EJRR 2/2012

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Issue 2/2012

Table of Contents
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Alberto Alemanno

European Journal of Risk Regulation 2/2012: pp. 143-144
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The European Journal of Risk Regulation opens this new issue with a symposium devoted to the European Parliament’s role in risk governance. By building upon a workshop organised at the European Parliament’s premises in Strasbourg last Spring, it focuses on the operation of the little-known, yet important, Parliament’s own Science unit: the Science and Technology Options Assessment (STOA).

Paul Rübig

The Changing Face of Risk Governance: Moving from Precaution to Smarter Regulation
European Journal of Risk Regulation 2/2012: pp. 145-146 [Article]
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STOA, the European Parliament’s Technology Assessment body, which I had the honour to chair, has a mission to: (i) assess the impact of introducing and promoting new technologies, and (ii) identify the relevant policy options. In the context of its work, STOA has to address many different issues. One of the issues deserving STOA’s attention is the changing face of risk governance: “Moving from precaution to smarter regulation”.

René von Schomberg

The Precautionary Principle: Its Use Within Hard and Soft Law
European Journal of Risk Regulation 2/2012: pp. 147-156 [Article]
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The precautionary principle in public decision making concerns situations where following an assessment of the available scientific information, there are reasonable grounds for concern for the possibility of adverse effects on the environment or human health, but scientific uncertainty persists. In such cases provisional risk management measures may be adopted, without having to wait until the reality and seriousness of those adverse effects become fully apparent. This is the definition of the precautionary principle as operationalized under EU law. The precautionary principle is a deliberative principle. Its application involves deliberation on a range of normative dimensions which need to be taken into account while making the principle operational in the public policy context. Under EU law, any risk management measures to be adopted while implementing the precautionary principle, have to be proportionate to ensure the chosen high level of protection in the European Community. This article will illustrate the established practice concerning the release of genetically modified organisms into the environment and how the principle is implemented under hard law. The article also provides an outlook on what this may imply for the relative new case of nanotechnology and the use of precautionary principle within the context of soft law (use of codes of conduct).

Dirk Hudig

The Problem of Low and Uncertain Risks: Balancing Risks and Benefits
European Journal of Risk Regulation 2/2012: pp. 157-160 [Article]
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Both the Lisbon Treaty and the new Inter-Institutional Agreement strengthen the role of the European Parliament (EP) as co-legislator. At the same time, European Union (EU) officials increasingly recognise the need for broader acceptance of the principles and agreements of the Better (Smart) Regulation strategy, as proposed in an October 2010 Commission Communication.

Michael D. Rogers and Miro Smriga

Improving Regulatory Decisions through Targeted Research: A Case Study Concerning Amino Acids
European Journal of Risk Regulation 2/2012: pp. 161-168 [Article]
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This paper argues that the EU regulatory practice in the food area may be unnecessarily applying the Precautionary Principle by focussing on upper intake limits for naturally occurring nutrients, while not controlling the quality of the ingredients used in commercial products even though precedents of public health issues arising from adulterated ingredients do exist. Risk governance depends heavily on expert evidence and the case of amino acid supplements is used to document an industry-supported effort to strengthen the science database and thus enhance the regulatory process: Thus ensuring that amino acid use in the EU is safely and proportionately regulated. Scientific work conducted in the last decade by the not-for-profit association, the International Council on Amino Acid Science (ICAAS) is used as a simple case study highlighting the role of proactive clinical research in an era characterized by precaution in risk management, and by the escalating costs of scientific research, and the growing influence of the internet.

Jo Leinen

Risk Governance and the Precautionary Principle: Recent Cases in the Environment, Public Health and Food Safety (ENVI) Committee
European Journal of Risk Regulation 2/2012: pp. 169-173 [Article]
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As parliamentarians it is our job to represent the people of Europe and to make laws that are in the people’s best interest. This sounds simple at a first glance, but it is not as simple when you think about it twice.

Malcolm Harbour

Risk Governance and Risk Assessment – Key tools for an effective European Parliament
European Journal of Risk Regulation 2/2012: pp. 174-175 [Article]
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For more than 10 years, I have had the privilege of being Vice President of STOA, the European Parliament’s Science and Technology Options Assessment arm. During that time, I have been part of the team that has refocused STOA towards the crucial role of monitoring trends in science and technology, commissioning research to examine the implications for policy makers, and organising events to disseminate results.

