In the World Trade Organization (WTO), the US approach to science-based risks and trade restrictions prevailed over that of the European Union (EU). The EU, dissatisfied with the margin of action available when “relevant scientific evidence is insufficient”, largely kept intact its internal practice on marketing and importing genetically modified (GM) crops and GM-containing products. The goal of this article is to ascertain whether these regulatory preferences of the US and the EU translate into their post-Biotech external trade efforts. US and EU preferential trade agreements are scanned for rules on trade in biotechnology goods or the use of precautionary elements in regulation. It transpires that neither bloc systematically tries (or manages) to bend trade agreements to accommodate its defensive or offensive trade interests in this field. Among the possible reasons for this apparent inertia are the US confidence in the WTO baseline and the EU preference for a “don’t ask, don’t tell” approach to its trade-restrictive policy in this area.

The Digital Green Certificate (DGC) proposed by the European Commission on the basis of facilitating the free movement rights of European Union (EU) citizens will be capable of effectively serving as a COVID-19 passport. In this contribution, we cast doubt on whether the DGC is fit for purpose, highlighting in particular the potential for the DGC to in fact facilitate greater free movement restrictions for a large number of EU citizens, in particular those who have received non- European Medicines Agency (EMA)-approved vaccines such as Sputnik V in compliance with EU law. Under the proposal as amended by the European Parliament, any destination Member State that accepts proof of vaccination “in order to waive restrictions to free movement” must apply the same waiver to any DGC-holder that has received an EMA-approved vaccine and has the option of doing so for vaccines added to the World Health Organization (WHO) Emergency Use Listing; however, such equal treatment is not available for DGC-holders who have received non-EMA/WHO vaccines. While this measure was alleged to be taken on grounds of public health, a convincing public health case has not been put forward. Instead, the DGC proposal as it stands disregards the promise of the internal market and sets the stage for its fragmentation through geopolitics and bilateralism.

At the international level, proof of vaccination against SARS-CoV-2 offers an enticing promise to the return of normality, particularly for the much-desired reopening of national borders. At the same time, vaccination passports could be a false hope: the requirement of vaccine passports could adversely embed social and economic inequalities that reflect the power dynamics in international relations. Specifically, the ability to secure vaccines relates to the varying market and economic power across countries. This paper focuses on Taiwan as a case study to explore ways in which the use of COVID-19 certifications, if used as a precondition for international travel, would further exacerbate a binary of exclusion and inclusion as a function of geopolitics. With its relative success in containing the COVID-19 pandemic within its borders, Taiwan represents a low priority for vaccine distribution in the COVAX initiative. Furthermore, due to Taiwan’s contentious political status and its exclusion from the World Health Organization regime, if vaccination passports are required as a precondition for international travel, then outbound passengers from Taiwan potentially could be subjected to restriction of movement absent wide availability of vaccines domestically. This paper argues that insofar as sustainable pandemic control requires a global concerted effort, vaccination passports could further polarise a global response. This paper suggests that equitable access to effective vaccines worldwide and governance reform of global health would help to rebuild global solidarity and mitigate the unimaginable human, social and economic suffering arising from the pandemic.

On 20 May 2021, the European Commission, Council and Parliament announced a breakthrough in the trialogue negotiations to establish the European Union (EU) Digital COVID Certificate. Originally, this standardisation effort was labelled as “Digital Green Certificate” and – “[i]n view of the urgency” – presented without a data protection impact assessment. It should allow citizens and residents of Member States to prove that they are either vaccinated against COVID-19, have recently tested negative or are currently immune against the virus. This article considers the proposal from a privacy perspective, taking into account the opinion of EU data protection authorities, ongoing negotiations in the EU institutions and relevant developments on the national and international level. While the European Parliament and others tried to improve the original Commission proposal, questions around the appropriateness and effectiveness of the framework remain. The technological and organisational implementation is essentially left to Member States, who already have started to develop their own tracing and identification systems.

This article offers a critical discussion of the “Report on Liability for Artificial Intelligence and Other Emerging Digital Technologies” released by the Expert Group on Liability and New Technologies. In particular, the authors consider: the excessive diversity of applications encompassed through the notion of “artificial intelligence and other emerging technologies”; the distinction between high- and low-risk applications as a potential source of legal uncertainty; the primary reliance on evidentiary rules over substantive ones; the problematic role attributed to safety rules; the unclear relationship between the Product Liability Directive and other ad hoc liability regimes; the radical exclusion of electronic personhood as a way of addressing liability issues; and the limited contextualisation of compulsory insurance and no-compensation funds.

Many of today’s products and services fall into the category of products and services that are, as such, legal but still unhealthy. Think of smoking as an example. This paper deals with the question of which mix of legal instruments should ideally be used in the light of such products and services. It distinguishes between products and services that predominantly lead to “harm to oneself” or “harm to others”. In the end, most law and economics arguments point in the direction of ex ante safety regulation. However, when there are concerns about the quality of regulation (eg due to lobbying efforts), liability has important added value. In the “harm to others” scenario, safety regulation is even more warranted because the larger number of victims and the increased difficulty to prove the causal link render litigation burdensome. Strict liability has several advantages over negligence and is, therefore, generally preferred. A strong point of negligence, however, is that it enables the court to conduct its own weighing of costs and benefits, which in specific circumstances may be better than that of the regulator or the producer. Furthermore, it enables the judge to consider not only the harm to the user, but also the harm to others in setting the due care standard.

On 16 December 2020, the European Commission delivered on the plans proposed in the European Digital Strategy by publishing two proposals related to the governance of digital services in the European Union: the Digital Services Act (DSA) and the Digital Markets Act (DMA). The much-awaited regulatory reform is often mentioned in the context of content moderation and freedom of expression, market power and competition. It is, however, important to bear in mind the contractual nature of the relationship between users and platforms and the additional contracts concluded on the platform between the users, in particular traders and consumers. Moreover, the monetisation offered by digital platforms has led to new dynamics and economic interests. This paper explores the reform proposed by the European Commission by means of the DSA by touching upon four main themes that will be addressed from the perspective of consumer protection: (1) the internal coherence of European Union law; (2) intermediary liability; (3) the outsourcing of solutions to private parties; and (4) digital enforcement.

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.

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.

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.

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.