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Article

Access_open Age Barriers in Healthcare

Tijdschrift Erasmus Law Review, Aflevering 1 2020
Trefwoorden age discrimination, age equality, health care
Auteurs Rachel Horton
SamenvattingAuteursinformatie

    Age limits, minimum and maximum, and both explicit and ‘covert’, are still used in the National Health Service to determine access to a range of health interventions, including infertility services and cancer screening and treatment. Evidence suggests that chronological age is used as a proxy for a host of characteristics in determining access to healthcare: as a proxy for the capacity of an individual to benefit from an intervention; for the type of harm that may result from an intervention; for the likelihood of such benefit or harm occurring; and, in some cases, for other indicators used to determine what may be in the patient’s interest. Age is used as a proxy in this way in making decisions about both individual patients and wider populations; it may be used where no better ‘marker’ for the relevant characteristic exists or – for reasons including cost, practicality or fairness – in preference to other available markers. This article reviews the justifications for using age in this way in the context of the existing legal framework on age discrimination in the provision of public services.


Rachel Horton
Lecturer University of Reading.
Artikel

Bezoek in Nederlandse gevangenissen

De stand van zaken

Tijdschrift PROCES, Aflevering 2 2020
Trefwoorden Bezoek Visitation, Detentie Imprisonment, Leefklimaat Prison climate, Detentie-ervaringen prison experiences
Auteurs Maria Berghuis MSc, Dr. Hanneke Palmen en Prof. dr. Paul Nieuwbeerta
SamenvattingAuteursinformatie

    Prison visitation is important for protecting against social isolation during imprisonment. It is also essential for maintaining contacts that are important for life in prison and after release. It is therefore not surprising that both nationally and internationally important policy measures and scientific research have been undertaken on the topic. Nationally, however, limited scientific research is available regarding how many, how often and from whom prisoners receive visits, how visits are experienced and the possible effects of visitation, thus leaving many questions unanswered. Meanwhile, in the past ten years great changes have been made to visitation in Dutch prison policy and practice. Given these recent developments, both scientists and practitioners could benefit from an overview of the current state of affairs of visitation. This article aims to bridge the gap between research, policy and practice by summarizing findings from the Life in Custody study. This study includes a description of how visitation is organized legally, at the policy level and in practice, a thorough review of prior research on visitation and an analysis of the most recent national data on the prevalence and frequency of visitation, while considering important differences between prisoners and prisons.


Maria Berghuis MSc
Maria Berghuis MSc is promovenda Criminologie aan de faculteit Rechtsgeleerdheid van het Instituut voor Strafrecht & Criminologie in Leiden.

Dr. Hanneke Palmen
Dr. Hanneke Palmen is universitair hoofddocent Criminologie aan de faculteit Rechtsgeleerdheid van het Instituut voor Strafrecht & Criminologie in Leiden.

Prof. dr. Paul Nieuwbeerta
Prof. dr. Paul Nieuwbeerta is hoogleraar Criminologie aan de faculteit Rechtsgeleerdheid van het Instituut voor Strafrecht & Criminologie in Leiden.
Artikel

Access_open Religie op het werk?

Over positieve en negatieve godsdienstvrijheid bij private ondernemingen en tendensondernemingen

Tijdschrift Netherlands Journal of Legal Philosophy, Aflevering 1 2020
Auteurs Leni Franken en François Levrau
SamenvattingAuteursinformatie

    In this article we elaborate on the place of religion in the workplace. Does the individual freedom of religion imply that employers must always accommodate the religious claims of employees or can they boast a number of arguments allowing them to legitimately limit that freedom? And, conversely, do employers not also have a right to freedom of religion and a right to formulate certain religious expectations for their employees? In this contribution, we deal with these and related questions from a legal-philosophical perspective. The overall aim is to illustrate the extent to which univocal answers are jeopardized because of conceptual ambiguities. We first make a normative distinction between two strategies (i.e. difference-blind approach and difference-sensitive approach) and subsequently illustrate and elaborate on how and why these strategies can lead to different outcomes in legal cases. We illustrate the extent to which a contextual and proportional analysis can be a way out in theoretical and practical conundrums.


Leni Franken
Leni Franken is senior researcher and teaching assistant at the University of Antwerp.

