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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

Access_open Access and Reuse of Machine-Generated Data for Scientific Research

Journal Erasmus Law Review, Issue 2 2019
Keywords machine-generated data, Internet of Things, scientific research, personal data, GDPR
Authors Alexandra Giannopoulou
AbstractAuthor's information

    Data driven innovation holds the potential in transforming current business and knowledge discovery models. For this reason, data sharing has become one of the central points of interest for the European Commission towards the creation of a Digital Single Market. The value of automatically generated data, which are collected by Internet-connected objects (IoT), is increasing: from smart houses to wearables, machine-generated data hold significant potential for growth, learning, and problem solving. Facilitating researchers in order to provide access to these types of data implies not only the articulation of existing legal obstacles and of proposed legal solutions but also the understanding of the incentives that motivate the sharing of the data in question. What are the legal tools that researchers can use to gain access and reuse rights in the context of their research?


Alexandra Giannopoulou
Institute for Information Law (IViR) – University of Amsterdam.

Susan L. Brooks
Susan Brooks is an Associate Dean and Professor of Law, Drexel University Kline School of Law, Philadelphia, USA.

Jo-Anne Wemmers
Jo-Anne Wemmers is a Full Professor at the School of Criminology, Université de Montréal (Canada) and Researcher at the International Centre for Comparative Criminology, Montréal, Canada.

Albert Dzur
Albert Dzur is Distinguished Research Professor, Departments of Political Science and Philosophy, Bowling Green State University, Bowling Green, OH, USA.
Article

The European Union and Space

A ‘Star Wars’ Saga?

Journal European Journal of Law Reform, Issue 4 2019
Keywords EU space competence, EU Space Policy, Galileo, Copernicus, Framework Agreement ESA-EU
Authors Rebecca-Emmanuela Papadopoulou
AbstractAuthor's information

    This article explores the complex relationship between the European Union (EU) and space, alias space’s ever-growing place and role in the EU legal order. Two distinct paths are identified in this respect. On the one hand, as from the mid-1980s and despite the lack of an express ‘space competence’, space policy parameters were introduced in EU acts regulating telecommunications, satellite communications and electronic databases, but only to the extent necessary to serve the functioning of the single market. On the other hand, an autonomous EU Space Policy has been progressively elaborated as from the late 1990s through several initiatives, namely the strengthening of the collaboration with the European Space Agency and the setting up of the Galileo and Global Monitoring for Environment and Security (GMES)/Copernicus programmes. This tendency was corroborated by the conferral of an express space competence on the EU by the Lisbon Treaty, whose constitutional and institutional implications are explored in this article. It is submitted that the new space competence shall allow the EU to reach a stage of maturity and claim a greater degree of autonomy at the international level and, at the same time, to project its own governance model, thus enhancing the quality of international cooperation in space.


Rebecca-Emmanuela Papadopoulou
Rebecca-Emmanuela Papadopoulou is Assistant Professor, Law School, NKUA.
Article

Law Reform in Ireland

Implementation and Independence of Law Reform Commission

Journal European Journal of Law Reform, Issue 4 2019
Keywords law reform, statute law revision, better regulation, access to legislation, lawyer’s law
Authors Edward Donelan
AbstractAuthor's information

    This article describes the origins and work of the Law Reform Commission in Ireland. The model follows that in Common Law countries. Its work includes both substantive law reform and statute law revision (weeding out spent or unused statutes and undertaking consolidation or other work to make statute law more accessible.) The work of the Commission focuses on ‘lawyers’ law’ and, therefore, avoids subjects that could be politically controversial. Consequentially, the bulk of its recommendations are accepted and translated into legislation.


