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.

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.

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.

This article contributes to the discussion about proper product safety in the wake of disruptive digital technologies. By picking the example of 3D printing we analyse why incumbent product liability law does not incentivise optimal deterrence of harmful 3D printed products. We identify the new business models associated with 3D printing as the main trigger for the non-applicability of incumbent liability law. The new business models are characterised by making no strong reference to economies of scale. As a result, the informational content of specific producers and their products is scarce and the identification of tortfeasors becomes a challenge for the legal system. While there is yet no easy solution to the problem, we provide at the end of the article an inventory of institutions that may take the lead in finding new proper liability rules and safety regulations.

The primary concern of the present paper is the cost of acquiring information by judges and legislators in the process of regulating new technologies. The paper distinguishes between risky and uncertain applications of technology. A risky technology poses an obvious risk, and the problem before the regulator is one of comparing cost and benefit. We argue that the judiciary, which acquires information gratis from litigants, is better suited to the regulation of risky technologies. Uncertain technologies, on the other hand, can be harmful in ways which cannot be foreseen at the time of the technological innovation. Cost and benefit are incalculable; regulation must instead be based on subjective preferences about the degree of uncertainty that society should tolerate. Legislative law-making is designed with a view to aggregating subjective preferences. Accordingly, uncertain technologies should be regulated through statute.

New business models, such as that of Airbnb, have led to a rise in the use of residential properties as short-term lets. In this paper, the writer considers the social efficiency of the use of the public town planning system and alternative private law systems, to regulate the activity. Specifically, the paper considers the use of these in order to tackle spill-over amenity effects upon neighbouring properties. The writer applies the general framework of Ellickson (1973) in performing a comparative economic analysis of the systems. This includes an analysis of the “90-nights” rule of UK planning law, which applies to London. The writer argues that in the specific case of short-term lets, the private law systems disclose relatively low transaction costs. This, in conjunction with their allocative efficiencies, makes them preferred to town planning. Taking into account the problem of nonconvexities, it is concluded that the “90-nights” rule, and the requirement for planning permission for short-term lets, should be repealed. This conclusion encloses an understanding that the amenity effects considered here involve little uncertainty. The courts, if equipped with private information from litigants and public information from development plans, are well placed to regulate this activity.

Artificial intelligence (AI) is becoming a part of our daily lives at a fast pace, offering myriad benefits for society. At the same time, there is concern about the unpredictability and uncontrollability of AI. In response, legislators and scholars call for more transparency and explainability of AI. This article considers what it would mean to require transparency of AI. It advocates looking beyond the opaque concept of AI, focusing on the concrete risks and biases of its underlying technology: machine-learning algorithms. The article discusses the biases that algorithms may produce through the input data, the testing of the algorithm and the decision model. Any transparency requirement for algorithms should result in explanations of these biases that are both understandable for the prospective recipients, and technically feasible for producers. Before asking how much transparency the law should require from algorithms, we should therefore consider if the explanation that programmers could offer is useful in specific legal contexts.

In general, a functioning liability and insurance framework should ensure an adequate level of third party claimant protection and a reasonable and adequate final allocation of liability costs for the involved parties. This research examines whether the liability and insurance framework resulting from the amendment to German Road Traffic Act meets these two central objectives. The article shows that a reasonable and adequate allocation of liability costs is inhibited because of several barriers that hinder the shift of liability costs from the owner of the vehicle to the manufacturer. In particular, it is highly dependent on the practical application of subrogation claims. The ability and the motivation of motor insurers to conduct subrogation claims could be negatively affected because of a lack of required technical and engineering know-how and because a market-wide conduction of subrogation claims would erode the business model of motor insurance. This article proposes changes to the current framework particularly by removing specific exclusions of product liability and by easing the burden of proof of a product defect.

Chemical terrorist attacks by non-state actors have traditionally been characterised as low probability events; however, the apparent normalisation of chemical weapons use, including by terrorists, in the ongoing conflict in Syria is causing some in the international security community to question whether it will remain low probability. For Europe there is an additional potential concern, namely the numbers of EU citizens who are “foreign fighters” and whose return from the conflict zone might also result in “importing” chemical weapons use. This article examines the rise of the “chemical weapons-returning foreign fighter” narrative and considers aspects of the European response. These responses predate the current concerns and include important efforts to create a robust public health response, such as early alert and communication systems, so that the attractiveness of these weapons being used within a European context might be reduced. Although there are limitations as to how far one can transfer what happens in a Syrian context to Europe, the suggestion is made that some of the framing assumptions within this response architecture may be now inadvertently limiting the potential to identify and respond to chemical attacks.

