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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 Text and Data Mining in the EU ‘Acquis Communautaire’ Tinkering with TDM & Digital Legal Deposit

Journal Erasmus Law Review, Issue 2 2019
Keywords Web harvesting, data analysis, text & data mining, TDM, computational text
Authors Maria Bottis, Marinos Papadopoulos, Christos Zampakolas e.a.
AbstractAuthor's information

    Text and Data Mining (hereinafter, TDM) issue for the purpose of scientific research or for any other purpose which is included in the provisions of the new EU Directive on Copyright in the Digital Single Market (hereinafter, DSM). TDM is a term that includes Web harvesting and Web Archiving activities. Web harvesting and archiving pertains to the processes of collecting from the web and archiving of works that reside on the Web. In the following analysis we will elaborate briefly upon provisions in EU Copyright law which were discussed during the proposal for a new Directive on Copyright in the DSM as well as provisions which are included in the text of art.3 and art.4 of the new Directive 2019/790/EU per TDM. In addition, the following analysis presents legislation in very few EU Member States which pertains to TDM and preceded the rulings of Directive 2019/790/EU. Digital legal deposit remarkable examples from EU Member States are also presented in this paper. The example of Australia is also presented below hereto because it is one of the oldest and most successful worldwide. The National Library of Australia’s digital legal deposit is state-of-the-art.


Maria Bottis
Associate Professor, Department of Archives, Library Science and Museology, Ionian University, Corfu, Greece.

Marinos Papadopoulos
Attorney-at-Law, PhD, MSc, JD, Independent Researcher, Athens, Greece.

Christos Zampakolas
Archivist/Librarian, PhD, MA, BA, Independent Researcher, Ioannina, Greece.

Paraskevi Ganatsiou
Educator, MA, BA, Coordinator of Educational Projects in the Prefecture of Ionian Islands, Corfu, Greece.

    This article relies on the premise that to understand the significance of Open Access Repositories (OARs) it is necessary to know the context of the debate. Therefore, it is necessary to trace the historical development of the concept of copyright as a property right. The continued relevance of the rationales for copyright interests, both philosophical and pragmatic, will be assessed against the contemporary times of digital publishing. It follows then discussion about the rise of Open Access (OA) practice and its impact on conventional publishing methods. The present article argues about the proper equilibrium between self-interest and social good. In other words, there is a need to find a tool in order to balance individuals’ interests and common will. Therefore, there is examination of the concept of property that interrelates justice (Plato), private ownership (Aristotle), labour (Locke), growth of personality (Hegel) and a bundle of rights that constitute legal relations (Hohfeld). This examination sets the context for the argument.


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

Offenders’ understandings of forgiveness

Journal The International Journal of Restorative Justice, Issue 3 2019
Keywords Offenders, forgiveness, victim lens, offender lens
Authors Tamera Jenkins
AbstractAuthor's information

    Despite extensive research on victim perceptions of forgiveness comparatively little is known about the meaning offenders attach to forgiveness. Through in-depth interviews with 19 criminal offenders this study sought to lay foundational groundwork regarding offenders’ understandings of forgiveness. Offenders viewed forgiveness through both a ‘victim’ and ‘offender’ lens. From a victim perspective offenders described giving forgiveness as a response that enabled them to ‘let go’ or ‘get over’ personal harms. From an offender perspective receiving forgiveness was defined as being either conditional or unconditional. Conditional forgiveness was related to evidence of positive change in offenders that must occur prior to forgiveness while the essential characteristic of unconditional forgiveness was found to be love. A better understanding of the significance of forgiveness in the lives of criminal offenders has practical implications for clinicians, service providers, and criminal justice professionals involved in the treatment or custodial care of this population.


Tamera Jenkins
Tamera Jenkins, Ph.D., is an Adjunct Research Fellow at the School of Criminology and Criminal Justice of the Griffith University – Mount Gravatt Campus, Brisbane, Australia.
Article

Law Reform in Ireland

Implementation and Independence of Law Reform Commission

Journal European Journal of Law Reform, Issue 4 2019
Keywords law reform, statute law revision, better regulation, access to legislation, lawyer’s law
Authors Edward Donelan
AbstractAuthor's information

    This article describes the origins and work of the Law Reform Commission in Ireland. The model follows that in Common Law countries. Its work includes both substantive law reform and statute law revision (weeding out spent or unused statutes and undertaking consolidation or other work to make statute law more accessible.) The work of the Commission focuses on ‘lawyers’ law’ and, therefore, avoids subjects that could be politically controversial. Consequentially, the bulk of its recommendations are accepted and translated into legislation.


Edward Donelan
Edward Donelan, PhD, M.A., Barrister-at-Law (Kings Inns, Dublin, Middle Temple, London), Dip. Eur. Law, Dip. Arb. Better Regulation and Legislative Drafting Expert, currently working on projects with the Attorney General in Botswana to develop a programme of law reform for the newly established Law Reform Unit in the Chambers of the Attorney General.
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

Access to Justice and the Role of ODR Inside and Outside Brazilian Courts

Journal International Journal of Online Dispute Resolution, Issue 2 2019
Keywords online dispute resolution, access to justice, efficiency, technology
Authors Marco Rodrigues
AbstractAuthor's information

    Getting cases decided in court within a reasonable time is a problem in many countries and in some cases can present a veritable crisis of justice. An alternative that is commonly used in judicial proceedings (at least in many civil law countries) is to hold a preliminary hearing in order to encourage a settlement. This article aims to analyse online dispute resolution as an efficient alternative to resolve the crisis of justice in Brazil.


Marco Rodrigues
Professor of Civil Procedure, Rio de Janeiro University.
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.

