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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.

Tamás Szabados
Senior lecturer, ELTE Law School, Budapest.
Article

Magyar Jeti Zrt. v. Hungary

Judgment of the ECtHR Concerning the Imposition of Liability for Posting Hyperlinks to Defamatory Content

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2019
Keywords freedom of expression, defamatory content, liability of online press, Article 10 ECHR, hyperlinks
Authors Renáta Gyalog
AbstractAuthor's information

    The article aims to introduce the judgment of the ECtHR on the case Magyar Jeti Zrt. v. Hungary. Although in this Hungarian case the ECtHR dealt with a special provision of the Hungarian Civil Code that – under the interpretation of the domestic courts – imposes objective liability for posting hyperlinks which lead to third-party online content, the judgment can be considered as a big improvement compared to the previous decisions of the ECtHR concerning the freedom of expression. The judgment offers legal certainty and guidance for journalists who post hyperlinks by determining five relevant questions to be taken into account when deciding whether the liability of a press organ can be established for contents cited from other websites over which they have no control. Becoming the best ECtHR judgment of the year 2018 under the yearly vote announced by Strasbourg Observers blog portal also emphasizes the importance and the relevance of this decision for the digital media.


Renáta Gyalog
Assistant judge, Békéscsaba District Court, Hungary.
Article

The Rights of the Victim in Hungarian Criminal Proceedings

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2019
Keywords rights of victims, code of criminal procedure in Hungary, victims in criminal procedure, Directive 2012/29/EU, rights of vulnerable persons
Authors Anna Kiss
AbstractAuthor's information

    In the course of the development of criminal law victims lost their former leading role in the procedure and were pushed to the periphery of justice. Legal experts have come to realize that this tendency is tremendously unfair to the victim. European documents on the legal position of the victims increasingly called the attention of the legislature to the need of bringing about changes. In Hungary, the relevant new law was passed in June 2017. The Code came into effect in July 2018 and confirmed the victim’s procedural position. Since July, there are three groups of victims’ rights in Hungarian Criminal Proceedings: provision of information and support; participation in criminal proceedings; protection of victims and recognition of victims in need of special protection. In addition to describing the rights, the study also draws attention to the fact in light of the principle that all rights are worth upholding it is not enough to regulate the rights of victims. The study also warns that although the rights of victims are important, we should not forget the guarantees concerning suspects’ rights, which must also be ensured.


Anna Kiss
Senior research fellow, National Institute of Criminology, Budapest.
Article

From International Law in Books to International Law in Action

ELTE Law School’s Jessup and Telders Victories in 2019

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2019
Authors Gábor Katjár and Katalin Sulyok
Author's information

Gábor Katjár
Associate professor, ELTE Law School, Budapest, and coach of ELTE Jessup Team since 2010 as well as coach of ELTE Telders Team since 2016.

Katalin Sulyok
Senior lecturer, ELTE Law School, Budapest, and co-coach of ELTE Jessup Team in 2015, 2017 and 2019; co-coach of ELTE Telders Team in 2019.
Article

Access_open The Foundations of the Internal Market: Free Trade Area and Customs Union under Articles 28-31 TFEU

Journal Erasmus Law Review, Issue 3 2019
Keywords free trade area, customs union, internal market, European Union, Brexit
Authors Stefan Enchelmaier
Abstract

    This contribution places the provisions of the Treaty creating a free trade area and customs union between the Member States (Articles 28-31 TFEU) in their wider context. It then focuses on the interpretation of Article 30 in the jurisprudence of the Court of Justice of the European Union (CJEU). Throughout, it casts sideways glances at corresponding provisions of General Agreement on Tariffs and Trade (GATT). As it turns out, the abolition of customs duties and charges having equivalent effect, and the establishment of a customs union between Member States, were important milestones in the development of European unification. They became overshadowed later by more spectacular developments in the case law on the free movement of goods, persons and services. As a consequence, the importance of the customs provisions is widely underrated. Brexit concentrates the minds in this respect, as an important economy is about to rearrange and even recreate the basic building blocks of its international trading relations.


Stefan Enchelmaier
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.
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