The EJRR starts the year by publishing a set of timely research articles engaging with some of the most cutting-edge developments in the area of risk regulation: the normative debate surrounding the acceptability of behaviourally-informed regulation, the role of expertise in the regulation of electromagnetic fields, the governance of e-Health initiatives, and the controversial use of discount rate in Cost-Benefit regulatory analysis.

A Framework for the Responsible Use of the Nudge Approach to Behaviour Change in Public Policy

In Nudge (2008) Richard Thaler and Cass Sunstein suggested that public policy-makers arrange decision-making contexts in ways to promote behaviour change in the interest of individual citizens as well as that of society. However, in the public sphere and Academia alike widespread discussions have appeared concerning the public acceptability of nudgebased behavioural policy. Thaler and Sunstein’s own position is that the anti-nudge position is a literal non-starter, because citizens are always influenced by the decision making context anyway, and nudging is liberty preserving and acceptable if guided by Libertarian Paternalism and Rawls’ publicity principle. A persistent and central tenet in the criticism disputing the acceptability of the approach is that nudging works by manipulating citizens’ choices. In this paper, we argue that both lines of argumentation are seriously flawed. We show how the anti-nudge position is not a literal non-starter due to the responsibilities that accrue on policy-makers by the intentional intervention in citizens’ life, how nudging is not essentially liberty preserving and why the approach is not necessarily acceptable even if satisfying Rawls’ publicity principle. We then use the psychological dual process theory underlying the approach as well as an epistemic transparency criterion identified by Thaler and Sunstein themselves to show that nudging is not necessarily about “manipulation”, nor necessarily about influencing “choice”. The result is a framework identifying four types of nudges that may be used to provide a central component for more nuanced normative considerations as well as a basis for policy recommendations.

Private scientific organizations exert a great deal of influence in the regulation of some technological risks. The high level of expertise of their members is arguably a good reason for them to participate in making and monitoring risk regulations, in order to adjust these to scientific progress. Nevertheless, there are also sound reasons why governments shouldn’t uncritically follow the views expressed by such organizations. Taking the role played by the International Commission on Non-Ionizing Radiation Protection in the regulation of electromagnetic fields as an illustrative example, this paper shows that private scientific organizations such as these are structurally less well suited than democratic authorities when it comes to managing those risks.

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 study focuses on the role of the discount rate in cost-benefit analysis (CBA) of regulation, providing a systematic investigation into regulatory practice vis-à-vis the existing economic theories. In the first part, a quick survey of the main economic literature on the social discount rate (SDR) is presented. In the second part, the current institutional practice is investigated, firstly comparing the recommendations on discounting issued by institutional actors in the US (Office of Management Budget, Environmental Protection Agency) and the EU (Commission), and secondly examining the SDRs adopted in two samples of CBAs selected among Regulatory Impact Analyses of US EPA and Impact Assessments of EU Directorate-General for the Environment. A gap exists between economic theory and institutional practice in the selection of the SDR. Regulatory decisions which are based on CBA reflect the most workable economic literature on discounting rather than the most theoretically consistent one, thus yielding less reliable and less robust results. Scholars who aim at improving the quality of rule-making and at fostering the application of CBA in regulatory decisions should improve the “operational validity” of their research, thus providing practitioners with methods that are both consistent and workable.

Advances in the field of synthetic biology are creating many new practical applications. These new applications raise novel regulatory challenges. Biotechnological innovation was first addressed by the United States (US) National Institutes of Health (NIH) at the advent of recombinant DNA research.1 Today, synthetic biology requires consideration of the ethics and risks involved in the governance of an applied technology that spans national borders and has applications in a wide variety of sectors. Because approaches to governance vary by nation and sector, and can range from precautionary to prudent, it is necessary to consider the context from which different approaches arise if there is to be any successful move towards universal governance.

