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M.I. Kouskouna
Assistant Professor in EU Law, Law School, National and Kapodistrian University of Athens
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 What Is Left of the Radical Right?

The Economic Agenda of the Dutch Freedom Party 2006-2017

Journal Politics of the Low Countries, Issue 2 2019
Keywords radical right-wing populist parties, economic policies, welfare chauvinism, populism, deserving poor
Authors Simon Otjes
AbstractAuthor's information

    This article examines the economic agenda of the Dutch Freedom Party. It finds that this party mixes left-wing and right-wing policy positions. This inconsistency can be understood through the group-based account of Ennser-Jedenastik (2016), which proposes that the welfare state agenda of radical right-wing populist parties can be understood in terms of populism, nativism and authoritarianism. Each of these elements is linked to a particular economic policy: economic nativism, which sees the economic interest of natives and foreigners as opposed; economic populism, which seeks to limit economic privileges for the elite; and economic authoritarianism, which sees the interests of deserving and undeserving poor as opposed. By using these different oppositions, radical right-wing populist parties can reconcile left-wing and right-wing positions.


Simon Otjes
Assistant professor of political science at Leiden University and researcher at the Documentation Centre Dutch Political Parties of Groningen University.
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.

János Martonyi
Professor emeritus, University of Szeged; former Minister of Foreign Affairs (1998-2002 and 2010-2014).
Article

How Not to Build a Monetary Union?

The Structural Weaknesses of the EMU in the Light of the 2008 Crisis and the Institutional Reforms for Their Correction

Journal Hungarian Yearbook of International Law and European Law, Issue 1 2018
Authors György Marinkás
Author's information

György Marinkás
Assistant professor, University of Miskolc.
Article

Access_open Sustainable Enjoyment of Economic and Social Rights in Times of Crisis

Obstacles to Overcome and Bridges to Cross

Journal European Journal of Law Reform, Issue 4 2018
Keywords social and economic rights, austerity measures, Euro crisis, defaulting countries
Authors Dr. Natalie Alkiviadou
AbstractAuthor's information

    In 2008, the European Union was hit by the most severe financial downturn since the Great Recession of the 1930s. One of the major consequences of this phenomenon was the deterioration in the enjoyment of human rights, in particular economic and social rights. While it is indisputable that the crisis itself was directly correlated to the erosion of such rights, the conditions attached to the loan agreements between defaulting countries and the three lending institutions, namely the International Monetary Fund (IMF), the European Central Bank and the European Commission, have negatively affected the rights under consideration. Loans came with strict austerity measures, such as public expenditure cuts in the realm of, inter alia, public services, benefits and social security. This article considers the deterioration in the enjoyment of economic and social rights by Union inhabitants and particularly the anti-crisis strategy adopted by the European Union, which, as will be demonstrated, directly contributed to this deterioration. The stance of the three institutions was facilitated by the less than proactive, but improving, positioning of the Court of Justice of the European Union in case law, which will be assessed. It must be noted that it is not the three institutions acting alone in this process; the Member States are the ones who agree to the loans and their conditions and implement austerity measures on the ground. However, as will be reflected, the practical role and actual input of the countries themselves in this procedure is limited. The central theoretical tenet of the article is that the European Union is re-shifting its direction to the almost absolute adoption of an economic constitution, with little regard to its social counterpart. Within the aforementioned framework, this article seeks to assess the status of economic and social rights in a crisis-hit Union, provide a theoretical explanation for this occurrence and put forth possibilities for positive change, placing the protection and promotion of economic and social rights at the heart of any responses to crisis as a method to ensure their sustainable protection effectively.


Dr. Natalie Alkiviadou
Dr Natalie Alkiviadou is a Lecturer at the University of Central Lancashire Cyprus.
Article

The Sovereign Strikes Back

A Judicial Perspective on Multi-Layered Constitutionalism in Europe

Journal European Journal of Law Reform, Issue 2-3 2018
Keywords Constitutional identity, constitutionalism, fragmentation, globalization, multilayered constitution, sovereignty, trust
Authors Renáta Uitz and András Sajó
AbstractAuthor's information

    The supranational web of public law is often described as a new constitutionalism. It emerged in a globalized world together with global markets. In the course of the multilayered constitutional experiment, the old, national constitutional framework had lost its ability to deliver on the key features associated with constitutionalism: limiting the exercise of political powers and preventing the arbitrary exercise thereof. In the multilayered era it has become difficult to pinpoint the centre of authority. Ultimately, someone needs to govern, if not for other reasons, at least to avoid chaos. Is it possible to have the guarantees of freedom, rule of law and efficiency that a constitutional democracy seems to provide in a system where there is no sovereign with authority?


