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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 Text and Data Mining in the EU ‘Acquis Communautaire’ Tinkering with TDM & Digital Legal Deposit

Journal Erasmus Law Review, Issue 2 2019
Keywords Web harvesting, data analysis, text & data mining, TDM, computational text
Authors Maria Bottis, Marinos Papadopoulos, Christos Zampakolas e.a.
AbstractAuthor's information

    Text and Data Mining (hereinafter, TDM) issue for the purpose of scientific research or for any other purpose which is included in the provisions of the new EU Directive on Copyright in the Digital Single Market (hereinafter, DSM). TDM is a term that includes Web harvesting and Web Archiving activities. Web harvesting and archiving pertains to the processes of collecting from the web and archiving of works that reside on the Web. In the following analysis we will elaborate briefly upon provisions in EU Copyright law which were discussed during the proposal for a new Directive on Copyright in the DSM as well as provisions which are included in the text of art.3 and art.4 of the new Directive 2019/790/EU per TDM. In addition, the following analysis presents legislation in very few EU Member States which pertains to TDM and preceded the rulings of Directive 2019/790/EU. Digital legal deposit remarkable examples from EU Member States are also presented in this paper. The example of Australia is also presented below hereto because it is one of the oldest and most successful worldwide. The National Library of Australia’s digital legal deposit is state-of-the-art.


Maria Bottis
Associate Professor, Department of Archives, Library Science and Museology, Ionian University, Corfu, Greece.

Marinos Papadopoulos
Attorney-at-Law, PhD, MSc, JD, Independent Researcher, Athens, Greece.

Christos Zampakolas
Archivist/Librarian, PhD, MA, BA, Independent Researcher, Ioannina, Greece.

Paraskevi Ganatsiou
Educator, MA, BA, Coordinator of Educational Projects in the Prefecture of Ionian Islands, Corfu, Greece.
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

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

Economic Inequality, Capitalism and Law

Imperfect Realization of Juridical Equality, the Right to Property and Freedom of Contract

Journal European Journal of Law Reform, Issue 4 2019
Keywords capitalism, inequality, juridical, law, property
Authors Shabir Korotana
AbstractAuthor's information

    There is a general unease among the public across all jurisdictions about the progressive economic inequality that seems to define the new normal, and this phenomenon has been succinctly documented in numerous prominent studies. This trend of capitalism has been supported by the existing structures of the common law, albeit contrary to the aim and purpose of its original principles. The studies show that the modern capitalist societies display a persistent trend of increasing inequality, and this is summed up by the observation that modern capitalism generates progressive and intense economic inequality.
    Capitalism as a socio-economic system is structured and sustained by the law and by socio-economic systems of institutions. Capitalism is not only a social ordering; essentially, it is a legal ordering. At the heart of this legal ordering are private laws, and tort law, but the most important is contract law: freedom of contract. It is common law, similar to the private law in other jurisdictions, that is responsible for the extreme inequality because it allows the institutions of capitalism to function freely and without much control. The open-ended capitalism that allows accumulation of wealth without ceiling causes progressive inequality in society and consequently works against the very freedom and individualism that are supposed to be the ideals of common law and capitalism. Because of the existing institutions of capitalism and the legal construct, freedom, fairness and the intended progress of the individual were not properly realized; the understanding of the ideas and principles of freedom, individualism, juridical equality, the right to property and freedom of contract have been imperfectly realized. With rising inequality, it is this imperfect realization, particularly of juridical equality that is in question.


Shabir Korotana
Shabir Korotana is Senior Lecturer in Commercial Law at Brunel Law School, Brunel University London.
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.
Pending Cases

Case C-483/19, Fixed-term work

Ville de Verviers – v – J, reference lodged by the Cour du travail de Liège (Belgium) on 24 June 2019

Journal European Employment Law Cases, Issue 4 2019
Keywords Fixed-term work
Pending Cases

Case C-471/19, Gender discrimination

Middlegate Europe NV – v – Ministerraad, reference lodged by the Grondwettelijk Hof (Belgium) on 20 June 2019

Journal European Employment Law Cases, Issue 4 2019
Keywords Gender discrimination
Case Reports

2019/51 Stand-by time from home is paid working time (RO)

Journal European Employment Law Cases, Issue 4 2019
Keywords Working time
Authors Andreea Suciu and Gabriela Ion
AbstractAuthor's information

    Stand-by time from home represents working time of medical personnel even for the periods when no medical activity was actually performed (no attendance at the hospital was required), the salary rights for such period being determined as a percentage of the hourly rate for the basic salary and the number of hours when stand-by time from home was performed.


Andreea Suciu
Andreea Suciu is the Managing Partner of Suciu I The Employment Law Firm (https://suciu-employmentlaw.ro/).

Gabriela Ion
Gabriela Ion is an associate with Suciu I The Employment Law Firm (https://suciu-employmentlaw.ro/).
Research Notes

Paid Digital Campaigning During the 2018 Local Elections in Flanders

Which Candidates Jumped on the Bandwagon?

Journal Politics of the Low Countries, Issue 3 2019
Keywords local elections, candidates, campaign spending, digital campaigning
Authors Gunther Vanden Eynde, Gert-Jan Put, Bart Maddens e.a.
AbstractAuthor's information

    This research note investigates the role of paid digital campaigning in the 2018 local elections in Flanders. We make use of the official declarations which candidates are legally required to submit. In these declarations, candidates indicate whether and how much they invested in online campaigning tools during the four months preceding the elections. We collected data on a sample of 3,588 individual candidates running in the 30 municipalities of the Leuven Arrondissement. A multilevel logistic regression model shows that the odds of spending on digital campaigning increases among incumbent aldermen and local councillors. The latter finding supports the normalization thesis of digital campaigning. The results also show that scale is important – the more potential voters a candidate has, the higher the odds that the candidate invests in digital tools.


