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Will the EU Clinical Trials Regulation Support the Innovative Industry in Bringing New Medicines Faster to Patients?

Atzor, Sabine; Gokhale, Surendra; Doherty, Michael
Fonte: Springer International Publishing Publicador: Springer International Publishing
Tipo: Artigo de Revista Científica
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A perspective from the innovative industry is provided in this article about the long awaited legal proposal for a Clinical Trial Regulation (“Proposal”), adopted in July 2012. With this Proposal, the European Commission reacted to a call by all stakeholders for more harmonization and streamlining of the provisions for conducting clinical trials in the EU. Discrepant approaches between Member States, a failure to respect legal timelines, and a lack of formal coordination mechanisms within and between Member States have resulted in an increased workload for the industry and contributed to a decline in Europe’s attractiveness as a place to carry out research and development. The Proposal introduces a concept whereby the sponsor makes a single submission of the clinical trial application dossier to an EU portal, which is followed by a single assessment based on cooperation between Member States. A possibility for the sponsor to choose a ‘reporting Member State’ to take the lead on key aspects of the assessment is expected to support excellence building and work sharing of Competent Authorities in the EU. The Proposal respects the fact that certain aspects need to be reviewed nationally. The new process aims to lead to a single decision per clinical trial per concerned Member State. The rules are built on the principle of strict adherence to timelines for authorization. The timelines are ambitious but at the same time competitive...

Electrochemical and Thermodynamic Properties of Ln(III) (Ln = Eu, Sm, Dy, Nd) in 1-Butyl-3-Methylimidazolium Bromide Ionic Liquid

Yang, Xiao; He, Ling; Qin, Song; Tao, Guo-Hong; Huang, Ming; Lv, Yi
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 21/04/2014 Português
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The electrochemical behavior and thermodynamic properties of Ln(III) (Ln = Eu, Sm, Dy, Nd) were studied in 1-butyl-3-methylimidazolium bromide ionic liquid (BmimBr) at a glassy carbon (GC) electrode in the range of 293–338 K. The electrode reaction of Eu(III) was found to be quasi-reversible by the cyclic voltammetry, the reactions of the other three lanthanide ions were regarded as irreversible systems. An increase of the current intensity was obtained with the temperature increase. At 293 K, the cathodic peak potentials of −0.893 V (Eu(III)), −0.596 V (Sm(III)), −0.637 V (Dy(III)) and −0.641 V (Nd(III)) were found, respectively, to be assigned to the reduction of Ln(III) to Ln(II). The diffusion coefficients (Do), the transfer coefficients (α) of Ln(III) (Ln = Eu, Sm, Dy, Nd) and the charge transfer rate constants (ks) of Eu(III) were estimated. The apparent standard potential (E0*) and the thermodynamic properties of the reduction of Eu(III) to Eu(II) were also investigated.

Desenvolvimento de Modelos Químico - Quânticos para o Estudo de Complexos com Íons Lantanídeos e Actinídeos

Oliveira Freire, Ricardo; Mayall Simas, Alfredo (Orientador)
Fonte: Universidade Federal de Pernambuco Publicador: Universidade Federal de Pernambuco
Tipo: Outros
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Desde a sua concepção em 1994, o modelo SMLC, Sparkle Model for Lanthanide Complexes, tem sido utilizado apenas para o cálculo das geometrias do estado fundamental de complexos de Eu(III). Neste trabalho, aperfeiçoamos em muito este modelo para o íon Eu(III) e iniciamos o procedimento de extensão do mesmo para os outros íons lantanídeos. Desenvolvemos também uma versão do modelo para actinídeos, SMAC/AM1, em particular para o íon Th(IV). No processo de parametrização destes modelos, dois pontos são de fundamental importância: (i) a escolha de um conjunto de treinamento capaz de representar bem o nosso universo de estruturas de complexos e (ii) a escolha de uma função resposta capaz de possibilitar a reprodução satisfatória das propriedades de interesse, que no nosso caso foram comprimentos e ângulos de ligação envolvendo o íon metálico. Na primeira etapa, a escolha certa de um pequeno, mas representativo conjunto de treinamento foi fundamental, pois no processo de parametrização estas estruturas foram calculadas milhares de vezes até que os parâmetros capazes de reproduzir mais exatamente as estruturas cristalográficas fossem encontrados. Por este motivo, realizamos uma análise de agrupamentos hierárquicos para cada íon utilizando todas as estruturas disponíveis no CSD (Cambridge Structural Database 2003). Esta análise resultou...

