The EJRR starts the new year by hosting a pioneering symposium devoted to one of the latest policy innovations that is currently experimented in the United Kingdom and the United States: the fashionable, yet controversial, Nudge. This idea originates from the omonymous, 2008 best-selling book published by the economist Richard Thaler and the legal scholar Cass Sunstein. By building upon the findings of behavioural research, they refute the classic economic assumption that “each of us thinks and chooses unfailingly well”1 and they advocate the need for public authorities to nudge people to make decisions that serve their own long-term interests without however removing their right to choose.

This article critically reflects upon the introduction of behavioural, ‘nudging’ approaches into UK policy making, the latest in a series of regulatory innovations. Initiatives have focused particularly upon correcting lifestyle risk behaviours, marking a significant continuity with previous ‘nannying’ policy. On the other hand, nudging represents a departure, even inversion of previous approaches that involved the overstating of risk, being based partly upon establishing a norm that bad behaviours are less, rather than more common than supposed. Despite substantive similarities, its attraction lies in the reaction against the former approach but must also be understood in the context of the economic crisis and a diminished sense of liberty and autonomy that makes intimate managerial intervention seem unproblematic. Problems are, in fact, substantial, as nudging is caught between the utility of unconscious disguised direction and the need to allow some transparency, thereby choice. Further, it assumes clear, fixed ‘better outcomes’ but encourages no development of capacity to manage problems, contradicting a wider policy intent to build a more responsible and active citizenry. More practically, nudging faces considerable barriers to becoming a successfully implemented programme, in the context of severe, Conservativeled austerity with which it is now associated.

Behavioural economics is helping illuminate the limits of rational individual choice. At the same time, even as research identifies failures in rationality, policy must inquire about the possibility and legitimacy of government intervention. In ‘Nudging’ Healthy Lifestyles: The UK Experiments with the Behavioural Alternative to Regulation and the Market, Adam Burgess critically describes the introduction of behavioural approaches into UK policy making. In particular, Burgess is concerned with the wholesale adoption of nudge-style programmes to promote healthier living among citizens.

We deepen Adam Burgess’ insight that under current conditions nudging cannot solve complex policy problems reliably and without controversy. We do so by integrating his concerns about nudging into Braden Allenby and Daniel Sarewitz’s three-leveled model of the basic problems technology can address and generate. We use this model to explain why the UK experiment with nudging has revolved around techno-fixes with limited policy potential, and conclude that nudging is best seen as an emerging form of soft law.

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.

The novelty in Adam Burgess’ paper is that he assesses nudge policies in the context of the shift in the UK government’s approach to risk from the nannying policies of Labour to the nudge policies of the Conservatives. There is a wealth of ideas in this paper. I find it useful to disentangle some of these ideas focusing on the following two questions: 1. In what respects do Labour’s nannying policies and the Conservatives’ nudge policies differ? 2. What is problematic about Labour’s nannying and the Conservatives’ nudge policies? Subsequently I will reflect on how a particular strand of research in the social sciences can be made relevant to designing a more responsible way of dealing with societal risk and show how this approach can evade some of Burgess’ concerns.

Nowadays, biotechnologies are among the most interesting areas of science. Their development, fostered by intellectual property (IP) rights’ protection, leads to useful progress. Nonetheless, when, as with biotech inventions, environmental protection is at stake, this progress is not without controversy. The present contribution aims at examining the interferences between IP and environmental protection, as emerging in the framework of the European Patent Convention. To this extent, it will focus on the function and on the limits of the ordre public exception clause, with the purpose of suggesting a new role for science in disputes for revocation of biotech patents.

Recent calls for transparency targeted towards regulatory bodies such as the US Food and Drug Administration has prompted investigation into the indubitable adoption of such measures. Specifically, the FDA’s quarterly postings of AERS (Adverse Event Reporting System) signals on its CDER (Center for Drug Evaluation and Research) website, stemming from FDAAA legislation introduced in September 2007, is analysed from a risk perception and communication perspective. This paper consists of two qualitative studies examining public perceptions and subsequent reported behaviour related to increased transparency. Interviews were conducted on two separate samples of seventy respondents in both Pittsburgh and New York City. The results found that signals postings may prove counter productive in terms of increased public alarm and early or inappropriate termination of a drug appearing on the list. We also found communication from the FDA perceived as inaccessible or confusing, particularly that the AERS signals are posted strictly on the web, while the majority of our respondents cited their primary and secondary media sources as broadcast television. We recommend that the FDA reconsider its communication strategy of AERS to the public as it may prove to be a ‘transparency step too far.’

