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.

The importance of effectiveness in lawmaking is acknowledged by scholars and practitioners alike. Yet the concept remains one of the most vague terms in legal vocabulary. The article maintains that effectiveness has concrete content that reflects the systemic coherence and alignment between four fundamental elements of legislation: objectives, content, context and results. From this perspective effective legislation is the result of complex mechanics in the conceptualisation, design and drafting of the law and cannot materialise unless it is a clear concern in the early phases of lawmaking. The article takes a closer look at the fundamental elements of effectiveness and articulates the specific challenges that lawmakers are facing when attempting to design and draft effective rules. The “effectiveness test”, a conceptual tools that adds “effectiveness lenses” to the existing lawmaking toolkit, is developed in more depth to a set of critical questions that lawmakers need to address in order to make conscious decisions on effective drafts.

The recent reauthorisation of glyphosate in the European Union is a uniquely suitable opportunity to study the relationships between law and science because, unlike many other controversies that are commonly perceived through the science/democracy dichotomy, in this case the disagreement was between the “scientific” assessments of two purely “expert” bodies, the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA). This paper takes a close look at some details of the two assessments to show how scientific assessments are shaped by the legal environment to such an extent that it is impossible to separate “legal” from “technical” issues at any level; they are entangled together “all the way down”. Furthermore, it identifies three side effects of this entanglement that were previously unnoticed. First, obscure legal rules may provide (usually unintended) leverage to some of the parties. In turn, this forces everybody into proxy wars on the issue where the leverage is, at the expense of all other concerns that they may legitimately have. Finally, despite the strict legal regimentation of the scientific assessment, significant space for judgment remains, and discretion is never removed, only shifted to different places or levels.

Under what conditions can artificial intelligence contribute to political processes without undermining their legitimacy? Thanks to the ever-growing availability of data and the increasing power of decision-making algorithms, the future of political institutions is unlikely to be anything similar to what we have known throughout the last century, possibly with parliaments deprived of their traditional authority and public decision-making processes largely unaccountable. This paper discusses and challenges these concerns by suggesting a theoretical framework under which algorithmic decision-making is compatible with democracy and, most relevantly, can offer a viable solution to counter the rise of populist rhetoric in the governance arena. Such a framework is based on three pillars: (1) understanding the civic issues that are subjected to automated decision-making; (2) controlling the issues that are assigned to AI; and (3) evaluating and challenging the outputs of algorithmic decision-making.

Case C-528/13, Léger v. Ministre des Affaires sociales, de la Santé et des Droits des femmes; Établissement français du sang [2015] ECLI: EU:C:2015:288 (Fourth Chamber).

In the case of Léger commented on, the Court of Justice of the European Union dealt with a blanket ban on blood donation for men who had sexual relations with other men (MSM) in France. The Court found that such restrictions can be justified in light of specific epidemiological context and scientific knowledge available in Member States. The judgment, therefore, sheds lights on the boundaries of public health justifications, discrimination of gay and bisexual individuals, as well as the rising scope of EU sexual risk regulation. The present annotation argues that the Court has undermined the principle of non-discrimination and shows how the matter of blood donations should have been treated instead as a prerequisite of active sexual citizenship.

“When EU Heads of States and Governments unanimously gave the European Commission a mandate to negotiate the EU–US Transatlantic Trade and Investment Partnership on 17 June 2013, they understood that these talks would become the leitmotiv of a new era in EU trade policy. However, few people would have guessed that it would primarily be because of transparency.”

The public demands for more transparent EU negotiations have significantly increased, especially with regard to the EU–US negotiations of the Transatlantic Trade and Investment Partnership. For many pundits transparency in negotiations comes as a surprise, as the candid statement by the Commissioner's Malmström cabinet member illustrates, since traditionally EU negotiations almost exclusively take place behind closed doors and with almost no public disclosure of documents. Scholars have also noted how ‘remarkable’ the TTIP negotiations are for the fact that the negotiating directives were publically released, which was not a common practice before, leading someMembers of European Parliament to initiate adjudication for public disclosure of documents.

We shall first introduce the use of artificial intelligence (AI) in producing new intellectual creations, distinguishing approaches based on knowledge representation and on machine learning. Then we shall provide an overview of some significant applications of AI to the production of intellectual creations, distinguishing the extent to which they depend on pre-existing works, and the different ways in which such pre-existing works are used in the creative process. In addition, we shall discuss some methods to automatically assess the similarity of works and styles, in the context of AI technologies for text generation. Finally, we shall discuss the legal aspects of AI-reuse of copyrighted works, focusing on the rights of the authors of such works relative to the process and the outputs of AI.

