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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 The Right to Same-Sex Marriage: Assessing the European Court of Human Rights’ Consensus-Based Analysis in Recent Judgments Concerning Equal Marriage Rights

Journal Erasmus Law Review, Issue 3 2017
Keywords same-sex marriage, gay marriage, European consensus, margin of appreciation, consensus-based analysis by the ECtHR
Authors Masuma Shahid
AbstractAuthor's information

    This contribution assesses the consensus-based analysis and reasoning of the European Court of Human Rights in recent judgments concerning equal marriage rights and compares it to the Court’s past jurisprudence on European consensus and the margin of appreciation awarded to Member States regarding the issue of equal marriage rights. The contribution aims to analyse whether there is a parallel to be seen between the rapid global trend of legalisation of same-sex marriage and the development or evolution of the case law of the ECtHR on the same topic. Furthermore, it demonstrates that the Court’s consensus-based analysis is problematic for several reasons and provides possible alternative approaches to the balancing of the Court between, on the one hand, protecting rights of minorities (in this case same-sex couples invoking equal marriage rights) under the European Convention on Human Rights and, on the other hand, maintaining its credibility, authority and legitimacy towards Member States that might disapprove of the evolving case law in the context of same-sex relationships. It also offers insights as to the future of European consensus in the context of equal marriage rights and ends with some concluding remarks.


Masuma Shahid
Lecturer, Department of International and European Union Law, Erasmus School of Law, Rotterdam.

    The seriousness of the incorporation problem in interdisciplinary legal research, this article argues, depends on how legal research is understood. If legal research is understood as a single, inherently interdisciplinary discipline, the problem largely falls away. On this view, the incorporation of other disciplines into legal research is what legal academics have for the last 40 years already successfully been doing. If, on the other hand, legal research is best conceived as a multi-disciplinary field, consisting of a core discipline – doctrinal research – and various other types of mono-disciplinary and interdisciplinary research, the incorporation of other disciplines presents real difficulties. For legal academics engaged in socio-legal research, in particular, two problems arise: the practical problem of trying to address a legal professional and academic audience at the same time and the philosophical problem of trying to integrate the internal perspective of doctrinal research with the external perspective of other disciplines. In the final part of the article, these practical and philosophical difficulties are illustrated by reference to the author’s research on the politics of judicial review in new democracies.


Theunis Robert Roux
Theunis Robert Roux is Professor of Law at the University of New South Wales, Australia.

    This article sets out to contribute to the special issue devoted to multi-disciplinary legal research by discussing first the limits of purely doctrinal legal research in relation to a particular topic and second the relevant considerations in devising research that (inter alia) draws on non-legal, auxiliary disciplines to ‘fill in’ and guide the legal framework. The topic concerned is the (analysis of the) fundamental rights of minorities.
    The article starts with a long account of the flaws in the current legal analysis of the European Court of Human Rights regarding minorities’ rights, particularly the reduction in its analysis and the related failure to properly identify and weigh all relevant interests and variables. This ‘prelude’ provides crucial insights in the causes of the flaws in the Court’s jurisprudence: lack of knowledge (about the relevant interests and variables) and concerns with the Court’s political legitimacy.
    The article goes on to argue for the need for multi-disciplinary legal research to tackle the lack of knowledge: more particularly by drawing on sociology (and related social sciences) and political philosophy as auxiliary disciplines to identify additional interests and variables for the rights analysis. The ensuing new analytical framework for the analysis of minorities’ rights would benefit international courts (adjudicating on human rights) generally. To operationalise and refine the new analytical framework, the research should furthermore have regard to the practice of (a selection of) international courts and national case studies.


Kristin Henrard
Professor of minorities and fundamental rights at the Erasmus School of Law.

    The doctrinal methodology is in a period of change and transition. Realising that the scope of the doctrinal method is too constricting, academic lawyers are becoming eclectic in their use of research method. In this transitional time, legal scholars are increasingly infusing evidence (and methods) from other disciplines into their reasoning to bolster their reform recommendations.
    This article considers three examples of the interplay of the discipline of law with other disciplines in the pursuit of law reform. Firstly the article reviews studies on the extent of methodologies and reformist frameworks in PhD research in Australia. Secondly it analyses a ‘snapshot’ of recently published Australian journal articles on criminal law reform. Thirdly, it focuses on the law reform commissions, those independent government committees that play such an important role in law reform in common law jurisdictions.
    This examination demonstrates that while the doctrinal core of legal scholarship remains intact, legal scholars are endeavouring to accommodate statistics, comparative perspectives, social science evidence and methods, and theoretical analysis, within the legal research framework, in order to provide additional ballast to the recommendations for reform.


Terry Hutchinson
Associate Professor, Faculty of Law, QUT Law School (t.hutchinson@qut.edu.au); Marika Chang (QUT Law School) was the research assistant on this project.

Sanne Taekema

Wibren van der Burg
Sanne Taekema and Wibren van der Burg are Professor of Jurisprudence and Professor of Legal Philosophy and Jurisprudence, respectively, at the Erasmus School of Law in Rotterdam.
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