Personal autonomy is at the core of liberal societies, and its preservation has been a focus of European Union (EU) consumer and data protection law. Professionals increasingly use artificial intelligence in consumer markets to shape user preferences and influence their behaviours. This paper focuses on the long-term impact of artificial intelligence on consumer autonomy by studying three specific commercial practices: (1) dark patterns in user interfaces; (2) behavioural advertising; and (3) personalisation through recommender systems. It explores whether and to what extent EU regulation addresses the risks to consumer autonomy of using artificial intelligence in markets in the long term. It finds that new EU regulation does bring novelties to protect consumer autonomy in this context but fails to sufficiently consider the long-term consequences of autonomy capture by professionals. Finally, the paper makes several proposals to integrate the long-term risks affecting consumer autonomy in EU consumer and data protection regulation. It does so through an interdisciplinary approach, drawing from legal research and findings in the study of long-term thinking, philosophy and ethics and computer science.

Since 1974, the UK has followed a risk-based approach to safety that, in the event of an incident, is enforced through the courts. The legislation is intentionally non-prescriptive and thus requires duty holders and the courts to decide what control measures were reasonable in the circumstances from ex ante and ex post positions. This has proved challenging for all parties involved. This paper describes a series of cases that have shed light on the thought processes of the courts. It appears that there is some variability in decision-making that can be attributed to several factors, including understanding of the word “risk”, the acceptability of residual risk and the validity of historical data as a means of measuring risk. In the aftermath of incidents, there is a real danger that psychological factors may intervene when the prior risk is being assessed for sentencing purposes. It is argued that while the risk-based model continues to enjoy widespread support in the UK and is not challenged, its implementation could be much eased by attention to details. This would serve to simplify courtroom debates, support those practising risk-based regulation and enable risks to be better prioritised.

This article addresses the question of how the World Health Organization (WHO) Global Strategy to Reduce the Harmful Use of Alcohol (Global Strategy) and its Framework Convention on Tobacco Control (FCTC) have been used in the context of discussions about alcohol and tobacco measures, respectively, in the World Trade Organization (WTO) Committee on Technical Barriers to Trade. The article finds considerable differences not only in the extent to which the FCTC is used compared to the Global Strategy , but also in the ways in which the two global health instruments have been used in the WTO context. The article proffers three key reasons for these differences: the legal status of the instrument; the content of the instrument in terms of whether it contains guidance as to the use of detailed, evidence-based measures; and the role and legitimacy that the instrument accords to the relevant industry interests. The article considers how the insights from the research can inform the developments in global governance of alcohol that are underway in WHO policy. It also positions its findings in terms of the wider international law debates about hard law versus soft law, and whether different types of international regulatory instruments and the legal status of these instruments impact their effectiveness in supporting domestic public health measures.

“And remember you’re in France: The customer is always wrong!”

Many years ago, there was intense debate about what the Precautionary Principle (“PP”) is, or is not. More recently, as the battle lines in that debate have ossified, academic attention seems to have shifted to a focus on the somewhat more subtle question of how the term PP, whatever it may mean, is used by different actors in different contexts. David Vogel’s recent book, The Politics of Precaution: Regulating the Environmental Risks in Europe and the United States (2012) (hereafter “Politics”), is a good recent example of such commentary. Vogel's approach recognizes the diversity of relevant developments, he seeks to impose a coherent narrative framework on those developments.

Judgment of the Court (Fourth Chamber) of 5 March 2015 In Joined Cases C-503/13 and C-504/13, preliminary ruling in the proceedings Boston ScientificMedizintechnik GmbH v AOK Sachsen-Anhalt — Die Gesundheitskasse (C-503/13), Betriebskrankenkasse RWE (C-504/13)

On 5 March 2015, the European Court of Justice issued a preliminary ruling on two issues arising under the EU Product Liability Directive, which imposes objective, no-fault or strict liability, but not absolute liability, for defective products. Despite the wide range of issues arising under this directive, the Court has had only a few occasions to construe its ambiguous terms. This case, however, provided an opportunity to the Court to settle key issues relating to the defect test and the scope of damages compensable under the directive. As in other civil law cases, the question arises whether the Court's light treatment will provide a sound basis for the further development of product liability in Europe. The Court did not answer the questions posed by the referring court, but in some respects went beyond these questions and in other respects avoided the difficult issues raised thereby. As discussed in this note, the Court paints with a broad brush, and the test set forth in its judgment to determine whether a product is defective, may itself be defective.

