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The question whether assisted dying (euthanasia and assisted suicide) should be legalized is often treated, by judges and commentators alike, as a question which transcends national boundaries and diverse legal systems. One obvious example is the use made of the ‘Dutch experience’ in other jurisdictions. By treating the issue as a transcendent, global ethical question, the important context in which individual jurisdictions make decisions about assisted dying and the significance of the legal methods chosen to carry out those decisions is often lost. This book concentrates not on the issue of whether assisted dying should be legalized, but rather on the impact of the choice of a particular legal route towards legalization. Legal change on assisted dying may be achieved in a variety of ways: challenges to criminal prohibitions using constitutionally entrenched rights; the use of defences available to defendants who are prosecuted for assisting a death; legislative change; or referenda or ballot measures proposed by individual citizens or interest groups. The examination in this book of the impact of these different alternatives suggests that greater caution is needed before relying on the experience of one jurisdiction when discussing proposals for regulation of assisted dying in others, and the possible consequences of such regulation. The book seeks to demonstrate the need to explore the legal environment in which assisted dying is performed or proposed in order to evaluate the relevance of a particular legal experience to other jurisdictions.

Today, tens of millions of Americans rely on reproductive advances to help them carry out decisions more personal and far-reaching than almost any other they will ever make: They use birth control or abortion to delay or avoid having children; surrogacy or tissue donation to start or grow a family; and genetic diagnosis or embryo selection to have offspring who survive and flourish. This is no less than the medicine of miracles: It fills empty cradles; frees families from debilitating disease; and empowers them to plan a life that doesn’t include parenthood. But accidents happen: Embryologists miss ailments; egg vendors switch donors; obstetricians tell pregnant women their healthy fetuses will be stillborn. The aftermaths can last a lifetime, yet political and economic forces conspire against regulation to prevent negligence from happening in the first place. After the fact, social stigma and lawyers’ fees stave off lawsuits, and legal relief is a long shot: Judges and juries are reluctant to designate reproductive losses as worthy of redress when mix-ups foist parenthood on patients who didn’t want it, or childlessness on those who did. Some courts insist that babies are blessings, planned or not; others shrug over the fact that infertile couples weren’t assured offspring anyway. The result is a society that lets badly behaving specialists off the hook and leaves broken victims to pick up the pieces. Failed abortions, switched donors, and lost embryos may be First World problems—but these aren’t innocent lapses or harmless errors: They’re wrongs in need of rights.

This book examines aspects of English, United States, Canadian, and Australian law as it applies to the fetus, the pregnant woman, and the doctor or midwife who provides antenatal and perinatal care. A major part of the book consists of a critical examination of the law’s attempts to protect the fetus, which is threatened by conduct such as a criminal assault, maternal drug-taking, or parental refusal of medical treatment. The remainder of the work deals with the rapidly expanding and increasingly complex body of law on the liability of obstetricians, general practitioners, and midwives when negligent antenatal or perinatal care has been provided. There are numerous situations in which these health care professionals (or their employees) can be liable to pay damages. They can be sued if their negligence has harmed the mother, caused the birth of an injured, disabled, or stillborn child, or has resulted in the birth of an unwanted child. The book provides a comprehensive statement of the law on antenatal intervention to protect the fetus and on the responsibilities of those who care for pregnant women. By examining the nature of the relationship between a pregnant woman and her fetus, and the operation of child protection and criminal laws and the law of negligence, the book explores questions about maternal autonomy, the rights of the woman and the fetus, and the role of the law in protecting those rights and providing compensation when something goes wrong.

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 the 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 book 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 book 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.

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA’s successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

The emergence of Shaken Baby Syndrome (SBS) presents an object lesson in the dangers that lie at the intersection of science and criminal law. As often occurs in the context of scientific knowledge, understandings of SBS have evolved. We now know that the diagnostic triad alone does not prove beyond a reasonable doubt that an infant was abused, or that the last person with the baby was responsible for the baby’s condition. Nevertheless, our legal system has failed to absorb this new consensus. As a result, innocent parents and caregivers remain incarcerated and, perhaps more perplexingly, triad-only prosecutions continue even to this day. Flawed Convictions: Shaken Baby Syndrome and the Inertia of Injustice surveys the scientific, cultural, and legal history of Shaken Baby Syndrome from inception to formal dissolution. It exposes extraordinary failings in the criminal justice system’s treatment of what is, in essence, a medical diagnosis of murder. The story of SBS highlights fundamental inadequacies in the legal response to “science dependent prosecution.” A proposed restructuring of the law contends with the uncertainty of scientific knowledge.