Evaluation of the EU-Turkey Customs Union

World Bank
Fonte: Washington, DC Publicador: Washington, DC
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The implementation of the customs union (CU) in 1995 was the culmination of thirty-two years of association between the European Union (EU) and Turkey and was expected by Turkey to be the first step in the EU accession process. The CU has been a major instrument of integration for the Turkish economy into both European and global markets. The CU covers trade in just industrial goods (including the industrial components of processed agricultural products) and excludes primary agriculture, services, and public procurement but has proved to be a powerful force of regulatory convergence. The evaluation s objectives are to assess the impacts of the CU and to make forward looking, solution-orientated recommendations for its improvement with an emphasis on the economics behind the various trade irritants and options for dealing with problems related to asymmetries as well as examining the case for widening. The evaluation provides quantitative and qualitative estimates of the effects of the CU and demonstrates that the trade agreement has been highly beneficial for both Turkey and the EU. The evaluation consists of two main parts: (i) an evaluation of the impact of the CU on trade...

When is foreign policy not foreign policy? Cotonou, CFSP and external relations with the developing world

Holland, Martin
Fonte: Universidade Nacional da Austrália Publicador: Universidade Nacional da Austrália
Tipo: Working/Technical Paper Formato: 113323 bytes; 352 bytes; application/pdf; application/octet-stream
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Introduction: This paper attempts to discuss the EU’s external relations with the Developing World within the context of the Cotonou Agreement and the CFSP. While CFSP and Cotonou operate formally under distinct and autonomous mechanisms, it is argued here that despite this pillarisation of policy spheres and the narrow definition of EU foreign affairs, development policy forms a core element in EU foreign policy and is linked, consequently, to a broader understanding of CFSP. The paper falls into two parts: one locating the context within which EU development policy might be discussed; the other discussing the actual development policy reforms since 2000. Part one addresses a series of questions. First, the appropriate theoretical context for discussing EU development policy is debated. Second, the linkages between development policy and CFSP are examined. And third, the very basis of an EU development policy is considered in relation to the principle of subsidiarity. Part two examines the motivations behind the reform of EU development policy, discusses the central policy innovations proposed, and concludes by exploring the potential areas of future policy conflict that might arise. Undoubtedly, these are ambitious objectives in such a limited space: however...

Citizens‘ deliberations and the EU democratic deficit: Is there a model for participatory democracy?

Abels, Gabriele
Fonte: Universität Tübingen Publicador: Universität Tübingen
Tipo: ResearchPaper
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There is a longstanding debate on the EU’s democratic deficit. Recently, the EU has responded to this by, for example, including the idea of participatory democracy in the Lisbon treaty. This corresponds to first experiments with means for citizens’ participation that are rooted in the idea of participatory and deliberative democracy and supported by the EU Commission. In contrast to interest group politics, these attempts aim at including ‘normal’, i.e. non-interested and unorganized citizens into policy-making. Examples of such ‘democratic experimentalism’ are the citizens’ deliberation ‘Meeting of Minds’ or the European Citizens’ Consultations on Europe’s future. The objective of the paper is to discuss these models and their specific problems against the background of the general democratic deficit debate. The key questions are: Are these examples ‘best practices’? What are their effects? And what can we learn from them for the possibilities of participatory governance in the EU?; Seit geraumer Zeit wird intensiv über das Demokratiedefizit der EU diskutiert. In jüngster Zeit hat die EU auf dieses Defizit reagiert, indem z.B. die Idee einer partizipatorischen Demokratie Eingang in den Reformvertrag von Lissabon fand. Damit einher gehen erste Experimente mit Instrumenten der Bürgerbeteiligung...

