Public health and safety law Books

Book Synopsis'The 20th century has been described as the century where governments allowed cigarettes to kill more than 100 million people (i.e. more than the first and second World Wars and the holocaust together). This excellent book is a timely study of the complex, regulatory challenges of e-cigarettes. The review of the scientific evidence relating to electronic cigarettes in Part I - and of international and European regulatory approaches in Part II - of this interdisciplinary, comparative study demonstrates the need for multilevel health governance with due regard to international human rights law, world trade law and health law. European health and risk regulations aim at respecting EU fundamental rights, EU constitutional law principles (e.g. precautionary, subsidiarity and proportionality principles) and legitimate ''constitutional pluralism'' in multilevel health governance. The case-studies of American and Chinese regulations of e-cigarettes in Part III of this book illustrate that ''Chinese state-capitalism'' (e.g. its denial of human rights and constitutional protection of citizens) and Anglo-American neo-liberalism (e.g. its frequent neglect of economic and social rights and international public goods) offer less comprehensive protection of citizen interests, as also confirmed by the current 'US-China trade wars'. Professor Gruszczynski's innovative book succeeds in demonstrating the complexity of ''ordo-liberal'' trade and health regulations of ''market failures'' and ''governance failures'' reconciling civil, political, economic, social and cultural rights and health risks.' - Ernst-Ulrich Petersmann, European University Institute, Italy Combining the insights of leading legal scholars and public health experts, this timely book provides up-to-date analysis of the various legal problems emerging at different levels of governance (international, European and national) in the context of the regulation of e-cigarettes. Expert contributors investigate the possible application of the precautionary and harm reduction principles in this area, examining the legal constraints imposed on states by international and European rules, as well as the regulatory approaches currently in place in selected national jurisdictions. This ground-breaking book offers an interdisciplinary approach to the topic, combining insights from medical, public health and legal perspectives. The Regulation of E-cigarettes will be essential reading for both legal and public health scholars and students. Providing a comprehensive and in-depth assessment of the regulatory solutions applied to e-cigarettes, it will also be a key resource for governmental officials, NGO's and public health advocates. Trade Review'E-cigarettes have radically complicated the landscape of public health aims, agendas, and strategies, especially given the context of the tobacco endgame. They bring multiple layers of scientific, as well as political and regulatory, complexity and disagreement. This carefully-curated volume brings competing voices and perspectives, and at once highlights a crucial variety of considerations at the core of agendas to promote governance for health, and underscores the challenges we find in reason and reasoning within an environment of polarisation and uncertainty.' --John Coggon, University of Bristol, UK'This unique book addresses one of the most important challenges facing the tobacco control community today. Should regulators treat e-cigarettes as a public health threat or rather as a chance to fully eradicate the tobacco epidemic? Gruszczynski's interdisciplinary volume provides a much-needed map that can help answer this question.' --Witold Zatonski, Health Promotion Foundation, Poland'This is a fascinating collection of chapters on the regulation of an uncertain, ambiguous and controversial topic. I highly recommend it to anyone interested in the multitude of perspectives on the topic of e-cigarettes and the law. The volume contains contributions from both advocates of more lenient regimes and contributions propagating a stricter regulation. In addition, it contains chapters from different regions, from the global level as well as from different legal fields.' --Wouter Werner, Vrije Universiteit Amsterdam, the Netherlands and University of Curacao, CuracaoTable of ContentsContents: 1. Introduction: Regulating e-cigarettes in the face of uncertainty Lukasz Gruszczynski Part I Science, regulation and e-cigarettes 2. Divide and conquer? E-cigarettes as a disruptive technology in the history of tobacco control Mateusz Zatoński and Allan M. Brandt 3. Review of the scientific evidence relating to electronic cigarettes: Where do we stand now? Charlie A. Smith, Aleksandra Herbeć and Lion Shahab Part II International and European law perspectives 4. Taming the Schrödinger cat: E-cigarettes under the Framework Convention on Tobacco Control Lukasz Gruszczynski 5. A human rights approach to the regulation of electronic cigarettes Marie Elske C. Gispen and Jacquelyn D. Veraldi 6. A ban on Electronic Nicotine Delivery Systems: Step one into the WTO discrimination analysis Marina Foltea and Bryan Mercurio 7. Regulating e-cigarettes at the EU level Anna Pudło and Lukasz Gruszczynski 8. Vaping and the precautionary principle in EU law Giancarlo A. Ferro and Costanza Nicolosi Part III National law perspectives 9. E-cigarette regulation in Taiwan and China Chuan-Feng Wu, Ching-Fu Lin and Mao-Wei Lo 10. Regulation of e-cigarettes in US law Patricia I. Kovacevic 11. One does not simply sell e-cigarettes in Australia: An overview of Australian e-cigarette regulations Coral Gartner and Marilyn Bromberg Index

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Book SynopsisThis timely book emphasizes the importance of regulation in enabling and channelling innovation at a time when technology is increasingly embedded in healthcare. It considers the adequacy of current regulatory approaches, identifying apparent gaps, risks and liabilities, and discusses how these might be collectively addressed. The authors present possible solutions that balance the protection and promotion of public trust in healthcare against enabling technological progress and disruptive innovation.Offering both a theoretical and practical approach to challenges at the intersection of healthcare, law and technology, this thought-provoking book explores broad questions of regulation and innovation before analysing contextual applications of these topics. It moves from a wide-ranging consideration of the polycentric and changing nature of health regulation through to a more specific examination of topics including patient consent, the role of device representatives, privacy, artificial intelligence and big data.Providing an international perspective, Technology, Innovation and Healthcare will be a valuable resource for scholars and students of health law, innovation, technology law, law and development and law and society. It will also be of benefit to lawyers, healthcare professionals, technology developers and policy makers, seeking to better integrate technology with healthcare.Trade Review‘The authors summarize the challenges to managing technology in health care, explain how technology impacts care, and offer some exciting and innovative solutions. This is an interesting read for anyone contemplating a career in health care and those already in the field. Many current issues that impact everyday practice, such as data storage, patient privacy, beneficence, fair access to health care, patient autonomy, and professionalism and qualifications of health care providers, are explored. The text includes an excellent discussion of the advantages and disadvantages of technology for health care and addresses the regulations that guide innovative technology use so that laws protect both patients and providers. The role of regulations, national and international, is explained with equal attention to theory and practical rationale. In addition to its appeal for readers preparing for careers in health care, the book will interest policy makers and health care consumers. The text includes an excellent discussion of the advantages and disadvantages of technology for health care and health care consumers. The comprehensive chapter bibliographies will support any reader in delving into more detail as desired. Summing Up: Recommended. All readers.’ -- S C Grossman, CHOICE‘This is an excellent analysis of the relationship between law, innovation, technology, medicine and regulation. The book deals with both generalities at the beginning, then more specific issues – such as AI and data – that are both important now and will become even more so in the future. I can highly recommend it.’ -- José Miola, University of Leeds, UKTable of ContentsContents: PART I SETTING THE SCENE 1. Introduction to Technology, Innovation and Healthcare 2. The essence of innovation PART II INNOVATION AND THE PATIENT 3. Engaging with the voices in the regulatory enterprise in healthcare 4. Consent and innovation – embracing the unknown and empowering the patient 5. The role of medical device representatives in healthcare PART III INNOVATION AS THE FUTURE OF HEALTHCARE 6. When the treatment team involves non-humans: questions of responsibility 7. What does privacy mean in an era of big data? 8. Algorithms, trust and the use of big data in healthcare decisions Final thoughts Bibliography Index

