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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 Characteristics of Young Adults Sentenced with Juvenile Sanctions in the Netherlands

Journal Erasmus Law Review, Issue 1 2020
Keywords young adult offenders, juvenile sanctions for young adults, juvenile criminal law, psychosocial immaturity
Authors Lise J.C. Prop, André M. Van der Laan, Charlotte S. Barendregt e.a.
AbstractAuthor's information

    Since 1 April 2014, young adults aged 18 up to and including 22 years can be sentenced with juvenile sanctions in the Netherlands. This legislation is referred to as ‘adolescent criminal law’ (ACL). An important reason for the special treatment of young adults is their over-representation in crime. The underlying idea of ACL is that some young adult offenders are less mature than others. These young adults may benefit more from pedagogically oriented juvenile sanctions than from the deterrent focus of adult sanctions. Little is known, however, about the characteristics of the young adults sentenced with juvenile sanctions since the implementation of ACL. The aim of this study is to gain insight into the demographic, criminogenic and criminal case characteristics of young adult offenders sentenced with juvenile sanctions in the first year after the implementation of ACL. A cross-sectional study was conducted using a juvenile sanction group and an adult sanction group. Data on 583 criminal cases of young adults, sanctioned from 1 April 2014 up to March 2015, were included. Data were obtained from the Public Prosecution Service, the Dutch Probation Service and Statistics Netherlands. The results showed that characteristics indicating problems across different domains were more prevalent among young adults sentenced with juvenile sanctions. Furthermore, these young adults committed a greater number of serious offences compared with young adults who were sentenced with adult sanctions. The findings of this study provide support for the special treatment of young adult offenders in criminal law as intended by ACL.


Lise J.C. Prop
Research and Documentation Centre (WODC), Ministry of Justice and Security, Den Haag, the Netherlands.

André M. Van der Laan
Research and Documentation Centre (WODC), Ministry of Justice and Security, Den Haag, the Netherlands.

Charlotte S. Barendregt
Health and Youth Care Inspectorate, Ministry of Health, Welfare and Sport, Utrecht, the Netherlands.

Chijs Van Nieuwenhuizen
GGzE, Centre for Child and Adolescent Psychiatry, Eindhoven, the Netherlands and Scientific Center for Care & Welfare (Tranzo),Tilburg University, Tilburg, the Netherlands.
Article

Access_open Giving Children a Voice in Court?

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

Journal Erasmus Law Review, Issue 1 2020
Keywords age boundaries, right to be heard, child’s autonomy, civil proceedings, neuropsychology
Authors Mariëlle Bruning and Jiska Peper
AbstractAuthor's information

    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

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 What does it mean to be ‘illiberal’?

Journal Netherlands Journal of Legal Philosophy, Issue Pre-publications 2020
Keywords Liberalism, Illiberalism, Illiberal practices, Extremism, Discrimination
Authors Bouke de Vries
AbstractAuthor's information

    ‘Illiberal’ is an adjective that is commonly used by scholars. For example, they might speak of ‘illiberal cultures’, ‘illiberal groups’, ‘illiberal states’, ‘illiberal democracies’, ‘illiberal beliefs’, and ‘illiberal practices’. Yet despite its widespread usage, no in-depth discussions exist of exactly what it means for someone or something to be illiberal, or might mean. This article fills this lacuna by providing a conceptual analysis of the term ‘illiberal practices’, which I argue is basic in that other bearers of the property of being illiberal can be understood by reference to it. Specifically, I identify five ways in which a practice can be illiberal based on the different ways in which this term is employed within both scholarly and political discourses. The main value of this disaggregation lies in the fact that it helps to prevent confusions that arise when people use the adjective ‘illiberal’ in different ways, as is not uncommon.


Bouke de Vries
Bouke de Vries is a postdoctoral research fellow at Umeå University and the KU Leuven.
Article

Interest Representation in Belgium

Mapping the Size and Diversity of an Interest Group Population in a Multi-layered Neo-corporatist Polity

Journal Politics of the Low Countries, Issue Online First 2020
Keywords interest groups, advocacy, access, advisory councils, media attention
Authors Evelien Willems, Jan Beyers and Frederik Heylen
AbstractAuthor's information

    This article assesses the size and diversity of Belgium’s interest group population by triangulating four data sources. Combining various sources allows us to describe which societal interests get mobilised, which interest organisations become politically active and who gains access to the policy process and obtains news media attention. Unique about the project is the systematic data collection, enabling us to compare interest representation at the national, Flemish and Francophone-Walloon government levels. We find that: (1) the national government level remains an important venue for interest groups, despite the continuous transfer of competences to the subnational and European levels, (2) neo-corporatist mobilisation patterns are a persistent feature of interest representation, despite substantial interest group diversity and (3) interest mobilisation substantially varies across government levels and political-administrative arenas.


Evelien Willems
Evelien Willems, Departement Politieke Wetenschappen, Universiteit Antwerpen, Antwerpen, Belgium.

Jan Beyers
Jan Beyers, Departement Politieke Wetenschappen, Universiteit Antwerpen, Antwerpen, Belgium.

