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Davor Jancic the Barroso Initiative: Window Dressing Or Democracy Boost?
Davor Jancic The barroso initiative: window dressing or democracy boost? Article (Published version) (Refereed) Original citation: Jancic, Davor (2012) The barroso initiative: window dressing or democracy boost? Utrecht Law Review, 8 (1). pp. 78-91. ISSN 1871-515X © 2012 The Author This version available at: http://eprints.lse.ac.uk/51580/ Available in LSE Research Online: August 2013 LSE has developed LSE Research Online so that users may access research output of the School. Copyright © and Moral Rights for the papers on this site are retained by the individual authors and/or other copyright owners. Users may download and/or print one copy of any article(s) in LSE Research Online to facilitate their private study or for non-commercial research. You may not engage in further distribution of the material or use it for any profit-making activities or any commercial gain. You may freely distribute the URL (http://eprints.lse.ac.uk) of the LSE Research Online website. This article is published in a peer-reviewed section of the Utrecht Law Review The Barroso Initiative: Window Dressing or Democracy Boost? Davor Jančić* 1. Introduction: refurbishing EU parliamentary democracy Although historically five years is a negligible period of time, in European integration it can spark impor- tant developments. Such is the case with the so-called Barroso Initiative (the Initiative), named after João Manuel Durão Barroso, incumbent second-term President of the European Commission. The purpose of his Initiative is to reinforce the democratic basis of the Union by involving national parliaments of the Member States more closely in the EU policy-making processes beyond the texts of the founding treaties. -
The Principle of Subsidiarity and Its Enforcement in the EU Legal Order
The Principle of Subsidiarity and its Enforcement in the EU Legal Order The Role of National Parliaments in the Early Warning System Katarzyna Granat HART PUBLISHING Bloomsbury Publishing Plc Kemp House , Chawley Park, Cumnor Hill, Oxford , OX2 9PH , UK HART PUBLISHING, the Hart/Stag logo, BLOOMSBURY and the Diana logo are trademarks of Bloomsbury Publishing Plc First published in Great Britain 2018 Copyright © Katarzyna Granat , 2018 Katarzyna Granat has asserted her right under the Copyright, Designs and Patents Act 1988 to be identifi ed as Author of this work. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage or retrieval system, without prior permission in writing from the publishers. While every care has been taken to ensure the accuracy of this work, no responsibility for loss or damage occasioned to any person acting or refraining from action as a result of any statement in it can be accepted by the authors, editors or publishers. All UK Government legislation and other public sector information used in the work is Crown Copyright © . All House of Lords and House of Commons information used in the work is Parliamentary Copyright © . This information is reused under the terms of the Open Government Licence v3.0 ( http://www. nationalarchives.gov.uk/doc/open-government-licence/version/3 ) except where otherwise stated. All Eur-lex material used in the work is © European Union, http://eur-lex.europa.eu/ , 1998–2018. A catalogue record for this book is available from the British Library. -
Does Subsidiarity Ask the Right Question?
2. The Union shall also have exclusive competence for the conclusion of an internation- al agreement when its conclusion is provided for in a legislative act of the Union or is INSTITUTIONAL INNOVATIONS necessary to enable the Union to exercise its internal competence, or in so far as its con- clusion may affect common rules or alter their scope. Does Subsidiarity Ask the Right Question? But subsidiarity is not the only principle in the EU Treaty that relates to the distribution of Jörgen Hettne Senior Researcher, SIEPS powers between the EU and Member States. Article 5 TEU contains in fact three fundamen- Fredrik Langdal Researcher, SIEPS tal principles, which each impose limitations on the institutions of the Union: the principles of conferral, subsidiarity and proportionality. The meaning of these principles can be summarised as follows. The principle of conferral controls when the EU is able to act, the principle of subsidiarity when the EU should act and the principle of proportionality how the EU should act. In contrast to the principle of conferral, the principles ubsidiarity was formally introduced in the European Union (EU) with the Maastricht of subsidiarity and proportionality are therefore not concerned with the issue if the EU has the Treaty, which entered into force on 1 November 1993. By introducing this principle, power to do something or not, but rather impose certain conditions on how these powers should SMember States wanted to impose a check on how EU institutions used their powers. The be used. While the principle of subsidiarity regulates whether and to what extent the powers are principle of subsidiarity implies a preference for decisions to be taken as close as possible to to be exercised, the principle of proportionality shall ensure that they do not give rise to actions the people affected, but if more efficient outcomes can be reached at the central level, then that are more extensive than is necessary to achieve the objectives of the Union. -