Eff ective Multilateralism and the EU as a Military Power: Th e Worldview of Javier Solana

BARROS-GARCIA, Xiana
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Trabalho em Andamento Formato: 299566 bytes; application/pdf; digital
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The worldview of Javier Solana, first holder of the post of European Union High Representative for the Common Foreign and Security Policy, depicts a multipolar world which is full of negotiable conflicts. As a result of the impact of globalisation, member states are pressed to integrate further in the EU. Solana portrays an international scene where the EU enjoys a positive international image and which is favourable to a greater role for the EU. However, the EU is far from fulfilling its potential due to several ‘internal’ obstacles. These impediments come solely from inside Europe and the lack of adequate EU military capabilities ranks high among them. Regarding the objectives of the EU foreign policy, Javier Solana does not perceive any trade-off between the values and interest. Although Solana’s concept of multilateralism is decidedly flexible, one of the EU priorities is pushing for a more multilateral international scene. To conclude, Javier Solana aims with his worldview to represent, shape and, maybe more importantly, implement the existent European consensus in foreign affairs.

E Pluribus Europa? Assessing the Viability of the EU

GLENCROSS, Andrew
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Tese de Doutorado Formato: application/pdf; digital
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As a novel and complex polity, also subject to endless proposals for institutional reform, the viability of the EU is an open but under-theorized question. This thesis conceptualizes EU viability from an internal perspective, that is, the viability of the process of integration rather than Europe as a viable actor in international politics. Adopting the concept of a compound polity to understand the tensions inherent in the EU, viability is defined in relation to the -rules of the game- of this compound system. This gambit has a twofold purpose. Firstly, it permits an analogy with another historical case of a compound system, the antebellum US republic. Secondly, it enables the specification of two scenarios of viability in a compound polity: dynamic equilibrium and voluntary centralization. Four aspects of the rules of the game (institutions, expectations, competence allocation and representative functions) are analysed to determine which scenario the EU follows. The analogy with the early US and its own conflicts over these four elements of the rules of the game is then contrasted with the EU experience. Five differences in how these disputes arise and the means for trying to settle them are singled out to explain the differing problems of viability in both compound polities. The results of this analogical analysis are then used to explore the appropriateness of certain proposed changes to the rules of the game in the EU...

The Future of the EU Cultural Policy in the Protection of Intangible Cultural Heritage

LIXINSKI, Lucas
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Artigo de Revista Científica
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The protection of cultural heritage, especially of the intangible type, is a growing international concern. International legal instruments and policy initiatives on the protection of cultural heritage multiply worldwide, and we experience a true “heritage fever”. Considering this scenario, it is only to be expected that the European Union is also involved in the protection of cultural heritage. Article 151 of the current Treaty Establishing the European Community lays down the provisions on the protection of culture and cultural heritage for the EC. It mentions cooperation among Member States, and the special significance of a common European cultural heritage. The Treaty of Lisbon (2007), to enter into force, makes only small changes to this provision, and the amended Treaty on the Functioning of the European Union will keep the provision that determines the exclusion of the harmonization of laws and regulations in the Member States in cultural matters from the reach of the EU. This paper will analyze the current state of affairs of the cultural policy of the EU in terms of protection of cultural heritage, and will assess whether the maintenance of the current policy under the Lisbon Treaty is positive. I argue that the EU, as an international player of great importance...

The Perception of the EU as an Emerging Security Actor in Media Debates on Humanitarian and Military Interventions (1990-2006)

KANTNER, Cathleen; KUTTER, Amelie; RENFORDT, Swantje
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Trabalho em Andamento
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Next to states and established international organisations, the European Union is emerging as an actor in the realm of international conflict management. Has the media in the EU Member States reflected this change? Our study reveals that the EU, despite its limited institutional capacity in external security affairs, is present in media coverage on international conflict management. Awareness of EU institutions and other EU Member States has increased over time. This pattern is evident in all selected EU Member States, whereas it is considerably less pronounced in the US. The findings point to an appropriate media perception of EU foreign and security policy and to an emerging European problem-solving community. The study is based on a systematic content and corpus-linguistic analysis of a large data set encompassing 16 years of mass media coverage of humanitarian and military interventions in Austria, France, Germany, Ireland, the Netherlands, the UK and the US.; Issued by ARENA, Oslo - http://www.reconproject.eu/projectweb/portalproject/RECONWorkingPapers.html

