Lawrence O. Gostin – författare

The 2014-2015 Ebola outbreak in West Africa shocked the world with its devastation and its rapid migration to multiple continents. As the systems meant to respond to this sort of epidemic failed, the disease exposed not just weaknesses in international infectious disease surveillance and management, but the failures of governments, humanitarian organizations, and international institutions to handle the legal, ethical, and economic questions that arose with an event of this scale. Global Management of Infectious Disease After Ebola unites the insights of Ebola's first responders with those the world's foremost experts in law, economics, vaccine development, and global migration to identify missed opportunities from the Ebola crisis -- and to apply these lessons to emerging infectious disease threats. Framed with critical discussions of both the global health financing infrastructures that precipitated the response and the ethical and human rights dilemmas that resulted from it, this volume is much more than postmortem to an outbreak: it is a vital, sometimes damning examination of where we've been and where we're going in the face of emerging infectious diseases.

Institutions matter for the advancement of human rights in global health. Given the dramatic development of human rights under international law and the parallel proliferation of global institutions for public health, there arises an imperative to understand the implementation of human rights through global health governance. This volume examines the evolving relationship between human rights, global governance, and public health, studying an expansive set of health challenges through a multi-sectoral array of global organizations. To analyze the structural determinants of rights-based governance, the organizations in this volume include those international bureaucracies that implement human rights in ways that influence public health in a globalizing world. This volume brings together leading health and human rights scholars and practitioners from academia, non-governmental organizations, and the United Nations system. They explore the foundations of human rights as a normative framework for global health governance, the mandate of the World Health Organization to pursue a human rights-based approach to health, the role of inter-governmental organizations across a range of health-related human rights, the influence of rights-based economic governance on public health, and the focus on global health among institutions of human rights governance. Contributing chapters each map the distinct human rights efforts within a specific institution of global governance for health. Through the comparative institutional analysis in this volume, the contributing authors examine institutional dynamics to operationalize human rights in organizational policies, programs, and practices and assess institutional factors that facilitate or inhibit human rights mainstreaming for global health advancement.

Institutions matter for the advancement of human rights in global health. Given the dramatic development of human rights under international law and the parallel proliferation of global institutions for public health, there arises an imperative to understand the implementation of human rights through global health governance. This volume examines the evolving relationship between human rights, global governance, and public health, studying an expansive set of health challenges through a multi-sectoral array of global organizations. To analyze the structural determinants of rights-based governance, the organizations in this volume include those international bureaucracies that implement human rights in ways that influence public health in a globalizing world.This volume brings together leading health and human rights scholars and practitioners from academia, non-governmental organizations, and the United Nations system. They explore the foundations of human rights as a normative framework for global health governance, the mandate of the World Health Organization to pursue a human rights-based approach to health, the role of inter-governmental organizations across a range of health-related human rights, the influence of rights-based economic governance on public health, and the focus on global health among institutions of human rights governance. Contributing chapters each map the distinct human rights efforts within a specific institution of global governance for health.Through the comparative institutional analysis in this volume, the contributing authors examine institutional dynamics to operationalize human rights in organizational policies, programs, and practices and assess institutional factors that facilitate or inhibit human rights mainstreaming for global health advancement.

