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Article

Access_open Age Limits in Youth Justice

A Comparative and Conceptual Analysis

Journal Erasmus Law Review, Issue 1 2020
Keywords youth justice, age limits, minimum age of criminal responsibility, age of criminal majority, legal comparison
Authors Jantien Leenknecht, Johan Put and Katrijn Veeckmans
AbstractAuthor's information

    In each youth justice system, several age limits exist that indicate what type of reaction can and may be connected to the degree of responsibility that a person can already bear. Civil liability, criminal responsibility and criminal majority are examples of concepts on which age limits are based, but whose definition and impact is not always clear. Especially as far as the minimum age of criminal responsibility (MACR) is concerned, confusion exists in legal doctrine. This is apparent from the fact that international comparison tables often show different MACRs for the same country. Moreover, the international literature often seems to define youth justice systems by means of a lower and upper limit, whereas such a dual distinction is too basic to comprehend the complex multilayer nature of the systems. This contribution therefore maps out and conceptually clarifies the different interpretations and consequences of the several age limits that exist within youth justice systems. To that extent, the age limits of six countries are analysed: Argentina, Austria, Belgium, the Netherlands, New Zealand and Northern Ireland. This legal comparison ultimately leads to a proposal to establish a coherent conceptual framework on age limits in youth justice.


Jantien Leenknecht
Jantien Leenknecht is PhD Fellow of the Research Foundation Flanders (FWO) at KU Leuven, Institute of Social Law and Leuven Institute of Criminology.

Johan Put
Johan Put is Full Professor at KU Leuven, Institute of Social Law and Leuven Institute of Criminology.

Katrijn Veeckmans
Katrijn Veeckmans is PhD Fellow at KU Leuven, Institute of Social Law and Leuven Institute of Criminology.
Article

Access_open Age Barriers in Healthcare

Journal Erasmus Law Review, Issue 1 2020
Keywords age discrimination, age equality, health care
Authors Rachel Horton
AbstractAuthor's information

    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.
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

Journal Erasmus Law Review, Issue 1 2020
Keywords age limits, dynamic legal position, children’s rights, maturity, evolving capacities
Authors Stephanie Rap, Eva Schmidt and Ton Liefaard
AbstractAuthor's information

    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.
Article

Access_open The Relationship between Empirical Legal Studies and Doctrinal Legal Research

Journal Erasmus Law Review, Issue 2 2020
Keywords empirical legal studies, legal research methods, doctrinal legal research, new legal realism, critical legal studies, law and policy
Authors Gareth Davies
AbstractAuthor's information

    This article considers how empirical legal studies (ELS) and doctrinal legal research (DLR) interact. Rather than seeing them as competitors that are methodologically independent and static, it suggests that they are interdependent activities, which may each be changed by interaction with the other, and that this change brings both opportunities and threats. For ELS, the article argues that DLR should properly be understood as part of its theoretical framework, yet in practice little attention is given to doctrine in empirical work. Paying more attention to DLR and legal frames generally would help ELS meet the common criticism that it is under-theorised and excessively policy oriented. On the other hand, an embrace of legal thinking, particularly of critical legal thinking, might lead to loss of status for ELS in policy circles and mainstream social science. For DLR, ELS offers a chance for it to escape the threat of insular sterility and irrelevance and to participate in a founded commentary on the world. The risk, however, is that in tailoring legal analysis to what can be empirically researched legal scholars become less analytically ambitious and more safe, and their traditionally important role as a source of socially relevant critique is weakened. Inevitably, in offering different ways of moving to normative conclusions about the law, ELS and DLR pose challenges to each other, and meeting those challenges will require sometimes uncomfortable self-reflection.


Gareth Davies
Gareth Davies is Professor of European Law at the Faculty of Law of the Vrije Universiteit Amsterdam.
Article

Access_open Can Non-discrimination Law Change Hearts and Minds?

Journal Erasmus Law Review, Issue 3 2020
Keywords law and society, social change, discrimination, non-discrimination law, positive action
Authors Anita Böcker
AbstractAuthor's information

    A question that has preoccupied sociolegal scholars for ages is whether law can change ‘hearts and minds’. This article explores whether non-discrimination law can create social change, and, more particularly, whether it can change attitudes and beliefs as well as external behaviour. The first part examines how sociolegal scholars have theorised about the possibility and desirability of using law as an instrument of social change. The second part discusses the findings of empirical research on the social working of various types of non-discrimination law. What conclusions can be drawn about the ability of non-discrimination law to create social change? What factors influence this ability? And can non-discrimination law change people’s hearts and minds as well as their behaviour? The research literature does not provide an unequivocal answer to the latter question. However, the overall picture emerging from the sociolegal literature is that law is generally more likely to bring about changes in external behaviour and that it can influence attitudes and beliefs only indirectly, by altering the situations in which attitudes and opinions are formed.