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Book SynopsisLarge-scale adverse health and developmental outcomes related to tobacco affect millions of people across the world, raising serious questions from a human rights perspective. In response to this crisis, this timely book provides a comprehensive analysis of the promotion and enforcement of human rights protection in tobacco control law and policy at international, regional, and domestic levels. This thought-provoking book offers significant new insights to the topic, laying the foundations for a human rights based approach to tobacco control. Addressing the function of law as a tool to help combat one of the major public health challenges facing society, contributions by global scholars rebut human rights claims presented by the tobacco industry. Emphasis is instead placed upon the human rights of vulnerable individuals, children in particular, as a result of smoking and exposure to second-hand smoke. Illustrating ways in which the right to health can be advanced with regards to tobacco control, smoking and the use of e-cigarettes, this important book will be a vital resource for human rights and health law scholars and practitioners as well as policy makers in public health law. Contributors include: D. Barrett, D. Beyleveld, O.A. Cabrera, A. Constantin A. Garde, M.E. Gispen, L. Gruszczynski, J. Hannah, S. Karjalainen, L. Lane, S. Lierman, A.L. McCarthy, A. Mitchell, S. Negri, O. Nnamuchi, M. Roberts, A. Schmidt, M. Sormunen, A. Taylor, B. Toebes, M. van Westendorp, Y. ZhangTrade Review'Marie Elske Gispen and Brigit Toebes have written a book of worldwide importance and impact. Tobacco is still the leading preventable cause of death globally. Big Tobacco poses a major threat to the right to health. Using a human rights lens, Gispen and Toebes powerfully show how human flourishing demands bold action on tobacco control. The authors are thought leaders globally on health and human rights. Their book is both a superb work of scholarship and a call to action for public health and human rights scholars and advocates everywhere.' --Lawrence O. Gostin, Georgetown University, US'Human rights law, at international, regional and national levels, offers important concepts and processes for strengthening tobacco control. Understanding this, the tobacco industry has also sought to co-opt human rights laws and concepts to serve its economic interests. The importance of human rights law to tobacco control is not well understood, which is why this book - convening the leading experts in this emerging field - is such a welcome and important contribution.' --Roger Magnusson, The University of Sydney, Australia'A well conceptualized and comprehensive volume on a key issue of our time. Varied in their approach to the topic, the pieces brought together here move from the global to the regional to the national, highlighting the interplay between legal systems, and show how human rights-based approaches to tobacco can support specific measures and actions. Illustrating not only how tobacco can be understood as a human rights concern but where human rights arguments fall short, this book shows how critical attention to ethical, normative and legal arguments may move us forward not only in rhetorical but actionable ways.' --Sofia Gruskin, University of Southern California, USTable of ContentsContents: Preface Danius Puras 1. Introduction Marie Elske Gispen PART 1 NORMATIVE REFLECTIONS 2. Dignity, vulnerability and human agency in the context of tobacco Deryck Beyleveld 3. Is there a human right to tobacco control? Andreas Schmidt PART 2 INTERNATIONAL AND REGIONAL HUMAN RIGHTS APPROACHES TO TOBACCO CONTROL AND THEIR LINK TO OTHER FIELDS OF LAW 4. Tobacco control in international human rights law Oscar Cabrera and Andrés Constantin 5. Accountability, human rights and the responsibilities of the tobacco industry Lottie Lane 6. Is there a European human rights approach to tobacco control? Amandine Garde and Brigit Toebes 7. Exploring the role of the ASEAN in fostering human rights approaches to tobacco control in Southeast Asia Yi Zhang 8. Tobacco use, exploitation and vulnerability in Africa: a human rights analysis Obiajulu Nnamuchi 9. Tobacco control in the Inter-American human rights system Oscar Cabrera and Andrés Constantin 10. Human rights in the origins of the FCTC Allyn Taylor and Alisha McCarthy 11. Human rights and tobacco control: lessons from illicit drugs Damon Barrett and Julie Hannah 12. The role of IEL dispute settlement bodies in reinforcing the sovereign rights of States in the field of tobacco control Lukasz Gruszczynski PART 3 SPECIFIC ELEMENTS OF TOBACCO CONTROL LAW AND POLICY IN LIGHT OF HUMAN RIGHTS 13. Smoke-free environments: lessons from Italy Stefania Negri 14. The tobacco endgame: experiences from Finland Milka Sormunen and Sakari Karjalainen 15. E-cigarettes in Belgium : while the smoke clears the fog rises Steven Lierman and Mathijs van Westendorp 16. Human rights and tobacco plain packaging in Australia Andrew Mitchell and Marcus Roberts 17. Conclusions Brigit Toebes Index

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Book SynopsisThis timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research. This thought-provoking book provides new perspectives on the regulation of health research by demonstrating how RECs and other regulatory actors seek to fulfil these two functions by performing a role of 'regulatory stewardship'. This involves guiding researchers through stages of research approval, as well as seeking to maximise benefits for participants and society while minimising risks. Arguing that participant protection and research promotion should rightly be treated as twin objectives for health research regulators, this book asserts that there is a need for more overt recognition of the importance and function of the deliberative space in which RECs can negotiate the risks relevant to a research application. This book is a key resource for academics and students interested in health research and regulation, and the dynamic interaction of ethics and the law. Regulators and policy-makers will also find it to be an insightful and illuminating text for the practical insights that it reveals about research governance in action.Trade Review'This excellent book presents an original and intriguing insight into the ''black box'' of decisions made by Research Ethics Committees (RECs). Put simply, if you want to understand the changes that ethics review and research governance has undergone over the past ten to fifteen years, then this book is required reading. In its intense empirical approach to a topic normally addressed in rather more theoretical terms Regulatory Stewardship of Health Research lays down a challenge to socio-legal studies of regulation, pushing debates towards what he calls an ''anthropology of regulation'', drawing explicit attention to processes, passages, and change inherent in the regulation of modern medical research.' --Adam Hedgecoe, Cardiff University, UK'Dove's careful and detailed analysis of the regulatory system for health research is a refreshing and valuable contribution to theory and practice of ethics review committees - and not just for the UK, but for any jurisdiction thinking seriously about the twin goals of protecting research participants while promoting research. Researchers, research ethics committees, regulators and the public will each find insights about the ways society can make research better for all.' --Eric M. Meslin, Council of Canadian Academies, CanadaTable of ContentsContents: 1. Introduction 2. Conceptual framework—setting the scene for ‘protection’ and ‘promotion’ 3. The making of RECs as health research regulators 4. Anthropology of regulation 5. Operationalising ‘next-generation’ health research regulation—what is happening in practice? 6. Charting a framework for regulatory stewardship 7. Conclusion Index

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Book SynopsisWith contributions from over 30 international legal scholars, this topical Research Handbook on International Food Law provides a reflective and crucial examination of the rules, power dynamics, legal doctrines, societal norms, and frameworks that govern the modern global food system. The Research Handbook analyses the interlinkages between producers and consumers of food, as well as the environmental effects of the global food network and the repercussions on human health. Chapters explore the development of food law and governance strategies, the regulation of novel foods, including insects, and the application of technology and science in food production, such as genetically engineered food. The insightful contributions examine the legal challenges facing the global food system and suggest practical recommendations for future research and reform. Providing a comprehensive and interdisciplinary perspective on the complex legal landscape of food production and consumption, this Research Handbook will be essential reading for students and scholars of food law, consumer law, public international law, and regulation and governance, as well as food system advocates, international lawyers, and policymakers.Table of ContentsContents: 1 Introduction: making a case for international food law 1 Michael T. Roberts PART I DEVELOPMENT OF INTERNATIONAL FOOD LAW ROLE OF LAW IN GLOBAL GOVERNANCE OF FOOD 2 What’s the use of food regime analysis for international law? 17 Anne Saab 3 Food law’s agrarian question: capital, global farmland, and food security in an age of climate disruption 29 William Boyd 4 The intersection of international, European, and global food law: rules, trends, and challenges 63 Ferdinando Albisinni DEVELOPMENT OF FOOD LAW AND GOVERNANCE STRATEGIES 5 Drafting national food laws in a globally connected world 95 Jessica Vapnek and Melvin Spreij 6 The future of planning for food system governance 117 Laurie J. Beyranevand and Emily M. Broad Leib CULTURAL PRESERVATION IN DEVELOPMENT OF INTERNATIONAL FOOD LAW 7 The food–water nexus in the post-revolutionary Mexican Supreme Court 148 Peter L. Reich 8 Food law and third-world approaches to international law (TWAIL): ingredients in a movement, techniques for analysis, recipes for reform, and a future menu 166 Ernesto Hernández-López 9 Community and geography in a holistic approach to food law 183 Marsha A. Echols COMPARATIVE LAW APPLIED TO FOOD LAW 10 Comparative food law 199 Bernd van der Meulen and Bart Wernaart PART II INTERNATIONAL FOOD GOVERNANCE AND LAW FRAMEWORKS FOOD TRADE AND SAFETY 11 Global governance of food safety: the role of the FAO, WHO, and Codex Alimentarius in regulatory harmonization 227 Neal D. Fortin 12 Interactions between food safety protection and trade liberalization in the WTO and FTAs 243 Ching-Fu Lin 13 The Food Safety Modernization Act and international trade rules 261 David A. Wirth 14 ESG, supply chain due diligence and food systems transformation: changes and challenges 291 Uché Ewelukwa Ofodile 15 The regulation of insects as food 315 Steph Tai 16 Food safety governance and good practices for better rulemaking 332 Juanjuan Sun 17 Codex Alimentarius at home and abroad: the regulatory costs of developing and implementing international and national food-safety standards 347 Brian A. Fink LABELING AND CERTIFICATION 18 Sugar labeling: challenges and approaches 369 Alexia Brunet Marks 19 Private third-party verification of product claims: lessons from kosher certification 387 Timothy D. Lytton 20 Class action litigation targeting the food industry: U.S. and international perspectives 409 Tommy Tobin ENVIRONMENTAL LAW AND FOOD 21 Climate change issues in international food law 427 Francesco Bruno 22 Bodies as food system sacrifice zones 443 Margot J. Pollans TECHNOLOGY AND SCIENCE 23 The digital food economy, from food regulation to data governance 471 Pinghui Xiao and Vicki Waye 24 International regulation of genetically engineered food 498 Joanna K. Sax ANIMAL WELFARE 25 Using the law to enhance the welfare of food-producing animals: recognising sentience, raising standards 515 Caoimhín MacMaoláin HUMAN RIGHTS AND FOOD SOVEREIGNTY 26 When crits go to the UN: conversations with Olivier De Schutter, Hilal Elver and Michael Fakhri about the right to food 534 Amy J. Cohen and Nadia C.S. Lambek Index 552 Prepared by Michael T. Roberts

