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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 Mercosur: Limits of Regional Integration

Journal Erasmus Law Review, Issue 3 2019
Keywords Mercosur, European Union, regionalism, integration, international organisation
Authors Ricardo Caichiolo
AbstractAuthor's information

    This study is focused on the evaluation of successes and failures of the Common Market of the South (Mercosur). This analysis of Mercosur’s integration seeks to identify the reasons why the bloc has stagnated in an incomplete customs union condition, although it was originally created to achieve a common market status. To understand the evolution of Mercosur, the study offers some thoughts about the role of the European Union (EU) as a model for regional integration. Although an EU-style integration has served as a model, it does not necessarily set the standards by which integration can be measured as we analyse other integration efforts. However, the case of Mercosur is emblematic: during its initial years, Mercosur specifically received EU technical assistance to promote integration according to EU-style integration. Its main original goal was to become a common market, but so far, almost thirty years after its creation, it remains an imperfect customs union.
    The article demonstrates the extent to which almost thirty years of integration in South America could be considered a failure, which would be one more in a list of previous attempts of integration in Latin America, since the 1960s. Whether it is a failure or not, it is impossible to envisage EU-style economic and political integration in South America in the foreseeable future. So far, member states, including Brazil, which could supposedly become the engine of economic and political integration in South America, have remained sceptical about the possibility of integrating further politically and economically. As member states suffer political and economic turmoil, they have concentrated on domestic recovery before being able to dedicate sufficient time and energy to being at the forefront of integration.


Ricardo Caichiolo
Ricardo Caichiolo, PhD (Université catholique de Louvain, Belgium) is legal and legislative adviser to the Brazilian Senate and professor and coordinator of the post graduate programs on Public Policy, Government Relations and Law at Ibmec (Instituto Brasileiro de Mercado de Capitais, Brazil).
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, EU Customs Union, internal market, European Union, Brexit
Authors Stefan Enchelmaier
AbstractAuthor's information

    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
Stefan Enchelmaier, Dr iur (Bonn) habil (Munich) LLM (Edinb) MA (Oxon) is Professor of European and Comparative Law at Lincoln College, University of Oxford.
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 The Singapore International Commercial Court: The Future of Litigation?

Journal Erasmus Law Review, Issue 1 2019
Keywords international commercial court, Singapore, dispute resolution, litigation
Authors Man Yip
AbstractAuthor's information

    The Singapore International Commercial Court (‘SICC’) was launched on 5 January 2015, at the Opening of Legal Year held at the Singapore Supreme Court. What prompted the creation of SICC? How is the SICC model of litigation different from litigation in the Singapore High Court? What is the SICC’s track record and what does it tell us about its future? This article seeks to answer these questions at greater depth than existing literature. Importantly, it examines these questions from the angle of reimagining access of justice for litigants embroiled in international commercial disputes. It argues that the SICC’s enduring contribution to improving access to justice is that it helps to change our frame of reference for international commercial litigation. Hybridisation, internationalisation, and party autonomy, the underpinning values of the SICC, are likely to be the values of the future of dispute resolution. International commercial dispute resolution frameworks – typically litigation frameworks – that unduly emphasise national boundaries and formalities need not and should not be the norm. Crucially, the SICC co-opts a refreshing public-private perspective to the resolution of international commercial disputes. It illuminates on the public interest element of the resolution of such disputes which have for some time fallen into the domain of international commercial arbitration; at the same time, it introduces greater scope for self-determination in international commercial litigation.


Man Yip
BCL (Oxon).
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).
Editorial

Access_open International Business Courts in Europe and Beyond: A Global Competition for Justice?

Journal Erasmus Law Review, Issue 1 2019
Keywords international business courts, justice innovation, justice competition, global commercial litigation, private international law
Authors Xandra Kramer and John Sorabji
Author's information

Xandra Kramer
Xandra Kramer, Professor of Private Law at Erasmus University Rotterdam, and of Private International Law, Utrecht University.