The Charter of Fundamental Rights: History and Prospects in Post-Lisbon Europe

ANDERSON Q.C., David; MURPHY, Cian C.
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Trabalho em Andamento Formato: application/pdf; digital
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The EU Charter of Fundamental Rights has been incorporated into European constitutional law ten years after it was adopted by the EU institutions. In that time the Charter developed from a ‘solemn proclamation’ to a persuasive authority before the European Courts and now a binding Charter for the EU. It has been referred to in the case-law of both the European Court of Justice and the European Court of Human Rights. However, the Charter’s history and future are the subject of political contest and academic debate. Along with the accession to the European Convention on Human Rights, it is likely to provide much scope for debate in coming years. This paper assesses the Charter’s development from a proposal to increase EU legitimacy to its current status as the Union’s own Bill of Rights. It examines the rights protected by the Charter, their sources and how they may be interpreted in light of the ‘Explanations’ in the Official Journal. The case-law of the European Courts on the Charter is catalogued and analysed to determine the Charter’s likely value in human rights litigation. Finally, the chapter analyses the application of the Charter across the EU and considers its implications in the Member States that have limited its effect. Three related themes are woven throughout the analysis: the conflicting motivations of the Member States and the EU institutions...

Values in EU Foreign Policy

CREMONA, Marise
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Parte de Livro
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The focus of this chapter is on the role played in the EU’s foreign policy by those values which the EU claims as (in some sense) ‘its own’, and the legal instruments and processes through which values are both imported into, and exported from, the EU legal order. Values may be presented both as characteristic of the Union’s identity, and as the key to achieving specific Union objectives, especially security and stability within Europe and its neighbourhood. The external dimension of the EU’s values, which is the subject of this chapter, reflects both these constitutive and instrumentalist aspects. The aim is not to discuss the nature and content, or the ‘European’ or universal character, of specific values. Indeed, we shall start from the position that in order to lead to concrete outcomes, the ‘values’ which have a symbolic significance for the EU must find practical expression in legal norms. These norms, whether derived from the Treaties or imported into the EU legal order, may take on a foundational or constitutional character and thus become constitutive of the Union’s identity and its self-perception (and self-projection) as an international actor. The need to justify and to conceptualise the increasingly important role played in particular by human rights...

The Impact of Climate and Energy Policies on the Public Budget of EU Member States

OLMOS, Luis; RUESTER, Sophia; SARTORI, Martina; PAZIENZA, Maria Grazia; RANCI, Pippo; GLACHANT, Jean-Michel; GALEOTTI, Marzio
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Relatório Formato: application/pdf; digital
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In the current context, where public budgets are overstretched due to the economic crisis, there is a pressing need to understand the fiscal implications of climate policies. Policies intended to achieve decarbonization will impact both sides of a country’s budget via changes in the tax levels and composition of taxes on the one hand, as well as transfer payments and direct investments on the other. Back-of-the-envelope calculations – comparing net public revenues in 2020 for a Baseline and an Enhanced Policy scenario – show that the additional revenues from carbon pricing and the reduction in revenues from excise taxes on fossil fuels clearly dominate other direct and indirect effects of policies on public budgets such as the additional expenditures dedicated to RD&D targeting low-carbon technologies. The aggregated net budget impact of all direct and indirect effects of new climate policies implemented in the Enhanced Policy Scenario on public budgets in 2020 for the EU-27 as a whole – given our simplyfying assumptions – amounts to additional net public revenues of about €12.6bn (0.09% in terms of the EU-27 GDP) under medium-level abatement costs. This makes a non-negligible impact which is nevertheless much lower than the impact on public accounts from changes in main macroeconomic variables over time. Differences among Member States mainly depend on the additional revenues they will obtain from carbon pricing...

