Technological innovations are crucial drivers of economic, social, and environmental progress. While innovations lead the evolution of our societies and permeate all domains of human life, they also pose significant risks both to humans and the environment. Law and regulation are expected to enable innovation, while at the same time protecting society from unintended consequences. However, assessing new technological risks confronts deep uncertainty and limited knowledge. In contrast to simple risks (e.g. car accidents), technological risks (such as risks stemming from new health technologies, nanotechnology, biotechnology, or robotics as discussed in this special issue) cannot be calculated according to traditional technocratic models, namely as a statistically foreseeable function of probability and effects. It is widely recognised that regulating new and emerging technologies is challenging for law due to problems of uncertainty and limited knowledge in the assessment and management of technological risks. To address this challenge it is crucial to study the ways in which law and regulation can successfully respond and adapt to technological progress.

This article takes issue with the legitimacy of EU soft law instruments issued to deal with the COVID-19 crisis. Up to August 2020, we identified a total of 197 such instruments, and analysed the procedures for their adoption. We found little evidence of parliamentary involvement or stakeholder consultation, with COVID-19 soft law replicating decision-making patterns which have been constantly criticised in the literature as illegitimate and opaque. Giving due consideration to the exceptional nature of these measures, the article suggests some quick fixes which might increase, ex post factum, the legitimacy of these instruments.

Artificial intelligence (AI) is not only increasingly being used in business and administration contexts, but a race for its regulation is also underway, with the European Union (EU) spearheading the efforts. Contrary to existing literature, this article suggests that the most far-reaching and effective EU rules for AI applications in the digital economy will not be contained in the proposed AI Act, but in the Digital Markets Act (DMA). We analyse the impact of the DMA and related EU acts on AI models and underlying data across four key areas: disclosure requirements; the regulation of AI training data; access rules; and the regime for fair rankings. We demonstrate that fairness, under the DMA, goes beyond traditionally protected categories of non-discrimination law on which scholarship at the intersection of AI and law has focused on. Rather, we draw on competition law and the FRAND criteria known from intellectual property law to interpret and refine the DMA provisions on fair rankings. Moreover, we show how, based on Court of Justice of the European Union jurisprudence, a coherent interpretation of the concept of non-discrimination in both traditional non-discrimination and competition law may be found. The final section sketches out proposals for a comprehensive framework of transparency, access and fairness under the DMA and beyond.

Our study on smart contracts, self-executing agreements based on blockchain technology, can be placed in the field of inquiry within law and economics of contracts which explores new modes of contract enforcement as sources of market creation. We lay the foundations by characterising contract enforcement and trust mechanisms underlying contracts. Considering that trust reduces risks in economic exchange, we explain how the particular trust mechanism underlying smart contracts’ enforcement (no-party trust) provides opportunities for creating new markets and changing existing ones. We explore, among other things, whether using smart contracts could be a path to increasing the autonomy of consumers and offering a solution for democratising trade.

This article engages with two themes of contemporary EU governance: the role of evaluations within an effective and coherent policy–making process and the EU's constitutionalised commitment to promoting gender equality in all its activities (Article 8 TFEU). It focuses on the interface between ex ante and ex post evaluation and the contribution of evaluations to policy learning, with particular attention to the promotion of gender equality. A case study approach is followed, with EU research policy as the object of analysis.

This article sheds light on cybersecurity risk disclosure practices, offering explanations based on the corporate governance literature. We argue that cybersecurity risk management poses particular challenges for corporations due to amplified agency problems. Cybersecurity risks are increasing in number and growing in complexity for companies worldwide. The financial sector in the Benelux region was already digitalising rapidly when, in 2020, enhanced remote-working requirements due to the COVID-19 pandemic further contributed to risk exposure. Substantiating our theoretical discussion, we present and discuss insights as to the most pressing cybersecurity risk management issues in the financial sector based on evidence from semi-structured interviews with Chief Information Security Officers/Chief Security Officers from financial sector leads in the Benelux region. We discuss contemporary factors that might induce management to dedicate more attention to cybersecurity. This apparent shift in companies’ approaches regarding cybersecurity is likely to encounter obstacles and should not be expected to be an even and linear process, given the challenges of processing and communicating information in an environment featuring high uncertainty and technical complexity as well as potentially misaligned incentives.

The European Union is increasingly moving toward an integrated policy approach, which also acknowledges linkages between public health and (external) security policy. This introduction to the Special Issue sets out a research agenda on the emerging health-security nexus. It analyses recent policy developments with respect to the public health and security, and discusses interactions along the health-security nexus in the context of the European Union. It suggests drivers behind the integrated approach and it critically examines the health-security nexus from the perspective of effectiveness and legitimacy.

