U.S.-EU Cooperation on Regulatory Affairs


Book Description




Transatlantic Regulatory Cooperation


Book Description

'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.




Combating Tax Avoidance in the EU


Book Description

Following each Member State's need to rebuild a strong and stable economy after the 2007 financial crisis, the European Union (EU) has developed a robust new transparency framework with binding anti-abuse measures and stronger instruments to challenge external threats of base erosion. This is the first and only book to provide a complete detailed analysis of the Anti-Tax Avoidance Package and other recent and ongoing European actions taken in direct taxation. With contributions from both prominent tax academics and Spain's delegates to the European meetings where these rules are debated and promulgated, the book covers such issues and topics as the following: – the development of the EU Strategy towards Aggressive Tax Planning; – recent tax-related jurisprudence of the European Court of Justice; – the Anti-Tax Avoidance Directive; – tax treaties and non-tax treaties with tax consequences both between Member States and between Member States and third countries; – code of conduct for business taxation; – automatic exchange of information; – country-by-country reporting; – arbitration in tax matters; – external strategy for effective taxation regarding non-EU countries; – competition and state aid developments in direct taxation; – the Common Consolidated Tax Base; and – digital significant presence and permanent establishment. As the EU pursues its ambitious tax agenda, taxation's contribution to EU growth and competitiveness and its part in relations with the rest of the world will come into ever clearer focus. In addition to its insights into these trends, the book's unparalleled practical information and analysis will be of great value to tax practitioners dealing with investment analysis, tax planning schemes, and other features of the current international tax landscape.







The European Union REACH Regulation for Chemicals


Book Description

This book discusses the law and practice of the European Union's new chemical regulatory programmes known under the acronym ''REACH'. REACH is intended to ensure the safe management of risks associated with chemical substances throughout the supply chain. Its scope is very broad; subject to limited exceptions, REACH applies to all bulk chemicals used in industrial processes and to chemicals present in products such as cleaning products, paints, clothing, furniture, and electrical appliances. The newly established European Chemicals Agency (ECHA), the Commission, and member state authorities are in charge of administering the various parts of the REACH Regulation, creating a complex patchwork of government powers, procedures, and oversight. The volume is written by experienced REACH practitioners. It addresses both the key legal regulatory issues associated with REACH and the key management and practical challenges. In addition to analysing the scope, the processes, and the obligations of the industry under REACH, the book covers the strategy and management of REACH compliance from the perspective of the regulated entities. The focus is on the strategic and practical decisions facing companies subject to REACH's various regimes. Significant attention is paid to REACH consortia, which are a key instrument in compliance management, and to the competition law issues arising in connection with REACH consortia. It also covers legal remedies, enforcement, intellectual property rights, and civil liability for damages arising from chemical substances as well as how companies can shape their REACH compliance programme to reduce their liability exposure.




Case Studies in US Trade Negotiation: Making the rules


Book Description

"Volume 1 of this series presents five cases on trade negotiations that have had important effects on trade policy rulemaking, and an analytic framework for evaluating these negotiations."--BOOK JACKET.




Case Studies in US Trade Negotiation: Resolving disputes


Book Description

Between 1992 and 2000, US exports rose by 55 percent. By the year 2000, trade summed to 26 percent of US GDP, and the United States imported almost two-thirds of its oil and was the world's largest host country for foreign investors. America's interest in a more open and prosperous foreign market is now squarely economic. These case studies in multilateral trade policymaking and dispute settlement explore the changing substance of trade agreements and also delve into the negotiation process--the who, how, and why of decision making. These books present a coherent description of the facts that will allow for discussion and independent conclusions about policies, politics, and processes. Volume 2 presents five cases on trade negotiations that have had important effects on trade policy rulemaking, as well as an analytic framework for evaluating these negotiations.




The EU Constitution and U.S.-EU Relations


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Medical Devices and the Public's Health


Book Description

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.