Frederik Heylen
Frederik Heylen, Departement Politieke Wetenschappen, Universiteit Antwerpen, Antwerpen, Belgium.
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 Is the CJEU discriminating in age discrimination cases?

Journal Erasmus Law Review, Issue 1 2020
Keywords age discrimination, old people, young people, complete life view, fair innings argument
Authors Beryl ter Haar
AbstractAuthor's information

    Claims have been made that the Court of Justice of the European Union (CJEU) is more lenient in accepting age discriminating measures affecting older people than in those affecting younger people. This claim is scrutinised in this article, first, by making a quantitative analysis of the outcomes of the CJEU’s case law on age discrimination cases, followed by a qualitative analysis of the line of reasoning of the CJEU in these cases and concluding with an evaluation of the Court’s reasoning against three theoretical approaches that set the context for the assessment of the justifications of age discrimination: complete life view, fair innings argument and typical anti-discrimination approach. The analysis shows that the CJEU relies more on the complete life view approach to assess measures discriminating old people and the fair innings argument approach to assess measures discriminating young people. This results in old people often having to accept disadvantageous measures and young workers often being treated more favourably.


Beryl ter Haar
Beryl ter Haar is assistant professor and academic coordinator of the Advanced LL.M. Global and European Labour Law at Leiden University and visiting professor at the University of Warsaw.
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.

Kathleen Daly
Kathleen Daly is Professor in the School of Criminology and Criminal Justice, Griffith University, Brisbane, Australia.
Article

John Braithwaite

standards, ‘bottom-up’ praxis and ex-combatants in restorative justice

Journal The International Journal of Restorative Justice, Issue 1 2020
Authors Kieran McEvoy and Allely Albert
Author's information

Kieran McEvoy
Kieran McEvoy is Professor of Law and Transitional Justice and Senior Fellow at the Senator George J. Mitchell Institute for Global Peace, Security and Justice, Queens University Belfast, UK.

Allely Albert
Allely Albert is a PhD student with a University Studentship at the Senator George J. Mitchell Institute for Global Peace, Security and Justice, Queens University Belfast, UK.

Miranda Forsyth
Miranda Forsyth is an Associate Professor at the College of Asia and the Pacific, Australian National University, Canberra, Australia.

Valerie Braithwaite
Valerie Braithwaite is Professor at the College of Asia and the Pacific, Australian National University, Canberra, Australia.

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

    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
Article

A Linguistic Insight into the Legislative Drafting of English-Speaking Jurisdictions

The Use of ‘Singular They’

Journal European Journal of Law Reform, Issue 1 2020
Keywords gender neutrality, ‘singular they’, linguistic insight, legislative drafting, English-language jurisdictions
Authors Giulia Adriana Pennisi
AbstractAuthor's information

    Gender specificity in legislation started being questioned in the late 20th century, and the need to reform the way in which laws have been written for more than one-hundred years has been particularly evident in English-language jurisdictions. In the 1990s and 2000s, the adoption of a plain English style forced legislative drafters to avoid sentences of undue length, superfluous definitions, repeated words and gender specificity with the aim of achieving clarity and minimizing ambiguity.
    Experts in the legal field have suggested reorganizing sentences, avoiding male pronouns, repeating the noun in place of the pronoun, replacing a nominalization with a verb form, resorting to ‘the singular they’. This article gives a linguistic insight into the use of ‘singular they’ in English, beginning with a historical background and going on to assess the impact of its use in the primary legislation issued in a selection of English-language jurisdictions (Australia, Canada, New Zealand, the UK, the US) in the last decade (2008-2018). Given the environment of legislative drafting techniques, where considerable reliance on precedent is inevitable, proposals to change legislative language may produce interesting results in different jurisdictions.


Giulia Adriana Pennisi
Associate Professor (field of research, English Language and Translation) at the University of Palermo, Department of Political Science and International Relations; Associate Research Fellow at the Institute of Advanced Legal Studies, Sir William Dale Centre, University of London.
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 On the Eve of Web-Harvesting and Web-Archiving for Libraries in Greece

Journal Erasmus Law Review, Issue 2 2019
Keywords web harvesting, data analysis, text & data mining, TDM: Proposal EU Copyright Directive
Authors Maria Bottis, Marinos Papadopoulos, Christos Zampakolas e.a.
AbstractAuthor's information

    This conference paper submitted on the occasion of the 8th International Conference on Information Law and Ethics (University of Antwerp, December 13-14, 2018) that focused on modern intellectual property governance and openness in Europe elaborates upon the Text and Data Mining (TDM) issue in the field of scientific research, which is still-by the time of composition of this paper-in the process of discussion and forthcoming voting before the European Parliament in the form of provision(s) included in a new Directive on Copyright in the Digital Single Market. TDM is included in the proposal for a Directive of the European parliament and of the Council on copyright in the Digital Single Market-Proposal COM(2016)593 final 2016/0280(COD) that was submitted to the European Parliament.


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

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

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

Paraskevi Ganatsiou
Educator, MA, BA, Prefecture of Ionian Islands, Corfu, Greece.
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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