bluuebunny/crossref_metadata_2025 huggingface dataset:
Transparency Initiative by the FDA’s Center for Drug Evaluation and Research (CDER): Two qualitative studies of Public Perceptions
Authors: Chakraborty Sweta , Lofstedt Ragnar
Published: February 2017

Recent calls for transparency targeted towards regulatory bodies such as the US Food and Drug Administration has prompted investigation into the indubitable adoption of such measures. Specifically, the FDA's quarterly postings of AERS (Adverse Event Reporting System) signals on its CDER (Center for Drug Evaluation and Research) website, stemming from FDAAA legislation introduced in September 2007, is analysed from a risk perception and communication perspective. This paper consists of two qualitative studies examining public perceptions and subsequent reported behaviour related to increased transparency. Interviews were conducted on two separate samples of seventy respondents in both Pittsburgh and New York City. The results found that signals postings may prove counter productive in terms of increased public alarm and early or inappropriate termination of a drug appearing on the list. We also found communication from the FDA perceived as inaccessible or confusing, particularly that the AERS signals are posted strictly on the web, while the majority of our respondents cited their primary and secondary media sources as broadcast television. We recommend that the FDA reconsider its communication strategy of AERS to the public as it may prove to be a ‘transparency step too far.’
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. Greenpeace

1.

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-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]
Bleak Prospects for Research in GMP in Switzerland
Authors: Hettich Peter , Walther Simone
Published: February 2017

Many European countries, including Switzerland, share deep suspicions about the broad commercial application of Genetically Modified Plants (GMP) in agriculture. Research in GMP, however, is mostly welcome. In Switzerland, nevertheless, an overprotective legal framework against risks of GMP results in regulatory spillovers for research. This article explores how such expanded legal protection in combination with the application of a strong precautionary principle hampers freedom of research in the field of green gene technology. The authors do not seek, on this occasion, to question the general risk assessment of Swiss legislators and their desire for a high level of protection. However, field trials with GMP will cease to take place if the procedural burdens for researchers are not reduced. In particular, it will be vital to establish research zones (“protected sites”) if research in GMP is to continue to take place in Switzerland.
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.
Recent EU Regulatory Law Developments for the Pharmaceutical Industry
Authors: Chenesseau Audrey , Pavlou Anna
Published: February 2017

The present Flash News Report sets outs recent EU regulatory law developments (as of 25 June 2012) which pharmaceutical companies should be aware of in the areas of Pharmacovigilance, Information on Medicines, Pricing and Reimbursement, EU Data Protection and Advanced Therapy Medicinal Products.
Impact Assessment and the Policy Cycle in the EU
Authors: Luchetta Giacomo
Published: February 2017

With the Communication on Smart Regulation issued in October 2010, the European Commissiontried to foster a better management of the whole policy cycle. According to thatCommunication, amending policy proposals must be preceded by an ex-post assessmentof the current situation, allowing “closing the policy cycle”. This paper tries to answer thequestion whether the EU Impact Assessments System is fit to steer and close the policy cycle,and what is the relation between ex-ante IA and ex-post evaluation “on the ground” so far. This is done via a macro and micro analysis, based on scorecard approach and three casestudies, comparing the EU IA system performance with a theoretical benchmark derived from the EU policy document and process. The paper concludes that the EU Impact Assessmentsystem, as it is currently designed and implemented, is not yet fi t to steer and closethe policy cycle. To achieve this goal, all the analytical and empirical layers of the policycycle should be fully dealt with since the ex-ante phase.
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).
Nudge and the Manipulation of Choice
Authors: Hansen Pelle Guldborg , Jespersen Andreas Maaløe
Published: February 2017

