Market interventions to protect public health are likely to be subject to EU law challenge as contrary to the rules on free movement. In the Scotch Whisky case the CJEU stressed the importance of defined public health objectives and supporting evidence in the analysis of whether interventions are justified as “appropriate” and “necessary”. This article considers the wider implications of this judgment for the application of the proportionality test in free movement cases and in the case of innovative interventions that are adopted on a complex evidence base. The article argues that the unusual development that Scotch Whisky made to the CJEU’s wider trend towards greater engagement with evidence should be treated with caution, and that it is possible for national courts to apply the new guidance on the role of evidence in the proportionality analysis with sensitivity. The article also argues that policymakers must now be more aware of how they frame innovative interventions and the evidence supporting them.

Roundup, and other glyphosate-based herbicides, are the most heavily used pesticides in the history of the USA and globally. In March 2015, the International Agency for Research on Cancer (IARC) classified glyphosate as a “probable human carcinogen”. A portion of the 695,000 Americans then living in 2015 with non-Hodgkin lymphoma (NHL) became aware of IARC’s decision. Several thousand Roundup–NHL lawsuits had been filed by the end of 2017, rising to 18,400 by July 2019 and 42,000 by November 2019. Three cases have gone to trial, each won by the plaintiffs. The author has served as an expert witness for the plaintiffs in this litigation and has been compensated for his time spent. The impact of the litigation on the independent assessment of the science useful in determining whether glyphosate and glyphosate-based herbicide exposures are linked to NHL is reviewed, as is why the US Environmental Protection Agency (EPA) and IARC reached such different judgements regarding glyphosate human cancer hazard and risk. Two important “lessons learned” regarding the EPA versus IARC assessment of glyphosate cancer hazard and risk are highlighted. The first arises from differences in the magnitude of applicator risks from mostly dermal exposures to formulated glyphosate-based herbicides compared to just dietary exposures to technical glyphosate. The second relates to missed opportunities to markedly lower applicator exposures and risks with little or no impact on sales via reformulation, added warnings and worker safety provisions, company-driven stewardship programmes and greater determination by the EPA in the 1980s to compel Monsanto to add common-sense worker protection provisions onto Roundup labels (eg “wear gloves when applying this product”). Policy reforms designed to alleviate systemic problems with how pesticide hazards, exposures and risks are analysed, regulated and mitigated are described.

COVID-19 hits all of the cognitive triggers for how the lay public misjudges risk. Robust findings from the field of risk perception have identified unique characteristics of a risk that allow for greater attribution of frequency and probability than is likely to be aligned with the base-rate statistics of the risk. COVID-19 embodies these features. It is unfamiliar, invisible, dreaded, potentially endemic, involuntary, disproportionately impacts vulnerable populations such as the elderly and has the potential for widespread catastrophe. When risks with such characteristics emerge, it is imperative for there to be trust between those in governance and communication and the lay public in order to quell public fears. This is not the environment in which COVID-19 has emerged, potentially resulting in even greater perceptions of risk.

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 recent reauthorisation of glyphosate in the European Union is a uniquely suitable opportunity to study the relationships between law and science because, unlike many other controversies that are commonly perceived through the science/democracy dichotomy, in this case the disagreement was between the “scientific” assessments of two purely “expert” bodies, the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA). This paper takes a close look at some details of the two assessments to show how scientific assessments are shaped by the legal environment to such an extent that it is impossible to separate “legal” from “technical” issues at any level; they are entangled together “all the way down”. Furthermore, it identifies three side effects of this entanglement that were previously unnoticed. First, obscure legal rules may provide (usually unintended) leverage to some of the parties. In turn, this forces everybody into proxy wars on the issue where the leverage is, at the expense of all other concerns that they may legitimately have. Finally, despite the strict legal regimentation of the scientific assessment, significant space for judgment remains, and discretion is never removed, only shifted to different places or levels.

The world is currently facing the worst pandemic in a century and we were caught unprepared. COVID-19 has proven highly contagious and with severe consequences that are still unfolding. As of 16 April 2020, there were over 2 million confirmed cases and over 136,000 related deaths reported worldwide.1 Over 1 million of those confirmed cases were in the preceding 14 days, with the USA accounting for nearly half of those. Furthermore, the International Monetary Fund (IMF) is now warning that the world is about to suffer the worst economic recession since the Great Depression in the 1920s.2

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.

