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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).
Part I Courts and ODR

Testing the Promise of Access to Justice through Online Courts

Journal International Journal of Online Dispute Resolution, Issue 1-2 2018
Keywords online courts, empirical research, civil justice, access to justice
Authors Bridgette Toy-Cronin, Bridget Irvine, David M. Nichols e.a.
AbstractAuthor's information

    Modernization is increasingly knocking on the courthouse door. Many common law countries are investigating ways to introduce technology to improve civil courts, including the introduction of online courts. These state-led initiatives are primarily focused on lowering state costs in providing justice, as well as increasing access to dispute resolution. One possible solution some legal jurisdictions are exploring is ‘online courts’. Online courts hold the promise of making justice more accessible and affordable: a dispute can be filed at any time, from anywhere, by anyone. This model of delivering justice is envisioned as a system that either is lawyer-less or has a minimal role for lawyers. One of the assumptions underpinning an online court is, therefore, that laypeople can effectively explain a dispute to the court, without legal assistance. To date, there is no empirical research investigating that assumption. In this article, we will outline the proposed online court model, consider the need for robust empirical research, and describe a three-part investigation to explore how clearly and accurately people can explain a dispute.


Bridgette Toy-Cronin
Bridgette Toy-Cronin is the Director of the University of Otago Legal Issues Centre and a Senior Lecturer in the Faculty of Law, University of Otago.

Bridget Irvine
Bridget Irvine is a Postdoctoral Fellow at the University of Otago Legal Issues Centre.

David M. Nichols
David M. Nichols is an Associate Professor in Computer Science at the University of Waikato.

Sally Jo Cunningham
Sally Jo Cunningham is an Associate Professor in Computer Science at the University of Waikato.

Tatiana Tkacukova
Tatiana Tkacukova is a Senior Lecturer in the School of English, Birmingham City University. Authors appear in order of the contribution made to the paper.
Article

Restorative responses to campus sexual harm: promising practices and challenges

Journal The International Journal of Restorative Justice, Issue 3 2018
Keywords Sexual assault, feminist, restorative justice in colleges and universities
Authors Donna Coker
AbstractAuthor's information

    The purpose of this article is to examine restorative approaches to campus sexual harm. A restorative response may provide support and validation for survivors, a pathway for personal change for those who cause sexual harm, and assist in changing campus culture. The article addresses three significant challenges to developing a restorative response. The first challenge is the influence of a pervasive ideology that I refer to as crime logic. A second challenge is the need for an intersectional response that addresses the potential for bias in decisions by campus administrators and restorative justice practitioners. The third challenge is to develop restorative approaches for circumstances in which a victim/perpetrator dyad is not appropriate.


Donna Coker
Donna Coker is Professor of Law, University of Miami School of Law, Miami, USA. Contact author: dcoker@law.miami.edu.
Article

Measuring the restorativeness of restorative justice: the case of the Mosaica Jerusalem Programme

Journal The International Journal of Restorative Justice, Issue 2 2018
Keywords Restorative justice, criminal justice, criminal law taxonomy, victims, offenders
Authors Tali Gal, Hadar Dancig-Rosenberg and Guy Enosh
AbstractAuthor's information

    This study uses a Jerusalem-based restorative justice programme as a case study to characterise community restorative justice (CRJ) conferences. On the basis of the Criminal Law Taxonomy, an analytical instrument that includes seventeen measurable characteristics, it examines the procedural elements of the conferences, their content, goals and the role of participants. The analysis uncovers an unprecedented multiplicity of conference characteristics, including the level of flexibility, the existence of victim-offender dialogue, the involvement of the community and a focus on rehabilitative, future-oriented outcomes. The findings offer new insights regarding the theory and practice of CRJ and the gaps between the two.


Tali Gal
Tali Gal is Associate Professor and Senior Lecturer, School of Criminology, University of Haifa, Haifa, Israel.

Hadar Dancig-Rosenberg
Hadar Dancig-Rosenberg is Visiting Professor, UC Berkeley School of Law (2017-2018) and Associate Professor, Bar-Ilan University Faculty of Law, Ramat-Gan, Israel.

