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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).
Article

What Does It Take to Bring Justice Online?

Journal International Journal of Online Dispute Resolution, Issue 2 2019
Keywords ODR, access to justice, courts, online justice, remedy for small disputes
Authors Mirèze Philippe
AbstractAuthor's information

    Technology has revolutionized the world in the last century, although computation devices have existed for millennia and punched-card data processing for two centuries. After 70 years of progress in technology and telecommunications with all the knowledgeable computer specialists and the sophistication of online services, it is high time public and private justice offered fair access to a fundamental human right: justice online. The role of technology in dispute resolution is high on the agenda, and the topic is increasingly at the centre of discussions. In a world that is rapidly developing, it is surprising to observe that online dispute resolution (ODR) is lagging behind.


Mirèze Philippe
Special Counsel at the Secretariat of ICC International Court of Arbitration. She is co-founder of ArbitralWomen and Board member. She is also member of the Equal Representation in Arbitration Steering Committee, ICCA Diversity Task Force, Arbitrator Intelligence’s Board of Advisors, Council of the American Bar Association Section of Dispute Resolution, Paris Place d’Arbitrage, Association Arbitri’s Advisory Board, International Journal of Online Dispute Resolution’s Editorial Board, fellow of National Centre for Technology and Dispute Resolution (NCTDR), and Board member of International Council for Online Dispute Resolution’s (ICODR).
Article

The EU Approach to Consumer ODR

Journal International Journal of Online Dispute Resolution, Issue 2 2019
Keywords consumer alternative/online dispute resolution, European Union, ODR Regulation 524/2013, ADR Directive 2013/11, ODR platform
Authors Emma van Gelder
AbstractAuthor's information

    The EU internal market has undergone several developments in the past decades. One of the main developments is the inclusion of a digital dimension. One of the fields in which these developments are very evident is the consumer market. A further development of e-commerce is however hindered because there are no suitable redress mechanisms for consumers involved in low-value, high volume claims typically arising from e-commerce transactions. In response to the ills of existing redress mechanisms, an emerging trend of consumer alternative dispute resolution (ADR) and consumer online dispute resolution (ODR) schemes has been identified throughout the Member States (MS) aimed to offer consumers a swift, cheap and simple procedure through which they can enforce their rightsThis paper outlines the EU approach to Consumer ADR/ODR, gives some observations of the functioning of the legislation in practice and concludes with some thoughts for the future.


Emma van Gelder
PhD Candidate Erasmus University, Rotterdam.
Article

Digital Identity for Refugees and Disenfranchised Populations

The ‘Invisibles’ and Standards for Sovereign Identity

Journal International Journal of Online Dispute Resolution, Issue 1 2019
Keywords digital identity, sovereign identity, standards, online dispute resolution, refugees, access to justice
Authors Daniel Rainey, Scott Cooper, Donald Rawlins e.a.
AbstractAuthor's information

    This white paper reviews the history of identity problems for refugees and disenfranchised persons, assesses the current state of digital identity programmes based in nation-states, offers examples of non-state digital ID programmes that can be models to create strong standards for digital ID programmes, and presents a call to action for organizations like International Organization for Standardization (ISO) and the United Nations High Commissioner for Refugees (UNHCR).


Daniel Rainey
Daniel Rainey is a Board Member, InternetBar.Org (IBO), and Board Member, International Council for Online Dispute Resolution (ICODR)

Scott Cooper
Scott Cooper is a Vice President, American National Standards Institute (retired).

Donald Rawlins
Donald Rawlins is a Candidate (May 2019), Master of Arts in Dispute Resolution, Southern Methodist University.

Kristina Yasuda
Kristina Yasuda is a Director of Digital Identities for the InternetBar.org and a consultant with Accenture Strategy advising large Japanese corporations on their digital identity and blockchain strategy.

Tey Al-Rjula
Tey Al-Rjula is CEO and Founder of Tykn.tech.

Manreet Nijjar
Manreet Nijjar is CEO and Co-founder of truu.id, Member of the Royal College Of Physicians (UK), IEEE Blockchain Healthcare Subcommittee on Digital Identity, UK All Party Parliamentary Group on Blockchain and Sovrin Guardianship task force committee.
Article

What Is a Good Mediator?