Renáta Uitz
Renáta Uitz is Professor, Chair of the Comparative Constitutional Law Program, Department of Legal Studies, Central European University, Budapest.

András Sajó
András Sajo is University Professor, Central European University, Budapest. This volume (The EU Bill of Rights’ Diagonal Application to Member States. Ed. Csongor István Nagy) was published as part of the research project of the HAS-Szeged Federal Markets ‘Momentum’ Research Group.
Article

The Politicization of ex post Policy Evaluation in the EU

Journal European Journal of Law Reform, Issue 1-2 2017
Keywords policy evaluation, Better Regulation, participation, REFIT, politicization
Authors Stijn Smismans
AbstractAuthor's information

    The European Commission’s 2015 Better Regulation package has placed ex post evaluation at the centre of European governance. This strengthens a trend of gradual politicization of evaluation in European policymaking. This article analyses how the European Commission’s approach to ex post policy evaluation has changed over the last decade. It shows how evaluation has developed from a rather technical process to a more politicized process, which is clearly linked to political priority setting, subject to centralized control, and involving a wider set of actors. At the same time, the Commission avoids a profound debate on the merits and objectives of the process of evaluation itself. The article concludes on the merits and risks of evaluation at times of rising populism.


Stijn Smismans
Stijn Smismans is a professor of law at the School of Law and Politics and director of the Centre for European Law and Governance at Cardiff University.

Thibaut Renson
Thibaut Renson studeerde politieke wetenschappen in Gent, Aix-en-Provence en Londen. Hij is als assistent verbonden aan de vakgroep Politieke Wetenschappen van de UGent. Zijn onderzoeksinteresses liggen in burgerschap en politieke participatie. Hij werkt aan een doctoraat aan het Centrum voor Lokale Politiek, waarin hij het effect van deliberatieve democratie op sociaal leren in kaart brengt. In maart 2017 verschijnt het boek Wie is nog van de partij? Crisis en toekomst van partijleden in Vlaanderen bij Uitgeverij Acco, waarin hij meeschreef aan de hoofdstukken over participatie en democratie.
Article

Asymmetry as an Instrument of Differentiated Integration

The Case of the European Union

Journal European Journal of Law Reform, Issue 2 2016
Keywords asymmetry, comparative and EU law, differentiated integration, crisis, economic governance
Authors Giuseppe Martinico
AbstractAuthor's information

    This article offers a reflection on asymmetry as an instrument of differentiated integration in the current phase of the EU integration process. As for the structure, this work is divided into four parts: First, I shall clarify what I mean by asymmetry as an instrument of integration relying on comparative law. This comparative exercise is particularly useful because it allows us to acknowledge the strong integrative function performed by asymmetry in contexts different from but comparable to the EU system. Second, I shall look at EU law and recall the main features of asymmetry in this particular legal system. In the third part of the article I shall look at the implications of the financial crisis, which has increased the resort to asymmetric instruments. In the last part I shall deal with some recent proposals concerning the differentiated representation of the Eurozone. The idea of differentiated integration and that of asymmetry have been extended and adapted to many different processes by scholars over the years, but to avoid misunderstandings I would like to make clear that in this work I shall analyse those forms of asymmetries that are allowed and carried out only when respect for an untouchable core of integration is guaranteed. This is crucial to conceive asymmetry as an instrument of integration.


Giuseppe Martinico
Associate Professor of Comparative Public Law, Scuola Sant’Anna, Pisa; Research Fellow, Centre for Studies on Federalism, Turin; Honorary Professor at the European law research centre, University of Henan, Kaifeng, China. Article Completed on 23 February 2016. This article is part of the project "Gobernanza económica europea y transformación constitucional”, (MINECO, DER2014-57116P).
Article

Access_open The Erosion of Sovereignty

Journal Netherlands Journal of Legal Philosophy, Issue 2 2016
Keywords sovereignty, state, Léon Duguit, European Union, Eurozone
Authors Martin Loughlin
AbstractAuthor's information

    This article presents an account of sovereignty as a concept that signifies in jural terms the nature and quality of political relations within the modern state. It argues, first, that sovereignty is a politico-legal concept that expresses the autonomous nature of the state’s political power and its specific mode of operation in the form of law and, secondly, that many political scientists and lawyers present a skewed account by confusing sovereignty with governmental competence. After clarifying its meaning, the significance of contemporary governmental change is explained as one that, in certain respects, involves an erosion of sovereignty.