Guy Enosh
Guy Enosh is Associated Professor, Faculty of Welfare and Health Sciences, School of Social Work, University of Haifa, Haifa, Israel. Contact author: tgal1@univ.haifa.ac.il. Note: The first two authors have contributed equally; the third author contributed to the methodology. Acknowledgements: We are grateful to Gali Pilowsky-Menkes and Rotem Spiegler for outstanding data collection assistance. We are also grateful to Caroline Cooper, Netanel Dagan and Adi Libson for insightful comments. We are particularly indebted to the Mosaica workers and volunteers who provided us access to their materials while ensuring the privacy of all parties involved.
Article

Access_open The challenges for good practice in police-facilitated restorative justice for female offenders

Journal The International Journal of Restorative Justice, Issue 1 2018
Keywords Restorative justice, police, female offenders
Authors Birgit Larsson, Gillian Schofield and Laura Biggart
AbstractAuthor's information

    This article reports on the uses of police-led restorative justice (RJ) for female offenders by one constabulary in England from 2007 to 2012. The study consisted of (1) quantitative analysis of administrative police data on 17,486 participants, including 2,586 female offenders, and (2) qualitative analysis of twelve narrative interviews with female offenders sampled from the database. Quantitative data demonstrated that the majority of female offenders committed low-level offences and that the majority of participants experienced street RJ. Female offenders reported mixed experiences with RJ in qualitative interviews. On the whole, women did not understand what RJ was, leading to complications as many felt their victims were mutually culpable. Some felt that the police forced them to apologise and treated them like criminals while others felt the police gave them a second chance. The study raises questions about what the police can bring to RJ in relation to vulnerable women.


Birgit Larsson
Birgit Larsson is a lecturer at the School of Social Work, University of East Anglia, Norwich, UK. Contact author: b.larsson@uea.ac.uk.

Gillian Schofield
Gillian Schofield is a Professor at the School of Social Work, University of East Anglia, Norwich, UK.

Laura Biggart
Laura Biggart is lecturer at the School of Psychology, University of East Anglia, Norwich, UK.
Article

The Law of Consumer Redress in an Evolving Digital Market

Upgrading from Alternative to Online Dispute Resolution

Journal International Journal of Online Dispute Resolution, Issue 2 2017
Keywords e-Commerce, Online Dispute Resolution, Alternative Dispute Resolution, consumer redress
Authors Pablo Cortés
AbstractAuthor's information

    This article contains the Introduction of a book with the same title recently published by Cambridge University Press, which is reproduced here with its permission. The book offers an updated analysis of the various consumer dispute resolution processes, its laws and best practices, which are collectively referred as the Law of Consumer Redress. The book argues that many consumer redress systems, and in particular publicly certified Alternative Dispute Resolution (ADR) entities, are more than a mere dispute resolution mechanism as they provide a public service for consumers that complements, and often replaces, the role of the courts. In examining the current redress models (i.e., public enforcement, private enforcement and other market options), the book calls for greater integration amongst these various redress options. It also advocates, inter alia, for processes that encourage parties to participate in ADR processes, settle meritorious claims and ensure extrajudicial enforcement of final outcomes. Lastly, the book calls for a more efficient rationalization of certified ADR entities, which should be better coordinated and accessible through technological means.


Pablo Cortés
Pablo Cortés is Professor of Civil Justice, University of Leicester, UK.
Article

Access_open The Right to Mental Health in the Digital Era

Journal Erasmus Law Review, Issue 3 2016
Keywords E-health, e-mental health, right to health, right to mental health
Authors Fatemeh Kokabisaghi, Iris Bakx and Blerta Zenelaj
AbstractAuthor's information

    People with mental illness usually experience higher rates of disability and mortality. Often, health care systems do not adequately respond to the burden of mental disorders worldwide. The number of health care providers dealing with mental health care is insufficient in many countries. Equal access to necessary health services should be granted to mentally ill people without any discrimination. E-mental health is expected to enhance the quality of care as well as accessibility, availability and affordability of services. This paper examines under what conditions e-mental health can contribute to realising the right to health by using the availability, accessibility, acceptability and quality (AAAQ) framework that is developed by the Committee on Economic, Social and Cultural Rights. Research shows e-mental health facilitates dissemination of information, remote consultation and patient monitoring and might increase access to mental health care. Furthermore, patient participation might increase, and stigma and discrimination might be reduced by the use of e-mental health. However, e-mental health might not increase the access to health care for everyone, such as the digitally illiterate or those who do not have access to the Internet. The affordability of this service, when it is not covered by insurance, can be a barrier to access to this service. In addition, not all e-mental health services are acceptable and of good quality. Policy makers should adopt new legal policies to respond to the present and future developments of modern technologies in health, as well as e-Mental health. To analyse the impact of e-mental health on the right to health, additional research is necessary.


