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 ...

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.

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 Model Rules drafted by the Research Network on EU Administrative Law (ReNEUAL), together with an extended introduction. The Model Rules propose a clear and accessible legal framework through which the constitutional values of the EU can be embedded in the exercise of public authority.

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.

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.