bluuebunny/crossref_metadata_2025_split huggingface dataset:
“Better Regulation Yes – De-regulation No.”: A Trade Union's Perspective on the Regulatory Reform Agenda in the UK
Authors: Veale Sarah 
Published: February 2017

Good regulation is essential, to protect employees, consumers and the public, as well as the environment. To argue that the market should be allowed to be the determinant of working conditions, together with a bit of exhortation to employers to behave decently, is to accept the Victorian approach that allowed children to work in coal mines.The massive problems in the finance sector recently also show only too well the impact of weak regulation and de-regulation.That said, Governments do not always get it right when they do regulate and there is undoubtedly some regulation that is no longer necessary, or is out of date, or is over-complicated or hard to enforce. Neither have Governments showed themselves to be very good at assessing public risk or balancing public health and environment protection with innovation and growth. As the former Risk and Regulation Advisory Council suggested, risk is often assessed through the prism of media sensationalism, political point scoring, civil service attachment to legislation and “risk mongers” such as insurance companies that have a vested interest in talking up risk.
The Role of Experts in Assessing Damages – A Law and Economics Account
Authors: Faure Michael , Visscher Louis 
Published: February 2017

In this contribution we focus on the role of experts in the assessment of tort damages from an economic point of view. We distinguish two different aspects.First, we examine the role which economists might play in assessing damages in tort cases. This approach focuses on the insights that Law and Economics provides regarding the correct assessment of damages. We pay specific attention to two problematic forms of losses where economic insights may play an important role: pure economic loss and personal injury damage (both loss of income and compensation for immaterial losses due to fatal and non-fatal accidents).Second, we investigate from a Law and Economics point of view the role of experts in general (not only economists) in the assessment of damages. We discuss i.a. the question why experts may be involved in the assessment of damages, the potential problems (and the possible solutions) when using experts, and differences between party appointed experts and court appointed experts.It turns out that the economic analysis can provide a different, insightful viewpoint in some respects, such as the fact that market based mechanisms may help to provide incentives to party appointed experts to provide an accurate and objective damage assessment.
Nanotechnology
Authors: Laurent Brice 
Published: February 2017

Nanomaterials have been the object of numerous public and private initiatives aiming to manage their risks and maximise their benefits. Proponents of nanotechnology programmes argue that their potential negative impacts need to be dealt with appropriately, and wish to integrate these concerns early in the industrial development of these substances. Science policy programmes do not provide a clear definition of the term “nanomaterials”. Defining nanomaterials, however, has become a central concern. It is called for by manufacturers who wish to sell the “nano” quality of their products as well as by associations who wish to classify products in order to facilitate consumer choice or introduce constraints on production.This is more than an obscure technical and legal issue for specialists. Indeed, science and technology studies has shown that technical classifications perform social order, and that the creation of new entities destabilises the conduct of democratic life. For instance, Sheila Jasanoff demonstrates that the “ontological uncertainty” of biotechnological objects leads to the construction of different political forms in the United States and Europe. Building a legal and technical framework for biotechnology objects allocates public roles, defines expertise objectivity, and identifies public concerns – in short, it shapes political organisations at the same time as it constructs technological definitions.
On Methods Used to Check Compensation for Additional Costs Generated by a Policy of Selling Below Cost in the Door-to-Door Parcel Delivery Sector
Authors: Gębski Szymon 
Published: February 2017

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.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.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).
Biopatenting: “Angst” v. European Harmonization – The ECJ Decision on Stem Cell Patents
Authors: de Sousa e Brito Clara Sattler 
Published: February 2017

Case C-34/10 Brüstle v. Greenpeace1.Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that:–any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’;–it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.2.The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.3.Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.
Schizophrenic Stakes of GMO Regulation in the European Union
Authors: Mereu Claudio 
Published: February 2017

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.
Clarifying the Concept of Victim in the Motor Vehicle Drivers' Liability Insurance: The ECJ's Judgment in Case C-442/10
Authors: Mantrov Vadim 
Published: February 2017