Anita Böcker
Anita Böcker is associate professor of Sociology of Law at Radboud University, Nijmegen.
Article

Access_open A Positive State Obligation to Counter Dehumanisation under International Human Rights Law

Journal Erasmus Law Review, Issue 3 2020
Keywords Dehumanisation, International Human Rights Law, Positive State obligations, Framework Convention for the Protection of National Minorities, International Convention on the Elimination of all forms of Racial Discrimination
Authors Stephanie Eleanor Berry
AbstractAuthor's information

    International human rights law (IHRL) was established in the aftermath of the Second World War to prevent a reoccurrence of the atrocities committed in the name of fascism. Central to this aim was the recognition that out-groups are particularly vulnerable to rights violations committed by the in-group. Yet, it is increasingly apparent that out-groups are still subject to a wide range of rights violations, including those associated with mass atrocities. These rights violations are facilitated by the dehumanisation of the out-group by the in-group. Consequently, this article argues that the creation of IHRL treaties and corresponding monitoring mechanisms should be viewed as the first step towards protecting out-groups from human rights violations. By adopting the lens of dehumanisation, this article demonstrates that if IHRL is to achieve its purpose, IHRL monitoring mechanisms must recognise the connection between dehumanisation and rights violations and develop a positive State obligation to counter dehumanisation. The four treaties explored in this article, the European Convention on Human Rights, the International Covenant on Civil and Political Rights, the Framework Convention for the Protection of National Minorities and the International Convention on the Elimination of all forms of Racial Discrimination, all establish positive State obligations to prevent hate speech and to foster tolerant societies. These obligations should, in theory, allow IHRL monitoring mechanisms to address dehumanisation. However, their interpretation of the positive State obligation to foster tolerant societies does not go far enough to counter unconscious dehumanisation and requires more detailed elaboration.


Stephanie Eleanor Berry
Senior Lecturer in International Human Rights Law, University of Sussex.
Article

Access_open How Far Should the State Go to Counter Prejudice?

A Positive State Obligation to Counter Dehumanisation

Journal Erasmus Law Review, Issue 3 2020
Keywords prejudice, soft paternalism, empathy, liberalism, employment discrimination, access to goods and services
Authors Ioanna Tourkochoriti
AbstractAuthor's information

    This article argues that it is legitimate for the state to practice soft paternalism towards changing hearts and minds in order to prevent behaviour that is discriminatory. Liberals accept that it is not legitimate for the state to intervene in order to change how people think because ideas and beliefs are wrong in themselves. It is legitimate for the state to intervene with the actions of a person only when there is a risk of harm to others and when there is a threat to social coexistence. Preventive action of the state is legitimate if we consider the immaterial and material harm that discrimination causes. It causes harm to the social standing of the person, psychological harm, economic and existential harm. All these harms threaten peaceful social coexistence. This article traces a theory of permissible government action. Research in the areas of behavioural psychology, neuroscience and social psychology indicates that it is possible to bring about a change in hearts and minds. Encouraging a person to adopt the perspective of the person who has experienced discrimination can lead to empathetic understanding. This, can lead a person to critically evaluate her prejudice. The paper argues that soft paternalism towards changing hearts and minds is legitimate in order to prevent harm to others. It attempts to legitimise state coercion in order to eliminate prejudice and broader social patterns of inequality and marginalisation. And it distinguishes between appropriate and non-appropriate avenues the state could pursue in order to eliminate prejudice. Policies towards eliminating prejudice should address the rational and the emotional faculties of a person. They should aim at using methods and techniques that focus on persuasion and reduce coercion. They should raise awareness of what prejudice is and how it works in order to facilitate well-informed voluntary decisions. The version of soft paternalism towards changing minds and attitudes defended in this article makes it consistent with liberalism.


Ioanna Tourkochoriti
Lecturer Above the Bar, NUI Galway School of Law.

    The entry into force of the United Nations Convention on the Rights of Persons with Disabilities (CRPD) pushed state obligations to counter prejudice and stereotypes concerning people with disabilities to the forefront of international human rights law. The CRPD is underpinned by a model of inclusive equality, which views disability as a social construct that results from the interaction between persons with impairments and barriers, including attitudinal barriers, that hinder their participation in society. The recognition dimension of inclusive equality, together with the CRPD’s provisions on awareness raising, mandates that states parties target prejudice and stereotypes about the capabilities and contributions of persons with disabilities to society. Certain human rights treaty bodies, including the Committee on the Rights of Persons with Disabilities and, to a much lesser extent, the Committee on the Elimination of Discrimination against Women, require states to eradicate harmful stereotypes and prejudice about people with disabilities in various forms of interpersonal relationships. This trend is also reflected, to a certain extent, in the jurisprudence of the European Court of Human Rights. This article assesses the extent to which the aforementioned human rights bodies have elaborated positive obligations requiring states to endeavour to change ‘hearts and minds’ about the inherent capabilities and contributions of people with disabilities. It analyses whether these bodies have struck the right balance in elaborating positive obligations to eliminate prejudice and stereotypes in interpersonal relationships. Furthermore, it highlights the convergences or divergences that are evident in the bodies’ approaches to those obligations.