Historically, the fields of public health and human rights have remained largely separate. The AIDS pandemic, however, made it clear that a complex relationship exists between the two fields. Women and children have proven to be extremely vulnerable to infection with HIV due to their inability to protect themselves in intimate relationships, their sexual exploitation, and their lack of economic and educational alternatives. On the other hand, coercive government policies aimed at controlling the AIDS pandemic often infringe on the rights of individuals known or suspected of having AIDS, and decrease the effectiveness of public health measures. Protecting and promoting human rights is becoming one of the key means of preserving the health of individuals and populations.A penetrating analysis of the close relationship between public health and human rights, this book makes a compelling case for synergy between the two fields. Using the AIDS pandemic as a lens, the authors demonstrate that human health cannot be maintained without respect for the dignity and rights of persons, and that human rights cannot be deemed adequate and comprehensive without ensuring the health of individuals and populations. In the course of their analysis, Gostin and Lazzarini tackle some of the most vexing issues of our time, including the universality of human rights and the counter-claims of cultural relativity. Taking a cue from environmental impact assessments, they propose a human rights impact assessment for examining health policies. Such a tool will be invaluable for evaluating real-world public health problems and is bound to become essential for teaching human rights in schools of public health, medicine, government, and law.The volume critically examines such issues as HIV testing, screening, partner notification, isolation, quarantine, and criminalization of persons with HIV/AIDS, all within the framework of international human rights law. The authors evaluate the public health effects of a wide range of AIDS policies in developed as well as developing countries. The role of women in society receives special emphasis. Finally, the book presents three case histories that are important in the HIV/AIDS pandemic: discrimination and the transmission of HIV and tuberculosis in an occupational health care setting; breast feeding in the least developed countries; and confidentiality and the right of sexual partners to know of potential exposure to HIV. The cases challenge readers with some of the complex questions facing policy-makers, scientists, and public health professionals, and exemplify a method for analysing these problems from a human rights perspective. Gostin and Lazzarini have written a book that will be a valuable addition to the libraries of public health teachers and practitioners, legal scholars, bioethicists, policy makers, and public rights activists.

Human rights are essential to global health, yet rising threats in an increasingly divided world are challenging the progressive evolution of health-related human rights. It is necessary to empower a new generation of scholars, advocates, and practitioners to sustain the global commitment to universal rights in public health. Looking to the next generation to face the struggles ahead, this book provides a detailed understanding of the evolving relationship between global health and human rights, laying a human rights foundation for the advancement of transformative health policies, programs, and practices.International human rights law has been repeatedly shown to advance health and wellbeing - empowering communities and fostering accountability for realizing the highest attainable standard of health. This book provides a compelling examination of international human rights as essential for advancing public health. It demonstrates how human rights strengthens human autonomy and dignity, while placing clear responsibilities on government to safeguard the public's health and safety. Bringing together leading academics in the field of health and human rights, this volume: (1) explains the norms and principles that define the field, (2) examines the methods and tools for implementing human rights to promote health, (3) applies essential human rights to leading public health threats, and (4) analyzes rising human rights challenges in a rapidly globalizing world. This foundational text shows why interdisciplinary scholarship and action are essential for health-related human rights, placing human rights at the center of public health and securing a future of global health with justice.

Human rights are essential to global health, yet rising threats in an increasingly divided world are challenging the progressive evolution of health-related human rights. It is necessary to empower a new generation of scholars, advocates, and practitioners to sustain the global commitment to universal rights in public health. Looking to the next generation to face the struggles ahead, this book provides a detailed understanding of the evolving relationship between global health and human rights, laying a human rights foundation for the advancement of transformative health policies, programs, and practices.International human rights law has been repeatedly shown to advance health and wellbeing - empowering communities and fostering accountability for realizing the highest attainable standard of health. This book provides a compelling examination of international human rights as essential for advancing public health. It demonstrates how human rights strengthens human autonomy and dignity, while placing clear responsibilities on government to safeguard the public's health and safety. Bringing together leading academics in the field of health and human rights, this volume: (1) explains the norms and principles that define the field, (2) examines the methods and tools for implementing human rights to promote health, (3) applies essential human rights to leading public health threats, and (4) analyzes rising human rights challenges in a rapidly globalizing world. This foundational text shows why interdisciplinary scholarship and action are essential for health-related human rights, placing human rights at the center of public health and securing a future of global health with justice.

