Search result: 11 articles

x
Year 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

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).

    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

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 Waste Away

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

Journal Erasmus Law Review, Issue 4 2019
Keywords environmental crime, waste industry, shipbreaking, waste trafficking, environmental enforcement
Authors Karin van Wingerde and Lieselot Bisschop
AbstractAuthor's information

    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.
Article

Access_open The Dutch International Responsible Business Conduct Agreements

Effective Initiatives?

Journal Erasmus Law Review, Issue 4 2019
Keywords IRBC Agreements, effectiveness, OECD due diligence, access to remedy
Authors Martijn Scheltema
AbstractAuthor's information

    This contribution analyses the effectiveness of the Dutch International Responsible Business Conduct (IRBC) agreements and suggests some avenues for improvement. Several challenges in connection with effectiveness have been identified in evaluations of the IRBC agreements, and these are used as a starting point for the analysis. The focus is on three themes: (i) uptake, leverage and collaboration; (ii) implementation of OECD due diligence including monitoring and (iii) access to remedy. This contribution shows that low uptake may not be a sign of ineffectiveness per se, although in terms of leverage a sufficient number of participants or collaboration between agreements seems important. In connection with due diligence, it is recommended to align the implementation of OECD due diligence. Furthermore, an effective monitoring mechanism by a secretariat, as is currently implemented in the Textile agreement only, is most likely to bring about material changes in business behaviour. Other types of supervision seem less effective. Access to remedy poses a challenge in all IRBC agreements. It is recommended that the expectations the agreements have on access to remedy be clarified, also in connection with the role of signatories to the agreements in cases where they are directly linked to human rights abuse. Furthermore, it is recommended that a dispute resolution mechanism be introduced that enables complaints for external stakeholders against business signatories, comparable to that of the Textile agreement. However, rather than implementing separate mechanisms in all agreements, an overarching mechanism for all agreements should be introduced.


Martijn Scheltema
Martijn Scheltema is Professor of Private law at Erasmus School of Law, Erasmus University Rotterdam.
Article

Access_open The Potential of the Dutch Corporate Governance Model for Sustainable Governance and Long Term Stakeholder Value

Journal Erasmus Law Review, Issue 4 2019
Keywords corporate governance, company law, stakeholders, Dutch Corporate Governance Code, long-termism
Authors Manuel Lokin and Jeroen Veldman
AbstractAuthor's information

    This article addresses the question of how the Dutch regulatory and institutional setting enables policy coherence, specifically with regard to safeguarding stakeholders’ interests and promoting sustainable governance. To address this question, we engage with idiosyncratic theoretical notions in the Dutch corporate governance model. We follow the evolution of these notions in statutory company law and case law, their development in the Dutch Corporate Governance Code and their relation to the Enterprise Chamber as a unique institution. We establish how these theoretical views and practical institutions present significant means by which stakeholder concerns may be represented in the operation of company law and corporate governance more broadly and provide a number of ways in which these institutions and their operation can be further developed.


Manuel Lokin
Manuel Lokin is Professor of Company Law at Utrecht University and lawyer at Stibbe, Amsterdam.

Jeroen Veldman
Jeroen Veldman is Visiting Professor at the Interdisciplinary Institute for Innovation at Mines ParisTech in Paris, France and Honorary Senior Visiting Fellow at Cass Business School in London, UK.
Introduction

Access_open Towards Responsible Business Conduct in Global Value Chains

Relevant Legal Developments in the Netherlands

Journal Erasmus Law Review, Issue 4 2019
Keywords responsible business conduct, business and human rights, corporate social responsibility, sustainable development, the Netherlands
Authors Liesbeth Enneking and Jeroen Veldman
AbstractAuthor's information

    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 Due Diligence and Supply Chain Responsibilities in Specific Instances

The Compatibility of the Dutch National Contact Point’s Decisions With the OECD Guidelines for Multinational Enterprises in the Light of Decisions Made by the UK, German, Danish and Norwegian National Contact Points

Journal Erasmus Law Review, Issue 4 2019
Keywords due diligence, supply chain, OECD, NCP, specific instance
Authors Sander van ’t Foort
AbstractAuthor's information

    Since the introduction of a human rights chapter in the 2011 OECD Guidelines for Multinational Enterprises, National Contact Points (NCPs) have been increasingly dealing with specific instances referring to human rights violations by companies. According to the Organisation for Economic Cooperation and Development (OECD), the human rights provisions are the most cited provisions of the Guidelines. Specific instances include allegations such as a company’s failure to implement human rights due diligence, to apply the principles of free, prior and informed consent, to take supply chain responsibility, and/or to comply with the right to cultural heritage. Of all topics, human rights due diligence and human rights supply chain responsibilities are most commonly referred to in complaints based on the Guidelines. This article focuses on how NCPs have handled these topics of human rights due diligence and supply chain responsibility in specific instances. The Dutch NCP has been selected because it is celebrated in literature as the ‘gold standard’ because of its composition including independent members, its forward-looking approach, and because it is one of the most active NCPs in the world. All decisions of the Dutch NCP concerning these two topics are analysed in the light of the decisions of four other NCPs (UK, Denmark, Germany and Norway). A doctrinal methodology is used to analyse similarities and differences between the argumentations of the five NCPs.


Sander van ’t Foort
Sander van ’t Foort is Lecturer at Nyenrode Business University.
Article

Access_open Consumer Social Responsibility in Dutch Law

A Case Study on the Role of Consumers in Energy Transition

Journal Erasmus Law Review, Issue 4 2019
Keywords consumer, energy transition, social responsibility, Dutch law, EU law
Authors Katalin Cseres
AbstractAuthor's information

    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

Journal Erasmus Law Review, Issue 4 2019
Keywords sustainability, business, global value chains, planetary boundaries, sustainable corporate governance
Authors Beate Sjåfjell and Jeroen Veldman
AbstractAuthor's information

    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 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).
Interface Showing Amount

Sign up for email alert

If you sign up for the free email alert from Erasmus Law Review, you will automatically receive a message when a new article is published on the website.

Subscribe

You can search full text for articles by entering your search term in the search field. If you click the search button the search results will be shown on a fresh page where the search results can be narrowed down by category or year.