Andrea Broderick
Andrea Broderick is Assistant Professor at the Universiteit Maastricht, the Netherlands.
Article

Access_open Too Immature to Vote?

A Philosophical and Psychological Argument to Lower the Voting Age

Journal Erasmus Law Review, Issue 1 2020
Keywords voting age, children’s rights, youth enfranchisement, democracy, votes at 16
Authors Tommy Peto
AbstractAuthor's information

    This article argues in favour of lowering the voting age to 16. First, it outlines a respect-based account of democracy where the right to vote is grounded in a respect for citizens’ autonomous capacities. It then outlines a normative account of autonomy, modelled on Rawls’s two moral powers, saying what criteria must be met for an individual to possess a (pro tanto) moral right to vote. Second, it engages with empirical psychology to show that by the age of 16 (if not earlier) individuals have developed all of the cognitive components of autonomy. Therefore, since 16- and 17-year-olds (and quite probably those a little younger) possess the natural features required for autonomy, then, to the extent that respect for autonomy requires granting political rights including the right to vote – and barring some special circumstances that apply only to them – 16- and 17-year-olds should be granted the right to vote.


Tommy Peto
University of Oxford.
Article

New Sales and Contract Law in Argentina and France

Models for Reform Inspired by the CISG and the PICC?

Journal European Journal of Law Reform, Issue Online First 2020
Keywords contracts, sales, law reform, CISG, UNIDROIT Principles, Argentina, France, comparative law
Authors Edgardo Muñoz and Inés Morfín Kroepfly
AbstractAuthor's information

    The Argentine and the French civil codes have recently undergone substantial modifications to their contract law provisions. These novel statutes could serve as models for future B2B contract law reforms in Latin American jurisdictions and beyond, as former Argentine and French laws have done in the past. The authors offer a contribution that paves the way in that direction with a systematic comparative analysis. As a starting point, this article unveils the influence that the modern unified laws on contracts (UNIDROIT Principles on International Commercial Contracts (PICC) and United Nations Convention for the International Sale of Goods of 1980 (CISG)) have in Argentina’s and France’s new contract law. It also highlights the most obvious similarities and differences in both sets of rules. This contribution goes beyond simple tertium comparisons; the authors analyse which of the two laws offers better, or more effective, rules to achieve the desired contract law functions in various matters. Readers are provided with the best rule or solution to address the problem in question and, as the authors hope, they should conclude that both models provide for a range of complementary solutions for modern contract law reforms.


Edgardo Muñoz
Professor of Law, Universidad Panamericana. School of Law. Calzada Álvaro del Portillo 49, Zapopan, Jalisco, 45010, Mexico. Ph.D. (Basel), LL.M. (UC Berkeley), LL.M. (Liverpool), LL.B. (UIA Mexico), DEUF (Lyon), emunoz@up.edu.mx.

Inés Morfín Kroepfly
J.D., Universidad Panamericana, Guadalajara.
Article

Access_open Het classicistische politieke denken van Van Hogendorp

Journal Netherlands Journal of Legal Philosophy, Issue Pre-publications 2020
Keywords classicistisch politiek denken, constitutie, Van Hogendorp, Grondwet, politieke filosofie
Authors Alban Mik
AbstractAuthor's information

    Gijsbert Karel van Hogendorp is the auctor intellectualis of the 1818 Dutch constitution. It was his sketch for a new constitution that was used as a starting point for the deliberations of its original drafting committee. Van Hogendorp justifies his constitution as a restoration of the Burgundian constitution that applied before the Dutch Republic. In recent literature Van Hogendorp’s restorational argument is presented as an invention of tradition. In this article an alternative explanation is presented, namely that it is part of a form of classicist political thought that was common during the ancien régime. Van Hogendorp describes his constitution as a moderate monarchy, in which the three principles of monarchy, aristocracy and democracy are properly balanced. And he mainly defends this mixed regime by pointing out that it is a restoration of the old Burgundian constitution of the Netherlands. This way of reasoning is, as will be shown, typically classicistic.


Alban Mik
Alban Mik is onderzoeker aan de Afdeling Metajuridica, vakgroep Rechtsfilosofie van de Universiteit Leiden.

Jo-Anne Wemmers
Jo-Anne Wemmers is Professor in the School of Criminology, University of Montreal, Canada.

