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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.

    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

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 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 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.
Article

Access_open The Conduit between Technological Change and Regulation

Journal Erasmus Law Review, Issue 3 2018
Keywords technology, socio-technological change, money, windmill, data
Authors Marta Katarzyna Kołacz and Alberto Quintavalla
AbstractAuthor's information

    This article discusses how the law has approached disparate socio-technological innovations over the centuries. Precisely, the primary concern of this paper is to investigate the timing of regulatory intervention. To do so, the article makes a selection of particular innovations connected with money, windmills and data storage devices, and analyses them from a historical perspective. The individual insights from the selected innovations should yield a more systematic view on regulation and technological innovations. The result is that technological changes may be less momentous, from a regulatory standpoint, than social changes.


Marta Katarzyna Kołacz
Marta Katarzyna Kołacz, Ph.D. Candidate in the Department of Private Law, Erasmus School of Law, Erasmus University Rotterdam, The Netherlands.

Alberto Quintavalla
Alberto Quintavalla, LL.M., Ph.D. Candidate in the Rotterdam Institute of Law and Economics, Erasmus School of Law, Erasmus University Rotterdam, The Netherlands.
Article

Access_open Right to Access Information as a Collective-Based Approach to the GDPR’s Right to Explanation in European Law

Journal Erasmus Law Review, Issue 3 2018
Keywords automated decision-making, right to access information, right to explanation, prohibition on discrimination, public information
Authors Joanna Mazur
AbstractAuthor's information

    This article presents a perspective which focuses on the right to access information as a mean to ensure a non-discriminatory character of algorithms by providing an alternative to the right to explanation implemented in the General Data Protection Regulation (GDPR). I adopt the evidence-based assumption that automated decision-making technologies have an inherent discriminatory potential. The example of a regulatory means which to a certain extent addresses this problem is the approach based on privacy protection in regard to the right to explanation. The Articles 13-15 and 22 of the GDPR provide individual users with certain rights referring to the automated decision-making technologies. However, the right to explanation not only may have a very limited impact, but it also focuses on individuals thus overlooking potentially discriminated groups. Because of this, the article offers an alternative approach on the basis of the right to access information. It explores the possibility of using this right as a tool to receive information on the algorithms determining automated decision-making solutions. Tracking an evolution of the interpretation of Article 10 of the Convention for the Protection of Human Right and Fundamental Freedoms in the relevant case law aims to illustrate how the right to access information may become a collective-based approach towards the right to explanation. I consider both, the potential of this approach, such as its more collective character e.g. due to the unique role played by the media and NGOs in enforcing the right to access information, as well as its limitations.


Joanna Mazur
Joanna Mazur, M.A., PhD student, Faculty of Law and Administration, Uniwersytet Warszawski.

    In this paper I propose to analyse the binary notion of personal data and highlight its limits, in order to propose a different conception of personal data. From a risk regulation perspective, the binary notion of personal data is not particularly fit for purpose, considering that data collection and information flows are tremendously big and complex. As a result, the use of a binary system to determine the applicability of EU data protection law may be a simplistic approach. In an effort of bringing physics and law together, certain principles elaborated within the quantum theory are surprisingly applicable to data protection law, and can be used as guidance to shed light on many of today’s data complexities. Lastly, I will discuss the implications and the effects that certain processing operations may have on the possibility of qualifying certain data as personal. In other terms, how the chances to identify certain data as personal is dependent upon the processing operations that a data controller might put in place.


Alessandro El Khoury
Alessandro El Khoury, LLM, Legal and Policy Officer, DG Health & Food Safety, European Commission.
Article

Access_open Fostering Worker Cooperatives with Blockchain Technology: Lessons from the Colony Project

Journal Erasmus Law Review, Issue 3 2018
Keywords blockchain, collaborative economy, cooperative governance, decentralised governance, worker cooperatives
Authors Morshed Mannan
AbstractAuthor's information

    In recent years, there has been growing policy support for expanding worker ownership of businesses in the European Union. Debates on stimulating worker ownership are a regular feature of discussions on the collaborative economy and the future of work, given anxieties regarding the reconfiguration of the nature of work and the decline of standardised employment contracts. Yet, worker ownership, in the form of labour-managed firms such as worker cooperatives, remains marginal. This article explains the appeal of worker cooperatives and examines the reasons why they continue to be relatively scarce. Taking its cue from Henry Hansmann’s hypothesis that organisational innovations can make worker ownership of firms viable in previously untenable circumstances, this article explores how organisational innovations, such as those embodied in the capital and governance structure of Decentralised (Autonomous) Organisations (D(A)Os), can potentially facilitate the growth of LMFs. It does so by undertaking a case study of a blockchain project, Colony, which seeks to create decentralised, self-organising companies where decision-making power derives from high-quality work. For worker cooperatives, seeking to connect globally dispersed workers through an online workplace, Colony’s proposed capital and governance structure, based on technological and game theoretic insight may offer useful lessons. Drawing from this pre-figurative structure, self-imposed institutional rules may be deployed by worker cooperatives in their by-laws to avoid some of the main pitfalls associated with labour management and thereby, potentially, vitalise the formation of the cooperative form.