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.

In the wake of the outbreak of the COVID-19 crisis, the Swedish and Swiss governments adopted a similar policy approach. They enacted mostly non-binding measures to contain the epidemic, relying on the high level of interpersonal trust and trust in political institutions that exist in both of these (broadly comparable) countries to ensure compliance. However, unlike Sweden’s strategy, the Swiss policy response evolved during the early weeks of the “first wave”, achieving public health and socioeconomic results that have been considered as satisfactory, notwithstanding the complex institutional setting and policy process, the central location of Switzerland in continental Europe, its openness and its closeness with deeply affected regions in Italy and France. To shed light on this policy response and to draw lessons from it, this paper firstly discusses the role played by the new Swiss Epidemics Act. This law centralises decision-making capacity at the federal level and expands the competences of the central government, while leaving leeway to subnational units for implementation and recognising the need for increased international regulatory cooperation. Secondly, it shows how such a solution – a multi-level arrangement steered from the federal level with quite strong vertical and horizontal coordination mechanisms – could work as a blueprint for a European Health Union.

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.

A multitude of medical products are being developed and produced as part of efforts to tackle COVID-19. They are varied in nature and range from test kits to tracing apps, protective equipment, ventilators, medicines and, of course, vaccines. The design, testing and manufacture of many of these products differs from production in normal times due to the urgency of the situation and the rapid increase in demand created by the pandemic. This article considers the legal issues arising as a result of the production of emergency products, particularly from a products liability perspective. To what extent do existing concepts under the European Product Liability Directive, such as defect, causation and the various defences, permit the pandemic to be taken into account when a Court is considering issues of liability? What is the impact on liability of the modified regulatory regime? In light of that discussion, the case for alternative responses is examined from a comparative and European perspective, including the issue of Government indemnities for the manufacturers of products, legal exemptions from liability and alternative no-fault compensation schemes.

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.

New financial technology holds the promise of innovation and competition, challenging established products and services and frequently improving market processes. However, regulation of these new services faces a double challenge: to keep pace with innovation and facilitate new market entries while at the same time understanding and managing the regulatory risks that are involved.

At this stage, the existing EU regulatory framework is of little help: the bulk of the present body of financial regulation stems from a different time, with different regulatory problems in mind. EU regulation is also very slow to change and to adapt. Therefore, this paper proposes a regulatory “sandbox” – an experimentation space – as a step towards a regulatory environment where such new business models can thrive. A sandbox would allow market participants to test fintech services in the real market, with real consumers, but under the close scrutiny of the supervisor. The benefit of such an approach is that it fuels the development of new business practices and reduces the “time to market” cycle of financial innovation, while simultaneously safeguarding consumer protection. At the same time, a sandbox allows for mutual learning in a technical field which is sometimes poorly understood, both for firms and for the regulator. This would help to reduce the prevalent regulatory uncertainty for all market participants.

In the particular EU legal framework with various layers of legal instruments, the implementation of such a sandbox is not straightforward. In this paper, we propose a “guided sandbox”, operated by the EU Member States, but with endorsement, support, and monitoring by EU institutions. This innovative approach would be somewhat uncharted territory for the EU, and thereby also contribute to the future development of EU financial market governance as a whole.

This study focuses on the dispute over Korea’s import bans and the additional testing and certification requirements for Japanese foods and analyses the relevant findings of the reports of the Panel and the Appellate Body of the World Trade Organisation’s dispute settlement mechanism (DSM). Although the Panel had found that Korea’s measures were inconsistent with the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), the Appellate Body reversed most of these findings. Korea notified that it had completed the implementation of the reports of the Panel and the Appellate Body. However, the DSM has failed to contribute in settling this dispute positively and meaningfully, since it remains uncertain whether Korea’s import bans are based on scientific principles. Furthermore, the Appellate Body failed to complete its legal analysis of the inconsistency of Korea’s measures based on fact-findings and the facts uncontested between both disputing parties.