This report examines what has come to be known as “vaccine nationalism” through the lens of the early experience with the COVID-19 vaccination process. After explaining the meaning of the term, this report investigates how this phenomenon has manifested during the COVID-19 pandemic, identifying its epidemiological, economical, ethical and legal aspects. It also looks at the different international initiatives that have been adopted to deal with it, concentrating in this context on the COVAX project. The report concludes that the success of these initiatives has been limited. It also observes that COVID-19 vaccine nationalism appears to be a phenomenon that is characteristic of the high-income Western countries, while in aspiring non-Western powers the vaccine crisis is primarily seen as a way to advance their geopolitical goals.

On 13 March 2020 the Hungarian Government announced the immediate closure of all schools throughout the country to prevent the spread of COVID-19 forcing several hundred thousand children to learn from home, and teachers to ensure their education. The Hungarian Educational Authority hurried to issue recommendations on the use of digital education tools. During the COVID-19 pandemic and the special legal order consequently introduced by the Hungarian Government, Hungary has seen the emergence of such non-binding measures adopted by public entities, complementing governmental action against the pandemic, with the aim of providing guidance to bodies exercising a public service function (“addressees”). These protective measures adopted under the special legal order are deemed to be successful and are largely followed by the addressees. Since soft law has hitherto been neglected by both Hungarian administrative governance and the legal literature, the recent burgeoning of non-binding measures deserves scholarly attention. In this article, we set out to map the specific context of the emergence of domestic soft law and the conditions for its adoption and reception, relying on our case study conducted in respect of the National Educational Authority’s recommendations.

In combating the coronavirus pandemic in Germany, soft law has played an important, albeit not a central, role. Its use basically corresponds with that of “normal circumstances”. In accordance with the German constitutional order, almost all substantial decisions are made in a legally binding form. However, these are often prepared through or supplemented by soft law. This article shows that soft law has played an important role in fighting the pandemic and its effects in Germany, although there cannot be any doubt that legally binding forms of regulation have prevailed. At the same time, the current pandemic has shed light on the advantages and effects of soft law in the context of the German legal order.

Greece emerged as the EU’s poster child in the fight against COVID-19 during the first few months of the pandemic. In this contribution, we assess Greece’s use of soft regulation in its regulatory response to COVID-19. Using “acts of legislative content”, which can be broadly conceptualised as softly adopted hard law, the Greek government largely achieved flexibility and simplified adoption procedures without having to resort to soft law per se. The role of soft law was limited - it complemented hard law rather than constituting the primary basis of COVID-19 restrictions - but not completely negligible. Soft law instruments regulated the processing of personal data, and was also pivotal in clarifying the criminal sanctioning of COVID-related rule violations. Greece’s success in handling the first wave of the pandemic, while effective, was arguably unfair to asylum seekers who saw their right to apply for asylum curtailed, and their right to freedom of movement restricted when limitations on the rest of the population were lifted. With a second wave of infections currently in full swing, it is imperative to keep scrutinising regulatory responses to ensure that they place the health and dignity of every individual (whoever they might be) at their core and fully respect their fundamental rights.

Swedish measures to fight the spread of COVID-19 differ from the strategies used in other comparable countries. In contrast to the lockdown approach that has been applied in many European countries, the Swedish strategy has been based to a substantial extent on individuals taking responsibility under non-binding recommendations. This contribution explores the Swedish strategy from a constitutional and administrative law perspective, highlighting the tension between the formalist system for delegating norms under the Swedish Constitution and the pragmatic use of non-binding rules such as the “General Recommendations” adopted by the Public Health Agency. The article concludes that the official use of soft law instruments is confusing from a legal perspective, because non-binding rules do not offer the traditional formal mechanisms for legal protection, the publication of norms or accountability. The legal-realist approach of the Supreme Administrative Court’s case law, however, has the potential of balancing some of the unfortunate effects arising from the Swedish combination of formalism and pragmatism.