François Levrau
François Levrau is senior researcher and teaching assistant at the University of Antwerp.
Artikel

Access_open Liberal Democracy and the Judeo-Christian Tradition

Tijdschrift Netherlands Journal of Legal Philosophy, Aflevering 1 2020
Trefwoorden national identity, historical narratives, universal values, equal citizenship
Auteurs Tamar de Waal
SamenvattingAuteursinformatie

    Increasingly often, it is stated that the universal values underpinning Western liberal democracies are a product of a ‘Judeo-Christian’ tradition. This article explores the legitimacy of this claim from the perspective of liberal-democratic theory. It argues that state-endorsed claims about the historical roots of liberal-democratic values are problematic (1) if they are promoted as though they are above democratic scrutiny and (2) if they insinuate that citizens who belong to a particular (majority) culture remain the ‘cultural owners’ of the core values underpinning the state. More pragmatically, the paper suggests that the claim carries the risk of failing to facilitate all citizens becoming or remaining committed to nurturing fundamental rights and a shared society based on norms of democratic equality.


Tamar de Waal
Tamar de Waal is assistant professor of legal philosophy at the Amsterdam Law School of the University of Amsterdam.
Artikel

Access_open General Comment No. 24 – nieuw elan voor het jeugdstrafrecht?

Over leeftijdsgrenzen, ‘diversion’ en de bredere implicaties voor het jeugdstrafrecht

Tijdschrift Boom Strafblad, Aflevering 1 2020
Trefwoorden Kinderrechten, Jeugdstrafrecht, General Comment No. 24, Leeftijdsgrenzen
Auteurs Mr. dr. Y.N. (Yannick) van den Brink en Prof. mr. E.M. (Isabeth) Mijnarends
SamenvattingAuteursinformatie

    Het VN-Kinderrechtencomité heeft recentelijk zijn nieuwe General Comment No. 24 gepubliceerd over kinderrechten in het jeugdstrafrecht. Deze bijdrage verkent de mogelijke implicaties van dit General Comment voor het Nederlandse jeugdstrafrecht, aan de hand van interviews met professionals uit de jeugdstrafrechtspraktijk. Hierbij wordt specifiek aandacht besteed aan de minimumleeftijdsgrens voor jeugdstrafrechtelijke aansprakelijkheid en de buitengerechtelijke afdoening van jeugdstrafzaken (‘diversion’). Ook wordt in bredere zin gereflecteerd op de potentiële meerwaarde van het IVRK en General Comment No. 24 voor het Nederlandse jeugdstrafrecht.


Mr. dr. Y.N. (Yannick) van den Brink
Mr. dr. Y.N. van den Brink is universitair docent Jeugdrecht en Strafrecht aan de Universiteit Leiden en thans als Rubicon research fellow verbonden aan de University of Cambridge, Institute of Criminology (Verenigd Koninkrijk).

Prof. mr. E.M. (Isabeth) Mijnarends
Prof. mr. E.M. Mijnarends is landelijk coördinerend jeugdofficier bij het Openbaar Ministerie en tevens bijzonder hoogleraar Jeugdstrafrecht aan de Universiteit Leiden en heeft op persoonlijke titel als coauteur bijgedragen aan dit artikel.
Artikel

Access_open Juvenile Justice in the Caribbean Netherlands: Important considerations from a Children’s Rights Perspective

Tijdschrift Boom Strafblad, Aflevering 1 2020
Trefwoorden UNICEF Situation Analysis, Caribbean Netherlands, Children’s Rights, Juvenile Justice
Auteurs L. (La-Toya) Charles MSc.
SamenvattingAuteursinformatie

    The Dutch Government intends to implement a Juvenile Justice Law for the Caribbean Netherlands. This article addresses this development and gives some important considerations from a children’s rights perspective; particularly, the rights of children while in the juvenile justice system and the Government’s obligation to prevent children from entering into the system. The discussion hinges on the findings of UNICEF The Netherlands’ recently published Situation Analysis on the Rights of Children and Adolescents in the Caribbean Netherlands, focusing on child vulnerabilities that may eventually lead to criminality and recommendations regarding necessary provisions, collaboration between ministries and public entities, and the availability of data to monitor the effectiveness of government policy.


