Law Commons^™

Global Rules For Global Health: Why We Need An Independent, Impartial Who, Devi Sridhar, Julio Frenk, Lawrence O. Gostin, Suerie Moon

Georgetown Law Faculty Publications and Other Works

Over the past few years the World Health Organization (WHO) has been undergoing a significant reform process. The immediate trigger was a budget crisis in 2010 that spurred massive lay-offs at the global agency. But at a more fundamental level, deeper systematic changes in global health governance have made reform imperative. While WHO reform draws relatively little attention outside diplomatic circles in Geneva, at stake are critical issues that will impact public health everywhere. This article’s key messages are:

• Recent outbreaks of MERS highlight the need for a global response to infectious disease
• The WHO has had a crucial role …

Limiting What We Can Eat: A Bridge Too Far?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Innovative mayors across America are seeking to shape personal decisions about diet and physical activity, taking a page from tobacco control. But attempts to limit personal choices of what to eat have drawn the ire of vocal critics and sometimes the rebuke of judges, with former New York City mayor Michael Bloomberg’s limit on soda portions becoming a key flash point. The public broadly accepts state power to control infectious diseases, but often draws a line at limiting dietary choices. The author wants to dispel some of the well-worn arguments in the obesity wars.

Global Health And The Law, Lawrence O. Gostin, Devi Sridhar

Georgetown Law Faculty Publications and Other Works

The last two decades have brought revolutionary changes in global health, driven by popular concern over AIDS, novel influenzas, and maternal mortality. Given the rapid globalization that is a defining feature of today’s world, the need for a robust system of global health law has never been greater. Global health law has been defined as the legal norms, processes, and institutions designed primarily to attain the highest possible standard of physical and mental health for the world’s population. Global health law is not an organized legal system, with a unified treaty monitoring body, such as the World Trade Organization. There …

Legal And Ethical Responsibilities Following Brain Death: The Mcmath And Muñoz Cases, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

What are the legal and ethical implications of continuing to treat a brain dead patient? And may a hospital refuse to provide such treatment? These ethical and legal problems are raised in two recent cases. In the first Marlise Muñoz, a pregnant woman declared brain dead, was kept on life support against her family’s wishes due to the treating hospital’s interpretation of a Texas fetal protection law. In the other a hospital refused to treat Jahi McMath, a brain dead girl, despite her family's entreaties. The cases, at first, appear similar because in each case the hospital was refusing to …

Governing For Health As The World Grows Older: Healthy Lifespans In Aging Societies, Lawrence O. Gostin, Anna Garsia

Georgetown Law Faculty Publications and Other Works

So much of global health governance focuses intensely on a brief moment in the human lifespan—from a safe birth to infant and child survival. Yet, with all the attention to this early window of life (infancy to age five), the opposite end of the life spectrum is comparatively neglected. The Millennium Development Goals (MDGs) do not mention a healthy lifespan or a healthy old age. This inadequate attention to the older years of the life appears to be a glaring omission given the universal challenges posed by aging societies. Aging is a demographic fact in almost all countries, but it …

Public Health Emergencies: What Counts?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Vaccines and drugs to prevent and treat Ebola Virus Disease that have never been tested in humans, and in scarce supply raise profound ethical challenges. What if good evidence emerged demonstrating safety and efficacy of drugs? What would be an ethical method of allocating scarce beneficial resources? The apparent preference given to foreign aid workers over West Africans provoked a firestorm. In addition to discussing the ethical allocation of scarce drugs, this article also asks a more fundamental question: Why did it take nearly 40 years after the first Ebola outbreak in 1976 to launch clinical trials?

Future Oversight Of Recombinant Dna Research: Recommendations Of An Institute Of Medicine Committee, Lawrence O. Gostin, Bruce M. Altevogt, Andrew M. Pope

Georgetown Law Faculty Publications and Other Works

The National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee (RAC) in 1974 in response to public concerns about the safety of manipulating genetic material through recombinant DNA. The accumulation of 40 years of experience with gene transfer research has led to a better understanding of the risks. Yet, as gene transfer research has matured, the complexity of the overall regulatory environment has remained. Gene transfer research continues to be subjected to multiple layers of review: the Food and Drug Administration (FDA), institutional review boards, institutional biosafety committees, and the RAC. It is within the context of overlapping …

Libertarian Patriarchalism: Nudges, Procedural Roadblocks, And Reproductive Choice, Govind Persad

Georgetown Law Faculty Publications and Other Works

Cass Sunstein and Richard Thaler's proposal that social and legal institutions should steer individuals toward some options and away from others-a stance they dub "libertarian paternalism"-has provoked much high-level discussion in both academic and policy settings. Sunstein and Thaler believe that steering, or "nudging," individuals is easier to justify than the bans or mandates that traditional paternalism involves.