Case C-442/10, Churchill Insurance Company Limited v Benjamin Wilkinson and Tracy Evans v Equity Claims Limited [2011] ECR I-00000Article 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]
Access to Regulatory Information on Agrochemicals – To which extent does Regulation 1107/2009 prevail over the EU Transparency Legislation?
Authors: Garçon Gérardine 
Published: February 2017

Agrochemicals belong to the best tested and evaluated substances in Europe. Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market (“Regulation 1107”) sets forth the requirements regarding quality, safety and efficacy of agrochemicals and provides which documentation has to be submitted in order to obtain regulatory approval. The documents filed with the regulatory authorities contain proprietary information and know-how of the registrants. Accordingly, registrants have a legitimate interest in confidential treatment. Regulation 1107 thus contains specific confidentiality provisions.On the other hand, EU legislation on transparency, in particular the legislation implementing the Aarhus Convention, provides for rights of access to information held by institutions. Recently, a number of legal actions related to the regulatory procedures for agrochemicals have been based on the transparency legislation.This report analyses the relationship between the transparency legislation and Regulation 1107 with regard to rights of access to information provided in the regulatory process for agrochemicals.
The Product of Nature Doctrine in the Myriad Saga II
Authors: Gambini Emanuela 
Published: February 2017

In June 2013, the U.S. Supreme Court decided Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., holding that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring”.This case note gives an overview of the U.S. Supreme Court's decision, which is focused on the product of nature doctrine, and discusses its implications for the implementation of the criterion of isolation to DNA sequences and the United States Patent and Trademark Office's long-standing practice of granting patents on isolated DNA sequences (author's headnote).
Revision of the Regulatory Framework for Medical Devices in the European Union: The Legal Challenges
Authors: Hancher Leigh , Földes Maria Eva 
Published: February 2017

This special edition of the European Journal of Risk Regulation deals with a highly topical, complex and controversial subject matter – the reform of the regulation of medical devices in the European Union.At first sight, and as further detailed in the following articles, there appears to be a general consensus about the need to improve the EU (and indeed the US) regulatory framework on medical devices, especially for high-risk categories of devices. Stakeholders including representatives of the industry, patient and consumer organizations, national authorities, healthcare professionals, agree that there is a need for change. However, opinions differ on what needs to be changed and how. Three alternatives for reform of the current EU systemof regulation have been debated over the past years: the adoption of a pharmastyle system of pre-market authorisation; maintaining the status quo but strengthening implementation and supervision in the Member States; or finally, introducing common technical specifications together with specific guidelines for certain high-risk devices.
Trade, the Precautionary Principle, and Post-Modern Regulatory Process
Authors: Bergkamp Lucas , Kogan Lawrence 
Published: February 2017

The Transatlantic Trade and Investment Partnership (“TTIP”) has been hailed as an opportunity for the world's two largest consumer markets to expand inter- regional trade, investment and jobs, and to secure greater regulatory convergence that could considerably reduce costly and market-distorting extra-territorial non-tariff regulatory trade barriers. As fears of potential adverse effects on the World Trade Organization’s multilateral trading system have abated after the Doha round stalled, the initiation of the TTIP has been welcomed by the business communities on both sides of the Atlantic.Notwithstanding the anticipated benefits, questions arise with respect to both the way the negotiations are conducted and the topics covered. The TTIP negotiating mandate covers three main elements: (i) market access, (ii) regulatory convergence, and (iii) trade rules addressing shared global challenges.
Science, Scientist and Judges: Can Judges try Science?
Authors: Fioritto Alfredo 
Published: February 2017

