Download or read book EU Regulatory Decision Making and the Role of the United States written by Oliver Ziegler and published by Springer Science & Business Media. This book was released on 2012-09-05 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oliver Ziegler raises the question of what role economic interests of the United States play in the regulatory decision making process of the European Union. Critics often assume that U. S. dominance in the world economy, fueled by a powerful business elite, has significantly affected EU regulations at the expense of environmental and consumer protection standards. The author falsifies this proposition. He shows, first, that the EU often adopts regulations against the explicit opposition of the U. S. thereby ignoring the principles of transatlantic regulatory cooperation. Second, he demonstrates that business interests in the EU are usually not homogenous and often come second to environmental and consumer concerns. In addition, the author shows the increasing role of the European Parliament in EU regulatory decison making.
Download or read book The Brussels Effect written by Anu Bradford and published by Oxford University Press. This book was released on 2020-01-27 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: For many observers, the European Union is mired in a deep crisis. Between sluggish growth; political turmoil following a decade of austerity politics; Brexit; and the rise of Asian influence, the EU is seen as a declining power on the world stage. Columbia Law professor Anu Bradford argues the opposite in her important new book The Brussels Effect: the EU remains an influential superpower that shapes the world in its image. By promulgating regulations that shape the international business environment, elevating standards worldwide, and leading to a notable Europeanization of many important aspects of global commerce, the EU has managed to shape policy in areas such as data privacy, consumer health and safety, environmental protection, antitrust, and online hate speech. And in contrast to how superpowers wield their global influence, the Brussels Effect - a phrase first coined by Bradford in 2012- absolves the EU from playing a direct role in imposing standards, as market forces alone are often sufficient as multinational companies voluntarily extend the EU rule to govern their global operations. The Brussels Effect shows how the EU has acquired such power, why multinational companies use EU standards as global standards, and why the EU's role as the world's regulator is likely to outlive its gradual economic decline, extending the EU's influence long into the future.
Download or read book European Regulatory Agencies in EU Decision Making written by Christoph Ossege and published by Springer. This book was released on 2016-01-06 with total page 173 pages. Available in PDF, EPUB and Kindle. Book excerpt: European Regulatory Agencies (ERAs) have become increasingly important features in EU decision-making. They aim to provide expert advice independent of political or economic considerations. This book explains whether and under what conditions ERAs comply with this scientific mandate. Expanding on rational institutionalism, Ossege provides novel insights into the behaviour of ERAs, their autonomy from 'undue' external influence, and their impact on EU policy-making. The empirical comparison of three major ERAs - the European Medicines Agency, the European Food Safety Authority, and the European Chemicals Agency - not only shows that agencies capitalise on their expertise and rule-making competences to protect their autonomy. Rather, in making strategic use of their expertise, the ERAs also guard their autonomy in areas of high political salience, though their policy influence in these areas is partially circumscribed. Based on these insights, European Regulatory Agencies in EU Decision-Making locates its subject in the wider system of European Governance and considers the perennial question of how to reconcile the need for expert advice with democratic decision-making.
Download or read book Civil Society and Health written by Scott L. Greer and published by World Health Organization. This book was released on 2017-11-20 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: Civil Society Organizations (CSOs) can make a vital contribution to public health and health systems but harnessing their potential is complex in a Europe where government-CSO relations vary so profoundly. This study is intended to outline some of the challenges and assist policy-makers in furthering their understanding of the part CSOs can play in tandem and alongside government. To this end it analyses existing evidence and draws on a set of seven thematic chapters and six mini case studies. They examine experiences from Austria Bosnia-Herzegovina Belgium Cyprus Finland Germany Malta the Netherlands Poland the Russian Federation Slovenia Turkey and the European Union and make use of a single assessment framework to understand the diverse contexts in which CSOs operate. The evidence shows that CSOs are ubiquitous varied and beneficial and the topics covered in this study reflect such diversity of aims and means: anti-tobacco advocacy food banks refugee health HIV/AIDS prevention and cure and social partnership. CSOs make a substantial contribution to public health and health systems with regards to policy development service delivery and governance. This includes evidence provision advocacy mobilization consensus building provision of medical services and of services related to the social determinants of health standard setting self-regulation and fostering social partnership. However in order to engage successfully with CSOs governments do need to make use of adequate tools and create contexts conducive to collaboration. To guide policy-makers working with CSOs through such complications and help avoid some potential pitfalls the book outlines a practical framework for such collaboration. This suggests identifying key CSOs in a given area; clarifying why there should be engagement with civil society; being realistic as to what CSOs can or will achieve; and an understanding of how CSOs can be helped to deliver.
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Download or read book The Credibility of Expert Advice for Regulatory Decision making in the US and EU written by Ariane König and published by . This book was released on 2002 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Better Regulation Practices across the European Union written by OECD and published by OECD Publishing. This book was released on 2019-03-19 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt: Laws and regulations affect the daily lives of businesses and citizens. High-quality laws promote national welfare and growth, while badly designed laws hinder growth, harm the environment and put the health of citizens at risk. This report analyses practices to improve the quality of laws ...
