The purpose of this contribution is to briefly present the content of the EU–US Data Privacy Framework recently adopted by the European Commission and then to assess whether it meets the expectations expressed by the Court of Justice of the European Union in its Schrems II judgment and related case law.

High pharmaceutical pricing practices in Europe have been increasingly on the radar of the European Union, academia and civil society as a risk to Member State health budgets. It is therefore hardly surprising that, in recent years, competition authorities have resuscitated the excessive pricing prohibition contained in Article 102(a) TFEU. Focusing on this phenomenon, this piece highlights the diverse ways in which the United Brands test has been applied in pharmaceuticals by conducting a comparative study of the decisional practice of national competition authorities. Several observations and arguments are then derived therefrom, demonstrating that, while difficult (most notably in respect to patent-protected products), competition authorities and courts have established sophisticated ways of determining whether a pharmaceutical price is excessive in the sense of Article 102(a) TFEU. These findings should encourage hesitant competition authorities and private plaintiffs to at least carry out preliminary investigations when they suspect excessive pricing in pharmaceuticals is taking place.

This report discusses the main provisions of the recently adopted WHO Protocol to Eliminate Illicit Trade in Tobacco Products. While recognizing the remarkable achievement of the global community in its efforts to curb illicit trade in tobacco products at the international level, the report also highlights those aspects of the Protocol that may undermine its effectiveness in the long–term perspective. In this context the enforcement capabilities of developing countries are cited as a main concern.

This article analyses the role played by standards of protection in the regulation of catastrophic risks. It examines how to protect people against the occurrence of catastrophic events, considering that the related risk is highly uncertain and difficult to predict using rational methodologies. In this perspective, the article focuses on environmental risks and terrorist threats affecting common goods – namely environment and security – areas where any damage is susceptible to producing ruinous effects and huge casualties. Both natural and man-made disasters are capable of altering the normal legal relations that States are institutionally to ensure to their citizens. Therefore, the severity of the consequences of catastrophic events cannot be ignored, despite the low probability of their occurrence. However, in the absence of emergencies, exceptional measures may be adopted as a means of altering the legal framework, and thus the enjoyment, of fundamental freedoms and priorities in the allocation of public resources. No precautionary approach can escape from rational reflections about the opportunity-cost of any action, the cost-benefit analysis of countermeasures and the proportionality of every regulatory decision. In order to understand how to face those “low probability – high cost” risks, the article considers a specific method of regulating risks by resorting to standards of protection. By using thresholds of alarm, public administrations can decide upon best-fit countermeasures that will correspond to specific risk characterisations. To this end, the article analyses the administrative process of formulating standards and how they enable uncertain risks to be managed, thus promoting the development of a sound and accountable administration.

Critical Infrastructure (CI) provision is characterized by privatization of CI providers, transnational risks and a changing role of the state. We describe two paradigmatic systems of state liability with a view to CI liability, namely Germany as a fault system and Switzerland as a strict liability system. Both are unsatisfactory and not well adapted to the modern realities and exigencies of allocation of risks and liability in CI and show flaws from a functional, incentive-based perspective. Therefore, we make suggestions how those systems may be ameliorated, suggesting organizational, design and supervisory liability reforms.

In the context of the UK Supreme Court decision in Sienkiewicz v Greif (2011) this article discusses the question whether so-called “naked statistical evidence” can satisfy the civil standard of proof in English law, the “balance of probabilities”. It argues that what is required to satisfy the standard is a judicial belief that causation is more likely than not, rather than a categorical belief that causation occurred. Whether such a belief is justified depends on the weight of the evidence as well as the degree of probability it purports to establish, but there is no reason of principle why epidemiological evidence alone should not satisfy this standard.

Article 1(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27 must, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, be interpreted as meaning that a product which includes in its composition a substance which has a physiological effect when used in a particular dosage is not a medicinal product by function where, having regard to its content in active substances and under normal conditions of use, it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological functions in human beings (…) (official headnote).

The World Trade Organization’s (WTO) Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) disciplines WTO Members’ health regulations to prevent their misuse for protectionist purposes. In doing so, its obligations reflect several elements of the rule of law, including legal certainty, non-arbitrariness and non-discrimination, as well as a recognition of the rights of individuals. Through its obligations of non-discrimination, transparency and scientific justification and the scope it leaves for Members to prioritise the protection of health over trade liberalisation, the SPS Agreement can be regarded as entailing a rule-of-law approach. However, cognisant of the limits to the rule of law when transposed to the international level, it is important to avoid an overly “judicialised” approach to the disciplines of the SPS Agreement, and in particular its reliance on scientific justification to prevent arbitrariness in sanitary and phytosanitary regulation. Otherwise, there is a risk of intruding too far into the regulatory autonomy of States, weakening the “compliance pull” of the agreement and thus inadvertently undermining the rule of law in this area. An approach that instead recognises the inherent subjectivity and uncertainty in science and respects Members’ divergent priorities in health regulation would go further in engendering support for the rules-based system of international trade.

Today, there are a dozen labelling schemes pertaining to farm animal welfare in at least seven Member States. Despite the proliferation of animal welfare labels, European Union rules on food information to consumers concerning the treatment of farmed animals used in animal-source food production remain fragmented and incomplete. On the one hand, the rules contained in agricultural regulations primarily aim to harmonise marketing standards, but only for some products. On the other hand, consumer protection rules aim to protect consumers from misleading commercial claims but not misleading claims about animal treatment specifically. After examining the situation that has led to the proliferation of animal welfare food labels in the European Union, this article analyses the animal welfare food labelling landscape and presents different regulatory pathways to best harmonise consumer information on farm animal welfare.

Private safety auditors are key constituents of modern risk governance in global value chains (GVCs). However, high-impact safety incidents causing extensive harm inside and outside the chain have cast widespread doubts as to the integrity and rigour with which these commercial auditors carry out their professional services. Civil liability has been considered an important legal instrument to incentivise auditors to improve audit accuracy and integrity. Relying on English law, this article assesses the extent to which this premise holds true for product safety and social auditing. To that end, it studies the liability exposure of private safety auditors for negligent auditing in GVCs. It is argued that this exposure is primarily a function of the contractual obligations these auditors undertake to perform for producers or suppliers in GVCs. This finding draws attention to the need to better understand and define the scope of the safety audits offered for risk management purposes within GVCs.

In combating the coronavirus pandemic in Germany, soft law has played an important, albeit not a central, role. Its use basically corresponds with that of “normal circumstances”. In accordance with the German constitutional order, almost all substantial decisions are made in a legally binding form. However, these are often prepared through or supplemented by soft law. This article shows that soft law has played an important role in fighting the pandemic and its effects in Germany, although there cannot be any doubt that legally binding forms of regulation have prevailed. At the same time, the current pandemic has shed light on the advantages and effects of soft law in the context of the German legal order.

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.

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.

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).