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Tijdschrift Erasmus Law Review x Jaar 2019 x
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).

    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

Access_open Mercosur: Limits of Regional Integration

Tijdschrift Erasmus Law Review, Aflevering 3 2019
Trefwoorden Mercosur, European Union, regionalism, integration, international organisation
Auteurs Ricardo Caichiolo
SamenvattingAuteursinformatie

    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 Waste Away

Examining Systemic Drivers of Global Waste Trafficking Based on a Comparative Analysis of Two Dutch Cases

Tijdschrift Erasmus Law Review, Aflevering 4 2019
Trefwoorden environmental crime, waste industry, shipbreaking, waste trafficking, environmental enforcement
Auteurs Karin van Wingerde en Lieselot Bisschop
SamenvattingAuteursinformatie

    The increasing volume of waste generated globally is one of the most prominent environmental issues we face today. Companies responsible for the treatment or disposal of waste are therefore among the key actors in fostering a sustainable future. Yet the waste industry has often been characterised as a criminogenic one, causing environmental harm which disproportionately impacts the world’s most vulnerable regions and populations. In this article, we illustrate how companies operating in global supply chains exploit legal and enforcement asymmetries and market complexities to trade waste with countries where facilities for environmentally sound treatment and disposal of waste are lacking. We draw on two contemporary cases of corporate misconduct in the Global South by companies with operating headquarters in the Global North: Seatrade and Probo Koala. We compare these cases building on theories about corporate and environmental crime and its enforcement. This explorative comparative analysis aims to identify the key drivers and dynamics of illegal waste dumping, while also exploring innovative ways to make the waste sector more environmentally responsible and prevent the future externalisation of environmental harm.


Karin van Wingerde
Karin van Wingerde is Professor Corporate Crime and Governance, Department of Criminology, Erasmus School of Law, Erasmus University Rotterdam.

Lieselot Bisschop
Lieselot Bisschop is Professor Public and Private Interests, Department of Criminology and Erasmus Initiative on Dynamics of Inclusive Prosperity, Erasmus School of Law, Erasmus University Rotterdam.
Introduction

Access_open Towards Responsible Business Conduct in Global Value Chains

Relevant Legal Developments in the Netherlands

Tijdschrift Erasmus Law Review, Aflevering 4 2019
Trefwoorden responsible business conduct, business and human rights, corporate social responsibility, sustainable development, the Netherlands
Auteurs Liesbeth Enneking en Jeroen Veldman
SamenvattingAuteursinformatie

    The past few decades have seen an increasing scrutiny of the impacts – both positive and negative – that companies have on the societies in which they operate. The search for adequate responses to such scrutiny is reflected in developments in the societal, political and academic debate on three separate but interrelated concepts: corporate social responsibility, business and human rights and responsible business conduct. The focus in this Special Issue will be on law and policy relating to responsible business conduct in global value chains. The contributions in this Special Issue identify relevant developments and institutions in the Netherlands, including rules and regulations related to trade, investment and corporate governance as well as cases related to corporate and consumer responsibilities, and assess their role in relation to the potential to provide a positive response to the concern about the human and environmental impacts of business activities. Together, they provide a multi-perspective view of relevant gaps and/or best practices with regard to regulatory governance in the Netherlands while at the same time enabling a comparative debate on the extent to which these diverse developments and institutions are in line with stated policy goals in this context both at national and EU levels. In doing so, this Special Issue aims to contribute to further coherence between national and EU policies with regard to RBC in global value chains and sustainable development.


Liesbeth Enneking
Liesbeth Enneking is Professor of Legal Aspects of International Corporate Social Responsibility at Erasmus School of Law, Erasmus University Rotterdam.

Jeroen Veldman
Jeroen Veldman is Visiting Associate Professor at Rotterdam School of Management, Erasmus University Rotterdam, Visiting Associate Professor at Mines Paristech, Interdisciplinary Institute for Innovation, Paris and Section Editor Corporate Governance at the Journal of Business Ethics.
Article

Access_open The New Dutch Model Investment Agreement

On the Road to Sustainability or Keeping up Appearances?

Tijdschrift Erasmus Law Review, Aflevering 4 2019
Trefwoorden Dutch model BIT, foreign direct investment, bilateral investment treaties, investor-to-state dispute settlement, sustainable development goals
Auteurs Alessandra Arcuri en Bart-Jaap Verbeek
SamenvattingAuteursinformatie

    In 2019, the Dutch government presented a New Model Investment Agreement that seeks to contribute to the sustainability and inclusivity of future Dutch trade and investment policy. This article offers a critical analysis of the most relevant parts of the revised model text in order to appraise to what extent it could promote sustainability and inclusivity. It starts by providing an overview of the Dutch BIT (Bilateral Investment Treaty) programme, where the role of the Netherlands as a favourite conduit country for global FDI is highlighted. In the article, we identify the reasons why the Netherlands became a preferred jurisdiction for foreign investors and the negative implications for governments and their policy space to advance sustainable development. The 2019 model text is expressly set out to achieve a fairer system and to protect ‘sustainable investment in the interest of development’. While displaying a welcome engagement with key values of sustainable development, this article identifies a number of weaknesses of the 2019 model text. Some of the most criticised substantive and procedural provisions are being reproduced in the model text, including the reiteration of investors’ legitimate expectation as an enforceable right, the inclusion of an umbrella clause, and the unaltered broad coverage of investments. Most notably, the model text continues to marginalise the interests of investment-affected communities and stakeholders, while bestowing exclusive rights and privileges on foreign investors. The article concludes by hinting at possible reforms to better align existing and future Dutch investment treaties with the sustainable development goals.


