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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

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.
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