Calls for a European Health Union apparently challenge long-standing beliefs that national healthcare system organisation is a Member State competence. Interaction between Member State and European Union (EU) levels therefore fundamentally requires reflection in the design, overall structure and legal basis of any European Health Union. Article 168(7) Treaty on the Functioning of the European Union (TFEU) provides the current version of the seemingly limited EU competence with regards to national healthcare system organisation and has received surprisingly little attention thus far. On the one hand, within the wider EU health competence ‘web’, Article 168(7) TFEU constrains EU adoption of measures incentivising Member States to use particular treatments or to increase intensive care units in response to COVID-19. On the other hand, Article 168(7) TFEU is challenged by the perceived influence of Country-Specific Recommendations issued in the context of the European Semester on national health policies. This opinion piece provides an original assessment of Article 168(7) TFEU to argue that Treaty change to redress the balance between EU and Member State competence regarding national healthcare systems may be uncalled for given both the flexibility afforded by the provision and the complexity and diversity of Member State healthcare systems.

This article analyses the administrative measures and, more specifically, the administrative strategy implemented in the immediacy of the emergency by the Italian government in order to determine whether it was effective in managing the COVID-19 pandemic throughout the country. In analysing the administrative strategy, the article emphasises the role that the current system of constitutional separation of powers plays in emergency management and how this system can impact health risk assessment. An explanation of the risk management system in Italian and European Union (EU) law is provided and the following key legal issues are addressed: (1) the notion and features of emergency risk regulation from a pandemic perspective, distinguishing between risk and emergency; (2) the potential and limits of the precautionary principle in EU law; and (3) the Italian constitutional scenario with respect to the main provisions regulating central government, regional and local powers. Specifically, this article argues that the administrative strategy for effectively implementing emergency risk regulation based on an adequate and correct risk assessment requires “power sharing” across the different levels of government with the participation of all of the institutional actors involved in the decision-making process: Government, Regions and local authorities.

This section is meant to give readers an insight into the emerging field of nanotechnologies and risk regulation. It informs and updates readers on the latest European and international developments in nanotechnologies and risk regulation across different sectors (e.g., chemicals, food, cosmetics, pharmaceuticals) and policy areas (e.g., environmental protection, occupational health and consumer product, food and drug safety). The section analyzes how existing regulatory systems deal with new kinds of risks and reviews recent regulatory developments with a focus on how best to combine scientific freedom and technological progress with a responsible development and commercialization of nanotechnologies.

This contribution seeks to overcome the isolation of evaluation studies fromthe broader field of public policy analysis. Using as a case study the hybrid regulatory tool of cross compliance under the Common Agricultural Policy, the article charts the ongoing incorporation of ex ante and ex post evaluation processes over a ten year period, during which three major legislative reforms were undertaken. Anchoring its approach in the public policy work of Kingdon, the article emphasises the significance of the plurality of actors involved in the evaluation processes, the importance of timing, as well as the challenge to models of policy processes based on assumptions of rational linearity. In particular, the article demonstrates how the dis–ordering which may be observed in the stages of the policy process may equally be seen in the stages of policy appraisal. A particular focus is placed on the way in which objectives and indicators are defined and re–defined over time. The case study demonstrates that through policy appraisal, policy makers may learn what is, and what is not capable of being measured, which feeds back into the re–setting of objectives.

With respect to critical information and communication technologies (ICT), nations most often declare their national critical infrastructure to include telecommunication services and in some cases critical services offered by key Internet Service Providers (ISP). This paper debates whether nations, their policy-makers, legislation and regulation largely overlook and fail to properly govern the full set of ICT elements and services critical to the functioning of their nation. The related societal and economical risk, however, needs to be closely mitigated, managed and governed. Legal and regulatory obligations to increase the ICT resilience may sometimes encourage this process.

On Tuesday, January 18, 2011 President Obama issued a new executive order and two somewhat related memoranda which embody some of the principles discussed by the Office of Information and Regulatory Affairs (OIRA) Administrator Cass Sunstein in this Journal. Building on three decades worth of practice in the United States with regulatory review, the new order and memoranda maintain significant continuity with past experience, while emphasizing both “humanizing” and rationalizing elements in the practice of regulatory impact analysis.

Information dissemination across the supply chain to consumers about chemicals’ hazardous properties and presence in consumer products has been recognized as insufficient to improve to enable both producers and end-users to avoid hazardous chemicals and to manage risks to human health and the environment. A comparative analysis of the information requirements in four EU legislations (the CLP, the Cosmetics regulation, REACH, and the Toys Safety Directive) and three US legislations (California's Proposition 65 and Senate Bill 509, and the national TSCA) was conducted with the aim of studying to what extent existing regulatory information approaches require information to be disseminated to consumers. In general, the European legislations address and promote consumers’ access to information on chemicals in products more comprehensively than the American legislations, but the amount and type of information required to be disseminated to consumers varies widely. These differences include which chemicals are prioritised, if the chemical is used in a mixture or an article, what information dissemination strategies are used, and who is responsible for consumers accessing the information. It is recommended that chemical information policies should, at minimum, require chemical suppliers to inform consumers of hazardous chemicals present in their products and, if possible, recommend risk management measures to ensure a safe use of consumer products.

