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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

The New Regulation Governing AIR, VIR and Consultation

A Further Step Forward Towards ‘Better Regulation’ in Italy

Journal European Journal of Law Reform, Issue 4 2019
Keywords regulation, RIA, regulatory impact analysis, impact assessment, evaluation, consultation
Authors Victor Chimienti
AbstractAuthor's information

    This article describes the scope and contents of the newly adopted regulation governing regulatory impact analysis (RIA) and ex post evaluation of regulation (ExPER) in the Italian legal system. The article shows that this regulation has the potential to improve regulatory governance in Italy. Not only does it introduce innovations designed to increase transparency and participation, especially through strengthened consultation and communication mechanisms, but it also aims to improve the quality and effectiveness of regulatory analysis and evaluation activities. How the new regulation will be applied in practice, however, remains to be seen. In the meantime, the new set of rules are a welcome addition to Italy’s Better Regulation policy.


Victor Chimienti
Victor Chimienti is an international and EU lawyer currently working as a free-lance consultant on donor funded projects. In 1997, he graduated in Law with full marks at the University of Bari “Aldo Moro” (Italy), and, in 2006, obtained his Ph.D in International and EU Law from the same university. Meanwhile, he had attended post-graduate legal studies at LUISS University in Rome, Italy, specialising in international and EC business law. Dr. Chimienti has also served as Lecturer in International and Trade Law at the University of Foggia, Italy, and as Research Scholar in International & Comparative Law at the University of Michigan, USA. Among others, he specialises in Better Regulation tools and procedures, such as Regulatory Impact Analysis (RIA), Ex-Post Evaluation of Legislation, Monitoring, and Public Consultation.
Article

Split-Ticket Voting in Belgium

An Analysis of the Presence and Determinants of Differentiated Voting in the Municipal and Provincial Elections of 2018

Journal Politics of the Low Countries, Issue 3 2019
Keywords split-ticket voting, local elections, voting motives, Belgium, PR-system
Authors Tony Valcke and Tom Verhelst
AbstractAuthor's information

    This article tackles the particular issue of split-ticket voting, which has been largely overlooked in Belgian election studies thus far. We contribute to the literature by answering two particular research questions: (1) to what extent and (2) why do voters cast a different vote in the elections for the provincial council as compared to their vote in the elections for the municipal council?
    The article draws on survey data collected via an exit poll in the ‘Belgian Local Elections Study’, a research project conducted by an inter-university team of scholars.
    Our analysis shows that nearly 45% of the total research population cast a split-ticket vote in the local elections of 2018. However, this number drops to one out of four if we only consider a homogenous party landscape at both levels by excluding the numerous votes for ‘local’ lists (which occur mostly at the municipal level). This finding underlines the importance of accounting for the electoral and institutional context of the different electoral arenas in research on split-ticket voting in PR systems. In the Belgian context, split-ticket voting in 2018 also differed between the different parties and regions. Furthermore, it was encouraged by a higher level of education and familiarity with particular candidates. This candidate-centred and strategic voting was matched by party identification and the urban municipal context favouring straight-ticket voting. Other factors such as region, a rural municipal context and preferential voting seemed more relevant to determine voting for local parties than using the instrument of split-ticket votes as such.


Tony Valcke
Tony Valcke is Associate Professor at the Faculty of Political and Social Sciences of Ghent University (Belgium). He is a member of the Centre for Local Politics (CLP) and coordinator of the Teacher Training Department. His research, publications and educational activities focus on elections and democratic participation/innovation, (the history of) political institutions and (local) government reform, political elites and leadership, citizenship (education).

Tom Verhelst
Tom Verhelst is Assistant Professor at the Faculty of Political and Social Sciences at Ghent University (Belgium) and a postdoctoral research fellow at the Department of Political Science at Maastricht University (the Netherlands). His research focuses on the Europeanisation of local government (with a particular interest for the regulatory mobilisation of local government in EU decision-making processes) and on the role and position of the local council in Belgium and the Netherlands (with a particular interest for local council scrutiny).
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.
Human Rights Literature Reviews

Hungary

Journal East European Yearbook on Human Rights, Issue 1 2019
Authors Alexandra Sipos PhD
Author's information

Alexandra Sipos PhD
PhD student, Doctoral School of Sociology, Faculty of Social Sciences at Eötvös Loránd University, Budapest, Hungary.
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).
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
Human Rights Practice Reviews

Albania

Journal East European Yearbook on Human Rights, Issue 1 2019
Authors Anisia Mandro LLM
Author's information

Anisia Mandro LLM
Anisia Mandro (European Union Law - LLM), Legal Researcher and Legal Adviser in the area of competition law, data protection, and human rights; Consultant in approximation of national legislation with EU acquis Communautaire.
Article

