EJRR 1/2014



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Issue 1/2014

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Alberto Alemanno

Editorial
European Journal of Risk Regulation 1/2014: pp. 1-2
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The EJRR opens this new issue with a special collection devoted to the use of social sciences in risk assessment and risk management organizations in Europe and North America. It builds upon an international workshop held in January 2013, organized by the FrenchAgency for Food, Environmental andOccupationalHealth Safety (ANSES) and SciencesPo’s Center for the Sociology ofOrganisations (CSO).

Olivier Borraz and Benoit Vergriette

Opening Editorial
European Journal of Risk Regulation 1/2014: pp. 3-6
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This Special Issue of the European Journal of Risk Regulation is the result of an international workshop held in January 2013 in Paris, at the initiative of the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) and the Center for the Sociology of Organisations (CSO). Following a survey conducted in 2011 regarding the use of human and social sciences in fifteen public organisations in Europe and North America in charge of risk assessment and/or risk management related to environmental and health issues, an interdisciplinary group of researchers and practitioners from seven countries met to discuss the results of this survey and to compare experiences in the use of social sciences in country case studies.

Cécile Wendling

Incorporating Social Sciences in Public Risk Assessment and Risk Management Organisations
European Journal of Risk Regulation 1/2014: pp. 7-13 [Article]
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The objective of the article is to analyse the use of Humanities and Social Sciences (HSS) in public risk assessment and risk management organisations in France, Germany, the UK, the Netherlands, Canada and the United States based on more than a hundred interviews conducted with social sciences experts employed by or working for these organisations. If the added value brought by the integration of social scientists is recognised, the use of social sciences differs from one organisation to another. The article compares the different positions given to social scientists inside and outside the organisation, the various methods used and the different contents produced. The survey highlights a set of initiatives that are scattered, differentiated and ultimately have little in common – except that they often play a marginal role in the main activities of the agencies concerned.

Yannick Barthe

Scientific Expertise in Situations of Controversy: A Sociological Testimony
European Journal of Risk Regulation 1/2014: pp. 14-24 [Article]
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While there is now a large amount of social science research on scientific expertise, testimonies made by sociologists who themselves participated in scientific expertise on a controversial topic remain rare. It is this type of feedback and testimony that this paper will articulate and discuss. The aim is to propose a series of reflections on scientific expertise from a personal experience: the participation of the author as a sociologist in an expert committee set up by the former French Agency for the Safety of Health, the Environment and Work (AFSSET) on the topic of radio-frequencies. Several problematic aspects of scientific expertise will thus be discussed from this concrete experience: the problem of the composition of the expert group and the issue of conflict of interest, the way in which the work of expertise is organized within the group, the effects of the presence of an observer from an association, and the differences between scientific work and scientific expertise.

Hans Keune, Gudrun Koppen, Bert Morrens, Ann Colles, Johan Springael, Ilse Loots, Caroline Teughels, Hana Chovanova and Karen Van Campenhout

Extended Peer Evaluation of an Analytical Deliberative Decision Support Procedure in Environmental Health Practice
European Journal of Risk Regulation 1/2014: pp. 25-35 [Article]
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How can we assess the quality of an analytical deliberative decision support procedure in environmental health practice? Objectifying quality criteria is difficult for several reasons. Opening up evaluation to a diversity of critics is one approach to take into account different actor perspectives and complexity. We describe how social scientists organized extended peer evaluation of a participatory multi-criteria procedure that was applied in Flemish environmental health practice. International peer review was combined with local extended peer evaluation. Social scientists collaborated closely with natural scientists and policy representatives in designing several evaluative activities and in interpreting the results.We discuss how these different perspectives came to reach conclusions, with a special focus on methodological decision-making. A process of learning by doing and negotiating, finding a methodological path amidst practicalities, complexity and ambition.

Daniel Benamouzig, Olivier Borraz, Jean-Noël Jouzel and Danielle Salomon

A Sociological Checklist for Assessing Environmental Health Risks
European Journal of Risk Regulation 1/2014: pp. 36-45 [Article]
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The contribution of social sciences to risk assessment has often been confined to dimensions of risk perception and communication. This article relates an effort to promote knowledge from the social sciences that addresses other dimensions of risk issues. A sociological checklist produced for ANSES in France helps to identify and analyse social dimensions that should be given attention during the process of risk assessment.

Elaine Fahey

The EU’s Cybercrime and Cyber-Security Rulemaking: Mapping the Internal and External Dimensions of EU Security
European Journal of Risk Regulation 1/2014: pp. 46-60 [Article]
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By taking the EU Cyber Strategy as a case in point, this contribution examines how the distinction between external and internal security in contemporary EU law manifests itself in large-scale risk regulation and in particular, how the EU relies upon external norms to regulate risk. This article also maps the evolution of the rule-making processes themselves.

