With the birth and rise of cryptocurrencies following the success of Bitcoin and the popularity of “Initial Coin Offerings”, public awareness of blockchain technologies has substantially increased in recent years. Many blockchain advocates claim that these software artefacts enable radically new forms of decentralised governance by relying upon computational trust created via cryptographic proof, obviating the need for reliance on conventional trusted third-party intermediaries. But these claims rest on some key assumptions, which this paper subjects to critical examination. It asks: can existing mechanisms and procedures for collective decision-making of public blockchains (which we refer to as internal blockchain governance) live up to these ambitions? By drawing upon HLA Hart’s Concept of Law, together with literature from regulatory governance studies, we argue that unless public blockchain systems establish formal and effective internal governance, they are unlikely to be taken up at scale as a tool for social coordination, and are thus likely to remain, at best, a marginal technology.

The Common Fisheries Policy (CFP) is one of the ever-increasing policy areas that have witnessed the creation of forms of “networked enforcement”, meaning enforcement structures in which several national and EU authorities cooperate. Amongst those are a number of legal requirements and applications for sharing data on fisheries between national and European competent authorities. This form of networked enforcement casts some questions as regards the existence of corresponding accountability mechanisms, which serve to legitimate the enforcement activities in the CFP. The aim of this paper is to examine the networked enforcement mechanisms arising from the CFP, with a special focus on the data-sharing activities and the role of European Fisheries Control Agency as pivotal to the cooperation between national authorities, with a view to assessing the gaps of accountability arising from them, and analysing the possible alternative ways to provide the enforcement phase with legitimacy.

EU and UK animal protection laws are underpinned by arguments based on the perceived desirability of reducing animal suffering. Technological innovations, however, give rise to ethically problematic situations in which suffering is not present or where it is not necessarily the only issue. Moreover, these developments further expose non-suffering related problems that were already present in existing areas of animal use. The existing animal protection laws are not capable of adequately addressing these problems. The concept of dignity might be a promising alternative. It is capable of covering situations other than those in which welfare is an issue, and using it might make the law more internally consistent.

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 investigates the rise of algorithmic disease surveillance systems as novel technologies of risk analysis utilised to regulate pandemic outbreaks in an era of big data. Critically, the article demonstrates how intensified efforts towards harnessing big data and the application of algorithmic processing techniques to enhance the real-time surveillance and regulation infectious disease outbreaks significantly transform practices of global infectious disease surveillance; observed through the advent of novel risk rationalities which underpin the deployment of intensifying algorithmic practices to increasingly colonise and patrol emergent topographies of data in order to identify and govern the emergence of exceptional pathogenic risks. Conceptually, this article asserts further howthe rise of these novel risk regulating technologies within a context of big data transforms the government and forecasting of epidemics and pandemics: illustrated by the rise of emergent algorithmic governmentalties of risk within contemporary contexts of big data, disease surveillance and the regulation of pandemic.

In order to address “wicked problems”, complex, multi-level governance structures must be established. These structures in turn require sophisticated systems of controls over public power to safeguard the rule of law. This seems to have been ignored in EU legislative practice and relevant research. This article argues that future research and legislative design of controls over public power in the EU need to be guided by the principle of connecting, aligning and making interplay between relevant concepts, institutions, procedures and scopes of different types of control belonging to the many jurisdictions, whose actors are involved in the executing of (shared) tasks in the EU. Connecting the disciplines that study these issues is a necessary prerequisite to this endeavour.

Inside companies that produce significant risks, risk managers play a key role. They manage the connection between the risk regulation regime, which stresses public values, and the company, which pursues a broader array of organisational goals. This makes the role of risk managers ambivalent. To better understand this ambivalence and identify the means, motives and strategies that risk managers employ in response to this ambivalence, this article conducts a concise review of (classic) organisation and regulatory literature. Based on this review, we propose a typology that distinguishes four roles of risk managers: risk managers as supporting staff; risk managers as professionals; risk managers as boundary spanners; and risk managers as agents in regulatory communities. Each type subsequently describes how risk managers employ different strategies in their attempt to connect the risk regulation regime and the company, ie translating policies to practices, tailoring policies to practices, explaining and framing policies and practices, and (re)interpreting policies and practices together with regulators. The typology enables researchers and practioners to emphasise and more thoroughly analyse the variety and complexity of risk managers’ work, and can help regulators to broaden and fine-tune their strategies to improve connections with the various roles of risk managers.

