Search result: 9 articles

x
Year 2019 x
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

Access_open Waste Away

Examining Systemic Drivers of Global Waste Trafficking Based on a Comparative Analysis of Two Dutch Cases

Journal Erasmus Law Review, Issue 4 2019
Keywords environmental crime, waste industry, shipbreaking, waste trafficking, environmental enforcement
Authors Karin van Wingerde and Lieselot Bisschop
AbstractAuthor's information

    The increasing volume of waste generated globally is one of the most prominent environmental issues we face today. Companies responsible for the treatment or disposal of waste are therefore among the key actors in fostering a sustainable future. Yet the waste industry has often been characterised as a criminogenic one, causing environmental harm which disproportionately impacts the world’s most vulnerable regions and populations. In this article, we illustrate how companies operating in global supply chains exploit legal and enforcement asymmetries and market complexities to trade waste with countries where facilities for environmentally sound treatment and disposal of waste are lacking. We draw on two contemporary cases of corporate misconduct in the Global South by companies with operating headquarters in the Global North: Seatrade and Probo Koala. We compare these cases building on theories about corporate and environmental crime and its enforcement. This explorative comparative analysis aims to identify the key drivers and dynamics of illegal waste dumping, while also exploring innovative ways to make the waste sector more environmentally responsible and prevent the future externalisation of environmental harm.


Karin van Wingerde
Karin van Wingerde is Professor Corporate Crime and Governance, Department of Criminology, Erasmus School of Law, Erasmus University Rotterdam.

Lieselot Bisschop
Lieselot Bisschop is Professor Public and Private Interests, Department of Criminology and Erasmus Initiative on Dynamics of Inclusive Prosperity, Erasmus School of Law, Erasmus University Rotterdam.
Article

Access_open The Brussels International Business Court: Initial Overview and Analysis

Journal Erasmus Law Review, Issue 1 2019
Keywords international jurisdiction, English, court language, Belgium, business court
Authors Erik Peetermans and Philippe Lambrecht
AbstractAuthor's information

    In establishing the Brussels International Business Court (BIBC), Belgium is following an international trend to attract international business disputes to English-speaking state courts. The BIBC will be an autonomous business court with the competence to settle, in English, disputes between companies throughout Belgium. This article focuses on the BIBC’s constitutionality, composition, competence, proceedings and funding, providing a brief analysis and critical assessment of each of these points. At the time of writing, the Belgian Federal Parliament has not yet definitively passed the Bill establishing the BIBC, meaning that amendments are still possible.


Erik Peetermans
Erik Peetermans is a legal adviser at the Federation of Enterprises in Belgium (FEB).

Philippe Lambrecht
Philippe Lambrecht is the Director-Secretary General at the Federation of Enterprises in Belgium (FEB).
Article

Access_open The Emergence of International Commercial Courts in India: A Narrative for Ease of Doing Business?

Journal Erasmus Law Review, Issue 1 2019
Keywords Commercial contracts, Enforcement, Jurisdiction, Specialized courts, India
Authors Sai Ramani Garimella and M.Z. Ashraful
AbstractAuthor's information

    The liberal globalised order has brought increased focus on the regulation of international commerce, and especially dispute resolution. Enforcement of contracts has been a concern largely owing to the insufficiencies of the legal systems, especially relating to the institutional structure, and it holds true for India as well. The commercial courts mechanism – international and domestic – with innovative features aimed at providing expedited justice is witnessing much traction. India, similar to many other jurisdictions, legislated in favour of specialized dispute resolution mechanisms for commercial disputes that could help improve the procedures for enforcement of contracts. This research attempts to critique the comparable strengths and the reform spaces within the Indian legislation on commercial courts. It parses the status of commercial dispute resolution in India especially in the context of cross-border contracts and critiques India’s attempt to have specialised courts to address commercial dispute resolution.


Sai Ramani Garimella
Sai Ramani Garimella, PhD, is assistant professor of the faculty of legal studies at the South Asian University in New Delhi.

