This book focusses on the debates concerning aspects of intellectual property law that bear on access to medicines in a set of developing countries. Specifically, the contributors look at measures that regulate the acquisition, recognition, and use of patent rights on pharmaceuticals and trade secrets in data concerning them, along with the conditions under which these rights expire so as to permit the production of cheaper generic drugs. In addition, the book includes commentary from scholars in human rights, international institutions, and transnational activism. The case studies presented from 11 Latin American countries, have many commonalities in terms of economics, legal systems, and political histories, and yet they differ in the balance each has struck between proprietary interests and access concerns. The book documents this cross-country variation in legal norms and practice, identifies the factors that have led to differences in result, and theorizes as to how differentials among these countries occur and why they endure within a common transnational regulatory regime. The work concludes by putting the results of the investigations into a global administrative law frame and offers suggestions on institutional mechanisms for considering the trade-offs between health and wealth.

"Knowledge commons" describes the institutionalized community governance of the sharing and, in some cases, creation, of information, science, knowledge, data, and other types of intellectual and cultural resources. It is the subject of enormous recent interest and enthusiasm with respect to policymaking about innovation, creative production, and intellectual property. Taking that enthusiasm as its starting point, Governing Knowledge Commons argues that policymaking should be based on evidence and a deeper understanding of what makes commons institutions work. It offers a systematic way to study knowledge commons, borrowing and building on Elinor Ostrom's Nobel Prize-winning research on natural resource commons. It proposes a framework for studying knowledge commons that is adapted to the unique attributes of knowledge and information, describing the framework in detail and explaining how to put it into context both with respect to commons research and with respect to innovation and information policy. Eleven detailed case studies apply and discuss the framework exploring knowledge commons across a wide variety of scientific and cultural domains.

This book examines the aspects of prevention, mitigation, and management of environmental hazards and disasters from an international perspective. In light of the recent debate on climate change and the possible effects of such a change upon increasing frequency and magnitude of extreme environmental events, this publication overviews various policy and response discourses. Several case studies from various countries and world regions depicting recent experience in mitigation policy and program development and implementation and establishing links between vulnerability and mitigation are presented to provide further insights. This book is primarily intended for academics, policymakers, professionals, and practitioners in hazards reduction activities who are seeking a better understanding of the complex and dynamic aspects of nature and society.

This book provides an in-depth analysis of the unique structure of the Nigerian popular music industry. It explores the dissonance between copyright's thematic support for creative autonomy and the practical ways in which the law allows singer-songwriters' (performing authors') creative autonomy to be subverted in their contractual relationships with record labels. The book establishes the concept of creative autonomy for performing authors as a key criterion for sustainable economic development, and makes innovative legal and policy recommendations to help stakeholders preserve it.

Embryo research, cloning, assisted conception, neonatal care, pandemic vaccine development, saviour siblings, organ transplants, drug trials - modern developments have transformed the field of medicine almost beyond recognition in recent decades and the law struggles to keep up. In this highly acclaimed and very accessible book Margaret Brazier, Emma Cave and Rob Heywood provide an incisive survey of the legal situation in areas as diverse as fertility treatment, patient consent, assisted dying, malpractice and medical privacy. The seventh edition of this book has been fully revised and updated to cover the latest cases, Brexit-related regulatory reform and COVID-19 pandemic measures. Essential reading for healthcare professionals, lecturers, medical and law students, this book is of relevance to all whose perusal of the daily news causes wonder, hope and consternation at the advances and limitations of medicine, patients and the law. -- .

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

Climate change is among the world's most important problems, and solutions based on emission cuts or adapting to new climates remain elusive. One set of proposals receiving increasing attention among scientists and policymakers is 'solar geoengineering', (also known as solar radiation modification) which would reflect a small portion of incoming sunlight to reduce climate change. Evidence indicates that this could be effective, inexpensive, and technically feasible, but it poses environmental risks and social challenges. Governance will thus be crucial. In The Governance of Solar Geoengineering, Jesse L. Reynolds draws on law, political science, and economics to show how solar geoengineering is, could, and should be governed. The book considers states' incentives and behavior, international and national law, intellectual property, compensation for possible harm, and non-state governance. It also recommends how solar geoengineering could be responsibly researched, developed, and - if appropriate - used in ways that would improve human well-being and ensure sustainability.

Written by an award-winning historian of science and technology, Planet in Peril describes the top four mega-dangers facing humankind - climate change, nukes, pandemics, and artificial intelligence. It outlines the solutions that have been tried, and analyzes why they have thus far fallen short. These four existential dangers present a special kind of challenge that urgently requires planet-level responses, yet today's international institutions have so far failed to meet this need. The book lays out a realistic pathway for gradually modifying the United Nations over the coming century so that it can become more effective at coordinating global solutions to humanity's problems. Neither optimistic nor pessimistic, but pragmatic and constructive, the book explores how to move past ideological polarization and global political fragmentation. Unafraid to take intellectual risks, Planet in Peril sketches a plausible roadmap toward a safer, more democratic future for us all.

