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Article

Access_open Changes in the Medical Device’s Regulatory Framework and Its Impact on the Medical Device’s Industry: From the Medical Device Directives to the Medical Device Regulations

Journal Erasmus Law Review, Issue 2 2019
Keywords Medical Device Directive, Medical Device Regulation, regulatory, European Union, reform, innovation, SPCs, policy
Authors Magali Contardi
AbstractAuthor's information

    Similar to pharmaceutical products, medical devices play an increasingly important role in healthcare worldwide by contributing substantially to the prevention, diagnosis and treatment of diseases. From the patent law perspective both, pharmaceutical products and a medical apparatus, product or device can be patented if they meet the patentability requirements, which are novelty, inventiveness and entail industrial applicability. However, regulatory issues also impact on the whole cycle of the innovation. At a European level, enhancing competitiveness while ensuring public health and safety is one of the key objectives of the European Commission. This article undertakes literature review of the current and incoming regulatory framework governing medical devices with the aim of highlighting how these major changes would affect the industry at issue. The analysis is made in the framework of an on-going research work aimed to determine whether SPCs are needed for promoting innovation in the medical devices industry. A thorough analysis the aforementioned factors affecting medical device’s industry will allow the policymakers to understand the root cause of any optimal patent term and find appropriate solutions.


Magali Contardi
PhD candidate; Avvocato (Italian Attorney at Law).
Article

Access_open Access and Reuse of Machine-Generated Data for Scientific Research

Journal Erasmus Law Review, Issue 2 2019
Keywords machine-generated data, Internet of Things, scientific research, personal data, GDPR
Authors Alexandra Giannopoulou
AbstractAuthor's information

    Data driven innovation holds the potential in transforming current business and knowledge discovery models. For this reason, data sharing has become one of the central points of interest for the European Commission towards the creation of a Digital Single Market. The value of automatically generated data, which are collected by Internet-connected objects (IoT), is increasing: from smart houses to wearables, machine-generated data hold significant potential for growth, learning, and problem solving. Facilitating researchers in order to provide access to these types of data implies not only the articulation of existing legal obstacles and of proposed legal solutions but also the understanding of the incentives that motivate the sharing of the data in question. What are the legal tools that researchers can use to gain access and reuse rights in the context of their research?


Alexandra Giannopoulou
Institute for Information Law (IViR) – University of Amsterdam.
Article

Access_open Modern Intellectual Property Governance and Openness in Europe: A Long and Winding Road?

Journal Erasmus Law Review, Issue 2 2019
Keywords Intellectual Property, governance, data sharing
Authors Nikos Koutras
AbstractAuthor's information

    In the last decade a trend towards more ‘openness’ in terms of collaborations and access to knowledge has been observed in many different sectors and contexts. Along the spectrum of openness one can find many different varieties, such as open innovation, co-creation, open science (combined with open access and open data) and open source. Even traditionally rather ‘closed’ actors, such as publishing houses and the pharmaceutical industry, are gradually catching up and are trying to develop mechanisms to cope with this trend towards openness. Both public and private actors encounter challenges in combining this trend towards openness with the management of intellectual property rights (IPRs). Although a strong willingness may exist to collaborate, open up and share knowledge and data, IPRs often create boundaries and limitations towards cutting-edge collaborations and initiatives for openness and sharing. Over time, companies, universities, public research organisations, etc. have developed certain models to allow for openness while safeguarding ways to protect their IPRs. Yet the legal framework is often lagging behind and does not appear to reflect the socio-economic trend towards openness; in many jurisdictions, changes to IP legislation have rather focused on strengthening of the rights of IP owners. But this is not necessarily a problem as stakeholders tend to find workarounds in their day-to-day practice. This special issue aims to further the discussion about modern governance of IPRs in Europe and to explore different perspectives on how openness could be operationalised within the context of IP protection.


Nikos Koutras
Postdoctoral Researcher, Faculty of Law, University of Antwerp.

