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 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 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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

On 23 October 2019 the European Union enacted the Whistleblower Protection Directive. The directive introduces important common standards of protection for whistleblowers reporting on breaches of EU law and significantly increases the level of protection afforded to whistleblowers in many EU Member States. Many of the features of the directive go further than pre-existing national whistleblower protection regimes, particularly in relation to the categories of persons who may benefit from the protections under the directive and in terms of the flexibility of the prescribed reporting procedures. Nevertheless, the directive's effectiveness may be limited by certain grey-areas and missed opportunities in the final text of the instrument.

The specific status of active substance candidates for substitution (CfS) is detailed by Article 24 of plant protection Commission Regulation EC No 1107/2009 (PPP Regulation). The criteria of candidates for substitution are now clearly defined: low acceptable daily intake/acute reference dose/acceptable operator exposure level or two persistent, bio-accumulative or toxic criteria, or by nature of the critical effects: non-active isomers, carcinogen 1A/1B, toxic for reproduction 1A/1B or endocrine disruption properties, with these later properties now being well characterised. The total number of active substances CfS has been in constant evolution since 2011, with the first batch of candidates for substitution being published in 2015 and updated since then. After a slow decrease, growth is again observed, with another list of active substances being granted this status. CfS are substances targeted by the PPP Regulation that are supposed to be cancelled or non-renewed at the active substance level or substituted at the market authorisation level. CfS are also supposed to be replaced by substances with better toxicological profiles. However, after five years of implementation of the status, their number, which is intended to decrease, remains high, at sixty residual CfS. We exhibit here their evolution.

This report examines the pending Proposal for a directive on unfair trading practices in business-to-business relationships in the food supply chain, and its proposed amendments. It provides a general overview of the current content of the Proposal and analyses the proposed rules from a legal perspective. We find that: (1) the CAP legal basis may prove insufficient for regulation that covers the entire agri-food chain; and may (2) result in a strained relationship with the competition and consumer acquis; (3) the empirical basis for the prevalence of unfair trading practices, and the effect of their prohibition is relatively dire, which results in uncertainty with regard to the achievement of the future UTPD’s intended effect and effectiveness; (4) the choice for specific targeted prohibitions instead of general umbrella clauses may lead to ad hoc regulation that leaves large loopholes; (5) the institutional enforcement mechanism makes it likely that the Proposal contributes to the foundation for a new area of EU law, which will increasingly regulate practices in business-to-business relationships.

Some EU agencies have been recently entrusted with enforcement powers, which imply a crucial extension of their regulatory reach. However, other comparable agencies did not receive such powers. This paper explores the case of energy regulation as an instance of these “negative” cases, and suggests that the lack of enforcement powers may have been partially determined by business interest groups. To illustrate this argument, this article firstly relies on official documentation to show that key interest groups were consistently opposed to the option of granting enforcement powers to the EU agency in charge (ACER). Secondly, it is suggested that these interest groups, which have been largely incorporated in regulatory networks during the prehistory of the agency, had access to, and exerted influence in, the governance of EU energy policy, and could plausibly have been able to concretise their preferences. A systematic examination of the representation of interest groups in the European network of energy regulators (CEER/ERGEG) during the period 2004–2011 is undertaken to corroborate this point. The conclusion draws attention to the fact that, although interest groups are less visible than other actors and their presence is less formalised, they could be very influential on decision-making processes within European networks and agencies.

COVID-19 emerged as a cross-cutting problem across governance sectors and levels, urging the creation of a European Health Union. There are already a number of integrated European governance strategies – such as the European Energy Union (2015) and the European Green Deal (2019) – adopted for overcoming problems of governance fragmentation and inadequacy of fragmented policy responses to cross-cutting policy challenges. Past studies focused on the interaction between crisis and policy change and investigated the activation of different mechanisms to enhance integration. This article contributes to the debate over the creation of a European Health Union by unpacking the acknowledged dimensions of policy integration – policy frame, subsystem involvement, policy goals and policy instruments – in order to assess their manifestations in the new EU4Health policy and to establish what contextual conditions triggered the activation of the integration-enabling mechanisms that led to a more integrated European Health Union. In so doing, it offers an analytical illustration and discusses implications for decision-making.