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.

The European Union (EU) increasingly develops and implements policies infused with salient and sometimes conflicting values – for instance, in migration and criminal law cooperation. However, policy implementation studies have not frequently considered how such complex value trade-offs may affect practical implementation within Member States. This article therefore quantitatively and temporally examines the practical implementation of an EU flagship criminal law measure: the simplified extradition system known as the European Arrest Warrant (EAW). Using data on EAWs decided upon by the Dutch Amsterdam District Court, we test the impact of value trade-offs by examining whether (newly introduced) safeguards for the protection of requested persons adversely affect system efficiency (measured through case turnover times). The results suggest that the design of legal tests and adjustments made to the EAW system over time through the Court of Justice of the European Union affect the balance between fundamental rights protection and efficiency in the practical implementation of the EAW.

This article assesses the manner in which Commission Regulation (EU) 2015/1222 of 24 July 2015 establishing a guideline on capacity allocation and congestion management (“CACM”) alters the legal context within which power exchanges (“PXs”) perform their activities related to market coupling. By submitting the cooperation among the newly-introduced NEMO-entities, and between these NEMOs and TSOs, regarding market coupling to a new set of rules, CACM affects the market coupling activities of PXs in different ways. This article in particular examines from the power exchanges’ perspective (1) the need for the increased regulation introduced by CACM, (2) how CACM affects their activities in the context of market coupling and (3) whether CACM contributes to a better governance of market coupling.

This article aims to analyse liability issues as a further means to regulate risks, in case the precautionary measures of the delivered safety system fail. Through liability, the risk that cannot be prevented can be transferred onto those parties who are in the best position to spread them. The allocation of liability thus works as an incentive to the correct functioning of the preventive measures. Liability rules appear to be a key legal remedy which can ensure both tort reparation and a fair and efficient distribution of burdens in a legal order. In this vein, air traffic management (ATM) is addressed as a case study, which shows the main issues and the gaps that liability rules face when dealing with the trade off between risk and safety as conveyed by technology.

After having clarified the nature of the relations between risk and liability on the one hand, and automation and liability on the other hand, this article analyses liability issues in the framework of ATM by approaching this topic in a comparative way between the National Airspace System (NAS) of the United States of America (USA) and the Single European Sky (SES) of the European Union (EU).

This article highlights the importance of unbiased scientific advice in the European Union's legal system. It then analyses and compares the policies in force throughout the European Food Safety Authority, European Medicines Agency and European Commission's Scientific Committees with the one implemented by the US Food and Drugs Administration. The author argues that at the present time the framework adopted and implemented by the European Food Safety Authority seems to be the most complete and stringent amongst those taken into account in the article and he advances some proposals for further improvement of the policies regulating conflict of interest.

Ever more risky service activities are carried out across borders, creating spillovers and externalities. At the same time, if freedom to provide services is legally enabled, states can cooperate in multiple ways to mitigate the potential risks accruing from crossborder activities. Global Administrative Law Scholarship distinguishes five types of administrative regulation: “administration by formal international organizations; administrations based on collective action by transnational networks of governmental officials; distributed administration conducted by national regulators under treaty regimes, mutual recognition arrangements or cooperative standards; administration by hybrid intergovernmental–private arrangements; and administration by private institutions with regulatory functions. In practice many of these layers overlap or combine […]”. In the area of risky cross–border service provision, the EU has moved from a more decentralised version of networks and mutual recognition characterised by coordination and minimum harmonization of rules and standards to a more centralized commandand–control system with European authorities and supervision.

Despite robust evidence on the benefits of gum mastication as compared to its risks, places such as Singapore still outlaw chewing gum outside of medicinal purposes. Chewing gum has therapeutic and cognitive benefits such as reduced stress and increased attention, and its associated costs such as littering are disproportionately upheld and still prosecuted against in Singapore. This is a clear example of a policy implemented based on perception rather than cost–benefit analysis. Policies, even as minor as those related to gum mastication, must be entrenched in evidence, and any accompanying costs (eg littering) can and should be deterred through evidence-based communication efforts.