Journal Corporate Mediation Journal, Issue 2 2018
Keywords certification, mediation, mediator, MMMM-rule
Authors Thierry Garby
AbstractAuthor's information

    When the time comes to select a mediator, the judge, the lawyers, the parties or the mediation centre will want to find a good one. This raises two questions: what is a good mediator and how to find one?
    The answer to the first question seems rather simple: a good mediator is one that the parties are happy with. This raises another set of questions: if the parties were happy with a mediator in one case, would they be happy with the same person in another case? Would other parties be happy with this mediator as well? If the answers are not a yes without reservation to both of those questions, then the question becomes: who would be a good mediator for this case between these parties?


Thierry Garby
Thierry Garby is a well-known and experienced mediator with most international mediation centres, particularly with the International Chamber of Commerce (ICC), the World Bank Group and the United Nations.

Martin Brink
Martin Brink, PhD, is attorney at law, arbitrator and deputy judge at the The Hague Court of Appeals and an internationally certified mediator (MfN, IMI, CEDR Global Panel).
Article

Access_open Right to Access Information as a Collective-Based Approach to the GDPR’s Right to Explanation in European Law

Journal Erasmus Law Review, Issue 3 2018
Keywords automated decision-making, right to access information, right to explanation, prohibition on discrimination, public information
Authors Joanna Mazur
AbstractAuthor's information

    This article presents a perspective which focuses on the right to access information as a mean to ensure a non-discriminatory character of algorithms by providing an alternative to the right to explanation implemented in the General Data Protection Regulation (GDPR). I adopt the evidence-based assumption that automated decision-making technologies have an inherent discriminatory potential. The example of a regulatory means which to a certain extent addresses this problem is the approach based on privacy protection in regard to the right to explanation. The Articles 13-15 and 22 of the GDPR provide individual users with certain rights referring to the automated decision-making technologies. However, the right to explanation not only may have a very limited impact, but it also focuses on individuals thus overlooking potentially discriminated groups. Because of this, the article offers an alternative approach on the basis of the right to access information. It explores the possibility of using this right as a tool to receive information on the algorithms determining automated decision-making solutions. Tracking an evolution of the interpretation of Article 10 of the Convention for the Protection of Human Right and Fundamental Freedoms in the relevant case law aims to illustrate how the right to access information may become a collective-based approach towards the right to explanation. I consider both, the potential of this approach, such as its more collective character e.g. due to the unique role played by the media and NGOs in enforcing the right to access information, as well as its limitations.


Joanna Mazur
Joanna Mazur, M.A., PhD student, Faculty of Law and Administration, Uniwersytet Warszawski.
Part II Private Justice

Standards, Qualifications, and Certification for e-Mediators

Journal International Journal of Online Dispute Resolution, Issue 1-2 2018
Keywords Online Dispute Resolution, e-Mediation, ethics, standards of practice, qualifications, certification, International Mediation Institute, Association for Conflict Resolution, American Bar Association, American Arbitration Association, National Center for Technology and Dispute Resolution, International Council for Online Dispute Resolution, National Center for State Courts
Authors Ana Maria Gonçalves and Daniel Rainey
AbstractAuthor's information

    This article explores the question ‘how does one judge whether a mediator working online is competent?’ The authors compare the basic standards used to certify mediators working offline to a set of e-mediation standards developed by the International Mediation Institute, and suggest that training modules addressing the specific skills and competencies needed to be a successful online mediator be incorporated into basic mediator training.


Ana Maria Gonçalves
Ana Maria Gonçalves is the co-chair of the IMI ODR Taskforce, the founder and president of ICFML and a member of the Portuguese Mediation Federation (FMC). She is a graduate from UAL Lisbon and has a master of law degree. She is an IMI-certified mediator and is listed in the major international panels of mediators. She is a lecturer in major Portuguese and Brazilian Universities and is a regular speaker in International Conferences on the topics of ADR, mediation, negotiation and ODR. As a mediator, she works with a wide range of international clients, particularly on cross-border disputes, often online, and has mediated a wide variety of disputes in Europe, Australia and USA. She also designs and facilitates collaboration management training programs and, as an ICF-accredited PCC coach, she supports senior executives and professionals to develop their conflict management and negotiation skills.