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Book SynopsisDespite recurring efforts, a gap exists across a variety of contexts between the protection of patients’ safety in theory and in practice. This timely Research Handbook highlights these critical issues and suggests both legal and policy changes are necessary to better protect patients’ safety. Multidisciplinary in nature, this Research Handbook features contributions from eminent academics, policy makers and medical practitioners from the Global North and South, discussing the essential facets concerning patient safety and the law. It highlights how the role of legislation and case law has the potential to influence, both positively and negatively, medical practice and the quality of care. Chapters explore patient safety and the global health agenda; physiotherapy; ‘non-therapeutic’ clinical research with children; patient safety awareness in healthcare education; and the increasing use of robotics and artificial intelligence in healthcare.Outlining a wide range of international perspectives on patient safety and the law, this Research Handbook will appeal to academics and researchers specialising in health and medical law, human rights, and healthcare regulation. It will also serve as a valuable resource for legal and medical practitioners alike, as well as clinicians and professionals working in healthcare governance.Trade Review‘An essential guide to assessing the systemic failures that put patient safety and well-being at risk, the Research Handbook on Patient Safety and the Law explores the challenges to improved patient care using multi-disciplinary and international perspectives. The book provides an in-depth exploration of the legal, ethical, and policy issues at work and offers pragmatic responses to the complex array of factors that endanger patients.’ -- Barbara A. Reich, Professor of Law, Western New England University School of Law, US‘“First do no harm”, we're told. But in the legal literature patient safety is very far from the first consideration. This fascinating and comprehensive Research Handbook redresses the imbalance. Essential reading for everyone concerned with medical law, ethics and governance.’ -- Charles Foster, University of Oxford, UKTable of ContentsContents: 1 Patient safety and the law: an introduction 1 John Tingle, Caterina Milo, Gladys Msiska, and Ross Millar 2 The need for more conceptual underpinning in NHS patient safety and clinical negligence policy development 10 John Tingle 3 The law and ethics of informed consent after Montgomery and the safeguard of patients’ safety 22 Caterina Milo 4 ‘Non-therapeutic’ clinical research with children: responsibility in the balance? 37 Amber Dar 5 Balancing on a knife edge: patient safety and autonomy in the psychiatric context 56 Mollie E. L. Cornell 6 The role of tort law in protecting patient safety and autonomy in Australia 74 Barbara McDonald 7 Healthcare in conflict: legally protected, physically at risk 90 Emma J. Breeze 8 Does legalising abortion reduce deaths from unsafe abortion? Experiences in sub-Saharan Africa 108 Calum Miller 9 Physiotherapy in the UK: the second victim in a perfect storm? 125 Sue Greenhalgh, James Selfe, Laura Finucane, and Gillian Yeowell 10 Patient safety at the end of life: the role and limits of the law in England and Wales 141 Adam McCann 11 The ‘patient-friendly’ medical injury liability rules in Germany: implications for patient safety? 165 Marc Stauch 12 Patient safety in Germany 177 Dagmar Luettel, Victoria Klemm, and Reinhard Strametz 13 Patient safety, global governance, and the right to health in integrated primary health care 193 Jonathan Gorry, Linda Gibson, Denis Joseph Bukenya, Pauline Odeyemi, and Michael Obeng Brown 14 Patient safety and the global health agenda 206 Paulo Sousa, Ana Catarina Rodrigues, and José Pedro Teixeira 15 Patient safety in Uruguay 221 Homero Bagnulo, Alejandro Castello, and Carlos Vivas 16 Pregnancy and childbirth risks: clinical and legal perspectives 237 Pedro Melo, Abdea Coomarasamy, and Arri Coomarasamy 17 Patient safety challenges and practical ethical legal issues in low- and middle-income countries 257 Gladys Msiska, Evelyn Chilemba, Martha Kamanga, Chisomo Mulenga, Annie Namathanga, Patrick Mapulanga, and Abigail Kazembe 18 Child safety in developing countries 278 Felistas Chiundira and Pempho Katanga 19 Patient safety consciousness in healthcare education 297 Gladys Msiska, Gervasio Nyaka, Wanangwa Chikazinga, and Patricia Katowa-Mukwato 20 Developing patient safety standards 314 Helen Hughes 21 Dr Robot: robotics and AI in healthcare 336 Angela Eggleton 22 Patient safety and the law: a thematic review and assessment of future options 369 Ross Millar Index 377

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Book SynopsisElgar Advanced Introductions are stimulating and thoughtful introductions to major fields in the social sciences, business, and law, expertly written by the world’s leading scholars. Designed to be accessible yet rigorous, they offer concise and lucid surveys of the substantive and policy issues associated with discrete subject areas.This Advanced Introduction provides a succinct overview of the principles and rules that guide international food law. Neal D. Fortin explores how the globalisation of food supply chains has impacted international food law, making it a pressing concern for contemporary lawmakers. Exploring the maintenance of standards, rules and laws, alongside issues in relation to economics, trade agreements, and free-trade, this comprehensive book provides insight into the future of international food law.Key Features: Offers a historical overview of international food law, covering the key basic concepts Provides insights into key international trade agreements, agencies, and food safety controls Provides guidance on techniques for comparing and understanding the food law of different regions Incisive and accessible, this Advanced Introduction offers invaluable discussion of the major issues in the field for international law scholars, particularly those focusing on food law. It will also be a beneficial read for government officials involved in international trade and lawyers who deal with international food law looking for a better understanding of the history and key components of the topic.Trade Review‘Neal D. Fortin is a gifted teacher. Fortin’s clarity of thought and expression, organization, and insight, which have long marked his teaching and leadership in international food law, are displayed vividly in this much needed book. Advanced Introduction to International Food Law is a terrific primer for the beginning food law scholar seeking to understand the framework of international food law and an essential resource for the seasoned food law scholar to consult frequently for information and context.’ -- Michael T. Roberts, University of California, Los Angeles, USTable of ContentsContents: 1. Introduction and background 2. International food law at a glance 3. The law of international food trade 4. The WTO agreements and dispute settlement 5. Convergence, divergence, and complexity in global food law 6. Final thoughts Further Reading Index

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Book SynopsisElgar Advanced Introductions are stimulating and thoughtful introductions to major fields in the social sciences, business, and law, expertly written by the world’s leading scholars. Designed to be accessible yet rigorous, they offer concise and lucid surveys of the substantive and policy issues associated with discrete subject areas.This Advanced Introduction provides a succinct overview of the principles and rules that guide international food law. Neal D. Fortin explores how the globalisation of food supply chains has impacted international food law, making it a pressing concern for contemporary lawmakers. Exploring the maintenance of standards, rules and laws, alongside issues in relation to economics, trade agreements, and free-trade, this comprehensive book provides insight into the future of international food law.Key Features: Offers a historical overview of international food law, covering the key basic concepts Provides insights into key international trade agreements, agencies, and food safety controls Provides guidance on techniques for comparing and understanding the food law of different regions Incisive and accessible, this Advanced Introduction offers invaluable discussion of the major issues in the field for international law scholars, particularly those focusing on food law. It will also be a beneficial read for government officials involved in international trade and lawyers who deal with international food law looking for a better understanding of the history and key components of the topic.Trade Review‘Neal D. Fortin is a gifted teacher. Fortin’s clarity of thought and expression, organization, and insight, which have long marked his teaching and leadership in international food law, are displayed vividly in this much needed book. Advanced Introduction to International Food Law is a terrific primer for the beginning food law scholar seeking to understand the framework of international food law and an essential resource for the seasoned food law scholar to consult frequently for information and context.’ -- Michael T. Roberts, University of California, Los Angeles, USTable of ContentsContents: 1. Introduction and background 2. International food law at a glance 3. The law of international food trade 4. The WTO agreements and dispute settlement 5. Convergence, divergence, and complexity in global food law 6. Final thoughts Further Reading Index