Download or read book Beyond the Regulatory Polity written by Philipp Genschel and published by Oxford University Press, USA. This book was released on 2014 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume explores the involvement of the European Union in the exercise of core state powers such as foreign and defense policy, public finance, public administration, and the maintenance of law and order.
Download or read book Real World Evidence in Drug Development and Evaluation written by Harry Yang and published by CRC Press. This book was released on 2021-01-11 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise
Download or read book The Influence of Business Associations in the European Decision Making Process written by Uli Bethke and published by diplom.de. This book was released on 2006-01-20 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: Inhaltsangabe:Abstract: Since the adoption of the Single European Act (SEA) in 1986 more and more competencies have been transferred by EU Member States to decision makers in Brussels. Beside the objective of the completion of the Single Market the scope of Community policies has widened to political co-operation, technological development, and social policy. In addition, the powers of the European Parliament were strengthened and qualified majority voting was introduced for decisions related to the completion of the internal market. Since the summits of Maastricht and Amsterdam European integration has further gained in momentum. National governments again handed over sovereignty to the European level. Jacques Delors famous quote that 80% of regulations impacting on the economic sphere were decided in Brussels today demonstrates the shift of competency. Within the last 15 years Brussels has become an important centre of power. This transference of power to the European level also has affected the behaviour of interest groups. Before 1986 it usually was sufficient to lobby the own national administration in order to influence regulations. The main function of European peak organisations at the time was on the one hand to monitor events in Brussels and report them back to their member federations on the other hand they formed a transnational network for the exchange of information. The growing power of European institutions and the strengthening of the supranational element within the European Union required interest groups to broaden their participation in the European decision making process. In addition, the technical problems regarding the realisation of the internal market, e.g. harmonisation of services, standardisation of products etc. has triggered off an enormous demand for technical input on the side of the European institutions. Since the adoption of the SEA, thus, interest groups have proliferated. New groups with new interests have emerged. Long established organisations have increased their financial and personnel resources. After Washington D.C., Brussels has become the second biggest boomtown for lobbying activities. In 1992 the Commission has estimated that approximately 3000 special interest groups with a total of 10,000 lobbyists try to influence the institutions of the European Union. The directory of interest groups lists 891 European peak organisations. Beside these Eurogroups a myriad form of actors all trying to get [...]
Download or read book Transatlantic Regulatory Cooperation written by David Vogel and published by Edward Elgar Publishing. This book was released on 2011-01-01 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'In this increasingly globalised regulatory environment there is a need to better understand how the world's two most active trade-blocks are cooperating especially with regard to pending complicated regulations be it REACH or the proposed revision of US TSCA. In this most timely book, Vogel and Swinnen bring together an outstanding group of scholars to help explain the delicate and important intricacies of present policy debates, making the volume essential reading for policy researchers, regulators and consultants active in the area.' – Ragnar Lofstedt, King's College London, UK 'David Vogel and Johan Swinnen have assembled a first-rate book on regulatory cooperation between the US and EU. The case studies provide detailed and nuanced analyses of policy areas from water to climate change and biotechnology, and the concluding chapters offer well-judged and balanced assessments of the regulatory challenges for future transatlantic relations.' – Robert Falkner, London School of Economics and Political Science, UK 'Transatlantic Regulatory Cooperation represents a cutting-edge contribution to the study of economic regulation, and in particular the prospects for cooperation between the US and the EU as the world's dominant economic blocs. The authors, among the leading scholars in their fields, provide theoretically and empirically informed studies of transatlantic cooperation and conflict in areas such as the environment, climate change, food safety, and genetically modified foods, deriving provocative and compelling policy recommendations from each. The discussion of federalism, and the opportunities and constraints it presents for international cooperation, is superb.' – Mark A. Pollack, Temple University, US This well-documented book analyzes the possibilities and constraints of regulatory cooperation between the EU and the US (particularly California) with a specific focus on environmental protection, food safety and agriculture, biosafety and biodiversity. Transatlantic Regulatory Cooperation features eleven original essays by leading academics of regulation on both sides of the Atlantic. They explore topics such as the impact of federalism on regulatory policies both within the US and Europe, the transatlantic dynamics of water policy, climate change, pesticide and chemical regulation, and biotechnology. A primary focus of this timely study is on the shifting roles of California and the EU as regulatory leaders and ITS impact on future regulatory cooperation across the Atlantic. This informative book will appeal to graduate and postgraduate students, as well as academics and researchers in international relations, business, law and economics who are working on regulatory issues. The policy community which focuses on regulation and transatlantic regulatory relations will also find it an important resource.