In Nudge (2008) Richard Thaler and Cass Sunstein suggested that public policy–makers arrange decision–making contexts in ways to promote behaviour change in the interest of individual citizens as well as that of society. However, in the public sphere and Academia alike widespread discussions have appeared concerning the public acceptability of nudgebased behavioural policy. Thaler and Sunstein's own position is that the anti–nudge position is a literal non–starter, because citizens are always influenced by the decision making context anyway, and nudging is liberty preserving and acceptable if guided by Libertarian Paternalism and Rawls’ publicity principle. A persistent and central tenet in the criticism disputing the acceptability of the approach is that nudging works by manipulating citizens’ choices. In this paper, we argue that both lines of argumentation are seriously flawed. We show how the anti–nudge position is not a literal non–starter due to the responsibilities that accrue on policy–makers by the intentional intervention in citizens’ life, how nudging is not essentially liberty preserving and why the approach is not necessarily acceptable even if satisfying Rawls’ publicity principle. We then use the psychological dual process theory underlying the approach as well as an epistemic transparency criterion identified by Thaler and Sunstein themselves to show that nudging is not necessarily about “manipulation”, nor necessarily about influencing “choice”. The result is a framework identifying four types of nudges that may be used to provide a central component for more nuanced normative considerations as well as a basis for policy recommendations.
Towards Principles–Based Approaches to Governance of Health–Related Research Using Personal Data
Authors: Laurie Graeme , Sethi Nayha
Published: February 2017

Technological advances in the quality, availability and linkage potential of health data for research make the need to develop robust and effective information governance mechanisms more pressing than ever before; they also lead us to question the utility of governance devices used hitherto such as consent and anonymisation. This article assesses and advocates a principles–based approach, contrasting this with traditional rule–based approaches, and proposes a model of principled proportionate governance. It is suggested that the approach not only serves as the basis for good governance in contemporary data linkage but also that it provides a platform to assess legal reforms such as the draft Data Protection Regulation.
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.
Minors and Gambling Regulation
Authors: Carran Malgorzata (Margaret)
Published: February 2017

Early initiation of gambling has been argued to be closely correlated with placing players at higher risk of developing problem gambling behaviour in the future. The vast majority of jurisdictions, including Great Britain, attempts to eliminate minors’ access to gambling by making it illegal and by requiring gambling providers to adopt strict age-verification procedures. Despite those measures minors continue to successfully access gambling. This paper demonstrates that British legal framework suffers from many statutory loopholes. It considers weaknesses in the regulatory offences as well as enforcement deficiencies. It further highlights how the differences between black letter law, political rhetoric and practical application undermine the strength of the prohibition of gambling by minors.
The Science, Law and Policy of Neonicotinoids and Bees: A New Test Case for the Precautionary Principle
Authors: Alemanno Alberto
Published: February 2017

Once more, while facing an analogous risk phenomenon affecting their predominantly homogeneous societal and economic interests, the two sides of the Atlantic seem to adopt diverging stances. Amid the publication of several new studies and a set of EFSA scientific opinions linking the use of the world's most widely used pesticides to bee decline, the European Union adopted a temporary ban on their use. While the Commission does not expressly rely on it, its restrictive decision is clearly based on the controversial precautionary principle. Yet, as it is discussed in this article, the conformity of this decision with the requirements that determine the legal invocation of this principle remains doubtful.
Air Carriers’ Obligation in ‘Extraordinary Circumstances’
Authors: Tang Sophia
Published: February 2017

The closure of part of European airspace as a result of the eruption of the Eyjafjallajokull volcano constitutes “extraordinary circumstances” which does not release air carriers from their obligation, in the event of cancellation of a flight, to provide passengers care and assistance (author's headnote).
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.
Regulation of Nanomaterials in the EU: Proposed Measures to Fill in the Gap
Authors: Azoulay David , Buonsante Vito
Published: February 2017

