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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.
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.
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.
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
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 ...
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.
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.
People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
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.
Despite western Europe's traditional disdain for the United States' "adversarial legalism," the European Union is shifting toward a very similar approach to the law, according to Daniel Kelemen. Coining the term "eurolegalism" to describe the hybrid that is now developing in Europe, he shows how the political and organizational realities of the EU make this shift inevitable. The model of regulatory law that had long predominated in western Europe was more informal and cooperative than its American counterpart. It relied less on lawyers, courts, and private enforcement, and more on opaque networks of bureaucrats and other interests that developed and implemented regulatory policies in concert. European regulators chose flexible, informal means of achieving their objectives, and counted on the courts to challenge their decisions only rarely. Regulation through litigation-central to the U.S. model-was largely absent in Europe. But that changed with the advent of the European Union. Kelemen argues that the EU's fragmented institutional structure and the priority it has put on market integration have generated political incentives and functional pressures that have moved EU policymakers to enact detailed, transparent, judicially enforceable rules-often framed as "rights"-and back them with public enforcement litigation as well as enhanced opportunities for private litigation by individuals, interest groups, and firms.