EU-India Bilateral Remittances

TUMBE, Chinmay
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Relatório Formato: application/pdf; digital
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A hundred years ago, during colonial times, more than a hundred thousand migrants from Britain and Ireland worked in India, mostly as soldiers and administrators. In contrast, only around 4,000 Indians lived in Britain: 1,000 students and 2,500 persons working in navigation related activities. As a result, European countries were net recipients of migrants’ remittances from India. A century later, nearly a million emigrants from India live in the countries of the European Union (EU) and less than 10,000 EU expatriates work in India, making India a net recipient of migrants’ remittances from the EU. Considering the significantly large Indian emigrant base in the EU, few questions that emerge are: How much money flows from the EU to India by way of migrants’ remittances? What part of emigrant capital flows are sourced from the EU? And what are the country shares of these remittance flows? This paper attempts to address these questions basing its analysis on data compiled from numerous reports published by the Reserve Bank of India over the last three decades.; CARIM-India is co-financed by the European University Institute and the European Union.; CARIM-India: Developing a knowledge base for policymaking on India-EU migration

India-EU Engagement and International Migration: Challenges and policy imperatives

POTNURU, Basant Kumar; VISHISHTA, Sam
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Relatório Formato: application/pdf; digital
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In the absence of a multilateral framework and a rule based global structure for the governance of international migration of people in all its complexities, countries engage in bilateral or regional cooperation in an attempt to engage and harmonize international movements and strive for a win-win situation. India and the EU are major trading partners and are engaged in a strategic Joint Action Plan with annual summit level talks; both sides are on the cusp of a new beginning through the soon to be concluded Free Trade Agreement (FTA). India-EU engagements, while underlining the importance of engagement on movement of people, have not clearly spelt out, as of yet, any roadmap for facilitation and enhancement of movement of people between the regions. The current paper examines if, and how, the bilateral relationship or engagement between India and the EU over the years has influenced international migration flows between the two sides and what potential challenges and policy options they face for a successful engagement and facilitation of movement of people. The paper suggests that given India’s strategic position as a major country of origin for skilled and semi-skilled migrant workers, coupled with foreseeable requirements in the EU domestic markets. There is need for a closer examination of policy initiatives to embrace bilateral flows and make the exercise beneficial for both partners. The International migration flows between India and Europe in the past had always depended on the quality and strength of engagement between the countries and regions. Currently...

EU Energy Law and Policy Yearbook 2012

Fonte: Claeys & Casteels Publicador: Claeys & Casteels
Tipo: Livro
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The EU Energy Law & Policy Yearbook offers insights into the most recent opinions, assessments and tendencies in EU energy law and policy making. Like previous editions, it draws upon the various contributions from the annual Claeys & Casteels conference on ‘EU Energy Law & Policy’, which took place for the 7th time in 2012 in Brussels. It incorporates policy papers and academic articles, including keynote speeches and presentations by many distinguished academics and high-level officials from European institutions and industry. Topics include: the 2050 Energy Roadmap, practical priorities of the European Commission in respect of the completion of the internal energy market, the Energy Infrastructure Package, the EU Emissions Trading Scheme, energy efficiency and renewables policies, the security of energy supply, latest developments in competition law, recent Commission Decisions in the area of state aid.; PART I THE ENERGY PRIORITIES OF THE EU PART II THE INTERNAL ENERGY MARKET PART III ACHIEVING THE 20-20-20 TARGETS AND BEYOND PART IV THE SECURITY OF SUPPLY IN THE EU PART V THE EU COMPETITION POLICY AND THE ENERGY MARKETS

