The long subtitle of this paper, appearing in the first issue of the EJRR – a publication which fills a serious gap in the scholarly literature of the old continent – identifies what I take to be the key terms of the current debate on risk regulation. It is impossible to understand the evolution of risk regulation over the last three decades in Europe and the United States without having a good grasp of how these concepts, and their corresponding practices, interact. How, for example, does a particular institutional design affect the way scientific uncertainties are resolved? What decision rules are appropriate in situations of high scientific uncertainty? Which constitutional principles facilitate policy learning and accountability in the regulation of risk?

In a ruling on 25 July 2018, the Court of Justice of the European Union concluded that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs in the sense of Directive 2001/18, and that organisms obtained by means of techniques/methods of directed mutagenesis are not excluded from the scope of the Directive. Following the ruling, there has been much debate about the possible wider implications of the ruling. In October 2019, the Council of the European Union requested the European Commission to submit, in light of the CJEU ruling, a study regarding the status of novel genomic techniques under Union Law. For the purpose of the study, the Commission initiated stakeholder consultations early in 2020. Those consultations focused on the technical status of novel genomic techniques.

This article aims to contribute to the discussion on the legal status of organisms developed through novel genomic techniques, by offering some historical background to the negotiations on the European Union (EU) GMO Directives as well as a technical context to some of the terms in the Directive, and by analysing the ruling. The article advances that (i) the conclusion that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs under the Directive means that the resulting organisms must comply with the GMO definition, ie the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination; (ii) the conclusion that organisms obtained by means of techniques/methods of directed mutagenesis were not intended to be excluded from the scope of the Directive is not inconsistent with the negotiation history of the Directive; (iii) whether an organism falls under the description of “obtained by means of techniques/methods of directed mutagenesis” depends on whether the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination. Finally, the article offers an analysis of the EU GMO definition, concluding that for an organism to be a GMO in the sense of the Directive, the technique used, as well as the genetic alterations of the resulting organism, must be considered.

Technological advances in the quality, availability and linkage potential of health data for research make the need to develop robust and effective information governance mechanisms more pressing than ever before; they also lead us to question the utility of governance devices used hitherto such as consent and anonymisation. This article assesses and advocates a principles–based approach, contrasting this with traditional rule–based approaches, and proposes a model of principled proportionate governance. It is suggested that the approach not only serves as the basis for good governance in contemporary data linkage but also that it provides a platform to assess legal reforms such as the draft Data Protection Regulation.

This report introduces the challenges 3D bioprinting poses to the existing legal regime across bioethics, safety, regenerative medicine, and tissue engineering. We briefly review the 3D bioprinting technology and look into the relevant regulatory instruments for the pre-printing, printing, and post-printing stages. Special attention is paid to the applications of the EU Advanced Therapy Medicinal Products Regulation and the new Medical Device Regulation.

The importance of the concept of risk and risk management in the data protection field has grown explosively with the adoption of the General Data Protection Regulation (2016/679). The article explores the concept and the role of risk, as well as associated risk regulation mechanisms in EU data protection law. It shows that with the adoption of the General Data Protection Regulation there is evidence of a two-fold shift: first on a practical level, a shift towards risk-based data protection enforcement and compliance, and second a shift towards risk regulation on the broader regulatory level. The article analyses these shifts to enhance the understanding of the changing relationship between risk and EU data protection law. The article also discusses associated potential challenges when trying to manage multiple and heterogeneous risks to the rights and freedoms of individuals resulting from the processing of personal data.

This article offers a critical discussion of the “Report on Liability for Artificial Intelligence and Other Emerging Digital Technologies” released by the Expert Group on Liability and New Technologies. In particular, the authors consider: the excessive diversity of applications encompassed through the notion of “artificial intelligence and other emerging technologies”; the distinction between high- and low-risk applications as a potential source of legal uncertainty; the primary reliance on evidentiary rules over substantive ones; the problematic role attributed to safety rules; the unclear relationship between the Product Liability Directive and other ad hoc liability regimes; the radical exclusion of electronic personhood as a way of addressing liability issues; and the limited contextualisation of compulsory insurance and no-compensation funds.