Edward Donelan
Edward Donelan, PhD, M.A., Barrister-at-Law (Kings Inns, Dublin, Middle Temple, London), Dip. Eur. Law, Dip. Arb. Better Regulation and Legislative Drafting Expert, currently working on projects with the Attorney General in Botswana to develop a programme of law reform for the newly established Law Reform Unit in the Chambers of the Attorney General.
Article

The New Regulation Governing AIR, VIR and Consultation

A Further Step Forward Towards ‘Better Regulation’ in Italy

Journal European Journal of Law Reform, Issue 4 2019
Keywords regulation, RIA, regulatory impact analysis, impact assessment, evaluation, consultation
Authors Victor Chimienti
AbstractAuthor's information

    This article describes the scope and contents of the newly adopted regulation governing regulatory impact analysis (RIA) and ex post evaluation of regulation (ExPER) in the Italian legal system. The article shows that this regulation has the potential to improve regulatory governance in Italy. Not only does it introduce innovations designed to increase transparency and participation, especially through strengthened consultation and communication mechanisms, but it also aims to improve the quality and effectiveness of regulatory analysis and evaluation activities. How the new regulation will be applied in practice, however, remains to be seen. In the meantime, the new set of rules are a welcome addition to Italy’s Better Regulation policy.


Victor Chimienti
Victor Chimienti is an international and EU lawyer currently working as a free-lance consultant on donor funded projects. In 1997, he graduated in Law with full marks at the University of Bari “Aldo Moro” (Italy), and, in 2006, obtained his Ph.D in International and EU Law from the same university. Meanwhile, he had attended post-graduate legal studies at LUISS University in Rome, Italy, specialising in international and EC business law. Dr. Chimienti has also served as Lecturer in International and Trade Law at the University of Foggia, Italy, and as Research Scholar in International & Comparative Law at the University of Michigan, USA. Among others, he specialises in Better Regulation tools and procedures, such as Regulatory Impact Analysis (RIA), Ex-Post Evaluation of Legislation, Monitoring, and Public Consultation.
Article

APEC Online Dispute Resolution Framework

Journal International Journal of Online Dispute Resolution, Issue 2 2019
Keywords APEC, ODR, e-Commerce, small business, dispute resolution
Authors Michael J. Dennis
AbstractAuthor's information

    The Internet and communications technology are changing every aspect of our lives. Now ODR is set to revolutionize commercial dispute resolution across APEC with the adoption of a new ODR Collaborative Framework. In this article, we will look at the challenges APEC small businesses face today and how the APEC ODR Collaborative Framework provides a much-needed solution to improve justice and boost trade.


Michael J. Dennis
Private International Law Consulting, ODR Advisor to the APEC Economic Committee.
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

ODR as a Public Service

The Access to Justice-Driven Canadian Experience

Journal International Journal of Online Dispute Resolution, Issue 2 2019
Keywords ODR, access to justice, courts, legal process, sense of fairness
Authors Nicolas Vermeys and Jean-François Roberge
AbstractAuthor's information

    Canadian courts and tribunals are successfully incorporating online dispute resolution (ODR) mechanisms into their processes in order to offer user-centric dispute resolution systems aimed at increasing access to justice. Although they use different approaches, three such examples, British Columbia’s Civil Resolution Tribunal, Ontario’s Condominium Authority Tribunal, and Quebec’s PARLe-OPC platform, have all demonstrated how public ODR can increase litigants’ sense of justice while respecting basic legal tenets. This article serves as a short introduction to this user-centric Canadian approach.


Nicolas Vermeys
Nicolas Vermeys is the Associate Dean of Programs at the Université de Montréal’s Faculty of law, the Associate director of the Cyberjustice Laboratory, and a Researcher at the Centre de recherche en droit public (CRDP).

Jean-François Roberge
Jean-François Roberge is a Professor and the Director of the Dispute Prevention and Resolution programmes at the Université de Sherbrooke Faculty of law.
Article

Readiness for Family and Online Dispute Resolution

Journal International Journal of Online Dispute Resolution, Issue 2 2019
Keywords online dispute resolution, family dispute resolution, domestic violence, ripeness and readiness, divorce
Authors Nussen Ainsworth, Lisa Zeleznikow and John Zeleznikow
AbstractAuthor's information

    The International Conflict Resolution Community has developed considerable theory and many case studies about ripeness and readiness for mediation. Readiness involves a readiness of the disputant to resolve the conflict, while ripeness indicates the time is appropriate to attempt a resolution. There is a sparse amount of theory about these issues in commercial and family dispute resolution (FDR). We discuss the practice of readiness for mediation, FDR and online dispute resolution and develop practices about when to mediate such disputes – especially when domestic violence has occurred.


Nussen Ainsworth
Nussen Ainsworth, Victoria University, Melbourne, Australia – nussen.ainsworth@vu.edu.au.