Daniel Rainey
Daniel Rainey is a principle in Holistic Solutions, Inc., and he served as the co-chair of the IMI ODR Task Force. He is an adjunct professor at multiple universities in the United States, and he serves as a Board Member for the InternetBar.Org (IBO) and the Northern Virginia Mediation Service (NVMS). He is a member of the Virginia State Supreme Court’s Access to Justice Commission Self-Represented Litigants Committee, a Fellow of the National Center for Technology and Dispute Resolution (NCTDR) and a founding Board Member of the International Council for Online Dispute Resolution (ICODR).
Article

Access_open Armed On-board Protection of Dutch Vessels: Not Allowed Yet But Probably Forthcoming

Journal Erasmus Law Review, Issue 4 2018
Keywords vessel protection, private armed guards, state monopoly on force, masters position, state control
Authors Paul Mevis and Sari Eckhardt
AbstractAuthor's information

    This article provides an overview of the developments about the armed on-board protection of Dutch vessels under Dutch law. The Dutch position has changed over the years. In 2011, the starting point was that private security companies (PSCs) are not to be allowed. It was expected that adequate protection of Dutch vessels could be provided by vessel protection detachments (VPDs). Although not considered as an absolute statutory bar, the state monopoly on force was considered the main argument against PSCs. After optimising the use of VPDs and given the development in other countries, the approach changed into a ‘VPS, unless …’-approach. Under the new Protection of Merchant Shipping Act that is expected to come into force in the second half of 2019, PSCs can be employed only if no VPS is available. This article gives an overview of the argumentation in this change of view over the years. It also explores the headlines, criteria and procedures of the new law and some other topics, including the position of the master under the upcoming law. In line with the other country reports, it enables the comparative study in the last article of this special issue.


Paul Mevis
Paul Mevis is professor of criminal law and criminal procedure at Erasmus University Rotterdam.

Sari Eckhardt
Sari Eckhardt holds a master’s degree in criminal law and has worked as a student assistant at the Rotterdam Erasmus University’s Department of Criminal Law and is currently working at De Bont Advocaten.
Article

Access_open Evidence-Based Regulation and the Translation from Empirical Data to Normative Choices: A Proportionality Test

Journal Erasmus Law Review, Issue 2 2018
Keywords evidence-based, regulation, proportionality, empirical law studies, law and society studies
Authors Rob van Gestel and Peter van Lochem
AbstractAuthor's information

    Studies have shown that the effects of scientific research on law and policy making are often fairly limited. Different reasons can be given for this: scientists are better at falsifying hypothesis than at predicting the future, the outcomes of academic research and empirical evidence can be inconclusive or even contradictory, the timing of the legislative cycle and the production of research show mismatches, there can be clashes between the political rationality and the economic or scientific rationality in the law making process et cetera. There is one ‘wicked’ methodological problem, though, that affects all regulatory policy making, namely: the ‘jump’ from empirical facts (e.g. there are too few organ donors in the Netherlands and the voluntary registration system is not working) to normative recommendations of what the law should regulate (e.g. we need to change the default rule so that everybody in principle becomes an organ donor unless one opts out). We are interested in how this translation process takes place and whether it could make a difference if the empirical research on which legislative drafts are build is more quantitative type of research or more qualitative. That is why we have selected two cases in which either type of research played a role during the drafting phase. We use the lens of the proportionality principle in order to see how empirical data and scientific evidence are used by legislative drafters to justify normative choices in the design of new laws.


Rob van Gestel
Rob van Gestel is professor of theory and methods of regulation at Tilburg University.

Peter van Lochem
Dr. Peter van Lochem is jurist and sociologist and former director of the Academy for Legislation.
Article

Access_open Peer mentoring justice-involved youth: a training model to promote secondary desistance and restorative justice among mentors

Journal The International Journal of Restorative Justice, Issue 2 2018
Keywords Peer mentoring, justice-involved youth, formerly incarcerated, secondary desistance, training programmes
Authors Mayra Lopez-Humphreys and Barbra Teater
AbstractAuthor's information

    This article introduces a mentoring programme for justice-involved youth that utilises the unique and often overlooked resources offered by adults with a history of incarceration, and the innovative training model that aims to promote secondary desistance and restorative justice among the mentors. An examination of the generative role of peer mentoring and its overlap with restorative justice as a healing process that provides opportunities for offenders to make indirect amends that contribute to the social rehabilitation of their communities is presented. An overview of the history and anticipated aims of mentoring programmes for justice-involved youth is provided, followed by a discussion of the importance of secondary desistance in peer mentoring programmes and a review of the elements, conceptual underpinnings and anticipated benefits of the training programme for the mentors. The training programme is argued to offer approaches that support the primary and secondary desistance-orientated changes and the reparative work needed within the mentor.