Jo-Anne Wemmers
Jo-Anne Wemmers is a Full Professor at the School of Criminology, Université de Montréal (Canada) and Researcher at the International Centre for Comparative Criminology, Montréal, Canada.

Albert Dzur
Albert Dzur is Distinguished Research Professor, Departments of Political Science and Philosophy, Bowling Green State University, Bowling Green, OH, USA.
Article

Complying with display rules: the ‘managed heart’ in restorative justice

complementing ritual theories of emotional bonding

Journal The International Journal of Restorative Justice, Issue 3 2019
Keywords Emotional bonding, emotion management, display rules, offstage performance, re-storying
Authors Bas van Stokkom
AbstractAuthor's information

    In this theoretical study it is argued, first, that ritual theories – at least those which are dominant in restorative justice literature – place too much emphasis on the potential positive impacts of emotional bonding. The author discusses some critical issues with respect to emotional bonding and points out that mutual understanding is rather the result of narrative re-appraising and re-assessing. Secondly, to explain the rather low emotional temperature of many (youth) conferences, emphasis is placed on emotion management theory, thereby suggesting that participants’ reservations and discomfort are related to rather demanding display rules (enact a sincere and authentic role; enact cooperativeness; etc.). The author identifies reasons why (young) participants cannot get grips on these rules and resort to a resigned ‘offstage’ performance. It is argued that display rules form an integral part of a relatively compelling ‘emotional regime’, a specific set of affective behavioural norms which define the ‘manners’ during the meeting. In this regime there is considerable social pressure to conform to norms and standards how to express emotions, which contradicts the restorative justice rhetoric of voluntary and spontaneous dialogue.


Bas van Stokkom
Bas van Stokkom is criminologist and research fellow at the Faculty of Law, Radboud University Nijmegen, the Netherlands.
Article

The shame of injustice: the ethics of victimology and what it means for restorative justice

Journal The International Journal of Restorative Justice, Issue 3 2019
Keywords Victimology, restorative justice, shame, Bernard Williams, Susan Brison
Authors Antony Pemberton
AbstractAuthor's information

    The role of shame in restorative justice has a long pedigree. Most often shame has been conceptualised in terms of the act of the offender. The focus of this paper is instead on the shame of the person experiencing wrongdoing: a victim who is neither guilty nor responsible for the experience. This has the advantage of making more clear that shame fundamentally concerns an experience of ‘who I am’ rather than ‘what I have done’, while the reaction to the experience of shame in victimization should involve attention to the identity-related questions that are posed by this experience. This way of viewing shame is connected to the distinction between countering injustice and doing justice, and offers a number of fresh insights into victimological phenomena in restorative justice and restorative justice more generally.


Antony Pemberton
Professor of Restorative Justice, Leuven Institute of Criminology, KU Leuven, Leuven, Belgium; Professor of Victimology, Tilburg Law School, Tilburg University, Tilburg, the Netherlands.

Jacques Claessen
Jacques Claessen is an Associate Professor of Criminal Law and an Endowed Professor of Restorative Justice at Maastricht University and Honorary Judge at the District Court of Limburg, the Netherlands.
Article

The European Union and Space

A ‘Star Wars’ Saga?

Journal European Journal of Law Reform, Issue 4 2019
Keywords EU space competence, EU Space Policy, Galileo, Copernicus, Framework Agreement ESA-EU
Authors Rebecca-Emmanuela Papadopoulou
AbstractAuthor's information

    This article explores the complex relationship between the European Union (EU) and space, alias space’s ever-growing place and role in the EU legal order. Two distinct paths are identified in this respect. On the one hand, as from the mid-1980s and despite the lack of an express ‘space competence’, space policy parameters were introduced in EU acts regulating telecommunications, satellite communications and electronic databases, but only to the extent necessary to serve the functioning of the single market. On the other hand, an autonomous EU Space Policy has been progressively elaborated as from the late 1990s through several initiatives, namely the strengthening of the collaboration with the European Space Agency and the setting up of the Galileo and Global Monitoring for Environment and Security (GMES)/Copernicus programmes. This tendency was corroborated by the conferral of an express space competence on the EU by the Lisbon Treaty, whose constitutional and institutional implications are explored in this article. It is submitted that the new space competence shall allow the EU to reach a stage of maturity and claim a greater degree of autonomy at the international level and, at the same time, to project its own governance model, thus enhancing the quality of international cooperation in space.


