Due to the astounding revolution sparked off by genetic engineering, the artificial modification of the genome through targeted alterations of DNA and RNA is now competing with the traditional phenotype use of living organisms (selective plant and animal breeding, consumption, manufacturing of products, energy production, etc.). Although until recently these were insurmountable obstacles, interspecies barriers to reproduction are fading away, and it is now possible to transfer genes from one species to the genome of another. In short, the artificial genetic engineering is replacing selective breeding. Furthermore, a new age is dawning – that of synthetic biology – in which man will no longer content himself with modifying existing organisms but, thanks to the radical modification of the genome, will be able to create new cells and new organisms.

I am delighted to announce the birth of the European Journal of Risk Regulation. This new academic journal reflects the growing importance of both national and European regulations intended to protect health, safety, security and the environment – as well as the accompanying institutional challenges for the European Union governance.

This large body of law is known as risk regulation. It seeks to reduce the risks of harm to individuals and society, stemming from all threats whether industrial or natural, voluntary or involuntary. Arguably, this portion of EU legislation already represents the most important and widespread part of the internal market acquis and, due to its international success, it contributes to make the EU a de facto global regulator. As such, it provides a new and valuable lens through which to analyse the European integration process.

The three Directives concerning medical devices are currently under revision and a long process that started with a consultation in 2008 seems to be nearing its conclusion with two Regulation proposals in the pipeline and at the time of writing under discussion in the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI Committee). In this article we examine if the proposed Regulation for medical devices will deliver on the promises. We will focus on what we know to be the hot topics for industry. Since the article is forward- looking about draft legislation currently in the legislative process, it is by necessity speculative on points and the proposals may have changed by the time this article is printed.

It is frequently suggested that the EU in general and Parliament in particular suffer from an addiction to making rules and regulations on all things from chemicals to chocolates and from buses to booze. Classically, this is the first repost of the critic who sees the EU as legal procurator dressing up the legislative Christmas tree. Firstly, it is important to note that there are legitimate concerns that regulations passed in Europe are not always based on the best available science and perhaps even the best scientists. It is up to those with responsibility for making regulation to make it according to best verifiable evidence at hand. When you consider how important the potential implications are for industry and consumers alike then it is clearly of great importance to increase the use of risk analysis tools.

When asked to explain the difference between risk and hazard it is perhaps helpful to consider the life of a zoo keeper in charge of the Lions’ den. The animals themselves can be seen as a “hazard”, when the animals are free and uncaged, people in the surrounding area are exposed to the risk that they may be attacked. However, when the animal is caged, we’re dealing with altogether different beasts as only the zoo keeper (who knows how to handle the risk) could be exposed to certain dangers. It may remain “hazardous” but while those around it are protected there is no exposure to attack, therefore there is no risk.

This paper deals with the debate on the methods to regulate hedge funds, with a particular focus on direct or indirect regulation. After having briefly examined the pros and the cons of directly regulating these investment schemes, it comes to the conclusion (largely shared by most scholars) that hedge funds should not be directly regulated, while regulation should concern their management companies and, most of all, their counterparts (lenders in the first place) with a view to managing systemic risk. In addition, regulation should also set precise thresholds for access which should aim at protecting unsophisticated investors from hazardous moves, without, however, falling into the trap of regulating hedge fund themselves.

The attention is then turned to the European Union and to its Alternative Investment Fund Managers Directive (AIFMD). An analysis is conducted on some of the most significant approaches to hedge fund regulation which have fuelled (and are partly still fuelling) the debate within EU institutions in its struggle to provide Member States with a valid response to the financial crisis, and on some key provisions of the first level AIFMD. In this light the author concludes that, despite the declared intent to regulated fund managers, the directive often seems to regulate hedge fund themselves. This does not seem to be in line with the thoughts of most scholars and market operators on hedge fund regulation and also looks at odds with other pieces of EU legislation (in particular with the so-called “Newcits”).

The General Court has dismissed the actions brought Budějovický Budvar against the registration of the Community trade mark “Bud” for beer that was sought for by Anheuser-Busch. The main reason is the insignificant use in France and Austria of the appellation of origin “Bud”.

An issue that may arise for both the plaintiff and defendant in a patent dispute involving pharmaceutical technology concerns the risks associated with selling an allegedly infringing product prior to the dispute being resolved. The plaintiff has the option to seek a preliminary injunction. Deciding whether to grant an injunction involves fact specific analysis. The economic components in such an analysis, which are addressed in this report, are: assessing whether the plaintiff will suffer irreparable harm without an injunction, measuring the balance of harms to the plaintiff and defendant, and evaluating whether the public interest will be served by an injunction.