This article takes issue with the legitimacy of EU soft law instruments issued to deal with the COVID-19 crisis. Up to August 2020, we identified a total of 197 such instruments, and analysed the procedures for their adoption. We found little evidence of parliamentary involvement or stakeholder consultation, with COVID-19 soft law replicating decision-making patterns which have been constantly criticised in the literature as illegitimate and opaque. Giving due consideration to the exceptional nature of these measures, the article suggests some quick fixes which might increase, ex post factum, the legitimacy of these instruments.

COVID-19 has demonstrated the fragility of EU free movement rules when we are faced with an unknown virus of such magnitude and strength that it threatens our lives, health systems, economies and society. The aim of this text is to show the dynamics between the threat of COVID-19 and the rules imposed as a response to the pandemic, which have impacted the functioning of the EU internal market and the Schengen area. The text will concentrate on the application of the precautionary principle and public health restrictions, caused by COVID-19, to free movement of persons in the EU. The analysis will lead to three conclusions. First, it will be shown that the decisions to apply free movement restrictions and the logic followed in the EU COVID-19-related documents can be viewed as a triumph of the precautionary principle. Second, it will be argued that implementing the precautionary principle has a transformative effect on the application of the principle of proportionality in EU law. Finally, it will be shown that COVID-19 has emphasised and increased the difference between the conditions for the applicability of public health restrictions when compared to restrictions based on public policy and public security grounds.

In a ruling on 25 July 2018, the Court of Justice of the European Union concluded that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs in the sense of Directive 2001/18, and that organisms obtained by means of techniques/methods of directed mutagenesis are not excluded from the scope of the Directive. Following the ruling, there has been much debate about the possible wider implications of the ruling. In October 2019, the Council of the European Union requested the European Commission to submit, in light of the CJEU ruling, a study regarding the status of novel genomic techniques under Union Law. For the purpose of the study, the Commission initiated stakeholder consultations early in 2020. Those consultations focused on the technical status of novel genomic techniques.

This article aims to contribute to the discussion on the legal status of organisms developed through novel genomic techniques, by offering some historical background to the negotiations on the European Union (EU) GMO Directives as well as a technical context to some of the terms in the Directive, and by analysing the ruling. The article advances that (i) the conclusion that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs under the Directive means that the resulting organisms must comply with the GMO definition, ie the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination; (ii) the conclusion that organisms obtained by means of techniques/methods of directed mutagenesis were not intended to be excluded from the scope of the Directive is not inconsistent with the negotiation history of the Directive; (iii) whether an organism falls under the description of “obtained by means of techniques/methods of directed mutagenesis” depends on whether the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination. Finally, the article offers an analysis of the EU GMO definition, concluding that for an organism to be a GMO in the sense of the Directive, the technique used, as well as the genetic alterations of the resulting organism, must be considered.

The marketing of tobacco, alcohol, unhealthy food and gambling services is harmful to public health, the European economy and sustainability. If the European Union (EU) has embraced the regulation of cross-border marketing for tobacco products for over two decades, it has consistently resisted evidence-driven calls to regulate the marketing of other harmful commodities, preferring instead to rely on ineffective industry pledges. This contribution reflects on why the EU has failed to use its competence to regulate cross-border marketing more systematically to protect health and highlights why the time is ripe to reconsider the issue, before concluding with a possible way forward.

Based on a mix of conceptual insights and findings from cases, this paper discusses three ways in which the effectiveness of regulation in the areas of competition, data and consumer protection can be improved by tailoring substantive protections and enforcement mechanisms to the extent of market power held by firms. First, it is analysed how market power can be integrated into the substantive scope of protection of data protection and consumer law, drawing inspiration from competition law’s special responsibility for dominant firms. Second, it is illustrated how more asymmetric and smarter enforcement of existing data protection rules against firms possessing market power can strengthen the protection of data subjects and stimulate competition based on lessons from priority-setting and cooperation by consumer authorities. Third, it is explored how competition law’s special responsibility for dominant firms can be further strengthened in analogy with the principle of accountability in data protection law. Similarly, it is discussed how positive duties to ensure fair outcomes for consumers are developed in consumer law. The analysis offers lessons for improving the ability of the three regimes to protect consumers by imposing greater responsibility on firms with greater market power and thus posing greater risks for consumer harm.

