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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 Modern Intellectual Property Governance and Openness in Europe: A Long and Winding Road?

Journal Erasmus Law Review, Issue 2 2019
Keywords Intellectual Property, governance, data sharing
Authors Nikos Koutras
AbstractAuthor's information

    In the last decade a trend towards more ‘openness’ in terms of collaborations and access to knowledge has been observed in many different sectors and contexts. Along the spectrum of openness one can find many different varieties, such as open innovation, co-creation, open science (combined with open access and open data) and open source. Even traditionally rather ‘closed’ actors, such as publishing houses and the pharmaceutical industry, are gradually catching up and are trying to develop mechanisms to cope with this trend towards openness. Both public and private actors encounter challenges in combining this trend towards openness with the management of intellectual property rights (IPRs). Although a strong willingness may exist to collaborate, open up and share knowledge and data, IPRs often create boundaries and limitations towards cutting-edge collaborations and initiatives for openness and sharing. Over time, companies, universities, public research organisations, etc. have developed certain models to allow for openness while safeguarding ways to protect their IPRs. Yet the legal framework is often lagging behind and does not appear to reflect the socio-economic trend towards openness; in many jurisdictions, changes to IP legislation have rather focused on strengthening of the rights of IP owners. But this is not necessarily a problem as stakeholders tend to find workarounds in their day-to-day practice. This special issue aims to further the discussion about modern governance of IPRs in Europe and to explore different perspectives on how openness could be operationalised within the context of IP protection.


Nikos Koutras
Postdoctoral Researcher, Faculty of Law, University of Antwerp.
Article

Access_open Text and Data Mining in the EU ‘Acquis Communautaire’ Tinkering with TDM & Digital Legal Deposit

Journal Erasmus Law Review, Issue 2 2019
Keywords Web harvesting, data analysis, text & data mining, TDM, computational text
Authors Maria Bottis, Marinos Papadopoulos, Christos Zampakolas e.a.
AbstractAuthor's information

    Text and Data Mining (hereinafter, TDM) issue for the purpose of scientific research or for any other purpose which is included in the provisions of the new EU Directive on Copyright in the Digital Single Market (hereinafter, DSM). TDM is a term that includes Web harvesting and Web Archiving activities. Web harvesting and archiving pertains to the processes of collecting from the web and archiving of works that reside on the Web. In the following analysis we will elaborate briefly upon provisions in EU Copyright law which were discussed during the proposal for a new Directive on Copyright in the DSM as well as provisions which are included in the text of art.3 and art.4 of the new Directive 2019/790/EU per TDM. In addition, the following analysis presents legislation in very few EU Member States which pertains to TDM and preceded the rulings of Directive 2019/790/EU. Digital legal deposit remarkable examples from EU Member States are also presented in this paper. The example of Australia is also presented below hereto because it is one of the oldest and most successful worldwide. The National Library of Australia’s digital legal deposit is state-of-the-art.


Maria Bottis
Associate Professor, Department of Archives, Library Science and Museology, Ionian University, Corfu, Greece.

Marinos Papadopoulos
Attorney-at-Law, PhD, MSc, JD, Independent Researcher, Athens, Greece.

Christos Zampakolas
Archivist/Librarian, PhD, MA, BA, Independent Researcher, Ioannina, Greece.

Paraskevi Ganatsiou
Educator, MA, BA, Coordinator of Educational Projects in the Prefecture of Ionian Islands, Corfu, Greece.

    In this paper I propose to analyse the binary notion of personal data and highlight its limits, in order to propose a different conception of personal data. From a risk regulation perspective, the binary notion of personal data is not particularly fit for purpose, considering that data collection and information flows are tremendously big and complex. As a result, the use of a binary system to determine the applicability of EU data protection law may be a simplistic approach. In an effort of bringing physics and law together, certain principles elaborated within the quantum theory are surprisingly applicable to data protection law, and can be used as guidance to shed light on many of today’s data complexities. Lastly, I will discuss the implications and the effects that certain processing operations may have on the possibility of qualifying certain data as personal. In other terms, how the chances to identify certain data as personal is dependent upon the processing operations that a data controller might put in place.


Alessandro El Khoury
Alessandro El Khoury, LLM, Legal and Policy Officer, DG Health & Food Safety, European Commission.
Article

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

Journal Erasmus Law Review, Issue 2 2018
Keywords evidence-based, regulation, proportionality, empirical law studies, law and society studies
Authors Rob van Gestel and Peter van Lochem
AbstractAuthor's information

    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 The Right to Mental Health in the Digital Era

Journal Erasmus Law Review, Issue 3 2016
Keywords E-health, e-mental health, right to health, right to mental health
Authors Fatemeh Kokabisaghi, Iris Bakx and Blerta Zenelaj
AbstractAuthor's information

    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.

    The article takes as its point of departure some of the author’s multidisciplinary projects. Special attention is given to the question of whether the disciplines united in the various research team members already constituted a kind of ‘inter-discipline’, through which a single object was studied. The issue of how the disciplinary orientations of the research team members occasionally clashed, on methodological issues, is also addressed.
    The outcomes of these and similar multidisciplinary research projects are followed back into legal practice and academic legal scholarship to uncover whether an incorporation problem indeed exists. Here, special attention will be given to policy recommendations and notably proposals for new legislation. After all, according to Van Dijck et al., the typical role model for legal researchers working from an internal perspective on the law is the legislator.
    The author concludes by making a somewhat bold case for reverse incorporation, that is, the need for (traditional) academic legal research to become an integral part of a more encompassing (inter-)discipline, referred to here as ‘conflict management studies’. Key factors that will contribute to the rise of such a broad (inter-)discipline are the changes that currently permeate legal practice (the target audience of traditional legal research) and the changes in the overall financing of academic research itself (with special reference to the Netherlands).


Annie de Roo
Erasmus School of Law, Erasmus University Rotterdam.

Alberto Alemanno
Associate Professor of Law, HEC Paris, and Editor of the European Journal of Risk Regulation. The author wishes to thank two anonymous referees for their valuable inputs. Comments are welcome at: <alemanno@hec.fr>.
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