EJRR 3/2014



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Issue 3/2014

Table of Contents
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Alberto Alemanno

Editorial
European Journal of Risk Regulation 3/2014: pp. 283-285
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By focusing on the interactions between science, policy and law, the European Journal of Risk Regulation has always been interested in exploring the role of scientific advice in policymaking. While we have published several contributions discussing the role of expertise in both policymaking, through the analysis of EU agencies and adjudication, we have never had the opportunity to perform a broader analysis discussing the various institutional settings for scientific advice, and more specifically that of the Chief Scientific Advisor (CSA). Like

Alberto Alemanno

What Role – if any – for a Chief Scientist in the European Union System for Scientific Advice?
European Journal of Risk Regulation 3/2014: pp. 286-292 [Article]
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At a time of increasing recognition worldwide of the role of Chief Science Advisers as of critical importance in improving dialogue between science and policy, the European Union, notably the European Commission, is currently considering – under the pressure of civil society organisations – whether to maintain or scrap this recently-created position. After contextualizing this debate within the broader efforts undertaken by the Barroso Commission to strengthen science in EU policymaking, this article discusses what role, if any, a Chief Scientistmay play within the EU systemof scientific advice. After denouncing the lack of a public debate about the merits of this post at the time of its creation, the article takes as a point of departure the criticisms made against this position and assesses them in the light of the mandate entrusted to the Chief Scientist Advisor. It argues that the major point of disagreement on this post revolves around the question of whether the Chief Scientist Advisor, as it currently stands, helps or hinders the EU incorporating the ‘best science’ into policy. After identifying the flaws of the actual mandate and the challenges faced by the first holder of the position, it argues that the burden of proof rests with the EU Commission to prove the merits, and more specifically, the rationale for having yet another source of scientific advice in the EU.

James Wilsdon

The Past, Present and Future of the Chief Scientific Advisor
European Journal of Risk Regulation 3/2014: pp. 293-299 [Article]
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At the end of August 2014, scientists and policymakers from forty-eight countries gathered at the Heritage Hotel in Auckland, New Zealand to debate the science and art of scientific advice.1 Jointly hosted by Sir Peter Gluckman, chief scientific advisor to the PrimeMinister of NewZealand, and the International Council for Science (ICSU), the Auckland summit was the largest ever meeting of its kind, attracting science advisors, advisory bodies and academic experts fromAlbania to Zimbabwe, and a host of countries in between.

Julie Girling

The Role of Science in 21st Century EU Policy- Making
European Journal of Risk Regulation 3/2014: pp. 300-302 [Article]
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Today,more than ever, citizens expect value formoney, not only from their elected representatives, but also from the laws and regulations passed to protect them. As the European economy faces continued challenges and limited economic growth, citizens rely on policy-makers to encourage innovation and stimulate growth and jobs.

Marie-Valentine Florin

Dealing with the Challenge of Evidence-based Decision-making in Situations of Uncertainty and Emergency
European Journal of Risk Regulation 3/2014: pp. 303-308 [Article]
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Collection and provision of scientific information for policy and decision-making is particularly important during emergencies or when uncertainty and ambiguity creates situation of fear and anxiety. This article offers two suggestions for addressing natural or technology risks, leveraging research by the International Risk Governance Council (IRGC)1 and project contributors. The first advice is that concepts and instruments for risk governance be recognised and used as intermediation between evidence and policy. The second is that the role of the Chief Scientific Adviser in public sector organisations includes those of the Chief Risk Officer. These suggestions could help address the challenge for policymakers to deal with uncertainty and emergency, when little or contradictory evidence is available.

Dirk Hudig

Better Risk Regulation Governance for a Stronger Europe
European Journal of Risk Regulation 3/2014: pp. 309-313 [Article]
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The Institutionalisation of the EU Chief Scientific Adviser Office

The start of a new European Commission represents a unique opportunity to build on successful regulatory reforms and to create the institutional architecture needed to ensure that high quality scientific evidence is used effectively in EU decision-making. The appointment by President Barroso of a Chief Scientific Adviser (CSA) in 2011 constituted an important springboard in this respect. The CSA Office has made a considerable and positive difference to the regulatory environment. This article argues for embedding the CSA Office into the institutional and procedural arrangements of the Commission by re-defining its organisational role and responsibilities as well as the resources allocated to it. The institutionalisation of the CSA Office and the creation of a fully-fledged risk regulation regime would provide a robust element of the EU’s response to the demands for better governance by its citizens, as expressed in the recent European elections.