This Article considers the connection between libertarian paternalism and the regulation of reproductive choice. I first discuss the use of nudges to discourage women from exercising their right to choose an abortion, or from becoming or remaining pregnant. I then argue that …

Towards A Framework Convention On Global Health, Lawrence O. Gostin, Eric A. Friedman, Kent Buse, Attiya Waris, Moses Mulumba, Mayowa Joel, Lola Dare, Ames Dhai, Devi Sridhar

Georgetown Law Faculty Publications and Other Works

A global health treaty, a Framework Convention on Global Health (FCGH)–grounded in the right to health, with the central goal of reducing immense domestic and global health inequities–could serve as a robust global governance instrument to underpin the United Nations post-2015 Millennium Development Goals (MDGs). It would ensure for all people the three essential conditions for a healthy life–public health, health care, and the positive social determinants of health–while advancing good governance, responding to drivers of health disadvantages for marginalized populations, elevating health in other legal regimes, and enhancing people's ability to claim their rights.

The legally binding nature of …

Realizing The Right To Health Through A Framework Convention On Global Health?, Eric A. Friedman, Jashodhara Dasgupta, Alicia E. Yamin, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

This article introduces a special issue of Health and Human Rights (volume 15, issue 1) that features articles exploring potential elements of and key questions and issues surrounding the Framework Convention on Global Health (FCGH). The FCGH is a proposed global health treaty that would be grounded in the right to health, with the aim of closing domestic and global health inequities. It would set standards and ensure financing for health care and public health services, while also addressing social determinants of health. The FCGH would raise the priority of health in other sectors, ensure effective private sector regulation, and …

Advancing The Right To Health Through Global Organizations: The Potential Role Of A Framework Convention On Global Health, Eric A. Friedman, Lawrence O. Gostin, Kent Buse

Georgetown Law Faculty Publications and Other Works

Organizations, partnerships, and alliances form the building blocks of global governance. Global health organizations thus have the potential to play a formative role in determining the extent to which people are able to realize their right to health.

This article examines how major global health organizations, such as WHO, the Global Fund to Fight AIDS, TB and Malaria, UNAIDS, and GAVI approach human rights concerns, including equality, accountability, and inclusive participation. We argue that organizational support for the right to health must transition from ad hoc and partial to permanent and comprehensive.

Drawing on the literature and our knowledge of …

Tackling The Global Ncd Crisis: Innovations In Law And Governance, Bryan P. Thomas, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

35 million people die annually of non-communicable diseases (NCDs), 80% of them in low- and middle-income countries—representing a marked epidemiological transition from infectious to chronic diseases and from richer to poorer countries. The total number of NCDs is projected to rise by 17% over the coming decade, absent significant interventions. The NCD epidemic poses unique governance challenges: the causes are multifactorial, the affected populations diffuse, and effective responses require sustained multi-sectorial cooperation. The authors propose a range of regulatory options available at the domestic level, including stricter food labeling laws, regulation of food advertisements, tax incentives for healthy lifestyle choices, …

Better Health, But Less Justice: Widening Health Disparities After National Federation Of Independent Business V. Sebelius, Emily W. Parento, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

At the time it was enacted in 2010, the Patient Protection and Affordable Care Act (ACA) was widely applauded by health activists, as it meant that the United States would at last join the overwhelming majority of industrialized countries in providing its population with guaranteed access to affordable health care. Roughly half of the increase in access to health insurance was to come from the expansion of Medicaid eligibility to all U.S. citizens and legal residents with income below 138% of the Federal Poverty Level. However, the Supreme Court’s 2012 ruling in National Federation of Independent Business v. Sebelius ( …

Towards A Framework Convention On Global Health: A Transformative Agenda For Global Health Justice, Lawrence O. Gostin, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

International law has responded weakly to the inequities in health care, public health, and the broader determinates of health that collectively cause the greatest loss of lives and human potential every year. Approximately one-third of global deaths can be attributed to enduring and unconscionable inequities. Despite significant progress in improving global health over the past several decades, these inequities persist. Current global governance for health is inadequate to the task of resolving these inequities, from lack of accountability and enforcement to inadequate funding and the absence of leadership required to respond to the threats to health that arise from other …

Bloomberg’S Health Legacy: Urban Innovator Or Meddling Nanny?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Michael Bloomberg leaves the mayoralty of New York City, with his health legacy is bitterly contested. The public health community views him as an urban innovator—a rare political and business leader willing to fight for a built environment conducive to healthier, safer lifestyles. To his distractors, however, Bloomberg epitomizes a meddling nanny—an elitist dictating to largely poor and working class people about how they ought to lead their lives. His policies have sparked intense public, corporate, and political ire—critical of sweeping mayoral power to socially engineer the city and its inhabitants.