At the time that REACH was being drawn up, the issue of nanomaterials was only in its infancy, so no specific provisions were adopted in the REACH Regulation to address them. While everyone recognises the important industrial and competitiveness potential of nanomaterials, the uncertainties over their potential impact on human health and the environment are also highlighted, triggering calls for a review and possible adaptations to the regulatory system in place. With respect to REACH, the Commission has started to consider possible legislative changes; however, these are likely to take several years to materialise. In the meantime, some Member States are considering initiatives to impose national rules, including reporting schemes and labelling requirements. The legality of these measures is questionable, however, considering that REACH today applies to nanomaterials, as also to any other chemical substance and that the REACH Regulation is regarded as totally harmonising the market access conditions for chemical substances in the EU.

Our article summarises the current regulatory status of nanomaterials under REACH and specifies the legal framework under which the legality of national initiatives contemplated by the Member States to regulate nanomaterials must be reviewed. It is the view of the authors that Member States cannot rely on the argument that REACH does not contain specific provisions on nanomaterials, nor require registration of substances manufactured or imported below 1 tonne, to consider that the matter is not totally harmonised under EU law and thus justify the adoption of national measures to regulate nanomaterials. However, Member States can use the REACH processes, including the evaluation, authorisation and restriction processes to propose conditions for or restrictions of the marketing and use of nanomaterials at the EU level, in the conditions specified in the Regulation. They can also trigger the application of the safeguard clauses of REACH and of the Treaty on the Functioning of the European Union. It is only within that strict framework that reference to the precautionary principle can be made to justify the introduction of national measures.

Tort cases apply particular standards of behaviour to defendants and society, often using common-sense sounding benchmarks such as “reasonableness”. This article explores the ways in which courts establish facts, for the purpose of making a decision on appropriate standards of behaviour, by using sources of authority from the world beyond tort. Facts, rather than being separate from and prior to the application of the legal norms, are often inseparably bound with legal judgment in any particular decision. Two areas of tort law are assessed: some of the English asbestos cases, and the Dutch Urgenda climate change case. The facts required for the setting of, and compliance with, the standard of negligence in these cases are found in a range of external sources, including standards, rules and understandings from scientific bodies, regulators, legal and non-legal documents.

Taking the Urgenda case on climate change liability as an example, this article researches the more general question into the legitimacy of risk regulation by civil courts. Which principles determine the legitimacy of a civil court’s participation, especially in the domain of societal risk regulation? The central claim is that these principles concern (amongst many other things) the position of the court, the tools of the court, and the attitude of the court. In other words, they have their source in constitutional law, civil (procedural) law, and professional ethics respectively. This claim is substantiated by an analysis of these principles, their interpretation, and the way they contribute to a normative/theoretical framework for the assessment of the legitimacy of judicial rulings.

Towards the end of 2011, the (then) Responsible Gambling Fund published a report which, inter alia, offers an overview of the research gaps in relation to the impact of advertising on disordered gambling. In this article, the authors of the report summarise their main findings. They conclude that evaluating the impact of gambling advertising is highly complex. Nonetheless, advertising forms an important component of the broader environment in which behaviour and attitudes are shaped. The empirical evidence base is weak and therefore conclusions about whether gambling advertising is associated with increased levels of disordered gambling cannot be drawn. However, there is some evidence that advertising alters perceptions and attitudes towards gambling. Yet, evidence demonstrating translation of this into behavioural change is weak. Particular attention should be given to vulnerable population groups such as adolescents and disordered gamblers. In view of further research, a set of recommendations is provided.

This article discusses the legal remedies available for Competent Authorities, patients and healthcare professionals to prevent harmful incidents involving medical devices. It outlines a theoretical framework for ex-ante and ex-post regulation of medical devices. It then focuses on certain aspects of ex-post regulation. Participation by Competent Authorities with a supervisory role, healthcare professionals and patients in ex-post regulatory legal processes is analysed in the light of the current European Union legal framework and the revised framework proposed by the European Commission. It also discusses whether the proposed new legal framework enables the Competent Authorities, patients and healthcare professionals to prevent the harm caused by unsafe medical devices. Ex-ante regulation might prevent the entrance on the market of unsafe devices whereas ex-post regulation might dismiss the unsafe devices. The contribution concludes by suggesting a number of improvements to the supervisory system of medical devices in Europe.

