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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).

    This article relies on the premise that to understand the significance of Open Access Repositories (OARs) it is necessary to know the context of the debate. Therefore, it is necessary to trace the historical development of the concept of copyright as a property right. The continued relevance of the rationales for copyright interests, both philosophical and pragmatic, will be assessed against the contemporary times of digital publishing. It follows then discussion about the rise of Open Access (OA) practice and its impact on conventional publishing methods. The present article argues about the proper equilibrium between self-interest and social good. In other words, there is a need to find a tool in order to balance individuals’ interests and common will. Therefore, there is examination of the concept of property that interrelates justice (Plato), private ownership (Aristotle), labour (Locke), growth of personality (Hegel) and a bundle of rights that constitute legal relations (Hohfeld). This examination sets the context for the argument.


Nikos Koutras
Postdoctoral Researcher, Faculty of Law, University of Antwerp.
Article

Complying with display rules: the ‘managed heart’ in restorative justice

complementing ritual theories of emotional bonding

Journal The International Journal of Restorative Justice, Issue 3 2019
Keywords Emotional bonding, emotion management, display rules, offstage performance, re-storying
Authors Bas van Stokkom
AbstractAuthor's information

    In this theoretical study it is argued, first, that ritual theories – at least those which are dominant in restorative justice literature – place too much emphasis on the potential positive impacts of emotional bonding. The author discusses some critical issues with respect to emotional bonding and points out that mutual understanding is rather the result of narrative re-appraising and re-assessing. Secondly, to explain the rather low emotional temperature of many (youth) conferences, emphasis is placed on emotion management theory, thereby suggesting that participants’ reservations and discomfort are related to rather demanding display rules (enact a sincere and authentic role; enact cooperativeness; etc.). The author identifies reasons why (young) participants cannot get grips on these rules and resort to a resigned ‘offstage’ performance. It is argued that display rules form an integral part of a relatively compelling ‘emotional regime’, a specific set of affective behavioural norms which define the ‘manners’ during the meeting. In this regime there is considerable social pressure to conform to norms and standards how to express emotions, which contradicts the restorative justice rhetoric of voluntary and spontaneous dialogue.


Bas van Stokkom
Bas van Stokkom is criminologist and research fellow at the Faculty of Law, Radboud University Nijmegen, the Netherlands.
Article

Restorative justice, anger, and the transformative energy of forgiveness

Journal The International Journal of Restorative Justice, Issue 3 2019
Keywords Restorative justice, ritual, anger, apology, forgiveness
Authors Meredith Rossner
AbstractAuthor's information

    Restorative justice has long been positioned as a justice mechanism that prioritises emotion and its expression. It is also unique in its ritual elements, such as the ritualized expression of anger and the symbolic exchange of apology and forgiveness. This paper draws on insights from research and practice in restorative justice and recent developments in criminology/legal theory and the philosophy of justice to suggest some ways that the broader criminal justice landscape can incorporate elements of successful restorative justice rituals into its practice. I argue that the unique elements of restorative justice- its ability to harness anger into a deliberative ritual for victims and offenders, its focus on symbolic reparations, and its ability to engender a form of forward-looking forgiveness that promotes civility- can provide a framework for rethinking how criminal justice institutions operate.


Meredith Rossner
Meredith Rossner will from 2020 be a Professor of Criminology, Centre for Social Research and Methods, Australian National University, Canberra, Australia. In 2019 she was an Associate Professor of Criminology at the London School of Economics and a visitor at the Center for Law and Public Affairs, Princeton University.
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

Law Reform and the Executive

Journal European Journal of Law Reform, Issue 4 2019
Keywords law reform, parliamentary counsel, legislative drafting, Australia, Victoria
Authors Adam Bushby
AbstractAuthor's information

    This article comments on the process of law reform in Australia from the perspective of a legislative drafter. After a description of the Australian political and parliamentary system and a discussion of the role of the legislative drafter, a brief summary of the formal law reform processes in Australia is provided, including a discussion of how legislative drafting offices participate in the law reform process. Participation includes the drafting of Bills giving effect to law reform proposals based on drafting instructions approved by Cabinet, providing for the undertaking of statutory reviews, as well as the remaking of legislation. It is the role of the legislative drafter to assist the government by turning policy into legislation, so the focus here is on the practical implementation of law reform rather than the independence of law reform bodies.


