Health Law and Policy Commons^™

Health Care Reform — A Historic Moment In Us Social Policy, Lawrence O. Gostin, Elenora E. Connors

Georgetown Law Faculty Publications and Other Works

On March 23, 2010, President Obama signed into law the first U.S. comprehensive health care reform bill, the Patient Protection and Affordable Care Act (PPACA). After almost a century of failed attempts, the U.S. now has a national health care system which promises to increase access to care, increase consumer choice, and ban insurance discrimination for individuals with preexisting medical conditions. The PPACA is expected to expand insurance coverage to 32 million individuals by 2019 through a variety of measures. At a cost of $938 billion over 10 years, the PPACA is projected to reduce the deficit by $143 billion …

The Unconscionable Health Gap: A Global Plan For Justice, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

International norms recognize the special value of health. The WHO Constitution states that “the enjoyment of the highest attainable standard of health” is a fundamental human right. The right to health, moreover, is a treaty obligation with clear obligations. Despite robust international norms, unconscionable health disparities exist between the world’s rich and poor, causing enormous suffering. The WHO urges “closing the health gap in a generation” through action on the social determinants of health. As the Marmot Commission observed: “the social conditions in which people are born, live, and work are the single most important determinant of good or ill …

Reducing Distracted Driving: Regulation And Education To Avert Traffic Injuries And Fatalities, Lawrence O. Gostin, Peter D. Jacobson

Georgetown Law Faculty Publications and Other Works

In this article, we consider the legal and policy implications of distracted driving (the tendency of people to use electronic devices while operating a motor vehicle). After reviewing the empirical evidence showing that distracted driving has serious adverse consequences, we discuss the legal basis for governmental interventions to reduce distracted driving. These interventions include laws restricting the use of electronic devices while driving, especially sending text messages. Since drivers have at best a reduced expectation of privacy, these restrictions should easily survive legal challenges. At the same time, it is important to consider the responsibility of automobile manufacturers to improve …

Restoring Health To Health Reform, Lawrence O. Gostin, Peter D. Jacobson

Georgetown Law Faculty Publications and Other Works

In this article, we discuss the public health provisions of the Patient Protection and Affordable Care Act (PPACA--P.L. 111-148). We first set forth a framework to identify the key reforms that are needed for a robust public health system. These include workforce and infrastructure investments. We then assess the PPACA against these criteria. We conclude that although the act would make significant investment in public health (especially in wellness and prevention programs), it does little to improve the existing structural deficiencies that the public health system must overcome if it is to be effective in improving the population’s health.

The President’S Global Health Initiative, Lawrence O. Gostin, Emily A. Mok

Georgetown Law Faculty Publications and Other Works

The U.S. Global Health Initiative (GHI) represents the Obama administration’s new strategy for international development assistance in health. With a pledge of $63 billion over six years, GHI aims to fund PEPFAR and a set of broader global health issues (e.g., maternal and child health, nutrition, and neglected tropical diseases). GHI is also being framed as “smart power” whereby health would serve as a critical tool for U.S. foreign policy.

However, as the U.S. enters a period of severe budgetary restraint and as domestic crises rise to the fore, the promise of global health reform could become illusory. The lack …

The National Individual Health Insurance Mandate: Ethics And The Constitution, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Within weeks, after signing the nation’s first comprehensive health insurance reform, twenty states filed lawsuits challenging the constitutionality of the Bill’s most politically charged feature—an individual purchase mandate. If anything, the tax penalty is too low compared with the cost of insurance, so it may not sufficiently incentivize healthy individuals. But it remains deeply controversial because it compels individuals to purchase coverage they choose not to have, raising the question whether Congress can lawfully and ethically require individuals to contract with, and transfer money to, a private party. To be sure, the individual mandate lacks a clear American precedent. (It …

Commandeering The People: Why The Individual Health Insurance Mandate Is Unconstitutional, Randy E. Barnett

Georgetown Law Faculty Publications and Other Works

The “Patient Protection and Affordable Care Act” includes what is called an “individual responsibility requirement” or mandate that all persons buy health insurance from a private company and a separate “penalty” enforcing this requirement. In this paper, I do not critique the individual mandate on originalist grounds. Instead, I explain why the individual mandate is unconstitutional under the existing doctrine by which the Supreme Court construes the Commerce and Necessary and Proper Clauses and the tax power. There are three principal claims.