Lorna Schrefler and Jacques Pelkmans

Better Use of Science for Better EU Regulation
European Journal of Risk Regulation 3/2014: pp. 314-323 [Article]
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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.

Merijn Chamon

EU Risk Regulators and EU Procedural Law
European Journal of Risk Regulation 3/2014: pp. 324-337 [Article]
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Before the Treaty of Lisbon, EU agencies were unknown in the EU’s primary law defined procedural law. Today, following (i) the Treaty’s entry into force, (ii) the Common Approach on Decentralised Agencies and (iii) the European Court of Justice’s ruling in Short-selling it is interesting to take a look at the peculiar position of EU agencies under the EU’s primary and secondary law defined procedural law.

Barend van Leeuwen

PIP Breast Implants, the EU’s New Approach for Goods and Market Surveillance by Notified Bodies
European Journal of Risk Regulation 3/2014: pp. 338-350 [Article]
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With the New Approach for goods, the EU has created a regulatory framework for placing products on the market in which both public and private parties have an important role to play. The various cases which have been brought after the PIP breast implants scandal show the difficulties with trying to link this ex ante regulatory framework to potential liability for defective products. National courts have reached different conclusions about the scope of the obligations of certification bodies in the New Approach. Since these issues are about the fundaments of the construction of the New Approach, it would be desirable for the ECJ, and perhaps even the European legislator, to get involved.

Ragnar Lofstedt

Chemical Control Policy in Sweden, What is Next?
European Journal of Risk Regulation 3/2014: pp. 351-358 [Article]
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Sweden has long been seen as a pioneer in the area of chemical control policy. In 1995 it put forward a so called “generation goal” which called for a phasing out of all human made chemicals within a 25 year period. The Swedish Government took up the challenge of how to best reach this goal by putting forward a number of environmental quality objectives, which were approved by the Swedish Parliament in 1999. What has happened since then? Will Sweden reach its proposed generation goal? This paper addresses these two questions.

Justo Corti Varela

Biotechnology: Opt-out Clause in the Cultivation of GMOs is closer (or not)
European Journal of Risk Regulation 3/2014: pp. 359-361 [Report]
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In July 2010, in order to lift the blockage to authorizing proceedings, the European Commission proposed a Regulation revising Directive 2001/18/EC1. Although it was presented as a new strategy in the coexistence policy, in reality, it was a way to provide a legal basis for Member States to decide on GMO cultivation on grounds other than those based on scientific assessment of environmental andhealthrisks.

Ignacio Carreño

Food: European Commission Proposes to Revise the EU’s Legislative Framework on Novel Foods and Animal Cloning
European Journal of Risk Regulation 3/2014: pp. 362-365 [Report]
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I. Introduction On 18 December 2013, the European Commission adopted a package of three proposals to revise the EU’s legislative framework on novel foods. The package consists of a proposal for a Regulation of the European Parliament and of the Council on novel foods,1 a proposal for a Directive of the European Parliament and of the Council on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes2 and a proposal for a Council Directive on the placing on the market of food from clones.

Stefano Barazza

Intellecutal Property: The Draft Trans-Pacific Partnership Agreement and its Implications for Public Health and Access to Medicines: The UNITAID Report
European Journal of Risk Regulation 3/2014: pp. 366-373 [Report]
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This report provides an overview of the potential impact of the draft Trans-Pacific Partnership Agreement on public health and access to medicines, in light of a recent analysis conducted by UNITAID. The international organization observed that the increased intellectual property protection endorsed in the draft agreement,which calls for the adoption of TRIPSplus standards, is likely to severely impact generic competition, affecting the availability of medicines in developing countries, and reducing the ability of governments to set the appropriate balance between the protection of innovation and the safeguard of public health.