Adam Bushby
Senior Parliamentary Counsel, Office of the Chief Parliamentary Counsel, Department of Premier and Cabinet, Victoria, Australia. This article reflects the opinions of the author only, and should not be taken as representing the stance of the Office of the Chief Parliamentary Counsel, Victoria, Australia. I would, of course, welcome any feedback from anyone with an interest in law reform.
Article

Parliamentary Control over Delegated Legislation in Japan

Journal European Journal of Law Reform, Issue 4 2019
Keywords statutory instruments, sole law-making organ, supplementary resolution, legislative veto, Committee on Oversight of Administration
Authors Katsuhiro Musashi
AbstractAuthor's information

    The delegation of legislation from the parliament to the administration plays an important role in a modern administrative state. In Britain, parliamentary control – whereby the parliament has the right to approve or veto a delegated legislation – has been institutionalized and implemented. On the other hand, the Japanese parliament is powerless to approve a delegated order beforehand or ex post. Therefore, improper procedures such as the deviation of the delegated order from the enabling act by a governmental agency, or the introduction of arbitrary administrative measures, have been carried out under insufficient supervision by the parliament in Japan. The National Diet of Japan should, ideally, also hold the power to control the administrative order on the basis of the legal principles formulated by the Diet. Therefore, we propose the introduction of a parliamentary control system that invalidates the ex post enactment of a cabinet order if both Houses of parliament refuse the order within 40 days of its submission. These procedures would have increased efficacy when augmented with a political check function on the proposed cabinet orders by the parliament’s Committee on Oversight of Administration, or their standing committees.


Katsuhiro Musashi
Katsuhiro Musashi is Professor of Law and Policy at the Faculty of Policy Studies, Doshisha University in Kyoto, Japan.
Article

Independence and Implementation

In Harmony and in Tension

Journal European Journal of Law Reform, Issue 4 2019
Keywords Law Commission, law reform, legislation, independence, implementation
Authors Matthew Jolley
AbstractAuthor's information

    This article examines the factors that have influenced the independence of the Law Commission of England and Wales and the implementation of its recommendations. It discusses innovations in Parliamentary procedure for Law Commission Bills, the Protocol between Government and the Law Commission; and the requirement for the Lord Chancellor to report annually to Parliament on the implementation of the Law Commission’s proposals. It makes the case that the relationship between independence and implementation is complex: at times the two pull in opposite directions, and at times they support each other.


Matthew Jolley
Matthew Jolley is Head of Legal Services and Head of the Property, Family and Trust Law Team at the Law Commission of England and Wales. This article is written in a personal capacity – with thanks to Christine Land, Rachel Preston and Sarah Smith for their assistance with background research.
Case Reports

2019/43 Dismissal after childbirth-related leave (DK)

Journal European Employment Law Cases, Issue 4 2019
Keywords Gender discrimination
Authors Christian K. Clasen
AbstractAuthor's information

    The Danish Western High Court has ruled that the dismissal of an employee shortly after returning from childbirth-related leave did not constitute discrimination within the meaning of the Danish Act on Equal Treatment of Men and Women.


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

    The High Court (HC) dismissed an application by an employer for an interim injunction to prevent strike action organised by two trade unions, who were demanding parity of treatment for their members as compared to members of another union. It was more likely than not that the two unions would succeed in establishing, at the full trial of the matter, that the statutory protection under UK law for industrial action applied.


Kerry Salisbury
Kerry Salisbury is an Associate at Lewis Silkin LLP.
Article

An Important Planning Instrument: Strategic Environmental Assessment (EU Directive 2001/42).