John Sorabji
John Sorabji, Senior Teaching Fellow, UCL, London/Principal Legal Adviser to the Lord Chief Justice and the Master of the Rolls.
Article

Access_open The Conduit between Technological Change and Regulation

Journal Erasmus Law Review, Issue 3 2018
Keywords technology, socio-technological change, money, windmill, data
Authors Marta Katarzyna Kołacz and Alberto Quintavalla
AbstractAuthor's information

    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 Armed On-board Protection of Italian Ships: From an Apparent Hybrid Model to a Regulated Rise of Private Contractors

Journal Erasmus Law Review, Issue 4 2018
Keywords maritime security services, Italian hybrid system, military and private personnel, use of force, relation with the shipmaster
Authors Giorgia Bevilacqua
AbstractAuthor's information

    The sharp increase of piracy attacks in the last two decades was followed by a parallel increase of demand in the maritime security sector. A plenty of flag States around the world have started to authorize the deployment of armed security guards, either military or private, aboard commercial ships. In 2011, Italy also introduced the possibility of embarking armed security services to protect Italian flagged ships sailing in dangerous international waters. Like the other flag States’ legal systems, the newly adopted Italian legislation aims to preserve the domestic shipping industry which was particularly disrupted by modern-day pirates. On the other hand, the doubling of approaches of the Italian legal and regulatory framework, initially privileging military personnel and then opting for the private solution, took the author to investigate the main relevant features of the Italian model of regulation and to analyze the recent developments of the domestic legal practice on counterpiracy armed security services, focusing on the role that customary and treaty obligations of international law played for the realization at national level of on-board armed protection of Italian ships. The use of lethal force at sea and the relationship between the shipmaster and the security guards will receive specific attention in this article.


Giorgia Bevilacqua
Researcher at the Università degli Studi della Campania Luigi Vanvitelli.
Article

Access_open Empirical Legal Research in Europe: Prevalence, Obstacles, and Interventions

Journal Erasmus Law Review, Issue 2 2018
Keywords empirical legal research, Europe, popularity, increase, journals
Authors Gijs van Dijck, Shahar Sverdlov and Gabriela Buck
AbstractAuthor's information

    Empirical Legal research (ELR) has become well established in the United States, whereas its popularity in Europe is debatable. This article explores the popularity of ELR in Europe. The authors carried out an empirical analysis of 78 European-based law journals, encompassing issues from 2008-2017. The findings demonstrate that a supposed increase of ELR is questionable (at best).
    Moreover, additional findings highlight:

    • An increase for a few journals, with a small number of other journals showing a decrease over time;

    • A higher percentage of empirical articles for extra-legal journals than for legal journals (average proportion per journal is 4.6 percent for legal journals, 18.9 percent for extra-legal journals);

    • Criminal justice journals, environmental journals, and economically oriented journals being more likely to publish empirical articles than other journals;

    • More prestigious journals being more likely to publish empirical articles than less-prestigious journals;

    • Older journals being more likely to publish empirical work than younger journals, but not at an increasing rate;

    • Journals being legal/extra-legal, journals in a specific field, journal ranking, or the age of the journal not making it more (or less) likely that the journal will publish empirical articles at an increasing (or decreasing) rate.
      Considering the lack of convincing evidence indicating an increase of ELR, we identify reasons for why ELR is seemingly becoming more popular but not resulting in more empirical research in Europe. Additionally, we explore interventions for overcoming the obstacles ELR currently faces.


Gijs van Dijck
Professor of Private Law at Maastricht University, the Netherlands.

Shahar Sverdlov
Law student at the Vrije Universiteit Amsterdam, the Netherlands.

Gabriela Buck
Law student at Maastricht University, the Netherlands.
Article

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

Journal Erasmus Law Review, Issue 2 2018
Keywords evidence-based, regulation, proportionality, empirical law studies, law and society studies
Authors Rob van Gestel and Peter van Lochem
AbstractAuthor's information

    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.

Dr. Beatriz Barreiro Carril
Lecturer of International Law (Rey Juan Carlos University).