Health Union raises bioethical questions ranging from resource allocation and risk balancing to respect for specific bioethical prohibitions, as an analysis of the European Parliament’s proposal for such a union shows. To date, European Union (EU) health law has succeeded in avoiding or circumscribing such questions, leading to the limited and inconsistent patchwork of EU bioethical provisions we currently have. Can this continue with a Health Union? This article argues that whilst full harmonisation is neither possible nor desirable, Health Union should entail a deepening of bioethical integration. This should occur via a robust legislative process involving citizen panels and ethical advisory group input; if Treaty change occurs, this process could be included in primary law. This is so for three reasons. First, addressing Health Union’s unavoidable bioethical questions coherently and openly reduces the risk of inadequate protection and, conversely, of interest groups “smuggling in” unsupported answers. Second, this will ensure respect for primary law, including Article 2 TEU and Article 3 CFR. Third, EU biolaw offers a middle ground between limited national and weak international human rights law on bioethics, whilst also consolidating European identity.

The financial crisis in 2008 and the COVID-19 pandemic today have made it clear that both financial and medical crises spread pervasively across borders. The financial crisis proved that the health of the entire European banking system stands and falls with the health of a single systemically important bank. As such, in the past decade, European Union (EU)-wide cooperation and regulation have been strengthened to ensure financial health across Europe. Today, the COVID-19 crisis reveals the de facto existence of a European healthcare system, where Member States’ medical health is interlinked and challenged. It too highlights the need for a more coordinated approach. This paper will draw lessons from European financial regulation and stress testing to make recommendations for EU-wide healthcare. The paper will show the latent benefits that a stress test might have on healthcare performance through mechanisms of governmentality. Moreover, it will pinpoint shortcomings in the financial stress test that could pose looming dangers for a European Health Union, such as a lack of de facto risk sharing. The paper concludes with pragmatic suggestions for a way forward in European healthcare regulation.

What could a European Union (EU) response mechanism to health emergencies look like in the context of a more integrated Health Union? Despite an increased EU role in the preparedness, monitoring and coordination of health emergencies over the past two decades, Member States’ responses to the first wave of COVID-19 were surprisingly uncoordinated. In light of calls to improve cooperation regarding future health emergencies, this article discusses the creation of EU surveillance, preparedness and response mechanisms for health emergencies. Using insights from previous research and secondary literature, we highlight gaps in the existing serious cross-border health threats regulatory framework and discuss opportunities for further EU action. Based on a comparison with other EU crisis management mechanisms (the Banking Union, risk preparedness in the electricity sector and food safety), we discuss different crisis decision-making and coordination models and their potential applicability to the health sector. We then formulate several propositions to strengthen Decision 1082/2013/EU on serious cross-border health threats to streamline ex ante pandemic preparedness and organise emergency responses.

Personalised nutrition, the tailoring of nutrition products, services or advice to individual characteristics such as genetics, phenotype, nutritional intake and/or exercise routine, is increasingly attracting the interest of industry, consumers and researchers. This article provides an overview of the current European Union (EU) regulatory framework as applying to personalised nutrition and draws attention to the important role of EU food law in the regulation of this innovative approach to nutrition. It is argued that personalised nutrition challenges the regulatory borderline between health and lifestyle products or services and, furthermore, also pushes the boundaries of current food safety and health claims legislation.

While, historically, alcohol production and sale were local matters, commercialised and industrialised alcohol has supervened, globalised initially through European empires, transforming alcohol’s place in everyday life. But alcohol was not included in the current international drug control system, initiated in 1912. In the current “UN system” of 35 intergovernmental agencies, alcohol has been a recurrent concern in the work only of the World Health Organization (WHO). Examples are given of the sporadic involvement in alcohol issues of other agencies, and the history of WHO’s involvement between 1950 and early 2020 is briefly described. At WHO, the place of alcohol programming in its structure and which other topics it is linked with have been recurrent issues. Civil society support for alcohol initiatives has been comparatively weak, and alcohol industry counter-pressure has been strong. Alcohol issues have thus received less attention at the intergovernmental level than the harm would justify. Constraining factors have included not only lobbying by industry interests, but also the multi-sectoral nature of alcohol problems and the international cultural position of alcohol as a luxury good served at gatherings of political and media elites.