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2019
Keywords environmental impact assessment, Directive 2001/42, strategic planning, assessment of plans, environmental report
Authors Ludwig Krämer
AbstractAuthor's information

    Directive 2001/42 requires the elaboration of an environmental impact assessment, before certain national, regional or local plans or programs related to the environment are adopted. The paper presents the content of the Directive and summarizes the case-law of the CJEU on the Directive. Furthermore, it raises a number of legal questions hitherto left undiscussed by the European courts.


Ludwig Krämer
Derecho y Medio Ambiente S.L., Madrid
Article

The Precautionary Principle in the Fundamental Law of Hungary

Judicial Activism or an Inherent Fundamental Principle? An Evaluation of Constitutional Court Decision No. 13/2018. (IX. 4.) AB on the Protection of Groundwater

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2019
Keywords Constitutional Court of Hungary, precautionary principle, judicial activism, Article P of the Fundamental Law of Hungary, constitutional protection of the environment
Authors Marcel Szabó
AbstractAuthor's information

    Acting upon the motion of the President of the Republic, the Constitutional Court of Hungary ruled in its Decision No. 13/2018. (IX. 4.) AB that the regulation which would have allowed establishing new wells up to the depth of 80m without a license or notification was contrary to the Fundamental Law. The Constitutional Court found in its decision that the regulation would endanger the volume and quality of underground water in a way that, considering the precautionary principle, was no longer compatible with the protection of natural resources and cultural artefacts forming the common heritage of the nation as laid down in Article P(1) of the Fundamental Law or Article XXI(1) of the same on the right to a healthy environment. It was in this decision that the Constitutional Court first outlined in detail the constitutional significance of the precautionary principle, with this principle forming the central part of the decision’s reasoning. Within the framework of this study I examine whether this decision based on the precautionary principle can be considered the ‘extraction’ of what is inherently present in the Fundamental Law or on the contrary, whether it was an activist approach imposing the principle on the Fundamental Law.


Marcel Szabó
Professor of law, Pázmány Péter Catholic University, Budapest; justice, Constitutional Court of Hungary.
Article

Fair Trial under Scrutiny

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2019
Keywords Constitutional Court of Hungary, right to a fair trial, Article 6 ECHR, Article XXVIII of the Fundamental Law of Hungary, Hungarian Code of Criminal Procedure
Authors Ágnes Czine
AbstractAuthor's information

    The right to a fair trial has an eminent position in the Fundamental Law of Hungary both because of the importance of the right and the great number of applications and jurisprudence it has been the subject of. This study presents the legal background of fair trial and its place in the Hungarian legal system, analyzing the jurisprudence of the Hungarian Constitutional Court on the right to fair trial, and in particular, the obligation to adjudicate within a reasonable time. While the Constitutional Court has developed a consistent practice in this regard, there are nevertheless new issues that may make the amendment of certain pieces of legislation necessary. This paper presents a case-study on a new development in the Constitutional Court’s practice on the issue of deciding the case within a reasonable time.


Ágnes Czine
Justice, Constitutional Court of Hungary.
Article

Conference on the Evaluation of Legislation

Report on the ‘Evaluation of Legislation’ Conference Organized by Pázmány Péter Catholic University, 3 May 2019, Budapest

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2019
Authors Noémi Suri
Author's information

Noémi Suri
Assistant professor, Pázmány Péter Catholic University, Budapest.
Article

Snapshot of the EU Soft Law Research Landscape

Main Issues and Challenges

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2019
Keywords soft law, normativity, bindingness, directive-like recommendations, hybridity
Authors Petra Lea Láncos
AbstractAuthor's information

    Inspired by research into international soft law norms, the last two decades have seen an intensified investigation of the non-binding measures of the EU. With the proliferation of such norms at EU level, attempts at a taxonomy of EU soft law have been undertaken. The present paper tries to map the current status of EU soft law research, highlighting possible directions for future research.