    Despite enjoying distinct and privileged constitutional statuses, the Indigenous minorities of Malaysia, namely, the natives of Sabah, natives of Sarawak and the Peninsular Malaysia Orang Asli continue to endure dispossession from their customary lands, territories and resources. In response, these groups have resorted to seeking justice in the domestic courts to some degree of success. Over the last two decades, the Malaysian judiciary has applied the constitutional provisions and developed the common law to recognise and protect Indigenous land and resource rights beyond the literal confines of the written law. This article focuses on the effectiveness of the Malaysian courts in delivering the preferred remedy of Indigenous communities for land and resource issues, specifically, the restitution or return of traditional areas to these communities. Despite the Courts’ recognition and to a limited extent, return of Indigenous lands and resources beyond that conferred upon by the executive and legislative arms of government, it is contended that the utilisation of the judicial process is a potentially slow, costly, incongruous and unpredictable process that may also not necessarily be free from the influence of the domestic political and policy debates surrounding the return of Indigenous lands, territories and resources.


Yogeswaran Subramaniam Ph.D.
Yogeswaran Subramaniam is an Advocate and Solicitor in Malaysia and holds a PhD from the University of New South Wales for his research on Orang Asli land rights. In addition to publishing extensively on Orang Asli land and resource rights, he has acted as legal counsel in a number of landmark indigenous land rights decisions in Malaysia.

Colin Nicholas
Colin Nicholas is the founder and coordinator of the Centre for Orang Asli Concerns (COAC). He received a PhD from the University of Malaya on the topic of Orang Asli: Politics, Development and Identity, and has authored several academic articles and books on Orang Asli issues. He has provided expert evidence in a number of leading Orang Asli cases. The law stated in this article is current as on 1 October 2017.

Kristin Henrard Ph.D.
Kristin Henrard is professor minorities and fundamental rights in the department of International and EU law of the Erasmus School of Law in the Netherlands.

Jeremie Gilbert
Jeremie Gilbert is professor of Human Rights Law at the University of Roehampton in the UK.

    In the process of adjudication and litigation, indigenous peoples are usually facing a very complex and demanding process to prove their rights to their lands and ancestral territories. Courts and tribunals usually impose a very complex and onerous burden of proof on the indigenous plaintiffs to prove their rights over their ancestral territories. To prove their rights indigenous peoples often have to develop map of their territories to prove their economic, cultural, and spiritual connections to their territories. This article reflects on the role played by the mapping of indigenous territories in supporting indigenous peoples’ land claims. It analyses the importance of mapping within the process of litigation, but also its the impact beyond the courtroom.


Jeremie Gilbert PhD
Jeremie Gilbert is professor of Human Rights Law, University of Roehampton.

Ben Begbie-Clench
Ben Begdie-Clench is a consultant working with San communities in southern Africa.

    Indigenous claims have challenged a number of orthodoxies within state legal systems, one of them being the kinds of proof that can be admissible. In Canada, the focus has been on the admissibility and weight of oral traditions and histories. However, these novel forms are usually taken as alternative means of proving a set of facts that are not in themselves “cultural”, for example, the occupation by a group of people of an area of land that constitutes Aboriginal title. On this view, maps are a neutral technology for representing culturally different interests within those areas. Through Indigenous land use studies, claimants have been able to deploy the powerful symbolic capital of cartography to challenge dominant assumptions about “empty” land and the kinds of uses to which it can be put. There is a risk, though, that Indigenous understandings of land are captured or misrepresented by this technology, and that what appears neutral is in fact deeply implicated in the colonial project and occidental ideas of property. This paper will explore the possibilities for an alternative cartography suggested by digital technologies, by Indigenous artists, and by maps beyond the visual order.


Kirsten Anker Ph.D.
Associate Professor, McGill University Faculty of Law, Canada. Many thanks to the two anonymous reviewers for their frank and helpful feedback.

