This timely book provides the first legal and policy analysis of the intellectual property (IP) aspects of a rapidly-growing category of regulatory measures affecting the presentation and advertising of certain health-related goods. The key goods examined are tobacco, alcohol, food, and pharmaceuticals. Chapters focusing on both distinct policy areas and specific country examples serve to unearth the inherent tension emerging between these new measures as well as other categories of public health measures and IP regimes. This book discusses how to balance the legitimate interests of governments to promote human health and the protection and enforcement of IP rights. It also further explores how to amend IP regimes with a view to encouraging companies to produce and market healthier products. Comprehensive and engaging, this book will provide innovative research angles to academics and students in the areas of both health and IP law. Its wealth of examples and analytic style will also prove insightful to legal professionals who advise on issues related to IP and public health as well as policy makers, governments and NGOs. Contributors include: A. Alemanno, J. Blum, E. BonadioI, I. Calboli, I. Carreno, M. Chon, M. Davison, M. Elsmore, M.T. Fujiye, E. Laurenza, A. Marsoof, A. Mitchell, V. Vadi

'Even the best-laid policy plans go awry. What do we do when, despite our best preventive efforts, a surprise crisis occurs? How do we regulate a disaster while it is unfolding? From volcanoes to tornadoes, and tsunamis to terrorists, extreme events test our resilience. In this illuminating volume, regulatory scholar Alberto Alemanno and his colleagues diagnose the complex combination of natural disasters and flawed institutions that make these crises so difficult to manage. They offer a set of insights and remedies that must be read by anyone concerned to deal with disasters in the future.' - Jonathan B. Wiener, Duke University'This comprehensive edited volume makes an important and much needed contribution to an increasingly important dimension of risk assessment and management, namely emergency risk regulation. Drawing upon the responses of government, businesses, and the public to the 2010 volcanic eruption in Iceland - which disrupted European air travel, it offers important lessons for policy-makers who are likely to confront similar unanticipated global risks. The recent nuclear power disaster in Japan makes this volume both timely and prescient.' - David Vogel, University of California, Berkeley Emergency crises have always tested our ability to organize and swiftly execute a coordinated response. Both natural and unnatural disasters pose new questions to which previous experience provides only limited answers. These challenges are arguably greater than ever, in a more globalized world confronted by a truly transnational hazard. This is the first volume that addresses the complexities of the volcanic ash cloud that overshadowed Europe in April 2011, but has subsequently struck again in Australia, Chile and Europe. It does so from a multidisciplinary perspective, drawing upon research from economics, law, sociology and other fields, as well as volcanology and leading expertise in jet engineering. While our knowledge base is wide-ranging, there is a common focus on the practical lessons of the ash cloud crisis both for subsequent eruptions and for emergency risk regulation more generally. Among many other insights Governing Disasters explains why it was that industry and regulators were largely unprepared for a phenomenon about which we were not scientifically ignorant. It concludes that the toolbox of risk regulation should not be expected to provide ready-made solutions but applied flexibly, creatively and with some humility. This unique and timely resource will be useful to policy makers, scholars, officials of international organizations, research institutions and consumer groups who want to acquire or further develop their capacities for risk regulation. For teaching purposes it is ideal for courses on risk regulation, disaster law and policy, and crisis management or as a supplement in courses on environmental law, transport law, space law or land use. Contributors: A. Alemanno, N. Bernard, V. Brannigan, C.M. Briggs, M. Broberg, A. Burgess, G.G. Castellano, S. Chakraborty, A. Fioritto, F. Hansstein, L. Jachia, A. Jeunemaitre, C. Johnson, C. Lawless, F.B. Lopez-Jurado, D. Macrae, M. Mazzocchi, V. Nikonov, M. Ragona, M. Simoncini, A.M. Viens

This volume presents the viewpoints of academics, food lawyers, industry and consumer representatives as well as those of EU policymakers on the first ten years of activity of one of the most prominent European agencies. Its broader purpose, however, is to discuss the future role played by EFSA within the rapidly-evolving area of EU food law and policy. By revisiting and discussing the milestones in the history of EFSA, the collection provides forward-looking views of food leaders and practitioners on the future scientific and regulatory challenges facing the European Union. In particular, by presenting a critical assessment of the agency's activities within its different areas of work, the book offers readers a set of innovative tools for evaluating policy recommendations and better equips experts and the public to address pressing regulatory issues in this emotive area of law and policy. Despite its celebratory mood, the book's focus is more about the future than the past of EU food law and policy. Each chapter discusses how EFSA's role has evolved and identifies what it should have done differently while presenting an overall assessment of how the agency has discharged its mandate.