Ignacio Carreño

Food: The European Commission Considers the UK Traffic Light Nutrition- Labelling Scheme as Voluntary Nutritional Information and Not as a ‘Non-Beneficial’ Nutrition Claim
European Journal of Risk Regulation 1/2014: pp. 61-64 [Report]
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I. Introduction Themeeting of the Standing Committee on the Food Chain and Animal Health (hereinafter, the SCoFCAH) held in Brussels on 4 October 2013 (Section General Food Law), addressed a request from Italy for a discussion on the voluntary front-of-pack (hereinafter FoP) nutrition labelling scheme recommended by the UK authorities. A number of EU Member States shared the concerns of Italy vis-à-vis the scheme recommended in the UK and some recalled their position in favour of a harmonised system and requested the European Commission’s views.

Blanca Salas

Food: Specific Rules on Derogations for Generic Descriptors under the Nutrition and Health Claims Regulation Entered into Force
European Journal of Risk Regulation 1/2014: pp. 65-67 [Report]
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I. Introduction On 20 September 2013, the European Commission adopted Commission Regulation (EU) No. 907/2013 of 20 September 2013 setting the rules for applications concerning the use of generic descriptors (denominations) 1 (hereinafter, Regulation (EU) No. 907/2013). Pursuant to Article 1(4) of Regulation (EC) No. 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods2 (hereinafter, Nutrition and Health Claims Regulation),3 specific generic descriptors that have traditionally been used to indicate a particular class of foods or beverages, which could imply an effect on health,may be exempted fromthe application of the Nutrition and Health Claims Regulation following a request by the food business operators concerned.

Rachel Chu

Intellectual Property: Bristol-Myers Squibb and the Medicines Patent Pool – An Unlikely Marriage?
European Journal of Risk Regulation 1/2014: pp. 68-72 [Report]
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The Role of the Medicines Patent Pool in Stimulating the Development and Availability of Global Health Medicines

I. Introduction Bristol-Myers Squibb’s (BMS) recent agreementwith the Medicines Patent Pool (MPP) to license atazanavir, an antiretroviral (ARV) drug,1 adds an important compound to the pool’s arsenal of treatments for HIV/AIDS and has the potential to substantially strengthen developing countries’ defence against the disease. Nevertheless, the effectiveness of the agreement and the MPP itself are limited to a very niche area of global health.

Oliver Bartlett

Lifestyle Risks: Distilling Prospects: Reflections on the Proportionality of Minimum Unit Pricing under EU Law
European Journal of Risk Regulation 1/2014: pp. 73-78 [Report]
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I. Introduction On 3 May 2013 the Scottish Court of Session ruled thatminimumunit pricing of alcoholic beverages did not breach EU law on the free movement of goods. It held that the Alcohol (Minimum Pricing)(Scotland) Act 2012,1 passed in June 2012 but not implemented pending the completion of legal action, did constituteameasurehavingequivalenteffect toaquantitative restriction underArticle 34TFEU, but that such a restriction of tradewas justified as proportionate under Article 36 TFEU as it was the most effective way of achieving the legitimate aim of reducing the consumption levels of harmful and hazardous drinkers.

Stefano Barazza

Pharmaceuticals: Pay-for-Delay Agreements in the Pharmaceutical Sector: Towards a Coherent EU Approach?
European Journal of Risk Regulation 1/2014: pp. 79-86 [Report]
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This Report examines the competition law issues that arise, in the EU pharmaceutical sector, from pay-for-delay agreements concluded between an originator company and a generic manufacturer. The Commission’s approach to these agreements is reviewed evaluating the findings of the on-going monitoring activity of patent settlements, the outcome of recent investigations, and the legislative proposals specifically aimed at dealing with the phenomenon. Finally, a comparison of the EU and US approaches provides a clear indication of the challenges that still lie ahead.