Globalization has unleashed the spread of communicable and non-communicable diseases, connected societies through vulnerability to common threats, and revealed the limitations of domestic legislation in addressing economic, social, and political determinants of health. Yet if globalization has presented challenges to disease prevention and health promotion, with the COVID-19 pandemic making clear the governance challenges ahead, global health law offers the promise of bridging national boundaries to alleviate global inequities.The academic field of global health law analyzes the law and policy frameworks that apply to the new public health threats, non-state actors, and regulatory instruments that structure global health. Arising out of international health law--which narrowly focuses on relationships among states--the field of global health law reflects the changing institutional architecture, norms, and diplomacy necessary to respond to the health threats of the twenty-first century. The new law and policy frameworks, placing public health obligations on the global community of state and non-state actors, ensure justice in global health through institutions that embrace values of transparent governance, multisectoral engagement, and legal accountability. As the study and practice of global health law has expanded over the past decade, and especially through the COVID-19 response, students and scholars require a foundational text to comprehend this shifting landscape. Lawrence O. Gostin and Benjamin Mason Meier have edited this text to help readers understand the promise of law and policy in global health. Assembling leading academics across the field of global health law, this volume (1) explains the conceptual frameworks and governance institutions that define the field, (2) applies global health governance to disease prevention and health promotion, (3) examines economic institutions that influence global health, and (4) analyzes international legal efforts to address rising health threats.

This volume brings together two important contemporary social movements: human rights and disability rights. It analyses the global struggle to realize equality, dignity, and comprehensive human and civil rights for persons with intellectual disabilities. In twenty original chapters, distinguished contributors from a range of disciplines address the latest international developments in the field. These include international human rights standards and other sources of legal protection, nondiscrimination laws and the economics of equality, preventative technology, remediation and habilitation, and lifestyle chices and autonomy. The volume is unique in specifically considering the human rights of persons with intellectual disabilities from an international perspective. It identifies recent internatinal advances in their human rights and public policy positions, in addition to making recommendations for further advances at both the national and international levels.Although human rights are universal and persons with intellectual disabilities are entitled to protection under general human rights law, the authors argue that there are differences that must be taken into account in order that the intellectually disabled can enjoy even the most basic of rights. This volume explores the implications of altering the status quo, and offers policy-makers and professionals ways to learn from each other's innovations in protecting rights, implementing quality assurance measures, and applying the concepts of inclusion and the 'least restrictive environment'.

This volume brings together two important contemporary social movements: human rights and disability rights. It analyses the global struggle to realize equality, dignity, and comprehensive human and civil rights for persons with intellectual disabilities. In 20 chapters, contributors from a range of disciplines address the latest international developments in the field. These include international human rights standards and other sources of legal protection, nondiscrimination laws and the economics of equality, preventative technology, remediation and habilitation, and lifestyle chices and autonomy. The volume specifically considers the human rights of persons with intellectual disabilities from an international perspective. It identifies recent internatinal advances in their human rights and public policy positions, in addition to making recommendations for further advances at both the national and international levels.

Advancing the Human Right to Health offers a prospective on the global response to one of the greatest moral, legal, and public health challenges of the 21st century - achieving the human right to health as enshrined in the Universal Declaration of Human Rights (UDHR) and other legal instruments. Featuring writings by global thought-leaders in the world of health human rights, the book brings clarity to many of the complex clinical, ethical, economic, legal, and socio-cultural questions raised by injury, disease, and deeper determinants of health, such as poverty. Much more than a primer on the right to health, this book features an examination of profound inequalities in health, which have resulted in millions of people condemned to unnecessary suffering and hastened deaths. In so doing, it provides a thoughtful account of the right to health's parameters, strategies on ways in which to achieve it, and discussion of why it is so essential in a 21st century context. Country-specific case studies provide context for analysing the right to health and assessing whether, and to what extent, this right has influenced critical decision-making that makes a difference in people's lives. Thematic chapters also look at the specific challenges involved in translating the right to health into action. Advancing the Human Right to Health highlights the urgency to build upon the progress made in securing the right to health for all, offering a timely reminder that all stakeholders must redouble their efforts to advance the human right to health.

