The potential of artificial intelligence (AI) has grown exponentially in recent years, which not only generates value but also creates risks. AI systems are characterised by their complexity, opacity and autonomy in operation. Now and in the foreseeable future, AI systems will be operating in a manner that is not fully autonomous. This signifies that providing appropriate incentives to the human parties involved is still of great importance in reducing AI-related harm. Therefore, liability rules should be adapted in such a way to provide the relevant parties with incentives to efficiently reduce the social costs of potential accidents. Relying on a law and economics approach, we address the theoretical question of what kind of liability rules should be applied to different parties along the value chain related to AI. In addition, we critically analyse the ongoing policy debates in the European Union, discussing the risk that European policymakers will fail to determine efficient liability rules with regard to different stakeholders.

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.

What type of enforcement is the most effective to punish violations of food law or to prevent them from occurring in the first place? This article examines the question of which mix of private and public enforcement exists in European Union (EU) food law and whether this mix corresponds to the recommendations of existing social science research. Based on this research, we contend that EU-determined enforcement mechanisms differ in effectiveness across Member States. New technologies have the potential to stimulate a novel mix of public and private enforcement tools at the EU and national levels.

The issue of super-intelligent artificial intelligence (AI) has begun to attract ever more attention in economics, law, sociology and philosophy studies. A new industrial revolution is being unleashed, and it is vital that lawmakers address the systemic challenges it is bringing while regulating its economic and social consequences. This paper sets out recommendations to ensure informed regulatory intervention covering potential uncontemplated AI-related risks. If AI evolves in ways unintended by its designers, the judgment-proof problem of existing legal persons engaged with AI might undermine the deterrence and insurance goals of classic tort law, which consequently might fail to ensure optimal risk internalisation and precaution. This paper also argues that, due to identified shortcomings, the debate on the different approaches to controlling hazardous activities boils down to a question of efficient ex ante safety regulation. In addition, it is suggested that it is better to place AI in the existing legal categories and not to create a new electronic legal personality.

Increasing interest from stakeholders has brought about a new emphasis on risk regulation in the oil and gas industry. Our basis for this work is the offshore oil and gas industry, which is composed of major operators, entrepreneurs and contractors working globally, but we focus on Norwegian and US activities. The fundamental strategies, institutions, legal traditions and explanations of regulation are reviewed and, together with empirical data, a novel model with the means of identifying “effective” regulation has been developed. The model presented here incorporates three dimensions: the industry’s intentions; their resources and expertise and trust in the regulator (and vice versa: the regulator’s trust in the industry); and the space where functional respective normative rules are deemed most effective.

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.

Under the notion of human rights due diligence (HRDD), firms are under a responsibility to account for the social and environmental impact connected to their operations across global value chains. This responsibility intersects with the sphere of operation of voluntary sustainability standards (VSS), which certify production against certain social and environmental criteria. With mandatory European rules on HRDD in the making, the question arises regarding the extent of alignment of VSS with HRDD notions and, consequently, the possibility for this form of transnational private regulation to complement European Union (EU) HRDD legislation. After presenting the regulatory effects of HRDD in global value chains and its current transposition in EU instruments, this contribution examines the relationship between private standards and HRDD. By delving into the substantive requirements and policies of several schemes certifying agricultural commodities, this paper studies the extent to which they manage social and environmental risks in global value chains and the possible support they provide to firms subject to the upcoming HRDD obligations.

Governments around the world are strictly regulating information on social media in the interests of addressing fake news. There is, however, a risk that the uncontrolled spread of information could increase the adverse effects of the COVID-19 health emergency through the influence of false and misleading news. Yet governments may well use health emergency regulation as a pretext for implementing draconian restrictions on the right to freedom of expression, as well as increasing social media censorship (ie chilling effects). This article seeks to challenge the stringent legislative and administrative measures governments have recently put in place in order to analyse their negative implications for the right to freedom of expression and to suggest different regulatory approaches in the context of public law. These controversial government policies are discussed in order to clarify why freedom of expression cannot be allowed to be jeopardised in the process of trying to manage fake news. Firstly, an analysis of the legal definition of fake news in academia is presented in order to establish the essential characteristics of the phenomenon (Section II). Secondly, the legislative and administrative measures implemented by governments at both international (Section III) and European Union (EU) levels (Section IV) are assessed, showing how they may undermine a core human right by curtailing freedom of expression. Then, starting from the premise of social media as a “watchdog” of democracy and moving on to the contention that fake news is a phenomenon of “mature” democracy, the article argues that public law already protects freedom of expression and ensures its effectiveness at the international and EU levels through some fundamental rules (Section V). There follows a discussion of the key regulatory approaches, and, as alternatives to government intervention, self-regulation and especially empowering users are proposed as strategies to effectively manage fake news by mitigating the risks of undue interference by regulators in the right to freedom of expression (Section VI). The article concludes by offering some remarks on the proposed solution and in particular by recommending the implementation of reliability ratings on social media platforms (Section VII).

