This book is the first major work that addressesa core question in biomedical research: the question of acceptable risk. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law, which state that the risk and burden to the participant must be in proportion to potential benefits to the participant, society or science.

This investigation addresses research on healthy volunteers, children, vulnerable subjects, and includes placebo controlled clinical trials.It represents a major contribution towards clarifying the most central, but also the most controversial and complex issue in biomedical research law and bioethics. The EU Clinical Trial Directive, the Council of Europe's Oviedo Convention (and its Additional Protocol), and national regulation in member states are covered.Itis a relevant work for lawyers andethicists, and thepractical approach makesa valuable tool for researchers and members of research ethics committees supervising biomedical research."

The 21st century will present unprecedented challenges. Already in its first decade we have seen the dramatic impact of two systemic risks, that of climate change and that of the financial crisis. The cause but also the solution to these crises lies in a deeper understanding of the underlying factors and int- dependencies. New ways must be found to overcome deep obstacles and find common solutions to seemingly intractable problems. The water crisis in the Middle East is a central challenge of the 21st century. The future of the people of the region depends on finding lasting solutions. Due to the exhaustion and pollution of available sources, compounded by climate change, demographic change and economic development, the pressures of water resource management will grow. New solutions must urgently be found as business as usual is not sustainable. This book provides vital new insights into possible elements of a sustainable future in one key area, that of the Jordan River and Dead Sea Basin. The future development of the Jordanian, Palestinian and Israeli people depends on finding a just and sustainable system of water resource management in this Basin. Given the potential for regional and other conflicts arising out of tensions over water, the ramifications are wider and even global in significance. This volume provides fresh regional and international perspectives which greatly assist in our understanding of the issues and their possible resolution.

In this ground-breaking work, Teresa Thorp tackles the causes and effects of climate injustice by methodically mapping out an approach by which to reach a negotiatedconsensus with legal force to protect present and future generations. Using the law and policy of climate change as a vehicle for illustrating how to shape our future,she comprehensively overturns the widely held contemporary view of climate justice as inconstant charitable acts, relative systemic notions and static concepts isolatedfrom the common good and a congruent rule of law. Responding to the adverse impacts of climate change (heat waves, extended drought, severe flooding anddesertification), which represent an urgent and potentially irreversible threat to human societies and the planet, requires a new and cohesive way of thinking aboutglobal policy and the law. The mission of guaranteeing and realising human dignity, human security and human rights is multi-fold. Looking through the lens of kaleidoscopic normativity, anextensible language anchored in common juridical elements should facilitate how norms enter the socio-legal frame and interact within it. Users need to be able todisplay and interpret the congruent legal norm in order to obey and apply it. Galvanising this process by constitutionalising first principles and consequential normsis vital for attaining fraternity between nations and among all people. Climate Justice - A Voice for the Future is an essential read for scholars, practitioners and all those genuinely interested in reaching consensus on a post-2015 global climate accord, a unified development agenda and a cohesive pact for disaster-risk reduction.

The book outlines the regulatory environment for disaster prevention and management in broad social, economic and political context. The first half of the book focuses mainly on Japan, especially the 3-11 events: the earthquake and tsunami that devastated the Tohoku area on 11 March 2011 and the Fukushima Daiichi nuclear power plant radiation leaks. The second half focuses on the USA (the only other Asia-Pacific country to have experienced a serious nuclear emergency), Indonesia, China, New Zealand, Australia and international law. One question explored is whether socio-legal norms play different roles in preventing and managing responses to natural disasters compared to man-made disasters. Another is how disaster law interacts with society across very diverse societies in the disaster-prone Asia-Pacific region. The book also addresses the increasingly important roles played by international law and regional regimes for cross-border cooperation in disaster prevention and relief, including the functions played by military forces.