This unique guidebook presents a comprehensive analysis of the new Americans with Disabilities Act (ADA), the most significant federal civil rights law in almost 30 years, and its impact on over four million American businesses, state and local governments, nonprofit associations, 87 percent of America's private sector jobs, and 22.7 million working-age people with disabilities.

Written by two Washington-based experts on the new federal mandate, the book relies on extensive interviews with federal officials and the expert opinion of business leaders, leaders in the disability community, and the authors of the legislation. Fersh and Thomas provide a clear analysis of the final federal regulations and their implications for businesses, nonprofit associations, state and local governments, and managers and employers who need to make modifications to physical barriers in places of public accommodation, such as stores and restaurants, and in barriers to equal employment in the workplace. The book uses case histories and Congressional reports and testimony to illustrate new employment procedures--from applications, testing, and insurance benefits to job descriptions, reasonable accommodation, and new rights in telecommunications and public ground transportation. The social, legislative, and economic history that led to the laW's enactment is illustrated through photographs and 18 tables. Included are specific guidelines on how to interview and work with people with disabilities, containing specific sections on people who use wheelchairs, and people with mental retardation, cerebral palsy, epilepsy, hearing and visual impairments, AIDS, speech impairments, learning disabilities, and mental illness. Also featured are how to sections for developing a compliance plan, implementing reasonable accommodation, and how to create an ADA awareness program for employees. The book explores the successful use of workers with disabilities in companies over the last twenty years, and the high costs of unemployment among working-age people with disabilities in tax revenues and lost productivity. Leaders and experts, such as I. King Jordan, Ph.D., president of Gallaudet University, provide short articles on their perspective of the ADA.

This book introduces "biolaw" as an integrated and distinct field in contemporary legal studies. Corresponding to the legal dimension of bioethics, the term "biolaw" is already in use in academic and research activities to denote legal issues emerging mostly from advanced technological applications. This book is a genuine attempt to rationalize the field of biolaw after almost four decades of continuous production of relevant legislation and judgments worldwide. This experience is a robust basis for defending a) a separate legal object, covering the total of legal norms that govern the management of life as a natural phenomenon in all its possible forms, and b) an "evolutionary" approach that opens the discussion on a future conciliation of legal regulation with the Theory of Evolution on the ground of biolaw.

In the last few decades university teaching has been recognised as an activity which can be studied and improved through educational scholarship. In some disciplines this is now well established. It remains emergent in legal education. The field is rich with questions to be answered, issues to be raised. This book provides the first overall review of legal education scholarship. The chapters outline the history of legal education research and provide a detailed analysis of the trends in areas of publication. Beyond this, the book suggests a typology for further conceptualising the field and a series of suggested paths for future research. The book originated from the 2017 UNSW conference "Research in Legal Education: State of the Art?" It features internationally respected authors who bring their perspectives on how legal education - as a field of research - should be conceptualised. The collection is arranged into three themes. First, a historical view is taken of the emergence of legal education scholarship and its roots that predate modern educational theory. Secondly, the book provides overviews of the extant field of publications, highlighting areas of interest and neglect, and delineating the trends in current publication. Thirdly, the book provides a set of suggested typologies for describing legal education research and a series of essays for future directions which both critique current approaches and provide inspiration for future directions. The State of Legal Education Research represents an authoritative introduction to the field, a set of conceptual tools with which to describe it, and inspiration for researchers to expand and grow research into legal education.

This book considers contested responsibilities between the public and private sectors over the use of online data, detailing exactly how digital human rights evolved in specific European states and gradually became a part of the European Union framework of legal protections. The author uniquely examines why and how European lawmakers linked digital data protection to fundamental human rights, something heretofore not explained in other works on general data governance and data privacy. In particular, this work examines the utilization of national and European Union institutional arrangements as a location for activism by legal and academic consultants and by first-mover states who legislated digital human rights beginning in the 1970s. By tracing the way that EU Member States and non-state actors utilized the structure of EU bodies to create the new norm of digital human rights, readers will learn about the process of expanding the scope of human rights protections within multiple dimensions of European political space. The project will be informative to scholar, student, and layperson, as it examines a new and evolving area of technology governance - the human rights of digital data use by the public and private sectors.

This book details various stages in the introduction, establishment and evolution of China's environmental management system. By combining a literature review, comparative analysis, and case study, it investigates the environmental management system in several key periods in order to systematically assess the necessary measures and appropriate adjustments the Chinese Government implemented to reconcile the growing conflicts between economic development and resources conservation, in the context of rapid economic growth and economic transformation. Given its scope, the book offers a valuable resource for experts, scholars, and government officials in related fields.

