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 European Securities and Markets Authority (ESMA) has received considerable academic attention for its newly acquired regulatory powers and the issues of legitimacy and controls concerning its far-reaching powers. ESMA's supervisory tasks are not less impressive but they are underinvestigated. In light of the recent English judgment on the exercise of ESMA's inspection powers in the UK, this article focuses on the question of judicial control over inspection power of ESMA. It shows that judicial control has been established in principle. However, the existing legal framework based on different national procedures allows ESMA escaping judicial control by chance or on purpose. This article argues for the necessity of addressing the identified controlling gap by, for instance, eliminating the differences or conditioning inspection-related discretion and promoting judicial cooperation. Since EU and national enforcement powers have become increasingly shared, the system of control cannot remain completely separated, as it is the case today. How the EU supervisor is to be controlled should not be up to the EU supervisor to choose.

The article examines China's food standardization system, its reform and remaining challenges. Upon examining China's general standardization system, the article argues that the food standardization institutional framework has originated from the general standardization, which has developed a four-level hierarchy mechanism. It further examines the most salient features of China's food standardization system, namely, top-down hierarchy and intensive government involvement, and suggests that these features caused a regulatory failure. Although China recently reformed this fi eld, and the food safety standard hierarchy has been streamlined, challenges remain. The article reviews China's current reform in the food standardization system by providing a description, analysis and comparison of approaches from Europe and China.

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.

This article looks at the different regulatory approaches on food irradiation, starting with international standards on food irradiation, describing the approach in the US and other third countries, and finally in the EU, where there has been a regulatory standstill since 1999. The current EU approach on food irradiation, which authorises irradiation of certain predefined product categories and sets upper dose limits, does not appear to be in line with the approach used under the relevant internationally-recognised standards, such as the Codex Alimentarius and the International Plant Protection Convention. There are potential legal conflicts between the current regulatory framework on food irradiation in the EU and the international trade framework of the World Trade Organization. Ultimately, the EU must base its measures on scientific principles, on relevant international standards, and choose the least trade-distortive measures that are available (i.e., ensure that they are applied only to the extent necessary to protect human, animal or plant life or health). In 2011, the European Food Safety Authority published new risk assessments on food irradiation, which the European Commission has requested in view of drafting new EU legislation on food irradiation, and which appear to open the way for a fundamental altering of the regulatory parameters (such that food irradiation regulations must be scientifically-justified and in line with the relevant international standards), and seem to weaken the EU stance vis-à-vis the possible instances where the current rules on food irradiation prevent (de jure or de facto) access to the EU market by third countries’ operators and products, particularly those of developing countries.

This section regularly examines Regulatory Impact Assessment (IA) at three levels: the EU, the Member States and internationally. Contributions aim to cover aspects such as the interface between IA and risk analysis, looking at methodologies as well as legal and political science-related issues. Contributions are meant to report and critically assess recent developments in the field, develop strategic thinking, and make constructive recommendations for improving performance in IA processes.

This section discusses the regulation of “lifestyle risks” a term that can apply to both substances and behaviours. Lifestyle risks take place along the line of “abstinence - consumption - abuse - addiction”. This can concern substances such as food, alcohol or drugs, as well as behaviours such as gambling or sports. The section also addresses the question of the appropriate point of equilibrium between free choice and state intervention (regulation), as well as the question of when risks can be considered to be acceptable or tolerable. In line with the interdisciplinary scope of the journal, the section aims at updating readers on both the regulatory and the scientific developments in the field. It analyses legislative initiatives and judicial decisions and at the same time it provides insight into recent empirical studies on lifestyle risks.

Some understandings of European Union health law are based on a presumption of law as a static and closed system. This approach to the Union as a legal entity has important ramifications. The Union is a political system created by and subject to the rule of law. Its successes (and failures) are attributable to the legalisation of solving externalities and ensuring Member State solidarity to gain benefits from integration. Member States, which create and sustain the Union by repeated acts of sovereign choice, choose to subject themselves to the rule of (Union) law. This protects both the Member States and the Union institutions (imperfectly, but nonetheless) from charges of illegitimacy. While recognising the benefits of such an approach to European Union integration and law-making, we take the view that law also has an important dynamic potential. That dynamic potential is inherent in all law, for law is embodied in text, and always open to interpretation, as the external contexts that give legal text meaning in the real-world change through time. We trace the dynamic potential of Union health law by looking at its legal basis to its foundational Treaties, and we plot its trajectory going forward.

Before the Treaty of Lisbon, EU agencies were unknown in the EU's primary law defined procedural law. Today, following (i) the Treaty's entry into force, (ii) the Common Approach on Decentralised Agencies and (iii) the European Court of Justice's ruling in Short–selling it is interesting to take a look at the peculiar position of EU agencies under the EU's primary and secondary law defined procedural law.

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.

