council calls on Commission to further explore the use of regulatory sandboxes and experimentation clauses as tools for better regulation
Extended Composition of General Court delivers ruling upholding Commission’s decision to fine Lithuanian national railway company in abuse of dominant position-case
Tuesday 17 November
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The Council of the EU adopted a set of conclusions on Monday on the role of regulatory sandboxes and experimentation clauses as tools for an innovation-friendly, future-proof, sustainable, and resilient EU regulatory framework in the digital age.
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The European Court of Human Rights in B and C v. Switzerland (applications nos. 43987/16 and 889/19) ruled that Swiss authorities breached the prohibition of inhuman or degrading and ill-treatment in Article 3 of the European Convention on Human Rights by failing to assess the risks involved in the deportation of a gay man to Gambia.
Wednesday 18 November
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The General Court in Extended Composition ruled in competition case Lietuvos geležinkeliai AB v European Commission (T-814/17), upholding the Commission’s Decision to impose a ne on Lithuanian national railway company Lietuvos geležinkeliai AB (LG) for abuse of dominant position, and reduced the ne from 27,873,000 to 20,068,650 euros.
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European Ombudsman examining work of European Centre for Disease Prevention and Control Wednesday 18 November
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Court of Justice rules that Article 132(1)(f) VAT exemption not available for Kaplan International Colleges as a cost sharing group
The European Ombudsman announced that it would be further examining the work of the European Centre for Disease Prevention and Control, in light of the Commission’s proposal to extend the latter’s mandate.
Wednesday 18 November
Commission closes investigation into public support for Air Nostrum’s fleet renewal in Spain
Phonograms combined in audiovisual or cinematographic form mean television channel owner does not have to pay IP right holders according to Court of Justice
Wednesday 18 November
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The European Commission closed its in-depth investigation initiated in October 2019 regarding Spanish public support to regional airline Air Nostrum for the renewal of its eet. This comes as Air Nostrum decided to renounce the aid in question after revising its investment plans following the COVID-19 outbreak.
Council Presidency and European Parliament reach political agreement on REACT-EU Thursday 19 November
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The German Presidency of the Council and the European Parliament reached a political agreement on REACT-EU on Wednesday, an emergency legislative initiative to make 47.5 billion euros available to the Member States and regions more severely affected by the COVID-19 pandemic.
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The Court of Justice ruled in Kaplan International Colleges UK Ltd v HMRC (C-77/19) that the exemption under Article 132(1)(f) of VAT Directive 2006/112 does not apply for services supplied by ‘cost sharing groups’ as a single taxable person under its Article 11, if the members of that group are not all also members of that independent group of persons.
Wednesday 18 November
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The Court of Justice ruled in Atresmedia Corporación de Medios de Comunicación SA v AGEDI and AIE (C147/19) that under EU Directives on rental and lending rights related to copyright ‘single equitable remuneration’ does not have to be paid for broadcasting an audiovisual recording containing the ‘xation of audiovisual work’ which includes a phonogram.
Rule of law and budget conditionality: Council texts published Thursday 19 November
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The Council of the EU and European Parliament’s provisional agreement on a new general regime of conditionality to protect the EU budget was conrmed by the Council’s COREPER II for the rule of law conditionality mechanism. The Own Resources Decision, which required unanimity, was not conrmed following Hungary and Poland’s votes against approving it.
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European Economic Area Council videoconference: main takeaways Thursday 19 November
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Parliament calls for Council to adopt MFF and ORD despite Hungary and Poland’s vetoes
Members of the EEA Council held a video conference on Wednesday to discuss the overall functioning of the Agreement on the European Economic Area, to hold an orientation debate on Europe’s Digital Future, and to discuss other pressing issues affecting the EEA Area.
Thursday 19 November
Council Conclusions on the EU Action Plan on Human Rights and Democracy 2020-2024
European Court of Auditors identifies shortcomings and makes recommendations in respect of Commission’s enforcement of competition rules
Friday 20 November
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The European Parliament’s Conference of Presidents called on the Council of the EU to formally adopt the Multiannual Financial Framework (MFF) and the Own Resources Decision (ORD) in order to begin the ratication process.
The Council of the EU approved its Conclusions endorsing the EU Action Plan on Human Rights and Democracy 2020-2024 on Thursday, which sets out the EU’s ambition and priorities in this eld in its relations with all third countries, taking into account COVID-19, the digital age and climate change.