Mayra Lopez-Humphreys
Mayra Lopez-Humphreys is Associate Professor, Department of Social Work, City University of New York College of Staten Island, New York, United States of America.

Barbra Teater
Barbra Teater is Professor, Department of Social Work, City University of New York College of Staten Island, New York, United States of America. Contact author: mayra.humphreys@csi.cuny.edu.

    Currently, the space industry is witnessing a commercialisation wave which, at least in parts, can be considered as disruptive. New technology and market trends associated to this commercialisation wave are circumscribed by the term NewSpace. Along with the NewSpace trend, there is a wave of investment in commercial space activities. Favourable framework conditions supporting commercialisation are key factors for investment decisions and the commercial success of companies along the entire value chain.
    Laws and regulations concerning commercial space activities are established in many countries, but they are currently reviewed and amended in the light of technology and market trends. Certain new services and applications are not yet addressed under national laws, or there is no consensus on their treatment at international level. Overall, there are significant uncertainties and/or evolutions regarding the legal framework in which space companies are operating. Companies along the value chain require different types of governmental approvals, including licenses under national space legislation, licenses under national telecommunications or media law, frequency assignments, market access authorizations, or export/import licenses. Delays in authorisation procedures and/or the denial/revocation of governmental approvals may have serious impacts on investments in space ventures.
    So far, investment treaties have not been extensively employed by the space industry for ensuring favourable political and legal conditions supporting their activities. However, the wave of commercial space companies and activities around the globe raises questions on the potential future role of public investment law.


Erik Pellander
BHO Legal, Germany, erik.pellander@bho-legal.com.

    The Danish Supreme Court has ruled that a medical diagnosis is not required when deciding whether a person suffers from a disability protected under Directive 2000/78.


Christian K. Klasen
Christian K. Clasen is a partner at Norrbom Vinding, Copenhagen.

    The basic principles of space law such as the freedom of use of outer space and the UN Remote Sensing Principles, grants the freedom of remote sensing activities from outer space, and although many technological difficulties exist, as a result of continuous endeavor in R&D, the possible civil and private use of satellite remote sensing data to solve various issues is increasing in various fields such as disaster management, global environment issues, and is expected to further increase.
    The expansion of the use of Satellite Remote Sensing Data by current and new users is welcomed, however not all data could be with no restrictions. As a solution to this matter, on November 15th, 2017, the Remote Sensing Data Act came into full effect in Japan. The Act was established based on the fact that the use of satellite remote sensing data by private actors have increased, rules are necessary to prevent wrongful use, and a legal system is necessary to promote the new industry and services that use satellite remote sensing data. It is similar to the legislation related to remote sensing in many other countries that have high resolution satellites such as the U.S., Canada, France and Germany.
    The Act mainly sets an authorization regime for use of satellite remote sensing instruments, and a Certificate for the use of satellite remote sensing data, in order to ensure appropriate handling of remote sensing data. Japan Aerospace Exploration Agency (JAXA) is subject to these authorization and certificates. JAXA has worked closely with the Cabinet Office on the application, and now gains two authorization of the satellites, including the first Authorization based on this law.
    This paper introduces the legal system in brief, and how JAXA responds to the authorization scheme. Furthermore, describes the impacts of the law on the practical use of data, and suggestions for future improvements.


Daisuke Saisho
Japan Aerospace Exploration Agency, Management and Integration Department, Space Technology Directorate I, Japan Aerospace Exploration Agency,2-1-1 Sengen, Tsukuba, Ibaraki, Japan, 305-0061.

    The majority of the world still does not have access to the internet, and this “digital divide” is not only an issue in developing countries. Unconnected populations exist in every country, and regulators must find ways to provide universal access to the internet. Furthermore, the demand for connectivity (internet and data) is growing exponentially, and existing terrestrial solutions likely will be insufficient. Regulators must foster new technologies such as the newest non-geostationary satellite constellations, which have almost no delay for two-way voice and data connections and can provide broadband to the most remote and unconnected populations and industries. To ensure the fast deployment of these solutions, regulators should support technology-neutral regulations (such as blanket licensing) that encourage speedy rollout of innovative services, as well as have transparent “open skies” policies that promote competition (which has been proven to boost economies).