Case n. 380, 22.10.2012, Victims of the earthquake v. Barberi et al., (members of the NationalCommission for the Prediction and Prevention of Major Risks),Tribunal of L'Aquila, grounds delivered on 29.01.2013; (first degree of judgment).Articles 113, 589, c.1and 3, 590 Criminal Code (113 – Cooperation in negligent homicide, 589 – Negligent homicide, 590 – Negligent personal injury)The Tribunal of L’Aquila condemned seven members of the National Commission for the Prediction and Prevention of Major Risks to six years in prison for manslaughter because they dismissed the role of scientists in a March 31, 2009 meeting. The meeting was convoked in L’Aquila to provide the population of L'Aquila, which was scared after a continuous series of tremors lasting three months, with serious information on a scientific base. On the contrary, the members of the Commission supported a press campaign launched by the Chief of the National Civil Protection to reassure the population. Five days after the meeting, a serious tremor took place causing more than 300 deaths.
In the Aftermath of the “Myriad Case” – Myriad Is Denied Preliminary Injunction Against Ambry Genetics
Authors: Gambini Emanuela 
Published: February 2017

On March 10, 2014, the U.S. District Court of Utah, Central Division, decided in University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, holding that “Plaintiffs are not entitled to a preliminary injunction”, as they “are unable to establish that they are likely to succeed on the merits of the claims” nor “that the equitable factors support issuance of the requested injunction”.This case note gives an overview of the U.S. District Court's of Utah memorandum decision and order denying plaintiffs’ motion for preliminary injunction and discusses its implications for the implementation of the criterion of isolation to “synthetic” DNA sequences, such as primers and probes.
Risk in Public-Private Partnerships and Critical Infrastructure
Authors: Bovis Christopher H. 
Published: February 2017

The process risk allocation is essential for effective PPP contracts, depending on the scope of defined tasks and responsibilities between the parties in their quest to deliver public services. However, risk in critical infrastructure is sui generis risk which could not be treated contractually and transferred by the public sector to the private sector or retained by the party to an arrangement which is suited best to borne such risks.Risk in critical infrastructure, being either internal or external, is endemic to the relevant services andwhen critical infrastructure is delivered by public-private partnerships or owned by private actors, the treatment of such risk merits a third-party approach. Such third-party could be an industry in itself, such as insurance, re-insurance or hedge fund insurance bond finance, or a sector / industry approach which related to the owners/operators of the relevant infrastructure, by means of collective apportioning and mitigation of risks associated with the failure of providing services fromsuch infrastructure. The most innovative way of treating risk of critical infrastructure remains in the discretion of EU Member States, in the form of integrating costs related to risk assessment and security measurers to protect critical infrastructure into tariff arrangements of relevant services. In such manner, the enduser / consumer of services ensures and collectively insures their delivery against any type of risk which is not quantified and determined as part of corporate arrangements between the state and the private sector provider of services.
Better for Whom?
Authors: Sarpi Francesco 
Published: February 2017

At first sight, the new “better regulation package” probably appears as one of the most ambitious and comprehensive set of measures on the quality of EU regulation developed in recent years. It introduces relevant innovations as far as both better regulation tools(impact assessment-IA, ex post evaluation, consultation) and governance (the Regulatory Scrutiny Board-RSB, the REFIT Platform and the proposal on the new Inter-institutional agreement on Better Lawmaking-IIA)are concerned. Moreover, the package is a clear demonstration of the Commission's political commitment towards the relaunch of the smart regulation agenda, already proved by its inclusion within the scope of the mandate of the First Vice President, Mr. Timmermans.Nonetheless, ambition and wideness are not the only relevant criteria to judge the package. It could indeed be assessed also from a different perspective, i.e. by analysing the possible effects it could produce and the incentives it could provide for some key players: EU institutions, Member States (MS) and stakeholders.
Limits of NGO Rights to Invoke Access to Justice under the Aarhus Convention
Authors: Garçon Gérardine 
Published: February 2017