This report discusses a proposal fromthe Center for International Environmental Law(CIEL), ClientEarth and Friends of the Earth Germany (Bund) on the regulation of nanomaterials in the European Union. It discusses in particular, the proposal for a horizontal regulation on nanomaterials (also referred to as a nano-patch for existing legislation) that would fill in the regulatory gap on nanomaterials. The proposal goes beyond a review of the REACH text and encompasses all EU legislation relevant to nanomaterials. The proposed instrument would amend the REACH text with delimitation in scope to all areas relevant to nanomaterials (on the model of Regulation 1272/2008 on the classification, labelling and packaging of chemicals). The main aim of the regulation is to ensure that hazard, risk and exposure assessments for all forms and uses of such materials are adequately carried out and taken into consideration.
EU Risk Regulators and EU Procedural Law
Authors: Chamon Merijn
Published: February 2017

Before the Treaty of Lisbon, EU agencies were unknown in the EU's primary law defined procedural law. Today, following (i) the Treaty's entry into force, (ii) the Common Approach on Decentralised Agencies and (iii) the European Court of Justice's ruling in Short–selling it is interesting to take a look at the peculiar position of EU agencies under the EU's primary and secondary law defined procedural law.
PIP Breast Implants, the EU's New Approach for Goods and Market Surveillance by Notified Bodies
Authors: Leeuwen Barend van
Published: February 2017

With the New Approach for goods, the EU has created a regulatory framework for placing products on the market in which both public and private parties have an important role to play. The various cases which have been brought after the PIP breast implants scandal show the difficulties with trying to link this ex ante regulatory framework to potential liability for defective products. National courts have reached different conclusions about the scope of the obligations of certification bodies in the New Approach. Since these issues are about the fundaments of the construction of the New Approach, it would be desirable for the ECJ, and perhaps even the European legislator, to get involved.
Chemical Control Policy in Sweden, What is Next?
Authors: Lofstedt Ragnar
Published: February 2017

Sweden has long been seen as a pioneer in the area of chemical control policy. In 1995 it put forward a so called “generation goal” which called for a phasing out of all human made chemicals within a 25 year period. The Swedish Government took up the challenge of how to best reach this goal by putting forward a number of environmental quality objectives, which were approved by the Swedish Parliament in 1999. What has happened since then? Will Sweden reach its proposed generation goal? This paper addresses these two questions.
Assessing the Commercial Success of a Pharmaceutical Product Covered by a Patent
Authors: Rozek Richard P.
Published: February 2017

In U.S. patent cases, a factor for demonstrating that an invention is non–obvious is the commercial success of the product embodying that invention. There must also be a nexus or connection between the patented characteristics of the claimed product and its commercial success. One may presume that a nexus exists if the characteristics of a product that is shown to have commercial success are covered by the patent claims at issue. In Europe, “commercial success alone is not to be regarded as indicative of inventive step. The following requirements must first be met: a long–felt need must have been fulfilled, and the commercial success must derive from the technical features of the invention and not fro mother influences (e.g. selling techniques or advertising).” Based on my understanding of U.S. and European patent law relevant to the issue of commercial success, this paper addresses some of the economic issues and associated data to consider in assessing whether a patented pharmaceutical product is a commercial success.
Is 142 Euro Equal to 350 000 Euro? The CJEU Interpretation of “Personal Injury” and “Injured Party” in EU Motor Insurance Law
Authors: Mantrov Vadim
Published: February 2017

In reviewing two similar cases, the CJEU clarified several essential elements of EU motor insurance law. First, the CJEU clarified the concept of “personal injury” as an insurable risk (another is damage to property) by holding that it also covers non–material damage and the concept of “injured party” by establishing that it also covers the next of kin of a person who died as a result of a road traffic accident. Second, the CJEU affirmed its previous case law that EU Member States are precluded from lowering the minimum insurance coverage as set in the amount of 350 000 euro by EU motor insurance law. In particular, the CJEU found that a Latvian national legal provision which provides fixed insurance redress in the amount of 142 (now 150) euro for non–material damage for the next of kin of a person who died in an accident is incompatible with EU motor insurance law (author's summary).
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.
Uses and Potential Abuses of “Negative Claims” in the EU: The Urgent Need for Better Regulation
Authors: Carreño Ignacio , Vergano Paolo
Published: February 2017

