bluuebunny/crossref_metadata_2025_split huggingface dataset:
Purpose-Bound Patent Protection for Genes
Authors: Lamping Matthias 
Published: February 2017

Case C-428/08, Monsanto Technology [2010]The Biotech Directive does not provide for absolute patent protection of DNA sequences. Protection is subject and restricted to the disclosed function (or purpose) of a gene; if the function is not fulfilled at the time of the alleged infringement the protection is therefore suspended. National law may not depart from the protection conferred by the Directive due to its exhaustive character (author's headnote).
Risk vs Hazard and the Two Souls of EU Risk Regulation: A Reply to Ragnar Lofstedt
Authors: Alemanno Alberto 
Published: February 2017

When called upon to regulate risk, the EU carries the threefold onus to (i) protect its people(s); (ii) ensure the functioning of the internal market; and also (iii) to allocate the resources available wisely and efficiently.This creates a number of pressures and dilemmas for the EU, notably for the Commission when initiating legislation and for the EP and the Council when co-legislating.According to a familiar script – faithfully narrated by Ragnar Lofstedt in his opening article –, the EU has, in recent years, been subscribing to a progressive ideal of regulation based on evidence. As a result, by making a commitment to the use of optimization tools, such as risk assessment and regulatory impact assessment, the EU has been gradually developing a European risk regulation model that seems to put the EU at the forefront of a wider move towards evidence-based policy-making. Given the historical affection of the EU integration process to technocratic modes of governance, this choice is not surprising.
How Chemicals Are Regulated in the European Union: A Commentary
Authors: Jørgensen Dan 
Published: February 2017

Professor Ragnar Lofstedt has written a very interesting and thought provoking paper “Risk versus Hazard Assessment – How to Regulate in the 21st Century”. The paper reflects upon the advantages and disadvantages of using risk assessments compared to hazard assessments of chemical compounds. It investigates the debate that has been going on in recent years in Europe between regulators, politicians, NGOs and industry on the subject.This commentary will discuss some of the assumptions that the analysis rests on as well as some of the conclusions that are presented in the paper.First, the commentary will discuss the definition and critique of the “risk assessment” approach that Lofstedt presents. The commentary here concludes that Lofstedt's analysis of risk assessment does not take sufficiently into account the fact that risks can not always be calculated in an exact way because uncertainty rather than certainty is the condition when analysing chemicals.
A Comment to Ragnar Lofstedt's Risk versus Hazard
Authors: Skinner Peter 
Published: February 2017

It is frequently suggested that the EU in general and Parliament in particular suffer from an addiction to making rules and regulations on all things from chemicals to chocolates and from buses to booze. Classically, this is the first repost of the critic who sees the EU as legal procurator dressing up the legislative Christmas tree. Firstly, it is important to note that there are legitimate concerns that regulations passed in Europe are not always based on the best available science and perhaps even the best scientists. It is up to those with responsibility for making regulation to make it according to best verifiable evidence at hand. When you consider how important the potential implications are for industry and consumers alike then it is clearly of great importance to increase the use of risk analysis tools.When asked to explain the difference between risk and hazard it is perhaps helpful to consider the life of a zoo keeper in charge of the Lions’ den. The animals themselves can be seen as a “hazard”, when the animals are free and uncaged, people in the surrounding area are exposed to the risk that they may be attacked. However, when the animal is caged, we’re dealing with altogether different beasts as only the zoo keeper (who knows how to handle the risk) could be exposed to certain dangers. It may remain “hazardous” but while those around it are protected there is no exposure to attack, therefore there is no risk.
Regulating New Risks: Emergency Contexts, Institutional Reform and the Difficulties of Europeanisation – Case Studies from Portugal
Authors: Gonçalves Maria Eduarda 
Published: February 2017

The expression “risk regulation” conveys the idea of normalisation of the way in which the State deals with the problems raised by risk, through rules, institutions and procedures set up to either prevent risk or manage it once it materialises. It must be conceded, however, that there is a tension between risk regulation (understood as a means of bringing risk under control) and the fact that the emergence of new risks has persistently caused turmoil. For this reason, risk is proving to be a serious test of the State's ability to pursue the public interest when dealing with issues which are characteristically complex, both technically and socially.The European Union has responded to the BSE and GMO crises by developing a truly European risk regulation system which has been a major driver of legal and institutional reform. Implementation has been far from homogeneous across the Member States, however, my premise being that the objective of normalisation has met perhaps unexpected obstacles in Southern European countries like Portugal, raising the question of the kind of local conditions which may either favour or hinder Europeanisation processes. This paper discusses the topic based on the analysis of three case studies illustrating the way the Portuguese state has tackled environmental and public health risks, and the impact of EU law and policy on the whole question.
A Brief Comment on Science-based Risk Regulation Within the European Union
Authors: Stibernitz Barbara 
Published: February 2017