Alessandra Arcuri

Back to the Future: US-Tuna II and the New Environment-Trade Debate
European Journal of Risk Regulation 2/2012: pp. 177-189 [Article]
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This article discusses a number of pitfalls of the US-Tuna II Panel Report. This Report is interesting because it offers an occasion to reflect on some provisions of the Technical Barrier to Trade (TBT) Agreement, which may be crucial for the assessment of the legality of environmental labelling regimes. The most troubling part of the Report is the one dealing with the trade-restrictive nature of the measure. The Panel seems to have relied on a test by which if a measure does not reach its objectives perfectly, any other ineffective measures adopted with allegedly the same goals can be judged as a valid less-trade restrictive alternative. In other words, two wrongs seem to make a right in the view of the Panel; a conclusion that, for obvious reasons, will not be greeted with enthusiasm by environmentalists.

Vesco Paskalev

Can Science Tame Politics: The Collapse of the New GMO Regime in the EU
European Journal of Risk Regulation 2/2012: pp. 190-201 [Article]
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On 2 March 2010 the European Commission authorised the cultivation of a BASF’s genetically modified potato “Amflora” throughout the European Union. This came after a tortuous process commenced in 1996 and so far it is the only authorisation of a GMO for cultivation in EU since the current regulation was established.1 On 3 March 2010, President Barroso announced that the Commission intends to propose amendments to the current regulation to allow the Member States to prohibit the cultivation of GMO authorised for cultivation in the EU and it did so on June 13, 2010. This is one of the very few cases where decision-making power is effectively devolved back from Union to state level; it is even more impressive that this is happening on the initiative of the Commission and despite the obvious negative consequences for the internal market.2 In the meantime BASF botched the 2011 growing season for Amflora in Sweden and in 2012 announced that it withdraws its GM crops from the EU. This article follows the saga purports to find the reasons why it entailed an immediate change.

Claudio Mereu

Schizophrenic Stakes of GMO Regulation in the European Union
European Journal of Risk Regulation 2/2012: pp. 202-211 [Article]
[Click here to show Abstract]

EU legislation on genetically modified organisms (GMOs) is the most stringent legislation governing the matter in the world, laying down strict conditions relating to labelling, traceability, threshold and release on the market. In light of a recent Commission proposal to amend Directive 2001/18, which currently regulates the release of GMOs on the European market, this article asks whether and on what basis such stringency is justified. This is done through an in depth analysis of the EU regulatory framework for GMOs while at the same time highlighting the multiple interests at stake (environmental, scientific, industrial, political, national and European). This article argues that the European institutions should proceed to amend Directive 2001/18 on the basis of a detailed examination of the benefits as well as the risks that GMOs present. This article, however, raises concern that the European regulatory framework will focus exclusively on the risks or on political concerns relating to GMOs instead, for it is a fear of GMOs that seems to permeate the system from top to bottom.

Guillermina Forno and Eduardo Orti

Biotechnology - Biosimilars: Current situation and future expectations
European Journal of Risk Regulation 2/2012: pp. 213-218 [Report]
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Biotherapeutics, also known as biomedicines, biopharmaceuticals or biotechnology products, can be used for the augmentation or replacement of naturally occurring proteins in numerous pathological conditions, including common diseases and rare genetic conditions. Currently, the two mature biotherapeutic

Emanuela Gambini

Biotechnology: The Product of Nature Doctrine in the Myriad Saga
European Journal of Risk Regulation 218-223: pp. Stück [Report]
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On March 26, 2012, the U.S. Supreme Court granted the petition for a writ of certiorari on Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al. (the “Myriad case”)1. This decision vacated the judgment of appeal and remanded the case to the United States Court of Appeals for the Federal Circuit for further consideration in light

Ignacio Carreño

Food: Overview of the Standard of Review for Possible Justifications to Introduce National Food Labelling Rules in the EU
European Journal of Risk Regulation 2/2012: pp. 223-225 [Report]
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Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers,1 which consolidated the existing Directives on food labelling and nutrition labelling in a single text, entered into force on 12 December 2011 as a further step towards the harmonisation of food labelling laws in the EU.

Ignacio Carreño

Food: EU and US Mutually Recognise their Respective Organic Standards and Control Systems as Equivalent
European Journal of Risk Regulation 2/2012: pp. 225-227 [Report]
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On 15 February 2012, the EU Commission, the US Department of Agriculture (hereinafter, the USDA) and the US Trade Representative concluded in Nuremberg, Germany (at the BioFach World Organic Fair, the world’s largest fair for organic products), a bilateral agreement recognising their respective standards and control systems for organic food as equivalent.

Evisa Kica

Nanotechnology: The Drive Towards Nanotechnology Standardization: Shifting Roles in Governance and Key Challenges
European Journal of Risk Regulation 2/2012: pp. 227-234 [Report]
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In recent decades, the development and the application of nanotechnology has been seen in various technological fields ranging from healthcare to food, agriculture, cosmetics and transportation. A number of disciplines, including electronics, biotechnology

Elen Stokes and Diana M. Bowman

Nanotechnology: Looking Back to the Future of Regulating New Technologies: The Cases of Nanotechnologies and Synthetic Biology
European Journal of Risk Regulation 2/2012: pp. 235-241 [Report]
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The regulatory radar has long been attuned to the challenges and opportunities of technological development. New technologies and their high-tech derivatives present regulators with a host of difficult, though not always unfamiliar, questions. The first of these usually centres on whether to regulate, proceeding to questions of how regulation ought to develop if intervention of some kind is deemed appropriate.