John Braithwaite
John Braithwaite is an Emeritus Professor, Australian National University, Canberra, Australia.

Philip Pettit
Philip Pettit is L.S. Rockefeller University Professor of Human Values, University Center for Human Values, Princeton University, Princeton, USA, and Distinguished University Professor of Philosophy, School of Philosophy, Australian National University, Canberra, Australia.

    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.
Article

Still Consociational? Belgian Democracy, 50 Years After ‘The Politics of Accommodation’

Journal Politics of the Low Countries, Issue 1 2020
Keywords Belgium, consociational democracy, Lijphart, federalism, ethnolinguistic conflict
Authors Didier Caluwaerts and Min Reuchamps
AbstractAuthor's information

    Despite the enduring importance of Lijphart’s work for understanding democracy in Belgium, the consociational model has come under increasing threat. Owing to deep political crises, decreasing levels of trust in elites, increasing levels of ethnic outbidding and rising demands for democratic reform, it seems as if Lijphart’s model is under siege. Even though the consociational solution proved to be very capable of transforming conflict into cooperation in Belgian politics in the past, the question we raise in this article is whether and to what extent the ‘politics of accommodation’ is still applicable to Belgian democracy. Based on an in-depth analysis of the four institutional (grand coalition, proportionality, mutual veto rights and segmental autonomy) and one cultural (public passivity) criteria, we argue that consociational democracy’s very nature and institutional set-up has largely hollowed out its potential for future conflict management.


Didier Caluwaerts
Didier Caluwaerts is professor of political science at the Vrije Universiteit Brussel. His research deals with democratic governance and innovation in deeply divided societies. With Min Reuchamps, he has recently published “The Legitimacy of Citizen-led Deliberative Democracy: The G1000 in Belgium” (Routledge, 2018).

Min Reuchamps
Min Reuchamps is professor of political science at the Université catholique de Louvain (UCLouvain). His teaching and research interests are federalism and multi-level governance, democracy and its different dimensions, relations between language(s) and politics and in particular the role of metaphors, as well as participatory and deliberative methods.
Article

Gender-Neutral Drafting

A View from Wales

Journal European Journal of Law Reform, Issue 1 2020
Keywords gender, legislation, English, Welsh, LGBTQIA+
Authors Thomas Glyn Watkin
AbstractAuthor's information

    The gender classification of words in English is different from that in many other languages, including Welsh. The approach in Welsh is more closely aligned to that in languages such as French, Spanish or Italian, but there are also differences. The differences include the manner in which possessive pronouns and possessive adjectives are employed. These differences pose difficulties for bilingual drafting in English and Welsh.
    This article will consider some of those difficulties, their root causes and some possible solutions as well as look at issues that may or may not complicate matters further in the future.


Thomas Glyn Watkin
Queen’s Counsel (honoris causa); Fellow of the Learned Society of Wales; Honorary Professor of Law, Bangor University. First Welsh Legislative Counsel (2007-2010); Professor of Law, Bangor Law School (2004-2007); Professor of Law, Cardiff Law School (2001-2004).
Article

Language and Gender

The Importance of Including a Gender Perspective in the Language of the Constitutional Reform in Spain

Journal European Journal of Law Reform, Issue 1 2020
Keywords language, gender, Constitution, reform, Spain
Authors Ana Marrades
AbstractAuthor's information

    Language is a reflection of culture, and at the same time it helps to build that culture. In the same way, it can be used to transform it. Language serves for describing a culture, to show what we see, but at the same time, it strengthens the relationships of power that exist on the basis of male power. In this way, we can use language to build other kinds of relationships based on equality.
    The Spanish Constitution is written in the masculine. Although it is based on equality, masculine language shows that the power relations lean towards men, and this hides women’s participation. When a text or a legal message uses structures or words that hide or discriminate against one gender, it can be said that linguistic sexism exists, and this violates the principle of equality. This is a reflection about what is happening in our society because language describes cultural values. This exclusion of women in the constitutional text is in itself a denial of them as subjects of rights and as citizens. This is not only a denial of the part of power that corresponds to them, but also the consolidation of a collective story of female subordination.
    Therefore this article aims to focus on the need to carry out a revision of the Spanish Constitution in female and inclusive language that, in parallel to the recognition and guarantee of parity democracy, makes women visible as autonomous subjects. In addition, it also breaks with the male universality of the language and the monopoly of male language to define the sources of the law, as well as rights, powers, institutions, values and policies.


Ana Marrades
Senior lecturer in Constitutional law, University of Valencia.
Article

Access_open The Potential of Public Policy on Open Access Repositories

Journal Erasmus Law Review, Issue 2 2019
Keywords public policy, dissemination, governance, open access, repositories
Authors Nikos Koutras
AbstractAuthor's information

    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

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).
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