Rebecca-Emmanuela Papadopoulou
Rebecca-Emmanuela Papadopoulou is Assistant Professor, Law School, NKUA.
Article

Parliamentary Control over Delegated Legislation in Japan

Journal European Journal of Law Reform, Issue 4 2019
Keywords statutory instruments, sole law-making organ, supplementary resolution, legislative veto, Committee on Oversight of Administration
Authors Katsuhiro Musashi
AbstractAuthor's information

    The delegation of legislation from the parliament to the administration plays an important role in a modern administrative state. In Britain, parliamentary control – whereby the parliament has the right to approve or veto a delegated legislation – has been institutionalized and implemented. On the other hand, the Japanese parliament is powerless to approve a delegated order beforehand or ex post. Therefore, improper procedures such as the deviation of the delegated order from the enabling act by a governmental agency, or the introduction of arbitrary administrative measures, have been carried out under insufficient supervision by the parliament in Japan. The National Diet of Japan should, ideally, also hold the power to control the administrative order on the basis of the legal principles formulated by the Diet. Therefore, we propose the introduction of a parliamentary control system that invalidates the ex post enactment of a cabinet order if both Houses of parliament refuse the order within 40 days of its submission. These procedures would have increased efficacy when augmented with a political check function on the proposed cabinet orders by the parliament’s Committee on Oversight of Administration, or their standing committees.


Katsuhiro Musashi
Katsuhiro Musashi is Professor of Law and Policy at the Faculty of Policy Studies, Doshisha University in Kyoto, Japan.
Article

Smart Legal Contracts

A Shift in Conflict Prevention and Dispute Resolution

Journal International Journal of Online Dispute Resolution, Issue 2 2019
Keywords smart contracts, blockchain, contracts, conflict prevention, ODR
Authors Aura Esther Vilalta Nicuesa
AbstractAuthor's information

    This article is aimed at clarifying the legal implications of blockchain when applied to contracts and the impact of smart contracts in conflict prevention and dispute resolution.


Aura Esther Vilalta Nicuesa
Chair in Civil Law at the Universitat Oberta de Catalunya.
Article

What Does It Take to Bring Justice Online?

Journal International Journal of Online Dispute Resolution, Issue 2 2019
Keywords ODR, access to justice, courts, online justice, remedy for small disputes
Authors Mirèze Philippe
AbstractAuthor's information

    Technology has revolutionized the world in the last century, although computation devices have existed for millennia and punched-card data processing for two centuries. After 70 years of progress in technology and telecommunications with all the knowledgeable computer specialists and the sophistication of online services, it is high time public and private justice offered fair access to a fundamental human right: justice online. The role of technology in dispute resolution is high on the agenda, and the topic is increasingly at the centre of discussions. In a world that is rapidly developing, it is surprising to observe that online dispute resolution (ODR) is lagging behind.