There have been relatively few serious incidents of chemical or biological terrorism in Europe; however, there is growing concern over how non-state groups might exploit chemistry and biology for hostile purposes in the future. This article uses the historical record of past incidents of chemical and biological weapons (CBW) adoption by non-state actors to inform understandings of the current and future risks. To achieve this, the article analyses six interlinked clusters of factors that can be seen as important in assessing the risk of whether or not to adopt such weapons. These are: the perceived relative advantage of CBW and their utilities; the complexity of such weapons; their ideological compatibility; the role of organisational structures; the visibility and ‘fashionability’ of such weapons; and the wider environmental context. Drawing from past cases of CBW adoption and the present European context, an analysis of these factors suggests that sophisticated CBW with gigantic effect are possible, but unlikely; however, the adoption and use of scruffy low-level chemical weapons is a distinct possibility. Accordingly, European public health agencies need to prepare for the possibility of a variety of CBW, not all of which are likely to be weapons of “mass destruction”.

The European Union is increasingly moving toward an integrated policy approach, which also acknowledges linkages between public health and (external) security policy. This introduction to the Special Issue sets out a research agenda on the emerging health-security nexus. It analyses recent policy developments with respect to the public health and security, and discusses interactions along the health-security nexus in the context of the European Union. It suggests drivers behind the integrated approach and it critically examines the health-security nexus from the perspective of effectiveness and legitimacy.

The regulatory literature has long been concerned with the challenges of technological innovation, yet it says relatively little about what we understand as “innovative” and how innovation “types” impact on regulation. This article unpacks the concept of “innovation” and analyses its significance for the development of regulatory strategy. It shows that innovation types – such as “incremental” and “radical” innovation – are not clear-cut, but involve differences of interpretation. This interpretive flexibility makes them powerful discursive resources in regulatory decision-making. Through a study of the EU’s regulation of nanotechnology, the article shows how arguments of “incremental” and “radical” innovation can be mobilised to very different effect. These different ways of conceptualising new technology affect decisions on: (i) the desirability of legislative reform; (ii) the evidence-base for regulation; and (iii) the use of the precautionary principle. The study also shows how the framing of technology as “incrementally” innovative can contribute to a strategy of “deliberate regulatory ignorance”. The article concludes by arguing that the incremental/radical distinction can be put to more positive use, so that regulatory choices take account of the different techno-scientific and socio-economic dimensions of innovation.

This report introduces the challenges 3D bioprinting poses to the existing legal regime across bioethics, safety, regenerative medicine, and tissue engineering. We briefly review the 3D bioprinting technology and look into the relevant regulatory instruments for the pre-printing, printing, and post-printing stages. Special attention is paid to the applications of the EU Advanced Therapy Medicinal Products Regulation and the new Medical Device Regulation.

I begin with two admissions. First, I am relatively new to risk regulation, and indeed academia in general, so this piece is based on still quite nascent views. Second, I fell into risk regulation scholarship almost by accident – therefore I hope this piece will provide an illustration of how strong the intellectual draw of the field is, having already captured my imagination at least!

In the following three sections I set out my risk regulation journey, and the understanding of the field I have developed so far. After summarising how I was drawn to risk regulation, I attempt to reflect philosophically on the purposes of risk regulation research, after which I outline the questions that I believe risk regulation scholars should be asking now and in future years, along with my corresponding research priorities.

On 08 October 2013, the General Court of the European Union (hereinafter General Court) delivered a judgment based on the Aarhus Regulation 1367/2006 on the access to information on substances under plant protection law, which attracted considerable attention among experts with conflicting response from environmental associations and industry. The judgment – still appealable at the time this article was written – would in case of becoming unappealable result in extensive limitations to the protection of commercial and industrial secrets under plant protection law, but additionally also generally under substance law. The following article analyses the content of the decision.

In recent years the concepts of ‘nudge’ and ‘libertarian paternalism’ have become popular theoretical as well as practical concepts inside as well as outside academia. But in spite of the widespread interest, confusion reigns as to what exactly is to be regarded as a nudge and how the underlying approach to behaviour change relates to libertarian paternalism. This article sets out to improve the clarity and value of the definition of nudge by reconciling it with its theoretical foundations in behavioural economics. In doing so it not only explicates the relationship between nudges and libertarian paternalism, but also clarifies how nudges relate to incentives and information, and may even be consistent with the removal of certain types of choices. In the end we are left with a revised definition of the concept of nudge that allows for consistently categorising behaviour change interventions as such and that places them relative to libertarian paternalism.

The EU's new approach to policy evaluation is characterised by a focus on closing the policy cycle (linking ex ante and ex post appraisal) and by applying evaluation to all types of policy intervention, whether expenditure or regulatory policy. This article analyses the main features and challenges of this new approach. It first studies the conceptual and interdisciplinary challenge of such an encompassing approach to evaluation. It then assesses the new approach in the light of four key objectives of ex ante and ex post appraisal; ensuring evidence and learning; accountability, transparency and participation; policy coherence; and reducing the regulatory burden.