Martin Loughlin
Martin Loughlin is Professor of Public Law at the London School of Economics and Political Science and EURIAS Senior Fellow at the Freiburg Institute of Advanced Studies (FRIAS).

Anastasia Karatzia
Assistant Professor in EU law, Department of International and European Union Law, Erasmus School of Law, Erasmus University Rotterdam.

Menelaos Markakis
DPhil Candidate in Law, University of Oxford, Researcher, Erasmus University of Rotterdam.
Symposium

Europa na het Brexit-referendum

Journal Res Publica, Issue 4 2016
Authors Mathieu Segers, Sander Loones and Goele Janssen
Author's information

Mathieu Segers
Mathieu Segers is hoogleraar eigentijdse Europese geschiedenis en Europese integratie aan de Universiteit Maastricht.

Sander Loones
Sander Loones is Europarlementslid en N-VA-ondervoorzitter.

Goele Janssen
Goele Janssen is directrice van de Europese Beweging in België.

Wouter Wolfs
Wouter Wolfs is aspirant van het FWO aan het Instituut voor de Overheid aan de KU Leuven. Hij doet onderzoek naar parlementaire democratie in de Europese Unie, euroscepticisme en Europese politieke partijen. Hij bereidt een proefschrift voor over het financieringsregime van Europese partijen en stichtingen.

    This paper provides a dialectical-historical description of the EU's constitutional discourse. It is argued that the early Community's member state blind principle of justice implied the notion of a European political community and led to the establishment of fair procedures for decision making. This coming of age of an encompassing European constitutional narrative of justice and fairness prompted the question of the demarcation between the political role of the European political community and that of member states' political communities. The answer proved to be subsidiarity. However, subsidiarity has introduced national conceptions of justice in the Union's constitutional discourse, at the risk of making European justice dependent on national conceptions of justice.


Dries Cools
Dries Cools works at the National Bank of Belgium and holds a Master of Laws and a Master in Philosophy of the KU Leuven and an LL.M. of Harvard Law School.

Péter Fáykiss
Péter Fáykiss is the Head of the Macro-prudential policy department at the Magyar Nemzeti Bank (MNB), the central bank of Hungary. He graduated at Corvinus University of Budapest in 2009. After graduation, he joined MNB, where he worked as analyst at the Financial Stability Department. Between 2013 and 2014 he worked as Deputy Head of Financial Services Department at the Ministry for National Economy, and was responsible inter alia for the implementation of CRD IV in Hungary.

Dániel Papp
Dr. Daniel Papp is member of the Macro-prudential policy department at the Magyar Nemzeti Bank as a legal advisor. He graduated at ELTE law school in 2012. After having supervisory experience at the former Hungarian Financial Supervisory Authority, he was enrolled at LUND University for a postgraduate law course, called European Business Law (LL.M.). He made extensive research on the forming European supervisory framework, since his master thesis was about the Single Supervisory Mechanism and the Assessment of Hungary’s Possible Approach.

Anikó Szombati
Anikó Szombati leads the Macroprudential Directorate of Magyar Nemzeti Bank, the central bank of Hungary. This Directorate is responsible for the fulfillment of tasks originating from the Central Bank Act recognizing MNB as the macro-prudential authority of Hungary. The macro-prudential authority’s major task is to identify and mitigate system-wide risks in the financial intermediary system. The Directorate also contributes to the formulation of central bank opinion in major structural issues related to the financial sector developed either at EU or at the country level.

Ferdi De Ville
Ferdi De Ville is docent Europese Politiek aan het Centrum voor EU-Studies van de Universiteit Gent. Zijn onderzoeksbelangstelling gaat voornamelijk uit naar Europees handelsbeleid en de politiek-economische gevolgen van de eurocrisis.

Bertjan Wolthuis
Bertjan Wolthuis is Assistant Professor at the department of Legal Theory and Legal History at VU University Amsterdam.
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