Richard Meads and Lorenzo Allio

Regulatory Impact Assessment: A “Win-Win-Win” Scenario – Reaping the Benefits of an EU Law on Administrative Procedure
European Journal of Risk Regulation 1/2014: pp. 87-92 [Report]
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A Law on Administrative Procedure (LAP) is an essential institutional feature of democratic and effective governments. It is a general law on executive law-making, setting out how laws and regulations should be made. The need for a LAP at EU-level is growing – to counter the EU’s legitimacy deficit and to make the regulatory process more predictable and robust. At the same time, the EU regulatory “machine” faces new challenges and pressures, as it seeks to implement highly complex (risk management) regulation. Greater regulatory effectiveness depends on more transparency, evidence quality standards and participation. As such, an EU LAP appears to be the natural culmination of the EU Smart Regulation agenda. Since the European Parliament in 2013 called for the Commission to adopt a LAP-related legislative proposal, the debate has gained in visibility and political salience. This article makes the case for an EU LAP for the EU institutions, citizens and businesses – provided the Law enshrines the four key principles of good administration (transparency and consistency; public participation; public record; and accountability); it establishes clear and legally- binding procedural standards; and it covers as a principle also rule-making and adjudication decisions by all EU institutions and bodies involved in the preparation, adoption, implementation and repeal of secondary legislation.

MeterTyphaine Beaupérin

Regulatory Impact Assessment: “Think small first in the EU”? A Reality Check
European Journal of Risk Regulation 1/2014: pp. 93-96 [Report]
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EUROCHAMBRES Report on the European Commission’s Application of the SME Test

Despite recent efforts by the European Commission to improve the application of the SME test by its services, EUROCHAMBRES 2013 SME Test Benchmark reveals that the Commission is still, in the majority of the dossiers analysed, failing to ‘think small first’ and take into account the costs and benefits to smaller businesses in the preparation of legislative proposals.

Alexia Herwig

Trade, Investment and Risk: Lost in Complexity? The Panel’s Report in European Communities – Measures Prohibiting the Importation and Marketing of Seal Products
European Journal of Risk Regulation 1/2014: pp. 97-101 [Report]
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The EU seals case1 is the firstWTO dispute focusing on animal welfare concerns. It throws up a number of interesting questions about how the TBT Agreement and GATT apply to regulatory policies because of the many different regulatory goals the EU pursued with its policy on seals and because it also regulated ethical behaviour of consumers who should not support any seal suffering even if occurring only indirectly via purchases of seal products hunted humanely. The EU sought to justify its comprehensive ban and exceptions on the basis of several objectives, including animal welfare concerns, EU public morals, the preservation of Inuit traditions and the protection of fisheries.

Lucas Bergkamp

The Quiet Revolution in EU Administrative Procedure: Judicial Vetting of Precautionary Risk Assessment
European Journal of Risk Regulation 1/2014: pp. 102-110 [Case Note]
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Case T-333/10, ATC and Others v Commission, 16/09/2013 (‘Animal Trading’), nyr.

I. Introduction As the undefined precautionary principle does not have any clear triggers and boundaries,1 disputes are bound to arisewhere it is invoked. Consequently, the European courts are regularly confronted with arguments that measures based on the precautionary principle violate EUlaw. Challenges to precautionary measures are typically supported by a series of arguments, such as the lack of authority (ultra vires), and violation of the proportionality principle, the legitimate expectation principle, the duty to investigate carefully, and the duty to state reasons. The Animal Trading case is no exception.

Stavroula Karapapa

Trade Mark Use Explained: Insights from the General Court in “Bud”
European Journal of Risk Regulation 1/2014: pp. 111-114 [Case Note]
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Joined Cases T-225/06, T-255/06, T-257/06 and T-309/06, Budějovický Budvar, národni podnik v Office for Harmonisation in the Internal Market (Trade Marks and Designs) (OHIM), nyr.

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”.

Vadim Mantrov

A Victim of a Road Traffic Accident not Fastened by a Seat Belt and Contributory Negligence in the EU Motor Insurance Law
European Journal of Risk Regulation 1/2014: pp. 115-123 [Case Note]
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Case C-300/10, Vítor Hugo Marques Almeida v Companhia de Seguros Fidelidade-Mundial SA and Others [2012] ECR I-00000

This case note relates to the recent judgement (23 October 2012) by the Court of Justice of the European Union in the case No C-300/10 concerning interrelation of the European Union motor insurance law and the national civil liability regulation. As the civil liability arising from motor traffic accidents is not approximated by the European Union law, its regulation falls within the national law. Yet, application of the national civil liability law shall not undermine the obligation to provide insurance coverage for victims of road traffic accidents. The discussed case concerns a situation when a victim who was not fastened by a seat belt at the moment of a motor traffic accident was injured, and this raises a question whether such victim may be compensated due to contributory negligence. This note provides a brief summary of the previous case law, facts, review of Advocate’s General Opinion and the judgment and their analysis.

Giacomo Luchetta

Book Review
European Journal of Risk Regulation 1/2014: pp. 124-125 [Book Review]
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Influencing the Preparation of EU Legislation: A Practical Guide to Working with Impact Assessments

by Erik Akse London: John Harper Publishing, 2013, 330 pp., € 65,00; Softcover


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