Nowadays as political decision making involves such a huge range of complex matters, scientific experts have become more and more involved in European risk regulation. The support by so-called independent experts may, on the one hand, be seen as a guarantee of rational decision making, increasing the quality of decisions as well as the general acceptance of all people affected. On the other hand, the number of expert groups, scientific committees and agencies helping the Commission in fulfilling its duties is vast and confusing.In addition, scientific advisory bodies often face the burden of unrealizable independence, as well as a lack of transparency and democratic control. This article sums up the central position of science-based risk regulation within the European Union (EU), referring to the necessity for expert opinion as well as to consequent problems concerning the involvement of these experts in risk regulatory actions.
Long Awaited Guidance on the Meaning of “Regulatory Act” for Locus Standi Under the Lisbon Treaty
Authors: Buchanan Camilla 
Published: February 2017

Case T-262/20 Microban International Ltd and Microban (Europe) Ltd v. CommissionThe conditions for bringing direct actions before the EU General Court have been opened under Article 263, fourth paragraph, of the Treaty on the Functioning of the European Union (“TFEU”) through the introduction of less restrictive rules on legal standing for private applicants challenging regulatory acts. The term “regulatory act” covers all acts of general application apart from legislative acts and includes implementing measures adopted by the European Commission under the comitology procedure. Initial case law provides welcome guidance on the application of the new rules on standing but questions still remain (author's headnote).
The Changing Face of Risk Governance: Moving from Precaution to Smarter Regulation
Authors: Rübig Paul 
Published: February 2017

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”.This is currently being debated on various levels, including that of the WTO (World Trade Organization), where science-based decision-making has always played an important role. The JRC (Joint Research Centre) is very active in this field and has developed, among others, a science-based approach to risk assessment in the area of nanotechnology. With the comitology procedure becoming more and more important, the European Parliament and its members have to assume their role with respect to risk management and explain it to the public.
Against the Failures of Risk Regulation Liability and Safety in Air Traffic Management (ATM)
Authors: Simoncini Marta , Contissa Giuseppe 
Published: February 2017

This article aims to analyse liability issues as a further means to regulate risks, in case the precautionary measures of the delivered safety system fail. Through liability, the risk that cannot be prevented can be transferred onto those parties who are in the best position to spread them. The allocation of liability thus works as an incentive to the correct functioning of the preventive measures. Liability rules appear to be a key legal remedy which can ensure both tort reparation and a fair and efficient distribution of burdens in a legal order. In this vein, air traffic management (ATM) is addressed as a case study, which shows the main issues and the gaps that liability rules face when dealing with the trade off between risk and safety as conveyed by technology.After having clarified the nature of the relations between risk and liability on the one hand, and automation and liability on the other hand, this article analyses liability issues in the framework of ATM by approaching this topic in a comparative way between the National Airspace System (NAS) of the United States of America (USA) and the Single European Sky (SES) of the European Union (EU).
Synthetic Marijuana Not a “Medicinal Product”
Authors: Luzak Joasia 
Published: February 2017

Joined Cases C-358/13 and C-181/14, Markus D. and G.Substances which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health do not fall within the scope of the definition of a “medicinal product” in the Directive 2001/83 (official headnote).Consumer safety and medicines control legislation is not suitable to penalise the introduction of new psychoactive substances on European markets (author's headnote).Art 1(2)(b) Directive 2001/83
On Obesity as a Disability
Authors: Cathaoir Katharina Ó 
Published: February 2017

Case C-354/13, Fag og Arbejde (FOA) v Kommunernes Landsforening (KL) [2014] (not yet reported)There is no general principle under European Union law prohibiting discrimination on the basis of obesity in regard to employment and occupation. Obesity alone is not a disability but can constitute a disability where it is accompanied by a limitation resulting from long term physical, mental or psychological impairments which in interaction with various barriers may hinder the full and effective participation of the individual in professional life on an equal basis with other workers (official headnote).In December 2014, the Court of Justice of the European Union (CJEU) issued a preliminary ruling addressing, firstly, whether obesity is a protected ground of non–discrimination, and, secondly, whether obesity can amount to a disability. This piece begins with an introduction to the topic of obesity, followed by the facts of the case, the CJEU's judgment and a comment on the decision.
Mere Retailers May be Penalised for Salmonella Contaminations in Fresh Poultry
Authors: Michl Walther 
Published: February 2017