Over the past years, a series of milk crises in China — culminating in the melamine milk scandal in 2008 — have seriously undermined public confidence in food safety. Drawing on international experience to strengthen its regulatory system, China recently introduced elements of risk assessment in its two main Food Safety Laws, namely the Law on the Quality and Safety of Agricultural Products and the Food Safety Law, which represent its basic legislation and institutional framework in terms of food safety. The article explores this new Chinese risk assessment framework in an international context. Specifically, given the similarities between the melamine milk scandal in China and the bovine spongiform encephalopathy (BSE) crisis in Europe in the 1990s in terms of both severity and link to respective corresponding reforms, much of the article focuses on a comparison of the food risk assessment institutions of the two jurisdictions in the aftermath of the crises.

Decision 1082/2013 on Serious Cross-border Health Threats (Health Threats Decision) was adopted in 2013 with the aim of preparing for and responding to serious health threats. In this legislation, the European Union adopts an “all-hazards” approach which strongly relies on the exchange of information as a driver of regulatory activities. This article first demonstrates that the electronic systems of information exchange constitute a key tool in EU Health Crisis and Disaster Management (“EHCDM”). Second, it identifies the distinctive features of these mechanisms in the EU context: the reinforcement of a statutory policy shift towards securitisation of public health, the peculiarity of the EU composite administrative procedures as well as the facilitation of the quality of the sense-making activities. Finally, the article uncovers the possible problems which may affect the adequate functioning of EHCDM and argues the routes for further research. The piece links legal analysis with the interdisciplinary conceptual lens to offer an important contribution to closer characterisation of the EHCDM as a field in its own right together with a better understanding of the EU public health law and administration in the context of transboundary crisis management and health security governance.

This report provides an overview of the potential impact of the draft Trans–Pacific Partnership Agreement on public health and access to medicines, in light of a recent analysis conducted by UNITAID. The international organization observed that the increased intellectual property protection endorsed in the draft agreement,which calls for the adoption of TRIPSplus standards, is likely to severely impact generic competition, affecting the availability of medicines in developing countries, and reducing the ability of governments to set the appropriate balance between the protection of innovation and the safeguard of public health

The year 2013 has witnessed a new entry in the EU “better regulation” toolbox: the Cumulated Cost Assessment (CCA). The CCA is set to answer an apparently simple question: what is the cumulative cost imposed by a selection of EU rules and policies on a given economic sector? In this contribution we present the CCA methodology and its building blocks, as well as the results of the first two empirical applications of this tool. More importantly, we elaborate on two key features that make the CCA a valuable addition to the better regulation toolbox: it creates a methodological bridge between the policy and competitiveness assessment instruments, and it clarifies empirically how a wide array of policies interact with one another when and after they are actually implemented, an element that is often a weak link in policy–appraisal. We conclude with some remarks on how the CCA opens the avenue for a set of challenging and interesting methodological and policy considerations.

Joined Cases C-404/12P and C-405/12P

The Aarhus Convention was concluded in order to strengthen the rights of the public on access to information, public participation in decision-making and access to justice in environmental matters. The Convention provides that members of the public shall have access to administrative or judicial procedures to challenge measures by private persons and public authorities that contravene provisions of national law relating to the environment. At EU level, a regulation made the Aarhus Convention applicable to EU institutions. Pursuant to that regulation, review of measures adopted by EU institutions is limited to administrative acts. Two NGOs challenged the legality of that limitation and filed legal action. The case was related to the establishment of EU maximum residue levels for active substances contained in crop protection products. The Commission refused to review this measure which it considered to be no administrative act. The Court of Justice of the European Union has recently given its judgment in that case. The impact of the judgment goes beyond the crop protection sector as it concerns the scope of the internal review concept in general. Further, but not less important, the Court has clarified to which extent international treaties concluded by the EU can be relied upon by individuals.

When called upon to regulate risk, the EU carries the threefold onus to (i) protect its people(s); (ii) ensure the functioning of the internal market; and also (iii) to allocate the resources available wisely and efficiently.

This creates a number of pressures and dilemmas for the EU, notably for the Commission when initiating legislation and for the EP and the Council when co-legislating.