The Principle of Subsidiarity in the European Union: 'Gobbledygook'
THE PRINCIPLE OF SUBSIDIARITY IN THE EUROPEAN UNION: ‘GOBBLEDYGOOK’ ENTRAPPED BETWEEN JUSTICIABILITY AND POLITICAL SCRUTINY? THE WAY FORWARD Izvorni znanstveni rad UDK 341.645(4)EU 341.176(4)EU 339.923:061.1](4)EU 061.1(4)EU Primljeno: 8. svibnja 2017. Davor Petrić* The principle of subsidiarity in the European Union confines the policy-making and law-making competences of Union authorities to situations where the designated policy aims cannot be more effectively achieved at lower (i.e. national, regional or local) levels of governance. There are two institutionalised avenues envisaged to safeguard the EU institutions’ compliance with this principle. Besides the jurisdiction of the Court of Justice in ruling on all legal questions arising from the application and interpretation of the Treaties, another important instrument is entrusted to the Member States’ parliaments. This consists of the political scrutiny of the proposed EU laws with regard to compliance with subsidiarity. This paper intends to juxtapose these institutionalised avenues through an analysis of the principle of subsidiarity as it appears throughout the case law of the Court of Justice and within the subsidiarity monitoring procedure performed by the national parliaments. The aim is to assess the suitability of the judicial and parliamentary procedures for ensuring compliance with subsidiarity, and whether the principle, owing to its dual nature, i.e. both legal and political, can be efficiently complied with at all in the course of EU regulatory practice, either as being judicially enforced or politically safeguarded. After identifying the key shortcomings of both procedures, it will be shown that the present system is rather complex and ineffective. -
Regulation (EU) No 536/2014 on Clinical Trials for Medicinal Products
27.5.2014 EN Official Journal of the European Union L 158/1 I (Legislative acts) REGULATIONS REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168(4)(c) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) In a clinical trial the rights, safety, dignity and well-being of subjects should be protected and the data generated should be reliable and robust. The interests of the subjects should always take priority over all other interests. (2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation. (3) The existing definition of a clinical trial as contained in Directive 2001/20/EC of the European Parliament and of the Council (3) should be clarified. For that purpose, the concept of clinical trial should be more precisely defined by introducing the broader concept of ‘clinical study’ of which the clinical trial is a category. That category should be defined on the basis of specific criteria. -
Call for Evidence Subsidiarity and Proportionality FINAL 26 3 14.Docx Contents 1
CALL FOR EVIDENCE ON THE GOVERNMENT’S REVIEW OF THE BALANCE OF COMPETENCES BETWEEN THE UNITED KINGDOM AND THE EUROPEAN UNION Semester 4 SUBSIDIARITY AND PROPORTIONALITY Foreign and Commonwealth Office Opening date: 27 March 2014 Closing date: 30 June 2014 C:\Users\kwilde\AppData\Local\Microsoft\Windows\Temporary Internet Files\Outlook Temp\Call for Evidence Subsidiarity and Proportionality FINAL 26 3 14.docx Contents 1. Introduction .................................................................................................................................... 3 2. EU competence and principles ....................................................................................................... 4 3. A brief history of the EU Treaties .................................................................................................... 6 4. Subsidiarity ....................................................................................... Error! Bookmark not defined. Subsidiarity in the treaties .................................................................................................................. 9 The roles of different EU institutions in upholding Subsidiarity ....................................................... 10 Subsidiarity in the EU courts ............................................................................................................. 12 The role of national parliaments....................................................................................................... 13 Scrutiny ........................................................................................................................................ -
European University Institute, Florence Department of Law