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

Access_open Towards Responsible Business Conduct in Global Value Chains

Relevant Legal Developments in the Netherlands

Journal Erasmus Law Review, Issue 4 2019
Keywords responsible business conduct, business and human rights, corporate social responsibility, sustainable development, the Netherlands
Authors Liesbeth Enneking and Jeroen Veldman
AbstractAuthor's information

    The past few decades have seen an increasing scrutiny of the impacts – both positive and negative – that companies have on the societies in which they operate. The search for adequate responses to such scrutiny is reflected in developments in the societal, political and academic debate on three separate but interrelated concepts: corporate social responsibility, business and human rights and responsible business conduct. The focus in this Special Issue will be on law and policy relating to responsible business conduct in global value chains. The contributions in this Special Issue identify relevant developments and institutions in the Netherlands, including rules and regulations related to trade, investment and corporate governance as well as cases related to corporate and consumer responsibilities, and assess their role in relation to the potential to provide a positive response to the concern about the human and environmental impacts of business activities. Together, they provide a multi-perspective view of relevant gaps and/or best practices with regard to regulatory governance in the Netherlands while at the same time enabling a comparative debate on the extent to which these diverse developments and institutions are in line with stated policy goals in this context both at national and EU levels. In doing so, this Special Issue aims to contribute to further coherence between national and EU policies with regard to RBC in global value chains and sustainable development.


Liesbeth Enneking
Liesbeth Enneking is Professor of Legal Aspects of International Corporate Social Responsibility at Erasmus School of Law, Erasmus University Rotterdam.

Jeroen Veldman
Jeroen Veldman is Visiting Associate Professor at Rotterdam School of Management, Erasmus University Rotterdam, Visiting Associate Professor at Mines Paristech, Interdisciplinary Institute for Innovation, Paris and Section Editor Corporate Governance at the Journal of Business Ethics.
Article

Access_open The New Dutch Model Investment Agreement

On the Road to Sustainability or Keeping up Appearances?

Journal Erasmus Law Review, Issue 4 2019
Keywords Dutch model BIT, foreign direct investment, bilateral investment treaties, investor-to-state dispute settlement, sustainable development goals
Authors Alessandra Arcuri and Bart-Jaap Verbeek
AbstractAuthor's information

    In 2019, the Dutch government presented a New Model Investment Agreement that seeks to contribute to the sustainability and inclusivity of future Dutch trade and investment policy. This article offers a critical analysis of the most relevant parts of the revised model text in order to appraise to what extent it could promote sustainability and inclusivity. It starts by providing an overview of the Dutch BIT (Bilateral Investment Treaty) programme, where the role of the Netherlands as a favourite conduit country for global FDI is highlighted. In the article, we identify the reasons why the Netherlands became a preferred jurisdiction for foreign investors and the negative implications for governments and their policy space to advance sustainable development. The 2019 model text is expressly set out to achieve a fairer system and to protect ‘sustainable investment in the interest of development’. While displaying a welcome engagement with key values of sustainable development, this article identifies a number of weaknesses of the 2019 model text. Some of the most criticised substantive and procedural provisions are being reproduced in the model text, including the reiteration of investors’ legitimate expectation as an enforceable right, the inclusion of an umbrella clause, and the unaltered broad coverage of investments. Most notably, the model text continues to marginalise the interests of investment-affected communities and stakeholders, while bestowing exclusive rights and privileges on foreign investors. The article concludes by hinting at possible reforms to better align existing and future Dutch investment treaties with the sustainable development goals.


Alessandra Arcuri
Alessandra Arcuri is Professor at Erasmus School of Law and Erasmus Initiative Dynamics of Inclusive Prosperity, Erasmus University Rotterdam.

Bart-Jaap Verbeek
Bart-Jaap Verbeek is Researcher at Stichting Onderzoek Multinationale Ondernemingen (SOMO) and PhD Candidate Political Science at the Radboud University.
Article

Control in International Law

Journal African Journal of International Criminal Justice, Issue 1 2019
Keywords Effective / overall control, international human rights law, international criminal law, responsibility of states, statehood
Authors Joseph Rikhof and Silviana Cocan
AbstractAuthor's information

    The concept of control has permeated various disciplines of public international law, most notable international criminal law, international humanitarian law, international human rights law and the law of statehood as well as the law of responsibility for states and international organizations. Often this notion of control has been used to extend the regular parameters in these disciplines to capture more extraordinary situations and apply the same rules originally developed within areas of law, such as the application of the laws of war to occupation, the rules of human rights treaties to extraterritorial situations or state responsibility to non-state actors. This article will examine this notion of control in all its facets in international law while also addressing some of its controversies and disagreements in the jurisprudence of international institutions, which have utilized this concept. The article will then provide an overview of its uses in international law as well as its overlap from one discipline to another with a view of providing some overarching observations and conclusions.


