Although the applicable standard of review under Articles 2.2/5.1 of the SPS Agreement is not de novo, an investigation of the WTO panel remains intrusive in terms of objectivity and coherence of risk assessment. Moreover, the panel's review does not end with a final conclusion reached by the WTO Member in the risk assessment. It also extends to the quality of the reasoning and the intermediate interferences that led to the conclusion. If a WTO Member exercises expert judgment in its risk assessment, this needs to be sufficiently transparent and well documented (author's headnote).

The obligations of Article 5.1 and 5.6 are distinctive and independent from each other. Therefore, a violation of the first provision does not imply infringement of the latter one (author's headnote).

A visual display ban on tobacco products, imposed by national legislation of an EEA State, such as the one at issue in the case at hand, constitutes a measure having equivalent effect to a quantitative restriction on imports within the meaning of Article 11 EEA if, in fact, the ban affects the marketing of products imported from other EEA States to a greater degree than that of imported products which were, until recently, produced in Norway. It is for the national court to identify the aims which the legislation at issue is actually intended to pursue and to decide whether the public health objective of reducing tobacco use by the public in general can be achieved by measures less restrictive than a visual display ban on tobacco products (author's headnote).

The aim of this paper is to review the basic literature on scientific uncertainty in its statistical paradigm in order to provide enlightenment on one pivotal facet of the precautionary principle, i.e. the allocation of the burden of proof to demonstrate that an activity is not harmful to the environment. The purpose is not to explain a new theory of statistical inference, but to show how regulatory policymaking that is properly informed by scientific expertise and designed to avoid one type of error, may actually make other errors more likely and thus expose the public to danger. This problem is explained in terms of the conceptual as well as operational conflicts that arise when knowledge about statistical-inferential methods is applied to policymaking. The paper argues that this issue can be resolved by first reconsidering the burden of proof as a burden of uncertainty.

A national component is a necessary basis for a measure to freeze assets and once the Netherlands repealed the Sanctieregeling 2003 which formed the basis for Stichting Al Aqsa's asset freeze at the national level, the Community basis for the asset freeze also seized to exist (author's headnote).

The European Court of Justice (ECJ) rendered a decision regarding supplementary protection certificates (SPCs) for plant protection products and provisional marketing authorisation. The ECJ clarified that SPCs for patented plant protection products may also be based on provisional marketing authorizations pursuant to Article 8(1) Directive 91/114 (author's headnote).

Cautious skepticism rather than euphoric joy surrounds the activities of the European Commission developing its new – flexible – approach towards cultivation of Genetically Modified Organisms (GMOs). Following its announcement in the summer of 2010, new elements of the reform unravel at the beginning of 2011.

GMO regulation has experienced a rather uneasy track in the European Union. The specificity of the sector, with its economic importance, its social controversies as well as the high levels of uncertainty as to the long-term effects, have all contributed to various political and regulatory troubles in Europe and worldwide. After the revision of the first wave of regulation in 2001-2003, the de facto moratorium, and ensuing conflicts under the WTO adjudication, the situation seemed to be settling down.

In September 2011, the World Trade Organization (WTO) panel report in US – Clove Cigarettes was released. The report addressed a complaint brought by Indonesia concerning prohibitions on certain flavored tobacco products implemented by the United States (US). The dispute is one of a number of contemporary disputes under the WTO Agreement on Technical Barriers to Trade (TBT Agreement). Given that relatively few disputes have been resolved under the TBT Agreement, the outcome may have significant implications for interpretation of the agreement and risk regulation through technical regulations. The panel report may also have more specific implications for risk regulation in the context of tobacco products (author's headnote).

In rendering this decision, the Federal Supreme Court of Switzerland entered for the first time into a detailed analysis of questions relating to the cost-effectiveness of human healthcare. The decision, concerned with the availability of a drug for a rare genetic disease, makes it clear that the maximum amount available from a public health insurance provider for the medical treatment in a particular case has been reached once the amount requested by the individual patient cannot also be provided to all other persons in a comparable situation. It remains unclear, however, how cost-effectiveness is to be assessed below this maximum amount (author's headnote).

The EU has taken influence on the administrative laws of the Member States by introducing elements of public information, participation of stakeholders and private enforcement, and environmental law was the frontrunner of this development. The same tendency can be observed at the international level, culminating in the adoption of the Århus Convention in 1998. This has created tensions with traditional administrative law systems that have strongly relied on public authorities to produce the correct outcome whilst severely restricting private participation and private access to justice. The Trianel case, dealing with the protection of habitats against a coal power plant, demonstrates the need for fundamental adjustment of German administrative law, and it may lead to subsequent changes of the modalities of administrative procedural law in order to really allow the private enforcement of the public interest (authors’ headnote).

Article 88 (1) (a) of Directive 2001/83/EC must be interpreted as meaning that it does not prohibit the dissemination on a website, by a pharmaceutical undertaking, of information relating to medicinal products available on medical prescription only, where that information is accessible on the website only to someone who seeks to obtain it and that dissemination consists solely in the faithful reproduction of the packaging of the medicinal product, in accordance with Article 62 of Directive 2001/83, and in the literal and complete reproduction of the package leaflet or the summary of the product's characteristics, which have been approved by the authorities with competence in relation to medicinal products (official headnote).

