Zoekresultaat: 80 artikelen

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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

Tijdschrift Erasmus Law Review, Aflevering 2 2019
Trefwoorden Medical Device Directive, Medical Device Regulation, regulatory, European Union, reform, innovation, SPCs, policy
Auteurs Magali Contardi
SamenvattingAuteursinformatie

    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).
Artikel

Access_open Advocaten in Europa: vertegenwoordiging op het hoogste niveau?

Tijdschrift Recht der Werkelijkheid, Aflevering 3 2019
Trefwoorden Representation, Lawyers, European Court of Justice, Preliminary References, Relational Expertise
Auteurs Jos Hoevenaars PhD
SamenvattingAuteursinformatie

    Research on the significance of representation indicates that lawyers contribute to positive outcomes of legal procedures not only by their substantive expertise but also by the relational expertise they bring. The latter involves understanding how to navigate the relationships involved in getting work done. In this paper these insights are used to investigate the highly specific and atypical practise of the preliminary reference procedure in the European legal system in order to reveal how lawyers deal with such an unexpected change of (legal) context. The empirical data, collected through semi-structured interviews with twenty-eight lawyers with past experience with the procedure, reveals the significant ways in which lawyers’ positive contribution to such cases is undermined by their lack of both substantive and relational expertise in pleading a case before the European Court of Justice. The fact that such cases do not necessarily fall into the hands of the professionals best equipped to plead such disputes before the Court, and the inability of the less well-off parties in particular to hire further expertise, points in the direction of a disadvantaged position for this group of litigants in having their interest represented effectively at the European level.


Jos Hoevenaars PhD
Jos Hoevenaars is postdoc onderzoeker aan de Erasmus Universiteit Rotterdam.
Artikel

Access_open Using Case Studies for Research on Judicial Opinions. Some Preliminary Insights

Tijdschrift Law and Method, november 2019
Trefwoorden case study, judicial opinions, empirical legal research, qualitative methods, research on judicial opinions
Auteurs Mateusz Stępień
SamenvattingAuteursinformatie

    There is a pressing need to develop a research methodology for studying judicial opinions that goes beyond both dogmatic analyzes and the established positions developed within philosophy of law and legal theory (e.g. the hermeneutic and argumentative approaches). One possible way is to adopt or modify methodologies developed within empirically oriented social sciences. Most social science textbooks devoted to methodology of empirical research deal with case studies. So far, this research framework developed within the social sciences has not been applied directly to judicial opinions, though they have been used for some empirical legal research studies. Even et first sight, case study research would appear to have potential for use with judicial opinions. The aim of the paper is to answer the question, how and to what extent can case study methodology developed within the social sciences be fruitfully used to examine judicial opinions? The general answer is undoubtedly positive (case studies can bring new, non-trivial threads to the research methodology on judicial opinions), though with many serious and far-reaching reservations.


Mateusz Stępień
Assistant Professor, Department of Law and Administration, Jagiellonian University, Cracow, Poland.
Article

Access_open Joinder of Non-Consenting Parties: The Singapore International Commercial Court Approach Meets Transnational Recognition and Enforcement

Tijdschrift Erasmus Law Review, Aflevering 1 2019
Trefwoorden international commercial courts, international business courts, third parties, third party joinder, recognition and enforcement
Auteurs Drossos Stamboulakis en Blake Crook
SamenvattingAuteursinformatie

    In this article we explore the approach of the Singapore International Commercial Court (the ‘SICC’) to jurisdiction and joinder of non-consenting parties, and way that any resulting judgments are likely to be treated by foreign enforcing courts. This novel juncture arises as international commercial courts, such as the SICC, rely predominantly upon party autonomy to enliven their jurisdiction over disputants. This does not require any territorial link of the parties or the dispute to the host jurisdiction (Singapore). At the same time, however, the SICC is granted a mandate under Singaporean law to join non-consenting parties, again with no necessary territorial link. Where such joinder occurs, any resulting judgment is likely to face significant difficulties if recognition and enforcement is sought outside of Singapore. To support this argument, we first set out the ways in which non-consenting disputants may be joined to proceedings before the SICC, and offer some initial thoughts on how these powers are likely to be exercised. Second, we argue that any such exercise of jurisdiction – that lacks either territorial or consent-based jurisdiction grounds – is unlikely to gain support internationally, by reference to transnational recognition and enforcement approaches, and the SICC’s most likely recognition and enforcement destinations. Finally, we offer some concluding remarks about the utility of international commercial court proceedings against non-consenting parties, including the possibility they may impact on domestic recognition and enforcement approaches in foreign States.


