In this article, we ask what the impact is of the role of the EU administration in responding to emergencies in terms of (changes to) the rule of law. A response to an emergency in some cases creates exceptions to rule of law guarantees that bind the authorities to procedural rules and fundamental rights. These exceptions can become more permanent and even change the constitutional order of the EU. We articulate the legal framework for health emergencies, and discuss how the EU court has interpreted and developed this framework in two key decisions. We then ask whether this framework offers adequate safeguards for upholding the rule of law in cases of major health emergencies. We conclude that public health emergencies can bend and even break rule of law requirements for the EU administration, and advocate for more legal guidance on proportionality, which may offer better safeguards suited for protecting the rights of affected parties.

This article discusses the development of a more supranational EU approach to regulate risks of “serious cross-border threats to health” such as pandemic disease outbreaks. It argues that the EU’s public health measures to prevent and tackle pandemics could affect individual patients’ rights, because the rights of individual European citizens are balanced against the importance of protecting the European community as a whole. This results in a tension between public health and individual rights in the EU, especially with regard to the right to informed consent, a central right in health law. In response to the 2013–2016 Ebola outbreak in West Africa, the EU introduced several preventive and responsive measures in the Member States to prevent the pandemic from spreading to the EU. The case study analysis of Dutch pandemic policies established in reaction to this outbreak shows that national pandemic policies are substantially shaped by EU actions, which has implications for the protection of the individual right to informed consent in the Member States.

Decision 1082/2013 on Serious Cross-border Health Threats (Health Threats Decision) was adopted in 2013 with the aim of preparing for and responding to serious health threats. In this legislation, the European Union adopts an “all-hazards” approach which strongly relies on the exchange of information as a driver of regulatory activities. This article first demonstrates that the electronic systems of information exchange constitute a key tool in EU Health Crisis and Disaster Management (“EHCDM”). Second, it identifies the distinctive features of these mechanisms in the EU context: the reinforcement of a statutory policy shift towards securitisation of public health, the peculiarity of the EU composite administrative procedures as well as the facilitation of the quality of the sense-making activities. Finally, the article uncovers the possible problems which may affect the adequate functioning of EHCDM and argues the routes for further research. The piece links legal analysis with the interdisciplinary conceptual lens to offer an important contribution to closer characterisation of the EHCDM as a field in its own right together with a better understanding of the EU public health law and administration in the context of transboundary crisis management and health security governance.

The so-called European migration crisis has sparked significant attention from scholars and raises questions about the role of solidarity between states and the European Union (EU) in providing policy solutions. Tension exists between upholding the rights of those seeking entry and pooling resources between Member States to provide a fair and efficient migration system. This article deconstructs the shifts that have occurred in EU migration policy since 2015 to highlight how narratives of health have become tools of governance. It does so to illuminate how health narratives operate to minimise the impact that conflicts on the nature and substance of EU solidarity have on policy development in response to the perceived crisis. A governmentality lens is used to analyse the implications of increasingly prescribed policy applications based on screening and categorising, and how measures operate to responsibilise migrants and third-countries to act according to EU values. It is argued this approach to governance results in migrants facing legal uncertainty in terms of accessing their rights and excludes them from the EU political space, which is problematic for how EU governance can be understood.

I use the examples of medical devices, clinical trials and health data, to look at the framing of harm through the language of technological risk and failure. Across the examples, there is little or no suggestion of failure by those formally responsible. Failure is seen as arising when harm becomes refracted through calculative techniques and judgments, and reaches a point where the expectations of safety built into technological framings of regulation are thwarted. Technological framings may marginalise the contribution patients, research participants and others can make to regulation, which may in turn underlie harm and lead to the construction of failure. This marginalisation may amount to epistemic injustice. Epistemic injustice and its link to failure, which has normative weight over and above harm, can present a risk to organisational standing and reputation. This risk can be used to improve the knowledge base to include stakeholder knowledges of harm, and to widen responsibilities and accountabilities. This promises to allow regulation to better anticipate and prevent harm and failure, and improve the efficacy and legitimacy of the health research enterprise.