Primus Inter Pares? In Search of ‘Fundamental’ Human Rights

Journal East European Yearbook on Human Rights, Issue 1 2019
Keywords hierarchy, jus cogens, International Court of Justice, European Court of Human Rights, Inter-American Court of Human Rights
Authors Julia Kapelańska-Pręgowska
AbstractAuthor's information

    International human rights law is one of the most developed and codified regimes (branches) of public international law. Since 1948 and the adoption of the Universal Declaration of Human Rights, the number and scope of human rights standards evolved considerably. Prima facie this tendency reflects a generally positive phenomenon and is driven by the human rights approach in international law, but at the same time it may raise questions of the system’s efficiency, internal coherence, hierarchy of rights and mechanisms of protection and monitoring. Against the richness of human rights standards, designations such as ‘fundamental’, ‘essential’, ‘basic’, ‘crucial’ or ‘core’ are being used and ascribed to diverse concepts (inter alia, customary international human rights, erga omnes obligations, non-derogable rights, jus cogens or absolute rights). The article explores the provisions of general human rights instruments – the UDHR, the two Covenants and regional treaties, as well as relevant case-law of the ICJ, ECtHR and IACtHR in search of a definition and catalogue of fundamental human rights.


Julia Kapelańska-Pręgowska
Chair of Human Rights, Faculty of Law and Administration, Nicolaus Copernicus University in Toruń, Poland.

    This was a case alleging detrimental treatment for whistleblowing brought by an employee working outside the UK against two co-workers also working abroad in the same location. The Court of Appeal (CA) ruled that there was no jurisdiction for the Employment Tribunal (ET) to hear the claim in relation to personal liability of the co-workers because they were outside the scope of UK employment law. The CA’s judgment potentially has implications for other types of claim brought by UK employees posted abroad where similar personal liability provisions apply, such as discrimination and harassment.


Richard Lister
Richard Lister is a Managing Practice Development Lawyer at Lewis Silkin LLP.

    A number of collective labour agreements unjustifiably have excluded allowances from holiday pay. Recently, social partners have had difficulties in repairing these flaws. Two recent cases demonstrate this, both similar claims but with different outcomes. This leaves social partners with the problem of how to proceed.


Jan-Pieter Vos
Jan-Pieter Vos is a lecturer of Labour Law at the Erasmus University Rotterdam, the Netherlands and editor of EELC.

    Both the French Supreme Court and the Versailles Court of Appeal held that an employer, who must ensure that liberties and fundamental rights of each employee are respected in the working community, may lawfully prohibit the wearing of any visible sign of political, philosophical or religious beliefs in the workplace, provided that the rule contained in the company rules and regulations applies without distinction to employees in direct contact with the customers of the company only. But in the absence of such rules, sanctioning an employee who refuses to remove her Islamic veil based on the wish of a customer, which does not qualify as a genuine and determining occupational requirement, amounts to an unlawful direct discrimination and should consequently be held null and void.


Claire Toumieux
Claire Toumieux is partner and Thomas Robert is an attorney at Allen & Overy LLP in Paris, France.

Thomas Robert
Article

Access_open The Brussels International Business Court: Initial Overview and Analysis

Journal Erasmus Law Review, Issue 1 2019
Keywords international jurisdiction, English, court language, Belgium, business court
Authors Erik Peetermans and Philippe Lambrecht
AbstractAuthor's information

    In establishing the Brussels International Business Court (BIBC), Belgium is following an international trend to attract international business disputes to English-speaking state courts. The BIBC will be an autonomous business court with the competence to settle, in English, disputes between companies throughout Belgium. This article focuses on the BIBC’s constitutionality, composition, competence, proceedings and funding, providing a brief analysis and critical assessment of each of these points. At the time of writing, the Belgian Federal Parliament has not yet definitively passed the Bill establishing the BIBC, meaning that amendments are still possible.


Erik Peetermans
Erik Peetermans is a legal adviser at the Federation of Enterprises in Belgium (FEB).

Philippe Lambrecht
Philippe Lambrecht is the Director-Secretary General at the Federation of Enterprises in Belgium (FEB).
Article

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

Journal Erasmus Law Review, Issue 1 2019
Keywords international commercial courts, international business courts, third parties, third party joinder, recognition and enforcement
Authors Drossos Stamboulakis and Blake Crook
AbstractAuthor's information

    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).
Article

Access_open Chambers for International Commercial Disputes in Germany: The State of Affairs

Journal Erasmus Law Review, Issue 1 2019
Keywords Justizinitiative Frankfurt, Law Made in Germany, International Commercial Disputes, Forum Selling, English Language Proceedings
Authors Burkhard Hess and Timon Boerner
AbstractAuthor's information