    The judgment of the Inter-American Court of Human Rights in the case of Kaliña and Lokono Peoples v. Suriname is noteworthy for a number of reasons. Particularly important is the Court’s repeated citation and incorporation of various provisions of the 2007 United Nations Declaration on the Rights of Indigenous Peoples into its interpretation of the American Convention on Human Rights. This aids in greater understanding of the normative value of the Declaration’s provisions, particularly when coupled with the dramatic increase in affirmations of that instrument by UN treaty bodies, Special Procedures and others. The Court’s analysis also adds detail and further content to the bare architecture of the Declaration’s general principles and further contributes to the crystallisation of the discrete, although still evolving, body of law upholding indigenous peoples’ rights. Uptake of the Court’s jurisprudence by domestic tribunals further contributes to this state of dynamic interplay between sources and different fields of law.


Fergus MacKay JD
Article

Access_open Legal Legitimacy of Tax Recommendations Delivered by the IMF in the Context of ‘Article IV Consultations’

Journal Erasmus Law Review, Issue 2 2017
Keywords legitimacy, International Monetary Fund (IMF), Article IV Consultations, tax recommendations, global tax governance
Authors Sophia Murillo López
AbstractAuthor's information

    This contribution examines the legal legitimacy of ‘Article IV Consultations’ performed by the IMF as part of its responsibility for surveillance under Article IV of its Articles of Agreement. The analysis focuses on tax recommendations given by the Fund to its member countries in the context of Consultations. This paper determines that these tax recommendations derive from a broad interpretation of the powers and obligations that have been agreed to in the Fund’s Articles of Agreement. Such an interpretation leads to a legitimacy deficit, as member countries of the Fund have not given their state consent to receive recommendations as to which should be the tax policies it should adopt.


Sophia Murillo López
Sophia Murillo López, LL.M, is an external PhD candidate at the Erasmus University Rotterdam and a member of the ‘Fiscal Autonomy and its Boundaries’ research programme.
Article

Access_open The Questionable Legitimacy of the OECD/G20 BEPS Project

Journal Erasmus Law Review, Issue 2 2017
Keywords base erosion and profit shifting, OECD, G20, legitimacy, international tax reform
Authors Sissie Fung
AbstractAuthor's information

    The global financial crisis of 2008 and the following public uproar over offshore tax evasion and corporate aggressive tax planning scandals gave rise to unprecedented international cooperation on tax information exchange and coordination on corporate tax reforms. At the behest of the G20, the OECD developed a comprehensive package of ‘consensus-based’ policy reform measures aimed to curb base erosion and profit shifting (BEPS) by multinationals and to restore fairness and coherence to the international tax system. The legitimacy of the OECD/G20 BEPS Project, however, has been widely challenged. This paper explores the validity of the legitimacy concerns raised by the various stakeholders regarding the OECD/G20 BEPS Project.


Sissie Fung
Ph.D. Candidate at the Erasmus University Rotterdam and independent tax policy consultant to international organisations, including the Asian Development Bank.
Article

Access_open The Peer Review Process of the Global Forum on Transparency and Exchange of Information for Tax Purposes

A Critical Assessment on Authority and Legitimacy

Journal Erasmus Law Review, Issue 2 2017
Keywords Global Forum on Transparency and Exchange of Information, exercise of regulatory authority, due process requirements, peer review reports, legitimacy
Authors Leo E.C. Neve
AbstractAuthor's information

    The Global Forum on transparency and exchange of information for tax purposes has undertaken peer reviews on the implementation of the global standard of exchange of information on request, both from the perspective of formalities available and from the perspective of actual implementation. In the review reports Global Forum advises jurisdictions on required amendments of regulations and practices. With these advices, the Global Forum exercises regulatory authority. The article assesses the legitimacy of the exercise of such authority by the Global Forum and concludes that the exercise of such authority is not legitimate for the reason that the rule of law is abused by preventing jurisdictions to adhere to due process rules.


Leo E.C. Neve
Leo Neve is a doctoral student at the Erasmus School of Law, Rotterdam.
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