David Keyaerts

Regulatory Impact Assessment: The Impact of Better Regulation in the Case Law of the European Court of Justice
European Journal of Risk Regulation 2/2012: pp. 241-247 [Report]
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The title of this report refers to the better regulation, now smart regulation, program rolled out by the European Commission.1 The built-up, the rationales and objectives, the tools and future developments have been broadly discussed in economic and political science literature.

Enrico Bonadio

Pharmaceuticals: India Grants a Compulsory Licence of Bayer’s Patented Cancer Drug: The Issue of Local Working Requirement
European Journal of Risk Regulation 2/2012: pp. 247-250 [Report]
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Compulsory licences allow third parties to exploit a patented invention without the consent of the patentee. They therefore deprive patentees of their most important right, i.e. the right to say “no” to the exploitation of their invention by third parties.

Benn McGrady

Appellate Body Report, United States – Clove Cigarettes
European Journal of Risk Regulation 2/2012: pp. 251-256 [Case Note]
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In September 2011, the World Trade Organization (WTO) released the report of a panel tasked with considering a complaint brought by Indonesia concerning prohibitions on certain flavored tobacco products implemented by the United States (US). The panel concluded that the US violated WTO law and recommended that the US be asked to bring its laws into conformity with WTO law.1 The US appealed the panel’s decision. The Appellate Body of the WTO upheld the panel report on April 4, 2012. This case note gives a brief overview of the Appellate Body’s report and examines the implications for tobacco control and public health more generally.

Vadim Mantrov

Clarifying the Concept of Victim in the Motor Vehicle Drivers’ Liability Insurance: The ECJ’s Judgment in Case C-442/10
European Journal of Risk Regulation 2/2012: pp. 257-260 [Case Note]
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Case C-442/10, Churchill Insurance Company Limited v Benjamin Wilkinson and Tracy Evans v Equity Claims Limited [2011] ECR I-00000 Article 3 No. 1 of Council Directive on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, and to the enforcement of the obligation to insure against such liability, as amended, codified and repealed by Directive 2009/103/EC, OJ L - 103, of 02.05.1972. pp. 1–6. [First Motor Insurance Directive] Article 2 No. 1 of Second Council Directive 84/5/EEC of 30 December 1983 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, as amended, codified and repealed by Directive 2009/103/EC, OJ L – 8, of 11.01.1984. pp. 17–20. [Second Motor Insurance Directive] Article 1 No. 1 of Third Council Directive 90/232/EEC of 14 May 1990 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, as amended, codified and repealed by Directive 2009/103/EC, OJ L – 129, of 19.05.1990. pp. 33–35. [Third Motor Insurance Directive]

Alexander Weiss

Fundamental Freedoms Strengthen the Rights of Patients (again)
European Journal of Risk Regulation 2/2012: pp. 261-263 [Case Note]
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The Portuguese Republic has failed to fulfil its obligations under Article 49 EC (Article 56 TFEU) by making no provision for reimbursement of non-hospital medical care provided in another Member State which does not involve the use of major and costly equipment exhaustively listed in the national legislation, other than in the circumstances specified in Regulation (EEC) No 1408/71 […] or, to the extent that Decree-Law No 177/92 allows reimbursement in respect of such care, by making such reimbursement subject to prior authorization (official headnote).

Fabrizio Cafaggi

The Reality of Precaution – Comparing Risk Regulation in the US and Europe
European Journal of Risk Regulation 2/2012: pp. 265-272 [Book Review]
[Click here to show Abstract]

by Jonathan Wiener, Michael Rogers, James Hammitt, and Peter Sand (eds). Washington: Resource for the Future Press, 2011 602 pp., $69.95, Paperback.

Giorgio Tosetti Dardanelli

The financial crisis in constitutional perspective – The dark side of functional differentiantion
European Journal of Risk Regulation 2/2012: pp. 273-275 [Book Review]
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Edited by Poul F Kjaer, Gunther Teubner and Alberto Febbrajo Oxford: Hart Publishing, 2011, 444 pp., £60.00, Hardcover.

Timo Fest

Corporate Finance Law Principles and Policy
European Journal of Risk Regulation 2/2012: pp. 275-277 [Book Review]
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Edited by Louise Gullifer and Jennifer Payne Oxford: Hart Publishing, 2011, 788 pp., £37.50, Paperback.

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ISSN 16 19-52 72

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