This article assesses the impact of the global economic crisis on the European Union and analyzes the recently enacted and future legislative response to repair the EU financial sector. It closely discusses and critiques the main initial response legislation, the European Economic Recovery Plan, finding that the central regulation contained short-term measures, yet managed to remain within the EU's long-term goals. The article also closely examines the significant risk regulation considerations highlighted by the economic crisis, notably those considerations contained in the De Larosiere Report and the Basel III Framework, and discusses the importance of implementing financial risk regulations to stabilize and revitalize the EU financial sector. Ultimately, the article concludes that the EU's recently enacted legislative measures are consistent with, but also must continue in tandem with, the longterm policies of the EU, while including new and crucial financial risk regulatory measures.

Financial regulation is an issue where differences between the EU and US are highly sensitive. Indeed, EU and US apply in a different manner the financial standards adopted at international level by the Basel Committee and have different systems of financial supervision.

Due to these significant differences between the two systems, it is very difficult for the EU and US to reach an agreement on common financial standards within the TTIP negotiations. Actually, as the differences in regulation between the two systems are an obstacle to the access of the financial operators of each Party to the market of the other Party, the absence of common standards in this sector could nullify the efficacy of norms of market access that will be probably contained within the TTIP.

Moreover, in a risk regulation perspective, considering the weight that the US and EU financial relationship have on the global system and taking account of the effect of destabilization that could be generated by the divergent requirements imposed to the credit institutions on the two sides of the Atlantic, the lack of common financial standards between the EU and US could have a great impact on global financial stability.

The field of robotics is remarkably wide, with many social settings now entailing and increasingly requiring the use of robots to support a variety of human activities. Unsurprisingly, robots’ form and shape, their level of intelligence and intended purpose can vary significantly depending on the relevant industry.1 Domestic robots are already a reality in a growing number of family homes. They include both humanoid robots which support those in need (such as the elderly, people with disabilities or children) and robots for household consumer markets, including domestic vacuum cleaners and grass-trimmers. Humanoid robots only account for a small fraction of the industry, with robotic arms for industrial automation being instead widespread.2

On 8 October 2010, the European Commission issued a communication paper on Smart Regulation in the European Union. The paper reports on progress made, future priorities and strategy in the field of regulatory reform, for the information of interested outsiders. It is the latest in a series of such communications, issued on a regular basis since the first major, systematic action plan in 2002.

However, this most recent communication comes at a time when the context has changed noticeably. First, the financial crisis sparked by the credit crunch has altered attitudes to regulation. More attention is now being paid to the effectiveness of regulation and its overall quality than before. The Communication acknowledges this and underlines that regulation is essential to ensure that markets deliver sustainable prosperity for all. Second, a number of the Commission’s tools have been in place for some time, allowing it to draw useful lessons from its own experiences as well as from those of other countries. Its impact assessment system recently underwent a major examination by the European Court of Auditors.

This article aims to analyse the role of law in the identification of the responsibility domain of ‘regulatory science’ (Jasanoff, 1990) within the risk regulatory process. The main research question is therefore,what kindof relationshipbetween science andpolicy-making lawshould design in risk regulation.

In order to address this issue, this contribution focuses on the recent verdict of the Tribunal of L’Aquila. After the earthquake occurred in L’Aquila on the 6th April 2009, six Italian scientists that had participated in the Major Risks Commission's meeting have been condemned for the multiple manslaughter of 29 people who were among the 309 victims of the earthquake, ‘for having assessed the risks related to seismic activity in the L’Aquila territory in an inaccurate, generic and ineffective way’ and for having provided ‘information which was imprecise, incomplete and contradictory as to the nature, the causes and the hazardousness and on the future development of the seismic activity’.

As far as risk assessment and risk communication are concerned, firstly the tasks of the Major Risks Commission under the Italian Civil Protection law will be analysed. Against this backdrop, the issues related to this expert body's responsibility will be addressed and the gaps in the current accountability regime will be pointed out.

The article provides an inclusive outlook on artificial intelligence by introducing a three-legged design perspective that includes, but also moves beyond, ethical artificial systems design to stress the role of moral habituation of professionals and the general public. It is held that an inclusive ethical design perspective is essential for a flourishing future with artificial intelligence.