Erudite, pragmatic, and charged with detailed, substantive knowledge of an astonishing range of contexts and research fields, this timely collection of important essays on the law and society of disaster management stands as an exemplary international academic response to the disasters of 11 March 2011.(Annelise Riles)"

It is estimated that over one-half of all litigation today is related, in some degree, to issues involving economic damages. This handbook presents the basic elements involved in the evaluation of economic damages associated with wrongful death and personal injury cases. It will assist practicing attorneys to understand, through examples, the conceptual issues involved in the determination of economic damages, and the methods used to evaluated such damages.

The book is divided into two main sections. The first section of the book is devoted to estimation procedures specific to wrongful death cases. Nine key elements involved in an analysis of economic losses are systematically presented and illustrated in separate chapters. Reference tables are included to illustrate the variety of situations which exist, and the impact that changes in key assumptions about the situations have on the analysis. The second section of the book builds upon the concepts developed in the first section, and illustrates how to calculate economic losses in personal injury cases. These chapters also have examples and reference tables to assist the practicing attorney. A glossary of basic economic terms and an extensive bibliography are included.

This book explores the normative and legal evolution of the Social Dimension - labour law, social security law and family law - in both the EU and its Member States, during the last decade. It does this from a wide range of theoretical and legal-substantive perspectives. The past decade has witnessed the entering into force of the Lisbon Treaty and its emphasis on fundamental rights, a new coordination regulation within the field of social security (Regulation 883/2004/EC), and the case law of the Court of Justice of the European Union in the so-called Laval Quartet. Furthermore structural changes affecting demographics and family have also challenged solidarity in new ways. The book is organised by reference to distinct 'normative patterns' and their development in the fields of law covered, such as the protection of established groups, the position of market functional values and the scope for just distribution. The book represents an innovative and important interdisciplinary approach to analysing EU law and Social Europe, and contributes a complex, yet thought-provoking, picture for the future. The contributors represent an interesting mix of well-known and distinguished as well as upcoming and promising researchers throughout Europe and beyond.

This publication identifies and discusses important challenges affecting eHealth in the EU and North America in the three areas of law, ethics and governance. It makes meaningful contributions to the eHealth discourse by suggesting solutions and making recommendations for good practice and potential ways forward. Legal challenges discussed include issues related to electronic medical records, telemedicine, the Internet and pharmaceutical drugs, healthcare information systems and medical liability. Ethical challenges focus on telehealth and service delivery in the home, Web 2.0 and the Internet, patient perceptions and ethical frameworks. Governance challenges focus on IT governance in healthcare, governance and decision-making in acute care hospitals, and different models of eHealth governance. The publication provides useful support materials and readings for persons active in developing current understandings of the legal, ethical and governance challenges involved in the eHealth context.

"Defining the Family: Law, Technology, and Reproduction in an Uneasy Age" provides a sweeping portrait of the family in American law from the nineteenth century to the present. The family today has come to be defined by individuality and choice. Pre-nuptial agreements, non-marital cohabitation, gay and lesbian marriages have all profoundly altered our ideas about marriage and family. In the last few years, reproductive technology and surrogacy have accelerated this process of change at a breathtaking rate. Once simple questions have taken on a dizzying complexity: Who are the real parents of a child? What are the relationships and responsibilities between a child, the woman who carried it to term, and the egg donor? Between viable sperm and the wife of a dead donor?

The courts and the law have been wildly inconsistent and indecisive when grappling with these questions. Should these cases be decided in light of laws governing contracts and property? Or it is more appropriate to act in the best interests of the child, even if that child is unborn, or even unconceived? No longer merely settling disputes among family members, the law is now seeing its own role expand, to the point where it is asked to regulate situations unprecedented in human history. Janet L. Dolgin charts the response of the law to modern reproductive technology both as it transforms our image of the family and is itself transformed by the tide of social forces.