L. (La-Toya) Charles MSc.
Children’s Rights Advocacy Specialist at UNICEF The Netherlands.
Artikel

Trials in absentia of foreign terrorist fighters in the Netherlands and Belgium

Tijdschrift Crimmigratie & Recht, Aflevering 1 2020
Trefwoorden the right to be present, trials in absentia, foreign terrorist fighters, The Netherlands, Belgium
Auteurs Mr. Zoë Heij
SamenvattingAuteursinformatie

    Judgements rendered in the accused’s absence form a special category of criminal judgements that undoubtedly do not provide for the same safeguards that would be in place when a judgement is rendered in the accused’s presence. Nonetheless, provided that strict conditions are adhered to, trials in absentia can be compatible with the accused’s right to be present. This article examines the standards that have been developed under international human rights law, providing for the normative framework, to see to what extent the trials in absentia of foreign terrorist fighters in the Netherlands and Belgium comply therewith. By pointing to analogies and contrasts, this article wishes to contribute to finding answers to this dilemma.


Mr. Zoë Heij
Mr. Z. Heij behaalde de research master in Public International Law aan de Universiteit van Amsterdam. Zij liep ten tijde van het schrijven van dit artikel stage bij Prakken d’Oliveira.
Artikel

From the securitisation of migration to the criminalisation of solidarity towards migrants

The shrinking space for NGOs and volunteers in the Mediterranean Sea

Tijdschrift Crimmigratie & Recht, Aflevering 1 2020
Trefwoorden migration, securitisation, solidarity, growing pattern of criminalisation
Auteurs Fleur Boixiere
SamenvattingAuteursinformatie

    In recent years, migration has been at the centre of European debates and the number of migrants trying to cross the Mediterranean remains alarming. To this day, hundreds of people continue to risk their lives crossing the Mediterranean on small boats in order to flee conflict zones, persecution or extreme poverty. However, due to the lack of legal alternatives, migrants engage in dangerous journeys and find themselves helpless in the hands of smugglers. This article will address the growing pattern of criminalisation of migration and humanitarian assistance throughout Europe and consider the extent to which national, European and international anti-smuggling laws affect the work of civil society actors.


Fleur Boixiere
Fleur Boixiere is a former student of Public International Law at Leiden University and this contribution is based on her Master thesis. While writing her article, she did an internship at the ICC.
Case Law

2020/1 EELC’s review of the year 2019

Tijdschrift European Employment Law Cases, Aflevering 1 2020
Auteurs Ruben Houweling, Daiva Petrylaitė, Peter Schöffmann e.a.
Samenvatting

    Various of our academic board analysed employment law cases from last year. However, first, we start with some general remarks.


Ruben Houweling

Daiva Petrylaitė

Peter Schöffmann

Attila Kun

Francesca Maffei

Jean-Philippe Lhernould

Niklas Bruun

Jan-Pieter Vos

Luca Ratti

Anthony Kerr

Petr Hůrka

Michal Vrajík

    On 3 October 2019, in case C-274/18 (Schuch-Ghannadan), the ECJ held that a national regulation, which provides for different maximum total durations of successive fixed-term employment contracts for part-time workers on the one hand and full-time workers on the other, could result in a discrimination of part-time workers and an indirect discrimination of women.


Ines Kager
Mag. Ines Kager is teaching and research assistant at WU Vienna University of Economics and Business.

    Relying on the prohibition of age discrimination stemming from Directive 2000/78, the Brussels Labour Tribunal, in a judgment of 28 November 2019, ruled that an age limit of 25 for the recruitment of air traffic controllers constituted direct discrimination. Its decision was grounded on the fact that even if there are objective reasons related to air traffic safety which may justify setting an age limit for applicants, the employer must adduce concrete evidence based on scientific facts.


Gautier Busschaert
Gautier Busschaert is an attorney-at-law at Van Olmen & Wynant, Brussels.
Article

Access_open Giving Children a Voice in Court?