This study focuses on the role of the discount rate in cost–benefit analysis (CBA) of regulation, providing a systematic investigation into regulatory practice vis–à–vis the existing economic theories. In the first part, a quick survey of the main economic literature on the social discount rate (SDR) is presented. In the second part, the current institutional practice is investigated, firstly comparing the recommendations on discounting issued by institutional actors in the US (Office of Management Budget, Environmental Protection Agency) and the EU (Commission), and secondly examining the SDRs adopted in two samples of CBAs selected among Regulatory Impact Analyses of US EPA and Impact Assessments of EU Directorate–General for the Environment. A gap exists between economic theory and institutional practice in the selection of the SDR. Regulatory decisions which are based on CBA reflect the most workable economic literature on discounting rather than the most theoretically consistent one, thus yielding less reliable and less robust results. Scholars who aim at improving the quality of rule–making and at fostering the application of CBA in regulatory decisions should improve the “operational validity” of their research, thus providing practitioners with methods that are both consistent and workable.

The ageless question regarding the interpretation of the average consumer benchmark at EU level recently gained momentum. The Court of Justice of the European Union has de facto deviated in a judgment from a strict application of the formula of the “reasonably well informed and reasonably observant and circumspect” consumer established in Gut Springenheide. This report investigates the possible implications of this judgment on the implementation of behavioural sciences in the “average consumer” benchmark.

The novelty in Adam Burgess’ paper is that he assesses nudge policies in the context of the shift in the UK government's approach to risk from the nannying policies of Labour to the nudge policies of the Conservatives. There is a wealth of ideas in this paper. I find it useful to disentangle some of these ideas focusing on the following two questions:

1. 1. In what respects do Labour's nannying policies and the Conservatives’ nudge policies differ?

2. 2. What is problematic about Labour's nannying and the Conservatives’ nudge policies?

Subsequently I will reflect on how a particular strand of research in the social sciences can be made relevant to designing a more responsible way of dealing with societal risk and show how this approach can evade some of Burgess’ concerns.

Artificial intelligence (AI) is not only increasingly being used in business and administration contexts, but a race for its regulation is also underway, with the European Union (EU) spearheading the efforts. Contrary to existing literature, this article suggests that the most far-reaching and effective EU rules for AI applications in the digital economy will not be contained in the proposed AI Act, but in the Digital Markets Act (DMA). We analyse the impact of the DMA and related EU acts on AI models and underlying data across four key areas: disclosure requirements; the regulation of AI training data; access rules; and the regime for fair rankings. We demonstrate that fairness, under the DMA, goes beyond traditionally protected categories of non-discrimination law on which scholarship at the intersection of AI and law has focused on. Rather, we draw on competition law and the FRAND criteria known from intellectual property law to interpret and refine the DMA provisions on fair rankings. Moreover, we show how, based on Court of Justice of the European Union jurisprudence, a coherent interpretation of the concept of non-discrimination in both traditional non-discrimination and competition law may be found. The final section sketches out proposals for a comprehensive framework of transparency, access and fairness under the DMA and beyond.

At a time of increasing recognition worldwide of the role of Chief Science Advisers as of critical importance in improving dialogue between science and policy, the European Union, notably the European Commission, is currently considering – under the pressure of civil society organisations – whether to maintain or scrap this recently–created position. After contextualizing this debate within the broader efforts undertaken by the Barroso Commission to strengthen science in EU policymaking, this article discusses what role, if any, a Chief Scientist may play within the EU systemof scientific advice. After denouncing the lack of a public debate about the merits of this post at the time of its creation, the article takes as a point of departure the criticisms made against this position and assesses them in the light of the mandate entrusted to the Chief Scientist Advisor. It argues that the major point of disagreement on this post revolves around the question of whether the Chief Scientist Advisor, as it currently stands, helps or hinders the EU incorporating the ‘best science’ into policy. After identifying the flaws of the actual mandate and the challenges faced by the first holder of the position, it argues that the burden of proof rests with the EU Commission to prove the merits, and more specifically, the rationale for having yet another source of scientific advice in the EU.