European and American drug regulators govern a multi-billion-dollar pharmaceutical industry selling its products on the world's two largest medicines markets. This is the first book to investigate how effectively American and supranational EU governments have regulated innovative pharmaceuticals regarding public health during the neo-liberal era of the last 30 years. Drawing on years of fieldwork, the authors demonstrate that pharmaceutical regulation and innovation have been misdirected by commercial interests and misconceived ideologies, which induced a deregulatory political culture contrary to health interests. They dismantle the myth that pharmaceutical innovations necessarily equate with therapeutic advances and explain how it has been perpetuated in the interests of industry by corporate bias within the regulatory state, unwarranted expectations of promissory science, and the emergent patient-industry complex. Endemic across both continents, the misadventures of pharmaceutical deregulation are shown to span many therapeutic areas, including cancer, diabetes and irritable bowel syndrome. The authors propose political changes needed to redirect pharmaceutical regulation in the interests of health.

During the past decade, the media landscape and the coverage of sports events have changed fundamentally. Sports fans can consume the sports content of their choice, on the platform they prefer and at the time they want. Furthermore, thanks to electronic devices and Internet, content can now be created and distributed by every sports fan. As a result, it is argued that media regulation which traditionally contains rules safeguarding access to information and diversity would become redundant. Moreover, it is sometimes proposed to leave the regulation of the broadcasting market solely to competition law.This book, illustrates that media law is still needed, even in an era of abundance, to guarantee public's access to live and full sports coverage. Dealing with the impact of new media on both media and competition law this book will greatly appeal to academics and stakeholders from various disciplines, such as legal and public policy, political science, media and communications studies, journalism and European studies. Additionally it contains valuable information and points of view for policy makers, lawyers and international and intergovernmental organisations, active in media development. The book contains an up-to-date analysis and overview of the different competition authorities' decisions and media provisions dealing with the sale, acquisition and exploitation of sports broadcasting rights. Katrien Lefever is Senior Legal Researcher at IBBT - The Interdisciplinary Centre for Law and ICT (ICRI), KU Leuven, Belgium. The book appears in the ASSER International Sports Law Series, under the editorship of Prof. Dr. Robert Siekmann, Dr. Janwillem Soek and Marco van der Harst LL.M.

The term "total petroleum hydrocarbons" (TPHs) is used for any mixture of several hundred hydrocarbons found in crude oil, and they represent the sum of volatile petroleum hydrocarbons and extractable petroleum hydrocarbons. The petrol-range organics include hydrocarbons from C6 to C10, while diesel-range organics are C10-C28 hydrocarbons. Environmental pollution by petroleum hydrocarbons is one of the major global concerns, particularly in oil-yielding countries. In fact, there are more than five million potentially contaminated areas worldwide that represent, in general, a lost economic opportunity and a threat to the health and well-being of humans and the environment. Petroleum-contaminated sites constitute almost one-third of the total sites polluted with chemicals around the globe. The land contamination caused by industrialization was recognized as early as the 1960s, but less than a tenth of potentially contaminated lands have been remediated due to the nature of the contamination, cost, technical impracticability, and insufficient land legislation and enforcement. This book is the first single source that provides comprehensive information on the different aspects of TPHs, such as sources and range of products, methods of analysis, fate and bioavailability, ecological implications including impact on human health, potential approaches for bioremediation such as risk-based remediation, and regulatory assessment procedures for TPH-contaminated sites. As such, it is a valuable resource for researchers, graduate students, technicians in the oil industry and remediation practitioners, as well as policy makers.

"This book is motivated, to a large extent, by some recent troubling developments in public discourse, namely the developments in information, misinformation and disinformation practices. From the beginning of history, various and diverse means or channels of communication have been used to inform, misinform (unintentionally) and disinform (deliberately). However, in recent decades, the emergence and development of new information and communications technologies (ICT), combined with the ever-increasing digitalisation and globalisation of almost every aspect of modern life, among others, have opened up new and uncharted avenues to that end. This book therefore focuses on disinformation practices occurring with the help of digital media as these practices bring to the fore profound negative ramifications for the functioning of a democratic polity. " - from the Introduction by the editors "It would be pleasant to think that democracies will always wake up to their threats - internal and external - and heal themselves in good time before it is too late. [...] Yet, it is not too late to find public policy solutions which can restore information technologies to their original role of facilitators of democracy rather than their undertakers. But the timeframe is closing and we need these solutions sooner rather than later. This is why the present volume of expert analyses bringing together many academics arrives at just the right time. It aspires to deepen our understanding of the dangers of fake news and disinformation, but also charts well informed and realistic ways ahead. To my mind, it is certainly one of the most comprehensive and useful studies of this topic to date and I recommend it to the general reader as much as to the policy-maker as a reliable guide and mentor." - from the Foreword by Prof. Dr. Jamie Shea, Vesalius College, Brussels