" . . . glimpses of intriguing changes in social arrangements and cultural understandings in relation to surrogacy. Disturbing motherhood indeed." —New Scientist"Larry Gostin has put together the definitive collection of essays on one of the most perplexing and titillating topics in contemporary medical ethics. This book includes contributions from some of the leading scholars on the legal, ethical, and social aspects of surrogacy, as well as several critical perspectives on the famous Baby M case—must reading for understanding the surrogate motherhood controversy." —Robert M. Veatch"Highly recommended . . . " —Choice" . . . a valuable resource for those concerned with an exceedingly difficult ethical, legal, and political problem." —Ethics"There is a wealth of information here on the current 'status questionis' in the United States, and anyone involved in the surrogacy debate, in the U.S. or otherwise, will find working through this material very worthwhile." —Canadian Philosophical Review" . . . an excellent sample of some of the best and most varied thinking so far on the numerous conceptual, moral, social, and policy questions raised by contract motherhood." —The Journal of Clinical Ethics

The influenza pandemic caused by the 2009 H1N1 virus underscores the immediate and critical need to prepare for a public health emergency in which thousands, tens of thousands, or even hundreds of thousands of people suddenly seek and require medical care in communities across the United States. Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations draws from a broad spectrum of expertise--including state and local public health, emergency medicine and response, primary care, nursing, palliative care, ethics, the law, behavioral health, and risk communication--to offer guidance toward establishing standards of care that should apply to disaster situations, both naturally occurring and man-made, under conditions in which resources are scarce. This book explores two case studies that illustrate the application of the guidance and principles laid out in the report. One scenario focuses on a gradual-onset pandemic flu. The other scenario focuses on an earthquake and the particular issues that would arise during a no-notice event.Outlining current concepts and offering guidance, this book will prove an asset to state and local public health officials, health care facilities, and professionals in the development of systematic and comprehensive policies and protocols for standards of care in disasters when resources are scarce. In addition, the extensive operations section of the book provides guidance to clinicians, health care institutions, and state and local public health officials for how crisis standards of care should be implemented in a disaster situation.

Lawrence O. Gostin's seminal Public Health Law is widely acclaimed as the definitive statement on public health law at the turn of the twenty-first century. In this bold third edition, Gostin is joined by Lindsay F. Wiley to analyze major health threats of our time such as chronic diseases, emerging infectious diseases, antimicrobial resistance, bioterrorism, natural disasters, opiod overdose, and gun violence. The authors draw on constitutional law, administrative law, local government law, and tort law to develop their conception of law as a tool for protecting the public's health. The book creates an intellectual framework for modern public health law and supports that framework with illustrations of the scientific, political, and ethical issues involved. In proposing innovative solutions for the future of the public's health, Gostin and Wiley's essential study provides a blueprint for public and political debates to come.New issues covered in this edition: corporate personhood rights raised in response to regulations of tobacco, food and beverages, alcohol, firearms, prescription drugs, and marijuana; local government authority to protect the public's health; deregulation and harm reduction as modes of public health law intervention; taxation, spending, and alteration of the socioeconomic environment as modes of public health law intervention; access to health care as a strategy for protecting the public's health; taxation, spending, licensing, zoning, and shared-use strategies for chronic disease prevention; the public health law perspective on violence and injury prevention; and health justice as a framework for reducing health disparities and protecting the public's health.

Public Health Law and Ethics: A Reader, 3rd Edition probes the legal and ethical issues at the heart of public health through an incisive selection of judicial opinions, scholarly articles, and government reports. Crafted to be accessible to students while thorough enough for use by practitioners, policy makers, scholars, and teachers alike, the reader can be used as a stand-alone resource or alongside the internationally acclaimed Public Health Law: Power, Duty, Restraint, 3rd Edition. This updated edition reader includes new discussions of today’s most pressing health threats, such as chronic diseases, emerging infectious diseases, antimicrobial resistance, biosecurity, opioid overdose, gun violence, and health disparities.