First (Part II), since the New Deal, the Supreme Court has developed a doctrine allowing the regulation of …

Adaptation To The Health Consequences Of Climate Change As A Potential Influence On Public Health Law And Policy: From Preparedness To Resilience, Lindsay F. Wiley

Georgetown Law Faculty Publications and Other Works

Because the health effects of climate change are likely to be significant and far-reaching, a key component of climate change adaptation will be our public health infrastructure. Perhaps counter-intuitively, recent emphasis in public health law on preparedness for extraordinary events may be to the detriment of our ability to cope with the health impacts of climate change. While existing emergency preparedness law will necessarily be an important backdrop for health-focused climate change adaptation efforts (especially with regard to natural disasters and infectious disease outbreaks), the focus on emergency preparedness in recent years does not necessarily situate us well for handling …

Implementing Public Health Regulations In Developing Countries: Lessons From The Oecd Countries, Lawrence O. Gostin, Emily A. Mok, Monica Das Gupta, Max Levin

Georgetown Law Faculty Publications and Other Works

The enforcement of public health standards is a common problem in many developing countries. Public health agencies lack sufficient resources and, too often, enforcement mechanisms rely on slow and erratic judicial systems. These limitations can make traditional public health regulations difficult to implement. In this article, we examine innovative approaches to the implementation of public health regulations that have emerged in recent years within OECD countries. These approaches aim to improve compliance with health standards, while reducing dependence on both the legal system and the administrative resources of public health agencies.

This article begins by discussing some traditional forms of …

National And Global Responsibilities For Health, Lawrence O. Gostin, Mark Heywood, Gorik Ooms, Anand Grover, John-Arne Røttingen, Wang Chenguang

Georgetown Law Faculty Publications and Other Works

Preventable and treatable injuries and diseases are overwhelming sub-Saharan Africa, the Indian subcontinent, and other impoverished areas of the world. Why are health outcomes among the world’s poor so dire after the first decade of the Millennium Development Goals (MDGs) and despite a quadrupling of international health assistance over the past two decades? We believe that this dynamic can change by establishing clearer understandings of, and forging consensus around and governance structures to support, national and global responsibilities to improve global health.

With the goal of a new post-MDG global health paradigm, we are establishing the Joint Action and Learning …

The Joint Action And Learning Initiative On National And Global Responsibilities For Health, Lawrence O. Gostin, Gorik Ooms, Mark Heywood, Just Haffeld, Sigrun Møgedal, John-Arne Røttingen, Eric A. Friedman, Harald Siem

Georgetown Law Faculty Publications and Other Works

A population’s health and wellbeing is primarily a national responsibility. Every state owes all of its inhabitants a comprehensive package of essential health goods and services under its obligations to respect, protect, and fulfill the human right to health. Yet health is also a global responsibility. Every state has a duty to ensure a safe and healthy world, with particular attention to the needs of the world’s poorest people. Improving health and reducing unconscionable health inequalities is both an international obligation under the human right to health and a matter of global social justice.