In 2014, the European Joint Procurement Agreement (JPA) was introduced as an innovative instrument to organise the procurement of vaccines and medications in preparation for pandemics. An overriding purpose of the JPA is to secure equitable and cost-effective access to medical supplies for participating EU Member States during serious health crises. This article aims to understand the current use of the JPA in response to the COVID-19 pandemic. Post-analysis of the recent use of the JPA, the article will discuss how the regional procurement mechanism can be strengthened to support the development of a European Health Union. In particular, the article will firstly question whether the four recent JPA procurement actions facilitated equitable access to medical supplies and services. Secondly, it will ask whether the centralised procurement actions preserved the integrity of the Internal Market. The importance and originality of this study are that it addresses an instrument, the JPA, which has been largely overlooked by legal scholars, and it explores how the provisions for the joint procurement of medical countermeasures as included in Article 5 of Decision 1082/2013/EU on serious cross-border threats to health could be extended to support the functioning of a European Health Union.

In the COVID-19 pandemic, whistleblowers have become the essential watchdogs disrupting suppression and control of information. Many governments have intentionally not disclosed information or failed to do so in a timely manner, misled the public or even promoted false beliefs. Fierce public interest defenders are pushing back against this censorship. Dr Fen and Dr Wenliang were the first whistleblowers in China to report that a new pandemic was possibly underway, and ever since, numerous other whistleblowers around the world have been reporting on the spread of the virus, the lack of medical equipment and other information of public interest. This paper maps the relevant whistleblowing cases in China, the USA and Europe and shows that many whistleblowers are initially censored and face disciplinary measures or even dismissals. At the same time, whistleblowing during the COVID-19 pandemic has drawn public attention to the shortcomings of institutional reporting systems and a wider appreciation of whistleblowers as uniquely placed to expose risk at early stages. Ultimately, whistleblowing as a means of transparency is not only becoming ever less controversial, but during COVID-19 it has become the “remedy” to censorship.

The sharing economy has become a reality in many sectors, including energy. Energy consumers are increasingly able and willing not only to produce their own energy and thus become prosumers, but also to sell this energy on the local or national energy market along with ‘traditional’ energy market players. Thus, the role of prosumers is de facto extended as to include the parallel roles of consumers, producers, suppliers and traders. Against this background, this article inquires whether it is possible for prosumers to share energy under the current Dutch regulatory framework. This question has been evaluated from the theoretical perspective of the regulatory disconnection between innovation and regulation.

On 26 June 2015, the Chilean Official Journal published Decree No. 13 of 16 April 2015 (hereinafter Decree 13/2015) amending Decree 977/1996 Reglamento sanitario de los alimentos (hereinafter, the Food Health Regulation, as it is widely referred to in English, although the correct translation would be Food Sanitary Regulation). In particular, Decree 13/2015 requires warning messages in the shape of a black octagon in the form of a STOP sign to be placed on the front-of-pack with the text ‘High in…’ when food products exceed certain levels of energy, sodium, sugars or saturated fats. Although novel in the food sector, Chile's measure is part of a trend of public policies aimed at tackling lifestyle risks by conveying certain information to the public. While warning messages that reduce the visual appeal of the packaging of products are ubiquitous in the tobacco sector, these types of messages are now also gradually being extended to the alcohol and food sectors.

At a time when policy makers want to change the behaviour of citizens to tackle a broad range of social problems, such as climate change, excessive drinking, obesity and crime, a promising new policy approach has appeared that seems capable of escaping the liberal reservations typically associated with all forms of regulatory action. After having relied on the assumption that governments can only change people's behaviour through rules and regulations, policy makers now seem ready to design policies that better reflect how people really behave, not how they are assumed to behave as rational agents. The approach, which stems from the increasingly ubiquitous findings of behavioural research, is generally captured under the evocative concept of ‘nudge’. Inspired by ‘libertarian paternalism’, it suggests that the goal of public policies should be to steer citizens towards making positive decisions as individuals and for society while preserving individual choice. Acting as ‘choice architects’ policy makers organize the context, process and environment in which individuals make decisions. In so doing, they exploit some patterns of irrationality, often called ‘cognitive biases’, to manipulate people's choices. Thus, in the famous Cafeteria example, the school's management might try to affect students’ diet by rearranging the display of food to make it more likely that students will choose the healthy option. This innovative approach to policy making is part of a broader shift from traditional regulation to regulatory governance that is generally referred to as New Governance.