Consumers are increasingly interested in the sustainability of food products, but so far, no specific European Union (EU) legislation has been developed to harmonise sustainability claims. We analyse which efforts already undertaken within the EU dealing with sustainability claims on products apply to sustainable food claims. We show that whilst sustainability can address three different dimensions (environmental, social and economic), it is crucial to clearly define sustainability in order to allow for the development of concrete regulations and guidance documents. EU legislative initiatives so far seem to be focused on environmental aspects, whilst Member States approach sustainability more broadly. At the same time, substantiation methods can only be successful when sustainability is well defined. We conclude that whilst there is a large range of initiatives taken at different levels, the foundation of these initiatives remains weak when there is no clear scope of terminology nor clarification of substantiation requirements. Currently existing self-regulatory initiatives could support protecting consumers from misleading claims by providing specific provisions for (food) business operators on how to make sustainability claims. Only when claims can be trusted and understood by consumers will they be able to make more sustainable purchase decisions. This plays an important role in the overall policy objective of the EU of climate neutrality by 2050.

This article contributes to the discussion about managing the risks and uncertainties of emerging technologies through increased stakeholder participation. Authorities have increasingly invited stakeholders from high-technology sectors to participate in assessing the risks of, and designing responses to, new technologies. Yet authorities often struggle to attract stakeholders from such sectors to participate; a critical challenge identified but still undertheorised in the literature. Responding to this gap, this article presents a case study of the UK’s regulatory sandbox for financial technologies, applying a document study, questionnaire and interviews to explore fintech firm motivations and apprehensions about participation. Drawing on the bureaucratic reputation literature, the study finds that fintech firms have a range of practical, reputational and normative motivations to participate, and these motivations are inextricably tied to the regulator’s strong reputation with the sector as procedurally correct, high-performing and morally committed to facilitating innovation. On this basis, recommendations for practitioners and hypotheses for future research into the drivers of stakeholder participation in regulatory decision-making surrounding emerging technologies are proposed.

Signed in 2009, the plant protection Commission Regulation EC No 1107/2009 created a new category of active substances, the low-risk substances, with specific status defined in Article 22. The initial and specific criteria, not suitable for microorganisms and natural substances, were modified in 2018, and the first low-risk substance, allocating Part D of Regulation EC No 540/2011, was granted in the same year. Since then, thirty-three low-risk substances have been granted with this specific status through approvals and renewals, while a larger list of potential low-risk substances from already-approved active substances was published. This list is only exploited during renewals, and this process would take another five years to complete. After four years of the implementation of this status, the number of such substances is still low, but is intended to increase slowly. Two more low-risk substances are already pending in 2021, which will bring the number of low-risk substances to thirty-five, while the initial list of potential low-risk substances (only renewals) included fifty-seven substances.

Plant-based meat-like food is increasingly popular, and the meat industry has been opposing the use of terms traditionally used for meat and meat products for plant-based alternatives. Against this background, on 29 June 2022 the Government of France adopted Decree No. 2022-947 on the use of certain names used to designate foodstuffs containing vegetable proteins 1 (hereinafter, Decree No. 2022-947), which prohibits the use of names designating foodstuffs of animal origin to be used to describe, market or promote foodstuffs containing vegetable proteins. This article discusses the new French legislation and looks at the situation at the European Union (EU) level where, differently from dairy terms such as “milk” and “yoghurt”, “meaty” terms such as “burger” and “sausage” are not reserved for meat and meat products. France has become the first EU Member State to impose such a ban, while the EU rejected in 2020 a similar proposal that would have resulted in EU-wide restrictions.

Analysts agree that public opposition is one of the main factors that hinder ambition in many countries’ carbon pricing policy agenda. This article argues that motivated reasoning contributes to this opposition by inducing the public to underestimate the effectiveness of carbon pricing to mitigate climate change and yield co-benefits. This article also argues that measures of implicit carbon pricing can help overcome public opposition to carbon taxes and emissions trading schemes due to motivated reasoning. These measures are becoming increasingly available thanks to recent work by the International Monetary Fund, the Organisation for Economic Co-operation and Development and private-sector actors, and therefore they offer a potential instrument for reducing public opposition to carbon taxes and emissions trading schemes in various countries. A strength of the approach proposed in this article – compared to some of the mainstream approaches to risk regulation – is that it tries is to keep the regulation of climate risks in line with public attitudes towards these risks.

The latest Russian regulatory reform (2016) sought to introduce the risk-orientated approach – a move away from the “blanket inspections” (or the risk regulation reflex – a term coined by Blanc in 2011) method that has been criticised by the Russian business community. The present paper aims to assess its success using administrative data on federal watchdogs’ inspections. We argue that this reform ultimately failed in its goal regarding the overall number of inspections, and thus the volume of regulatory burden did not change significantly throughout the reform. This failure resulted from two mechanisms. First, the legal framing of the reform radically redefined risk as the probability of incompliance (as opposed to the likelihood of accident). Second, the watchdogs used key performance indicators that incentivised “street-level” inspectors to maintain the pre-reform regulatory burden levels.