It is over 40 years since we began to reflect upon risk in a more social than technological and economic fashion, firstly making sense of the gap between expert and public assessment of risks, such as to our health and environment. With fixed certainties of the past eroded and the technological leaps of 'big data', ours is truly an age of risk, uncertainty and probability - from Google's algorithms to the daily management of personal lifestyle risks. Academic reflection and research has kept pace with these dizzying developments but remains an intellectually fragmented field, shaped by professional imperatives and disciplinary boundaries, from risk analysis to regulation and social research. This is the first attempt to draw together and define risk studies, through a definitive collection written by the leading scholars in the field. It will be an indispensable resource for the many scholars, students and professionals engaging with risk but lacking a resource to draw it all together.

This volume presents the viewpoints of academics, food lawyers, industry and consumer representatives as well as those of EU policymakers on the first ten years of activity of one of the most prominent European agencies. Its broader purpose, however, is to discuss the future role played by EFSA within the rapidly-evolving area of EU food law and policy. By revisiting and discussing the milestones in the history of EFSA, the collection provides forward-looking views of food leaders and practitioners on the future scientific and regulatory challenges facing the European Union. In particular, by presenting a critical assessment of the agency's activities within its different areas of work, the book offers readers a set of innovative tools for evaluating policy recommendations and better equips experts and the public to address pressing regulatory issues in this emotive area of law and policy. Despite its celebratory mood, the book's focus is more about the future than the past of EU food law and policy. Each chapter discusses how EFSA's role has evolved and identifies what it should have done differently while presenting an overall assessment of how the agency has discharged its mandate.

The premise of this volume is that business regulations are expected to grow in the near future as a consequence of the emergence of a "(world) risk society." Risks related to terrorism, climate change, and financial crises, for example, will penetrate all conditions of life. Increasingly, the decisions and actions of some bring about risks for many in this era of globalization. Controlling these risks implies managing the world through high-quality regulation, with a particular emphasis on businesses and financial institutions. Central to this approach is the argument that a major, if not the primary, aim of regulation is to internalize externalities, or in a broader context, to repair market failure. Such repair can only be accomplished when the costs are smaller than the welfare gains. Featuring contributions from researchers and policy analysts from the fields of economics, management, law, sociology, political science, and environmental policy, this book focuses on three major topics: * Social risks and business regulation * Preconditions for better business regulation * Theoretical issues related to better business regulation Collectively, the authors demonstrate that the easier it is for regulated businesses to comply at the lowest costs possible-without jeopardizing the related public goals-the greater the degree of compliance. When successful, the net result is a balance of individual and collective net benefits, and by further implication, sustainable business practice and economic growth.

The premise of this volume is that business regulations are expected to grow in the near future as a consequence of the emergence of a "(world) risk society." Risks related to terrorism, climate change, and financial crises, for example, will penetrate all conditions of life. Increasingly, the decisions and actions of some bring about risks for many in this era of globalization. Controlling these risks implies managing the world through high-quality regulation, with a particular emphasis on businesses and financial institutions. Central to this approach is the argument that a major, if not the primary, aim of regulation is to internalize externalities, or in a broader context, to repair market failure. Such repair can only be accomplished when the costs are smaller than the welfare gains. Featuring contributions from researchers and policy analysts from the fields of economics, management, law, sociology, political science, and environmental policy, this book focuses on three major topics: * Social risks and business regulation * Preconditions for better business regulation * Theoretical issues related to better business regulation Collectively, the authors demonstrate that the easier it is for regulated businesses to comply at the lowest costs possible-without jeopardizing the related public goals-the greater the degree of compliance. When successful, the net result is a balance of individual and collective net benefits, and by further implication, sustainable business practice and economic growth.