This book assesses the fragmentation of the U.S. health care system in chapters by the nation's leading professors in law, medicine, economics, health, business, and political science. The book demonstrates the extent of fragmentation among doctors who treat individual patients, even within single hospitals, and the even worse fragmentation that exists over time and across patients. The book further shows that this fragmentation leads to increased medical error, higher costs, less preventive care, and misallocations of health care resources. It identifies possible causes of fragmentation, including laws that mandate separate payments for each provider, restrict hospitals or others from controlling or rewarding the set of providers treating a patient to assure coordinated care, and provide affirmative disincentives for coordinating care by paying more for uncoordinated care that requires more services. Finally, the book examines and proposes reforms that could make our health care system less fragmented, more efficient, and more effective. The book and its proposals are particularly well-timed because the U.S. will have to consider these problems and how best to ameliorate them as the U.S. considers how best to implement its new health care statute.

This is a book for anyone who has ever paused to wonder: Will cloning ever be legal? Why it is that ‘saviour siblings’ and sex selection provoke such strong reactions? Will there ever be such a thing as an artificial womb? Assisted reproductive technologies are unique in their capacity to challenge our assumptions and elicit passionate responses. Looking at the moral, philosophical, and legal issues surrounding cases of surrogacy, single or same-sex parenthood, retrieval of sperm from dead or dying patients, and the insemination of post-menopausal women, this book questions whether these rapidly-developing technologies are refashioning the nature of the family. The UK has played a unique role in the development and regulation of reproductive technologies, and has been at the forefront of controversy over ‘saviour siblings’, designer babies, reproductive cloning, and embryo research. This book provides a clear and simple account of the techniques involved in assisted reproduction and embryo research, and discusses the legal and ethical implications of some of these technologies, illustrated by compelling descriptions of real-life cases. The book also addresses the ways in which reproductive technologies are regulated, critically examining the role of the Human Fertilisation and Embryology Authority and comparing the UK's approach with that of other countries. Finally, it contemplates the possibility that some of our most deeply-held assumptions about human nature may be called into question by further developments in stem cell research and fertility treatments.

This volume is the product of a joint conference of the University of Chicago Law School and Medical School on health reform that was convened after NFIB v. Sebelius was decided. An interdisciplinary group of experts—economists, lawyers, health care professionals—discussed the meaning of the case, its impact on the implementation of the Affordable Care Act (ACA), and the question of health care reform. The authors of this volume shed some light on a set of key issues that inform current health care policy in the United States, the recent health care reform legislation, and future avenues of reform. The first section of the book deals with legal challenges to the ACA and the way the Supreme Court's decision shaped the contours of the law's implementation. The authors discuss the case overall and in a jurisprudential and administrative law context, as well implications for the future. The second section discusses the fiscal consequences of the ACA from both economic and accounting perspectives. The third section presents cases for and against the ACA and discusses inefficiencies in the market and payment reform. The fourth section deals with health care technology and examines the cost-effectiveness of various technologies and the complex relationship between health insurance expansions and new medical technologies. The final section focuses on the new health insurance exchanges and presents two opposing views on whether there are significant search frictions when individuals shop for health insurance contracts and whether the ACA will promote efficiency or forestall innovation.

This book offers a comprehensive legal and ethical analysis of the most interesting and broadest reaching development in health care of the last twenty years: its globalization. This book ties together the manifestation of this globalization in four related subject areas—medical tourism, medical migration (the physician “brain drain”), telemedicine, pharmaceutical research and development—and integrates them in a philosophical discussion of issues of justice and equity relating to the globalization of health care. Medical tourism and telemedicine are growing, multi-billion-dollar industries affecting large numbers of patients. Estimates show that more than 400,000 patients (50,000 of whom were American) sought treatment at a single facility in Thailand in 2005. The U.S. heavily depends on foreign-trained doctors to staff its health care system; as of 2005, a fifth of all doctors practicing in the United States were believed foreign trained. This recruitment has had serious effects on the supply of doctors in the developing world; for example, between 1986 and 1995, 61% of all graduates of the Ghana Medical School left their country for employment. Forty percent of clinical trials are now run in the developing world, with indications of as much of a 10-fold increase in the past twenty years, and NGOs across the world are agitating for increased access to necessary pharmaceuticals in the developing world they claim would save millions from early death at a relatively low cost. Coming on the heels of the most expansive reform to U.S. health care in fifty years, this book also produces an intricate map for some of the leading thinkers in the field to plot the ways in which this globalization will develop as the reform is implemented.

