Zoekresultaat: 8 artikelen

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Jaar 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

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

Tijdschrift Erasmus Law Review, Aflevering 2 2019
Trefwoorden Intellectual Property, governance, data sharing
Auteurs Nikos Koutras
SamenvattingAuteursinformatie

    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.
Artikel

The concept of violence in (times of) crisis

On structural, institutional and anti-institutional violence

Tijdschrift Tijdschrift over Cultuur & Criminaliteit, Aflevering 2 2019
Trefwoorden structural violence, institutional violence, anti-institutional violence, economic crisis, Greece
Auteurs Marilena Drymioti
SamenvattingAuteursinformatie

    Attempting to understand the Greek narrative of crisis, this paper examines the most prominent forms of violence that emerged in the period of acute economic recession and political upheaval in Greece namely structural, institutional and anti-institutional violence. This paper aims to highlight existing theoretical gaps and avoid common fallacies of the current body of knowledge. In contrast to some of the more common features of the discussion on violence, this note sets out to: a) acknowledge that violence is not necessarily a physical act, b) acknowledge that the outcomes of violence performances might not be physical either, c) specify and adequately distinguish agency and structural dynamics and d) address the cultural and contextual aspects of violence. Vital to this endeavor is to acknowledge, identify and understand the interactive relation between different forms of violence that emerge during the same period of time in a context in which conflict escalates.


Marilena Drymioti
Marilena Drymioti is promovendus aan de Sectie Criminologie van de Erasmus Universiteit Rotterdam.
Case Reports

2019/51 Stand-by time from home is paid working time (RO)

Tijdschrift European Employment Law Cases, Aflevering 4 2019
Trefwoorden Working time
Auteurs Andreea Suciu en Gabriela Ion
SamenvattingAuteursinformatie

    Stand-by time from home represents working time of medical personnel even for the periods when no medical activity was actually performed (no attendance at the hospital was required), the salary rights for such period being determined as a percentage of the hourly rate for the basic salary and the number of hours when stand-by time from home was performed.


Andreea Suciu
Andreea Suciu is the Managing Partner of Suciu I The Employment Law Firm (https://suciu-employmentlaw.ro/).

Gabriela Ion
Gabriela Ion is an associate with Suciu I The Employment Law Firm (https://suciu-employmentlaw.ro/).
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

Tijdschrift Erasmus Law Review, Aflevering 4 2019
Trefwoorden due diligence, supply chain, OECD, NCP, specific instance
Auteurs Sander van ’t Foort
SamenvattingAuteursinformatie

    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.

    The author discusses the recent ECJ judgments in the cases Egenberger and IR on religious discrimination.


Andrzej Marian Świątkowski
Andrzej Marian Świątkowski, is a Jean Monet Professor of European Labour Law and Social Security, Jesuit University Ignatianum, Krakow, Poland and a member of the EELC Academic Board.
Artikel

Een juridische bypass voor innovaties

Tijdschrift RegelMaat, Aflevering 3 2019
Trefwoorden innovatie, fintech, regulatory sandbox, experimenteerwet, zelfrijdende auto
Auteurs Mr. S. Philipsen en Prof. mr. E.F. Stamhuis
SamenvattingAuteursinformatie

    In het voorliggende artikel wordt verslag gedaan van een onderzoek naar de verschillende verschijningsvormen van een tijdelijke bypass van bestaande rechtsnormen die ten behoeve van innovatie gebruikt worden. Vooral die instrumenten zijn beschreven die toegepast worden om innovatieve producten in het echte leven te testen, wanneer dat zonder die bypass niet of niet zonder meer verenigbaar zou zijn met het geldende recht. Een theoretisch model om de praktische verschijningsvormen te ordenen wordt gevolgd door een beschrijving van wettelijke experimenteerbepalingen en regulatory sandboxes. De kritische beoordeling van deze twee vormen in het licht van de geldende normen en beginselen voert tot een set vuistregels, met behulp waarvan een vergunnende overheid een bypass kan aanleggen.


Mr. S. Philipsen
Mr. S. (Stefan) Philipsen is universitair docent Staatsrecht aan de Universiteit Utrecht.

Prof. mr. E.F. Stamhuis
Prof. mr. E.F. (Evert) Stamhuis is hoogleraar Law & Innovation aan de Erasmus School of Law.
Kroniek

Kroniek economie in het mededingingsrecht 2018

Tijdschrift Markt & Mededinging, Aflevering 2 2019
Auteurs Nicole Rosenboom, Anna den Boer en Maurice de Valois Turk
Auteursinformatie

Nicole Rosenboom
N. Rosenboom is werkzaam als senior consultant bij Oxera LLP Amsterdam.

Anna den Boer
A. den Boer is werkzaam als consultant Oxera LLP Amsterdam.

Maurice de Valois Turk
M. de Valois Turk is werkzaam als partner bij Oxera LLP Amsterdam.
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