It is over 40 years since we began to reflect upon risk in a more social than technological and economic fashion, firstly making sense of the gap between expert and public assessment of risks, such as to our health and environment. With fixed certainties of the past eroded and the technological leaps of 'big data', ours is truly an age of risk, uncertainty and probability - from Google's algorithms to the daily management of personal lifestyle risks. Academic reflection and research has kept pace with these dizzying developments but remains an intellectually fragmented field, shaped by professional imperatives and disciplinary boundaries, from risk analysis to regulation and social research. This is the first attempt to draw together and define risk studies, through a definitive collection written by the leading scholars in the field. It will be an indispensable resource for the many scholars, students and professionals engaging with risk but lacking a resource to draw it all together.

As the European Union undergoes a major, self-proclaimed democratic exercise - the Conference on the Future of Europe - and approaches Treaty change, this volume offers a new model of citizen participation to address Europe's long-standing democracy challenge, and respond to the aftermath of the COVID-19 pandemic. Proposed are a set of democratic innovations, ranging from citizens' assemblies to regulatory gaming to citizens' initiatives and lobbying, which are complementary, not antagonistic, to existing representative democracy across the European continent. These innovations are emerging bottom-up across the continent and getting traction at local, national and EU level in a new era powered by technology. This book brings together academics as well as practitioners to give a forward-looking, holistic view of the realities of EU citizen participation across the spectrum of participatory opportunities. They all converge in arguing that, after many years of proven experimentation, the EU must institutionalize supranational, participative and deliberative, democratic channels to complement representative democracy and each other, and ultimately improve the effectiveness of EU citizen participation. While this institutional approach will not magically treat the EU democratic malaise, it should make the system more intelligible, accessible, and ultimately responsive to citizen demand-without necessarily undertaking Treaty reform. The attempt to harness citizen participation to help address the current EU crisis needs the type of multi-faceted approach presented in this book. One that recognises the potential of existing and new democratic mechanisms, and also, importantly, the links between different instruments of citizen participation to improve the overall quality of EU's democratic system.

Behavioural sciences help refine our understanding of human decision-making. Their insights are immensely relevant for policy-making since public intervention works much better when it targets real people rather than imaginary beings assumed to be perfectly rational. Increasingly, governments around the world are keen to rely on those insights for reshaping public interventions in a wide range of policy areas such as energy, health, financial services and data protection. When policy-making meets behavioural sciences, effective and low-cost regulations can emerge in the form of default rules, smart disclosure and simplification requirements. While behaviourally-informed intervention has a huge potential for policymaking, it also attracts legitimacy and practicability concerns. Nudge and the Law takes a European perspective on those issues and explores the legal implications of the emergent phenomenon of behavioural regulation by focusing on the challenges and opportunities it may offer to EU policy-making and beyond.

Behavioural sciences help refine our understanding of human decision-making. Their insights are immensely relevant for policy-making since public intervention works much better when it targets real people rather than imaginary beings assumed to be perfectly rational. Increasingly, governments around the world are keen to rely on those insights for reshaping public interventions in a wide range of policy areas such as energy, health, financial services and data protection. When policy-making meets behavioural sciences, effective and low-cost regulations can emerge in the form of default rules, smart disclosure and simplification requirements. While behaviourally-informed intervention has a huge potential for policymaking, it also attracts legitimacy and practicability concerns. Nudge and the Law takes a European perspective on those issues and explores the legal implications of the emergent phenomenon of behavioural regulation by focusing on the challenges and opportunities it may offer to EU policy-making and beyond.

This collection of essays looks at the role the European Union could and should play in promoting healthier lifestyle, in light of the moral, philosophical, legal and political challenges associated with the regulation of individual choices. By tackling the main non-communicable diseases (NCD) risk factors (tobacco consumption, harmful use of alcohol, unhealthy diets and lack of physical activity), the contributors endeavour to identify common themes and determine whether and, if so, to what extent the lessons learned in relation to each area of EU intervention could be transposed to the others. By focusing on the European Union legal order, the book highlights both the opportunities that legal instruments offer for NCD prevention and control agenda in Europe, as well as the constraints that the law imposes on policy-makers.