Immigration and health are two of the most contentious issues facing policy makers today. Policies that relate to both issues—to the health of newcomers—often reflect misimpressions about immigrants, their health, and their impact on health care systems. Although immigrants are typically younger and healthier than natives, and many newcomers play a vital role in providing care in their new lands, natives are often reluctant to extend basic health care to immigrants. Likewise, many nations turn against immigrants when epidemics strike, falsely believing that native populations can be kept well by keeping immigrants out. This book demonstrates how such reactions thwart attempts to create efficient and effective health policies and efforts to promote public health. The book argues that because health is a global public good and people benefit from the health of neighbor and stranger alike, it is in everyone’s interest to ensure the health of all. Reviewing issues as diverse as medical repatriation, epidemic controls, the right to health, the medical brain drain, organ tourism, and global climate change, the book shows why solidarity between natives and newcomers is ethically required and in the service of health for all.

This book deals with the following controversial issues in Jewish Law: abortion, assisted reproduction, genetics, the obligation to heal, patient autonomy, treatment of the terminally ill, the definition of death, organ donations, and the allocation of scarce medical resources. The book focuses upon the complex interplay between legal and moral elements in the decision-making process, particularly when questions of life and death (such as abortion and treatment of the terminally ill) are involved. The author argues that the moral element in Jewish biomedical law is of a universal, rational nature, and its theoretical basis may be located in a weak form of Natural law theory regarding the value of human life in the Jewish legal tradition. The concept of patient autonomy in Jewish biomedical law is more limited than in contemporary liberal jurisprudence, and is based upon theological as well as strictly legal elements. The influence of scientific thinking upon the decision-making process in Jewish biomedical law is illustrated in a discussion of the contemporary debate concerning the permissibility of heart transplants. In most chapters, Jewish law is compared and contrasted with Canon and Common Law, and the volume also discusses the role played by Jewish biomedical law in modern, secular Israeli law. In this context, it addresses the thorny issue of combining religious law with democratic principles within the framework of a secular legal system.

This book is the latest volume in the Current Legal Issues series, which is based upon an annual colloquium held at University College London. Each year, leading scholars from around the world gather to discuss the relationship between law and another discipline of thought. Each colloqium examines how the external discipline is conceived in legal thought and argument, how the law is pictured in that discipline, and analyses points of controversy in the use, and abuse, of extra-legal arguments within legal theory and practice. Law and Bioethics contains a broad range of essays by scholars of law, medicine, biosciences, and philosophy interested in the interactions between law and bioethics. It includes topical studies examining the regulation of stem cell research, human rights and bioethics, the regulation of reproductive technologies, and distributive justice in healthcare and pandemic planning. This book will be of interest to scholars and advanced students of legal theory, moral philosophy, medical law, bioethics, and medical ethics.

The book explains the principle of the sanctity or inviolability of human life and its continuing relevance to English law governing aspects of medical practice at the beginning and end of life. It shows that the principle, though widely recognized as an historic and foundational principle of the common law, has been widely misunderstood, not least in the legal academy, at the Bar and on the Bench. Part I of the book identifies the confusion and clarifies the principle, distinguishing it from “vitalism” on the one hand and a “qualitative” evaluation of human life on the other. Part II addresses legal aspects of the beginning of life, including the history of the law against abortion and its relevance to the ongoing abortion debate in the US; the law relating to the “morning after” pill; and the legal status of the human embryo in vitro. Part III addresses legal aspects of the end of life, including the euthanasia debate; the withdrawal of tube-feeding from patients in a “persistent vegetative state”; and the duty to provide palliative care.

This book is based upon an annual colloquium held at University College London. Each year leading scholars from around the world gather to discuss the relationship between law and another discipline of thought. Each colloquium examines how the external discipline is conceived in legal thought and argument, how the law is pictured in that discipline, and analyses points of controversy in the use, and abuse, of extra-legal arguments within legal theory and practice. This book, the sixteenth volume in the Current Legal Issues series, offers an insight into the scholarship examining the relationship between global health and the law. Covering a wide range of areas from all over the world, chapters in the volume look at areas of human rights, vulnerable populations, ethical issues, legal responses, and governance.