Any business having experienced a product recall knows how costly this can be. Sometimes the main costs of the recall are concentrated around counteracting bad publicity, but if several or large numbers of batches are affected by the recall, the costs of the recall itself can mount up considerably.

In many large companies the overall responsibility for quality assurance and product safety is placed in a different part of the organization from the one responsible for product liability insurance and recall insurance.

As a consequence inside the organization there is not always a common understanding of what the insurance should cover and what the insurance actually does cover – or of whether and when the insurance company should become involved in the process.

The conditions of urgency for the granting of the interim suspension of a decision concerning the non-inclusion of an active substance in Annex I to Directive 91/414 should not be applied rigidly and mechanically and must be assessed in light of the specific circumstances of the case, in particular the progress of re-submission under Commission Regulation 33/2008, and be subject to a test of reasonableness (author's headnote).

The General Court annuls Decision C(2004) 1614 final, in which the Commission declared that the modified exemption to the aggregates levy in Northern Ireland, as notified by the United Kingdom, fell within the scope of Article 87(1) EC [107(1) TFEU] but was compatible with the common market on the basis of Article 87(3)(c) EC [107(3)(C) TFEU] (author's headnote).

Cases C-236/08 to C-238/08 Google France SARL, Google Inc. v. Louis Vuitton Malletier SA (C.236/08) and Google France SARL v. Viaticum, Luteciel SARL (C-237/08) and Google France SARL v. Centre national de recherche en relations humaines (CNRRH) SARL, Pierre-Alexis Thonet, Bruno Raboin, Tiger SARL (C-238/08)

1. The proprietor of a trade mark is entitled to prohibit an advertiser from advertising, on the basis of a keyword identical with that trade mark which that advertiser has, without the consent of the proprietor, selected in connection with an internet referencing service, goods or services identical with those for which that mark is registered, in the case where that advertisement does not enable an average internet user, or enables that user only with difficulty, to ascertain whether the goods or services referred to therein originate from the proprietor of the trade mark or an undertaking economically connected to it or, on the contrary, originate from a third party.

1. 1. The Commission is not entitled to assume that State resources constitute an advantage when it fails to examine whether: (i) the total amount of those resources exceeds the total amount of the net additional costs incurred by an undertaking providing an SGEI; (ii) that undertaking has other net additional costs associated with the provision of an SGEI for which it has the right to claim compensation.

2. 2. The use of a method different from that arising from Altmark Trans is justified only when the Commission is prevented, for objective reasons, from undertaking an examination of the information provided by a Member State.

3. 3. Even if the General Court is wrong in law when it examines information that was not subject to any analysis in the Commission’s decision, this did not affect the validity of its foregoing finding on the illegality of the contested decision (author’s headnotes).

The transfer of climate-friendly technologies from developed countries to developing countries has been identified in international forums as a key factor in efforts to mitigate climate change. Commentators and negotiators have argued, however, that efforts to transfer climate-friendly technologies from developed countries to developing countries have fallen far short of what is needed. Although a host of barriers play a role in the pace of transfer of clean technologies, such as lack of financial resources, inadequate infrastructure, trade barriers, and lack of skilled workers to name a few, intellectual property rights (IPRs) have been accused of being a particularly significant barrier. Developing countries have made strong proposals to severely curtail IPRs on clean technologies, particularly patent rights. These proposals present potential threats to patent rights on clean technologies in developing countries and include expanded compulsory licensing, excluding clean technologies from patenting, and revoking existing patent rights on clean technologies in developing countries. The motivation for such proposals stem largely from theoretical considerations, when, in fact, recent studies provide evidence that patent rights are not a barrier to the transfer of clean technologies to the developing world and, to the contrary, are more likely facilitating the diffusion of clean technologies in developing countries.

The interaction between organised interests and the European Union institutions has been subject to increasing study and analysis in recent years, and the relevance of this increasingly important research agenda has been highlighted by political scandals and developments in 2011.

Beneath the calm and measured prose of Dr. Caroline Foster lies a tsunami for the field of risk assessment in international adjudication.

Dr. Foster, a senior lecturer at the Faculty of Law, University of Auckland, looks boldly in the eye the difficult question of the influence of scientific evidence on international courts and tribunals. In an era where international law is endeavouring to come to terms with environmental protection, sustainable development, and public health and safety regulations and policies, international tribunals are called upon to adjudicate matters of extreme scientific complexity and, in this context, to understand the scientific approach to risk. One can no longer escape the realisation that judges and arbitrators on international tribunals rely on scientific expertise, and that this has a significant impact on their decision-making. This is one of the central tenets of Dr. Foster's book, and the basis for her analysis.

The General Court reaffirms its traditional form-based approach to dominance (author's headnote).

In November 2010, 171 Parties to the WHO Framework Convention on Tobacco Control (WHO FCTC) unanimously adopted the Punta del Este Declaration on implementation of the Convention. The Declaration follows the filing of an international investment claim against Uruguay by Philip Morris Products (Switzerland) and related companies. The Declaration reaffirms the commitment of the 171 WHO FCTC Parties to implementation of the Convention and addresses the relationship between the WHO FCTC and international trade and investment agreements, particularly in the context of intellectual property rights. This article outlines the Request for Arbitration, sets out the Declaration and the broader normative context in which it arose before touching briefly on the implications of the Declaration.