Alessandra Arcuri
Alessandra Arcuri is Professor at Erasmus School of Law and Erasmus Initiative Dynamics of Inclusive Prosperity, Erasmus University Rotterdam.

Bart-Jaap Verbeek
Bart-Jaap Verbeek is Researcher at Stichting Onderzoek Multinationale Ondernemingen (SOMO) and PhD Candidate Political Science at the Radboud University.
Article

Access_open Consumer Social Responsibility in Dutch Law

A Case Study on the Role of Consumers in Energy Transition

Tijdschrift Erasmus Law Review, Aflevering 4 2019
Trefwoorden consumer, energy transition, social responsibility, Dutch law, EU law
Auteurs Katalin Cseres
SamenvattingAuteursinformatie

    As our economies continue to focus on growth, competition and maximisation of consumer choice, the global increase in consumption takes vast environmental and social costs and cause irreversible harm to our climate and environment. The urgency of reducing human footprint and to diminish one of the root causes of a declining climate and environment is irrefutable. In the shift that globally has to take place, a decentralised energy system relying on more distributed generation, energy storage and a more active involvement of consumers form a crucial component of renewable energy solutions. The move from a highly centralised to a more decentralised power system involves an increasing amount of small-scale (intermittent) generation from renewable energy which is located closer to the point of final consumption. In order to steer consumption towards sustainability national governments and supranational organisations have adopted policies and corresponding legislation that address individual consumers as rational and active choice-makers who make socially responsible choices when they receive the ‘right’ amount of information. By relying on insights from modern consumption theories with contributions from sociology, this article questions the effectiveness and legitimacy of these ‘consumer-centred’ policies and laws. First, the article argues that the single focus on individual consumer behaviour as a rational and utility maximising market actor fails to take into account the complexity of consumption, which is fundamentally influenced by social norms and its broader institutional setting. Although consumers are willing to consume more sustainably, they are often ‘locked in by circumstances’ and unable to engage in more sustainable consumption practices even if they want to. Second, by relying on evidence from sociological studies the article argues that individual consumers are not the most salient actors in support of sustainable consumption. Even though the urgency of the energy transition and the critical role consumers play in (un)sustainable energy consumption is acknowledged in both the EU and its Member States, their laws and policies remain grounded on goals of economic growth with competitive economies, the sovereignty of consumer choice and wealth maximisation, instead of aiming at slower economic growth or even degrowth, reducing overall resource use and consumption levels and introducing radically different ways of consumption.
    Third, the role of law is underlined as a social institution both as a constraint on the autonomous acts of consumption, dictating the normative frameworks within which the role of consumer is defined, and as a facilitator which consumers might also employ, in order to determine for themselves particular normative parameters within which consumption can occur.
    The Netherlands, which serves as a case study in this article, has reached important milestones in its energy transition policy since 2013. Still, it remains strongly focused on economic rationality and market competitiveness. Even though various models of consumer participation exist and local consumer energy initiatives are flourishing and are recognised as key actors in the energy transition, they remain embedded in institutional, structural and behavioural settings where consumers still face challenging sociocultural barriers to sustainable practices.
    In light of these legal, political and social complexity of energy transition, the article offers a critical analysis of the current Dutch law in its broader legal context of EU law in order to answer the question what the role of (energy) law is in steering consumers towards sustainable energy consumption.


Katalin Cseres
Katalin Cseres is Associate Professor of Law, Amsterdam Centre for European Law & Governance (ACELG), University of Amsterdam.
Article

Access_open SMART Reflections on Policy Coherence, Legal Developments in the Netherlands and the Case for EU Harmonisation

Afterword to Erasmus Law Review Special Issue Towards Responsible Business Conduct in Global Value Chains

Tijdschrift Erasmus Law Review, Aflevering 4 2019
Trefwoorden sustainability, business, global value chains, planetary boundaries, sustainable corporate governance
Auteurs Beate Sjåfjell en Jeroen Veldman
SamenvattingAuteursinformatie

    The EU-funded project Sustainable Market Actors for Responsible Trade (SMART, 2016-2020), undertook an interdisciplinary and multilevel regulatory analysis of the barriers and possibilities for securing the contribution of private and public market actors to a sustainable future. Jurisdiction-specific contributions were an essential part of this broad regulatory analysis. This afterword reflects on the Dutch contributions included in this Special Issue, emphasising the urgency of securing policy coherence for sustainable business. The afterword highlights how individual initiatives by national legislators such as those of the Netherlands can be inspiring examples, while they also bring with them challenges including questions of scope and of legal certainty for businesses, specifically with regard to cross-border operations and activities. This leaves business with the difficult task of figuring out the various requirements and expectations and may lead to regulatory competition between EU member states. The afterword therefore concludes with a call for EU harmonisation, to give sustainability-oriented business a level playing field and provide legal certainty both for decision-makers in business and for those affected by the conduct of business across global value chains.


