In the currently volatile global economic environment, China’s perspectives on the rule of law in international economic law are of significance. In principle, China shares developing countries’ attitudes towards international economic law. China also seeks to play a constructive role in the development of international economic law, endorsing a flexible and pragmatic approach. China has concluded international trade and investment treaties designed to constrain its policy space and is an active supporter of the World Trade Organization’s dispute settlement and investor-state dispute settlement mechanisms, with a good record of compliance. Recent trade tensions demonstrate challenges for the international rule of law but also emphasise the role of law in overcoming political challenges.

Water stress is a growing concern in Europe, partly due to the changing climate context. Despite the cross-cutting impacts that water availability has on different areas under the competence of the European Union (EU), there is not currently a comprehensive and systematic legal framework addressing this issue. The purpose of this article is therefore to examine the EU legislation that concerns the measures aimed at mitigating these risks. To this purpose, it is first examined how droughts and water scarcity are framed within EU legal acts. Based on such an overview, the analysis is directed to the mechanisms developed at the EU level for monitoring, identifying and forecasting water stress risks, as well as the legal provisions relating to the planning tools. The remainder of the article is devoted to the regulation of preventative measures for water scarcity and drought risk reduction, following the water hierarchy resulting from COM(2007) 414.

One of the less popular and less investigated topics of law is the use of biocontrol agents (BCAs). Despite the general growing attention to the use of BCAs in primary production, a comprehensive regulatory framework is still lacking. When shifting to possible uses of BCAs in the following phases of the food chain, legislation is even more incomplete (and inadequate) despite the challenging opportunities they offer both for pest control and for pathogen control. The paper will provide an overview of the uses of BCAs taking into consideration all the food chain stages, the relevant partial EU regulatory scheme and its critical issues.

Drawing on the findings from the contributions to this Special Issue, this article maintains that, fifteen years after Lisbon, a debate on the law and politics of delegated rulemaking in the European Union (EU) is as relevant as ever. That is because the functional and procedural integration of the Member States in the EU multilevel and multi-jurisdictional legal system, supplanted by unprecedented challenges for supranational crisis management in the recent years, often led to unpredictable and often controversial configurations of delegated rulemaking. One may thus conclude that, fifteen years later, the constitutional framework put in place in the Lisbon Treaty has not been able to effectively constrain the normative development that evolved from delegated rulemaking, which often followed a different path. Hence the Lisbon Treaty provides only a partial blueprint for delegated rulemaking, leaving out rulemaking by EU agencies, regulatory frameworks and private parties, as well as increasingly composite and hybrid cooperation formulas involving EU and national executive actors. The future of EU delegated rulemaking will very much depend on the capacity to reach consensus on important meta-principles and political conceptions, such as democratisation and parliamentarisation, shaping the normative spaces generated within the sui generis dynamic European model of governance.

The Framework for Sustainable Food Systems law will either not be published at all or after a long delay. Whereas the first part of the article constructs an empirical and theoretical underpinning about why the EU Member States should therefore act on food sustainability, the second part focuses on what legal measures Member States can take.

In the first part, leaning on food systems thinking, we argue that in the absence of EU action in the matter, the Member States remain the most potent lever for taking regulatory action on addressing sustainability in the food system.

In the second part, the article provides an exploratory study of potential national legal instruments for making domestic food systems more sustainable, with an emphasis on the regulation of offer and consumption of foods and food environments. The article discusses the following legal instruments in the context of EU law and Member States’ room for action, with examples from a comparative perspective: public procurement purchasing by governments, product composition requirements, fiscal measures, non-fiscal pricing instruments, labelling & certification, marketing, and the regulation of private and public food environments. The article further concludes that it may prove useful to better enshrine the food sustainability paradigm in law at national level.

Trade and sustainable development (TSD) chapters in international trade agreements include labour provisions with a view to prevent a “race to the bottom” and reaffirm the existing international labour commitments. When properly formulated and implemented, these provisions could have positive normative impacts on the international and domestic rule of law. This article provides a critical analysis of the evolution of labour standards in international trade agreements, particularly focusing on the European Union’s (EU) approach, in comparison with the approach in the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). More specifically, it considers ways in which trade agreements contribute to the improvement of labour standards in domestic legal systems. While EU trade agreements embrace minimum standards under international labour law rather than higher standards that apply in the EU legal order, the article argues that there is at least a normative shift towards a more efficient implementation of labour rights through EU agreements, which could make a limited contribution to the rule of law.

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.