Age Boundaries for Involvement of Children in Civil Proceedings and the Relevance of Neuropsychological Insights

Tijdschrift Erasmus Law Review, Aflevering 1 2020
Trefwoorden age boundaries, right to be heard, child’s autonomy, civil proceedings, neuropsychology
Auteurs Mariëlle Bruning en Jiska Peper
SamenvattingAuteursinformatie

    In the last decade neuropsychological insights have gained influence with regard to age boundaries in legal procedures, however, in Dutch civil law no such influence can be distinguished. Recently, voices have been raised to improve children’s legal position in civil law: to reflect upon the minimum age limit of twelve years for children to be invited to be heard in court and the need for children to have a stronger procedural position.
    In this article, first the current legal position of children in Dutch law and practice will be analysed. Second, development of psychological constructs relevant for family law will be discussed in relation to underlying brain developmental processes and contextual effects. These constructs encompass cognitive capacity, autonomy, stress responsiveness and (peer) pressure.
    From the first part it becomes clear that in Dutch family law, there is a tortuous jungle of age limits, exceptions and limitations regarding children’s procedural rights. Until recently, the Dutch government has been reluctant to improve the child’s procedural position in family law. Over the last two years, however, there has been an inclination towards further reflecting on improvements to the child’s procedural rights, which, from a children’s rights perspective, is an important step forward. Relevant neuropsychological insights support improvements for a better realisation of the child’s right to be heard, such as hearing children younger than twelve years of age in civil court proceedings.


Mariëlle Bruning
Professor of Child Law at Leiden Law Faculty, Leiden University.

Jiska Peper
Assistant professor in the Developmental and Educational Psychology unit of the Institute of Psychology at Leiden University.
Article

Access_open Safeguarding the Dynamic Legal Position of Children: A Matter of Age Limits?

Reflections on the Fundamental Principles and Practical Application of Age Limits in Light of International Children’s Rights Law

Tijdschrift Erasmus Law Review, Aflevering 1 2020
Trefwoorden age limits, dynamic legal position, children’s rights, maturity, evolving capacities
Auteurs Stephanie Rap, Eva Schmidt en Ton Liefaard
SamenvattingAuteursinformatie

    In this article a critical reflection upon age limits applied in the law is provided, in light of the tension that exists in international children’s rights law between the protection of children and the recognition of their evolving autonomy. The main research question that will be addressed is to what extent the use of (certain) age limits is justified under international children’s rights law. The complexity of applying open norms and theoretically underdeveloped concepts as laid down in the UN Convention on the Rights of the Child, related to the development and evolving capacities of children as rights holders, will be demonstrated. The UN Committee on the Rights of the Child struggles to provide comprehensive guidance to states regarding the manner in which the dynamic legal position of children should be applied in practice. The inconsistent application of age limits that govern the involvement of children in judicial procedures provides states leeway in granting children autonomy, potentially leading to the establishment of age limits based on inappropriate – practically, politically or ideologically motivated – grounds.


Stephanie Rap
Stephanie Rap is assistant professor in children’s rights at the Department of Child Law, Leiden Law School, the Netherlands.

Eva Schmidt
Eva Schmidt is PhD candidate at the Department of Child Law, Leiden Law School, the Netherlands.

Ton Liefaard
Ton Liefaard is Vice-Dean of Leiden Law School and holds the UNICEF Chair in Children’s Rights at Leiden University, Leiden Law School, the Netherlands.

    This article engages in a comparison of the regulation of PR in the Netherlands and the UK (specifically England and Wales). The latter is a good comparator as it operates a similar regulatory approach to the Netherlands, that of conditional acceptance of PR, the condition being (prior) consent. Furthermore, the UK boasts a more detailed and mature legal framework that continues to be tested through caselaw, and thus offers insight into how a regulatory approach conditional upon the (prior) consent of the deceased can fare.
    The article starts with a brief exposition of the new Dutch guidelines and the current legislative position in the Netherlands vis-à-vis posthumous reproduction (part II). Likewise, the relevant UK guidelines and legislative position are summarized (part III). This article draws out the similarities and differences between the two regimes, as well as engaging in a critical analysis of the regulations themselves. It then looks at how the UK regime has been challenged in recent years through caselaw in anticipation of the issues that might confront the Netherlands in future (part IV). The article concludes (part V) that the key lesson to be drawn from the UK experience is that clarity and consistency is crucial in navigating this ethically, emotionally, and time sensitive area. Further, that both the UK and the Netherlands can expect demand for more detailed and precise regulatory guidance as requests for the procedure increase, and within evermore novel circumstances.