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.

Algorithmic and high frequency trading use computer algorithms to execute strategies and the confluence of trends in computer hardware, programming, mathematical modelling, and financial innovation have pushed the limits of trading speed to unprecedented levels. Algorithms are fast and automatically spread disruptions through the financial system. Over the last decade, the ensuing systemic risk called for new regulations. This article attempts an early assessment of the new European legal framework (Mifid 2 and Market Abuse Regime) intended to tackle the technological risks of the modern trading paradigm.

This article explores the prospects for the EU to develop a coherent policy regarding climate engineering (CE). To this end, we explore the most significant legal parameters derived from EU law from which such a future EU policy would have to arise. Obviously, in view of the principle of conferral, it must first be established if the EU enjoys competences to initiate a discrete policy on climate engineering. The mere fact that the EU presides over a plethora of climate mitigation and adaptation instruments is not sufficient to conclude that it likewise has competence to initiate a policy of intentional environmental change. Rather, precisely because climate engineering is such a different response to climate change than anything undertaken before, we must establish whether that difference is of a nature so as to rule out a future EU policy on climate engineering.

With the SARS-CoV-2 pandemic entering its second year, public and private actors alike grow eager to achieve some semblance of normality. In this context, the idea of “vaccination passports” or “immunity certificates” as a means of resuming social and economic activity has been gaining momentum all around the world. This article aims to provide a legal analysis of this initiative through the lens of the proportionality principle. A proportionality test is conducted in order to determine whether the degree of infringement of the human rights implicated is balanced by the potential of a certification system to mitigate the risks of the virus. The results from this analysis show that the targeted aims can be achieved through already existing measures with a lesser impact on civil and fundamental human rights. Moreover, in a context of uncertainty around the immunopathology of COVID-19, the introduction of these certificates presents ethical and scientific challenges, which lead us to believe that this measure is unlikely to play a central role in stopping the spread of the disease, and it could set the pace for a dangerous precedent, allowing for extensive discrimination and exacerbating already existing inequalities and disparities.

Cognitive neuroscience was born when the theories and methods of cognitive psychology and neuropsychology were combined after a long period of parallel development. Over the last few decades, neuroscientific studies have begun to meet the challenge of understanding cognitive functions, thereby identifying the causal chain of neural events that underlies cognition. The development of powerful brain imaging technologies is now likely to present a range of opportunities in many spheres of public life, such as the criminal and civil justice system, and the business world.

This special edition of the European Journal of Risk Regulation deals with a highly topical, complex and controversial subject matter – the reform of the regulation of medical devices in the European Union.

At first sight, and as further detailed in the following articles, there appears to be a general consensus about the need to improve the EU (and indeed the US) regulatory framework on medical devices, especially for high-risk categories of devices. Stakeholders including representatives of the industry, patient and consumer organizations, national authorities, healthcare professionals, agree that there is a need for change. However, opinions differ on what needs to be changed and how. Three alternatives for reform of the current EU systemof regulation have been debated over the past years: the adoption of a pharmastyle system of pre-market authorisation; maintaining the status quo but strengthening implementation and supervision in the Member States; or finally, introducing common technical specifications together with specific guidelines for certain high-risk devices.

Regulation of critical infrastructure (CI) is in vogue; and accordingly every government presently develops legal governance regimes. In this paper, I try to analyse some of the present efforts to identify and govern CI. I argue that while the legal definitions introduced contribute little to the actual identification of critical infrastructure, they alter the responsibility and modus operandi of the identification. Political discretion is re-organized into administrative decisions. By relying on similar observations from risk sociology, I set out to criticize the present implementation for masking the hard political choices inherent in the work with CI, and thereby creating a dysfunctional governance regime for the protection of CI.

On 13 March 2020 the Hungarian Government announced the immediate closure of all schools throughout the country to prevent the spread of COVID-19 forcing several hundred thousand children to learn from home, and teachers to ensure their education. The Hungarian Educational Authority hurried to issue recommendations on the use of digital education tools. During the COVID-19 pandemic and the special legal order consequently introduced by the Hungarian Government, Hungary has seen the emergence of such non-binding measures adopted by public entities, complementing governmental action against the pandemic, with the aim of providing guidance to bodies exercising a public service function (“addressees”). These protective measures adopted under the special legal order are deemed to be successful and are largely followed by the addressees. Since soft law has hitherto been neglected by both Hungarian administrative governance and the legal literature, the recent burgeoning of non-binding measures deserves scholarly attention. In this article, we set out to map the specific context of the emergence of domestic soft law and the conditions for its adoption and reception, relying on our case study conducted in respect of the National Educational Authority’s recommendations.