Zoekresultaat: 5 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).
Artikel

Top-down and out?

Reassessing the labelling approach in the light of corporate deviance

Tijdschrift Tijdschrift over Cultuur & Criminaliteit, Aflevering 2 2019
Trefwoorden labelling, corporate crime, moral entrepreneurs, peer group, late modernity
Auteurs Anna Merz M.A.
SamenvattingAuteursinformatie

    Multi-national corporations are increasingly facing attention and disapproval by different actors, including authorities, public and (non-) commercial organizations. Digital globalization and especially social media as a low-cost, highly interactive and multidirectional platform shape a unique context for this rising attention. In the literature, much attention has been devoted to top-down approaches and strategies that corporations use to avoid stigmatization and sanctioning of their behaviour. Reactions to corporate harm are, however, seldom researched from a labelling perspective. As a result, corporations are not considered as objects towards whom labelling is targeted but rather as actors who hamper such processes and who, as moral entrepreneurs, influence which behaviour is labelled deviant. Based on theoretical analysis of literature and case studies, this article will discuss how the process of labelling has changed in light of the digitalized, late-modern society and consequently, how the process should be revisited to be applicable for corporate deviance. Given a diversification of moral entrepreneurs and increasingly dependency of labelling and meaning-making on the online sphere, two new forms of labelling are introduced that specifically target institutions; that is bottom-up and horizontal labelling.


Anna Merz M.A.
Anna Merz is promovendus aan de Sectie Criminologie van de Erasmus Universiteit Rotterdam.
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.
Artikel

Securitisatieverordening van kracht!

Tijdschrift Maandblad voor Vermogensrecht, Aflevering 10 2019
Trefwoorden securitisatie, STS, cessie, CRR, toetsingsvermogen
Auteurs Mr. M. Kuilman
SamenvattingAuteursinformatie

    Sinds 1 januari 2019 is een raamwerk voor simple, transparant and standardised (STS) securitisaties van kracht. In deze bijdrage wordt een aantal vermogensrechtelijke en prudentiële gevolgen van een securitisatie besproken en de impact van het nieuwe raamwerk. Daarbij wordt gekeken naar de richtsnoeren en de toelichting van de EBA.


Mr. M. Kuilman
Mr. M. Kuilman is werkzaam bij De Nederlandsche Bank N.V. op de divisie juridische zaken.
Artikel

A Look Back at Courage and a Look Forward to the Future of Non-Contractual Liability of Individuals for Breaches of EU Law

Tijdschrift Maandblad voor Vermogensrecht, Aflevering 7-8 2019
Trefwoorden non-contractual liability, compensation, direct horizontal effect, effectiveness, effective judicial protection
Auteurs F. Bassi LL.M.
SamenvattingAuteursinformatie

    The Courage ruling establishes that private parties are liable to compensate other private parties for the harm caused by a breach of Art. 101(1) TFEU. This article discusses whether a breach by private parties of other provisions of the TFEU with ‘direct horizontal effect’ also gives rise to non-contractual liability and what are the conditions for such liability to arise.


F. Bassi LL.M.
F. Bassi LL.M. is a PhD Candidate at Radboud University Nijmegen and at KU Leuven.
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