Tremendous changes have occurred over the past decade in the provision of services to students with disabilities. Federal mandates continue to define requirements for a free appropriate public education (FAPE) in the least restrictive environment. Additionally, there has been an increase in the number of lawsuits filed against school districts regarding the provision of educational services for students with disabilities. Case studies are a helpful way to understand these difficult issues. The case studies presented here are actual students eligible for special education and related services. The case studies are represented not to tell districts and parents that this is the only way questions about special education law can be answered, but to provide likely answers along with commentary for analysis. The cases were developed to help new (and experienced) special education leaders and supervisors survive the pressures of working with students with disabilities while working to provide appropriate services and prevent litigation.

Consultant and long-time Food and Drug Administration (FDA) food labeling expert James Summers answers the many questions surrounding FDA food labeling regulations and compliance in Food Labeling Compliance Review. This comprehensive manual and fully searchable, accompanying CD-ROM are designed to aid in understanding the requirements of the FDA. Food Labeling Compliance Review is a must-have for regulatory officials, industry personnel, and others responsible for assuring that the label and labeling of domestic and imported food products in interstate commerce comply with the requirements of the Federal Food, Drug and Cosmetic Act, as amended. The new fourth edition of Food Labeling Compliance Review fully covers recently enacted provisions requiring labeling for allergens, trans fats, and qualified health claims. Clearly illustrated with dozens of charts, sample label panels and "Nutrition Facts" boxes, Food Labeling Compliance Review is the practical, no-nonsense tool needed by both the experienced and inexperienced food label reviewer. * Current, complete, and accurate food labeling guidance concerning FDA regulations * Covers new requirements for labeling allergens, trans fats, and qualified health claims * Essential for all food manufacturers, packers, labelers, relabelers, and distributors * Fully illustrated with clear Q and A explanations * Fully-searchable CD-ROM enables quick look ups

This book analyses the features and functionality of the relationship between the law, individual or collective values and medical-scientific evidence when they have to be interpreted by judges, courts and para-jurisdictional bodies. The various degrees to which scientific data and moral values have been integrated into the legal discourse reveal the need for a systematic review of the options and solutions that judges have elaborated on. In turn, the book presents a systematic approach, based on a proposed pattern for classifying these various degrees, together with an in-depth analysis of the multi-layered role of jurisdictions and the means available to them for properly handling new legal demands arising in plural societies. The book outlines a model that makes it possible to focus on and address these issues in a sustainable manner, that is, to respond to individual requests and technological advances in the field of biolaw by consistently and effectively applying suitable legal instruments and jurisdictional interpretation.

Many decisions in the legal system and elsewhere depend on predictions of bad behaviors, including crimes and mental illnesses. Some scientists have suggested recently that these predictions can become more accurate and useful if they are based in part on biological information, such as brain structure and function, genes, and hormones. The prospect of such bioprediction, however, raises serious concerns about errors and injustice. Can biological information significantly increase the accuracy of predictions of bad behavior? Will innocent or harmless people be mistakenly treated as if they were guilty or dangerous? Is it fair to keep people in prisons or mental institutions longer because of their biology? Will these new instruments of bioprediction be abused in practice within current institutions? Is bioprediction worth the cost? Do we want our government to use biology in this way? All of these scientific, legal, and ethical questions are discussed in this volume. The contributors are prominent neuroscientists, psychologists, sociologists, philosophers, ethicists, and legal scholars. This volume will interest everyone with hopes that bioprediction will solve problems or fears that bioprediction will be applied unjustly.

The aim of this book is to delve into the impact of the Information and Communications Technologies in the criminal prevention and investigation, by addressing the state of the art of different measures and its implementation in different legal systems vis a vis the protection of human rights. Yet this research not only pursues a diagnostic goal but furthermore aims at providing a reconstruction of this problematic area in light of modern, human rights-oriented notion of criminal justice. This broadens the scope of this investigation, which encompasses both unprecedented safeguards to traditional, or anyway widely recognized individual rights and the emergence of new rights, such as the right to informational self-determination, and the right to information technology privacy. The book addresses the problems and potentials in the areas of criminal prevention and criminal investigation, taking into account that due to electronic surveillance and the progress in the use of big data for identifying risks, the borders between preventive and investigative e-measures is not clear-cut.