Mirèze Philippe
Special Counsel at the Secretariat of ICC International Court of Arbitration. She is co-founder of ArbitralWomen and Board member. She is also member of the Equal Representation in Arbitration Steering Committee, ICCA Diversity Task Force, Arbitrator Intelligence’s Board of Advisors, Council of the American Bar Association Section of Dispute Resolution, Paris Place d’Arbitrage, Association Arbitri’s Advisory Board, International Journal of Online Dispute Resolution’s Editorial Board, fellow of National Centre for Technology and Dispute Resolution (NCTDR), and Board member of International Council for Online Dispute Resolution’s (ICODR).
Article

ODR as a Public Service

The Access to Justice-Driven Canadian Experience

Journal International Journal of Online Dispute Resolution, Issue 2 2019
Keywords ODR, access to justice, courts, legal process, sense of fairness
Authors Nicolas Vermeys and Jean-François Roberge
AbstractAuthor's information

    Canadian courts and tribunals are successfully incorporating online dispute resolution (ODR) mechanisms into their processes in order to offer user-centric dispute resolution systems aimed at increasing access to justice. Although they use different approaches, three such examples, British Columbia’s Civil Resolution Tribunal, Ontario’s Condominium Authority Tribunal, and Quebec’s PARLe-OPC platform, have all demonstrated how public ODR can increase litigants’ sense of justice while respecting basic legal tenets. This article serves as a short introduction to this user-centric Canadian approach.


Nicolas Vermeys
Nicolas Vermeys is the Associate Dean of Programs at the Université de Montréal’s Faculty of law, the Associate director of the Cyberjustice Laboratory, and a Researcher at the Centre de recherche en droit public (CRDP).

Jean-François Roberge
Jean-François Roberge is a Professor and the Director of the Dispute Prevention and Resolution programmes at the Université de Sherbrooke Faculty of law.
Article

Readiness for Family and Online Dispute Resolution

Journal International Journal of Online Dispute Resolution, Issue 2 2019
Keywords online dispute resolution, family dispute resolution, domestic violence, ripeness and readiness, divorce
Authors Nussen Ainsworth, Lisa Zeleznikow and John Zeleznikow
AbstractAuthor's information

    The International Conflict Resolution Community has developed considerable theory and many case studies about ripeness and readiness for mediation. Readiness involves a readiness of the disputant to resolve the conflict, while ripeness indicates the time is appropriate to attempt a resolution. There is a sparse amount of theory about these issues in commercial and family dispute resolution (FDR). We discuss the practice of readiness for mediation, FDR and online dispute resolution and develop practices about when to mediate such disputes – especially when domestic violence has occurred.


Nussen Ainsworth
Nussen Ainsworth, Victoria University, Melbourne, Australia – nussen.ainsworth@vu.edu.au.

Lisa Zeleznikow
Lisa Zeleznikow, Jewish Mediation Centre, Melbourne, Australia – lisa@jmc.org.au.

John Zeleznikow
John Zeleznikow, Victoria University, Melbourne, Australia – john.zeleznikow@vu.edu.au.
Pending Cases

Case C-407/19, Free movement, fixed-term work

Katoen Natie Bulk Terminals NV, General Services Antwerp NV – v – Belgische Staat, reference lodged by the Raad van State (Belgium) on 24 May 2019

Journal European Employment Law Cases, Issue 4 2019
Keywords Free movement, fixed-term work
Rulings

ECJ 11 September 2019, case C-397/18 (Nobel Plastiques Ibérica), Disability discrimination

DW – v – Nobel Plastiques Ibérica SA and Others, Spanish case

Journal European Employment Law Cases, Issue 4 2019
Keywords Disability discrimination
Abstract

    The concept of ‘disability’ within the meaning of Directive 2000/78 must be understood as referring to a limitation of capacity which results in particular from long-term physical, mental or psychological impairments which, in interaction with various barriers, may hinder the full and effective participation of the person concerned in professional life on an equal basis with other workers. Selection criteria for dismissal may constitute indirect discrimination.