    The European Commission recently conducted a public consultation on the measures that may be taken to ensure the full application of the principle of equal pay between women and men. Its evaluation report is expected before the end of this year. The new Swiss legislation on monitoring and disclosure of the gender pay gap may be inspiration for future EU initiatives in this area.


Sara Rousselle-Ruffieux
Sara Rousselle-Ruffieux is an attorney-at-law at Lenz & Staehelin, Geneva, Switzerland.

Case Reports

2019/47 Transfer of undertakings does not include temporary agency workers (AT)

Journal European Employment Law Cases, Issue 4 2019
Keywords Transfer of undertakings, Transfer, Employees who transfer/refuse to transfer
Authors Thomas B. Pfalz
AbstractAuthor's information

    In a series of rulings the Austrian Supreme Court has made it clear that temporary agency workers are transferred to the transferee only if they are assigned to the transferor on a permanent basis. According to the Court, the facts of the cases at hand are not comparable to those of the ECJ ruling in Albron Catering BV (C-242/09). Hence the temporary agency workers remain with their original employer. However, some aspects of the Court’s reasoning seem unclear if not contradictory with regard to other recent judgments.


Thomas B. Pfalz
Thomas B. Pfalz is a Senior Scientist at the Institute for Law at the University of Klagenfurt.

    The Supreme Court found that the Court of Appeal did not properly examine whether the difference of treatment of employees based on a social plan may be justified.


Ioana Cazacu
Ioana Cazacu is Managing Associate with POPOVICI NIŢU STOICA & ASOCIAŢII, Bucharest, Romania.
Case Reports

2019/43 Dismissal after childbirth-related leave (DK)

Journal European Employment Law Cases, Issue 4 2019
Keywords Gender discrimination
Authors Christian K. Clasen
AbstractAuthor's information

    The Danish Western High Court has ruled that the dismissal of an employee shortly after returning from childbirth-related leave did not constitute discrimination within the meaning of the Danish Act on Equal Treatment of Men and Women.


Christian K. Clasen
Christian K. Clasen is a partner at Norrbom Vinding, Copenhagen.

    Relying on the prohibition of age discrimination stemming from Directive 2000/78, the Labour Tribunal of Leuven refused to apply a Collective Labour Agreement establishing the minimum monthly salary for employees depending on their work experience even if not relevant and the Royal Decree enforcing it. The jurisdiction grounded its decision on the fact that this gave a strong advantage to older employees without objective justification.


Gautier Busschaert
Gautier Busschaert is an attorney-at-law at Van Olmen & Wynant, Brussels, Belgium.
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
Article

Reasoning in Domestic Judgments in New Democracies

A View from Strasbourg

Journal East European Yearbook on Human Rights, Issue 1 2019
Keywords European Court of Human Rights, Article 6, new democracies, reasoning in domestic judgments
Authors Dragoljub Popović
AbstractAuthor's information

    One of the shortcomings in the functioning of the justice systems in new democracies consists of insufficient reasoning in judgments. The European Court of Human Rights (Court) had to deal with the issue in cases in which applicants invoked Article 6 of the Convention for the Protection of Human Rights and Fundamental Freedoms (Convention). The Court’s case law developments concerning the issue are analysed in this article. The general rule emerged in leading cases and was subsequently followed. It says there is an obligation incumbent on national courts to provide reasons for their judgments. Therefore, insufficient reasoning in a judgment given at the domestic level of jurisdiction provides grounds for finding a violation of Article 6 of the Convention. The problem of lack of adequate reasoning in domestic judgments has been given attention among scholars, judges and practising lawyers in new democracies. The Court’s jurisprudence provides guidance to solutions aimed at improvement of the administration of justice in those countries, which are Member States of the Convention.


Dragoljub Popović
Former judge of the ECtHR, attorney-at-law at the Belgrade Bar, professor of law at Union University (Belgrade, Serbia) and a visiting professor at Creighton University (Omaha, NE, USA).

    The author discusses the recent ECJ judgments in the cases Egenberger and IR on religious discrimination.


Andrzej Marian Świątkowski
Andrzej Marian Świątkowski, is a Jean Monet Professor of European Labour Law and Social Security, Jesuit University Ignatianum, Krakow, Poland and a member of the EELC Academic Board.

    The Latvian Supreme Court recently used the ECJ Max Planck and Kreuziger judgments to explain how an employer can escape its obligation to compensate an employee for unused leave at the end of the employment relationship. The employer must prove that (a) it was possible for the employee to use the leave, and (b) the employer has in good time informed the employee that leave, if not used, might be lost and will not be compensated.


Gautier Busschaert
Gautier Busschaert is an Attorney at Van Olmen & Wynant.

    The Luxembourg Court of Appeal (Cour d’appel de Luxembourg) confirmed that an employee dismissed with notice and exempted from performing their work during the notice period is no longer bound by the non-competition duties arising from their loyalty obligation and can therefore engage in an employment contract with a direct competitor of their former employer during that exempted notice period. However, the Court of Appeal decided that, even if the former employee is in principle entitled to use the know-how and knowledge they acquired with their former employer, the poaching of clients during the notice period must, due to the facts and circumstances and in the light of the rules applicable in the financial sector, be considered as an unfair competition act and therefore constitutes serious misconduct justifying the termination of the employment contract with immediate effect.


Michel Molitor
Michel Molitor is the managing partner of MOLITOR Avocats à la Cour SARL in Luxembourg, www.molitorlegal.lu.

Régis Muller
Régis Muller is partner within the Employment, Pension & Immigration department of MOLITOR Avocats à la Cour SARL in Luxembourg, www.molitorlegal.lu.
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