EUROPEAN UNIVERSITY INSTITUTE, FLORENCE DEPARTMENT OF LAW EUI Working Paper LAW No. 2002/10 Legitimising European Governance: Taking Subsidiarity Seriously within the Open Method of Coordination PHIL SYRPIS BADIA FIESOLANA, SAN DOMENICO (FI) All rights reserved. No part of this paper may be reproduced in any form without permission of the author. [email protected] © 2002 Phil Syrpis Printed in Italy in August 2002 European University Institute Badia Fiesolana I – 50016 San Domenico (FI) Italy Legitimising European Governance: Taking Subsidiarity Seriously within the Open Method of Coordination Phil Syrpis* I Introduction The familiar story about the challenge - for some, the crisis - facing the European Union goes something like this. Economic integration has been achieved. The internal market is complete, and the Euro has already become - as all currencies become, at least for those with means - a humdrum reality. In the efficiency-generating, politically-neutral years of (largely) negative integration, redistributive policy had been left to the Member States. This option is no longer open. In today’s brave new world, characterised by ever-increasing interdependence between economic actors, in part forged internally (ironically perhaps, the product of the completion of the internal market and EMU), and in part thrust upon Europe as a result of the external pressures of globalisation, Member States are being rendered impotent. There is a perceived need for common responses. The challenge is to articulate these responses in a way which does not offend the widely-held popular belief that policy, especially redistributive policy, made at the European level is somehow ‘less legitimate’ than policy made at national level. -
Production of Radiopharmaceuticals for Clinical and Research Uses
Production of radiopharmaceuticals for clinical and research uses The European perspective Philip Elsinga UMC Groningen The Netherlands The Rules European players in (radio‐) pharmaceutical legislation National authorities European Union • National regulations EMA D.G. Health • Licencing (London) (Brussels) • Inspection Medicinal products: • National Pharmacopeia • Directives • Evaluation • Control laboratories • Regulations • Supervision Professional organisations • Pharmacovigilance Council of Europe • PIC/S GMP •EANM E.D.Q.M. (Strasbourg) •AIPES Marketing •European Authorisation •..... Pharmacopeia Quality •OMCL network European laws and rules Directives Must be transposed to be effective Regulations Are immediately enforceable Other rules Decisions of the Council Opinions Recommendations Regulatory documents of importance for Radiopharmaceuticals (RP) Directive 2001/20/EC “Clinical Trial Directive” Directive 2001/83/EG Qualified Person,... Directive 2003/94/EC GMP Directive 2004/27/EC API according to GMP Directive 2005/28/EC GCP / Authorization for IMP CHMP/SWP/28367/2007 First in human clinical trial guideline (EMEA) Regulation (EC) No 1394/2007 Advanced therapy regulation The current challenge for PET‐radiopharmaceutical development are pharmaceutical regulations, not radiation safety issues Eudralex The Rules Governing Medicinal Products in the European Union http://ec.europa.eu/health/index_en.htm Vol 1: Medicinal Products for Human Use Directives 2001/83/EC: Community code relating to medicinal products for human use -
The Principle of Subsidiarity and Institutional Predispositions: Do the European Parliament, the German Bundestag, and the Bavarian Landtag Define Subsidiarity Differently?
www.ssoar.info The principle of subsidiarity and institutional predispositions: do the European Parliament, the German Bundestag, and the Bavarian Landtag define subsidiarity differently? Martin, Aaron Veröffentlichungsversion / Published Version Arbeitspapier / working paper Zur Verfügung gestellt in Kooperation mit / provided in cooperation with: SSG Sozialwissenschaften, USB Köln Empfohlene Zitierung / Suggested Citation: Martin, A. (2010). The principle of subsidiarity and institutional predispositions: do the European Parliament, the German Bundestag, and the Bavarian Landtag define subsidiarity differently? (CAP Working-Paper). München: Universität München, Sozialwissenschaftliche Fakultät, Centrum für angewandte Politikforschung (C.A.P). https://nbn- resolving.org/urn:nbn:de:0168-ssoar-423687 Nutzungsbedingungen: Terms of use: Dieser Text wird unter einer Deposit-Lizenz (Keine This document is made available under Deposit Licence (No Weiterverbreitung - keine Bearbeitung) zur Verfügung gestellt. Redistribution - no modifications). We grant a non-exclusive, non- Gewährt wird ein nicht exklusives, nicht übertragbares, transferable, individual and limited right to using this document. persönliches und beschränktes Recht auf Nutzung dieses This document is solely intended for your personal, non- Dokuments. Dieses Dokument ist ausschließlich für commercial use. All of the copies of this documents must retain den persönlichen, nicht-kommerziellen Gebrauch bestimmt. all copyright information and other information regarding legal Auf sämtlichen Kopien dieses Dokuments müssen alle protection. You are not allowed to alter this document in any Urheberrechtshinweise und sonstigen Hinweise auf gesetzlichen way, to copy it for public or commercial purposes, to exhibit the Schutz beibehalten werden. Sie dürfen dieses Dokument document in public, to perform, distribute or otherwise use the nicht in irgendeiner Weise abändern, noch dürfen Sie document in public. -
Protecting Member State Autonomy in the European Union: Some Cautionary Tales from American Federalism