The global volume of travel has grown steadily for decades and hence the border closures and travel restrictions in response to COVID-19 have created an unforeseen impact on the number of international border crossings. In air traffic alone the data show a striking 75.6% decrease in the number of scheduled international passengers. We might hasten to think that the strict travel restrictions due to the COVID-19 crisis have in principle treated mobile populations equally – for once we have all been banned from travelling. We could even consider the recent initiatives to introduce “vaccination certificates” as a fair and democratic way to reintroduce safe international travelling. In reality, the idea of a COVID-19 certificate is but a new layer in the broader landscape of highly uneven global mobility where travellers’ citizenship and place of origin truly matter. This article discusses some of the major inequalities embedded in the global mobility regime and argues that the idea of the COVID-19 certificate as an equaliser remains completely disconnected from these underlying realities. To conclude, the article discusses problems related to uneven access to digital travel documents, such as the proposed COVID-19 certificate.

In this contribution we focus on the role of experts in the assessment of tort damages from an economic point of view. We distinguish two different aspects.

First, we examine the role which economists might play in assessing damages in tort cases. This approach focuses on the insights that Law and Economics provides regarding the correct assessment of damages. We pay specific attention to two problematic forms of losses where economic insights may play an important role: pure economic loss and personal injury damage (both loss of income and compensation for immaterial losses due to fatal and non-fatal accidents).

Second, we investigate from a Law and Economics point of view the role of experts in general (not only economists) in the assessment of damages. We discuss i.a. the question why experts may be involved in the assessment of damages, the potential problems (and the possible solutions) when using experts, and differences between party appointed experts and court appointed experts.

It turns out that the economic analysis can provide a different, insightful viewpoint in some respects, such as the fact that market based mechanisms may help to provide incentives to party appointed experts to provide an accurate and objective damage assessment.

Modern technologies enable traders to design more personal and comprehensive product labelling, as well as to improve product traceability through the supply chain. Personalised and comprehensive product information could raise consumers’ product awareness, shaping new consumers’ product and safety expectations. The improved product traceability through the supply chain could extend the producers’ control over the product, beyond the moment the product left the manufacturing process. This paper examines the impact of modern technologies on European rules of product liability. Specifically, it considers whether the recognition of a defective product in the currently reviewed Product Liability Directive should continue to follow the test of the public’s safety expectations, as well as whether producers could continue to rely on the defence of a product not being defective when they put it into circulation.

This article reports on and discusses the findings of the first systematic study on Regulatory Impact Assessment (RIA) reforms in developing and transition economies. The macro part of the study reveals that between 2001 and 2016 60 such reforms were launched in total, with 20 of them leading to functional RIA systems two years or more after they were initiated. Appropriate and complete reform design, analysed by measuring compliance with six internationally recognised “good practices”, is found to be a necessary but not sufficient condition for early success. To develop a better understanding of challenging factors for RIA reforms’ success the micro part of the investigation analyses four case studies (Botswana, Cambodia, Kenya and Uganda). Findings point to the importance of donor flexibility and patience and the need for building reform constituencies inside and outside government. The traditional orthodoxy of regulatory impact assessment reforms as an extension of red tape reduction is challenged. The article finally presents several possible policy implications of the findings.

The regulatory literature has long been concerned with the challenges of technological innovation, yet it says relatively little about what we understand as “innovative” and how innovation “types” impact on regulation. This article unpacks the concept of “innovation” and analyses its significance for the development of regulatory strategy. It shows that innovation types – such as “incremental” and “radical” innovation – are not clear-cut, but involve differences of interpretation. This interpretive flexibility makes them powerful discursive resources in regulatory decision-making. Through a study of the EU’s regulation of nanotechnology, the article shows how arguments of “incremental” and “radical” innovation can be mobilised to very different effect. These different ways of conceptualising new technology affect decisions on: (i) the desirability of legislative reform; (ii) the evidence-base for regulation; and (iii) the use of the precautionary principle. The study also shows how the framing of technology as “incrementally” innovative can contribute to a strategy of “deliberate regulatory ignorance”. The article concludes by arguing that the incremental/radical distinction can be put to more positive use, so that regulatory choices take account of the different techno-scientific and socio-economic dimensions of innovation.

The centralised authorisation of GMOs in the European Union (EU) has received considerable academic attention in recent years, partly due to the fact thatMember States have not been able to agree on authorisation decisions in the comitology committee. As a consequence, these authorisations are given by the European Commission. These decisions are invariably in favour of authorisation despite the fact that Member States had been divided on this issue. Apart from the on-going discussions on a possible reform of the GMO authorisation (allowing for national restrictions or prohibitions), the new comitology rules brought about by the Lisbon Treaty are of equal importance as they might affect the authorisation of GMOs. In this article we discuss some of the changes to comitology and present empirical material on the first authorisation decisions after the entering into force of the new comitology rules. By drawing on delegation theory we will argue that, for the time being, the level of politicisation ofGMOauthorisation is unlikely to change.