Ruth Pritchard-Kelly
Vice President of Regulatory Affairs, OneWeb.

Daniel Rainey
Daniel Rainey is a Fellow of the National Center for Technology and Dispute Resolution, and a Member of the Self-Represented Litigants Committee of the Virginia State Supreme Court’s Access to Justice Commission.
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

Intersecting Professions

A Public Health Perspective on Law to Address Health Care Conflicts

Journal International Journal of Conflict Engagement and Resolution, Issue 1 2017
Keywords public health, Alternative Dispute Resolution, public law, health promotion
Authors Michal Alberstein and Nadav Davidovitch PhD
AbstractAuthor's information

    This paper examines the intersection between the two professions – law and medicine – with reference to systematic transformations that have characterized their development in the past century. In particular, the paper examines the co-emergence of the new public health and health promotion scholarship along with the development of the Alternative Dispute Resolution (ADR) movement in the second half of the 20th century. The two movements, with their later developments, have aspired to change the focus of professionals in the field, and both have been tremendously successful on the one hand, and on the other have remained marginal to mainstream training and identity building of contemporary lawyers and doctors.


Michal Alberstein
Michal Alberstein is a Full Professor at The Faculty of Law, Bar-Ilan University, Israel. She is also the Primary Investigator on an ERC consolidator grant to study Judicial Conflict Resolution (JCR).

Nadav Davidovitch PhD
Nadav Davidovitch, MD, MPH, PhD is an epidemiologist and public health physician. He is a Full Professor and Director, School of Public Health, Faculty of Health Sciences and the Guilford-Glaser Faculty of Business and Management at Ben-Gurion University of the Negev in Israel.
Article

Get Your Money’s Worth from Investment Advice

Analysing the Clash over the Knowledge and Competence Requirements in the Markets in Financial Instruments Directive (MiFID II)

Journal European Journal of Law Reform, Issue 1-2 2017
Keywords Better Regulation, ESMA, financial regulation, expertise, MiFID II
Authors Aneta Spendzharova, Elissaveta Radulova and Kate Surala
AbstractAuthor's information

    This special issue aims to examine whether there is an enduring politicization in the European Union (EU) “Better Regulation” agenda despite the emphasis on neutral evidence-based policy making. Our article addresses this overarching research question by focusing on the use of stakeholder consultations in the case of financial sector governance, particularly, the amended Markets in Financial Instruments Directive (MiFID II). We show that calibrating key provisions in MiFID II, such as those concerning knowledge and expertise, is not a simple exercise in rational problem definition and policy design. The provisions examined in this article have important repercussions for financial sector firms’ business strategies and operations. Thus, investment firms, banks, training institutes and public organizations have mobilized and actively sought to assert their views on the appropriate requirements for professional knowledge and experience in MiFID II. We found that, following the stakeholder consultation, the European Securities and Markets Authority (ESMA) opted for a minimum harmonization approach at the EU level. At the same time, ESMA also supported giving the respective national competent authorities sufficient remit to issue additional requirements in accordance with national laws and regulatory practices. Our article demonstrates that while public consultations provide rich evidence for the policy making process, they also contribute to the lasting politicization of regulatory decisions.


Aneta Spendzharova
Aneta Spendzharova is Assistant Professor in the Political Science department of Maastricht University, The Netherlands.

Elissaveta Radulova
Elissaveta Radulova is Assistant Professor in the Political Science department of Maastricht University, The Netherlands.

Kate Surala
Kate Surala is a graduate student in the MSc in Law and Finance, Pembroke College, University of Oxford, UK.
Article

The Indonesian Space Act

Pristine Entrant in the Asia-Pacific Region

Journal International Institute of Space Law, Issue 4 2017
Authors Kumar Abhijeet
Author's information

Kumar Abhijeet
Doctoral candidate, Institute of Air and Space Law, University of Cologne, Assistant Professor, National Law School of India University, Bangalore, kumarabhijeet@nls.ac.in.
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