This article analyses the administrative measures and, more specifically, the administrative strategy implemented in the immediacy of the emergency by the Italian government in order to determine whether it was effective in managing the COVID-19 pandemic throughout the country. In analysing the administrative strategy, the article emphasises the role that the current system of constitutional separation of powers plays in emergency management and how this system can impact health risk assessment. An explanation of the risk management system in Italian and European Union (EU) law is provided and the following key legal issues are addressed: (1) the notion and features of emergency risk regulation from a pandemic perspective, distinguishing between risk and emergency; (2) the potential and limits of the precautionary principle in EU law; and (3) the Italian constitutional scenario with respect to the main provisions regulating central government, regional and local powers. Specifically, this article argues that the administrative strategy for effectively implementing emergency risk regulation based on an adequate and correct risk assessment requires “power sharing” across the different levels of government with the participation of all of the institutional actors involved in the decision-making process: Government, Regions and local authorities.

This short paper aims to unpack some of the assumptions underlying the “Policy and Investment Recommendation for Trustworthy AI” provided by the High-Level Expert Group on Artificial Intelligence (AI) appointed by the European Commission. It elaborates in particular on three aspects: on the technical-legal dimensions of trustworthy AI; on what we mean by AI; and on the impact of AI. The consequent analysis results in the identification, amongst others, of three recurrent simplifications, respectively concerning the definition of AI (sub-symbolic systems instead of “intelligent” informational processing systems), the interface between AI and institutions (neatly separated instead of continuity) and a plausible technological evolution (expecting a plateau instead of a potentially near-disruptive innovation).

Since the International Agency on Cancer Research’s monograph found glyphosate to be a likely carcinogen, the regulatory focus on the chemical has centred on this determinative criterion for regulatory action. Yet, other pertinent factors, such as the effects of glyphosate on fresh and ground water and ensuing effects on biodiversity, have received less attention as legitimate rationales for regulating the chemical. This underrepresentation prevents a wider policy discussion on the environmental and human health effects of the chemical and fails to disrupt assumptions of path-dependently continuing on agriculture’s chemical treadmill. To avoid ad hoc post hoc chemical regulation, we assess four areas of chemical regulatory oversight in Europe with regard to glyphosate affecting water: (1) the undue emphasis on in laboratorio versus in situ testing; (2) assessing single chemicals (isolated glyphosate) versus admixtures (glyphosate plus surfactants and adjuvants) that are used in practice; (3) the tendency to downplay harms to non-human life; and (4) the lack of policy coherence in the existing regulatory framework. Focusing on European Union regulation of pesticide and water policy affecting aquatic environments, we conclude that issues of measurement and priority have become highly politicised in both science and policy, requiring preventative, precautionary frameworks utilising plural forms of measurement.

This contribution will draw on the literature that has accumulated on how the Court of Justice of the European Union (CJEU) has responded to the European Banking Union, which was established in similar crisis circumstances that now face the European Union (EU) in the age of COVID-19, to illustrate the legal issues on which the CJEU’s input will be particularly important in the shaping of any future European Health Union. This contribution will highlight three legal issues in particular: the interpretation of EU Treaty provisions in the health field; the scope of EU competence; and the powers of EU institutions and agencies. This contribution will argue that the CJEU case law to date on health issues is encouraging with respect to competence and agencies, but more cautious with respect to the Treaty’s health provisions.

This article discusses the role of European Union (EU) State aid law in the COVID-19 crisis. It contends that different Treaty derogations have played unique roles in addressing the core determinants of the economic risk linked to the pandemic (ie the “exposure” to lockdown measures and the “vulnerability” of certain sectors to them), and in increasing the resilience of national economies. Moreover, this article examines the extent to which EU State aid law has been used to manage and mitigate health risks, by allowing Member States to enhance the preparedness and capacity of their healthcare sector (broadly conceived) to respond to the pandemic. On the whole, this article maintains that State aid control has been used by the European Commission as an important “risk management tool”, and it highlights the role of the Commission as the crisis management authority.