“Negative claims” can be defined as claims indicating that certain ingredients, nutrients or substances are not present in a foodstuff. Legitimate uses of regulated negative claims in the EU include some nutrition claims and “gluten-free” claims. Some EU Member States have legislated on “GM-free” claims. The article describes in more detail some cases (i.e., BPA-free, MSG-free, Aspartame-free and palm oil-free), where negative claims are used with an implied message that whatever is used instead of the often “demonised” substance is safer, healthier or greener. The article argues that EU and EU Member States’ legislators and regulators should ensure that consumers are not misled by astute marketing techniques that have no informative agendas, but simply aim at denigrating certain products in order to promote “free-from” products. This issue is particularly timely and important given the imminent application of the EU's Food Information Regulation and the additional costs that it will impose on the industry in the name of providing complete, reliable and evidence-based information to consumers.
Impact Assessment in the European Union: Lessons from a Research Project
Authors: Dunlop Claire A. , Radaelli Claudio M.
Published: February 2017

In this article, we present some major lessons drawn from a recently completed research project. Our research dealt with ex ante evaluation, mainly impact assessment (IA).We shed new light on research questions about the control of bureaucracy, the role of IA in decisionmaking, economics and policy learning, and the narrative dimension of appraisal.We identify how our findings stand in relation to conventional arguments about these issues, and reflect on their normative implications. We finally reason on the possible extensions of our arguments to the wider field of policy evaluation, connecting IA and ex post evaluation.
Evaluation in the European Commission: For Accountability or Learning?
Authors: Højlund Steven
Published: February 2017

The article accounts for the development of the European Commission's evaluation system. The article shows how internal and external developments shape an evaluation system aiming for both accountability and policy learning. In 58 interviews, several justifications for the evaluation system emerge, including four types of accountability as well as an evaluation system constructed to facilitate learning from past experience. In the system's commencement, financial and legal accountability overshadow the focus on policy learning that was perceived to be in contradiction with the two former. However, the article also demonstrates that accountability and policy learning are not necessarily opposed to each other.
Ex Ante and Ex Post Evaluations: Two Sides of the Same Coin?
Authors: Mergaert Lut , Minto Rachel
Published: February 2017

This article engages with two themes of contemporary EU governance: the role of evaluations within an effective and coherent policy–making process and the EU's constitutionalised commitment to promoting gender equality in all its activities (Article 8 TFEU). It focuses on the interface between ex ante and ex post evaluation and the contribution of evaluations to policy learning, with particular attention to the promotion of gender equality. A case study approach is followed, with EU research policy as the object of analysis.
Regulating a Moving Nerve
Authors: Lauta Kristian Cedervall
Published: February 2017

Regulation of critical infrastructure (CI) is in vogue; and accordingly every government presently develops legal governance regimes. In this paper, I try to analyse some of the present efforts to identify and govern CI. I argue that while the legal definitions introduced contribute little to the actual identification of critical infrastructure, they alter the responsibility and modus operandi of the identification. Political discretion is re-organized into administrative decisions. By relying on similar observations from risk sociology, I set out to criticize the present implementation for masking the hard political choices inherent in the work with CI, and thereby creating a dysfunctional governance regime for the protection of CI.
Critical Infrastructure Protection from a National Perspective
Authors: Brem Stefan
Published: February 2017

This article addresses conceptional components of national strategies on critical infrastructure protection (CIP). In particular, it focuses on the Swiss CIP programme and its strategic components. As in other countries, Switzerland divides its national infrastructure into critical sectors, but rather distinctively it subdivides them into critical subsectors and even lists specific critical infrastructure objects in a classified inventory. The article stresses the importance of a pragmatic public private partnership in further strengthening the CI's resiliency, but also argues for a more explicit legal foundation to provide some clearer guidelines in this evolving field of collaboration.
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 Regulatory Impact Assessment
Authors: Purnhagen Kai P.- , Feindt Peter H.
Published: February 2017