This book, the third volume in the Current Legal Issues series, provides a treatment of an area that will stimulate and enlighten anyone interested in law and medicine. This book considers the many areas where medicine intersects with the law. Advances in medical research, reproductive science, and genetic research give rise to ethical and legal issues that are well known. These are reflected in chapters on cloning, organ donation, choosing genetic characteristics, and the use of Viagra. At the same time changes in health care funding call into question the rights of patients, whilst a rise in medical negligence litigation calls into question the doctor’s duty of care. What rights will patients have in a privately funded health service and what room is there for the patient’s right to choose or refuse treatment in such a system? The changing structure of health care is in the government’s hands comes whilst the supply of technology and drugs flows unregulated by market forces. In the future clashes between what can be done and what ought to be done will be increasingly referred to the courts. All of these important and changing facets of law and medicine are reflected in this book.

Current Legal Issues, like its sister series Current Legal Problems, is based upon an annual colloquium held at University College London. Each year leading scholars from around the world gather to discuss the relationship between law and another discipline of thought. Each colloquium examines how the external discipline is conceived in legal thought and argument, how the law is pictured in that discipline, and analyses points of controversy in the use, and abuse, of extra-legal arguments within legal theory and practice. This book, the latest volume in the Current Legal Issues series, offers an insight into the state of law and neuroscience scholarship today. Focussing on the inter-connections between the two disciplines, it addresses the key issues informing current debates.

This book focuses on the science and regulatory policy and law surrounding the discovery, development, and marketing of new medicines. It reviews consumer protection and intellectual property laws that are applicable to the development and commercialisation of medicinal products. It also provides a deeper understanding of the scientific and technical issues for lawyers and legal issues for those involved with regulatory policy and decision-making, such as senior executives in the pharmaceutical industry. The book covers the European and UK legislation on medicines and healthcare products together with the UK implementing legislation and instruments, and key case law. It discusses the structure and function of the regulatory authorities, applications to carry out clinical trials, intellectual property issues, product liability issues, and litigation.

This book assays how the remarkable discoveries of contemporary neuroscience impact our conception of ourselves and our responsibility for our choices and our actions. Dramatic (and indeed revolutionary) changes in how we think of ourselves as agents and as persons are commonly taken to be the implications of those discoveries of neuroscience. Indeed, the very notions of responsibility and of deserved punishment are thought to be threatened by these discoveries. Such threats are collected into four groupings: (1) the threat from determinism, that neurosciences shows us that all of our choices and actions are caused by events in the brain that precede choice; (2) the threat from epiphenomenalism, that our choices are shown by experiment not to cause the actions that are the objects of such choice but are rather mere epiphenomena, co-effects of common causes in the brain; (3) the threat from reductionist mechanism, that we and everything we value is nothing but a bunch of two-valued switches going off in our brains; and (4) the threat from fallibilism, that we are not masters in our own house because we lack the privileged knowledge of our own minds needed to be such masters. The book seeks to blunt such radical challenges while nonetheless detailing how law, morality, and common-sense psychology can harness the insights of an advancing neuroscience to more accurately assign moral blame and legal punishment to the truly deserving.

This book analyses various issues concerning the application of law to the field of medical practice, education, and research from a global perspective with particular focus on India. The volume, analytical in approach and comprehensive in coverage, ought to evoke vital public interest in that it examines technological advancements in the medical field that have legal, social, and ethical implications. The issues, including organ transplant, euthanasia, surrogacy and abortion, sex selection, the concept of consent, clinical trials, designer babies, cosmetic enhancement and confidentiality, are common to all countries but vary in their moral perception due to the diverse cultural underpinnings of each country. The author adopts an interdisciplinary approach combining law with medicine to address these issues. This book is also a comparative study with a special focus on Indian case law and jurisdictions from other countries including the US and the UK. Open ended, yet objective, written by a sitting judge of Punjab & Haryana High Court, the book does not fail to capture the inadequacies and improper approaches in the arena of legal regulation of medical education and medical practice. The book holds the key to informed public debates on issues of critical importance by providing deep insights into concepts like reservation and the constitutional goal of social justice, respect for patient autonomy, and setting the frontiers of ethical practice, policy initiatives for affordable healthcare and use of technology to assure good quality of treatment to the rural milieu as well.