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.

Even though carbon pricing is widely accepted as the most efficient policy instrument for climate change mitigation, it has been severely held back by a lack of public support. Building on research in behavioural sciences, we propose a revenue recycling scheme that aims to foster public support for carbon taxes. The scheme has two main strengths: (i) it may allow the implementatin of carbon taxes with higher tax rates than those currently prevailing in most jurisdictions; (ii) it relies on a number of accessible technologies, and thus it can be implemented in a wide variety of settings, both in urban and rural areas of developing and developed countries.

In the EU, pharmaceuticals are subject to a marketing authorisation requirement that, depending on the type of product concerned, can be obtained either centrally through a Commission decision with EU-wide effects or in the Member States, potentially subject to mutual recognition in composite authorisation procedures. These composite decision-making processes can nowadays be considered a standard way of administrative decision-making in the EU internal market. Yet, judicial supervision remains anchored in the separation of jurisdictions between the national and the EU level, and between national levels. This article explores the challenges posed to judicial review in the case of pharmaceutical marketing authorisations when European administrative composite structures are used.

Since 2007, a surge of new gambling opportunities, often referred to as social casino gaming, has emerged on social media platforms and mobile apps. At the present time, the social casino gaming industry is unregulated and challenges our conventional understanding of gambling and risk. Currently, the minimum age requirement to create a profile on Facebook and engage in social casino games is 13 years of age. The emergence of this new gambling frontier, and its low barrier to entry, inevitably adds a new layer of risk and raises several ethical considerations for public health and risk regulation professionals, particularly to developers’ use of game mechanics and advanced data analytics. Using findings from a virtual ethnographic case study focusing on Zynga Poker (ZP), this article will call attention to potential ethical and risk concerns about game mechanics and the use of big data to personalise players’ gameplay to optimise player engagement and monetisation.

This article examines the convergence of myriad forms of information on people who come to be targets of state and public control due to the perceived risk they present through having been alleged to have not disclosed their HIV-positive status to sex partners. Attending to the material, violent impacts of criminalisation – violence, both legal and extralegal – this article outlines how punishment is enhanced and amplified through the flow of information. Focusing on the material impacts of flows of information about the daily lives of people who face criminalisation moves analysis beyond solely a theoretical object of inquiry and helps to frame an understand that the effects of big data operate not just “within” big data surveillance, but also “beyond” big data surveillance.

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.

In the aftermath of the Technical Board of Appeal’s decision T 1063/18 of 5 December 2018 (“the Pepper case”), the President of the EPO has referred, in G 3/19, two questions to the Enlarged Board of Appeal pursuant to Article 112(1)(b) of the European Patent Convention concerning the patentability of products obtained from essentially biological processes under Article 53(b) EPC. The Technical Board of Appeals in T 1063/18 upheld that the new Rule 28(2) of the Implementing Regulations to the European Patent Convention conflicts with Article 53(b) EPC, as it has been interpreted by the Enlarged Board of Appeal in G 2/12 and G 2/13 (the “Tomato II” and “Broccoli II” cases), namely that “the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plants material such as fruit”. Moreover, the TBA concluded that Article 58(b) EPC should prevail over Rule 28(2) EPC-IR. Since this ruling challenges the Administrative Council’s amendment to Rule 28 EPC-IR, the President deemed it necessary to refer the conflict to the EBA in order to “restore legal certainty”.

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.

This article compares the regulatory liability of German banks for aiding tax evasion under the German Act on Regulatory Offences with the UK corporate offences of failure to prevent the facilitation of tax evasion under the Criminal Finances Act (CFA) 2017. The study demonstrates that the approaches share some similarities; however, major differences are also evident. Unlike the German approach, the CFA provisions are designed as strict liability provisions, whereas the German regulatory offence requires an intentional or negligent omission to take the supervisory measures required to prevent contraventions of the law. Moreover, the scope of the offences under UK law is wider than the scope of their German equivalent. In addition, the CFA provisions do not place financial limits on the fines that can be imposed. Because of these differences, the CFA is likely to be more effective in preventing banks from aiding tax evasion than its German counterpart. Consideration should therefore be given to reforming German law to make it more like its UK equivalent, especially in the post-Panama Papers world.