Joined Cases C-404/12P and C-405/12PThe Aarhus Convention was concluded in order to strengthen the rights of the public on access to information, public participation in decision-making and access to justice in environmental matters. The Convention provides that members of the public shall have access to administrative or judicial procedures to challenge measures by private persons and public authorities that contravene provisions of national law relating to the environment. At EU level, a regulation made the Aarhus Convention applicable to EU institutions. Pursuant to that regulation, review of measures adopted by EU institutions is limited to administrative acts. Two NGOs challenged the legality of that limitation and filed legal action. The case was related to the establishment of EU maximum residue levels for active substances contained in crop protection products. The Commission refused to review this measure which it considered to be no administrative act. The Court of Justice of the European Union has recently given its judgment in that case. The impact of the judgment goes beyond the crop protection sector as it concerns the scope of the internal review concept in general. Further, but not less important, the Court has clarified to which extent international treaties concluded by the EU can be relied upon by individuals.
Just the TTIP of the Iceberg? Dynamics and Effects of Information Leaks in EU Politics
Authors: Patz Ronny 
Published: February 2017

“[M]any observers agree that the Commission has been ‘leaking like a sieve’”.Leaks have become a major element of European Union politics. The Transatlantic Trade and Investment Partnership (TTIP) leak in early May 2016 is neither the first of its kind nor will it be the last. Transparency by leaks – or “transleakancy” as the series of publications of confidential TTIP negotiation documents has already been coined – is one element of the political game that different interest groups, governmental and non–governmental, play on both sides of the Atlantic. And yet, leaked EU documents have been shared in wider policy-networks all along, independent of whether they have received media attention or not. The difference is that leaks similar to those that we see on TTIP have reached a new level of importance. Here, themere fact of their existence makes them newsworthy. The impact of these leaks on public debates is seen as amajor risk for negotiators.
The Cases ofEdam HollandandGouda Holland
Authors: Mantrov Vadim 
Published: February 2017

Cases C-517/14 P and C-519/P, Schutzgemeinschaft Milch und Milcherzeugnisse e.V. v European Commission, Kingdom of the Netherlands, Nederlandse Zuivelorganisatie, unreported 24 October 2014 (Seventh Chamber).In the two related cases commented on, the Court of Justice of the European Union (CJEU) dealt with assessment of locus standi in the case of an applicant who disputed the validity of registration of two indications of geographical origin (IGOs), namely Edam Holland and Gouda Holland, being compound designations and containing a famous generic word designation (name), i.e. Edam and Gouda respectively. The importance of both cases relates, on the one hand, to the fact that registration of these IGOs was challenged on the basis of the generic names Edam and Gouda which are extensively used in practice, occupying a considerable market share. On the other, both cases could be a signal whether the CJEU re–affirms its restrictive approach to assessment of locus standi under Article 263 (4) TFEU. Although the CJEU re–affirmed its longstanding case law on restrictive assessment of locus standi also concerning registration of a compound geographical designation on the basis of a generic name, yet, as is argued in this case note, this approach did not take into account the specifics of registering IGOs (author's summary).
Peer-to-Peer Lending: Opportunities and Risks
Authors: Lenz Rainer 
Published: February 2017

AbstractWeb-based financial intermediation on a peer-to-peer (P2P) basis will eventually prevail as an economically superior form of organisation compared to the traditional banking business model. P2P lending is the most popular type of crowdfunding, whereby an internet platform collects small amounts of funds from individuals in a crowd to finance collectively a larger loan to individuals or businesses. Unlike a commercial bank, the platform does not take risks through its own contractual positions. Whereas banks accumulate risks by taking positions on their balance sheet, platforms decentralise the risks by spreading them to their users. The emergence of financial platform businesses challenges legislators and regulators in several respects: the “easy way” of modifying existing finance and banking laws is inadequate; the internal organisation and knowledge of staff is not well suited to regulating crowdfunding; and capital mediation by crowdfunding platforms requires a different regulatory approach than banking. Finally, there is no doubt that P2P lending platforms will in the long run need a dedicated, single European regulatory framework.