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Book SynopsisThe drastic impact of the COVID-19 pandemic highlighted many of society’s systemic inequalities. This timely and prescient book explores the role that Intellectual Property Rights (IPRs) played in the pandemic and argues for developing a framework of sustainability, innovation, and global justice in IPR systems, to build a more globally sustainable regime.IPRs impact products and processes which address fundamental societal needs, yet innovation is largely incentivised by the granting of exclusive rights which can limit accessibility to new products and technologies. In light of the COVID-19 pandemic, Intellectual Property Rights in the Post Pandemic World adopts a cross-disciplinary approach to analyse the relationship between IPRs, sustainability, innovation and the circular economy. Chapters examine pressing issues concerning responding to crises, inventions, the circular economy, follow-on innovation and multi-stakeholder collaboration, among others, as possible ways to finance sustainability. Throughout, this book focuses on how the IP system was challenged by the events of the pandemic, with a view to understanding how IPRs can be used to promote progressive social and sustainable innovation in the future.This book will be beneficial for researchers in intellectual property law and development law along with practitioners and policy makers. It will also prove valuable for students with a particular interest in law, social sciences and public health.Trade Review‘This is a timely and much-needed book, which provides important insights into the “what’s next?” of intellectual property on a global scale: by stressing the relationship between innovation, sustainability and global justice, this book brings to the fore the multi-faceted nature of intellectual property and the need for “fairness” to be part of the relevant ecosystem of rights and interests, as well as free spaces and the public domain.’ -- Eleonora Rosati, Stockholm University, Sweden‘Intellectual Property Rights in the Post Pandemic World offers thought-provoking, reflective, and nuanced insights into the intersection of intellectual property, sustainability, and innovation in a rapidly evolving landscape following the global pandemic. This work not only illuminates the complex terrain but also presents alternative perspectives rooted in real-world challenges. It charts a path towards a more equitable and adaptive global intellectual property landscape, compelling us to rethink, reimagine, and rebalance the intellectual property system.’ -- Althaf Marsoof, Nanyang Business School, Singapore‘This book addresses fundamental questions of intellectual property rights in the aftermath of the pandemic in a variety of contributions by an international authorship. It makes an up-to-date contribution to the current discussion on the role of intellectual property rights in the international context of sustainability, innovation and global justice.’ -- Prof. Dr. Claudia Seitz, M.A. (London), Professor for Public Law, European Law, International Law and Life Sciences Law at the Faculty of Law of the Private University in the Principality of LiechtensteinTable of ContentsContents: 1 Intellectual property rights in the post pandemic world: an introduction 1 Taina Pihlajarinne, Jukka Mähönen and Pratyush Nath Upreti PART I NEW PARADIGMS OF INTELLECTUAL PROPERTY RULES IN COVID-19 2 A critical appraisal of the COVID-19 TRIPS waiver 11 Peter K. Yu 3 An elusive response from developed countries to a TRIPS waiver request to address COVID-19 31 Carlos Correa and Nirmalya Syam 4 Crisis, invention, and innovation 57 Shubha Ghosh 5 Alternative IP theories 75 Hans Morten Haugen 6 Intellectual property, friendship and the pandemic: a reflection 95 Pratyush Nath Upreti PART II TRANSFORMING IP TOWARDS GLOBAL JUSTICE WITH INNOVATION AND SUSTAINABILITY 7 Rethinking intellectual property through decoloniality and other lenses 118 Yousuf A. Vawda 8 The right to research as guarantor for sustainability, innovation and justice in EU copyright law 138 Christophe Geiger and Bernd Justin Jütte 9 Trademark, privacy and data protection 170 Tianxiang He and Qingchuan Xie 10 Artificial intelligence, patents and health innovation 188 Enrico Bonadio and Magali Contardi 11 IP, medical AI and public health crisis 205 Yahong Li PART III SHAPING INTELLECTUAL PROPERTY FINANCING FOR SUSTAINABLE INNOVATION 12 Relationship and intersections between intellectual property, property (as security) and circular economy 225 Sean Thomas 13 The UNDP Accelerator Lab Network 246 Matthew Rimmer 14 The potential of follow-on innovation financing instruments to support a sustainable transition 277 Natacha Estèves, Alina Wernick and Suelen Carls 15 IPR and beyond 299 Dhanay Cadillo-Chandler, Rosa Maria Ballardini and Jouko Nuottila 16 Seeking and hiding: corporate disclosure norms, enhancing non-financial information transparency using the technology readiness level (TRL) system 319 Janice Denoncourt 17 Conclusions: towards a (new) framework of sustainability, innovation and global justice for intellectual property 348 Taina Pihlajarinne, Jukka Mähönen and Pratyush Nath Upreti Index 352

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Book SynopsisGenetically modified organisms (GMOs) are an extraordinary innovation. They raise great expectations of economic prosperity and improved capacity to address pressing problems of poverty and environmental degradation, whilst simultaneously raising great concerns about the type of social and physical world they promise. Finding space in regulation to consider the full range of issues provoked by GMOs is a huge challenge. This book explores the EU's elaborate regulatory framework for GMOs, which extends far beyond the process of their authorisation (or not) for the EU market, embracing disparate legal disciplines including intellectual property, consumer protection and civil liability. The regulation of GMOs also highlights questions of EU legitimacy in a context of multi-level governance, both internally towards national and local government, and externally in a world where technologies and their regulation have global impacts. This book will be of interest to academics and students in both law and social sciences, as well as practising lawyers and policy makers. It addresses questions that are significant for those involved in environmental or food issues, as well as specialists in GMOs.Trade Review'Lee's book is a valuable addition to the literature for those wishing to broaden their understanding of the range of legal disciplines involved in GMO regulation.' -- Tracey Epps, European Review of Agricultural Economics'Maria Lee's work is a successful attempt to illustrate the "big legal issues" behind the regulation of genetically modified organisms (GMOs). This study, which is thorough and well documented, is particularly welcomed in view of the need for a dialogue between different legal specialisms for which GMOs are a relevant area of research. . . [The] book provides a very interesting and insightful examination of the legal problems raised by GMOs. I would warmly recommend its reading to academics and practitioners who are interested in European risk regulation law, environmental law, biotechnology and trade law.' -- Sara Poli, European Law ReviewTable of ContentsContents: 1. Introduction 2. GMOs in the EU: The Scope of the Debate 3. GMOs and Risk Regulation in the EU 4. Living with GMOs (1): Coexistence, Liability and Labelling 5. Living with GMOs (2): Ownership 6. The Global Context of International Trade 7. Conclusions Bibliography Index

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Book SynopsisGenetically modified organisms (GMOs) are an extraordinary innovation. They raise great expectations of economic prosperity and improved capacity to address pressing problems of poverty and environmental degradation, whilst simultaneously raising great concerns about the type of social and physical world they promise. Finding space in regulation to consider the full range of issues provoked by GMOs is a huge challenge. This book explores the EU's elaborate regulatory framework for GMOs, which extends far beyond the process of their authorisation (or not) for the EU market, embracing disparate legal disciplines including intellectual property, consumer protection and civil liability. The regulation of GMOs also highlights questions of EU legitimacy in a context of multi-level governance, both internally towards national and local government, and externally in a world where technologies and their regulation have global impacts. This book will be of interest to academics and students in both law and social sciences, as well as practising lawyers and policy makers. It addresses questions that are significant for those involved in environmental or food issues, as well as specialists in GMOs.Trade Review'Lee's book is a valuable addition to the literature for those wishing to broaden their understanding of the range of legal disciplines involved in GMO regulation.' -- Tracey Epps, European Review of Agricultural Economics'Maria Lee's work is a successful attempt to illustrate the "big legal issues" behind the regulation of genetically modified organisms (GMOs). This study, which is thorough and well documented, is particularly welcomed in view of the need for a dialogue between different legal specialisms for which GMOs are a relevant area of research. . . [The] book provides a very interesting and insightful examination of the legal problems raised by GMOs. I would warmly recommend its reading to academics and practitioners who are interested in European risk regulation law, environmental law, biotechnology and trade law.' -- Sara Poli, European Law ReviewTable of ContentsContents: 1. Introduction 2. GMOs in the EU: The Scope of the Debate 3. GMOs and Risk Regulation in the EU 4. Living with GMOs (1): Coexistence, Liability and Labelling 5. Living with GMOs (2): Ownership 6. The Global Context of International Trade 7. Conclusions Bibliography Index

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Book SynopsisThis book provides a detailed and comparative examination of medical patent law and the issues at the heart of the medical treatment exclusion for therapeutic treatments, surgical treatments and diagnostic methods. It first considers the historical basis for exclusion and the development of law and policy in Europe, the United States and other commonwealth countries. The book goes on to provide a detailed analysis of the issues related to new medical technologies, such as gene therapy, dosage regimes, and medical diagnostics, in light of the medical treatment exclusion. Medical Patent Law will strongly appeal to patent agents and attorneys, solicitors and barristers working in patent and intellectual property law and medical law worldwide, as well as medical practitioners and healthcare professionals; scientists, researchers and managers in the chemicals, medical; pharmaceuticals and biotechnology industries. Postgraduates on LLM medical law and intellectual property courses and academics specializing in medical law or patent law, will also find much to interest them.Trade Review‘Ventose makes a fresh, lively and incredibly thorough contribution to the literature in this work. He canvasses the European, English and American authorities in a systematic, methodical and - dare I say - surgical manner. The book is a ‘must read’ for practitioners, academics and students alike interested in patentable subject matter, public policy and medico-legal ethics. It will be a welcome addition to any legal collection.’ -- Emir Aly Crowne, University of Windsor, Barrister & Solicitor, Law Society of Upper Canada and Co-Founder and Co-Chair, Harold G. Fox Intellectual Property Moot‘Medical patents are a matter of life and death. Such patents have a critical impact upon patient care, medical research, and the administration of healthcare (and, indeed, are in part responsible for ballooning health care budgets). This comprehensive book by Eddy D. Ventose provides a systematic comparative analysis of medical patents. The work explores the historical taboo against patenting methods of human treatment; charts the spectrum of policy positions on medical patents, ranging from permissive to prohibitive; and examines contemporary battles over patenting methods of medical correlation in the Supreme Court of United States.’ -- Matthew Rimmer, The Australian National University College of Law and ACIPA, AustraliaTable of ContentsContents: Foreword Preface 1. Introduction 2. Arguments for Patent Protection 3. Arguments Against Patent Protection 4. Therapeutic Methods 5. Surgical Methods 6. Diagnostic Methods 7. Second and Further Medical Uses 8. Manner of New Manufacture 9. United Kingdom Patents Act 2004 10. United States of America 11. Conclusions Bibliography Index

