Search result: 6 articles

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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).
Article

Access_open Access and Reuse of Machine-Generated Data for Scientific Research

Journal Erasmus Law Review, Issue 2 2019
Keywords machine-generated data, Internet of Things, scientific research, personal data, GDPR
Authors Alexandra Giannopoulou
AbstractAuthor's information

    Data driven innovation holds the potential in transforming current business and knowledge discovery models. For this reason, data sharing has become one of the central points of interest for the European Commission towards the creation of a Digital Single Market. The value of automatically generated data, which are collected by Internet-connected objects (IoT), is increasing: from smart houses to wearables, machine-generated data hold significant potential for growth, learning, and problem solving. Facilitating researchers in order to provide access to these types of data implies not only the articulation of existing legal obstacles and of proposed legal solutions but also the understanding of the incentives that motivate the sharing of the data in question. What are the legal tools that researchers can use to gain access and reuse rights in the context of their research?


Alexandra Giannopoulou
Institute for Information Law (IViR) – University of Amsterdam.

    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 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 Associate Professor, Department of Criminology, Erasmus School of Law, Erasmus University Rotterdam.

Lieselot Bisschop
Lieselot Bisschop is Associate Professor, Department of Criminology and Erasmus Initiative on Dynamics of Inclusive Prosperity, Erasmus School of Law, Erasmus University Rotterdam.
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
Dr. Sander van ’t Foort is Lecturer at the Nyenrode Business Universiteit in the Netherlands.
Article

Access_open Requirements upon Agreements in Favour of the NCC and the German Chambers – Clashing with the Brussels Ibis Regulation?

Journal Erasmus Law Review, Issue 1 2019
Keywords international commercial courts, the Netherlands Commercial Court (NCC), Chambers for International Commercial Disputes (Kammern für internationale Handelssachen), Brussels Ibis Regulation, choice of court agreements, formal requirements
Authors Georgia Antonopoulou
AbstractAuthor's information

    In recent years, the Netherlands and Germany have added themselves to the ever-growing number of countries opting for the creation of an international commercial court. The Netherlands Commercial Court (NCC) and the German Chambers for International Commercial Disputes (Kammern für internationale Handelssachen, KfiH) will conduct proceedings entirely in English and follow their own, diverging rules of civil procedure. Aspiring to become the future venues of choice in international commercial disputes, the NCC law and the legislative proposal for the establishment of the KfiH allow parties to agree on their jurisdiction and entail detailed provisions regulating such agreements. In particular, the NCC requires the parties’ express and in writing agreement to litigate before it. In a similar vein, the KfiH legislative proposal requires in some instances an express and in writing agreement. Although such strict formal requirements are justified by the need to safeguard the procedural rights of weaker parties such as small enterprises and protect them from the peculiarities of the NCC and the KfiH, this article questions their compliance with the requirements upon choice of court agreements under Article 25 (1) Brussels Ibis Regulation. By qualifying agreements in favour of the NCC and the KfiH first as functional jurisdiction agreements and then as procedural or court language agreements this article concludes that the formal requirements set by the NCC law and the KfiH proposal undermine the effectiveness of the Brussels Ibis Regulation, complicate the establishment of these courts’ jurisdiction and may thus threaten their attractiveness as future litigation destinations.


Georgia Antonopoulou
PhD candidate at Erasmus School of Law, Rotterdam.
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