Case C-443/13, Ute Reindl v Bezirkshauptmannschaft Innsbruck, ECLI:EU:2014:23701. Fresh poultry must be free from salmonella contaminations at all the stages of distribution including the retail stage.2. National law may impose a penalty on a food business operator which is active only at the distribution stage for placing salmonella–contaminated foodstuff on the market. It is for the national courts to determine whether such a penalty observes the principle of proportionality as laid down in Article 17 para. 2 of Regulation No 178/2002.
Pinpointing the Appropriate Legal Basis for External Action
Authors: Butler Graham 
Published: February 2017

Case C-658/11, European Parliament v Council of the European Union [2014] (not yet reported)CFSP acts can be challenged before the Courtwhen the arguments relate to procedural points outside of the CFSP articles in Title V TEU. The Court can annul Council CFSP acts when the proper notification procedures to the Parliament stemming from Article 218 TFEU have not been followed. The effects of CFSP acts can remain in place, even after the Court annuls them, until such a time when the act has been replaced.
Consumers May be Misled Despite the List of Ingredients Being Displayed on the Packaging of a Foodstuff
Authors: Ruiz Cairo Elisabet 
Published: February 2017

Case C-195/14, Teek anne ECLI:EU:C:2015:361, not yet publishedThe labelling of a foodstuff must not mislead the consumer by giving the impression that a particular ingredient is present, even though it is not in fact present. The list of ingredients may, even though correct and comprehensive, not be capable of correcting sufficiently the consumer's erroneous or misleading impression that stems from such labelling (official headnote)
TTIP Regulatory Cooperation
Authors: Herwig Alexia 
Published: February 2017

The leaked TTIP documents reveal that the EU and US are discussing the introduction of a detailed set of procedural requirements for the adoption of regulatory measures. Default provisions are set forth in the chapter on regulatory cooperation, applicable to goods and services. More specific provisions are being negotiated in the chapters on technical barriers to trade and on sanitary and phytosanitary measures. If they conflict with the regulatory cooperation chapter, they prevail.This article analyses the regulatory cooperation chapter insofar as it pertains to trade in goods but to the exclusion of SPS matters and anything provided in the TBT chapter itself. The questions this article examines are to what extent the TTIP proposals expand upon the obligations the two parties have already taken on under WTO law and to what extent the resulting regulatory coordination is consistent withWTO law. It will be shown that the US proposals on procedure may constrain substantive regulatory discretion beyond what applies under the GATT and TBT Agreement of the WTO. It will alsobe shown that the needs to conduct trade impact assessments and a detailed explanation of the necessity of measures anticipate a legal challenge to necessity and will provide information of much use to complainants in meeting their burden of proof.
Between Politics and Expertise: An Italian Perspective on Constitutional Law and Scientific Legitimacy
Authors: Morvillo Marta 
Published: February 2017

The dialectic between the technically (or scientifically) possible and the legally possible, which is implied in decision-making in conditions of uncertainty, raises crucial issues from a constitutional perspective. In particular, the emergence of a new factor of legitimacy – which could be envisaged as a form of “scientific legitimacy” – can be detected and needs to be integrated within the constitutional discourse.Through an overview of the case law of the Italian Constitutional court, the paper aims at highlighting the possible approaches to the need of a deeper integration of technical and scientific knowledge within the public decision-making processes, in an attempt to strike a balance capable of avoiding the two extremes of scientifically weak decisions on one hand, and of “technical deference” to experts on the other.
Transparency Regulation in Financial Markets – Moving into the Surveillance Age?
Authors: Chiu Iris H-Y 
Published: February 2017

In the wake of the global financial crisis, the trajectory of legal reforms is likely to turn towards more transparency regulation. This article argues that transparency regulation will take on a new role of surveillance as intelligence and data mining expand in the wholesale financial sector, supporting the creation of designated systemic risk oversight regulators.The role of market discipline, which has been acknowledged to be weak leading up to the financial crisis, is likely to be eclipsed by a more technocratic governance in the financial sector. In this article, however, concerns are raised about the expansion of technocratic surveillance and whether financial sector participants would internalise the discipline of regulatory control. Certain endemic features of the financial sector will pose challenges for financial regulation even in the surveillance age.
Sharing Energy
Authors: Butenko Anna 
Published: February 2017