Drossos Stamboulakis
B.Com, LLB (Hons) (Monash); LLM (EMLE); Law Lecturer, USC School of Law (University of the Sunshine Coast, Australia)

Blake Crook
PhD Candidate, Faculty of Law (University of Melbourne, Australia), B.Com (Acc), LLB (Hons) (Sunshine Coast).
Law Review

2019/1 EELC’s review of the year 2018

Tijdschrift European Employment Law Cases, Aflevering 1 2019
Auteurs Ruben Houweling, Catherine Barnard, Filip Dorssemont e.a.
Samenvatting

    For the second time, various of our academic board analysed employment law cases from last year. However, first, we start with some general remarks.


Ruben Houweling

Catherine Barnard

Filip Dorssemont

Jean-Philippe Lhernould

Francesca Maffei

Niklas Bruun

Anthony Kerr

Jan-Pieter Vos

Luca Ratti

Daiva Petrylaite

Andrej Poruban

Stein Evju
Artikel

The UN Convention on the Rights of Persons with Disabilities in Practice

A Comparative Analysis of the Role of Courts

Tijdschrift Handicap & Recht, Aflevering 1 2019
Trefwoorden CRPD, disabilities, discrimination, court, human rights
Auteurs Prof. Dr. L.B. Waddington en Dr. A.C. Broderick
SamenvattingAuteursinformatie

    On the 25th and 26th October 2018, the Faculty of Law of Maastricht University hosted a conference on The UN Convention on the Rights of Persons with Disabilities in Practice: A Comparative Analysis of the Role of Courts. This article presents some of the key findings of the conference and summarises several of the speakers’ contributions to the conference.


Prof. Dr. L.B. Waddington
Prof. Dr. L.B. (Lisa) Waddington is European Disability Forum Chair in European Disability Law, Maastricht University.

Dr. A.C. Broderick
Dr. A.C. (Andrea) Broderick is Assistant Professor at Maastricht University.
Artikel

Access_open Van Middelburg tot Almelo. Het hoe en waarom van prejudiciële vragen aan het Hof van Justitie van de Europese Unie door Nederlandse lagere rechters

Tijdschrift Recht der Werkelijkheid, Aflevering 3 2018
Trefwoorden Prejudiciële procedure, Hof van Justitie van de Europese Unie, Nationale rechters, Motieven om te verwijzen, rechtspolitiek
Auteurs Dr. Jasper Krommendijk LLM
SamenvattingAuteursinformatie

    Het Hof van Justitie van de Europese Unie heeft baanbrekende uitspraken gedaan, vooral als gevolg van prejudiciële vragen van nationale rechters op grond van art. 267 VWEU. Het zijn vooral niet-verwijzingsplichtige lagere rechters geweest die voor deze aanvoer hebben gezorgd. Dit artikel onderzoekt hoe dit kan worden verklaard en kijkt naar de motieven van Nederlandse lagere rechters om al dan niet prejudiciële vragen te stellen aan het HvJ. Het doet dit op basis van interviews met 22 rechters en een uitgebreide juridische analyse van uitspraken. Dit artikel toont aan dat met name pragmatische en praktische overwegingen een rol spelen bij het besluit om te verwijzen. Daarnaast laat dit artikel zien dat er meer verschillen zijn binnen een lidstaat dan tussen lidstaten onderling, met name tussen gerechtelijke instanties en individuele rechters.

    The Court of Justice of the European Union has rendered landmark cases, especially following references for a preliminary ruling from national courts on the basis of Art. 267 TFEU. Primarily lower courts that are not obliged to refer have been responsible for such cases. This article examines how these references of lower courts can be explained by focusing on the motives of the Dutch lower court judges to refer, or not to refer. It does so on the basis of interviews with 22 judges and an extensive legal analysis of judgments. This article shows that practical and pragmatic considerations play an important role in the court’s decision to refer. In addition, there are more differences within one Member States than between EU Member States, especially between particular courts and individual judges.


Dr. Jasper Krommendijk LLM
Jasper Krommendijk is universitair docent Europees recht aan de Radboud Universiteit.