Public Health Law and Ethics defines these fields for a new generation. This bold and updated edition probes how the Covid-19 pandemic has fundamentally changed the legal landscape for public health practice. Through incisive analysis of public health legislation, judicial opinions, and scholarly research, this accessible primer articulates the scope and limits of governmental powers and duties to protect the public's health, builds a case for why social justice must be prioritized as a core value of public health ethics, examines the role of the courts in striking down democratically enacted laws, and covers today’s most pressing health issues, such as chronic diseases, opioid overdoses, gun violence, disability rights, sexual and reproductive autonomy, and racial and gender equity. The book creates a framework for ensuring public health interventions are based on sound scientific evidence and consistent with ethical values, revealing complex answers to the essential question of what community members owe one another when it comes to health.

With lessons learned from COVID-19, a world-leading expert on pandemic preparedness proposes a pragmatic plan urgently needed for the future of global health security.The COVID-19 pandemic revealed how unprepared the world was for such an event, as even the most sophisticated public health systems failed to cope. We must have far more investment and preparation, along with better detection, warning, and coordination within and across national boundaries. In an age of global pandemics, no country can achieve public health on its own. Health security planning is paramount.Lawrence O. Gostin has spent three decades designing resilient health systems and governance that take account of our interconnected world, as a close advisor to the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and many public health agencies globally. Global Health Security addresses the borderless dangers societies now face, including infectious diseases and bioterrorism, and examines the political, environmental, and socioeconomic factors exacerbating these threats. Weak governance, ineffective health systems, and lack of preparedness are key sources of risk, and all of them came to the fore during the COVID-19 crisis, even—sometimes especially—in wealthy countries like the United States. But the solution is not just to improve national health policy, which can only react after the threat is realized at home. Gostin further proposes robust international institutions, tools for effective cross-border risk communication and action, and research programs targeting the global dimension of public health.Creating these systems will require not only sustained financial investment but also shared values of cooperation, collective responsibility, and equity. Gostin has witnessed the triumph of these values in national and international forums and has a clear plan to tackle the challenges ahead. Global Health Security therefore offers pragmatic solutions that address the failures of the recent past, while looking toward what we know is coming. Nothing could be more important to the future health of nations.

Biosecurity comprehensively analyzes the dramatic transformations that are reshaping how the international community addresses biological weapons and infectious diseases. The book examines the renewed threat from biological weapons, and explores the new world of biological weapons governance. Gostin and Fidler argue that the arms control approach in the Biological Weapons Convention no longer dominates. Other strategies have emerged to challenge the arms control approach, and the book identifies four important policy trends—the criminalization of biological weapons, regulation of the biological sciences, management of the biodefense imperative, and preparation for biological weapons attack. The book also explores the challenges to public health resulting from new security threats. The authors look at the linkages between security and public health policy, both at the national and international level. For instance, Gostin and Fidler scrutinize the difficulty of developing policies that improve defenses against both biological weapons and the threat of infectious diseases from new viral strains. The new worlds of biological weapons and public health governance raise the importance of crafting policy responses informed by the rule of law. Thinking about the rule of law underscores the importance of finding globalized forms of biosecurity governance. The book explores patterns in recent governance initiatives and advocates building a "global biosecurity concert" as a way to address the threats biological weapons and infectious diseases present in the early 21st century.

Elgar 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 an accessible overview of the right to health, exploring its meaning, significance and practical applications in contemporary real-world contexts.Lawrence Gostin, Lisa Forman and Andrés Constantin investigate how the right to health shapes laws, policies and practices across diverse topics, including reproductive rights, the environment, digital health, infectious diseases and humanitarian crises. Chapters cover the key concepts, challenges and opportunities in these distinct areas, highlighting how human rights can drive fairer and more effective health systems. They shed light on the foundations, history and evolution of the field, as well as the notion of accountability as a core human rights principle.Key Features:Explores major UN human rights treaties and mechanismsEvaluates cutting-edge health technologies, from artificial intelligence to digital healthExamines global action regarding both communicable and non-communicable diseasesThe Advanced Introduction to the Right to Health is an essential resource for scholars and students of human rights, public and global health law. Containing actionable advice and policy implications, it is also highly relevant to legal professionals, health practitioners and policymakers in the same fields.