The Rapid Alert System for Food and Feed (the socalled ‘RASFF’) is at the heart of food risk management within the European Union. It aims at providing authorities with an effective tool for exchanging information on measures taken to ensure food safety. It was created in 2002 by the General Food Law Regulation to help Member States to coordinate their food safety actions. Nearly ten years later, the adoption of Regulation 16/2011 of 10 January 2011, laying down implementing measures for the RASFF, intends to clarify the specific conditions and procedures applicable to the transmission of notifications through this tool, thus providing more legal certainty in the system.

Following the accident at the Fukushima nuclear plant on 11 March 2011, the European Union was informed that radioactive levels in certain food products originating in Japan, such as milk and spinach, exceeded the normal permitted levels under Japanese legislation. The European Commission judged that such levels of radioactivity could pose a threat to public health in the European Union and therefore began introducing specific additional import conditions for Japanese food products as a precautionary measure.

Nowadays as political decision making involves such a huge range of complex matters, scientific experts have become more and more involved in European risk regulation. The support by so-called independent experts may, on the one hand, be seen as a guarantee of rational decision making, increasing the quality of decisions as well as the general acceptance of all people affected. On the other hand, the number of expert groups, scientific committees and agencies helping the Commission in fulfilling its duties is vast and confusing. In addition, scientific advisory bodies often face the burden of unrealizable independence, as well as a lack of transparency and democratic control. This article sums up the central position of science-based risk regulation within the European Union (EU), referring to the necessity for expert opinion as well as to consequent problems concerning the involvement of these experts in risk regulatory actions.

In a judgment on 20 October 2011, following an action brought by the German Federation of Consumer Organisations (Verbraucherzentrale Bundesverband), the Italian confectioner Ferrero was ordered by the Frankfurt Court of Appeals (Oberlandesgericht Frankurt, hereinafter the Court) to change the nutrition labelling on its Nutella brand or, if it desists, to face fines of up to 250,000 EUR.1 The first instance court in February 2011 had ruled in favour of Ferrero.

On 18 October 2011 the Court of Justice of the European Union (CJEU) released its decision in Brüstle v Greenpeace.1 This is a widely reported case on the exclusion from patentability of inventions related to human embryonic stem cells (HESCs) on morality grounds. This report aims to verify whether the Brüstle ruling may expose the EU and some of its Member States to a WTO challenge for failing to comply with Article 27(2) of the TRIPS Agreement as well as whether the decision may have an impact in fields other than HESCs and thus be invoked to oppose the issuance, or challenge the validity, of any patent obtained through immoral or unlawful activities.

The terms lifestyle and risk are so commonplace today that we tend to take their meaning (and social history) for granted. This is unfortunate, since neither of them is either value-free or unequivocal. Linking them – in an abstract sense as well as with regard to policy – is therefore bound to raise multiple questions regarding the definition of boundaries. If we recognise that lifestyle is not a matter of individual agency alone but also a question of structure and, similarly, if risk assessment is not just determining objects or incidences of risk but also about establishing the societal and environmental contexts within which specific negative outcomes are more likely to happen, then we are confronted with the challenge of how to approach the subject of lifestyle risk without falling prey to the temptation to impose normative expectations This paper takes issue with some of the ideas advanced in the article by Planzer and Alemanno published in EJRR 4/2010 “Lifestyle Risks: Conceptualization of an Emerging Category of Research” by considering the framing of the concept of lifestyle risk. The emergence of this concept is symptomatic of a general trend from both the right and the left of the political spectrum to re-emphasise individual responsibility for social welfare – what Planzer and Alemanno refer to as “financial solidarity”. Yet the best way to effect such financial solidarity, and more specifically to balance individual and state responsibility, is neither obvious nor uncontested. Accordingly, the notion of “lifestyle risk” is likely to become a battleground for determining the scope of state intervention, where one of the principal questions will be what gets classified as “lifestyle risk” and what does not, and how this changes over time.