Refugee resettlement in the EU : 2011-2013 report

Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Relatório Formato: application/pdf; digital
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Know Reset aimed at conducting a systematic inventory of resettlement frameworks and practices in the EU, providing a comparative analysis and assessment of resettlement in the Member States, evaluating their resettlement capacity while addressing policy recommendations to the EU and its Member States in order to enhance cooperation and improve resettlement activities. To better understand Member States’ decision-making and better explore the potential for developing resettlement capacity in the EU, the Project has covered the 27 EU Member States whatever the nature and degree of their involvement in refugee resettlement. Unique field research has also been conducted in three major countries of first asylum (Kenya, Pakistan, Tunisia) by external experts hired for the Project, who dedicated their observation and analysis on EU Member States resettlement practices in the pre-departure phase. The Final Report compiles various deliverables of the Know Reset Project: a series of tables and graphs for quantitative and qualitative country comparison, 27 "Resettlement Country Profiles", 3 Country of First Asylum Reports and 2 EU Comparative Reports.; KNOW RESET - Building Knowledge for a Concerted and Sustainable Approach to Refugee Resettlement in the EU and its Member States; KNOW RESET is co-financed by the European University Institute and the European Union.

Facilitating migration between India and the EU : a policy perspective

GUPTA, Pralok
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Relatório Formato: application/pdf; digital
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Global migration to the European Union (EU) has expanded significantly since the 1990s and is being considered as an important tool to resolve domestic labour shortages in many of its Member States. Migration from India to the EU has so far not been significant except in the case of a few Member States and a few sectors. Nonetheless, there is a growing trend of Indians emigrating to the EU and the governments on both sides have also started looking at facilitating migration between the two regions. The emigration policies of the Indian Government and the policy orientation of the EU governments towards Indian migrants are important not only in deciding the quantum of Indian emigrants going to the EU but also their choice of destination country within the EU. Policy facilitation is also important for preventing exploitation of Indian emigrants both before and after leaving India.; CARIM-India: Developing a knowledge base for policymaking on India-EU migration; CARIM-India is co-financed by the European University Institute and the European Union

The EU as a family- friendly destination? : Family reunification rights for Indian nationals in the EU and Access of family members to the Labour Market

EISELE, Katharina; HEIMANN, Carla
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Relatório Formato: application/pdf; digital
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This article analyses and evaluates the family reunification schemes for Indian nationals in the EU with a focus on the three EU Member States the Netherlands, Germany and Denmark from a comparative legal perspective. First, the EU legislation governing the reunification of families is examined that is applicable to third-country nationals regardless of nationality. Second, this article investigates how the national laws of the selected three Member States are designed, in which respect they are favourable or not, and whether the legal frameworks allow family members to become part of the labour force in the host Member State. These analyses allow to draw a number of conclusions as to how “family-friendly” the EU and some of its Member States present themselves, and whether the legal schemes under review promote the objective of making the EU more attractive as destination for third-country workers, including Indian nationals.; CARIM-India: Developing a knowledge base for policymaking on India-EU migration; CARIM-India is co-financed by the European University Institute and the European Union

Limits to EU powers : a case study on individual criminal sanctions for the enforcement of EU law

ÖBERG, Jacob
Fonte: Instituto Universitário Europeu Publicador: Instituto Universitário Europeu
Tipo: Tese de Doutorado Formato: application/pdf; digital
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The question posed by this thesis is how limits can be constructed to the exercise of EU powers. While there are limits to the exercise of EU competences in the Treaties and in the Court of Justice’s jurisprudence, it is argued that those limits suffer from conceptual and practical problems. In particular, the Court does not have appropriate criteria to examine whether the limits of the Treaties have been exceeded by the Union legislator. The thesis uses one of the new, and controversial, competences that the Union has obtained, the power to impose criminal sanctions, as a case study to propose a mechanism by which legislative powers can be kept in check. This is an illuminating and relevant case study. Firstly, it nicely illustrates the limits to the exercise of EU competences. Secondly, legislative practice and political statements suggest that this competence will be used regularly in the future. The thesis makes two proposals. First, by interpreting the scope of the EU’s powers under the Treaties to impose criminal sanctions the thesis shows the limits to the exercise of EU competences. It demonstrates the scope of EU’s competences by analyzing current and proposed criminal law measures. Secondly, noting that a construction of the limits to EU competences also needs to tackle the institutional challenges of judicial review...