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Book SynopsisHIV/AIDS remains a major global health problem, despite the progress made in its prevention and treatment. Addressing this problem is not only a matter of more and better drugs, they need to be widely accessible and be affordable to the poor. This book makes, with a much welcomed interdisciplinary approach, an excellent contribution to understanding how the intellectual property regime can influence health policies and the lives of millions of people affected by the disease. The analysis provided by the various authors that contributed to this book will be of relevance not only to those working in the area of HIV/AIDS, but to those more broadly interested in public health governance and the role of intellectual property rights.'- Carlos Correa, University of Buenos Aires, Argentina'This is an important, innovative and, at times, controversial collection. Inter-disciplinary in approach, this collection will have appeal to those concerned with the global injustice in the context of HIV/AIDS. Investigating the legal, political and economic determinants of access to essential medicines, this is thought provoking collection which will resonate with many in both the academic and public policy community.'- Bryan Mercurio, The Chinese University of Hong KongThis important book brings together leading scholars from multiple disciplines, including intellectual property, human rights, public health, and development studies, as well as activists to critically reflect on the global health governance regime.The Global Governance of HIV/AIDS explores the implications of high international intellectual property standards for access to essential medicines in developing countries. With a focus on HIV/AIDS governance, the volume provides a timely analysis of the international legal and political landscape, the relationship between human rights and intellectual property, and emerging issues in global health policy. It concludes with concrete strategies on how to improve access to HIV/AIDS medicines.This interdisciplinary, global, and up-to-date book will strongly appeal to academics in law, international relations, health policy and public policy, as well as students, policymakers and activists.Contributors include: F.M. Abbott, O. Aginam, T. Amin, L. Biron, A. Denburg, G.E. Evans, J. Harrington, J. Harrison, K. Lee, K.C. Shadlen, P.K. YuTrade Review‘The different chapters are presented in a coherent manner and are all characterized by a precise yet easy to understand language that makes the book an enjoyable and accessible read for researchers and students alike.’ -- Queen Mary Journal of Intellectual Property‘HIV/AIDS remains a major global health problem, despite the progress made in its prevention and treatment. Addressing this problem is not only a matter of more and better drugs, they need to be widely accessible and be affordable to the poor. This book makes, with a much welcomed interdisciplinary approach, an excellent contribution to understanding how the intellectual property regime can influence health policies and the lives of millions of people affected by the disease. The analysis provided by the various authors that contributed to this book will be of relevance not only to those working in the area of HIV/AIDS, but to those more broadly interested in public health governance and the role of intellectual property rights.’ -- Carlos Correa, University of Buenos Aires, Argentina‘This is an important, innovative and, at times, controversial collection. Inter-disciplinary in approach, this collection will have appeal to those concerned with the global injustice in the context of HIV/AIDS. Investigating the legal, political and economic determinants of access to essential medicines, this is a thought provoking collection which will resonate with many in both the academic and public policy community.’ -- Bryan Mercurio, The Chinese University of Hong KongTable of ContentsContents: 1. Introduction Obijiofor Aginam and John Harrington 2. Communitarian Globalism and Disease: A Normative Orientation for Global Health Governance Obijiofor Aginam 3. Is AIDS Treatment Sustainable? Kenneth C. Shadlen 4. Access to Paediatric Medicines: The Global Political Economy of Drug Production and Supply for Children in the Developing World Avram Denburg and Kelley Lee 5. Trade Agreements, Intellectual Property and Access to Essential Medicines: What Future Role for the Right to Health? James Harrison 6. Re-visiting the Patents and Access to Medicines Dichotomy: An Evaluation of TRIPs Implementation and Public Health Safeguards in Developing Countries Tahir Amin 7. Seizure of Generic Pharmaceuticals in Transit Based on Allegations of Patent Infringement: A Threat to International Trade, Development and Public Welfare Frederick M. Abbott 8. Patent Licensing Strategies for the Research and Development of Pharmaceuticals in Developing Countries Gail E. Evans 9. Increasing Access through Incentives for Innovation: The Health Impact Fund Laura Biron 10. Building IPC4D to Promote Access to Essential Medicines Peter K. Yu 11. The Global Governance of HIV/AIDS and the Rugged Road Ahead: An Epilogue Peter K. Yu Appendices Index

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Book SynopsisThis innovative book examines the role an automobile emissions tax could play in reducing emissions in the United States. The author concludes that an emissions tax has the potential to reduce emissions from households vehicles significantly, even when travel demand is relatively price inelastic. Beginning with a theoretical discussion of a first-best tax, a second-best tax on passenger vehicles is developed. This study contains detailed analyses of: the design of the tax behavioural responses that lead to emissions reductions, including reductions in the household's vehicle miles of travel and the scrapping of low-value, high emitting vehicles the effect of the tax on the reduction of emissions the effect of the tax on households in different income quintiles the emissions reducing potential of a gasoline tax compared to an emissions tax This study uses a simulation model to analyse the sensitivity of travel demand and the resulting emissions, to different tax rates and demand elasticities. The author concludes that an emissions tax has the potential to reduce emissions from household vehicles significantly, even when travel demand is relatively price inelastic.Taxing Automobile Emissions for Pollution Control will prove invaluable to policymakers and academics in the field of environmental management and environmental economics and policy.Trade Review'This important and seminal book examines a proposed system of emissions taxes based on vehicle discharges, as an alternative to our present cumbersome, costly, and not highly successful system relying on direct controls. . . . this book is the first rigorous and thorough examination of such an emissions charge system. . . . Maureen Sevigny has professionally and carefully, as a scientifically cautious scholar, made an analysis of a specific air quality plan. Everyone concerned with bad air from motor vehicle emissions should note this study. . . . This work should not be ignored. It is a nice piece of analysis.' -- Stanley G. Long, Transportation JournalTable of ContentsContents: 1. Introduction 2. Designing a Tax on Mobile Source Emissions 3. Effects on Travel Demand and Maintenance 4. The TIERS Model 5. Modelling the Scrappage Effect of the Tax 6. Summary and Conclusions Index

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Book SynopsisJuristen, Ärzte, Pharmakologen und Apotheker finden in diesem Werk vier wesentliche Aspekte des Medizinrechts: das Arztrecht, das Arzneimittelrecht, das Recht der Medizinprodukte und das Transfusionsrecht. Die rechtliche Darstellung medizinischer, pharmazeutischer und medizintechnischer sowie transplantations- und transfusionsrechtlicher Probleme verdeutlichen Entscheidungen und praktische Fälle. Ein Blick auf ausländische Entscheidungen, Regeln und Tendenzen rundet das Bild ab. Europarechtliche Vorgaben werden eingehend beleuchtet. Die 7. Auflage setzt neue Akzente im Bereich des Transplantationsrechts, der Patientenverfügung und der Sterbebegleitung und zeigt neuere Entwicklungen in Europa im Recht der medizinischen Forschung, auch an Tieren. Wegen der genauen Gliederung und des ausführlichen Registers ist das Buch auch als Nachschlagewerk geeignet.Trade Review“... Dieses Buch ist nicht nur ein Handbuch, das eine vertiefte Übersicht darüber, was das Medizinrecht in seiner Gesamtheit heute ist, bietet und die einzelnen behandelten Themen gründlich aufarbeitet. Dieses Buch ist mindestens ebenso gut als Lehrbuch und sogar als Repetierhilfe nutzbar ...“ (Adrian Schmidt-Recla, in: MedizinRecht, Jg. 33, 2015, S. 146)Table of ContentsArztrecht.- Arzneimittelrecht.- Medizinprodukterecht.- Transfusionsrecht.- Anhang.

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Book SynopsisToday the threat of violence impacting worker safety and business operations is a major concern. It is crucial that thoughtful violence prevention policies and supporting violence response plans be developed before any incidents occur in order to properly prepare to use, respond, engage, and react appropriately. Once violence begins or ends is not good enough. The threats are real, and the risks must be managed. A violent threat from a current or former employee, domestic violence or relationship violence spillovers, and the threat posed by criminals committing crimes against people and property are concerns for which all organizations must prepare. Incident avoidance is not acceptable – indeed, most likely not possible. Our job is to make it manageable.This book, Combating Workplace Violence, provides a basic understanding of workplace violence as well as prevention policy and plan development in nontechnical terms. The key to the successful development and implementation of a w+orkplace prevention policy is the collaborative proactive leadership of company executives and management and the assistance of a qualified, reputable consultant. While the information and tools contained here are designed to serve as a baseline for any organization's solution to workplace violence, the material is useful to inform and educate any member of an organization. The unique framework (V-REEL®) for analyzing the organization's internal environment to determine what can be done to try to eradicate or reduce workplace violence is especially useful. Ancillaries following each chapter provide additional information and tools to assist your planning. We envision this book being used to inform managers, human resource professionals, workers, and academics in all types of organizations. Hopefully, using the material and framework of this book, more organizations will develop policies, procedures, and practices to prevent workplace violence.

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Book SynopsisToday the threat of violence impacting worker safety and business operations is a major concern. It is crucial that thoughtful violence prevention policies and supporting violence response plans be developed before any incidents occur in order to properly prepare to use, respond, engage, and react appropriately. Once violence begins or ends is not good enough. The threats are real, and the risks must be managed. A violent threat from a current or former employee, domestic violence or relationship violence spillovers, and the threat posed by criminals committing crimes against people and property are concerns for which all organizations must prepare. Incident avoidance is not acceptable – indeed, most likely not possible. Our job is to make it manageable.This book, Combating Workplace Violence, provides a basic understanding of workplace violence as well as prevention policy and plan development in nontechnical terms. The key to the successful development and implementation of a w+orkplace prevention policy is the collaborative proactive leadership of company executives and management and the assistance of a qualified, reputable consultant. While the information and tools contained here are designed to serve as a baseline for any organization's solution to workplace violence, the material is useful to inform and educate any member of an organization. The unique framework (V-REEL®) for analyzing the organization's internal environment to determine what can be done to try to eradicate or reduce workplace violence is especially useful. Ancillaries following each chapter provide additional information and tools to assist your planning. We envision this book being used to inform managers, human resource professionals, workers, and academics in all types of organizations. Hopefully, using the material and framework of this book, more organizations will develop policies, procedures, and practices to prevent workplace violence.