Here, I seek to show how Bloomberg has fundamentally …

The Power To Block The Affordable Care Act: What Are The Limits?, John D. Kraemer, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Though Supreme Court upheld most parts of the Affordable Care Act (ACA), Congress’ goals in enacting it could still be frustrated by non-implementation. During his campaign for president, Governor Romney promised “to issue Obamacare waivers to all fifty states.” While such blanket waivers would likely violate the Constitution’s Take Care Clause, the ACA does permit other waivers. To be lawful, however, they must meet certain requirements designed to enhance access and lower cost. A president who opposes the ACA might be able to limit its implementation by refusing to issue premium subsidies in federally operated insurance exchanges, and this might …

Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

Despite the imposition of increasingly substantial fines and recently successful efforts to impose individual liability on corporate executives under the Park doctrine, punishing pharmaceutical companies and their executives for unlawful promotional activities has not been as successful in achieving compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as the protection of the public health demands. Over the past decade, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have shifted their focus from correction and compliance to a more punitive model when it comes to allegedly unlawful promotion of pharmaceuticals. The shift initially focused …

Justice Roberts’ America, Robin West

Georgetown Law Faculty Publications and Other Works

Less than a week after the Roberts Court issued its decision in National Federation of Independent Business v Sebelius, Jeffrey Toobin, writing in The New Yorker, compared the first part of Chief Justice John Roberts's opinion, in which he found that the Commerce Clause did not authorize Congress to enact the "individual mandate" section of the Affordable Care Act (ACA) that requires all individuals to buy health insurance, with an Ayn Rand screed, noting that the pivotal sections of the argument were long on libertarian rhetoric but short on citations of authority. Roberts held (although "held" might be …

Global Health Justice: A Perspective From The Global South On A Framework Convention On Global Health, Lawrence O. Gostin, Ames Dhai

Georgetown Law Faculty Publications and Other Works

A global coalition of civil society and academics recently launched the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI), which is developing a post-Millennium Development Goal (MDG) framework for global health. JALI’s mission is the achievement of a global health treaty based on the right to health—a Framework Convention on Global Health (FCGH). The FCGH proposes establishing fair terms of international co-operation, with agreed-upon mutually binding obligations to create enduring health system capacities, meet basic survival needs, and reduce unconscionable inequalities in global health. States that bear a disproportionate burden of disease have the least …

Pillars For Progress On The Right To Health: Harnessing The Potential Of Human Rights Through A Framework Convention On Global Health, Eric A. Friedman, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Ever more constitutions incorporate the right to health, courts continue to expand their right to health jurisprudence, and communities and civil society increasingly turn to the right to health in their advocacy. Yet the right remains far from being realized. Even with steady progress on numerous fronts of global health, vast inequities at the global and national levels persist, and are responsible for millions of deaths annually. We propose a four-part approach to accelerating progress towards fulfilling the right to health: 1) national legal and policy reform, incorporating right to health obligations and principles including equity, participation, and accountability in …

A Framework Convention On Global Health: Health For All, Justice For All, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Health inequalities represent perhaps the most consequential global health challenge and yet they persist despite increased funding and innovative programs. The United Nations is revising the Millennium Development Goals (MDGs) that will shape the world for many years to come. What would a transformative post-MDG framework for global health justice look like? A global coalition of civil society and academics—the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI)—has formed an international campaign to advocate for a Framework Convention on Global Health (FCGH). Recently endorsed by the UN Secretary-General, the FCGH would reimagine global governance for …

Affordable Care Act Litigation: The Supreme Court And The Future Of Health Care Reform, Lawrence O. Gostin, Kelli K. Garcia

Georgetown Law Faculty Publications and Other Works

In Florida v. HHS, a lawsuit brought on behalf of 26 states challenging the constitutionality of the Patient Protection and Affordable Care Act (ACA), the Supreme Court will determine the future direction of health care reform in the United States. During the unprecedented 5-1/2 hours of oral arguments, the Court will hear 4 issues: the individual purchase mandate, severability, the Medicaid expansion and the Anti-Injunction Act.

The states challenging the ACA maintain that the purchase mandate uniquely penalizes individuals for failing to purchase insurance. Uninsured individuals, however, rarely do nothing. Instead, they self-insure, rely on family, and cost-shift to …

Marketing Pharmaceuticals: A Constitutional Right To Sell Prescriber-Identified Data?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Pharmaceutical companies have strong economic interests in influencing physician-prescribing behaviors. They advertise direct-to-the-consumer and to the physician. Beyond general marketing, manufacturers promote their drugs to physicians through “detailing”—sales representatives (“detailers”) visiting medical offices to persuade physicians to prescribe their products.