    The prospect of attracting foreign commercial litigants to German courts in the wake of Brexit has led to a renaissance of English-language commercial litigation in Germany. Leading the way is the Frankfurt District Court, where – as part of the ‘Justizinitiative Frankfurt’ – a new specialised Chamber for International Commercial Disputes has been established. Frankfurt’s prominent position in the financial sector and its internationally oriented bar support this decision. Borrowing best practices from patent litigation and arbitration, the Chamber offers streamlined and litigant-focused proceedings, with English-language oral hearings, within the current legal framework of the German Code of Civil Procedure (ZPO).1xZivilprozessordnung (ZPO).
    However, to enable the complete litigation process – including the judgment – to proceed in English requires changes to the German Courts Constitution Act2xGerichtsverfassungsgesetz (GVG). (GVG). A legislative initiative in the Bundesrat aims to establish a suitable legal framework by abolishing the mandatory use of German as the language of proceedings. Whereas previous attempts at such comprehensive amendments achieved only limited success, support by several major federal states indicates that this time the proposal will succeed.
    With other English-language commercial court initiatives already established or planned in both other EU Member States and Germany, it is difficult to anticipate whether – and how soon – Frankfurt will succeed in attracting English-speaking foreign litigants. Finally, developments such as the 2018 Initiative for Expedited B2B Procedures of the European Parliament or the ELI–UNIDROIT project on Transnational Principles of Civil Procedure may also shape the long-term playing field.

Noten

  • 1 Zivilprozessordnung (ZPO).

  • 2 Gerichtsverfassungsgesetz (GVG).


Burkhard Hess
Burkhard Hess is the Executive Director of the Max Planck Institute Luxembourg for International, European and Regulatory Procedural Law (MPI Luxembourg).

Timon Boerner
Timon Boerner is a Research Fellow at the MPI Luxembourg.
Article

Access_open The Court of the Astana International Financial Center in the Wake of Its Predecessors

Journal Erasmus Law Review, Issue 1 2019
Keywords international financial centers, offshore courts, international business courts, Kazakhstan
Authors Nicolás Zambrana-Tévar
AbstractAuthor's information

    The Court of the Astana International Financial Center is a new dispute resolution initiative meant to attract investors in much the same way as it has been done in the case of the courts and arbitration mechanisms of similar financial centers in the Persian Gulf. This paper examines such initiatives from a comparative perspective, focusing on their Private International Law aspects such as jurisdiction, applicable law and recognition and enforcement of judgments and arbitration awards. The paper concludes that their success, especially in the case of the younger courts, will depend on the ability to build harmonious relationships with the domestic courts of each host country.


Nicolás Zambrana-Tévar
LLM (LSE), PhD (Navarra), KIMEP University.
Article

Access_open Matchmaking International Commercial Courts and Lawyers’ Preferences in Europe

Journal Erasmus Law Review, Issue 1 2019
Keywords choice of court, commercial court, lawyers’ preferences, survey on lawyers, international court
Authors Erlis Themeli
AbstractAuthor's information

    France, Germany, Belgium, and the Netherlands have taken concrete steps to design and develop international commercial courts. Most of the projects claim to be building courts that match the preferences of court users. They also try to challenge England and Wales, which evidence suggests is the most attractive jurisdiction in the EU. For the success of these projects, it is important that their proposed courts corresponds with the expectations of the parties, but also manages to attract some of the litigants that go to London. This article argues that lawyers are the most important group of choice makers, and that their preferences are not sufficiently matched by the new courts. Lawyers have certain litigation service and court perception preferences. And while the new courts improve their litigation service, they do not sufficiently addressed these court perception preferences.


Erlis Themeli
Postdoc, Erasmus School of Law, Erasmus University Rotterdam.

    Austrian courts have to deal with an increasing number of cases concerning dismissal on grounds of (alleged) discrimination. The particular challenge is to a draw a conclusive distinction between the concepts of disability and sickness.


Peter C. Schöffmann
Peter C. Schöffmann is a teaching and research associate at the Institute for Austrian and European Labour Law and Social Security Law at Vienna University of Economics and Business, www.wu.ac.at/en/ars.

    Following an appeal by Uber against the Employment Appeal Tribunal’s (EAT) finding last year, which was featured in EELC 2018/9, that drivers engaged by Uber are ‘workers’ rather than independent contractors (reported in EELC 2018-1), the Court of Appeal (CA) has now upheld the EAT’s decision. The CA also upheld the finding of the Employment Tribunal (ET), which was featured in EELC 2017/10, that drivers are working when they are signed into the Uber app and ready to work (reported in EECL 2017-1). Uber has approximately 40,000 drivers (and about 3.5 million users of its mobile phone application in London alone) and so this decision has potentially significant financial consequences for the company.


Jemma Thomas
Jemma Thomas is a Senior Associate Solicitor at Lewis Silkin LLP.

    According to the Labour Court of Mons, calculating the termination indemnity of a worker based on the reduced remuneration paid during a career break called ‘time-credit’ is compatible with EU law, despite the Meerts judgment regarding parental leave.


Dr. Gautier Busschaert
Dr. Gautier Busschaert is attorney at Van Olmen & Wynant in Brussels, www.vow.be.
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