Lisa Zeleznikow
Lisa Zeleznikow, Jewish Mediation Centre, Melbourne, Australia – lisa@jmc.org.au.

John Zeleznikow
John Zeleznikow, Victoria University, Melbourne, Australia – john.zeleznikow@vu.edu.au.

    The UN General Assembly established the International Law Commission (“ILC”) in 1947 to assist States with the promotion of 1) the progressive development of international law and 2) its codification. The ILC’s first assignment from the General Assembly was to formulate the Nuremberg Principles, which affirmed the then radical idea that individuals can be held liable for certain international crimes at the international level. Since then, the ILC has played a seminal role in the development of modern international criminal law. In 2017, the ILC adopted on first reading a draft convention aimed at the prevention and punishment of crimes against humanity which it transmitted to States for comments. The draft treaty will help fill the present gap in the law of international crimes since States criminalized genocide in 1948 and war crimes in 1949, but missed the opportunity to do so for crimes against humanity. This Article examines the first reading text using the lens of the ILC’s two-pronged mandate. Part II explains how the ILC can take up new topics and the main reasons why it decided to propose a new crimes against humanity convention. Part III discusses positive features of the draft convention, highlighting key aspects of each of the Draft Articles. Part IV critiques the ILC draft treaty focusing on inconsistencies in the use of the ICC definition of the crime, immunities, amnesties, and the lack of a proposal on a treaty monitoring mechanism. The final part draws tentative conclusions. The author argues that, notwithstanding the formal distinction drawn by the ILC Statute between progressive development, on the one hand, and codification, on the other hand, the ILC’s approach to the crimes against humanity topic follows a well settled methodology of proposing draft treaties that are judged likely to be effective and broadly acceptable to States rather than focusing on which provisions reflect codification and which constitute progressive development of the law. It is submitted that, if the General Assembly takes forward the ILC’s draft text to conclude a new crimes against humanity treaty after the second reading, this will make a significant contribution to the development of modern international criminal law.


Charles C. Jalloh B.A. LL.B Ph.D
Professor of Law, Florida International University and Member, International Law Commission.
Article

Access_open Mercosur: Limits of Regional Integration

Journal Erasmus Law Review, Issue 3 2019
Keywords Mercosur, European Union, regionalism, integration, international organisation
Authors Ricardo Caichiolo
AbstractAuthor's information

    This study is focused on the evaluation of successes and failures of the Common Market of the South (Mercosur). This analysis of Mercosur’s integration seeks to identify the reasons why the bloc has stagnated in an incomplete customs union condition, although it was originally created to achieve a common market status. To understand the evolution of Mercosur, the study offers some thoughts about the role of the European Union (EU) as a model for regional integration. Although an EU-style integration has served as a model, it does not necessarily set the standards by which integration can be measured as we analyse other integration efforts. However, the case of Mercosur is emblematic: during its initial years, Mercosur specifically received EU technical assistance to promote integration according to EU-style integration. Its main original goal was to become a common market, but so far, almost thirty years after its creation, it remains an imperfect customs union.
    The article demonstrates the extent to which almost thirty years of integration in South America could be considered a failure, which would be one more in a list of previous attempts of integration in Latin America, since the 1960s. Whether it is a failure or not, it is impossible to envisage EU-style economic and political integration in South America in the foreseeable future. So far, member states, including Brazil, which could supposedly become the engine of economic and political integration in South America, have remained sceptical about the possibility of integrating further politically and economically. As member states suffer political and economic turmoil, they have concentrated on domestic recovery before being able to dedicate sufficient time and energy to being at the forefront of integration.