AbstractThe sharing economy has become a reality in many sectors, including energy. Energy consumers are increasingly able and willing not only to produce their own energy and thus become prosumers, but also to sell this energy on the local or national energy market along with ‘traditional’ energy market players. Thus, the role of prosumers is de facto extended as to include the parallel roles of consumers, producers, suppliers and traders. Against this background, this article inquires whether it is possible for prosumers to share energy under the current Dutch regulatory framework. This question has been evaluated from the theoretical perspective of the regulatory disconnection between innovation and regulation.
Will Chemical Packages be the only Future for Biotechnology? Why the Bayer-Monsanto Merger Could be a Good Opportunity to Put Things in the Right Place
Authors: Varela Justo Corti 
Published: February 2017

AbstractThis section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.
Regulating Sustainability Claims on Seafood - EU Ecolabel, Unfair Commercial Practices Directive or Seafood Information Requirements?
Authors: Schebesta Hanna 
Published: February 2017

AbstractIn February 2016, the Feasibility Report on options for an EU ecolabel scheme for fishery and aquaculture products was published. The study did not make a strong case for the introduction of a seafood EU Ecolabel and it is unlikely that the European Commission will pursue this policy option. We argue that sustainability information on seafood should not be framed through the EU Ecolabel debate. The more pressing issue concerns self-declared sustainability claims on seafood products. As a possible solution, we propose to address these by re-invigorating the labelling rules on seafood information in the Regulation on the Common Organisation of the Markets in Fishery and Aquaculture Products.
The Trade Law Consequences of “Brexit”
Authors: Vergano Paolo R. , Dolle Tobias 
Published: February 2017

AbstractThis section highlights the interface between international trade and investment law and municipal and international risk regulation. It is meant to cover cases and other legal developments in WTO law (SPS, TBT and TRIPS Agreements and the general exceptions in both GATT 1994 and GATS), bilateral investment treaty arbitration and other free trade agreements such as NAFTA. Pertinent developments in international standardization bodies recognized by the SPS and TBT Agreement are also covered.
New Transnational Governance and the Changing Composition of Regulatory Pluralism in Southeast Asia
Authors: Gillespie John 
Published: February 2017

AbstractOver the past three decades, Transnational Production Regimes (TPRs) have become the main source of technical and regulatory knowledge for Southeast Asia corporations. Typically TPRs transfer knowledge from lead firms located in the industrial North to supplier firms located in Southeast Asia. Regulatory knowledge transferred through TPRs largely bypasses Southeast Asian laws and legal institutions to directly influence the behavior of supplier firms. Although socio-economic studies show that TPRs are responsible for generating much wealth creation in the region, they hardly register in the socio-legal literature. Drawing on ethnographic studies conducted in Vietnam, this paper will attempt to explain why different types of TPRs produce different regulatory responses in Vietnamese firms. Preliminary findings suggest differences in the way that regulatory knowledge transmitted through Northeast Asian and Euro-American TPRs is absorbed and integrated into the organisational fabric of Vietnamese firms. They also shed light on two well-documented phenomena in Vietnam. In conclusion the paper will argue that TPRs displace state commercial laws and are partially responsible for the slow progress of conventional law and development projects in changing regulatory practices. It will contend that the different kinds of TPRs generate regulatory pluralism and the uneven application of state law in different business sectors.
The Conceptualisation of Pro Bono in Singapore
Authors: Whalen-Bridge Helena 
Published: February 2017

Abstract“Pro bono” is a familiar phrase in North American jurisdictions that generally refers to a lawyer’s provision of free legal services to indigent persons. The phrase “pro bono” has also come to imply a particular approach to a lawyer’s relationship to indigent persons, one that stresses the obligatory as opposed to the charitable nature of the services provided. To what extent has this phrase, and its conceptualisation of a lawyer’s role, been used in Asian jurisdictions? This article examines how one Asian jurisdiction, Singapore, conceptualises a lawyer’s relationship to indigent persons by examining newspaper usage of phrases describing legal services for indigent persons. The article argues that changes in usage over time, from free legal services and legal aid to inclusion of pro bono, coupled with increased discussions of access to justice, represent a shift to a more obligatory concept of indigent legal services. An obligatory conceptualisation potentially exerts greater pressure on lawyers to provide indigent legal services, but can also exert pressure to revise the historical lack of broad-based government funded criminal legal aid in Singapore.