Search result: 8 articles

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Year 2019 x
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

Access_open Mercosur: Limits of Regional Integration

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

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


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

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.
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 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 International Commercial Courts in France: Innovation without Revolution?

Journal Erasmus Law Review, Issue 1 2019
Keywords international commercial court, dispute resolution, business court, Brexit, judicial system
Authors Alexandre Biard
AbstractAuthor's information

    In 2018, in the wake of Brexit, the French legal profession took several important measures to strengthen the competitiveness of France and the French legal system, and to make Paris an attractive go-to-point for businesses when the latter have to deal with international commercial litigation. When taking a closer look at it, Brexit is only the top of the iceberg, and has mostly served as a catalyst. Reasons explaining the development of international commercial courts in France are manifold. They are consequences of long-standing efforts aimed at boosting the French judicial marketplace to adapt it to the requirements of globalization and to the expectations of multinational corporations. The setting-up of the French international business courts has made several procedural adjustments necessary. Although the latter undoubtedly represent clear innovations, they however do not constitute a full-blown revolution. France has indeed decided to maximize already-existing procedural rules, combined with a new organisational format inspired by the Common Law tradition. If it remains too early to draw clear conclusions on the impact of these new developments, it is essential to keep our ears to the ground, and to be forward-looking. We should carefully consider the possible side-effects on the French justice system considered as a whole, and in particular wonder whether these international commercial courts might in the future open the door to broader far-reaching evolutions within the judicial system. Finally, the multiplication of international business courts across Europe nowadays triggers some questions concerning the role and potential added value of an EU initiative in this domain.


Alexandre Biard
Postdoctoral researcher, Erasmus University Rotterdam.
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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