The European Commission's (Commission) Better Regulation Strategy (BRS) is the major guideline for the Commission to assess legislation. It draws on regulatory impact assessment (RIA) via cost–benefit analysis (CBA), expert advice, and simplification in EU law–making. Yet, the practice of RIA by the Commission as well as in EU member states, while unavoidably incomplete, has shown avoidable shortcomings. The Commission's New Better Regulation Strategy of 2015 (NBRS) contains language that appears to address these shortcomings. If pursued consequentially, it would require an approach that resembles what has been called responsive behavioural regulation. At the same time, global initiatives from inter alia the World Bank emerge to include behavioural insights into policy analysis in the form of responsive regulation. This piece assesses potential models of RIA that can help to articulate the behavioural assumptions which are implied by NBRS as enshrined in the policy document “Better regulation for better results”. The methodological implications of the NBRS require a significant departure from the reliance on classical CBA, which is characteristic for the previous “Better Regulation” documents submitted by the Commission and which we term Old Better Regulation Strategy (OBRS).
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.
A Comment and Epilogue
Authors: Howse Rob
Published: February 2017

The Appellate Body report in EC-Seal Products is a landmark decision in several respects: for its recognition that animal welfare is a matter of public morality that may justify a trade ban in response to cruelty; for the AB's new–found clarity with respect to the irrelevance of regulatory purpose in the determination of “treatment no less favourable” under the National Treatment and MFN provisions of the GATT; for its suggestion that trade measures not defined by product–related distinctions but other criteria are not covered by the TBT Agreement; and for its partial acknowledgement that a Member may maintain a measure consistent with Article XX even if the measure represents a complex trade–off between a main purpose and other purposes that may limit the extent the main purpose can be furthered. But the decision arguably raises as many questions as it answers, and some have already complained about the rather sphinx–like quality of the judgment.
Towards a Regime of Emission Litigation based on Science
Authors: Purnhagen Kai
Published: February 2017

Courts in Europe increasingly acknowledge an individual right to emission reduction against states. Such a right forms a new policy tool that can be used to enforce emission reduction. It can also be used to enforce scientifically sound environmental policy, as Courts recognise science as a default position when determining the content of the right. The individual right to emission reduction is another tool in the making to consider when implementing scientific insights into policy making.
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-405/12P

The 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.
Food Safety Regulation in TTIP: Much Ado About Nothing?
Authors: Matthews Alan
Published: February 2017

Disputes over food safety standards –what in the language of trade policy are called sanitary and phytosanitary standards (SPS) – have been at the heart of many transatlantic trade rows between the US and the EU. Examples include the EU bans on the import of hormone–treated beef, on pork treated with growth–promoting additives, or on poultry washed in antimicrobial rinses to reduce the amount of microbes on meat. As a result, the potential impact of the ongoing negotiations to reach a Transatlantic Trade and Investment Partnership (TTIP) free trade agreement between the US and EU on EU food standards has, rightly, attracted a lot of attention and no little anxiety. Opposition to “Chlorhühnchen” has become the rallying–call for anti–TTIP activists in many countries. NGOs argue that “TTIP will sacrifice food safety for faster trade”. Critics highlight possible procedural rules requiring transparency of decision–making and early warning mechanisms which would give interested parties (including of course business firms and lobby groups) the opportunity to comment on planned rule–making which it is argued are likely to lead to ‘regulatory chill’.
Two Continents, Divided by Deep Philosophical Waters?
Authors: Farrand Benjamin
Published: February 2017

The May 2016 leak of draft texts produced within the context of the on–going Transatlantic Trade and Investment Partnership negotiations has provided an interesting insight into the positions of the EU and US with regard to different dimensions of regulatory cooperation, with some chapters being complete or near completion (as other articles in this mini–symposium discuss), and others still in a more rudimentary format. One such field of regulation, covered in the leaked ‘Tactical State of Play’ document, covers geographical indicators (hereafter GIs). However, this coverage is very brief, stating that ‘discussions focused on the preparation of an intersessional discussion prior to the next round’. GIs, marks identifying the geographical origin, and by extension (so the argument goes) quality of goods, have continued to be a source of consternation in international trade regulation, with states unable to see eye–to–eye on how they should be protected, if at all.
The Pros and Cons of Legal Automation and its Governance
Authors: Pagallo Ugo , Durante Massimo
Published: February 2017