By law, pharmacies receive specific information with every prescription, including the physician’s name, the drug, and the dose. Pharmacies sell these records to Prescription Drug Intermediaries (data miners), who use advanced computing to analyze prescriber-identified information (which physicians prescribe what drugs, in what dose, and with what prescribing patterns). Data miners, in turn, lease sophisticated reports to pharmaceutical companies to …

Mandatory Hpv Vaccination And Political Debate, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Vaccinations are among the most cost-effective and widely used public health interventions, but have provoked popular resistance, with compulsion framed as an unwarranted state interference. When the FDA approved a human papillomavirus (HPV) vaccine in 2006, conservative religious groups strongly opposed a mandate, arguing it would condone pre-marital sex, undermine parental rights, and violate bodily integrity. Yet, Governor Rick Perry signed an executive order in 2007 making Texas the first state to enact a mandate — later revoked by the legislature.

Mandatory HPV vaccination reached the heights of presidential politics in a recent Republican debate. Calling the vaccine a "very …

Who’S Pandemic Influenza Preparedness Framework: A Milestone In Global Governance For Health, Lawrence O. Gostin, David P. Fidler

Georgetown Law Faculty Publications and Other Works

In May 2008, the World Health Organization (WHO) adopted the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits (PIP Framework). The PIP Framework’s adoption ended years of difficult negotiations, which began after Indonesia refused to share samples of avian influenza A (H5N1) with WHO in late 2006. Indonesia justified its actions on the need to create more equitable access for developing countries to benefits, such as vaccines and antivirals, derived from research and development on shared influenza virus samples. The global health community feared that failure to share influenza virus samples …

Health Insurance Reform And Intimations Of Citizenship, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

This article considers the implications of the Patient Protection and Affordable Care Act (PPACA) for social meanings of civic belonging in American society and for possible new forms of individual engagement with the health care system. Once fully implemented, PPACA will have many of the governance characteristics of other social insurance systems, in that it will define membership in a collective undertaking, establish a mechanism for collective security against a shared risk, and channel, incentivize and penalize specific behaviors. The article considers the extent to which PPACA has the potential to also produce new narratives and understandings of social solidarity …

Book Review: Social Justice: The Moral Foundations Of Public Health And Health Policy, Robin West

Georgetown Law Faculty Publications and Other Works

This essay is a review of Social Justice: The Moral Foundations of Public Health and Health Policy by Madison Powers & Ruth Faden (2006).

In this pathbreaking book, senior bioethicists Powers and Faden confront foundational issues about health and justice. How much inequality in health can a just society tolerate? In a world filled with inequalities in health and well-being, which inequalities matter most and are the most morally urgent to address? In order to answer these questions, Powers and Faden develop a unique theory of social justice that, while developed for the specific contexts of public health and health …

Obesity And The Struggle Within Ourselves, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The author argues that we ought to treat our eating, exercise habits, and girth as personal matters, for the most part, but that law can and should make a contribution, as an ally of our longer-term will against our immediate cravings. Law can be our ally in this fashion without command-and-control intrusion into our private lives. Such intrusion is at odds with our core beliefs and unlikely to produce public health success. It is more likely to provoke popular backlash--one reason why some who stand to gain from our unhealthy dining choices try to cast government efforts to inform these …

The Politics Of Public Health: A Response To Epstein, Lawrence O. Gostin, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

Conservatives are taking aim at the field of public health, targeting its efforts to understand and control environmental and social causes of disease. Richard Epstein and others contend that these efforts in fact undermine people’s health and well-being by eroding people’s incentives to create economic value. Public health, they argue, should stick to its traditional task—the struggle against infectious diseases. Because markets are not up to the task of controlling the transmission of infectious disease, Epstein says, coercive government action is required. But market incentives, not state action, he asserts, represent our best hope for controlling the chronic illnesses that …

Trust And Betrayal In The Medical Marketplace, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The author argues in this Comment that disingenuity as first resort is an unwise approach to the conflict between our ex ante and our later, illness-endangered selves. Not only does rationing by tacit deceit raise a host of moral problems, it will not work, over the long haul, because markets reward deceit's unmasking. The honesty about clinical limit-setting that some bioethicists urge may not be fully within our reach. But more candor is possible than we now achieve, and the more conscious we are about decisions to impose limits, the more inclined we will be to accept them without experiencing …