Morshed Mannan
Morshed Mannan, LLM (Adv.), PhD Candidate, Company Law Department, Institute of Private Law, Universiteit Leiden.
Article

Access_open Armed On-board Protection of German Ships (and by German Companies)

Journal Erasmus Law Review, Issue 4 2018
Keywords German maritime security, private armed security, privately contracted armed security personnel, anti-piracy-measures, state oversight
Authors Tim R. Salomon
AbstractAuthor's information

    Germany reacted to the rise of piracy around the Horn of Africa not only by deploying its armed forces to the region, but also by overhauling the legal regime concerning private security providers. It introduced a dedicated licensing scheme mandatory for German maritime security providers and maritime security providers wishing to offer their services on German-flagged vessels. This legal reform resulted in a licensing system with detailed standards for the internal organisation of a security company and the execution of maritime security services. Content wise, the German law borrows broadly from internationally accepted standards. Despite deficits in state oversight and compliance control, the licensing scheme sets a high standard e.g. by mandating that a security team must consist of a minimum of four security guards. The lacking success of the scheme suggested by the low number of companies still holding a license may be due to the fact that ship-owners have traditionally been reluctant to travel high-risk areas under the German flag. Nevertheless, the German law is an example of a national regulation that has had some impact on the industry at large.


Tim R. Salomon
The author is a legal adviser to the German Federal Armed Forces (Bundeswehr) and currently seconded to the German Federal Constitutional Court.
Article

Access_open Armed On-board Protection of Danish Vessels Authorisation and Use of Force in Self-defence in a Legal Perspective

Journal Erasmus Law Review, Issue 4 2018
Keywords piracy, private security companies (PSC), privately contracted armed security personnel (PCASP), use of force, Denmark
Authors Christian Frier
AbstractAuthor's information

    This article examines the legal issues pertaining to the use of civilian armed guards on board Danish-flagged ships for protection against piracy. The Danish model of regulation is interesting for several reasons. Firstly, the Danish Government was among the first European flag States to allow and formalise their use in a commercial setting. Secondly, the distribution of assignments between public authorities and private actors stands out as very pragmatic, as ship owners and contracting private security companies are empowered with competences which are traditionally considered as public administrative powers. Thirdly, the lex specialis framework governing the authorisation and use of force in self-defence is non-exhaustive, thus referring to lex generalis regulation, which does not take the special circumstances surrounding the use of armed guards into consideration. As a derived effect the private actors involved rely heavily on soft law and industry self-regulation instrument to complement the international and national legal framework.


Christian Frier
Christian Frier is research assistant at the Department of Law, University of Southern Denmark. He obtained his PhD in Law in March 2019.
Article

Access_open Making Sense of the Law and Society Movement

Journal Erasmus Law Review, Issue 2 2018
Keywords law and society, sociology of law, sociolegal, empirical legal studies
Authors Daniel Blocq and Maartje van der Woude
AbstractAuthor's information

    This article aims to deepen scholarly understanding of the Law and Society Movement (L&S) and thereby strengthen debates about the relation between Empirical Legal Studies (ELS) and L&S. The article departs from the observation that ELS, understood as an initiative that emerged in American law schools in the early 2000s, has been quite successful in generating more attention to the empirical study of law and legal institutions in law schools, both in- and outside the US. In the early years of its existence, L&S – another important site for the empirical study of law and legal institutions – also had its center of gravity inside the law schools. But over time, it shifted towards the social sciences. This article discusses how that happened, and more in general explains how L&S became ever more diverse in terms of substance, theory and methods.


Daniel Blocq
Daniel Blocq is assistant professor at Leiden Law School.

Maartje van der Woude
Maartje van der Woude is professor at Leiden Law School.
Article

Access_open Empirical Legal Research in Europe: Prevalence, Obstacles, and Interventions

Journal Erasmus Law Review, Issue 2 2018
Keywords empirical legal research, Europe, popularity, increase, journals
Authors Gijs van Dijck, Shahar Sverdlov and Gabriela Buck
AbstractAuthor's information

    Empirical Legal research (ELR) has become well established in the United States, whereas its popularity in Europe is debatable. This article explores the popularity of ELR in Europe. The authors carried out an empirical analysis of 78 European-based law journals, encompassing issues from 2008-2017. The findings demonstrate that a supposed increase of ELR is questionable (at best).
    Moreover, additional findings highlight:

    • An increase for a few journals, with a small number of other journals showing a decrease over time;

    • A higher percentage of empirical articles for extra-legal journals than for legal journals (average proportion per journal is 4.6 percent for legal journals, 18.9 percent for extra-legal journals);

    • Criminal justice journals, environmental journals, and economically oriented journals being more likely to publish empirical articles than other journals;

    • More prestigious journals being more likely to publish empirical articles than less-prestigious journals;

    • Older journals being more likely to publish empirical work than younger journals, but not at an increasing rate;

    • Journals being legal/extra-legal, journals in a specific field, journal ranking, or the age of the journal not making it more (or less) likely that the journal will publish empirical articles at an increasing (or decreasing) rate.
      Considering the lack of convincing evidence indicating an increase of ELR, we identify reasons for why ELR is seemingly becoming more popular but not resulting in more empirical research in Europe. Additionally, we explore interventions for overcoming the obstacles ELR currently faces.