Elgar 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 an accessible overview of the right to health, exploring its meaning, significance and practical applications in contemporary real-world contexts.Lawrence Gostin, Lisa Forman and Andrés Constantin investigate how the right to health shapes laws, policies and practices across diverse topics, including reproductive rights, the environment, digital health, infectious diseases and humanitarian crises. Chapters cover the key concepts, challenges and opportunities in these distinct areas, highlighting how human rights can drive fairer and more effective health systems. They shed light on the foundations, history and evolution of the field, as well as the notion of accountability as a core human rights principle.Key Features:Explores major UN human rights treaties and mechanismsEvaluates cutting-edge health technologies, from artificial intelligence to digital healthExamines global action regarding both communicable and non-communicable diseasesThe Advanced Introduction to the Right to Health is an essential resource for scholars and students of human rights, public and global health law. Containing actionable advice and policy implications, it is also highly relevant to legal professionals, health practitioners and policymakers in the same fields.

In this collection of essays, Lawrence O. Gostin, an internationally recognized scholar of AIDS law and policy, confronts the most pressing and controversial issues surrounding AIDS in America and around the world. He shows how HIV/AIDS affects the entire population - infected and uninfected - by influencing our social norms, our economy, and our country's role as a world leader. Now in the third decade of this pandemic, the nation and the world still fail to respond to the needs of persons living with HIV/AIDS and continue to tolerate injustice in their treatment, Gostin argues. AIDS, both in the United States and globally, deeply affects poor and marginalized populations, and many U.S. policies are based on conservative moral values rather than public health and social justice concerns. Gostin tackles the hard social, legal, political, and ethical issues of the HIV/AIDS pandemic: privacy and discrimination, travel and immigration, clinical trials and drug pricing, exclusion of HIV-infected health care workers, testing and treatment of pregnant women and infants, and needle-exchange programs. This book provides an inside account of AIDS policy debates together with incisive commentary. It is indispensable reading for advocates, scholars, health professionals, lawyers, and the concerned public.

In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners.The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: • expand the definition of "prisoner"; • ensure universally and consistently applied standards of protection; • shift from a category-based to a risk-benefit approach to research review; • update the ethical framework to include collaborative responsibility; and • enhance systematic oversight of research involving prisoners.

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Catastrophic disasters occurring in 2011 in the United States and worldwide--from the tornado in Joplin, Missouri, to the earthquake and tsunami in Japan, to the earthquake in New Zealand--have demonstrated that even prepared communities can be overwhelmed. In 2009, at the height of the influenza A (H1N1) pandemic, the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services, along with the Department of Veterans Affairs and the National Highway Traffic Safety Administration, asked the Institute of Medicine (IOM) to convene a committee of experts to develop national guidance for use by state and local public health officials and health-sector agencies and institutions in establishing and implementing standards of care that should apply in disaster situations-both naturally occurring and man-made-under conditions of scarce resources.Building on the work of phase one (which is described in IOM's 2009 letter report, Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations), the committee developed detailed templates enumerating the functions and tasks of the key stakeholder groups involved in crisis standards of care (CSC) planning, implementation, and public engagement-state and local governments, emergency medical services (EMS), hospitals and acute care facilities, and out-of-hospital and alternate care systems. Crisis Standards of Care provides a framework for a systems approach to the development and implementation of CSC plans, and addresses the legal issues and the ethical, palliative care, and mental health issues that agencies and organizations at each level of a disaster response should address. Please note: this report is not intended to be a detailed guide to emergency preparedness or disaster response. What is described in this report is an extrapolation of existing incident management practices and principles.Crisis Standards of Care is a seven-volume set: Volume 1 provides an overview; Volume 2 pertains to state and local governments; Volume 3 pertains to emergency medical services; Volume 4 pertains to hospitals and acute care facilities; Volume 5 pertains to out-of-hospital care and alternate care systems; Volume 6 contains a public engagement toolkit; and Volume 7 contains appendixes with additional resources.

The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns.Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated.This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.