Friday 20 November
Hunting for fun: derogation from EU wild birds Directive for cultural reasons possible according to AG Kokott
ECHA’s Board of Appeal: refusal to grant access to data held by other companies is void if applicant’s right to be heard has not been respected
Friday 20 November
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Advocate General Kokott’s Opinion in environmental case Association One Voice, Ligue pour la protection des oiseaux v Ministre de la Transition écologique et solidaire (C-900/19) was issued, advising the court that the traditional hunting method of using lime to trap birds is permitted under the derogation in Article 9(1)(c) of Directive 2009/147 on the conservation of wild birds.
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The European Court of Auditors published Special Report No 24/2020, an audit of how effectively the Commission detected and enforced infringements of EU competition rules regarding mergers and antitrust, cooperated with the national competent authorities, and assessed its own performance and reported on it.
Friday 20 November
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The Board of Appeal of the European Chemicals Agency (ECHA) annulled a decision adopted by the ECHA on 11 February 2019 - by which an application for access to data held by another company was rejected - because the appellant’s right to be heard had not been respected.
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Nº38 · NOVEMBER, 21 2020
weekend
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European Council meeting: remarks on the envisaged mechanism for rule of law conditionality in the context of the EU budget Friday 20 November
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The European Council met via video conference on Thursday to assess the situation of the COVID-19 pandemic in Europe and to discuss further coordination efforts. European Council President Charles Michel offered a brief update on the situation of the Multiannual Financial Framework and the rule of law conditionality mechanism to be included in it.
COVID-19: Protecting children’s rights Friday 20 November
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The Fundamental Rights Agency (FRA) has made remarks on the impact of the pandemic on the rights of children, emphasising the aspect of education in particular, referring to its survey of June 2020, which it states reveals a direct link between education and tolerance: ‘people who are more educated tend to be more tolerant of others’.
Insights, Analyses & Op-Eds Do mixed holding companies have the right to deduct the input VAT paid when changing the initial intended use of the acquired services?
Article 8(3) of Regulation (EC) No 207/2009 is applicable to identical or similar marks for identical or similar goods and services
By Jordi Sol
By Alberto Torralba
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Analysis of the Court of Justice’s ruling in Sonaecom (C-42/19) nding that the actual use of acquired services prevails over the initial intention for the purposes of the right to deduct for a mixed holding company.
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Analysis of the Court of Justice’s ruling in EUIPO v John Mills (C-809/18 P), establishing that Article 8(3) of the Trademark Regulation allows the holder of an earlier trade mark to oppose the registration of a trade mark applied for its agent or representative not only when the marks at issue are identical, but also when the signs are similar and cover similar goods or services.
The Lisbon Appeal Court’s interpreta- The reset of international data transtion of Cogeco or how a Court of Justi- fers following the publication of EDPB ce’s reformulation of the questions refe- guidance rred can change everything READ MORE ON EU LAW LIVE By Diana Calciu and Hélène Blaison By Guilherme Oliveira e Costa
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Analysis of the Lisbon Appeal Court’s interpretation of the Court of Justice’s preliminary ruling ruling (Cogeco C-637/17) in relation to limitation periods, in its own decision that an applicant’s claim to compensation, based on an antitrust private enforcement action, was timebarred.
EULAWLIVE stay alert keep smart
Analysis of the European Data Protection Board’s guidelines on the transfer of personal data outside the EU, taking a closer look at how EU law frames and regulates the processing of personal data from EU citizens, as well as explaining the latest developments on the matter.
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Nº38 · NOVEMBER, 21 2020
weekend
edition stay alert keep smart
Judicial protection and rule of law vs automatic recognition of administrative reorganisation measures for banks in pending judicial proceedings By Dolores Utrilla
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Insight on Advocate General Kokott’s Opinion in Banco de Portugal and Others (C-504/19), the procedural effects (in judicial proceedings pending in one Member State) of mutual recognition of reorganisation measures for credit institutions adopted in a different Member State, and on the compatibility with the right to effective judicial protection and the rule of law.
Library - Book Review
By Luis Arroyo Jiménez
Xavier Arzoz Santisteban Madrid: Centro de Estudios Políticos y Constitucionales
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La garantía constitucional del deber de reenvío prejudicial Luis Arroyo examines a book by Xabier Arzoz on the failure to comply with the duty to make a reference for a preliminary ruling by national courts, as well as the case law of both the European Court of Human Rights, and various national Constitutional Courts - in particular that of Spain. He notes that Xabier provides an alternative proposal and puts forward a normative claim on assessing compliance with Article 267(3) TFEU.
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