Beate Sjåfjell
Beate Sjåfjell is Professor, University of Oslo, Faculty of Law; Adjunct Professor, Norwegian University of Science and Technology, Faculty of Economics and Management. Coordinator of the now concluded H2020-funded project Sustainable Market Actors for Responsible Trade (SMART, 2016-2020), grant agreement 693642. Acknowledgment: This article draws on joint research in the SMART Project, and I am grateful to the whole team, and, in the context of this special issue, especially Jeroen Veldman for his leadership on the Dutch contribution to the project.

Jeroen Veldman
Jeroen Veldman is Visiting Associate Professor at Rotterdam School of Management, Erasmus University Rotterdam, Visiting Associate Professor at Mines Paristech, Interdisciplinary Institute for Innovation, Paris and Section Editor Corporate Governance at the Journal of Business Ethics.
Article

Access_open Commercial Litigation in Europe in Transformation: The Case of the Netherlands Commercial Court

Tijdschrift Erasmus Law Review, Aflevering 1 2019
Trefwoorden international business courts, Netherlands Commercial Court, choice of court, recognition and enforcements of judgements
Auteurs Eddy Bauw
SamenvattingAuteursinformatie

    The judicial landscape in Europe for commercial litigation is changing rapidly. Many EU countries are establishing international business courts or have done so recently. Unmistakably, the approaching Brexit has had an effect on this development. In the last decades England and Wales – more precise, the Commercial Court in London - has built up a leading position as the most popular jurisdiction for resolving commercial disputes. The central question for the coming years will be what effect the new commercial courts in practice will have on the current dominance of English law and the leading position of the London court. In this article I address this question by focusing on the development of a new commercial court in the Netherlands: the Netherlands Commercial Court (NCC).


Eddy Bauw
Professor of Private Law and Administration of Justice at Molengraaff Institute for Private Law and Montaigne Centre for Rule of Law and Administration of Justice, Utrecht University. Substitute judge at the Court of Appeal of Arnhem-Leeuwarden and the Court of Appeal of The Hague.
Article

Access_open The Brussels International Business Court: Initial Overview and Analysis

Tijdschrift Erasmus Law Review, Aflevering 1 2019
Trefwoorden international jurisdiction, English, court language, Belgium, business court
Auteurs Erik Peetermans en Philippe Lambrecht
SamenvattingAuteursinformatie

    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

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).
Editorial

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

Tijdschrift Erasmus Law Review, Aflevering 1 2019
Trefwoorden international business courts, justice innovation, justice competition, global commercial litigation, private international law
Auteurs Xandra Kramer en John Sorabji
Auteursinformatie

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 Emergence of International Commercial Courts in India: A Narrative for Ease of Doing Business?

Tijdschrift Erasmus Law Review, Aflevering 1 2019
Trefwoorden Commercial contracts, Enforcement, Jurisdiction, Specialized courts, India
Auteurs Sai Ramani Garimella en M.Z. Ashraful
SamenvattingAuteursinformatie

    The liberal globalised order has brought increased focus on the regulation of international commerce, and especially dispute resolution. Enforcement of contracts has been a concern largely owing to the insufficiencies of the legal systems, especially relating to the institutional structure, and it holds true for India as well. The commercial courts mechanism – international and domestic – with innovative features aimed at providing expedited justice is witnessing much traction. India, similar to many other jurisdictions, legislated in favour of specialized dispute resolution mechanisms for commercial disputes that could help improve the procedures for enforcement of contracts. This research attempts to critique the comparable strengths and the reform spaces within the Indian legislation on commercial courts. It parses the status of commercial dispute resolution in India especially in the context of cross-border contracts and critiques India’s attempt to have specialised courts to address commercial dispute resolution.


Sai Ramani Garimella
Sai Ramani Garimella, PhD, is assistant professor of the faculty of legal studies at the South Asian University in New Delhi.

M.Z. Ashraful
M.Z. Ashraful is the research student at South Asian University in New Delhi.
Article

Access_open Matchmaking International Commercial Courts and Lawyers’ Preferences in Europe

Tijdschrift Erasmus Law Review, Aflevering 1 2019
Trefwoorden choice of court, commercial court, lawyers’ preferences, survey on lawyers, international court
Auteurs Erlis Themeli
SamenvattingAuteursinformatie

    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.
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