Cybersecurity of medical devices has become a concrete concern for regulators and policymakers in the European Union and United States. Following the COVID-19 pandemic, there has been an increase in cyber-attacks on critical healthcare infrastructures and their IT systems, which have suffered service disruptions and put patients’ health and safety at risk. The increase in cyberattacks on healthcare infrastructure, including medical devices, exacerbated by the growing digitalisation of healthcare services in the EU and the US, has led legislators and regulatory bodies to pay more attention to cybersecurity. Cybersecurity of AI-based medical devices requires the assessment of three areas subject to evolving regulatory approaches: medical devices, Artificial Intelligence (AI), and cybersecurity. Although they may appear distinguished in regulatory matters, the existence of AI-based medical devices and their possible cyber vulnerabilities makes clear that the three are intertwined and deserve closer attention from a regulatory point of view. Few scholars have devoted attention to AI and cybersecurity together. Even less, in our understanding, few comprehensive and EU/US comparative pieces of literature reflect on this specific issue. This paper aims to fill this gap and address the main implications of different regulatory approaches toward AI medical device cybersecurity in the EU and the US. The research stems from the assumption that regulation of medical devices in the EU has been historically inspired by regulatory trends in the US, although with the different cultural, societal, and legal traditions that made them adapt to the specificities of the territory. The paper observes that the US is a rule-based system reflecting a “command-and-control” approach, while the EU system is a principle-based one. While they share the main characteristic of being risk-regulation-based systems, their differences impact how AI-enhanced cybersecurity is regulated.

International environmental law rarely refers to the rule of law. However, in fostering inter-state cooperation, international environmental agreements oblige parties to prohibit, restrict or control various activities that are harmful to the environment. The application of these constraints at the national level requires the rule of law to be taken into account.

Climate policy requires a steep and rapid reduction of greenhouse gas emissions, which are mainly caused by fossil fuels. Advertising that promotes fossil fuels and other carbon-intensive products undermines this objective. It normalises unsustainable consumption patterns and enables producers of harmful commodities to manipulate public discourse in order to delay or derail the energy transition – for example, by spreading misinformation, deflecting responsibility and promoting false solutions. For these reasons, there are increasing calls for a fossil fuel advertising ban along the lines of the tobacco advertising ban at both the European and the Member State level. This article evaluates the legality of such bans under European law, focusing on legislative competence, fundamental rights and internal market law. It finds that a fossil fuel advertising ban can be assumed to conform to the requirements of European law, especially if it is modelled after the tobacco advertising ban.

No matter how good a smart device may be, it remains useless outside the context of a digital ecosystem. Internet of Things (IoT) environments are possible as long as services and products can interconnect smoothly and exchange data in real time. Therefore, interoperability ranks high in global policy agendas, with the promise of bringing an end to network effects slanted in favour of ecosystem orchestrators. However, recent regulatory initiatives introducing interoperability obligations risk falling short of their intent or even risk generating unintended consequences in the absence of a coherent approach to standardisation. Against this backdrop, focusing on the UK Open Banking experience, this article makes a proposal for workable interoperability in IoT ecosystems aimed at ensuring market contestability without undermining incentives to innovate.

The Internet of Medical Things (IoMT) devices, as well as the Internet of Things phenomenon itself, are gaining a new group of customers every day, for whom it is almost a matter of course to use a wide range of devices, such as Internet-connected complex life support equipment or “smart” watches monitoring basic life parameters. With the growing popularity of such devices, however, questions about the safety of their users begin to arise, because almost in proportion to the number of benefits associated with the use of these products, the number of risks associated with them increases – eg improper functioning of Internet-connected life support equipment, in addition to threatening the life or health of its user, may affect the physical security of the product itself, the security of both personal and technical (eg non-personal) data processed by the specific product, or finally the cyber-security of the product. While the issues related to the protection of personal data and privacy, in general, have been discussed many times by the doctrine, the issues related to the protection of users of these devices under consumer law have not been considered much.

In this context, the question arises whether the current legal regulations provide an adequate and sufficient level of protection for IoMT users. In particular, whether the average IoMT user can actually exercise their rights under the provisions of consumer law and whether the protection afforded to him – both in terms of the scope of their rights and the scope of obligations and liability of manufacturers and suppliers of these devices – is not only illusory? In order to answer the above questions, the author will evaluate the prevailing market practices – still focused around the doctrine of “caveat emptor” or “let the buyer beware” – and compare them with these regulations and juxtapose them with relevant legal regulations. However, given the lack of geographical borders in the field of cyber security and privacy, the author will not only analyse EU cyber security legislation, but also US legislation in a comparative legal analysis. The choice of jurisdictions to be compared is also related to the size and importance of both the US and the EU for the global IoMT market. It should be noted that the United States has a dominant position in the IoMT, while the European Union is estimated to have the second largest IoMT market globally. At the same time, however, there are differences in legal systems between the two economic areas. An analysis carried out in this way will make it possible not only to answer the question posed above, but also to possibly identify those areas of regulation that need to be changed or adapted to the realities of IoMT.