Ricardo Caichiolo
Ricardo Caichiolo, PhD (Université catholique de Louvain, Belgium) is legal and legislative adviser to the Brazilian Senate and professor and coordinator of the post graduate programs on Public Policy, Government Relations and Law at Ibmec (Instituto Brasileiro de Mercado de Capitais, Brazil).
Article

Certain Factors Influencing Compliance with International Humanitarian Law

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2019
Keywords implementation of international humanitarian law, compliance measures and mechanisms, enforcement of international humanitarian law, non-state actors, individual criminal responsibility
Authors Réka Varga
AbstractAuthor's information

    There are various mechanisms within and outside the sphere of international humanitarian law (IHL) which contribute to a better application, respect and enforcement of its rules. The present study takes stock of specific factors or mechanisms that may have an effect on better respect. This analysis attempts to demonstrate that even though states could not agree on the setting up of a permanent mechanism to meet regularly and discuss IHLrelated issues (the so-called Compliance process), there are certain instruments which could lead to similar result. The UN’s role with respect to IHL is examined. The International Criminal Court (ICC) is also briefly analyzed from this perspective, bearing in mind the international politics within which it has to function. The International Humanitarian Fact-Finding Commission (IHFFC) that has successfully completed its first mandate is a string of hope if more frequently used. Soft law documents are filling a void caused by the fatigue of states in adopting new rules, at the same time they start to have a similarly binding effect as legally binding obligations. All these factors become especially interesting if we understand that most conflicts today are fought with the involvement of non-state armed groups who are not involved in law-making. This reality gives training, both within state and non-state armed forces a special significance. States should also make efforts to undertake enquiries in cases of serious violations of IHL, as well as through exercising jurisdiction to repress violations, be they their own nationals or not.


Réka Varga
Associate professor, Pázmány Péter Catholic University, Budapest; Member of the International Humanitarian Fact-Finding Commission.

Tamás Török
PhD candidate, University of Pécs.
Article

The European Charter for Regional or Minority Languages

Specific Features and Problems of Application

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2019
Keywords European Charter for Regional or Minority Languages, protection of minority languages, protection of regional languages, supervisory regime
Authors Gábor Kardos
AbstractAuthor's information

    As was the case after the Great War, World War II was followed by the setting up of international legal regimes to protect national (national, ethnic, linguistic, and religious) minorities in Europe. The emerging ideas of universalism and European unity were to prevent the aftermath of World War I, a conflict which erupted as a result of Western focusing the system of European minority protection on Central and Eastern Europe. The European Charter for Regional or Minority Languages protects minority languages, without granting minority rights. It provides an á la Carte system of obligations, with a supervisory system hinged on government reports. The Charter was intended to be a ‘high politics’ treaty. Nevertheless, with the protection of the minority linguistic heritage and the indirect provision of minority linguistic rights, it meant a first step towards bringing an end to the 19th century processes linguistic homogenization of the budding nationstates. As such, its implementation is highly political. The minority languages protected by the Charter are strongly varied in nature. If we add this factor to the á la Carte system of obligations, the sheer complexity of the system prevents evaluations of the Committee of Experts from being as consistent as they should be. An important contribution of the soft supervisory mechanism is that it at least puts some problematic issues on the agenda, however, experience has shown that the transposition of treaty obligations into national law is always a simpler task than creating the substantive conditions for the actual use of minority languages.


Gábor Kardos
Professor of law, ELTE Law School, Budapest; Member of the Committee of Experts of the European Charter for Regional or Minority Languages.
Article

The Rights of the Victim in Hungarian Criminal Proceedings

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2019
Keywords rights of victims, code of criminal procedure in Hungary, victims in criminal procedure, Directive 2012/29/EU, rights of vulnerable persons
Authors Anna Kiss
AbstractAuthor's information

    In the course of the development of criminal law victims lost their former leading role in the procedure and were pushed to the periphery of justice. Legal experts have come to realize that this tendency is tremendously unfair to the victim. European documents on the legal position of the victims increasingly called the attention of the legislature to the need of bringing about changes. In Hungary, the relevant new law was passed in June 2017. The Code came into effect in July 2018 and confirmed the victim’s procedural position. Since July, there are three groups of victims’ rights in Hungarian Criminal Proceedings: provision of information and support; participation in criminal proceedings; protection of victims and recognition of victims in need of special protection. In addition to describing the rights, the study also draws attention to the fact in light of the principle that all rights are worth upholding it is not enough to regulate the rights of victims. The study also warns that although the rights of victims are important, we should not forget the guarantees concerning suspects’ rights, which must also be ensured.


Anna Kiss
Senior research fellow, National Institute of Criminology, Budapest.

Petra Lea Láncos
Researcher, Deutsches Forschungsinstitut für öffentliche Verwaltung, Speyer; associate professor, Pázmány Péter Catholic University, Budapest.
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