In the last twenty years, the European Court of Auditors has placed increasing importance on the production of “special reports” examining the economy, efficiency and effectiveness of EU spending (the three “E”s). This institutional focus on performance audit, alongside traditional financial and compliance audit, has occurred at a time when the European Union is increasingly evaluating its own policies and programmes, under political pressure to demonstrate their added value. With performance audit, the EU's external auditors make value judgements on what was achieved through the EU budget, arguably bringing a greater political dimension to the Court as it works to deliver conclusions and recommendations meant to assist the legislature (European Parliament) in carrying out its scrutiny role and the executive (European Commission) in shaping better future policy. This raises questions about how financial accountability is interpreted, and whether it depends on the quality of audit reports or on the forums to which they are delivered, and subsequently, how they act upon them. This article analyses the factors that explain the increased use of special reports by the Court, questioning if they resemble evaluation studies. It examines their focus and impact, as well as the institutional challenges implicit in performance audit.

The risk-based approach has been introduced to the General Data Protection Regulation (GDPR) to make the rules and principles of data protection law “work better”. Organisations are required to calibrate the legal norms in the GDPR with an eye to the risks posed to the rights and freedoms of individuals. This article is devoted to an analysis of the way in which this new approach relates to “tick-box” compliance. How can the law enhance itself? If handled properly by controllers and supervisory authorities, the risk-based approach can bring about a valuable shift in data protection towards substantive protection of fundamental rights and freedoms. While the risk-based approach has a lot of potential, it also has a risk of its own: it relies on controllers to improve compliance, formulating what it means to attain compliance 2.0.

A number of virological, epidemiological and ethnographic arguments suggest that COVID-19 has a zoonotic origin. The pangolin, a species threatened with extinction due to poaching for both culinary purposes and traditional Chinese pharmacopoeia, is now suspected of being the “missing link” in the transmission to humans of a virus that probably originated in a species of bat. Our predation of wild fauna and the reduction in their habitats have thus ended up creating new interfaces that favour the transmission of pathogens (mainly viruses) to humans. Domesticated animals and wild fauna thus constitute a reservoir for almost 80% of emerging human diseases (SARS-CoV, MERS-CoV, Ebola). These diseases are all zoonotic in origin. As if out of a Chinese fairy tale, the bat and the pangolin have taught us a lesson: within an increasingly interdependent world, environmental crises will become ever more intertwined with health crises. Questions relating to public health will no longer be confined to the secrecy of the physician’s consulting room or the sanitised environment of the hospital. They are now being played out in the arena of international trade, ports and airports and distribution networks. Simply put, all human activity creates new interfaces that facilitate the transmission of pathogens from an animal reservoir to humans. This pluri-disciplinary article highlights that environmental changes, such as the reduction in habitats for wild fauna and the intemperate trade in fauna, are the biggest causes of the emergence of new diseases. Against this background, it reviews the different measures taken to control, eradicate and prevent the emergence of animal diseases in a globalised world.

The article accounts for the development of the European Commission's evaluation system. The article shows how internal and external developments shape an evaluation system aiming for both accountability and policy learning. In 58 interviews, several justifications for the evaluation system emerge, including four types of accountability as well as an evaluation system constructed to facilitate learning from past experience. In the system's commencement, financial and legal accountability overshadow the focus on policy learning that was perceived to be in contradiction with the two former. However, the article also demonstrates that accountability and policy learning are not necessarily opposed to each other.

The extensive disruption to and digital transformation of travel administration across borders largely due to COVID-19 mean that digital vaccine passports are being developed to resume international travel and kick-start the global economy. Currently, a wide range of actors are using a variety of different approaches and technologies to develop such a system. This paper considers the techno-ethical issues raised by the digital nature of vaccine passports and the application of leading-edge technologies such as blockchain in developing and deploying them. We briefly analyse four of the most advanced systems – IBM’s Digital Health Passport “Common Pass,” the International Air Transport Association’s Travel Pass, the Linux Foundation Public Health’s COVID-19 Credentials Initiative and the Vaccination Credential Initiative (Microsoft and Oracle) – and then consider the approach being taken for the EU Digital COVID Certificate. Each of these raises a range of issues, particularly relating to the General Data Protection Regulation (GDPR) and the need for standards and due diligence in the application of innovative technologies (eg blockchain) that will directly challenge policymakers when attempting to regulate within the network of networks.