Since the EU Directive (EC) No 128/2009 (SUD) was approved by the European Parliament, the establishment of a general framework aimed at securing the sustainable use of pesticides was laid down, and European Union (EU) Member States adopted National Action Plans in accordance with this Directive. Specifically, for EU Member States, pesticides, objectives and quantitative targets were created. Therefore, the EU Commission provided a methodology for risk assessment as the derivation of two harmonised risk indicators: HRI_1 and HRI_2. The present study focuses on HRI_1, as this can be implemented at the country level. Each EU Member State delivers annual harmonised risk indicators values to the Commission based on calculations using their own data and results. However, only the EU Commission can derive this HRI_1 (concatenated) indicator at the EU level. Therefore, the present study is an attempt to shed some light on the modus operandi used by the EU Commission to compile this HRI_1, and it also aims to clarify these calculations. Data originating from twenty-seven EU Member States were analysed. These data were compared to data published on the EU Commission website over time. Possible virtual developments including the modification and evolution of active substance statuses are envisaged.

Legal scholarship in the realm of international economic law has a blind spot: the practice of international trade. Cargo and container shipping is the blood and guts of international trade, and it is fuelled by bunker oil – a hydrocarbon mixture of the dirtiest petroleum-based products. Worryingly, there is empirical evidence of bunkers being intentionally contaminated with waste oils. This fraudulent contamination violates numerous international, national, and EU rules on waste management and poses immense risks to the health of planet and people alike. These same acts of fraud are also extremely profitable, and they facilitate the smooth functioning of our global economy. The fraud is itself not just incentivised in the tight-margins reality of international trade, but it is facilitated by the lack of proper legislation and the vulnerability of the existing means of enforcement in the areas where there is legislation to comply with. Economic operators often use falsified documents to market fuel oil that should be considered as waste. Systematic wrongdoing of this kind is detrimental to the environment and risks eroding the rule of law in both its formal and substantive conceptualisations.

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.

This article focuses on copyright issues pertaining to generative artificial intelligence (AI) systems, with particular emphasis on the ChatGPT case study as a primary exemplar. In order to generate high-quality outcomes, generative AI systems require substantial quantities of training data, which may frequently comprise copyright-protected information. This prompts inquiries into the legal principles of fair use, the creation of derivative works and the lawfulness of data gathering and utilisation. The utilisation of input data for the purpose of training and enhancing AI models presents significant concerns regarding potential violations of copyright. This paper offers suggestions for safeguarding the interests of copyright holders and competitors, while simultaneously addressing legal challenges and expediting the advancement of AI technologies. This study analyses the ChatGPT platform as a case example to explore the necessary modifications that copyright regulations must undergo to adequately tackle the intricacies of authorship and ownership in the realm of AI-generated creative content.

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.

The development of medical artificial intelligence is dependent on the availability of vast quantities of data, a considerable proportion of which is medical data containing sensitive information pertaining to the health and well-being of patients. The use of such data is subject to extensive legal regulation and is further hindered by financial and organisational constraints, which can result in limitations on accessibility. One potential solution to this problem is the use of synthetic data. This article examines the potential for their use in light of cybersecurity requirements derived from horizontal and sectoral EU legislation. The outcome of this analysis is that EU legislation does not contain specific regulations on the use of synthetic data. Consequently, it cannot be concluded that there is any prohibition on their use. Moreover, while the Medical Device Regulation (MDR) contains some general requirements for cybersecurity, these are further specified by the provisions of the AI Act. It is important to note, however, that the AI Act will not apply to Class I medical devices, which are subject only to the MDR. Furthermore, only indirect obligations within the scope under consideration can be derived from the horizontal regulations, which will apply in a limited number of cases.

On 8 June 2023, the European Commission published a long-awaited proposal for the establishment of an interinstitutional ethics body, meant to restore the public’s faith in the European Union’s administration following the Qatargate corruption scandal. Alas, the Commission’s proposal outlines a body that lacks investigative and sanctioning powers, has minimal administrative capacity and for the most part relies on the institution’s own policing. Put simply, it falls short of the promises made by the Commission’s President in her 2019 political guidelines, and much shorter of what was expected as a remedy to the European Union’s recent ethics-related scandals. In this short piece, we reflect on the Commission’s proposal for an inter-institutional ethics body in light of the overall ethics framework in the Union and provide a brief analysis of the Commission’s missed opportunity and of what could have been.