Designing a framework for evaluating laws, rules and policies within any given legal system is a daunting task. Comprehensive schemes risk ending up as mere paper realities because of the demands they place on evaluatorsas well as on the addressees of evaluations. More realistic evaluation frameworks on the other hand may not yield many results. The OECD has a long track record of encouraging member countries to deal with ‘regulation’ in the wider sense of the word in a rationalistic and systematic way. These encouragements tend to involve recommendations, peer reviews,and the use of country surveys in order to establish progress in what the OECD usually calls ‘regulatory policy’ or ‘regulatory management’ (‘better regulation’ in EU parlance and sometimes referred to as ‘meta-regulation’ in the literature). Recently a new tool has been added. In a move parallel to the EU's efforts to ‘complete the regulatory cycle’, the OECD has developed a new Framework for Regulatory Policy Evaluation (hereafter referred to as ‘Framework’).

Risk regulation is a major task of the EU. In this context, scientific knowledge and advice is critical to the preparation, formulation, legislation and later revision of EU risk regulation. However and with some notable exceptions (e.g. some EU Agencies, DG SANCO), there seems to be no systematic view, let alone, organisation for the ‘use of science’ for EU policy–making. It is in this light that the new function of Chief Scientific Advisor (CSA) to the President of the European Commission can best be appreciated. The authors first sketch how ‘science’ is used in the EU regulatory regime and what is or has become problematic about it. Subsequently, an informal SWOT analysis of the ‘use of science’ for EU policy is conducted. The contribution ends with an attempt to evaluate the CSA's accomplishments to date and how it can contribute to improving EU regulation. This is followed by a few recommendations on how the role of the CSA could be strengthened in the near future.

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.

The “sharing economy” represents a growing challenge to regulatory policy. In this article, I argue that these debates about the sharing economy are better understood as a broader normative and policy problem of updating our regulatory tools for the new dynamics of 21st century capitalism. The new “on-demand” economy reflects more widespread trends in the structure of business organization, driven by new developments in finance and technology. I argue that we should analyze these changes through the normative lens of the balance of economic power: what is especially troubling about the on-demand economy is the way in which it outstrips the modes of accountability and countervailing power enabled by 20th century labor, safety net, and economic regulations. The article then suggests key frontiers for regulatory innovation, in particular: (1) expanding regulatory oversight of concentrated market and economic power among on-demand platforms; (2) expanding the relative power of workers to counteract the concentrated power of platforms in the on-demand economy (for example by expanding safety net protections and the ability to organize collectively); and (3) by reinventing systems of collective urban planning processes in the face of the on-demand economy. All three of these focus areas for regulation would entail a variety of specific interventions, but share a common premise of rebalancing economic power in this new economy. The payoffs of these shifts would be more than an expansion of welfare or efficiency, but rather the creation of a policy regime that enables a richer form of economic freedom that achieves more genuine economic independence from domination of various kinds.

Cases C-517/14 P and C-519/P, Schutzgemeinschaft Milch und Milcherzeugnisse e.V. v European Commission, Kingdom of the Netherlands, Nederlandse Zuivelorganisatie, unreported 24 October 2014 (Seventh Chamber).

In the two related cases commented on, the Court of Justice of the European Union (CJEU) dealt with assessment of locus standi in the case of an applicant who disputed the validity of registration of two indications of geographical origin (IGOs), namely Edam Holland and Gouda Holland, being compound designations and containing a famous generic word designation (name), i.e. Edam and Gouda respectively. The importance of both cases relates, on the one hand, to the fact that registration of these IGOs was challenged on the basis of the generic names Edam and Gouda which are extensively used in practice, occupying a considerable market share. On the other, both cases could be a signal whether the CJEU re–affirms its restrictive approach to assessment of locus standi under Article 263 (4) TFEU. Although the CJEU re–affirmed its longstanding case law on restrictive assessment of locus standi also concerning registration of a compound geographical designation on the basis of a generic name, yet, as is argued in this case note, this approach did not take into account the specifics of registering IGOs (author's summary).

The leaked TTIP documents reveal that the EU and US are discussing the introduction of a detailed set of procedural requirements for the adoption of regulatory measures. Default provisions are set forth in the chapter on regulatory cooperation, applicable to goods and services. More specific provisions are being negotiated in the chapters on technical barriers to trade and on sanitary and phytosanitary measures. If they conflict with the regulatory cooperation chapter, they prevail.

This article analyses the regulatory cooperation chapter insofar as it pertains to trade in goods but to the exclusion of SPS matters and anything provided in the TBT chapter itself. The questions this article examines are to what extent the TTIP proposals expand upon the obligations the two parties have already taken on under WTO law and to what extent the resulting regulatory coordination is consistent withWTO law. It will be shown that the US proposals on procedure may constrain substantive regulatory discretion beyond what applies under the GATT and TBT Agreement of the WTO. It will alsobe shown that the needs to conduct trade impact assessments and a detailed explanation of the necessity of measures anticipate a legal challenge to necessity and will provide information of much use to complainants in meeting their burden of proof.