Article

Control in International Law

Journal African Journal of International Criminal Justice, Issue 1 2019
Keywords Effective / overall control, international human rights law, international criminal law, responsibility of states, statehood
Authors Joseph Rikhof and Silviana Cocan
AbstractAuthor's information

    The concept of control has permeated various disciplines of public international law, most notable international criminal law, international humanitarian law, international human rights law and the law of statehood as well as the law of responsibility for states and international organizations. Often this notion of control has been used to extend the regular parameters in these disciplines to capture more extraordinary situations and apply the same rules originally developed within areas of law, such as the application of the laws of war to occupation, the rules of human rights treaties to extraterritorial situations or state responsibility to non-state actors. This article will examine this notion of control in all its facets in international law while also addressing some of its controversies and disagreements in the jurisprudence of international institutions, which have utilized this concept. The article will then provide an overview of its uses in international law as well as its overlap from one discipline to another with a view of providing some overarching observations and conclusions.


Joseph Rikhof
Joseph Rikhof is an adjunct professor at the Common Law Faculty of the University of Ottawa.

Silviana Cocan
Silviana Cocan holds a double doctoral degree in international law from the Faculty of Law of Laval University and from the Faculty of Law and Political Science of the University of Bordeaux.
Article

The Smuggling of Migrants across the Mediterranean Sea

A Human Rights Perspective

Journal East European Yearbook on Human Rights, Issue 1 2019
Keywords smuggling, refugees, migration, readmission, interceptions
Authors J. Shadi Elserafy LL.M.,
AbstractAuthor's information

    Irregular migration by sea is one of the most apparent contemporary political issues, and one that entails many legal challenges. Human smuggling by sea is only one aspect of irregular migration that represents a particular challenge for States, as sovereignty and security interests clash with the principles and obligations of human rights and refugee law. In dealing with the problem of migrant smuggling by sea, States have conflicting roles, including the protection of national borders, suppressing the smuggling of migrants, rescuing migrants and guarding human rights.
    The legal framework governing the issue of migrant smuggling at sea stems not only from the rules of the law of the sea and the Smuggling Protocol but also from rules of general international law, in particular human rights law and refugee law. The contemporary practice of States intercepting vessels engaged in migrant smuggling indicates that States have, on several occasions, attempted to fragment the applicable legal framework by relying on laws that allow for enhancing border controls and implementing measures that undermine obligations of human rights and refugee law. This article seeks to discuss the human rights dimension of maritime interception missions and clarify as much as possible the obligations imposed by international law on States towards smuggled migrants and whether or not these obligations limit the capacity of States to act.


J. Shadi Elserafy LL.M.,
LL.M., Judge/Counselor at The Egyptian Council of State (The Higher Administrative Court of Justice).
Human Rights Practice Reviews

The Russian Federation

Journal East European Yearbook on Human Rights, Issue 1 2019
Authors Igor Bartsits, Oleg Zaytsev and Kira Sazonova PhD
Author's information

Igor Bartsits
Igor Bartsits is the Director of IPACS RANEPA, Doctor of Law, Professor, Honoured Lawyer of the Russian Federation.

Oleg Zaytsev
Oleg Zaytsev is the Dean of the School of Law, Doctor of Law, IPACS RANEPA.

Kira Sazonova PhD
Kira Sazonova is the Assistant Professor, Ph.D. in International Law, Ph.D. in Politics, IPACS RANEPA.
Article

On Lessons Learned and Yet to Be Learned

Reflections on the Lithuanian Cases in the Strasbourg Court’s Grand Chamber

Journal East European Yearbook on Human Rights, Issue 1 2019
Keywords human rights, European Convention on Human Rights, European Court of Human Rights, Lithuania
Authors Egidijus Kūris
Abstract

    During the two-and-a-half decades while Lithuania has been a party to the European Convention on Human Rights, the Grand Chamber of the European Court of Human Rights has decided five Lithuanian cases. They all (perhaps but one) raised controversial issues not only of law but also of those pertaining to matters non-legal: psychology, politics, history and so on. There had been follow-ups to most of them, allowing for consideration as to the merits and disadvantages of the respective judgments. These cases are narrated on in their wider-than-legal context and reflected upon from the perspective of their bearing on these issues and of the lessons they taught both to Lithuania, as a respondent State, and to the Court itself.


Egidijus Kūris
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