To find a proper balance between the increasing R&D activities in the rather inhomeogenous field of nanotechnologies and the necessary research on their possible adverse effects, which could trigger unfavourable or even hostile public debate, the European Commission developed several political documents, such as the European Strategy for Nanotechnology1 and the European Nanotechnology Action Plan2. In both documents a “safe, integrated and responsible” strategy was proposed and the European Commission postulates that “risk assessment related to human health, the environment, consumer and workers should be responsibly integrated at all stages of the life cycle of the technology”.

The Organization for Economic Cooperation and Development (OECD) has yet again rekindled the debate on measuring the performance of regulatory instruments and regulatory oversight institutions. This is a commendable initiative arising out of the OECD steering group on measuring and communicating regulatory reform. The debate on regulatory indicators and measures of regulatory reform is a bit of a classic, but there hasn’t been coordinated action across nations yet.

Health and safety regulatory agencies across the European Union have grappled with how best to regulate human activities and substances (such as chemicals including metals, food additives and preservatives) either as a risk or as a hazard. This has resulted in inconsistent regulatory practices across the European Union since the agencies were formed in the 1970s. The key component of this debate is whether regulatory decision-making can and should be based on hazard classification alone, foregoing risk assessment. From an economics perspective, decision making on the basis of hazard classification by itself usually ignores impact assessment, often resulting in poor regulatory policy-making that does not consider the potential increase of risk in other areas.1 Despite this knowledge, hazard classification remains in practice in European regulatory regimes due to political pressures to maintain public perceptions of safety. Therefore, in order to make the shift to risk-based regulation successfully, it is necessary to address existing public perceptions of risk and safety through evidence-based risk communications.

Case T-262/20 Microban International Ltd and Microban (Europe) Ltd v. Commission1 The conditions for bringing direct actions before the EU General Court have been opened under Article 263, fourth paragraph, of the Treaty on the Functioning of the European Union (“TFEU”) through the introduction of less restrictive rules on legal standing for private applicants challenging regulatory acts. The term “regulatory act” covers all acts of general application apart from legislative acts and includes implementing measures adopted by the European Commission under the comitology procedure. Initial case law provides welcome guidance on the application of the new rules on standing but questions still remain (author’s headnote).

Case C-442/09, Bablok and Others (not yet reported) An old German proverb says: What the farmer doesn’t know he doesn’t eat. In the case of the Bablok decision delivered by the European Court of Justice on 6 September 2011, it is not the farmers, but the judges who seem to be wary about the unknown. According to their judgement, substances derived from genetically modified plants require market authorisation to be placed on the market as food, even if the substance itself is not fertile anymore. Since the Court takes the view that pollen is an ingredient of honey rather than a natural component, honey contaminated with pollen from genetically modified organisms will fall within the classification of foodstuffs requiring marketing authorisation. So whenever a bee collects pollen from a genetically modified plant, this can make the entire honey harvest unmarketable. Not even the slightest contamination will be tolerated, irrespective of whether it was intentional. Because the prohibition to put unauthorised honey on the market applies abstractly, regardless of whether there is a concrete risk for the health of consumers, the judgement will have considerable impact on the coexistence of conventional, ecological and genetically-modified farming.

Case C-34/10 Brüstle v. Greenpeace 1. Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that: – any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’; – it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44. 2. The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable. 3. Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.

by Daniel Carpenter. Princeton and Oxford: Princeton University Press, 2010, 802 pp., €28.99, Softcover. Books about pharmaceutical regulation can be divided into two general categories: those written by legal and regulatory practitioners, presenting informative overview of the legal framework and lucid commentaries of its technicalities.

by David J. Ball and Laurence Ball-King Abingdon: Earthscan, 2011 204 pp., £21.99, Paperback. This book is an important and timely contribution to current debate within the United Kingdom about the extent to which occupational health & safety concepts and concerns have colonised the management of public space.

by Christa Altenstetter Piscataway, NJ: Transaction Publishers, 2007, 302 pp., $ 49.95, Hardcover This book is a welcome addition to the political science literature on medical product policymaking. Most researchers see medical devices as a poorer and perhaps less glamourized neighbour of the pharmaceutical regulation.