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Book SynopsisThis thought-provoking book draws together research from genetics, anthropology, psychology and the social sciences to show that widespread assumptions about the inevitability of human violence are almost entirely a collection of myths. While violence has been a recurring feature of human life, there is no reason to suppose that it is inherent in ''human nature''. On the contrary, patterns of aggressive behaviour are largely learned through experience and even those individuals who have often acted violently can learn to change. Rejecting the speculations of much contemporary writing about human aggression, Violence Rewired presents an evidence-based alternative: a multi-level model of action to reduce violence at both individual and collective levels, linked to public health initiatives developed by the World Health Organization. If humanity is to survive the challenges it faces, a more realistic appraisal of ourselves and our basic tendencies is an indispensable part of the solution.Trade Review'Violence Rewired is ground-breaking for its scope and rigour that takes us on a journey from our primate past to a potentially peaceful future. It dispels myths around our 'true nature' in a convincingly scientific and scholarly way that suits audiences ranging from nurses, judicial scholars, students to the scientifically curious.' Devon Polaschek, Joint Director of the New Zealand Institute for Security and Crime Science, University of Waikato, New Zealand'This book offers one of the most sensible and useful accounts of human violence to date. In familiar and concise prose, Violence Rewired provides readers with a comprehensive overview drawing on archaeology, biology, and psychology. The authors enlighten with state-of-the-art scientific literature on the effectiveness of global efforts to reduce violent behavior.' Birgit Völlm, Medical Director of the Forensic-Psychiatric Hospital, University of Rostock, Germany'The editors have conquered the complex challenge of comprehensively integrating biological, psychological, and social approaches to understanding violence. Their work presents a positive message: violent behaviour can be changed. This will be a big hit and eminent milestone for researchers in the field.' Tilman Steinert, Medical and Research Director of the Clinic for Psychiatry and Psychotherapy, Ulm University, Germany'This outstanding book provides a comprehensive overview of theories and relevant research results on violence from various scientific disciplines. Moreover, it supplies optimism and greater confidence about possibilities of effectively intervening with violent people. In short, it is a must-read for those who want to gain the best possible grasp of (preventing) violence.' Vivienne de Vogel, University of Applied Sciences Utrecht, and Researcher, De Forensische Zorgspecialisten, The Netherlands'It is a pleasure to welcome this book, which describes public health approaches to understanding and preventing violence. It includes wide-ranging reviews of biological, psychological and social factors, risk assessment instruments, and different types of interventions. This book will be of great interest to biologists, psychologists, social scientists, and anyone who is interested in understanding and preventing violence.' David P. Farrington, Emeritus Professor of Psychological Criminology, University of CambridgeTable of ContentsForeword. Between chimpanzees and bonobos: the challenge of violence prevention; Part I. Origins: 1. The prospect of human violence: pessimism or realism?; 2. The roots of human violence: in search of the 'hard wired'; 3. The biology of violence: possibilities and limitations; 4. Developmental factors in violence propensity: the learning of violence; 5. Structural violence: social and political factors in understanding violence; Part II. Solutions: 6. Advancing a global public health response to violence; 7. Risk assessment: can violence be predicted?; 8. Pharmaceutical interventions: medication, violence and the public health; 9. Psychosocial interventions: the unlearning of violence; 10. Changing structures: integrated interventions for violence; Conclusion; Appendix. Major UN initiatives to address violence 1986–2018.

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Book Synopsis, Boston College.Trade ReviewAn excellent book... Will be exceedingly helpful to clinicians and nonclinicians who are involved in the development of public policy. JAMA 2008 Easily readable and well referenced... It is an excellent, well-thought-out resource for where the U.S. is on the issue of gerontology as it relates to ethics and public policy... Highly recommended. Choice 2008 A good survey of many aging society issues. Future Survey 2007 Some of the individual chapters are superb... contains some interesting original material as well as a useful synthesis of the literature... There is something in it for almost everyone. New England Journal of Medicine 2008 This book is well edited and presented, which makes reading it quite straightforward, even while taking on at times some complex issues. -- Karen Le Ball Age and Ageing 2008 This book... is unique in that it explores issues and challenges at hand with the current aging society through an 'ethical' lens, and brings together experts in a wide range of fields covering sociobiology, social work, economics, public policy, theology, public health, bioethics, nursing and neurology -- Erica Yoonkyung Journal of Sociology and Social Welfare 2009 There is something for everyone in this collection -- John Bond Aging and Society 2008 It is a compilation of multiple thought-provoking analyses of the status of elderly and the aging, and includes current and future ramifications. -- Susan Wegener Inside GCM 2008Table of ContentsList of ContributorsAcknowledgmentsIntroduction: The Science and Ethics of Aging WellPart I: Autonomy and End-of-Life Decisions1. The Legal Aspects of End-Of-Life Decision Making2. Assessing Compentency to Make Medical Decisions at the End of Life: Clinician and Patient Issues3. The Ethics of Long-Term Care: Recasting the Policy Discourse4. Religiosity and Spirituality at the End of Life: Challenges and OpportunitiesPart II: The Future of Family Responsibility5. The Family and the Future: Challenges, Prospects, and Resilience6. Long-Term Care, Feminism, and an Ethics of Solidarity7. Aging, Generational Opposition, and the Future of the FamilyPart III: Policies and Politics of Genrational Responsibility8. Minority Elders in the United States: Implications for Public Policy9. Allocating Resources for Lifelong Learning for Older Adults10. Transforming Age-Based Policies to Meet Fluid Life-Course Needs11. The Political Paradoxes of Thinking outside the Life-Cycle Boxes12. Is Responsibility across Generations Politically Feasible?Part IV: Health and Wealth: Whose Responsibility?13. Social Security Reform and Responsibility across the Generations: Framing the Debate14. Setting the Agenda for Social Security Reform15. A Summary of Saving Social Security: A Balanced Approach16. Assessing the Returns from the New Medicare Drug Benefit17. Prescription Drugs and Elders in the Twenty-first CenturyIndex

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Book Synopsishealth care system.Trade ReviewThis slender volume offers value on several dimensions. First, it is an explication of recent history that connects the dots from prospective payment to Medicare-based deficit reduction to cost shifting to managed care. By the same token, the story here serves as a bracing corrective to the mythology of market-based reform and the assumption that government's role in health is inescapably a negative one. Health Affairs 2007 Whether discussing the Social Security Amendments of 1972 or the Balanced Budget Act of 1997, Mayes and Berenson entertain readers with insider anecdotes about the ideological and practical battles government policymakers fought with powerful provider lobbies. New England Journal of Medicine A highly readable book that traces the history of Medicare prospective payment systems from their enactment in 1983 until today. Journal of Health Politics, Policy and Law This book provides an excellent primer for physician leaders on the recent history of Medicare and the politics of elected officials using it as a cash cow. The authors challenge practicing physicians to carefully consider what may work in society's best interests to improve health outcomes, rather than primarily focusing on how Medicare benefits their net incomes. JAMA 2008 Mayes and Berenson offer an admirable product in this book, one that we should use to improve our own studies of the state and the agents who help define it. -- Andrew B. Whitford International Public Management Journal 2009Table of ContentsAcknowledgmentsList of AcronymsIntroduction1. Origins and Policy Gestation2. Development, Growing Appeal, and Passage of Prospective Payment3. The Phase-In Years and Beginning of "Rough Justice" for Hospitals4. Medicare Policy's Subordination to Budget Policy, Increased Hospital Cost Shifting, and the Rise of Managed Care5. The Resource-Based Relative-Value Scale Reforms for Physician Payment6. The Calm before the Storm7. The Reckoning and ReversalConclusion: How Medicare Does and Should Shape U.S. Health CareAppendix: InterviewsNotesReferencesIndex

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Book SynopsisNarrative examples of common situations demonstrate how conversations about medical error can lead to healing.Trade ReviewProfessional health collections will consider this essential. Midwest Book Review 2011Table of ContentsForeword, by Lucian L. Leape, M.D.AcknowledgmentsIntroduction1. Medical Error through the Eyes of Clinicians, Patients, and Families2. What Is a Medical Error?3. A Brief Overview of the Patient Safety Movement4. Communicating about Adverse Events and Medical Error5. Supporting Clinicians in Disclosure: The Coaching Model6. Practice-Based Learning for Coaches and Clinicians7. Practical Guidelines for Disclosure8. Learning through Enacting9. The Broad Spectrum of Adverse Events and Medical Error10. Organizational Strategies for Improving Disclosure Practice11. Future Directions and Closing ThoughtsAppendix: Practical Guidelines for DisclosureAnnotated Bibliography of Key WorksReferencesIndex

