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.

How can tort law contribute to a better understanding of the risk-based approach in the European Union’s (EU) Artificial Intelligence Act proposal and evolving liability regime? In a new legal area of intense development, it is pivotal to make the best use possible of existing regulation and legal knowledge. The main objective of this article is thus to investigate the relationship between traditional tort law principles, with a focus on risk assessments, and the developing legislation on artificial intelligence (AI) in the EU. The article offers a critical analysis and evaluation from a tort law perspective of the risk-based approach in the proposed AI Act and the European Parliament resolution on a civil liability regime for AI, with comparisons also to the proposal for a revised and AI-adapted product liability directive and the recently proposed directive on civil liability for AI. The discussion leads to the illumination of both challenges and possibilities in the interplay between AI, tort law and the concept of risk, displaying the large potential of tort law as a tool for handling rising AI issues.

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.

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.

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.

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.

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.

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.

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.

With the availability of cheaper technology and the rise of digitalisation, consumers can actively participate in markets and also offer their own services or self-/co-produce products and services. Active consumers are fundamental building-blocks of the European Union’s goal to achieve smart, sustainable and inclusive growth in Europe. In the energy sector active consumers play a key role in promoting competition, ensuring affordable energy prices and security of supply, as well as contributing to the EU’s environmental and climate goals. By engaging in more efficient energy use, consumers are crucial actors to manage the energy transition. However, the present legal framework does not fully facilitate this active role. The aim of this article is to answer the question how EU law conceptualises and supports the active role of consumers in the regulation of energy markets.

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.

Cars will become more autonomous and intelligent in the near future. Eventually, Autonomous Intelligent Cars (AICs) will contribute to road safety, will enable the mobilisation of disabled citizens and a will lead to a decrease of CO2 emissions. The European Union aims to stimulate responsible innovation in the field of AICs, in a way that (ethical) acceptability, sustainability and societal desirability are taken into account. The current legal frameworks are not observed to optimally facilitate innovation or successful societal deployment of AICs. This article explores challenges for both innovation and acceptance that follow from the current legal regimes on product liability, liability for motor vehicles and information privacy of consumers of AICs, and discusses these challenges in view of a regulatory balance that is to be reached between stimulation of innovation and consumer protection in the European Union.

Hazard is the potential of something to cause harm; risk is the likelihood of harm occurring. Chemicals regulation is largely focused on minimising risks associated with chemicals — and rightly so. However, in the EU the hazard classification of individual chemicals can impact significantly the regulation of products containing those chemicals, regardless of the actual risks that the products may pose to human health or the environment. This can lead to undesirable consequences, such as restrictions on the use of safe products, substitution towards less safe products, and disincentives to innovate. Such hazard-based regulation tends to be at odds with World Trade Organization rules and has raised significant concern with EU trading partners. This journal is an ideal forum for discussing how the EU can move towards a better and more coordinated legal framework for the regulation of chemicals.