In May 2011, the illegal use of the plasticizer di(2-ethylhexyl) phthalate in clouding agents for use in foods and beverages was reported in Taiwan. This food scandal has caused shock and panic among the majority of Taiwanese people and has attracted international attention raising once again concern regarding the contamination of food by chemical toxic compounds.1 However, although these accidents cause a lot of concern, it is worth remembering that governments throughout the world are intensifying their efforts to improve food safety. In Europe in particular, food policy is based on high safety standards, aimed to protect and promote consumers’ health. EU legislation specifies that food containing a level of contaminants that is unacceptable from a public health viewpoint, cannot be put on the market. Currently, one of the great challenges in food safety is the control of risks associated with mixtures of contaminants, which are constantly changing. Food may be contaminated by chemical substances through production practices, packaging, transport, or storage. The contamination might also result from environmental pollution through contaminated air, water, soil, and accumulation in the food chain. Among the most prominent groups of emerging food contaminants, those from industrial sources (perfluorinated compounds (PFCs), polybrominated biphenyls (PBBs) and, partially, nanomaterials) cause particular concern. Many of these can be associated with severe damage to human health, for example some are suspected to be cancer promoters. Other compounds have been associated with endocrine disruptor effects, or can be accumulated and biomagnified through the food chain.

On 22 November 2012, the European Medicines Agency (EMA) announced its intention to publish clinical trial data underlying EU marketing authorization applications, by 1 January 2014. The EMA made this announcement in the context of a workshop at its offices in London, which gathered stakeholders involved in clinical trials.

The Austrian Institute for European Law and Policy gathered leading experts in Vienna on 5 October 2012 for a conference entitled “Assessment of the European Citizens’ Initiatives in practice: registration, certification, online collection, transparency”. The major theme of the discussion was the appraisal of the first six months since the establishment of the European Citizens Initiative1 (ECI), considering the first batch of proposals that were tabled – some have already been rejected, while others are at the stage of collecting signatures.

On 17th October 2012, the European Commission (hereinafter, the Commission) adopted its proposal for a directive amending the Fuel Quality Directive1 and the Renewable Energy Directive2 (i.e., Proposal for a Directive of the European Parliament and of the Council amending Directive 98/70/EC relating to the quality of petrol and diesel fuels and amending Directive 2009/28/EC on the promotion of the use of energy from renewable sources3). The Fuel Quality Directive lays down technical specifications on the quality of fuel used in transportation, and requires EU Member States to reduce by 6 % the greenhouse gas intensity of transportation fuels by 2020. The Renewable Energy Directive establishes a common framework for the promotion of energy from renewable sources in the EU by, inter alia, setting mandatory national overall targets and measures for the use of energy from renewable sources in order to reduce emissions and to achieve the EU’s climate change and energy policy objectives.

This report discusses the main provisions of the recently adopted WHO Protocol to Eliminate Illicit Trade in Tobacco Products. While recognizing the remarkable achievement of the global community in its efforts to curb illicit trade in tobacco products at the international level, the report also highlights those aspects of the Protocol that may undermine its effectiveness in the long-term perspective. In this context the enforcement capabilities of developing countries are cited as a main concern.

On 26 September 2012, the European Commission published two proposals for the substantial amendment of the regulatory framework on medical devices: a ‘Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009,1 and a ‘Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices’2 (hereinafter, IVD).

EFTA Court, Case E-2/12, HOB-vín ehf. v. The State Alcohol and Tobacco Company of Iceland (ÁTVR) National rules of a EEA State, such as those at stake in the present judgment, under which a State monopoly on the retail sale of alcohol, may refuse to accept for sale alcoholic beverages that are lawfully produced and marketed in another EEA State on the grounds that the labelling of the products contains loaded or unrelated information, are in breach of Article 18 of Directive 2000/13/EC (‘the labelling Directive’ or ‘Directive’), and cannot be justified by a public health objective. Another rule requiring alcoholic beverages to carry stickers stating that their contents are alcoholic, in addition to the mandatory indication of the actual alcoholic strength by volume, ‘cannot be considered effective’ if it has been adopted without regard to the notification procedure laid down in Article 19 of the labelling Directive. However, individuals and economic operators who have been harmed by the incorrect application of the Directive may rely on the free movement of goods in order to render the State liable for the breach of EEA law, regardless of whether such a directive is being made or has been made part of the legal order of Iceland, since it has been incorporated in the EEA Agreement. Failure to notify the second rule in accordance with the Directive qualifies as a sufficiently serious breach of EEA law. Such a breach entails State liability if the national court finds a direct causal link between the breach of the obligation resting on the State and the damage sustained by the injured party (author’s headnote).

R. Brownswood and M. Goodwin, Law and the Technologies of the 21st Century, Cambridge University Press, 2012 Therese Murphy

A. De Guttry, M. Gestri and G. Venturini (Eds.), International Disaster Response Law, T.M.C. Asser Press, 2012 Marta Simoncini