How can we assess the quality of an analytical deliberative decision support procedure in environmental health practice? Objectifying quality criteria is difficult for several reasons. Opening up evaluation to a diversity of critics is one approach to take into account different actor perspectives and complexity. We describe how social scientists organized extended peer evaluation of a participatory multi-criteria procedure that was applied in Flemish environmental health practice. International peer review was combined with local extended peer evaluation. Social scientists collaborated closely with natural scientists and policy representatives in designing several evaluative activities and in interpreting the results.We discuss how these different perspectives came to reach conclusions, with a special focus on methodological decision-making. A process of learning by doing and negotiating, finding a methodological path amidst practicalities, complexity and ambition.

This article discusses a number of pitfalls of the US-Tuna II Panel Report. This Report is interesting because it offers an occasion to reflect on some provisions of the Technical Barrier to Trade (TBT) Agreement, which may be crucial for the assessment of the legality of environmental labelling regimes. The most troubling part of the Report is the one dealing with the trade-restrictive nature of the measure. The Panel seems to have relied on a test by which if a measure does not reach its objectives perfectly, any other ineffective measures adopted with allegedly the same goals can be judged as a valid less-trade restrictive alternative. In other words, two wrongs seem to make a right in the view of the Panel; a conclusion that, for obvious reasons, will not be greeted with enthusiasm by environmentalists.

Case C-442/10, Churchill Insurance Company Limited v Benjamin Wilkinson and Tracy Evans v Equity Claims Limited [2011] ECR I-00000

Article 3 No. 1 of Council Directive on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, and to the enforcement of the obligation to insure against such liability, as amended, codified and repealed by Directive 2009/103/EC, OJ L - 103, of 02.05.1972. pp. 1–6. [First Motor Insurance Directive]

Article 2 No. 1 of Second Council Directive 84/5/EEC of 30 December 1983 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, as amended, codified and repealed by Directive 2009/103/EC, OJ L – 8, of 11.01.1984. pp. 17–20. [Second Motor Insurance Directive]

Article 1 No. 1 of Third Council Directive 90/232/EEC of 14 May 1990 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, as amended, codified and repealed by Directive 2009/103/EC, OJ L – 129, of 19.05.1990. pp. 33–35. [Third Motor Insurance Directive]

There is little debate, particularly clear, ‘no bullshit’ debate within the risk and regulation community, much as there is a lack elsewhere within academia. Without it, much goes unclarifed and arguments aren't tested and pushed to their limits, which is generally where they need to go. On these grounds alone I would welcome the different approaches to European/American precaution set out by Vogel and Wiener. But there are more positive things to say about these competing representations, irrespective of which one prefers. This is a discussion rich in empirical detail but that goes beyond individual issues towards systemic patterns, relating the data to wider themes and an overall framework. What's more, it concerns a matter of real contemporary significance and interest that citizens generally – at least those of America and Europe – should know about, and even have a view upon. And it's genuinely interesting – irrespective of any engagement with the academic study of risk and regulation.

Towards the end of 2011, the Responsible Gambling Fund published a report which, inter alia, offers an overview of the research gaps in relation to the comparative effectiveness of gambling regulation. In the present article, the authors of the report provide a summary of the main findings. They conclude that hardly any empirical evidence is available that addresses, directly or indirectly, this subject. In view of further research, a set of recommendations is provided.

On the face of it, ‘better regulation’ sounds like a concept that no one could object to. But in contrast to past attempts to cut red tape for business and thus reduce unnecessary bureaucracy, the objective of the Juncker Commission's Better Regulation Agenda is to reduce “regulatory burden”.

The package, adopted on May 9th 2015, foresees the establishment of an impressive apparatus and toolbox for implementing the Agenda. Existing structures and procedures, such as the Regulatory Scrutiny Board and the Impact Assessment Guidelines, are being modified, and new elements such as the two REFIT Platforms, one for stakeholders and one for Member States, and the new Interinstitutional Agreement on better law-making, will be introduced.

The Agenda raises many questions and concerns From the perspective of a public interest organisation such as The European Consumer Organisation (BEUC). Several aspects of this new institutional and procedural architecture suggest that it is not designed to provide society–wide benefits by generating better regulation for all. Rhetoric about the need to reduce costs is the dominant theme throughout the entire package, framed by the ‘jobs and growth’ narrative.

This section discusses the regulation of “lifestyle risks”, a term that can apply to both substances and behaviours. Lifestyle risks take place along the line of “abstinence – consumption – abuse – addiction”. This can concern substances such as food, alcohol or drugs, as well as behaviours such as gambling or sports. The section also addresses the question of the appropriate point of equilibrium between free choice and state intervention (regulation), as well as the question of when risks can be considered to be acceptable or tolerable. In line with the interdisciplinary scope of the journal, the section aims at updating readers on both the regulatory and the scientific developments in the field. It analyses legislative initiatives and judicial decisions and at the same time it provides insight into recent empirical studies on lifestyle risks.