Gunther Vanden Eynde
Gunther Vanden Eynde is a doctoral researcher at the KU Leuven Public Governance Institute. His research interests include political finance, campaign spending and the social media campaigns of Belgian political parties and their candidates.

Gert-Jan Put
Gert-Jan Put is a Senior Researcher at the Research Center for Regional Economics, KU Leuven. His research focuses on candidate selection and intra-party competition, and has been published in Political Behavior, Party Politics and Electoral Studies.

Bart Maddens
Bart Maddens is a professor of political science at the KU Leuven Public Governance Institute His research interests include political finance, elections and multi-level systems. His work has been published in West European Politics, Party Politics and Electoral Studies.

Gertjan Muyters
Gertjan Muyters is a doctoral researcher at the KU Leuven Public Governance Institute. His research focuses on candidate turnover and political careers.
Article

The Right of Appeal against a Decision on Disciplinary Liability of a Judge

Journal East European Yearbook on Human Rights, Issue 1 2019
Keywords disciplinary proceedings, scope of judicial review, standard of judicial review, remedial measures
Authors Taras Pashuk PhD
AbstractAuthor's information

    This article deals with the questions of scope and the standard of judicial review of a disciplinary decision against a judge. It further addresses the issue of remedial powers, which should be granted to the reviewing authority in this type of cases. It is suggested that the scope of judicial review of a disciplinary decision against a judge should extend to questions of law, fact and discretion. What actually varies is the depth of review or, more precisely, the standards of review and the corresponding level of deference, which must be demonstrated to the primary decision-making authority. It is further suggested that there are several factors that have influence on the formation of the standards of review: the institutional, procedural and expertise factors. As to the remedial capacity, the reviewing court should be provided with the competence to apply adequate remedial measures. The reviewing court should be able to effectively eliminate the identified shortcomings in the proceedings before the first-instance authority. For the effective protection of the rights at issue, it may be important for the reviewing court not only to repeal the decision subject to review, but also take other remedial measures. The legitimacy and necessity for applying particular remedial action should be established by taking into account the same institutional, procedural and expertise factors.


Taras Pashuk PhD
PhD (Ivan Franko National University of Lviv, Ukraine), lawyer at the Registry of the European Court of Human Rights. This article has been written in personal capacity, and the thoughts expressed in it cannot be attributed to any Council of Europe body.
Article

On Lessons Learned and Yet to Be Learned

Reflections on the Lithuanian Cases in the Strasbourg Court’s Grand Chamber

Journal East European Yearbook on Human Rights, Issue 1 2019
Keywords human rights, European Convention on Human Rights, European Court of Human Rights, Lithuania
Authors Egidijus Kūris
Abstract

    During the two-and-a-half decades while Lithuania has been a party to the European Convention on Human Rights, the Grand Chamber of the European Court of Human Rights has decided five Lithuanian cases. They all (perhaps but one) raised controversial issues not only of law but also of those pertaining to matters non-legal: psychology, politics, history and so on. There had been follow-ups to most of them, allowing for consideration as to the merits and disadvantages of the respective judgments. These cases are narrated on in their wider-than-legal context and reflected upon from the perspective of their bearing on these issues and of the lessons they taught both to Lithuania, as a respondent State, and to the Court itself.


Egidijus Kūris

    The author discusses the recent ECJ judgments in the cases Egenberger and IR on religious discrimination.


Andrzej Marian Świątkowski
Andrzej Marian Świątkowski, is a Jean Monet Professor of European Labour Law and Social Security, Jesuit University Ignatianum, Krakow, Poland and a member of the EELC Academic Board.
Pending Cases

Case C-483/19, Fixed-term work

Ville de Verviers – v – J, reference lodged by the Cour du travail de Liège (Belgium) on 24 June 2019

Journal European Employment Law Cases, Issue 3 2019
Keywords Fixed-term work
Abstract

    Under a former Austrian law effective until February 2019, Good Friday was a public holiday only for a minority belonging to certain Christian Evangelical churches. In the case at hand, Austrian courts had to assess if this regulation and its legal consequences were valid under European Union law, or if they constituted discrimination.


Dr. Jana Eichmeyer LL.M
Dr. Jana Eichmeyer, LL.M is a lawyer at Eisenberger & Herzog in Vienna (www.ehlaw.at).

Dr. Karolin Andréewitch
Dr. Karolin Andréewitch is a lawyer at Eisenberger & Herzog in Vienna (www.ehlaw.at).
Case Reports

2019/29 Eweida versus Achbita: a storm in a teacup? (EU)

Journal European Employment Law Cases, Issue 3 2019
Keywords Religious discrimination
Authors Morwarid Hashemi LLM
AbstractAuthor's information

    Most scholars have argued that the Achbita judgment is not in line with the jurisprudence of the ECtHR, in particular with the Eweida judgment, and gives less protection to the employee than granted by the ECtHR. In this article, I provide a different perspective on the relation between both judgments and nuance the criticisms that followed the Achbita judgment.


Morwarid Hashemi LLM
Morwarid Hashemi LLM is a former student of 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).
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