PROTECTING MEMBER STATE AUTONOMY IN THE EUROPEAN UNION: SOME CAUTIONARY TALES FROM AMERICAN FEDERALISM ERNEST A. YOUNG* The European Union's ongoing "Convention on the Future of Europe" must tackle a fundamental issue offederalism: the balance between central authority and Mem- ber State autonomy. In this Article, Ernest Young explores two strategiesfor pro- tecting federalism in America-imposing substantive limits on central power and relying on political and procedural safeguards-andconsiders their prospects in Europe. American experience suggests that European attempts to limit central power by enumerating substantive "competences" for Union institutions are un- likely to hold up, and that other substantive strategies such as the concept of "sub- sidiarity" tend to work best as political imperatives rather than judicially enforceable doctrines. Professor Young then examines the "politicalsafeguards" of Member State autonomy in the EU as currently constituted. He argues that the balance between the center and the periphery is likely to be affected by how the EU resolves basic separation-of-powersquestions at the center. Efforts to address per- ceived deficiencies of the Union government in its resource base, lawmaking effi- ciency, and democratic legitimacy likewise will have a fundamental impact on federalism. Finally, Professor Young touches on two broader themes. He first asks whether Europeans, given their cultural distinctiveness, would prefer a stronger form of federalism than America has been able to maintain; if so, the American experience is relevant primarily as a cautionary tale. He then considers how Eu- rope's institutional experience and current debate can inform the American dis- course on federalism by helping Americans break free of ideological and historical preconceptionsand offering insights into emerging issues at the intersection of do- mestic constitutions and supranationalinstitutions. -
Subsidiarity and Proportionality in the Single Market
Subsidiarity and Proportionality in the Single Market An EU fit for inclusive growth Subsidiarity and Proportionality in the Single Market An EU fit for inclusive growth Imprint © 2018 Bertelsmann Stiftung Authors: Editing: Sigurd Naess-Schmidt David Gow Jonas Bjarke Jensen Graphs and figures: Copenhagen Economics Dietlind Ehlers Langebrogade 1 (entrance B3) DK-1411 Copenhagen Layout: Denmark Sabine Feige Project team: Title image: Dr. Dominic Ponattu (principal) Hans/pixabay.com - CC0, Public Domain, Dr. Katharina Gnath https://creativecommons.org/publicdo- Prof. Dr. Christian Kastrop main/zero/1.0/legalcode Dr. Marcus Wortmann Bertelsmann Stiftung Programme Europe’s Future Carl-Bertelsmann-Str. 256 33311 Gütersloh Germany Subsidiarity and Proportionality in the Single Market | Page 3 Preface The principles of subsidiarity and proportionality have been subject to intense debate. Which policy issues are best dealt with by central decision making at EU level, and which are best handled at member state level? This question takes on particular prominence when it comes to one of the EU’s cornerstones: the Single Market. While there has been a broad consensus on the economic benefits of free movement of labour, capital, goods and ser- vices, there are concerns about unnecessary regulation that fails to take local structures sufficiently into account. The Austrian government has made this a key point during its presidency of the Council of the EU in the second half of 2018. Bertelsmann Stiftung and Copenhagen Economics are here contributing to this debate with a study on the eco- nomic case for subsidiarity and proportionality in the EU. This report has been presented at the Presidency’s conference "Subsidiarity as a building principle of the European Union" in November 2018. -
Protocol (No 30) on the Application of the Principles of Subsidiarity and Proportionality (Amsterdam, 2 October 1997)
Protocol (No 30) on the application of the principles of subsidiarity and proportionality (Amsterdam, 2 October 1997) Caption: Protocol (No 30) annexed to the Treaty establishing the European Community by the Treaty of Amsterdam of 2 October 1997. Source: Official Journal of the European Communities (OJEC). 10.11.1997, No C 340. [s.l.]. ISSN 0378-6986. Copyright: All rights of reproduction, public communication, adaptation, distribution or dissemination via Internet, internal network or any other means are strictly reserved in all countries. The documents available on this Web site are the exclusive property of their authors or right holders. Requests for authorisation are to be addressed to the authors or right holders concerned. Further information may be obtained by referring to the legal notice and the terms and conditions of use regarding this site. URL: http://www.cvce.eu/obj/protocol_no_30_on_the_application_of_the_principles_of_subsidiarity_and_proportionality_am sterdam_2_october_1997-en-d2852fd3-6570-4cdd-a88e-4acf05478f6c.html Publication date: 25/09/2012 1 / 4 25/09/2012 Protocol (No 30) on the application of the principles of subsidiarity and proportionality THE HIGH CONTRACTING PARTIES, DETERMINED to establish the conditions for the application of the principles of subsidiarity and proportionality enshrined in Article 5 of the Treaty establishing the European Community with a view to defining more precisely the criteria for applying them and to ensure their strict observance and consistent implementation by all institutions;