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Book SynopsisThis bookis an essential guide and support to understanding of the science and policy, procedure and practice that underpins the REACH risk assessments required for the use and placing on the market of chemicals in the European Union. A clear understanding of information provision and how this affects the assessment of chemical safety is fundamentally important to the success of policy on chemicals and ultimately to the sustainability of the chemicals industry. Within the book, the scientific processes that underpin the policy are explained in a practical way. Importantly, it includes coverage of techniques to help solve the problems of using potentially risky and hazardous chemicals through the use of less hazardous alternatives and green chemistry', and also the analysis of the risks of the use of the most hazardous substances against the social and economic benefits of use. Chemical Risk Assessment: A Manual for REACHcovers the following main themes: <Table of ContentsList of Figures xv List of Tables xvii List of Contributors xix Introduction xxi 1. Introduction: Policy and Scientific Context of Chemicals Risk and Risk Management 1 1.1 Overview of the Risk Assessment of Chemical Substances 4 1.2 Chemical Hazard and Risk Programmes 5 1.2.1 REACH Overview 5 1.2.2 Registration 6 1.2.3 Evaluation 8 1.2.4 Authorisation and Restriction 11 1.2.5 Hazard and Risk Communication 14 1.2.6 Hazards 16 1.2.7 Overview of Types of Exposure 17 1.2.8 Overview of Risk Characterisation 19 1.2.9 Successful Interaction with REACH: Registration, Evaluation and Authorisation 21 1.2.10 Regulation and Assessment of Hazardous Chemicals Outside of the European Union 24 2. Roles and Responsibilities in REACH 39 2.1 The Structure and Responsibilities of the Authorities 39 2.1.1 Role of the ECHA 39 2.1.2 The Role of the Member State Committee (MSC) 40 2.1.3 The Role of the Member State Competent Authorities (MSCA) 40 2.2 Forum Enforcement Project – REACH-EN-FORCE-1 41 2.3 Future Aims of the HSE (an Example of a ECHA-Related Authority Acting in the UK) 41 2.4 What Does REACH Require as Regards Enforcement? 41 2.5 What Powers Do Enforcing Authorities Have? 42 2.6 The Responsibilities of Industry 42 2.6.1 Responsibilities of the Manufacturer 42 2.6.2 Responsibilities of the Importer 43 2.6.3 The Only Representative 43 2.6.4 Responsibilities of the Downstream User 43 2.7 Communication in the Supply Chain and with Regulators 44 2.7.1 Use Descriptor System 44 3. Control of Chemicals – Legislative and Policy Context 57 3.1 How EU Chemical Legislation Evolved 57 3.2 Air Quality Regulations 63 3.3 Water Framework Directive 64 3.4 Carcinogens at Work 65 3.5 Cosmetics 66 3.6 Biocidal and Plant Protection Products 67 3.7 Nationally (UK)-Implemented Legislative and Policy Frameworks 68 3.7.1 Workplace Exposure 68 3.7.2 Control of Substances Hazardous to Health Regulations (COSHH) 2002 69 3.7.3 Dangerous Substances and Explosive Atmospheres Regulations (DSEAR) 2002 72 3.8 UK Environmental Regulation 74 3.8.1 Overview and IPPC 74 3.8.2 Waste (England and Wales) Regulations 2011 SI 988 75 3.8.3 Water Legislation in the UK 75 3.8.4 Directive 2006/118/EC on the Protection of Groundwater against Pollution and Deterioration 77 3.8.5 Groundwater (England and Wales) Regulations 2009 (SI 2009 No. 2902) 77 3.8.6 Air Legislation in the UK 77 4. Identification of Substances for REACH – Practicalities 81 4.1 Substance Identification 81 4.1.1 Types of Substances 82 4.1.2 Mono-Constituent Substances 82 4.1.3 Multi-Constituent Substances (MCSs) 82 4.1.4 Substances with Unknown or Variable Composition, or of Biological Origin (UVCBs) 82 4.1.5 Nanomaterials 83 4.1.6 Articles 84 4.1.7 EC Number 84 4.2 Sameness 85 4.3 Essentially-Pure Substances 85 4.4 Approaching the Substance Data Set – Understanding the Substance 86 5. Physico-Chemical Properties for REACH – Purpose and Practicalities 89 5.1 Physico-Chemical Properties 89 5.2 Strategy in Physico-Chemical Testing Plans 91 5.2.1 Tier 1 Tests 91 5.2.2 Tier 2 Tests 92 5.2.3 Tier 3 Tests 93 5.3 Difficult-to-Measure Substances 94 5.3.1 Multiconstituent or UVCB Substances (Mixtures) 94 5.3.2 Poorly Soluble Substances 94 5.3.3 Volatile Substances 94 5.3.4 Unstable Substances Either by Hydrolysis, Photolysis or Oxidation 94 5.3.5 Ionisable Substances 95 5.3.6 Surface Active Substances 95 5.4 Hazardous Physico-Chemical Data 95 5.5 Relationship between Physico-Chemical Tests 95 5.6 Application of Physico-Chemical Test Data 96 5.7 Can Physico-Chemical Tests Be Omitted? 96 5.8 (Q)SAR and Physico-Chemical Tests 97 5.9 (Quantitative) Structure-Activity Relationships ((Q)SAR) 97 6. Assessing and Documenting the Intrinsic Properties of Substances in REACH 103 6.1 Introduction to REACH Data Requirements 103 6.1.1 Strictly Controlled Conditions 104 6.2 Hazards 108 6.3 PBT 108 6.4 Equivalent Concern 109 6.4.1 Adversity 109 6.4.2 Mode of Action 110 6.5 Test Proposal Rule 110 6.6 Availability of Existing Data and Rights of Access 111 6.7 Data Reliability 111 6.8 Data Gaps – Options for Surrogate Data for Description of Hazard and Risk – Including Read-Across 111 6.9 Read-Across 113 7. Assessing Environmental Properties Data 115 7.1 Environmental Properties Data 115 7.1.1 PNECs 115 7.1.2 Classification and Labelling (C&L) 116 7.1.3 PBT 116 7.2 Environmental Fate 116 7.2.1 Degradation 117 7.2.2 Bioaccumulation 120 7.2.3 Adsorption 121 7.3 Ecotoxicology 123 7.3.1 Introduction 123 7.3.2 Hazard Assessment and Risk Characterisation 123 7.3.3 Data Review 127 7.3.4 Testing of Difficult Substances 127 7.3.5 (Q)SARs, Data Waiving and EPM 128 7.3.6 Further Testing 129 7.3.7 Toxicity to Sewage Treatment Plant Microorganisms 129 7.4 Turning Intrinsic Properties into ‘No-Effect’ Concentrations 130 7.4.1 Selecting a Suitable Starting Point for a PNEC Calculation 131 7.4.2 Calculating a PNEC Using Assessment Factors 131 7.4.3 Calculating a PNEC Using Sensitivity Distribution 133 7.4.4 Calculating a PNEC Using Equilibrium Partitioning 133 7.4.5 Intermittent versus Continuous Releases 134 8. Environmental Exposure 137 8.1 Substance Identity and Approach to Exposure Assessment 137 8.2 Characterising Releases 138 8.2.1 Evaluating Use Pattern 138 8.3 Evaluating Releases 139 8.3.1 Reality Checking – Top Down and Bottom Up 141 8.4 Documentation for the Registration 142 8.4.1 Uncertainty 142 8.5 Local Scale Releases 142 8.5.1 Site Size 142 8.5.2 Site Inspections 143 8.6 Exposure Assessment – Models or Measurements? 143 8.6.1 Using Measurements 143 8.6.2 Using Models 145 8.6.3 Models or Measurements – Recommended Approach 145 8.6.4 Tools 145 8.7 Water 146 8.7.1 Release via Waste-Water 146 8.7.2 River Environment 148 8.7.3 Marine Environment 149 8.7.4 Sediments 149 8.8 Soil 149 8.8.1 WWTP Sludge and Agricultural Soil 149 8.8.2 Deposition 149 8.8.3 Biodegradation in Soil 150 8.8.4 Crops and Grassland 150 8.8.5 Industrial Soil 150 8.9 Air 150 8.9.1 Air in the Standard PEC Models 150 8.9.2 Ozone Depletion and Other Specific Effects 150 8.9.3 Long Range Pollutants 151 8.10 The Food Chain 151 8.10.1 Biomagnification 151 8.10.2 Secondary Poisoning 151 9. Assessing the Hazards to Human Health from Chemicals 153 9.1 Mammalian Toxicology 153 9.2 Exposure Routes and Local/Systemic Effect Types 153 9.3 Acute and Chronic Effects 154 9.4 Influences on Toxicity 154 9.5 How Chemicals Cause Harm 155 9.5.1 Asphyxiants 155 9.5.2 Narcotics 155 9.5.3 Irritants and Corrosives 155 9.5.4 Sensitisation (Allergic Reactions) 156 9.5.5 Carcinogenicity 156 9.5.6 Genotoxic Effects 157 9.5.7 Reproductive and Developmental Effects 157 9.5.8 Target Organ Effects 157 9.6 Toxicokinetics 157 9.7 Toxicological Testing 158 9.7.1 Data Gaps 159 9.7.2 Data Waiving 159 9.7.3 Acute Toxicity Studies 159 9.7.4 Short-Term, Repeated Dose Studies 160 9.7.5 Long-Term (Chronic) Studies 160 9.7.6 Other Systemic Effects 161 9.7.7 Local Effects 162 9.8 Genetic Toxicology 162 9.8.1 Introduction 162 9.8.2 Hazard Assessment 163 9.8.3 Risk Assessment 166 9.9 Turning Intrinsic Properties into ‘No-Effect’ Levels 166 9.9.1 Special Cases 169 10. Human Exposure to Chemicals 171 10.1 Exposure 171 10.2 Exposure to Chemicals in the Workplace 173 10.2.1 First Tier Models 173 10.2.2 Higher Tier Models 174 10.2.3 Risk Management Measures 174 10.2.4 Exposure in the Professional Use Setting 175 10.2.5 Models 176 10.2.6 Measurements 178 10.3 Risk Management Measures 179 10.4 Consumer Exposure 179 10.4.1 General Considerations for Exposure Estimation for Consumers 180 10.4.2 Tier 1 Models 180 10.4.3 Refinement of Initial Exposure Estimates, Higher Tier Models and Measurements 181 10.4.4 Risk Management Measures – Consumers 181 10.5 Indirect Exposure (Humans via the Environment) 182 10.6 Risk due to Physico-Chemical Hazard 182 11. Managing Hazard and Risk 185 11.1 Characterisation, Assessment and Management of Risk 185 11.2 What Is ‘Risk’ under REACH? 