Andy Stonard

Lifestyle Risks: Risk Regulation and Behaviour among Consumers of Alcohol, Drugs and Nicotine
European Journal of Risk Regulation 3/2014: pp. 374-379 [Report]
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This report is suggesting that some of themajor foundations that the regulation of alcohol, tobacco and nicotine, prescription drugs and illicit drugs is built on give serious cause for concern.

Richard P. Rozek

Pharmaceuticals: Assessing the Commercial Success of a Pharmaceutical Product Covered by a Patent
European Journal of Risk Regulation 3/2014: pp. 380-385 [Report]
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I. Introduction In U.S. patent cases, a factor for demonstrating that an invention is non-obvious is the commercial success of the product embodying that invention. There must also be a nexus or connection between the patented characteristics of the claimed product and its commercial success.

Sweta Chakraborty and Iris Chungng

Risk Communication: Challenges and Opportunities of Omnichannel Retailing
European Journal of Risk Regulation 3/2014: pp. 386-388 [Report]
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The retail sector faces risk challenges ranging from cyber security threats to active shooter incidents. These threats, coupled with advances in new technologies, social media and public perceptions of risk have required the retail sector to reevaluate the resiliency of their business.

Stefan Kulk and Frederik Zuiderveen Borgesius

Google Spain v. González: Did the Court Forget about Freedom of Expression?
European Journal of Risk Regulation 3/2014: pp. 389-398 [Case Note]
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Case C-131/12 Google Spain SL and Google Inc. v. Agencia Española de Protección de Datos and Mario Costeja González

I. Introduction When reviewing a job application letter, going on a first date, or considering doing business with someone, the first thing many people do is entering the person’s name in a search engine. A search engine can point searchers to information that would otherwise have remained obscure.

Vadim Mantrov

Is 142 Euro Equal to 350 000 Euro? The CJEU Interpretation of “Personal Injury” and “Injured Party” in EU Motor Insurance Law
European Journal of Risk Regulation 3/2014: pp. 399-406 [Case Note]
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Case C-277/12, Vitālijs Drozdovs v Baltikums AAS, Judgment of 24 October 2013, nyr. Case C-22/12, Katarína Haasová v Rastislav Petrík, Blanka Holingová, Judgment of 24 October 2013, nyr.

In reviewing two similar cases, the CJEU clarified several essential elements of EU motor insurance law. First, the CJEU clarified the concept of “personal injury” as an insurable risk (another is damage to property) by holding that it also covers non-material damage and the concept of “injured party” by establishing that it also covers the next of kin of a person who died as a result of a road traffic accident. Second, the CJEU affirmed its previous case law that EU Member States are precluded from lowering the minimum insurance coverage as set in the amount of 350 000 euro by EU motor insurance law. In particular, the CJEU found that a Latvian national legal provision which provides fixed insurance redress in the amount of 142 (now 150) euro for non-material damage for the next of kin of a person who died in an accident is incompatible with EU motor insurance law (author’s summary).

Emanuela Gambini

In the Aftermath of the “Myriad Case” - Myriad Is Denied Preliminary Injunction Against Ambry Genetics
European Journal of Risk Regulation 3/2014: pp. 407-412 [Case Note]
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I. University of Utah Research Foundation, et al., v. Ambry Genetics Corporation On 10 March 2014, the U.S. District Court of Utah, Central Division, deniedMyriad preliminary injunction against Ambry Genetics Corporation in University of Utah Research Foundation, et al., v. Ambry Genetics Corporation (the “Ambry Case” or “Ambry”)1 and thememorandumdecisionmay clarify what are the implications of the U.S. Supreme Court’s judgment in Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al.2 (“Myriad”), issued on 13 June 2013.

Lucas Bergkamp, David Miers, Thomas Dietz, Iris H-Y Chiu

Book Reviews
European Journal of Risk Regulation 3/2014: pp. 413-432
[Click here to show Abstract]


EU Environmental Law, Governance and Decision-Making, by Maria Lee, Hart Publishing, 2014

Empirical Views on European Gambling Law and Addiction, by Simon Planzer, Springer International Publishing, 2014

The Risk Society Revisited: Social Theory and Governance, by Eugene A. Rosa, Ortwin Renn and Aaron McCright, Temple Univeristy Press, 2014

Europe and the Governance of Global Finance, by Daniel Mügge (ed.), Oxford University Press, 2014


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