Quality control in pharmaceutical products and medical devices is vital for users as failing to comply with national and international regulations can lead to accidents that could easily be avoided. For this reason, manufacturing a quality medical product will support patient safety. Microbiologists working in both the pharmaceutical and medical device industries face considerable challenges in keeping abreast of the myriad microbiological references available to them and the continuously evolving regulatory requirements. Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry presents the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards to not cause problems to the health of patients. It reinforces and updates the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices. Covering topics such as pharmaceutical nano systems, machine learning, and software validation, this book is an essential resource for managers, engineers, supervisors, pharmacists, chemists, academicians, and researchers.

The WROCLAW COMMENTARIES address legal questions as well as political consequences related to freedom of, and access to, the arts and (old/new) media; questions of religious and language rights; the protection of minorities and other vulnerable groups; safeguarding cultural diversity and heritage; and further pertinent issues. Specialists from all over Europe and the world summarise and comment on core messages of legal instruments, the essence of case-law as well as prevailing and important dissenting opinions in the literature, with the aim of providing a user-friendly tool for the daily needs of decision or law-makers at different juridical, administrative and political levels as well as others working in the field of culture and human rights.

This book examines the role and practical dynamics of governmental environmental law enforcement agencies and individuals who combat environmental crime. It will inform researchers about the 'real world' experiences of practitioners and provide an intellectual space for practitioners to examine critically what it is they do and why.

It is widely assumed today that the "welfare state" is contracting or retrenching as an effect of the close scrutiny to which entitlement to social-security benefits is being subjected in most developed countries. In this book, 15 authorities from nine different countries - the UK, the Netherlands, France, Germany, Spain, Denmark, Finland, Norway and the US - investigate to what extent this assumption is warranted. The papers were originally presented at a Conference on "The Future of Social Security" held at the University of Stirling in June 2000. Taking into account developments and initiatives at every administrative level from sub-national employment agencies to the OECD and the World Bank, they draw on both data and theories in a broad spectrum of related disciplines, including political science, economics, sociology and law. Detailed materials allow the reader to formulate well-defined responses to such questions as: is there indeed waning public support for social security?; is the "demographic time bomb" of an ageing population as serious a problem as we are often led to believe?; how seriously do supranational reform proposals tend to underestimate cross-national differences? to what degree is "activation policy" merely rhetorical?; to what extent do employment-office staff reformulate and redefine policies "on the ground" to accommodate specific case-by-case realities? Specific criteria for entitlement (such as disability) and such central issues as "gendered" assumptions, access to benefit programmes and the involvement of trade unions are examined in a variety of contexts. As an authoritative assessment of the current state of social-security reform - its critical issues, its direction, and its potential impacts - this book should prove to be of value to all professionals and officials concerned with social programmes at any government level.

The vast majority of the world's scientists agree: we have reached a point in history where we are in grave danger of destroying Earth's life-sustaining capacity. But our attempts to protect natural ecosystems are increasingly ineffective because our very conception of the problem is limited; we treat 'the environment' as its own separate realm, taking for granted prevailing but outmoded conceptions of economics, national sovereignty and international law. Green Governance is a direct response to the mounting calls for a paradigm shift in the way humans relate to the natural environment. It opens the door to a new set of solutions by proposing a compelling new synthesis of environmental protection based on broader notions of economics and human rights and on commons-based governance. Going beyond speculative abstractions, the book proposes a new architecture of environmental law and public policy that is as practical as it is theoretically sound.