Fatemeh Kokabisaghi
Fatemeh Kokabisaghi, Iris Bakx and Blerta Zenelaj are Ph.D. candidates at the Institute of Health Policy and Management, Erasmus University Rotterdam. All authors contributed equally.

Iris Bakx
Fatemeh Kokabisaghi, Iris Bakx and Blerta Zenelaj are Ph.D. candidates at the Institute of Health Policy and Management, Erasmus University Rotterdam. All authors contributed equally.

Blerta Zenelaj
Fatemeh Kokabisaghi, Iris Bakx and Blerta Zenelaj are Ph.D. candidates at the Institute of Health Policy and Management, Erasmus University Rotterdam. All authors contributed equally.
Article

Hybrid Peacebuilding in Northern Ireland and the Border Counties

The Impact of the International Fund for Ireland and the European Union’s Peace III Fund

Journal International Journal of Conflict Engagement and Resolution, Issue 2 2015
Keywords Northern Ireland, economic aid, elicitive approach, liberal peace, grass-roots everyday peacemakers
Authors Julie Hyde and Sean Byrne
AbstractAuthor's information

    This article draws upon a wide qualitative study of the experiences and perceptions held by 107 community group leaders and 13 funding agency development officers within the liminal context of Northern Ireland and the Border Counties. These organizations received funding from the European Union’s Peace III Program and/or the International Fund for Ireland. Semi-structured interviews were conducted with key figures in these groups and agencies during the summer of 2010. This data is explored in relation to the concept of hybrid peacebuilding so as to better identify and articulate the potentialities and challenges associated with grass-roots macro-level interactions. The empirical findings indicate the necessity of flexibility in empowering local decision makers in a hybridized peacebuilding process. Local people should be involved with the funders and the governments in constructing and in implementing these processes. The theoretical findings are consistent with previous research that favors elicitive and local rather than top-down bureaucratic and technocratic processes. More attention needs to be paid to how local people see conflict and how they build peace. The prescriptive/practical implications are that policymakers must include the grass roots in devising and implementing peacebuilding; the grass roots need to ensure their local practices and knowledge are included; and external funders must include local people’s needs and visions in more heterogeneous hybrid peacebuilding approaches. The article is original, providing grass-roots evidence of the need to develop the hybrid peacebuilding model.


Julie Hyde
Julie Hyde is a Ph.D. Candidate in peace and conflict studies at the University of Manitoba. Her research focuses on critical approaches to peacebuilding, peace education, and indigenous/non-indigenous relationships.

Sean Byrne
Sean Byrne is professor of peace and conflict studies and director of the Arthur V Mauro Centre for Peace and Justice, St. Paul’s College, University of Manitoba. He has published extensively in the area of critical and emancipatory peace building. He was a consultant to the special advisor to the Irish Taoiseach on arms decommissioning. He is a consultant on the Northern Ireland peace process to the senior advisor for Europe and Eurasia at the U.S. Senate foreign relations committee. His research was funded by SSHRC and the USIP.
Article

Reframing War to Make Peace in Northern Ireland

IRA Internal Consensus-Building for Peace and Disarmament

Journal International Journal of Conflict Engagement and Resolution, Issue 1 2015
Keywords Northern Ireland, intra-group negotiations, disarmament, political transition, IRA
Authors Dr. Benedetta Berti and Ariel Heifetz Knobel
AbstractAuthor's information

    In exploring alternatives to armed struggle, how do non-state armed groups embark on such complex internal discussions, and how do they reframe their worldview and strategy to persuade their militants to support such transition?
    The article tackles this question by examining the internal processes of consensus-building that brought the most prominent militant organization in Northern Ireland – the Provisional Irish Republican Army (IRA) – from violent struggle for independence to non-violent political participation in the political system it had previously fought to expel.
    The study relies on fieldwork and applied research through interviews, conducted in Northern Ireland and Ireland with key stakeholders, ranging from ex-prisoner leaders and former militants to politicians, official negotiators and civil society practitioners who work with various conflict parties on the ground. Historical literature and primary sources are also used, including Sinn Féin and IRA official documents. All primary sources are integrated with the theoretical literature on intra-group consensus-building and discursive reframing.
    The analysis underscores the importance of discursive practices to ensure frame-shift in both the understanding of the conflict (consensus mobilization) and the means chosen to wage it (action mobilization). The case of the IRA further reveals the importance of preserving continuity with an organization’s core ideological pillars as a key mechanism to minimize chances of internal strife, along with enlisting credible supporters from the ‘militant constituency’ – such as former prisoners and/or militants with deep and personal involvement in the group’s armed struggle.