    ---

    Dit artikel vergelijkt de regulering van postume reproductie (PR) in Nederland en het Verenigd Koninkrijk (in het bijzonder Engeland en Wales). Laatstgenoemde is daarvoor zeer geschikt, aangezien het VK een vergelijkbare reguleringsbenadering heeft als Nederland, namelijk de voorwaardelijke acceptatie van PR, waarbij (voorafgaande) toestemming de voorwaarde is. Bovendien beschikt het VK over een gedetailleerder en volwassener juridisch kader dat continu wordt getoetst door middel van rechtspraak. Dit kader biedt daarmee inzicht in hoe een regulerende benadering met als voorwaarde (voorafgaande) toestemming van de overledene kan verlopen.
    Het artikel vangt aan met een korte uiteenzetting van de nieuwe Nederlandse richtlijnen en de huidige positie van de Nederlandse wetgever ten opzichte van postume reproductie (deel II). De relevante Britse richtlijnen en het wetgevende standpunt worden eveneens samengevat (deel III). Vervolgens worden de overeenkomsten en verschillen tussen de twee regimes naar voren gebracht, met daarbij een kritische analyse van de regelgeving. Hierop volgt een beschrijving van hoe het VK de afgelopen jaren is uitgedaagd in de rechtspraak, daarmee anticiperend op vraagstukken waarmee Nederland in de toekomst te maken kan krijgen (deel IV). Tot slot volgt een conclusie (deel V) waarin wordt aangetoond dat de belangrijkste les die uit de Britse ervaring kan worden getrokken, is dat duidelijkheid en consistentie cruciaal zijn bij het navigeren door dit ethische, emotionele en tijdgevoelige gebied. En daarnaast, at zowel het VK als Nederland een vraag naar meer gedetailleerde en precieze regelgeving kunnen verwachten naarmate verzoeken om deze procedure toenemen, met daarbij steeds weer nieuwe omstandigheden.


Dr. N. Hyder-Rahman
Nishat Hyder-Rahman is a Post-doctoral Researcher at the Utrecht Centre for European Research into Family Law, Molengraaff Institute for Private Law, Utrecht University.
Artikel

Open markt vs. kernwaarden

Tijdschrift Advocatenblad, Aflevering 3 2020
Auteurs Stijn Dunk, Kees Pijnappels en Floris Tilanus
Auteursinformatie

Stijn Dunk

Kees Pijnappels

Floris Tilanus
Illustratie

    De grote toestroom van migranten en asielzoekers in de EU houdt vandaag nog steeds verschillende regelgevers wakker. Niet alleen de nationale overheden, maar ook de EU-regelgevers zoeken naarstig naar oplossingen voor de problematiek. Daartoe trachten de EU-regelgevers het Gemeenschappelijk Europees Asielstelsel (GEAS) bij te werken.
    Binnen de groep migranten en asielzoekers bestaat een specifiek kwetsbaar individu: de niet-begeleide minderjarige vreemdeling (NBMV). Hij is zowel vreemdeling als kind en kreeg reeds ruime aandacht binnen de rechtsleer. Nochtans werd deze aandacht niet altijd weerspiegeld in de EU-wetgeving. Het lijkt alsof hij door de regelgevers af en toe uit het oog verloren werd.
    Uit het onderzoek blijkt dat de EU-regelgevers nog een zekere weg te gaan hebben. In de eerste plaats bestaat er wat betreft het geheel aan regels met betrekking tot de NBMV weinig coherentie. De EU-regelgevers zouden bijvoorbeeld meer duidelijkheid kunnen scheppen door een uniforme methode vast te leggen voor de bepaling van de leeftijd van de NBMV. Hetzelfde geldt voor een verduidelijking van de notie ‘het belang van het kind’ binnen asiel en migratie. Verder blijken de Dublinoverdrachten en de vrijheidsontneming van de NBMV nog steeds gevoelige pijnpunten. Hier en daar moet aan de hervorming van het asielstelsel nog wat gesleuteld worden, zodat de rechten van de NBMV optimaal beschermd kunnen worden.
    ---
    Today, the large influx of migrants and asylum seekers into the European Union (EU) keeps several regulators awake. Not only national authorities, but EU regulators too are diligently searching for solutions to the problems. To this end, EU regulators are seeking to update the Common European Asylum System (CEAS).
    There is however a particularly vulnerable individual within the group of migrants and asylum seekers: the unaccompanied alien minor (UAM). These minors already received a great deal of attention within legal doctrine. However, this attention was not always reflected in EU legislation. It seems as if UAM are occasionally lost from sight by the regulators.
    This article shows that the EU regulators still have a certain way to go. First, there is little coherence in the set of rules relating to the UAM. The EU regulators could, for example, create more clarity by laying down a uniform method for determining the age of the UAM. The same applies to a clarification of the notion of 'best interests of the child' within the context of asylum and migration. Second, the proposal for a new Dublin Regulation and the proposal for a new Reception Conditions Directive still appear to be sensitive. Here and there, the reform of the asylum system still needs adjustments, so that the rights of UAM can be optimally protected."