M.Z. Ashraful
M.Z. Ashraful is the research student at South Asian University in New Delhi.
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

The Pull of Unbiased AI Mediators

Journal International Journal of Online Dispute Resolution, Issue 1 2019
Keywords automation, artificial intelligence, algorithm development, mediation, pull style communication
Authors Chris Draper
AbstractAuthor's information

    There is significant concern in the access to justice community that expanding current count-based online dispute resolution (ODR) efforts will further exacerbate the systemic inequities present in the American justice system. This well-founded fear stems from the fact that current ODR tools typically calibrate artificial intelligence (AI) algorithms with past outcomes so that any future cases are consistently analysed and filtered in a manner that produces similar results. As courts consider ODR tools for more complicated cases that often require mediation, there is significant disagreement on whether it is possible to create an AI mediator and how that could be achieved. This article argues that an effective AI mediator could be created if its design focuses not on the outcomes achieved by the mediation but on the manner of the communication prompts used by the AI mediator.


Chris Draper
Chris Draper, PhD, PE, is the Managing Director of Trokt, responsible for guiding the development, adoption and growth of the Trokt Online Dispute Resolution platform. Dr. Draper is a trained engineer with a focus on human-technology interface risks, a certified mediator with a focus on special needs education conflicts, and an expert on the evaluation of highly complex systems that assist in the human management of legally sensitive data. Dr. Draper received his Bachelor of Science from the University of California at Berkeley and his Doctor of Philosophy from the University of Glasgow.

    The proliferation of space debris and the imminent deployment of large constellations of satellites in LEO could negatively impact the long-term sustainability of outer space activities. A potential solution to clean up space and maintain a sustainable space environment is Active Debris Removal (ADR). The ADR is a potential revenue earning activity, but such activity needs a legal framework that will dissolve the existing concerns. Space law is fundamental for supporting a potential business case for commercial ADR missions. This paper will bring into discussion an international mechanism addressing the financial means for commercial ADR activity with a focus on LEO. By doing so, this paper will address the advent of ADR as lucrative activity and will analyze the proposal to finance an international fund by the launching states and ADR operators in a “Pay or play” fashion.
    In particular, this paper will analyze the need of an international funding mechanism for space debris removal and analyze the liability issues affecting the launching state and indirectly the private company with ADR capabilities. This paper aims to answer why private companies should contribute to an international fund for space debris removal depending on the Post-Mission Disposal capabilities of the satellites deployed in orbit and/or ADR solutions identified in case the satellites fail to answer the control commands. Further, this paper will analyze the prospects to manage the activity for ADR by accessing this fund.


Claudiu Mihai Tăiatu
LLM (Adv.) in Air and Space Law, International Institute of Air and Space Law, Leiden University.

    The Moon contains resources such as Helium-3, Titanium, and Rare Earth Elements, that can potentially be extracted and incorporated into different products.
    The Outer Space treaty provides every state the right to extract and use resources from the Moon, however with limitations under the treaty. Under Article IV para 2 of the treaty, all State parties are mandated to ‘use’ the Moon exclusively for peaceful purposes. However the treaty fails to define the term ‘peaceful’. This ambiguity offers opportunity of such extracted minerals to be used for military purposes, i.e. incorporated into weapons, armours, structures etc. by Space powers in the future. In that case, is military use of these lunar resources permitted under the Outer Space Treaty?
    Thus to analyse the legality this paper will adopt the rules of interpretation under The Vienna Convention on the Law of Treaties to establish that the term ”peaceful” can only be interpreted as ”Non-Military” and that any interpretation allowing ”Use” of the moon and its resources for military purposes would defeat the object and purpose of the treaty. The paper will also discuss the interpretative evolution of Peace, from Negative Peace i.e. mere absence of war or aggression, to a broader concept of Positive Peace to conclude that military use of resources extracted from the Moon is Non-peaceful and is prohibited under Outer Space Treaty. Finally, the paper will end at a functional approach to tackle the problems posed by the dual use of these Lunar Resources.


Tejas Bharadwaj
T. Bharadwaj, student, BA. LL.B School of Law, University of Petroleum and Energy Studies, Dehradun, Uttarakhand, India.

Harshith Iyer
H. Iyer, Student, B. Com. LL.B School of Law, University of Petroleum and Energy Studies, Dehradun, Uttarakhand, India.
Showing all 9 results
You can search full text for articles by entering your search term in the search field. If you click the search button the search results will be shown on a fresh page where the search results can be narrowed down by category or year.