This article traces the ascent of new digital surveillance practices for European health security in an era of heightened global pandemic vigilance. In doing so, the article demonstrates how the confluence of evolving processes of digitisation and production of new digital data sources have enabled EU health security agents in recent years to enhance infectious disease surveillance through novel digitised practices of epidemic intelligence. Subsequently, the article thus argues that the centralisation of these new epidemic intelligence technologies to the core of EU health security initiatives has been foundational to the ascent of a new blended health surveillance practice operating across the EU, which amalgamates the digitised surface alerts of these new big data surveillance technologies with the long-established and traditional disease surveillance legacies of EU Member States. By utilising the concept of surface knowledge in relation to the ascent of these European epidemic intelligence practices, this article demonstrates the key epistemic and methodological shifts which occur in the production of knowledge, alerts and signals for accelerated infectious disease surveillance and the governing of public health risks within the EU.

The EU has yet to develop definitive policies for the crypto-economy, and this article argues that policy development should follow a “systemic” and not “sectoral” approach. This is because the crypto-economy is not merely a financialised space and new productive activity is occurring that would benefit from more holistic policy development than regulation focused on securities and investments. This article proposes that the EU should develop policy for the crypto-economy based more broadly on innovation policy and perhaps feed into the Single Market project.

In today’s innovation-driven agrifood domain, the perspective of using so-called New Breeding Techniques (NBTs) on both non-human animals and plants calls into question the regulatory approach (process/product-based) to be used, while asking for a critical reflection on the potential impact of products on the industrial sector and citizens. A possible reconfiguration of European (EU) discipline will have to grapple with not only agrifood market’s interests and needs, but mostly and primarily with the growing quest for public and participatory discussion on the current dominant vision on life sciences. Only through restoring visibility to the intertwining of knowledge production will it be possible to obtain EU governance of gene editing that is more authoritatively reliable from a scientific stance, as well as more transparently discussed and democratically shared at legal and policy level.

This paper studies the specificities of shadow banking in Europe. It highlights striking differences between the EU and the US shadow banking sectors based on both market structure and legal micro-infrastructure of the shadow banking sectors in these two jurisdictions. It argues that these different institutional and legal infrastructures, as well as the different trajectories in the evolution of the shadow banking sectors in terms of business models, size and composition of actors and transactions, can be the driving force behind the differential regulatory treatment of shadow banking across the Atlantic. In highlighting such differences, this paper focuses on repo transactions, as the main instruments that play a significant role in credit intermediation outside the regulatory perimeter of the banking system. It then discusses money market funds and highlights differences in their structure, functioning, and their existing regulatory treatment. The paper concludes that the market structure, business models, and legacy legal and regulatory frameworks of shadow banking display substantial differences across the Atlantic. The findings in this paper rally against one-size-fits-all approaches to addressing the problems of the shadow banking system worldwide and recommends differentiated and more nuanced regulatory approaches to regulating shadow banking across the Atlantic.

In Xylella II the CJEU was called upon to assess whether Italy had failed to meet the obligations stemming from the Plant Health Directive and Decision 2015/789/EU, aiming to inhibit the spread of the plant pathogen Xylella fastidiosa in Apulia (Southern Italy). In carrying out its review, the Court relied to a large extent on the scientific evidence submitted by the Commission. It found that the Member State had failed to properly remove infected plants and monitor the presence of the pathogen in the 20km strip dividing the infected zone from the buffer zone. However, the Court also confirmed that in proceedings brought under Article 258, the burden of proof lies on the Commission, which may not rely on any presumption to demonstrate the State’s failure to meet EU law obligations. The Italian authorities are now expected to comply with the Court’s ruling, as financial sanctions may be imposed at a later stage.