Caranina Colpaert LLM
Caranina Colpaert is PhD researcher
Brexit

Access_open Wightman en het soevereine recht om lid van de EU te blijven

Tijdschrift Nederlands tijdschrift voor Europees recht, Aflevering 7-8 2019
Trefwoorden Brexit, artikel 50 VEU, soevereiniteit, 4 intrekking kennisgeving, uittreding
Auteurs Mr. dr. A. Cuyvers
SamenvattingAuteursinformatie

    Wightman bevestigt het unilaterale, soevereine recht van een lidstaat om een kennisgeving van uittreding in te trekken. Deze bijdrage bespreekt zowel dit recht op intrekking als de eventuele grenzen aan dit recht, waaronder wellicht misbruik van recht.
    HvJ 10 december 2018, zaak C-621/18, Wightman, ECLI:EU:C:2018:999.


Mr. dr. A. Cuyvers
Mr. dr. A. (Armin) Cuyvers is universitair hoofddocent Europees Recht aan het Europa Instituut Leiden Law School.

    Juliet Stumpf is de Robert E. Jones Professor of Advocacy and Ethics aan de Lewis & Clark Law School. Stumpf onderzoekt het fenomeen crimmigratie door een interdisciplinaire lens, waarbij ze inzichten uit het (immigratie- & straf-) recht in verband brengt met inzichten uit de sociale en geesteswetenschappen. Haar werk is gepubliceerd in een indrukwekkende reeks tijdschriften en boeken, waaronder een serie van ‘crimmigratie-artikelen’ waarvan haar inmiddels breed bekende artikel ‘The Crimmigration Crisis: Immigrants, Crime, and Sovereign Power’ (56 Am. U. L. Rev. 367) de eerste was.

Article

Access_open The Potential of Public Policy on Open Access Repositories

Tijdschrift Erasmus Law Review, Aflevering 2 2019
Trefwoorden public policy, dissemination, governance, open access, repositories
Auteurs Nikos Koutras
SamenvattingAuteursinformatie

    To address the potential of public policy on the governance of OARs it is necessary to define what is meant by public policy and the importance of public policy in designing an efficient governance framework. Critical components are the subject matter of public policy and its objectives. Hence, it is useful to consider declarations, policies and statements in relation to open access practice and examine the efficiency of these arrangements towards the improvement of stakeholders’ engagement in governance of OARs. Secondly, policies relating to dissemination of scientific information via OARs should be examined. In this regard, it is relevant to consider the public policy basis for Intellectual Property (IP) laws that concerning the utility of OARs. Therefore, economic theories relevant with the role of IP laws should be examined. Such examination depicts to what extend these laws facilitate the utility of OARs. In order to specify justifications for the desirability of OARs the objectives of social theories should be also considered. Thus, there is consternation that without legal protection against copying the incentive to create intellectual property will be undermined. As scholarly communication infrastructure evolves, it is necessary to recognize the efforts of the relationship between Intellectual Property Rights (IPRs) and communication technologies in the context of public policy and after engagement with it. After employing such multilevel approach, the paper argues about a socio-economic framework to enhance the governance of OARs through public policy.


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