On 15 December 2020, the European Commission published its proposal for the Digital Services Act, which is expected to be adopted before summer 2022. It carries out a regulatory overhaul of the twenty-one-year-old horizontal rules on intermediary liability in the e-Commerce Directive and introduces new due diligence obligations for intermediary services. Our analysis illuminates an important point that has so far received little attention: how would the Digital Services Act’s rules interact with existing sector-specific lex specialis rules? In this article, we look specifically at the intersection of the Digital Services Act with the regime for online content-sharing service providers (OCSSPs) set forth in Article 17 of Directive (EU) 2019/790 on Copyright in the Digital Single Market (CDSM Directive). At first glance, these regimes do not appear to overlap, as the rules on copyright are lex specialis to the Digital Services Act. A closer look shows a more complex and nuanced picture. Our analysis concludes that the Digital Services Act will apply to OCSSPs insofar as it contains rules that regulate matters not covered by Article 17 CDSM Directive, as well as specific rules on matters where Article 17 leaves a margin of discretion to Member States. This includes, to varying degrees, rules in the Digital Services Act relating to the liability of intermediary providers and to due diligence obligations for online platforms of different sizes. Importantly, we consider that such rules apply even where Article 17 CDSM Directive contains specific (but less precise) regulation on the matter. From a normative perspective, this might be a desirable outcome, to the extent that the Digital Services Act aims to establish “uniform rules for a safe, predictable and trusted online environment, where fundamental rights enshrined in the Charter are effectively protected”. Based on our analysis, we suggest a number of clarifications that might help us to achieve that goal.

While nudging has garnered plenty of interdisciplinary attention, the ethics of applying it to climate policy has been little discussed. However, not all ethical considerations surrounding nudging are straightforward to apply to climate nudges. In this article, we overview the state of the debate on the ethics of nudging and highlight themes that are either specific to or particularly important for climate nudges. These include: the justification of nudges that are not self-regarding; how to account for climate change denialists; transparency; knowing the right or best behaviours; justice concerns; and whether the efficacy of nudges is sufficient for nudges to be justified as a response to the climate crisis. We conclude that climate nudges raise distinct ethical questions that ought to be considered in developing climate nudges.

While it is a consumer’s prerogative to be offered all kinds of food products they can choose from, it is also a consumer’s own responsibility as to what kind of products they choose. It is still argued that free choice is only an illusion due to the general decline in food quality; in this context, the extent of free choice that the consumer has is considered, as well as the factors affecting it. These include fundamental European Union principles that demand strong science to prove safety, observe the lowest applicable quality standards and by extent offer a wide leniency range to food manufacturers when it comes to food quality. Another main factor stems from a food law that intensely focuses on securing food safety, while somehow disregarding quality. In addition to that, major efforts have been concentrated on strengthening food information for the purpose of enabling consumers to make healthier choices by both simplifying information on the front of packaging and increasing it on the back, while no direct changes targeting the composition of food have been proposed. As a result, what healthy food choices are left on the market and how accessible are they to consumers?

Various methods of genetic modification have been applied to plant breeding as an integral part of agriculture. This article examines a method of targeted mutagenesis – CRISPR-Cas9 – and its dysregulation in the European Union (EU). It provides clarity for food business operators relating to the traceability and labelling of food products induced using this biotechnology. In addition, it outlines policy recommendations to improve the regulation of such food products in the EU.

This paper argues for a sandbox approach to regulating artificial intelligence (AI) to complement a strict liability regime. The authors argue that sandbox regulation is an appropriate complement to a strict liability approach, given the need to maintain a balance between a regulatory approach that aims to protect people and society on the one hand and to foster innovation due to the constant and rapid developments in the AI field on the other. The authors analyse the benefits of sandbox regulation when used as a supplement to a strict liability regime, which by itself creates a chilling effect on AI innovation, especially for small and medium-sized enterprises. The authors propose a regulatory safe space in the AI sector through sandbox regulation, an idea already embraced by European Union regulators and where AI products and services can be tested within safeguards.

This article is a critical legal analysis of the proposed TRIPS waiver under World Trade Organization (WTO) law. It reviews the existing TRIPS flexibilities and the “August 2003 TRIPS waiver”, highlighting the obstacles to achieving the goals of these legal instruments. It demonstrates that numerous critical TRIPS flexibilities, notably TRIPS Article 31bis, are ineffective, prompting some countries to submit a new waiver proposal to the WTO. It highlights several WTO rules that are also quite ambiguous. This paper argues that a WTO clarification might be an alternative to the new TRIPS waiver proposal if it is ultimately rejected due to a lack of consensus among WTO members. Finally, this article emphasises the importance of adopting a balanced approach that may simplify complicated TRIPS rules, decrease the risk of trade-based retaliation and improve collaboration in knowledge transfer and scaling up the manufacture of and access to lifesaving vaccines, pharmaceuticals and healthcare equipment.

Many governments have implemented a controlled off-label use of medicines as a tool combined with reimbursement decisions, among other policies, to avoid pharmaceutical firms gaming regulatory systems based on the requirement for marketing authorisation. This article aims to compare the drug regulations in selected European Union countries (France, Italy and Germany) in order to identify specific provisions and concrete solutions implemented by them regarding that matter. The employment of an economic analysis of the law as a theoretical framework allows for the identification of the incentives created in the long run by the referred regulations. The scholarly literature identifies a myriad of drawbacks and advantages associated with off-label practices, and a welfare analysis is ambiguous. Off-label practices are a reality; thus, it is advisable to elaborate policy measures in order to address these practices and condition them on some requirements, taking into account that off-label practices imply trade-offs among access to healthcare, protection of public health, competitiveness and innovation in the industry.