Dr. Andreas Hofmann
Andreas Hofmann is a post-doctoral researcher at Freie Universität Berlin. He has held previous positions as lecturer at the University of Cologne and post-doctoral fellow at the Centre for European Research (CERGU), University of Gothenburg.
Article

Access_open The Conduit between Technological Change and Regulation

Tijdschrift Erasmus Law Review, Aflevering 3 2018
Trefwoorden technology, socio-technological change, money, windmill, data
Auteurs Marta Katarzyna Kołacz en Alberto Quintavalla
SamenvattingAuteursinformatie

    This article discusses how the law has approached disparate socio-technological innovations over the centuries. Precisely, the primary concern of this paper is to investigate the timing of regulatory intervention. To do so, the article makes a selection of particular innovations connected with money, windmills and data storage devices, and analyses them from a historical perspective. The individual insights from the selected innovations should yield a more systematic view on regulation and technological innovations. The result is that technological changes may be less momentous, from a regulatory standpoint, than social changes.


Marta Katarzyna Kołacz
Marta Katarzyna Kołacz, Ph.D. Candidate in the Department of Private Law, Erasmus School of Law, Erasmus University Rotterdam, The Netherlands.

Alberto Quintavalla
Alberto Quintavalla, LL.M., Ph.D. Candidate in the Rotterdam Institute of Law and Economics, Erasmus School of Law, Erasmus University Rotterdam, The Netherlands.
Article

Access_open Making Sense of the Law and Society Movement

Tijdschrift Erasmus Law Review, Aflevering 2 2018
Trefwoorden law and society, sociology of law, sociolegal, empirical legal studies
Auteurs Daniel Blocq en Maartje van der Woude
SamenvattingAuteursinformatie

    This article aims to deepen scholarly understanding of the Law and Society Movement (L&S) and thereby strengthen debates about the relation between Empirical Legal Studies (ELS) and L&S. The article departs from the observation that ELS, understood as an initiative that emerged in American law schools in the early 2000s, has been quite successful in generating more attention to the empirical study of law and legal institutions in law schools, both in- and outside the US. In the early years of its existence, L&S – another important site for the empirical study of law and legal institutions – also had its center of gravity inside the law schools. But over time, it shifted towards the social sciences. This article discusses how that happened, and more in general explains how L&S became ever more diverse in terms of substance, theory and methods.


Daniel Blocq
Daniel Blocq is assistant professor at Leiden Law School.

Maartje van der Woude
Maartje van der Woude is professor at Leiden Law School.
Article

Access_open Evidence-Based Regulation and the Translation from Empirical Data to Normative Choices: A Proportionality Test

Tijdschrift Erasmus Law Review, Aflevering 2 2018
Trefwoorden evidence-based, regulation, proportionality, empirical law studies, law and society studies
Auteurs Rob van Gestel en Peter van Lochem
SamenvattingAuteursinformatie

    Studies have shown that the effects of scientific research on law and policy making are often fairly limited. Different reasons can be given for this: scientists are better at falsifying hypothesis than at predicting the future, the outcomes of academic research and empirical evidence can be inconclusive or even contradictory, the timing of the legislative cycle and the production of research show mismatches, there can be clashes between the political rationality and the economic or scientific rationality in the law making process et cetera. There is one ‘wicked’ methodological problem, though, that affects all regulatory policy making, namely: the ‘jump’ from empirical facts (e.g. there are too few organ donors in the Netherlands and the voluntary registration system is not working) to normative recommendations of what the law should regulate (e.g. we need to change the default rule so that everybody in principle becomes an organ donor unless one opts out). We are interested in how this translation process takes place and whether it could make a difference if the empirical research on which legislative drafts are build is more quantitative type of research or more qualitative. That is why we have selected two cases in which either type of research played a role during the drafting phase. We use the lens of the proportionality principle in order to see how empirical data and scientific evidence are used by legislative drafters to justify normative choices in the design of new laws.


Rob van Gestel
Rob van Gestel is professor of theory and methods of regulation at Tilburg University.

Peter van Lochem
Dr. Peter van Lochem is jurist and sociologist and former director of the Academy for Legislation.

Annelien Bouland
Annelien Bouland (LLM, MSc) is een Meijers PhD kandidaat aan het Van Vollenhoven Institute for Law Governance and Society, Universiteit Leiden.
Case Reports

2018/18 Preliminary questions to ECJ about Brexit implications for UK citizens? (NL)

Tijdschrift European Employment Law Cases, Aflevering 2 2018
Trefwoorden Free movement, Work and residence permit, Other forms of free movement
Auteurs Jan-Pieter Vos
SamenvattingAuteursinformatie

    Recently, the Court of Amsterdam decided to ask preliminary questions to the ECJ about EU citizens’ rights of British nationals, anticipating Brexit. However, two weeks later, it allowed an appeal against this decision. It is therefore unclear if and when these questions will be asked.