Despite the potential benefits that PSSA designation can deliver, recent practice both within the IMO and by individual member States, has considerably undermined confidence in this emerging concept. The focus of this book is on the events within the IMO that have led to this lack of confidence arising. In doing so, this book presents an examination of coastal State practice with the PSSA concept.

In undertaking this analysis, the research provides evidence of the value of the PSSA concept, but also demonstrates its limitations. In this regard, the book presents a reality check which seeks to rationalise some of the heightened expectations with the concept that are apparent in the current debate. The research argues that States may seek to designate PSSAs more for their iconic status than for any demonstrable environmental benefits that may be realised."

Providing an overview of the various legal responses to conflicts involving the use of water resources, this text analyzes the continuous development of water law in the face of new threats of water shortages. The book is a result of the conference "Scarcity of Water, International, European and National Legal Aspects" held at the faculty of Law of the Erasmus University, Rotterdam in October 1995. It contains a selection papers presented at the conference and several additional contributions on the issues of water law and policy.

All over the world, there is a growing interest in the relationship between law and aging: How does the law influence the lives of older people? Can rights, advocacy and representation advance the social position of the aged and combat ageism? What are the new and cutting-edge frontiers in the field of elder law? Should there be a new international human rights convention in this field? These are only a few of the many questions that arise. This book attempts to answer some of these questions and to set the agenda for the future development of elder law across the globe. Taking into account existing research and knowledge, leading scholars from different continents (North America, Europe, Asia, and Australia) present in this book original and novel ideas regarding the future development of elder law. These ideas touch upon key topics such as elder guardianship, citizenship, mental capacity, elder abuse, human rights and international law, family relationships, age discrimination, and the right to die. This book can thus serve as an important reference work for all those interested in understanding where law and aging are headed, and for those concerned about the future legal rights of older persons.

This book discusses theoretical issues, standards, and professional considerations arising when legal and health practitioners undertake legal capacity assessments in the context of wills, enduring powers of attorney and advance health directives. The potential loss of cognition can erode autonomy as individuals lose the ability to make their own legally recognised decisions. This is an inescapable problem with significant legal, social, health and policy repercussions. This work synthesises and critically analyses the existing literature, including some of the best assessment models and guiding principles internationally, to generate a new methodology and understanding of what capacity assessment best practice means. This includes the impact of assessments on individual autonomy - the ideal method building upon respect for both autonomy as well as fundamental human rights. The triggers to assess capacity, who to involve in the assessment process, as well as how to conduct that assessment process are discussed. The crucial relationship between the legal and health professionals involved in assessments, including growing concerns around practitioner liability, is also explored. This analysis is undertaken through the innovative use of a therapeutic jurisprudence lens, the effect of which is to contribute new knowledge to this complex field.

This book explores the relationship between European Union law, culture, and identity. Community trade and competition rules have certainly affected many mundane, though highly formative, aspects of our day-to-day lives: when we shop, what we drink, even which football matches we watch on television. But Community law is not merely a vehicle for challenging established national rules which have a cultural dimension: Article 151 of the EC Treaty, which came into force in 1993, empowers the Community to 'contribute to the flowering of the cultures of the Member States', whilst at the same time bringing the 'common cultural heritage to the fore'. This book explores some of the challenges facing the European Union in developing convincing and coherent policies in the cultural domain. These challenges stem not only from the Union's fragmented institutional structure and Member State sensitivities but also from the uncertainty which surrounds the very meaning of the term 'culture' itself. The wide-ranging contributions illustrate how cultural issues can be seen to permeate all aspects of European Union law, by focussing on areas as diverse as international trade and aid, education, sport, language use, and the mass media.

Based on the findings of a large-scale, comparative research project, this book systematically assesses the institutional design and national influence of the Open Method of Coordination (OMC) on Social Inclusion and Social Protection, at the European Union (EU) level and in ten EU Member States. Besides offering novel empirical and theoretical insights into the operation and impact of the OMC, the book presents an up-to-date perspective on the future of social policy coordination within the Europe 2020 Strategy. The book is required reading for anyone concerned with understanding the contribution of new forms of governance to the past and future development of Social Europe.