Case T-397/13, Tilly Sabco v Commission, Judgment of the General Court (Fifth Chamber) of 14 January 2016, ECLI:EU:T:2016:8

Article 263 TFEU allows applicants to challenge regulatory acts which are of direct concern to them and do not entail implementing measures. In this judgment the General Court held effectively that the implementing measure cannot be hypothetical but must follow-on naturally from the underlying regulatory act. This note discusses the significance of this seemingly new element in the meaning of ‘entail implementing measures’ and its potential consequences.

This case note relates to the recent judgement (23 October 2012) by the Court of Justice of the European Union in the case No C-300/10 concerning interrelation of the European Union motor insurance law and the national civil liability regulation. As the civil liability arising from motor traffic accidents is not approximated by the European Union law, its regulation falls within the national law. Yet, application of the national civil liability law shall not undermine the obligation to provide insurance coverage for victims of road traffic accidents. The discussed case concerns a situation when a victim who was not fastened by a seat belt at the moment of a motor traffic accident was injured, and this raises a question whether such victim may be compensated due to contributory negligence. This note provides a brief summary of the previous case law, facts, review of Advocate's General Opinion and the judgment and their analysis.

Following the accident at the Fukushima nuclear plant on 11 March 2011, the European Union was informed that radioactive levels in certain food products originating in Japan, such as milk and spinach, exceeded the normal permitted levels under Japanese legislation. The European Commission judged that such levels of radioactivity could pose a threat to public health in the European Union and therefore began introducing specific additional import conditions for Japanese food products as a precautionary measure.

In this article a synthesis of formal models for the economic interpretation of the precautionary principle is presented, with their virtualities, limitations and measures to overcome them.

The concept of precaution has great relevance in environmental regulation in the European Union. On the one hand, and despite the somewhat vague nature of legislation, the interpretation of the precautionary principle has seen recent progress with the development of some economic models and their application. There is, however, a need for a regulatory framework for the implementation of this principle in environmental decision-making, i.e., to clarify concepts and management procedures that are appropriate to the nature of environmental risks.

It is therefore important to know the most relevant economic approaches and models with the aim of identifying their contribution to the debate on precaution in the context of environmental risk management and discuss their practical relevance in public decision-making.

This section is devoted to giving readers an inside view of the crossing point between intellectual property (IP) law and risk regulation. In addition to updating readers on the latest developments in IP law and policies in technological fields (including chemicals, pharmaceuticals, biotechnology, agriculture and foodstuffs), the section aims at verifying whether such laws and policies really stimulate scientific and technical progress and are capable of minimising the risks posed by on-going industrial developments to individuals’ health and safety, inter alia.

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.

The manufacturer of a substance that is used safely and, in more than 99.9% of cases, used as an intermediate (and thereforeis exempted from the authorisation procedure) is deemed to have no legal grounds for claiming the suspension of the inclusion of that substance in the Candidate List for lack of urgency. Its mere inclusion should not automatically result in any significant damages to the manufacturer, neither should the Candidate List serve as a regulatory blacklist (official headnote).

The EU's new approach to policy evaluation is characterised by a focus on closing the policy cycle (linking ex ante and ex post appraisal) and by applying evaluation to all types of policy intervention, whether expenditure or regulatory policy. This article analyses the main features and challenges of this new approach. It first studies the conceptual and interdisciplinary challenge of such an encompassing approach to evaluation. It then assesses the new approach in the light of four key objectives of ex ante and ex post appraisal; ensuring evidence and learning; accountability, transparency and participation; policy coherence; and reducing the regulatory burden.

Private scientific organizations exert a great deal of influence in the regulation of some technological risks. The high level of expertise of their members is arguably a good reason for them to participate in making and monitoring risk regulations, in order to adjust these to scientific progress. Nevertheless, there are also sound reasons why governments shouldn’t uncritically follow the views expressed by such organizations. Taking the role played by the International Commission on Non–Ionizing Radiation Protection in the regulation of electromagnetic fields as an illustrative example, this paper shows that private scientific organizations such as these are structurally less well suited than democratic authorities when it comes to managing those risks.

This Report examines the competition law issues that arise, in the EU pharmaceutical sector, from pay-for-delay agreements concluded between an originator company and a generic manufacturer. The Commission's approach to these agreements is reviewed evaluating the findings of the on-going monitoring activity of patent settlements, the outcome of recent investigations, and the legislative proposals specifically aimed at dealing with the phenomenon. Finally, a comparison of the EU and US approaches provides a clear indication of the challenges that still lie ahead.

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.

Case T-521/14, Kingdom of Sweden v European Commission, Judgment of the General Court (Third Chamber) of 16 December 2015, ECLI:EU:T:2015:976

Case T-521/14 is a new stop on the perilous journey towards the appropriate regulation of endocrine disrupting chemicals. The Biocidal Product Regulation required the Commission to adopt criteria defining endocrine disrupting properties by 13 December 2013; the deadline was not respected. Even though the failure to act was obvious, the Court's reasoning in T-521/14 matters greatly. It exposes a structural weakness in the EU's risk governance system by reminding the Commission that strong private opposition to regulatory action does not justify tampering with the level of environmental or health protection set by the legislator. The now adopted criteria indicate that this lesson was not taken to heart.