Joseph Rikhof
Joseph Rikhof is an adjunct professor at the Common Law Faculty of the University of Ottawa.

Silviana Cocan
Silviana Cocan holds a double doctoral degree in international law from the Faculty of Law of Laval University and from the Faculty of Law and Political Science of the University of Bordeaux.
Article

Delimiting Deportation, Unlawful Transfer, Forcible Transfer and Forcible Displacement in International Criminal Law

A Jurisprudential History

Journal African Journal of International Criminal Justice, Issue 1 2019
Keywords International criminal law, theory of international law, crimes against humanity, deportation, unlawful or forcible transfer
Authors Ken Roberts and James G. Stewart
AbstractAuthor's information

    The forced displacement of civilian populations is an issue of significant global concern and a subject of extensive legal debate. In international criminal law, forced displacement is criminalized by a complex network of distinct but overlapping offences. These include the Crimes Against Humanity of deportation, forcible transfer, persecution and other inhumane acts, and the grave breach of the Geneva Conventions of ‘unlawful deportation or transfer’. International courts and tribunals have been inconsistent in the adoption of these crimes in their statues and in their subsequent interpretation, making it all the more difficult to distinguish between them. The jurisprudential history of these crimes is lengthy and not without controversy, highlighted by inconsistent judicial approaches. In this article, we offer a critical jurisprudential history of these displacement crimes in international criminal law.
    In particular, we focus on the case law emanating from the International Criminal Tribunal for the former Yugoslavia, a court that comprehensively addressed crimes associated with ethnic cleansing, a characteristic feature of that conflict, with the result that displacement was a central focus of that court. We set out our jurisprudential history in chronological order, beginning with the earliest inceptions of displacement crimes at the ICTY and then tracing their development toward the establishment of a consensus. Our hope is that the article sheds light on the development of these offences, informs future debate, and acts as a useful template for those seeking to understand how these crimes may have a role to play in future international jurisprudence.


Ken Roberts
Ken Roberts is Senior Legal Officer, International, Impartial and Independent Mechanism (Syria).

James G. Stewart
James G. Stewart is Associate Professor, Allard School of Law, University of British Columbia.
Article

The Smuggling of Migrants across the Mediterranean Sea

A Human Rights Perspective

Journal East European Yearbook on Human Rights, Issue 1 2019
Keywords smuggling, refugees, migration, readmission, interceptions
Authors J. Shadi Elserafy LL.M.,
AbstractAuthor's information

    Irregular migration by sea is one of the most apparent contemporary political issues, and one that entails many legal challenges. Human smuggling by sea is only one aspect of irregular migration that represents a particular challenge for States, as sovereignty and security interests clash with the principles and obligations of human rights and refugee law. In dealing with the problem of migrant smuggling by sea, States have conflicting roles, including the protection of national borders, suppressing the smuggling of migrants, rescuing migrants and guarding human rights.
    The legal framework governing the issue of migrant smuggling at sea stems not only from the rules of the law of the sea and the Smuggling Protocol but also from rules of general international law, in particular human rights law and refugee law. The contemporary practice of States intercepting vessels engaged in migrant smuggling indicates that States have, on several occasions, attempted to fragment the applicable legal framework by relying on laws that allow for enhancing border controls and implementing measures that undermine obligations of human rights and refugee law. This article seeks to discuss the human rights dimension of maritime interception missions and clarify as much as possible the obligations imposed by international law on States towards smuggled migrants and whether or not these obligations limit the capacity of States to act.


J. Shadi Elserafy LL.M.,
LL.M., Judge/Counselor at The Egyptian Council of State (The Higher Administrative Court of Justice).
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