186 11.3 What Are Risk Reduction and Risk Management? 187 11.3.1 Risk 187 11.3.2 How Can Risks Be Controlled Adequately? 189 11.4 Where Safe Levels Cannot Be Established – CMRs and PBTs (and vPvBs) 190 11.5 Responsibilities in the Supply Chain – Introduction 190 11.6 Regulatory Requirements 191 11.7 Guidance 193 11.8 The Extended Safety Data Sheet 193 11.8.1 Current issues surrounding the use of eSDS by DUs 194 11.9 When Communication Is Difficult 194 11.10 Exposure Measurements in the Workplace – Occupational Hygiene 195 11.11 Control of Environmental Releases – Abatement Techniques 196 11.11.1 Engineering Controls 196 11.11.2 Enclosure and Containment 197 11.11.3 Bunding 197 11.11.4 Dedicated Equipment 197 11.11.5 Investment and Scale of Use – Economic Viability 197 11.11.6 Waste Stream Treatments 197 11.11.7 WWTP Treatments 198 11.11.8 Custom and Practise 198 11.11.9 Handling Standards 198 11.11.10 Clean-Down Practises 198 11.12 Effectiveness of Risk Reduction – Risk Management Options 200 11.13 Types of Risk Management – in the Workplace 201 11.13.1 Options Overview 202 11.13.2 Understanding Assumptions and Critical Issues 202 11.13.3 Risk Management Measures 202 11.14 Types of Risk Management – for the Environment 203 11.14.1 Unacceptable Risk 203 11.14.2 Options Overview 203 11.14.3 When a Data Set Is Not Complete 204 11.14.4 When a Data Set Is as Complete as It Can Be 204 11.14.5 Understanding Assumptions and Critical Issues 204 11.14.6 Strategies to Reduce the Amount of Substance Released to the Environment 204 11.15 Consumer Protection 205 12. Avoiding the Use of Hazardous Substances: Substitution and Alternatives 207 12.1 Properties That Contribute to Hazard and Risk for Human Health and the Environment 209 12.2 Assessment of Alternatives – Replacement of Use 210 12.3 What Is an Alternative? 211 12.4 Analysis of Alternatives 211 12.5 Substitution – Replacement with Substances of Reduced Hazard 211 12.5.1 Examples of Voluntary Substitution 212 12.5.2 Regulation-Led Substitution – Case Studies 213 12.6 Sustainability and Green Chemistry 218 12.7 What Is Green Chemistry in Practice? Principles and Concepts 219 12.7.1 Why Is Green Chemistry Important? 220 12.7.2 Research in Green Chemistry 220 12.7.3 Substance Design 220 12.7.4 Process Design 222 13. Hazards, Risks and Impacts – The Development and Application of Frameworks for the Assessment of Risk 225 13.1 Policy Context – Risk, Hazard and the Precautionary Principle 226 13.1.1 Assessment Frameworks – Hazard and Risk and Impacts 230 13.1.2 Precaution – Where No Safe Level Can Be Established 232 13.1.3 Application of Assessment Frameworks to Human Health and Environmental Protection 234 13.2 From Hazards to Risks to Impacts – Understanding the Implications of Exposure to Dangerous Chemicals 235 13.2.1 Introduction: The Need for a Culture of Safety 236 13.2.2 Responsible Care® 238 13.2.3 Standards and Management Tools 239 13.2.4 Risk Control and Management 241 13.2.5 Risk Control and Management in REACH 241 13.3 Risk Management Options – REACH Processes for Control of Hazardous and Risky Substances 244 13.3.1 Restrictions and Authorisations in REACH 244 13.3.2 Restrictions 246 13.3.3 Authorisations 247 14. Socio-Economic Analysis in REACH 251 14.1 Background – the Need for and Development of Socio-Economic Analysis in the Regulation of Chemicals 253 14.2 What Is SEA and Why Is It Needed and Applied in REACH? 254 14.2.1 What Is SEA within REACH? 254 14.3 Role, Purpose and Performing an SEA in REACH 255 14.3.1 Role and Purpose of an SEA in REACH 255 14.3.2 Doing an SEA in REACH 256 14.4 The Difficulties of Moving from Risks to Impacts 256 14.5 Regulatory Processes – Who Are the Decision Makers and What Are Their Roles? 265 14.6 The Wider Benefits of Performing an SEA 265 14.7 Developments and the Future 267 15. REACH: How It Is Working and May Develop 269 15.1 Introduction 269 15.2 Experiences and Observations 269 15.2.1 Observations 270 15.3 Basics of Successful Submission 271 15.4 Testing, Prediction and Read-Across 271 15.5 The Community Rolling Action Plan 272 15.6 EU and National Responsibilities 272 15.7 Risk-Based Regulation and the Precautionary Approach 272 15.8 Higher Tiers of Assessment 273 15.9 REACH Developments 274 15.9.1 Methods of Operation and Constant Change 274 15.9.2 Improved Efficiency of Operation 275 15.9.3 Increased Scope 275 15.9.4 Policy Development on the Control of Chemicals – EU and Global Perspectives 276 15.10 Rationalising Overlap with Other Legislation 276 15.11 Scientific Developments and Challenges 278 15.12 Impact on Industry 278 15.12.1 Manufacturers and Importers 278 15.12.2 Downstream Users and Consumers 278 15.12.3 Innovation 279 15.13 ECHA Evaluation Report 2012 279 16. Resources, Official Guidance, Further Reading and Centres of Expertise 283 16.1 Introduction to Resources and Organisations 283 16.1.1 Official Journal 283 16.1.2 ECHA and REACH-IT 284 16.1.3 CEFIC and Sector Groups 285 16.1.4 IUCLID Guidance 285 16.1.5 ECETOC 286 16.1.6 OECD 286 16.1.7 EU JRC 286 16.2 Facts and Statistics 286 Appendix A Substance Classification and Labelling under REACH 317 A.1 Important Differences 319 A.1.1 Physico-Chemical Hazards 320 A.1.2 Health Hazards 320 A.1.3 Environmental Hazards 321 A.1.4 Supplementary Labelling Requirements under the CLP Regulations 321 A.2 CLP Symbols 322 A.2.1 Comparison of DSP/DPD with CLP 2008 325 A.3 Specific Target Organ Systemic Toxicity – Single Exposure 334 A.3.1 Carcinogenic Substances 335 A.3.2 Mutagenic Substances 337 A.3.3 Effect during Lactation 337 A.3.4 Aquatic Environment 338 A.3.5 Ozone 338 A.4 Harmonised Classification and Labelling 339 Appendix B Further Discussion of Substance Identification and Sameness 341 B.1 Substance Identifiers 341 B.1.1 EC Name 341 B.1.2 CAS Registry Number (CAS# or CAS No.) 341 B.1.3 SMILES 341 B.1.4 InChI 342 B.2 Substance Analysis 342 B.2.1 Sameness 343 B.2.2 Impurities 344 B.2.3 Departures from the Agreed Norm 344 B.3 Straightforward Organic Substances 345 B.3.1 Identity 345 B.3.2 Purity and Characterisation 346 B.4 Complex Organic Substances 347 B.5 Inorganic Substances 348 B.5.1 Structure 349 B.5.2 Elemental Quantification 349 B.6 Analysis of UVCBs 349 Appendix C Tools for REACH Compliance: IUCLID, Chesar and In-House Databases 351 C.1 International Uniform Chemical Information Database (IUCLID) 351 C.2 IUCLID and PPORDs 354 C.3 Submission of PPORD to ECHA 354 C.3.1 IUCLID Submission 354 C.3.2 Notification by REACH-IT 355 C.4 Chesar 356 C.4.1 Introduction 356 C.4.2 Chesar Functionalities or Organisation of the Tool 356 C.4.3 Assessment workflow of Chesar 358 C.5 Advice on Storing of Data Outside of the IUCLID 358 C.5.1 Structure 359 C.5.2 Identifiers 360 C.5.3 Mechanistic Issues 360 C.5.4 Identification and Expression of Substance Identity 361 C.5.5 Result Values 361 C.5.6 SMILES and Textual Representations of Structure 361 C.5.7 Modifications to the Data Set 361 C.5.8 Composited Fields and Repeated Processes 361 C.5.9 Duplicates 362 C.5.10 Validation 362 C.5.11 Checking 363 C.5.12 Study Reports and Cataloguing 363 C.5.13 Snapshots and Backups 364 Appendix D Glossary 365 Index 383

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