Jan-Pieter Vos
Jan-Pieter Vos is a lecturer of Labour Law at Erasmus University Rotterdam.

    Legal doctrinal scholarship engages with the problems of legal practice: it systematizes, comments on, evaluates and debates what goes on in law. These activities do not occur in a vacuum: they are embedded in scholarly traditions and theories. This paper discusses the role of the theoretical frameworks used in legal research and has two related aims. First, it aims to provide some practical conceptualizations and guidelines regarding theoretical and normative frameworks that are useful to understand and conduct legal research. Second, it aims to investigate the relationships between different kinds of normative frameworks and their relationship to empirical work. In the second part, an argument is made for a pragmatist understanding of the interplay between normative theorizing and empirical study. How do these work together in judgments about the state of the law?


Sanne Taekema
Erasmus School of Law, Rotterdam; taekema@law.eur.nl.

Elisabetta Silvestri
Elisabetta Silvestri is Associate Professor of Italian Civil Procedure and Comparative Civil Procedure; Scientific Director of the postgraduate program on Mediation and ADR, Department of Law, University of Pavia. Co-Director of the annual seminar ‘Public and Private Justice’, Inter-University Centre, Dubrovnik, Croatia; member of the Scientific Advisory Board of Almo Collegio Borromeo, Pavia. She graduated from the University of Pavia and received a LL.M. degree from Cornell Law School. She is a member of the European Law Institute and the International Association of Procedural Law. She has written on Italian civil procedure and a variety of topics in the field of comparative procedure. She has lectured extensively in Italy and abroad; she is a member of one of the Working Groups established by the European Law Institute and UNIDROIT for the development of the project ‘From Transnational Principles to European Rules of Civil Procedure’.
Artikel

Mediation on trial: Dutch court judgments on mediation

Tijdschrift Nederlands-Vlaams tijdschrift voor mediation en conflictmanagement, Aflevering 4 2017
Trefwoorden Case law, The Netherlands, Voluntariness, Confidentiality
Auteurs Annie de Roo en Rob Jagtenberg
Auteursinformatie

Annie de Roo
Annie de Roo is associate professor of ADR and comparative law at Erasmus University Law School in Rotterdam, editor-in-chief of TMD, and vice chair of the exams committee of the Mediators Federation of the Netherlands MFN. She has published extensively on mediation and has inter alia been a Rapporteur three times for the European Commission on the use of mediation in employment disputes.

Rob Jagtenberg
Rob Jagtenberg is senior research fellow at Erasmus University and has published frequently on the relationship between public and private justice. He has been involved in research commissioned by the Worldbank, the Netherlands Council for the Judiciary, and various Dutch Ministries including the MoJ funded national project on court-connected mediation.
Artikel

ADR Clauses and International Perceptions: A Preliminary Report

Tijdschrift Nederlands-Vlaams tijdschrift voor mediation en conflictmanagement, Aflevering 3 2017
Trefwoorden ADR, Dispute resolution clauses, Questionnaire, commercial contracts
Auteurs Maryam Salehijam
SamenvattingAuteursinformatie

    This article provides a preliminary analysis of the 622 responses to a questionnaire conducted in the context of Maryam Salehijam’s PhD research which focuses on commercial parties’ agreement to mediate/conciliate. The questionnaire targeted ADR professionals and experts with experience in drafting, inserting, or enforcing dispute resolution clauses that provide for non-binding ADR mechanisms. Some of the key findings include that it is still not very common for commercial contracts to conclude agreements to mediate/conciliate. This begs the question of why the parties and/or their legal advisors do not conclude such agreements as regularly as agreements to arbitrate. Moreover, the questionnaire confirmed that there is widespread practice in contract drafting to copy and paste dispute resolution clauses. This practice is shocking in light of the rising number of cases in which the parties dis­agree regarding the binding nature of their dispute resolution clause.


Maryam Salehijam
Maryam Salehijam is a PhD Researcher at the University of Ghent (Transnational Law Centre), LL.M. International Laws (Maastricht University) and LL.B. European Law (Maastricht University).
Artikel

Enforceability of mediation clauses in Belgium and the Netherlands

Tijdschrift Nederlands-Vlaams tijdschrift voor mediation en conflictmanagement, Aflevering 3 2017
Trefwoorden Enforceability, Mediation clauses, contracts
Auteurs Ellen van Beukering-Rosmuller en Patrick Van Leynseele
SamenvattingAuteursinformatie