Download or read book Understanding EU Decision Making written by Edward Best and published by Springer. This book was released on 2016-02-04 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents in a concise and accessible way why the EU institutional system exists in its present form, how the EU fits into the world as a system of governance, and who is involved in EU policy processes. It outlines the historical context which has shaped the EU system, gives a summary of the system's basic principles and structures, and describes its actors, procedures and instruments. The main theme is to show that EU decision-making is not just a matter of action at some higher and separate level, of ‘them and us’, but rather that it involves different forms of cooperation between European, national and regional authorities, as well as interaction between public and private actors. Numerous short case studies illustrate how people’s day-to-day activities are affected by EU decisions, and how individuals’ concerns are represented in the decision-making process. The book provides insights and examples which will be very helpful for all students of European integration. It will also be a valuable resource for European citizens wishing to understand the basic realities and rationales, as well as some of the dilemmas, behind EU policy-making.
Download or read book The Federal Vision written by Kalypso Nicolaidis and published by OUP Oxford. This book was released on 2001-11-01 with total page 558 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Federal Vision is about the complex and changing relationship between levels of governance within the United States and the European Union. Based on a transatlantic dialogue between scholars concerned about modes of governance on both sides, it is a collective attempt at analysing the ramifications of the legitimacy crisis in our multi-layered democracies, and possible remedies. Starting from a focus on the current policy debatea over devolution and subsidiarity, the book engages the reader in to the broader tension of comparartive federalism. Its authors believe that in spite of the fundamental differences between them, both the EU and the US are in the process of re-defining a federal vision for the 21st century. This book represents an important new contribution to the study of Federalism and European integration, which seeks to bridge the divide between the two. It also bridges the traditional divide between technical, legal or regulatory discussions of federal governance and philosophical debates over questions of belonging and multiple identities. It is a multi-disciplinary project, bringing together historians, political scientists and theorists, legal scholars, sociologists and political economists. It includes both innovative analysis and prescriptions on how to reshape the federal contract in the US and the EU. It includes introductions to the history of federalism in the US and the EU, the current debates over devolution and subsidarity, the legal framework of federalism and theories of regulatory federalism, as well as innovative approaches to the application of network analysis, principal-agent models, institutionalist analysis, and political theories of citizenship to the federal context. The introduction and conclusion by the editors draws out cross-cutting themes and lessons from the thinking together of the EU and US experiences, and suggest how a federal vision could be freed from the hierarchical paradigm of the federal state and articulated around concepts of mutal tolerence and empowerment.
Download or read book Regulation Through Agencies in the EU written by Damien Geradin and published by Edward Elgar Publishing. This book was released on 2005-01-01 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: The past decade has witnessed a proliferation of regulatory agencies at both the national and the EU level. This coherent and clearly structured book is the first of its kind to analyse in equal measure, and interdependently, both national regulatory authorities and European agencies. It brings together a select group of highly esteemed contributors - authorities in their fields - to provide a systematic and over-arching view of regulation in the EU. Unlike many of the previous attempts to shed light on this increasingly opaque and complex co-existence of regulatory systems, this book takes a genuinely multi-disciplinary approach with integrated perspectives from law, politics and economics.
Download or read book Risk Analysis and Governance in EU Policy Making and Regulation written by Bernardo Delogu and published by Springer. This book was released on 2016-05-02 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an easy, but comprehensive and rigorous access to the main concepts, terminology, methods and procedures of risk analysis intended for all those involved in the EU policy and regulatory decision making on risks. It establishes a common ground of knowledge which enables a more informed dialogue on risks, a closer collaboration between decision makers and scientists and a better appraisal of the potential and limits of risk science. The book also brings together in an accessible way much multidisciplinary knowledge which had been dispersed over many technical documents and specialist books. The EU is in the front line of health, safety and environmental risk management. GMOs, food safety, hazardous chemicals, climate change, radiation hazards, are just a few of the popular risk issues addressed by the EU through policy and regulatory measures. The risk analysis paradigm, including risk assessment, management and communication has been at the core of the EU decision making for a long time already. EU Institutions strive for a science-based approach to risk management. Nevertheless, the dialogue and collaboration on risk issues between policy makers, stakeholders and scientists are still difficult and the potential and limits of science in support of decision making, as well as the basic concepts of risk analysis are not fully understood outside the narrow specialist circles.
Download or read book Integrating Scientific Expertise Into Regulatory Decision making written by Christian Joerges and published by Nomos Verlagsgesellschaft. This book was released on 1997 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reference to scientific expertise and regulatory decision-making has become common also within the European legal system. This trend has become especially important in the context of the European policy of completing and managing the internal market. The present volume comprises contributions by American, British, French and German lawyers and social scientists as well as officials and standardization experts from France and Brussels. It deals with general problems of integrating scientific expertise into legal framework of risk regulation. Its focus, however, are the specifics of European regulatory policies which are discussed with the examples of foodstuffs law and standardization. The volume is addressed to academics and practitioners interested in the understanding and functioning of European regulatory policies. Christian Joerges is a Co-director of the Centre of European Law and Politics in Bremen and part-time professor at the European University Institute, Florence; Karl-Heinz Ladeur was until 1996 professor at the EUI and now teaches law at the University of Hamburg; Ellen Vos is a Marie Curie Research Fellow at the Centre for European Law and Politics.
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-03-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
