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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.
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

Access_open Impact of International Law on the EU Customs Union

Journal Erasmus Law Review, Issue 3 2019
Keywords European Union, customs union, international law, customs legislation, autonomous standards
Authors Achim Rogmann
AbstractAuthor's information

    This contribution examines the various international instruments, in both hard and soft law, that have been established by international organisations such as the WTO and WCO and scrutinises how they have been implemented into EU legislation governing the EU Customs Union, thus demonstrating the substantial influence of international instruments on the Customs Union. As the relevant international instruments affect not only the traditional elements of European customs law, but also the EU’s entire export control regime and the framework of the internal market, this contribution demonstrates, moreover, how the Customs Union functions in a globalised world.


Achim Rogmann
Achim Rogmann, LL.M is professor of law at the Brunswick European Law School at Ostfalia Hochschule fur angewandte Wissenschaften.
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 Chambers for International Commercial Disputes in Germany: The State of Affairs

Journal Erasmus Law Review, Issue 1 2019
Keywords Justizinitiative Frankfurt, Law Made in Germany, International Commercial Disputes, Forum Selling, English Language Proceedings
Authors Burkhard Hess and Timon Boerner
AbstractAuthor's information

    The prospect of attracting foreign commercial litigants to German courts in the wake of Brexit has led to a renaissance of English-language commercial litigation in Germany. Leading the way is the Frankfurt District Court, where – as part of the ‘Justizinitiative Frankfurt’ – a new specialised Chamber for International Commercial Disputes has been established. Frankfurt’s prominent position in the financial sector and its internationally oriented bar support this decision. Borrowing best practices from patent litigation and arbitration, the Chamber offers streamlined and litigant-focused proceedings, with English-language oral hearings, within the current legal framework of the German Code of Civil Procedure (ZPO).1xZivilprozessordnung (ZPO).
    However, to enable the complete litigation process – including the judgment – to proceed in English requires changes to the German Courts Constitution Act2xGerichtsverfassungsgesetz (GVG). (GVG). A legislative initiative in the Bundesrat aims to establish a suitable legal framework by abolishing the mandatory use of German as the language of proceedings. Whereas previous attempts at such comprehensive amendments achieved only limited success, support by several major federal states indicates that this time the proposal will succeed.
    With other English-language commercial court initiatives already established or planned in both other EU Member States and Germany, it is difficult to anticipate whether – and how soon – Frankfurt will succeed in attracting English-speaking foreign litigants. Finally, developments such as the 2018 Initiative for Expedited B2B Procedures of the European Parliament or the ELI–UNIDROIT project on Transnational Principles of Civil Procedure may also shape the long-term playing field.

Noten

  • 1 Zivilprozessordnung (ZPO).

  • 2 Gerichtsverfassungsgesetz (GVG).


Burkhard Hess
Burkhard Hess is the Executive Director of the Max Planck Institute Luxembourg for International, European and Regulatory Procedural Law (MPI Luxembourg).

Timon Boerner
Timon Boerner is a Research Fellow at the MPI Luxembourg.
Editorial

Access_open International Business Courts in Europe and Beyond: A Global Competition for Justice?

Journal Erasmus Law Review, Issue 1 2019
Keywords international business courts, justice innovation, justice competition, global commercial litigation, private international law
Authors Xandra Kramer and John Sorabji
Author's information

Xandra Kramer
Xandra Kramer, Professor of Private Law at Erasmus University Rotterdam, and of Private International Law, Utrecht University.

John Sorabji
John Sorabji, Senior Teaching Fellow, UCL, London/Principal Legal Adviser to the Lord Chief Justice and the Master of the Rolls.
Article

Access_open The Court of the Astana International Financial Center in the Wake of Its Predecessors

Journal Erasmus Law Review, Issue 1 2019
Keywords international financial centers, offshore courts, international business courts, Kazakhstan
Authors Nicolás Zambrana-Tévar
AbstractAuthor's information

    The Court of the Astana International Financial Center is a new dispute resolution initiative meant to attract investors in much the same way as it has been done in the case of the courts and arbitration mechanisms of similar financial centers in the Persian Gulf. This paper examines such initiatives from a comparative perspective, focusing on their Private International Law aspects such as jurisdiction, applicable law and recognition and enforcement of judgments and arbitration awards. The paper concludes that their success, especially in the case of the younger courts, will depend on the ability to build harmonious relationships with the domestic courts of each host country.


Nicolás Zambrana-Tévar
LLM (LSE), PhD (Navarra), KIMEP University.
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

Access_open Matchmaking International Commercial Courts and Lawyers’ Preferences in Europe

Journal Erasmus Law Review, Issue 1 2019
Keywords choice of court, commercial court, lawyers’ preferences, survey on lawyers, international court
Authors Erlis Themeli
AbstractAuthor's information

    France, Germany, Belgium, and the Netherlands have taken concrete steps to design and develop international commercial courts. Most of the projects claim to be building courts that match the preferences of court users. They also try to challenge England and Wales, which evidence suggests is the most attractive jurisdiction in the EU. For the success of these projects, it is important that their proposed courts corresponds with the expectations of the parties, but also manages to attract some of the litigants that go to London. This article argues that lawyers are the most important group of choice makers, and that their preferences are not sufficiently matched by the new courts. Lawyers have certain litigation service and court perception preferences. And while the new courts improve their litigation service, they do not sufficiently addressed these court perception preferences.


Erlis Themeli
Postdoc, Erasmus School of Law, Erasmus University Rotterdam.
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