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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

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).
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 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 Right to Access Information as a Collective-Based Approach to the GDPR’s Right to Explanation in European Law

Tijdschrift Erasmus Law Review, Aflevering 3 2018
Trefwoorden automated decision-making, right to access information, right to explanation, prohibition on discrimination, public information
Auteurs Joanna Mazur
SamenvattingAuteursinformatie

    This article presents a perspective which focuses on the right to access information as a mean to ensure a non-discriminatory character of algorithms by providing an alternative to the right to explanation implemented in the General Data Protection Regulation (GDPR). I adopt the evidence-based assumption that automated decision-making technologies have an inherent discriminatory potential. The example of a regulatory means which to a certain extent addresses this problem is the approach based on privacy protection in regard to the right to explanation. The Articles 13-15 and 22 of the GDPR provide individual users with certain rights referring to the automated decision-making technologies. However, the right to explanation not only may have a very limited impact, but it also focuses on individuals thus overlooking potentially discriminated groups. Because of this, the article offers an alternative approach on the basis of the right to access information. It explores the possibility of using this right as a tool to receive information on the algorithms determining automated decision-making solutions. Tracking an evolution of the interpretation of Article 10 of the Convention for the Protection of Human Right and Fundamental Freedoms in the relevant case law aims to illustrate how the right to access information may become a collective-based approach towards the right to explanation. I consider both, the potential of this approach, such as its more collective character e.g. due to the unique role played by the media and NGOs in enforcing the right to access information, as well as its limitations.


Joanna Mazur
Joanna Mazur, M.A., PhD student, Faculty of Law and Administration, Uniwersytet Warszawski.
Article

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

Tijdschrift Erasmus Law Review, Aflevering 2 2018
Trefwoorden evidence-based, regulation, proportionality, empirical law studies, law and society studies
Auteurs Rob van Gestel en Peter van Lochem
SamenvattingAuteursinformatie

    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.
Article

Access_open Legal Constraints on the Indeterminate Control of ‘Dangerous’ Sex Offenders in the Community: The Spanish Perspective

Tijdschrift Erasmus Law Review, Aflevering 2 2016
Trefwoorden Supervised release, supervision, sex offenders, dangerousness, safety measures, societal upheaval, proportionality
Auteurs Lucía Martínez Garay en Jorge Correcher Mira
SamenvattingAuteursinformatie

    This article presents an overview of the legal regime provided in the Spanish system of criminal sanctions regarding the control of dangerous sex offenders in the community. It focuses on the introduction, in 2010, of a post-prison safety measure named supervised release. We describe the context of its introduction in the Spanish Criminal Code, considering the influence of societal upheaval concerning dangerous sex offenders in its development, and also the historical and theoretical features of the Spanish system of criminal sanctions. We also analyse the legal framework of supervised release, the existing case law about it and how the legal doctrine has until now assessed this measure. After this analysis, the main aim of this article consists in evaluating the effectiveness and the proportionality of the measure, according to the principle of minimal constraints and the rehabilitative function of the criminal sanctions in Spanish law, stated in Article 25.2 of the Spanish Constitution.


Lucía Martínez Garay
Lucía Martínez Garay is a Senior Lecturer at the University of Valencia, Department of Criminal Law.

Jorge Correcher Mira
Jorge Correcher Mira, Ph.D., is an Assistant Lecturer at the University of Valencia, Department of Criminal Law.
Article

Access_open The Right to Mental Health in the Digital Era

Tijdschrift Erasmus Law Review, Aflevering 3 2016
Trefwoorden E-health, e-mental health, right to health, right to mental health
Auteurs Fatemeh Kokabisaghi, Iris Bakx en Blerta Zenelaj
SamenvattingAuteursinformatie

    People with mental illness usually experience higher rates of disability and mortality. Often, health care systems do not adequately respond to the burden of mental disorders worldwide. The number of health care providers dealing with mental health care is insufficient in many countries. Equal access to necessary health services should be granted to mentally ill people without any discrimination. E-mental health is expected to enhance the quality of care as well as accessibility, availability and affordability of services. This paper examines under what conditions e-mental health can contribute to realising the right to health by using the availability, accessibility, acceptability and quality (AAAQ) framework that is developed by the Committee on Economic, Social and Cultural Rights. Research shows e-mental health facilitates dissemination of information, remote consultation and patient monitoring and might increase access to mental health care. Furthermore, patient participation might increase, and stigma and discrimination might be reduced by the use of e-mental health. However, e-mental health might not increase the access to health care for everyone, such as the digitally illiterate or those who do not have access to the Internet. The affordability of this service, when it is not covered by insurance, can be a barrier to access to this service. In addition, not all e-mental health services are acceptable and of good quality. Policy makers should adopt new legal policies to respond to the present and future developments of modern technologies in health, as well as e-Mental health. To analyse the impact of e-mental health on the right to health, additional research is necessary.


Fatemeh Kokabisaghi
Fatemeh Kokabisaghi, Iris Bakx and Blerta Zenelaj are Ph.D. candidates at the Institute of Health Policy and Management, Erasmus University Rotterdam. All authors contributed equally.

Iris Bakx
Fatemeh Kokabisaghi, Iris Bakx and Blerta Zenelaj are Ph.D. candidates at the Institute of Health Policy and Management, Erasmus University Rotterdam. All authors contributed equally.

Blerta Zenelaj
Fatemeh Kokabisaghi, Iris Bakx and Blerta Zenelaj are Ph.D. candidates at the Institute of Health Policy and Management, Erasmus University Rotterdam. All authors contributed equally.
Article

Access_open The Impact of the Economic Downturn in the Spanish Civil Justice System

Tijdschrift Erasmus Law Review, Aflevering 4 2015
Trefwoorden judiciary, judge-made justice, court fees, legal aid, ADR-methods
Auteurs Laura Carballo Piñeiro en Jordi Nieva Fenoll
SamenvattingAuteursinformatie

    The Spanish justice system has been shaken by the economic downturn as many other institutions have. This article addresses in the first place some statistical data that shed light as regards to the number of judges and the costs and length of the procedure in Spain. These figures help to understand, in the second place, the impact of austerity measures on the judiciary, namely, the freeze on the hiring of judges and the establishing of high court fees. While they mainly concern the supply side of justice services, others such cost reductions in legal aid have had, in the third place, an impact on the demand side, driving many citizens to social exclusion and to resorting to self-defence mechanisms. The final part of this article addresses some remedies that may alleviate judiciary’s workload, but that fall short of doing it. All in all, the Spanish justice system seems to require a holistic approach to patch up edges, but one in which the role of judge-made justice in a democratic society has to be central again.


Laura Carballo Piñeiro
Laura Carballo Piñeiro is Associate Professor of Private International Law at the Common Law Department of the University of Santiago de Compostela.

Jordi Nieva Fenoll
Jordi Nieva Fenoll is Professor of Procedure Law at the Administrative and Procedure Law Department of the University of Barcelona.

Andrea Pinna
Avocat au Barreau de Paris, France. Research Director at Institut de droit des affaires internationales Paris, France. Formerly Assistant Professor, Erasmus University Rotterdam. The author wishes to thank the board of the Erasmus Law Review and two anonymous referees for their useful comments. Research for this article was finalised September 1st, 2007.
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