Harmonizing Intermediary Copyright Liability in the EU: A Summary

This chapter reviews the lessons of European tort law for intermediary liability in copyright in order to plot a path towards the European harmonization of the area. In the absence of a complete EU framework for intermediary accessory copyright liability, Member States currently rely on home-grown solutions. This chapter examines three examples of such solutions: those of the UK, France, and Germany. The selected national jurisdictions represent three major tort law traditions of Europe. The analysis reveals three cross-jurisdictional approaches to intermediary liability in copyright: intra-copyright solutions, tort-based solutions, and injunction-based solutions. On the basis of these options, and taking into account the lessons of existing projects on the harmonization of European tort law, as well as the case law of the Court of Justice of the European Union, the chapter proposes a framework for European intermediary liability in copyright. As the chapter explains, this is informed by existing EU and national law on the copyright, tort, and fundamental rights level.

11. The Regulation of Medicines

All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate; providing students with a stand-alone resource. This chapter examines the regulation of medicines. It first explains what a medicine is and the need for it to have a marketing authorization before it can be put into circulation. It covers the importance not only of establishing safety and efficacy before licensing, but afterwards as well, through pharmacovigilance mechanisms. The chapter covers the increasing European harmonization of the rules covering the licensing and marketing of medicines, and briefly discusses the implications of Brexit. Finally, it looks at liability for defective medicines, and the strict liability regime under the Consumer Protection Act.

The Third French Individual and National Food Consumption (INCA3) Survey 2014–2015: method, design and participation rate in the framework of a European harmonization process

ObjectiveAssessing dietary exposure or nutrient intakes requires detailed dietary data. These data are collected in France by the cross-sectional Individual and National Studies on Food Consumption (INCA). In 2014–2015, the third survey (INCA3) was launched in the framework of the European harmonization process which introduced major methodological changes. The present paper describes the design of the INCA3 survey, its participation rate and the quality of its dietary data, and discusses the lessons learned from the methodological adaptations.DesignTwo representative samples of adults (18–79 years old) and children (0–17 years old) living in mainland France were selected following a three-stage stratified random sampling method using the national census database.SettingFood consumption was collected through three non-consecutive 24 h recalls (15–79 years old) or records (0–14 years old), supplemented by an FFQ. Information on food supplement use, eating habits, physical activity and sedentary behaviours, health status and sociodemographic characteristics were gathered by questionnaires. Height and body weight were measured.ParticipantsIn total, 4114 individuals (2121 adults, 1993 children) completed the whole protocol.ResultsParticipation rate was 41·5% for adults and 49·8% for children. Mean energy intake was estimated as 8795 kJ/d (2102 kcal/d) in adults and 7222 kJ/d (1726 kcal/d) in children and the rate of energy intake under-reporters was 17·8 and 13·9%, respectively.ConclusionsFollowing the European guidelines, the INCA3 survey collected detailed dietary data useful for food-related and nutritional risk assessments at national and European level. The impact of the methodological changes on the participation rate should be further studied.

Book review: Tax law (By: Professor PhD Mihaela Tofan)

Not long after the actual implementation of the two new codes (Fiscal Code and the Fiscal Procedure Code), researcher and university professor Mihaela Tofan from Alexandru Ioan Cuza University (Iasi - RO), published the book Tax law [RO: Drept fiscal], the CH Beck Publishing, Bucharest, 2016 (Code ABE:978-606-18-0566-2), pages 324. The big issues that the book answers are given proper treatment concepts, features and functions of taxes, and the inclusion here of the most important aspects of tax procedures. We note that this book opens a perspective on Romanian national rules, but at the same time, due to the need for European harmonization of rules of tax law, discusses the issue of this space.

Guidelines on severity assessment and classification of genetically altered mouse and rat lines

Genetic alterations can unpredictably compromise the wellbeing of animals. Thus, more or less harmful phenotypes might appear in the animals used in research projects even when they are not subjected to experimental treatments. The severity classification of suffering has become an important issue since the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes. Accordingly, the breeding and maintenance of genetically altered (GA) animals which are likely to develop a harmful phenotype has to be authorized. However, a determination of the degree of severity is rather challenging due to the large variety of phenotypes. Here, the Working Group of Berlin Animal Welfare Officers (WG Berlin AWO) provides field-tested guidelines on severity assessment and classification of GA rodents. With a focus on basic welfare assessment and severity classification we provide a list of symptoms that have been classified as non-harmful, mild, moderate or severe burdens. Corresponding monitoring and refinement strategies as well as specific housing requirements have been compiled and are strongly recommended to improve hitherto applied breeding procedures and conditions. The document serves as a guide to determine the degree of severity for an observed phenotype. The aim is to support scientists, animal care takers, animal welfare bodies and competent authorities with this task, and thereby make an important contribution to a European harmonization of severity assessments for the continually increasing number of GA rodents.

From cultural distance to skills deficits: “Expatriates,” “Migrants” and Swiss integration policy

This article examines two social categories brought into being by recent migration policies in Switzerland: the expatriate (or “expat”) and the migrant. Treating these categories as relationally constituted, the article explores how this distinction was constructed and managed in response to processes of European harmonization in the 1990s, employing shifting discourses of difference: while Switzerland’s Three Circle immigration model differentiated immigrants along lines of “cultural distance” vis-à-vis Switzerland, Swiss participation in the Agreement on the Free Movement of Persons contrasted these groups according to a new discourse of “skills.” Focusing on this discursive transition, the article argues that the expatriate-migrant distinction constructs differently valued immigrants whose contrasting relationship to the nation and “integration” is enacted in legal and social expectations surrounding language use. The article argues for critical attention to how “brain gain” and skills discourses enable, and extend border-maintaining discourses of “culture.”