This book provides a set of proposals for the new conceptual network required in order to establish civil law rules for a world permeated by Artificial Intelligence. These proposals are intended by their authors to push the debate on the new civil law forward. In spite of the natural conservatism of jurists, some innovative or even futuristic ideas are called for, also because the future, even this not-so-distant one, is difficult to foresee. Paradoxically, and unlike in the past, this lack of knowledge must not stop us from planning. If it does, humankind may, as some pessimists already claim, lose its chance to win the battle for control of the world. The rise and expansion of Artificial Intelligence and robotics in recent years has highlighted a pressing need to create a suitable legal framework for this new phenomenon. The debate on the subject, although wide-ranging and involving many new legal documents, is still quite general and preliminary in nature, although these preparatory works illustrate the very real need to develop appropriate new civil law arrangements. It is exactly the branch of private law where the necessity of these new rules appears to be the most imperative. Autonomous vehicles, medical robots, and expertise software raise fundamental questions on aspects of civil liability such as culpability; whereas the growth in popularity of automated, intelligent software systems for concluding contracts requires a new approach to many fundamental and deeply rooted elements of contract law, e.g. consciousness, intent, error, deception, interpretation of contracts and good faith. Ruling on these specific matters demands the identification and clarification of certain key points, which shall become the foundation for constructing AI/robot civil law.

Health is a matter of fundamental importance in European societies, both as a human right in itself, and as a factor in a productive workforce and therefore a healthy economy. New health technologies promise improved quality of life for patients suffering from a range of diseases, and the potential for the prevention of incidence of disease in the future. At the same time, new health technologies pose significant challenges for governments, particularly in relation to ensuring the technologies are safe, effective, and provide appropriate value for (public) money. To guard against the possible dangers arising from new health technologies, and to maximize the benefits, all European governments regulate their development, marketing, and public financing. In addition, several international institutions operating at European level, in particular the European Union, the Council of Europe, and the European Patent Office, have become involved in the regulation of new health technologies. They have done so both through traditional 'command and control' legal measures, and through other regulatory mechanisms, including guidelines, soft law, 'steering' through redistribution of resources, and private or quasi-private regulation. This collection analyses European law and its relationships with new health technologies. It uses interdisciplinary insights, particularly from law but also drawing on regulation theory, and science and technology studies, to shed new light on some of the key defining features of the relationships and especially the roles of risk, rights, ethics, and markets. The collection explores the way in which European law's engagement with new health technologies is to be legitimized, and discusses the implications for biological or biomedical citizenship.

The Supreme Court's decision in the Health Care Case, NFIB v. Sebelius, gripped the nation's attention during the spring of 2012. No one could have predicted the strange coalition of justices and arguments that would eventually lead the Court to uphold the Affordable Care Act's principal provisions. The constitutional case against the ACA was originally written off as frivolous, but after oral argument at the Court, many predicted that the unthinkable had now become likely. When the Supreme Court delivered its complicated and fractured decision, it offered new interpretations to four different clauses in the Constitution. This volume gathers together reactions to the decision from an ideologically diverse selection of the nation's leading scholars of constitutional, administrative, and health law. They offer novel insights into the meaning of the health care decision for President Obama, the Roberts Court, and the debate over constitutional interpretation.

By the end of the 1970s, contaminated sites had emerged as one of the most complex and urgent environmental issues affecting industrialized countries. The authors show that small and prosperous Switzerland is no exception to the pervasive problem of sites contamination, the legacy of past practices in waste management having left some 38,000 contaminated sites throughout the country. This book outlines the problem, offering evidence that open and polycentric environmental decision-making that includes civil society actors is valuable. They propose an understanding of environmental management of contaminated sites as a political process in which institutions frame interactions between strategic actors pursuing sometimes conflicting interests. In the opening chapter, the authors describe the influences of politics and the power relationships between actors involved in decision-making in contaminated sites management, which they term a "wicked problem." Chapter Two offers a theoretical framework for understanding institutions and the environmental management of contaminated sites. The next five chapters present a detailed case study on environmental management and contaminated sites in Switzerland, focused on the Bonfol Chemical Landfill. The study and analysis covers the establishment of the landfill under the first generation of environmental regulations, its closure and early remediation efforts, and the gambling on the remediation objectives, methods and funding in the first decade of the 21st Century. The concluding chapter discusses the question of whether the strength of environmental regulations, and the type of interactions between public, private, and civil society actors can explain the environmental choices in contaminated sites management. Drawing lessons from research, the authors debate the value of institutional flexibility for dealing with environmental issues such as contaminated sites.

The risk of athletes sustaining concussion while participating in professional team sports raises two serious concerns both nationally and internationally. First, concussion in sport carries a public health risk, given that injured athletes may have to deal with significant long-term medical complications, with some of the worst cases resulting in Chronic Traumatic Encephalopathy (CTE). Secondly, sports governing bodies are now exposed to the risk of financial and reputational damage as a consequence of legal proceedings being filed against them. A good example of this, among many other recent examples, is the case of the United States of America's National Football League (NFL), the governing body for American football, which, in 2015, committed to pay US$ 1 billion to settle the class action filed by its former professional players. This book examines how to most efficiently reduce these public health and legal risks, and proposes a harmonised solution across sports and legal systems.