    In this article authors discuss (possible) legal means and methods aimed at making mediation clauses effective and/or enforceable. In particular Belgian and Dutch law are examined. In part attention is also paid to English, French and Italian law. Against the background of recent EU-legislation the validity of mediation clauses is discussed as well, with a focus on consumer related disputes. By reviewing US case law with regard to the duty to participate in good faith in the mediation process, the authors also outline the limits of this concept for the effectiveness of mediation clauses. The central theme of the enforceability of mediation clauses has been looked at both from a procedural as from a financial angle. Substantial differences can be noted between the Belgian and the Dutch approach towards what courts should do when dealing with a dispute in which parties have previously agreed to mediation. Belgian law provides in art. 1725 § 2 Judicial Code that the court, if so requested by the defendant, is in principle obliged to suspend the examination of the case until the mediation has taken place. According to current case law, the situation in the Netherlands is that mediation clauses are in principle not enforceable (Supreme Court 2006). Following the most recent legislative proposal regarding mediation (July 2016) the court should examine whether mediation can still have an added value in case one party refuses to take part in a mediation as provided for in a clause invoked by the other party, prior to (possibly) proposing mediation. Based on the plans repeatedly announced by the Belgian Minister of Justice, it is likely that there will soon be an amendment to the mediation provisions in the Judicial Code that will allow courts to ‘force’ mediation upon the parties, even in the absence of a mediation clause. If this becomes the rule, judges would be well advised to exercise this power with due care. In the authors’ opinion the Dutch approach (as suggested in the most recent legislative proposal) in connection with mediation clauses, consisting in having the court examine whether mediation may (still) have an added value for the parties, could serve as a good guideline for the Belgian judges to use.


Ellen van Beukering-Rosmuller
Ellen J.M. van Beukering-Rosmuller is Universitair Docent Burgerlijk Procesrecht, Universiteit Leiden, Faculteit der Rechtsgeleerdheid.

Patrick Van Leynseele
Patrick H. Van Leynseele is lid van de balies van Brussel en New York en partner in het Brussels advocatenkantoor DALDEWOLF, een referentie inzake ADR. Met als achtergrond het ondernemingsrecht werkt hij als litigator en arbiter in internationale zaken. Hij schreef verschillende artikels inzake mediation en Med-Arb in vooraanstaande juridische tijdschriften.

    The purpose of this article is to investigate whether the notion of an interest should be taken more seriously than the notion of a right. It will be argued that it should; and not only because it can be just as amenable to the institutional taxonomical structure often said to be at the basis of rights thinking in law but also because the notion of an interest has a more epistemologically convincing explanatory power with respect to reasoning in law and its relation to social facts. The article equally aims to highlight some of the important existing work on the notion of an interest in law.


Geoffrey Samuel
Professor of Law, Kent Law School, The University of Kent, Canterbury, Kent, U.K. This article is a much re-orientated, and updated, adaption of a paper published a decade ago: Samuel 2004, at 263. The author would like to thank the anonymous referees for their very helpful criticisms and observations on an earlier version of the manuscript.
Artikel

Access_open Criminal law sanctions and the Return Directive: the position of illegally staying third-country nationals in the European Union

Tijdschrift Crimmigratie & Recht, Aflevering 1 2017
Trefwoorden Crimmigration, Return Directive, Entry ban, Sanctions, Criminal law
Auteurs Aniel Pahladsingh LL.M. en Jim Waasdorp LL.M.
SamenvattingAuteursinformatie

    At EU level, the use of substantive criminal law as a response to illegal migration is materialised by both the EU legislator and the Member States individually. EU involvement in criminalizing illegal migration takes place in a twofold manner: directly, through harmonization of national legislations, and indirectly, through the case law of the Court of Justice of the European Union (CJEU). An example of the latter is the case law of the CJEU regarding criminal law sanctions for breaching an entry ban. In this article, we will analyse judgments of the CJEU in the light of crimmigration law and make a distinction between the Member States’ power to classify a breach of an entry ban as an offence and to lay down criminal law sanctions in national legislation, and their power to impose such sanctions.


Aniel Pahladsingh LL.M.
Mr. A. Pahladsingh is jurist bij de Raad van State en rechter-plaatsvervanger bij de Rechtbank Rotterdam. Hij is tevens lid van de redactie van Crimmigratie & Recht.

Jim Waasdorp LL.M.
Mr. J.R.K.A.M. Waasdorp LL.M. works as a lawyer at the Administrative Jurisdiction Division of the Dutch Council of State (as of the 1st of June 2017, Jim is seconded to the Directorate General of Library, Research and Documentation of the Court of Justice of the European Union) and is a researcher at the University of Utrecht.
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