Gijs van Dijck
Professor of Private Law at Maastricht University, the Netherlands.

Shahar Sverdlov
Law student at the Vrije Universiteit Amsterdam, the Netherlands.

Gabriela Buck
Law student at Maastricht University, the Netherlands.
Article

Access_open Evidence-Based Regulation and the Translation from Empirical Data to Normative Choices: A Proportionality Test

Journal Erasmus Law Review, Issue 2 2018
Keywords evidence-based, regulation, proportionality, empirical law studies, law and society studies
Authors Rob van Gestel and Peter van Lochem
AbstractAuthor's information

    Studies have shown that the effects of scientific research on law and policy making are often fairly limited. Different reasons can be given for this: scientists are better at falsifying hypothesis than at predicting the future, the outcomes of academic research and empirical evidence can be inconclusive or even contradictory, the timing of the legislative cycle and the production of research show mismatches, there can be clashes between the political rationality and the economic or scientific rationality in the law making process et cetera. There is one ‘wicked’ methodological problem, though, that affects all regulatory policy making, namely: the ‘jump’ from empirical facts (e.g. there are too few organ donors in the Netherlands and the voluntary registration system is not working) to normative recommendations of what the law should regulate (e.g. we need to change the default rule so that everybody in principle becomes an organ donor unless one opts out). We are interested in how this translation process takes place and whether it could make a difference if the empirical research on which legislative drafts are build is more quantitative type of research or more qualitative. That is why we have selected two cases in which either type of research played a role during the drafting phase. We use the lens of the proportionality principle in order to see how empirical data and scientific evidence are used by legislative drafters to justify normative choices in the design of new laws.


Rob van Gestel
Rob van Gestel is professor of theory and methods of regulation at Tilburg University.

Peter van Lochem
Dr. Peter van Lochem is jurist and sociologist and former director of the Academy for Legislation.

    This paper examines three Inter-American Court (IACtHR) cases on behalf of the Enxet-Sur and Sanapana claims for communal territory in Paraguay. I argue that while the adjudication of the cases was successful, the aftereffects of adjudication have produced new legal geographies that threaten to undermine the advances made by adjudication. Structured in five parts, the paper begins with an overview of the opportunities and challenges to Indigenous rights in Paraguay followed by a detailed discussion of the adjudication of the Yakye Axa, Sawhoyamaxa, and Xákmok Kásek cases. Next, I draw from extensive ethnographic research investigating these cases in Paraguay to consider how implementation actually takes place and with what effects on the three claimant communities. The paper encourages a discussion between geographers and legal scholars, suggesting that adjudication only leads to greater social justice if it is coupled with effective and meaningful implementation.


Joel E. Correia Ph.D.
Postdoctoral Research Associate in the Center for Latin American Studies at the University of Arizona.

    In the process of adjudication and litigation, indigenous peoples are usually facing a very complex and demanding process to prove their rights to their lands and ancestral territories. Courts and tribunals usually impose a very complex and onerous burden of proof on the indigenous plaintiffs to prove their rights over their ancestral territories. To prove their rights indigenous peoples often have to develop map of their territories to prove their economic, cultural, and spiritual connections to their territories. This article reflects on the role played by the mapping of indigenous territories in supporting indigenous peoples’ land claims. It analyses the importance of mapping within the process of litigation, but also its the impact beyond the courtroom.


Jeremie Gilbert PhD
Jeremie Gilbert is professor of Human Rights Law, University of Roehampton.

Ben Begbie-Clench
Ben Begdie-Clench is a consultant working with San communities in southern Africa.

    Indigenous claims have challenged a number of orthodoxies within state legal systems, one of them being the kinds of proof that can be admissible. In Canada, the focus has been on the admissibility and weight of oral traditions and histories. However, these novel forms are usually taken as alternative means of proving a set of facts that are not in themselves “cultural”, for example, the occupation by a group of people of an area of land that constitutes Aboriginal title. On this view, maps are a neutral technology for representing culturally different interests within those areas. Through Indigenous land use studies, claimants have been able to deploy the powerful symbolic capital of cartography to challenge dominant assumptions about “empty” land and the kinds of uses to which it can be put. There is a risk, though, that Indigenous understandings of land are captured or misrepresented by this technology, and that what appears neutral is in fact deeply implicated in the colonial project and occidental ideas of property. This paper will explore the possibilities for an alternative cartography suggested by digital technologies, by Indigenous artists, and by maps beyond the visual order.


Kirsten Anker Ph.D.
Associate Professor, McGill University Faculty of Law, Canada. Many thanks to the two anonymous reviewers for their frank and helpful feedback.
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