The article examines the field of legal automation, its advantages and drawbacks, the ways in which legal constraints and safeguards can be embedded into technology and how the law may govern human behaviour through codes, IT architectures, and design. By stressing both benefits and shortcomings of legal automation, the article does not suggest that the latter is something “neutral”. Rather, making legal reasoning and enforcement automatic, so that even a machine can process and understand this information, should be conceived as a set of constraints and affordances that transform, or reshape, the environment of people’s interaction and moreover, the interplay of human and artificial agents, thereby affecting basic pillars of the (rule of) law. The overall aim is to flesh out goals and values that are at stake with choices of technological dependence, delegation and trust, so as to determine the good mix between legal automation and public deliberation.
Protection without Discrimination: Pregnancy and Occupational Health Regulations
Authors: Ove-Hansson Sven , Schenk Linda
Published: February 2017

Occupational exposures of pregnant workers can give rise to foetal damage. Two major types of strategies against detrimental effects on the foetus are described: differentiated protection that reduces only the exposure of pregnant workers (or only of female workers) and unified protection that reduces the exposure of all workers to a level that is sufficiently low to protect against detrimental effects on the foetus. The former strategy is shown to be inefficient, as it does not provide the desired protection. Protection only of pregnant workers is insufficient since protection is needed early in pregnancy when it is not known, and in the case of substances that are accumulated in the woman's body even prior to conception. Protection of all women is also insufficient to protect the foetus since evidence indicates that preconception exposure of the father can also give rise to malformations. Furthermore, differentiated protection that requires more costly protective measures for women tends to aggravate the already prevalent discrimination of women on the labour market. It is therefore concluded that unified protection is the only efficient and non-discriminatory strategy against foetal damage.
Geographical indications, “Food Fraud” and the Fight Against “Italian sounding” Products
Authors: Carreño Ignacio , Vergano Paolo R.
Published: February 2017

Food producers and consumers are confronted with ever-growing choices and increasing competition within the EU and around the world. This has already led to various cases of food fraud and a call for political and legal action. Food fraud can be defined as ‘‘the deliberate and intentional substitution, addition tampering or misrepresentation of food, food ingredients or food packaging, labelling, product information, or false or misleading statements made about a food product’’. Meanwhile, the issue of “food fraud”, by means of employing names, symbols and images of third countries and thereby inducing a false impression on the consumer, appears to have been neglected despite its increasing economic impact. While the EU recently approved two new Geographical Indications (hereinafter, GIs) from third countries, the issue of the protection of Italian products against “rip–off Italian products” with Italian sounding names has taken centre–stage again.
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).
Why Science Cannot Tame Politics: The New EU Comitology Rules and the Centralised Authorisation Procedure of GMOs
Authors: Klika Christoph , Kim Jinhee , Versluis Esther
Published: February 2017

The centralised authorisation of GMOs in the European Union (EU) has received considerable academic attention in recent years, partly due to the fact thatMember States have not been able to agree on authorisation decisions in the comitology committee. As a consequence, these authorisations are given by the European Commission. These decisions are invariably in favour of authorisation despite the fact that Member States had been divided on this issue. Apart from the on-going discussions on a possible reform of the GMO authorisation (allowing for national restrictions or prohibitions), the new comitology rules brought about by the Lisbon Treaty are of equal importance as they might affect the authorisation of GMOs. In this article we discuss some of the changes to comitology and present empirical material on the first authorisation decisions after the entering into force of the new comitology rules. By drawing on delegation theory we will argue that, for the time being, the level of politicisation ofGMOauthorisation is unlikely to change.
Peer-to-Peer Lending: Opportunities and Risks
Authors: Lenz Rainer
Published: February 2017

Web-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.