Socioeconomic disadvantages are amplified by the COVID-19 pandemic all over the world. Public actions and omissions severely affect the poor, alongside their precarious living, health and working conditions. As we slowly prepare for the aftermath of the pandemic, thanks to the progression of vaccination, especially in developed countries, certain measures taken in this context, more specifically the “vaccination certificates”, are likely particularly to affect the poor, who usually also belong to other vulnerable groups such as ethnic minorities or single parents, and could eventually constitute for them a state of permanent quarantine. In this contribution, I argue that COVID-19 vaccination certificates are a slippery slope towards exclusion and stigmatisation of the poor through a bureaucratic system based on privileges that raises important questions in light of the fundamental rights of the people who reside at society’s margins, struggling to conform to the “phantom of normalcy”.

In November 2010, 171 Parties to the WHO Framework Convention on Tobacco Control (WHO FCTC) unanimously adopted the Punta del Este Declaration on implementation of the Convention. The Declaration follows the filing of an international investment claim against Uruguay by Philip Morris Products (Switzerland) and related companies. The Declaration reaffirms the commitment of the 171 WHO FCTC Parties to implementation of the Convention and addresses the relationship between the WHO FCTC and international trade and investment agreements, particularly in the context of intellectual property rights. This article outlines the Request for Arbitration, sets out the Declaration and the broader normative context in which it arose before touching briefly on the implications of the Declaration.

In rendering this decision, the Federal Supreme Court of Switzerland entered for the first time into a detailed analysis of questions relating to the cost-effectiveness of human healthcare. The decision, concerned with the availability of a drug for a rare genetic disease, makes it clear that the maximum amount available from a public health insurance provider for the medical treatment in a particular case has been reached once the amount requested by the individual patient cannot also be provided to all other persons in a comparable situation. It remains unclear, however, how cost-effectiveness is to be assessed below this maximum amount (author's headnote).

This paper provides a holistic review of market surveillance in China from a legal perspective, supplemented by the authors’ practical knowledge. The fundamental legal bases of market surveillance, namely the Law on Product Quality, the Law on Import and Export Commodity Inspection and the Law on Standardization, along with their associated implementation regulations, are thoroughly examined. Thereby the special features of market surveillance in the Chinese context are presented. This, in particular, includes the differentiation between market surveillance on the production and circulation stages (pre-marketand post-market) and an introduction of the two major competent authorities, the GeneralAdministration of Quality Supervision, Inspection and Quarantine, the State Administrationfor Industry and Commerce, and their respective statutory functions specified by a range of laws and administrative regulations as well as the demarcation of their competencies. The authors also take efforts to explore market surveillance on two spe cial markets, foodand pharmaceuticals, which also includes the legal basis, legal instruments and competent authorities, representing different supervision approaches compared with ordinary products.In the end, market surveillance on and by conformity assessment bodies are briefl yreviewed to provide another angle for the observation of the Chinese system.

Case C-658/11, European Parliament v Council of the European Union [2014] (not yet reported)

CFSP acts can be challenged before the Courtwhen the arguments relate to procedural points outside of the CFSP articles in Title V TEU. The Court can annul Council CFSP acts when the proper notification procedures to the Parliament stemming from Article 218 TFEU have not been followed. The effects of CFSP acts can remain in place, even after the Court annuls them, until such a time when the act has been replaced.

In order to secure their fishery products market share in the EU, third countries, especially the developing ones, tend to transplant EU requirements into their domestic legal order. In reality, theses transplanted laws do not correspond to measures to reach a level of protection needed by the country of destination. Based upon the case of Benin, this paper intends to show that when these legal transplants are adversely made, they can in some cases have disastrous effects. It can be argued that an unintended result of EU policy was that it contributed to the collapse of the shrimp industry in Benin. The paper moreover argues that despite the stringency of the EU requirements, the implementation of its control policy might inadequately protect European consumers of shrimp.

The EU is continuously developing strategies, policies and regulations to confront pandemic and epidemic diseases. The actions of the EU in this field do not happen in a vacuum but are instead embedded in a complex international and transnational network. This article suggests the existence of a tension between public health policy and a twofold set of competing considerations: growing security concerns and market pressures. To structure the argument the article examines three distinct but related aspects: first, it clarifies the different levels of decision-making impacting on the EU’s policy and regulation of vaccines for PEDs: these levels are described as international, transnational and domestic, and the key players involved at each level are also identified; second, it analyses levels of responsiveness to and preparedness for outbreaks and analyses how past experiences have oriented the policy debate; third, it discusses issues of accountability of vaccine developers, authorising authorities and rule-makers involved in preparedness and response to emerging PEDs.