Dr. Benedetta Berti
Dr. Benedetta Berti is a Kreitman postdoctoral fellow at Ben Gurion University, a research fellow at the Institute for National Security Studies (INSS), a lecturer at Tel Aviv University and the author of Armed Political Organizations. From Conflict to Integration. <https://jhupbooks.press.jhu.edu/content/armed-political-organizations>.

Ariel Heifetz Knobel
Ariel Heifetz Knobel is a conflict transformation practitioner, facilitating Track 2 and Track 1.5 initiatives in Israel and the Palestinian Territories, and working with Northern Irish peacemakers to bring best practices to the region. She has served as Public Diplomacy Director for five states at the Israeli Consulate to New England, and as a mediator in Boston’s district courts.
Article

Internet Trolling and the 2011 UK Riots

The Need for a Dualist Reform of the Constitutional, Administrative and Security Frameworks in Great Britain

Journal European Journal of Law Reform, Issue 1 2014
Keywords UK riots, tort law, criminal law, dualism, Internet trolling
Authors Jonathan Bishop
Abstract

    This article proposes the need for ‘dualism’ in the legal system, where civil and criminal offences are considered at the same time, and where both the person complaining and the person responding are on trial at the same time. Considered is how reforming the police and judiciary, such as by replacing the police with legal aid solicitors and giving many of their other powers to the National Crime Agency could improve outcomes for all. The perils of the current system, which treats the accused as criminals until proven not guilty, are critiqued, and suggestions for replacing this process with courts of law that treat complainant and respondent equally are made. The article discusses how such a system based on dualism might have operated during the August 2011 UK riots, where the situation had such a dramatic effect on how the social networking aspects, such as ‘Internet trolling’, affected it.


Jonathan Bishop
Article

Judicial Case Management and the Complexities of Competing Norms Occasioned by Law Reforms

The Experience in Respect of Criminal Proceedings in Botswana

Journal European Journal of Law Reform, Issue 1 2014
Keywords case management, Botswana, criminal proceedings, law reform, subpoena
Authors Rowland J.V. Cole
AbstractAuthor's information

    The Botswana judicial and legal system has undergone a wave of reforms over the past few years. These reforms include judicial case management, which was introduced to reduce unnecessary delays and backlog in the hearing of cases. The introduction of judicial case management necessitates a revision of the rules of court. While the rules of the courts principally relate to civil proceedings, criminal proceedings are principally regulated by the Criminal Procedure and Evidence Act. However, the revised rules of court contain provisions that seek to bring criminal proceedings in line with judicial case management. A number of these provisions are inconsistent with the Criminal Procedure and Evidence Act. This presents problems for the implementation of these rules as the Criminal Procedure and Evidence Act is superior to the rules in the hierarchy of laws. Consequently, the implementation of judicial case management in criminal proceedings may prove to be an arduous task, and urgent harmonisation of the competing provisions is required.


Rowland J.V. Cole
LLB (Hons) (Sierra Leone), LLM (UNISA), LLD (Stell), Senior Lecturer, Department of Law, University of Botswana.
Article

Methods and Materials in Constitutional Law

Some Thoughts on Access to Government Information as a Problem for Constitutional Theory and Socio-Legal Studies

Journal European Journal of Law Reform, Issue 1 2011
Keywords Citizenship, democracy, government information, representative government, secrecy
Authors Barry Sullivan
AbstractAuthor's information

    To be subject to law, Hobbes argued, is to be deprived of liberty, as we understand it. In this respect, democratic governments are no different from others. Hobbes’s insight has not caused us to abandon our commitments to democracy, but it still challenges us to think hard about the nature of representative government, the nature of citizenship in a democratic society, and the conditions necessary for fulfilling the promise of democratic citizenship. Two recent trends are evident. Some citizens have embraced a more active sense of citizenship, which necessarily entails a more insistent need for information, while governments have insisted on the need for greater concentration of governmental power and a higher degree of secrecy. Much is to be learned from the approaches that various national and transnational regimes have taken with respect to this problem. This essay will consider the problem of access to government information from a comparative perspective and as a problem for constitutional theory and socio-legal studies.


Barry Sullivan
Cooney & Conway Chair in Advocacy and Professor of Law, Loyola University Chicago School of Law.

Montserrat González Garibay
Instituut voor Internationaal en Europees Beleid K.U.Leuven.
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