According to a familiar script – faithfully narrated by Ragnar Lofstedt in his opening article –, the EU has, in recent years, been subscribing to a progressive ideal of regulation based on evidence. As a result, by making a commitment to the use of optimization tools, such as risk assessment and regulatory impact assessment, the EU has been gradually developing a European risk regulation model that seems to put the EU at the forefront of a wider move towards evidence-based policy-making. Given the historical affection of the EU integration process to technocratic modes of governance, this choice is not surprising.

In a hot, flat, hyper–connected world, public perception of risk may determine if agriculture will save the planet by 2050 or destroy it. Science and technology options may hold the key to solving the situation, but, if media experience with “pink slime” and raw milk are any indication, society may be in for a bumpy ride. This article will examine global trends in food and agriculture, the interplay between food safety and public perceptions of risk, and the role of risk communication in addressing public perceptions.

This paper investigates traditional and new tools for increasing the effectiveness of rules and enforcement strategies. As a preliminary concern, it underlines that there are two sides to effectiveness that cannot be approached separately: effectiveness as perfect compliance with the terms of rules, and effectiveness as a result of rules which incentivise behaviours to meet the “spirit of the law”. In order to achieve this comprehensive approach to effectiveness, rules must be evidence-based, plain, understandable and accepted. Moreover, a clear understanding of compliance drivers is needed. Deterrence and all other possible motivations that go beyond the rational calculus should be assessed by decision-makers, such as internal motivation, procedural fairness, cooperation, social norms, heuristics and bias. Enriching the rationality assumption with other drivers of compliance does not mean dismissing traditional rules or enforcement tools, which conversely remain crucial for the purpose of supporting voluntary compliance and for preventing non-compliance. However, deterrence should be calibrated by a risk-based, responsive and proportional approach to (simplified) rules and enforcement strategies. Trust in public authorities, supportive and cooperative public administrations are also fundamental in order to increase voluntary compliance, and a cognitive-based approach should complement these views.

This report evaluates the current regulatory regime for health claims in the EU on the basis of a case study of the marketing of Optimel Control, a yoghurt drink which was marketed in several EU member states as a functional food aimed at suppressing appetite and maintaining weight control. Our case study of the marketing of Optimel Control in the Netherlands reveals that the use of non-textual marketing claims was much more important than the use of textual health claims. Because the current EU regulatory regime emphasizes the evaluation of the wording of health claims, but lacks an evaluation of non-textual claims we conclude that there is a regulatory void that producers can use to market their products in ways that suggest more health effects than scientifi cally warranted. As a result the protective effect of the current EU regulatory regime on health claims is less strong than what legislators may have intended. While it might seem most logical to simply expand EFSA's remit by also letting it look at non-textual claims, we argue that a better solution to close this gap is through a stricter monitoring of unfair commercial practices at national level.

The response to the COVID-19 crisis implied an unprecedented involvement of the European Union (EU) executive in public health matters. In June 2020, the Member States agreed upon a joint EU Vaccines Strategy, whereby the European Commission was enabled to negotiate, support and allocate vaccine doses on their behalf. Entailing political and redistributive choices, the Commission’s centralised procurement presents some innovative patterns when compared to traditional EU executive action. This paper will focus on the institutionalisation of such patterns within the legal framework of the Health Emergency Preparedness and Response Authority (HERA). Did EU administrative law offer appropriate tools for this process? Or did the EU merely formalise the procedural and organisational schemes set up during the crisis? Answers to these questions will contribute to a fuller understanding of the administrative dimension of the new European Health Union and shed light on some recent evolutions of the EU administrative system.

The transfer of climate-friendly technologies from developed countries to developing countries has been identified in international forums as a key factor in efforts to mitigate climate change. Commentators and negotiators have argued, however, that efforts to transfer climate-friendly technologies from developed countries to developing countries have fallen far short of what is needed. Although a host of barriers play a role in the pace of transfer of clean technologies, such as lack of financial resources, inadequate infrastructure, trade barriers, and lack of skilled workers to name a few, intellectual property rights (IPRs) have been accused of being a particularly significant barrier. Developing countries have made strong proposals to severely curtail IPRs on clean technologies, particularly patent rights. These proposals present potential threats to patent rights on clean technologies in developing countries and include expanded compulsory licensing, excluding clean technologies from patenting, and revoking existing patent rights on clean technologies in developing countries. The motivation for such proposals stem largely from theoretical considerations, when, in fact, recent studies provide evidence that patent rights are not a barrier to the transfer of clean technologies to the developing world and, to the contrary, are more likely facilitating the diffusion of clean technologies in developing countries.

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.