The mutual obligations of states to …

Rights Talk And Patient Subjectivity: The Role Of Autonomy, Equality And Participation Norms, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

Patients themselves have transformed the role of the patient in the health care system, making it far more complex than it ever has been before. As a result, the conceptual root of our contemporary understandings of “patient” is an assumption of autonomous subjectivity, i.e., of an individual aware of and capable of acting on her choices for medical care. The Symposium on Patient-Centered Health Law and Ethics of which this Article is a part considers the most recent stage in this evolution of meanings: the concept of patient-centeredness, with its implication of provider deference to the patient’s perspective. Throughout the …

The United States' Engagement In Global Tobacco Control: Proposals For Comprehensive Funding And Strategies, Thomas J. Bollyky, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Tobacco use kills more people annually than HIV/AIDS, tuberculosis, and malaria combined. Unless action is taken, tobacco-related diseases will kill hundreds of millions more in coming decades, mostly in low- and middle-income countries. Beyond its effects on morbidity and mortality, tobacco use has dramatic social and economic consequences, consuming healthcare budgets, robbing families of their primary wage earners, and hindering economic development. Tobacco consumption is shifting from industrialized to developing countries, spurred by rising incomes, trade liberalization, and intensive marketing.

Although Congress empowered the U.S. Food and Drug Administration to regulate tobacco domestically, the United States has failed to lead …

International Assistance And Cooperation For Access To Essential Medicines, Emily A. Mok

Georgetown Law Faculty Publications and Other Works

Access to essential medicines is a critical problem that plagues many developing countries. With a daunting number of domestic constraints technologically, economically, and otherwise developing countries are faced with a steep uphill battle to meet the human rights obligation of providing essential medicines immediately. To meet these challenges, the international human rights obligations of international assistance and cooperation can play a key role to help developing countries fulfill the need for access to essential medicines. This article seeks to highlight and expand upon the current understanding of international assistance and cooperation for access to essential medicines through a review of …

Pharmaceutical Patent Litigation Settlements: Implications For Competition And Innovation, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Although brand-name pharmaceutical companies routinely procure patents on their innovative medications, such rights are not self-enforcing. Brand-name firms that wish to enforce their patents against generic competitors must commence litigation in the federal courts. Such litigation ordinarily terminates in either a judgment of infringement, which typically blocks generic competition until such time as the patent expires, or a judgment that the patent is invalid or not infringed, which typically opens the market to generic entry. As with other sorts of commercial litigation, however, the parties to pharmaceutical patent litigation may choose to settle their case. Certain of these settlements have …

The O’Neill Institute For National And Global Health Law: Discovering Innovative Solutions For The Most Pressing Health Problems Facing The Nation And The World, Lawrence O. Gostin, Oscar A. Cabrera, Susan C. Kim

Georgetown Law Faculty Publications and Other Works

The connection between health and an individual’s ability to function in society, as well as the importance of health to a society’s economic, political, and social wellbeing necessitates finding innovative solutions to the world’s most pressing health problems. The O’Neill Institute for National and Global Health Law at Georgetown University seeks to demonstrate the role that academia can play in addressing complex national and global health problems in a comprehensive, evidence-based, intellectually-rigorous, and nonpartisan manner. The O’Neill Institute currently has three research programs: global health law, national health law, and the center for disease prevention and outcomes. Projects within these …

The Right To Bear Arms: A Uniquely American Entitlement, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

In District of Columbia v. Heller the Supreme Court held that individuals have a constitutional right to own firearms, notably to keep a loaded handgun at home for self-protection. The historic shift announced by Heller was the recognition of a personal right, rather than a collective right tied to state militias. In McDonald v. Chicago, the Supreme Court – in a familiar 5-4 ideological split – held that the 2nd Amendment applies not only to the federal government, but also to state and local gun control laws. In his dissent, Justice Stevens predicted that “the consequences could prove far more …

The International Response To Climate Change: An Agenda For Global Health, Lindsay F. Wiley, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

As the international community negotiates a successor to the Kyoto Protocol of the United Nations Framework Convention on Climate Change (UNFCCC), there is new reason to hope that meaningful action might be taken to prevent devastating climate change. Even the more ambitious mitigation targets currently under negotiation, however, will not be sufficient to avoid a profound effect on the public's health in coming decades, with the world's poorest, most vulnerable populations bearing the disproportionate burden. The influence of historic and current emissions will be so substantial that it is imperative to reduce global emissions while at the same time preparing …

Healthy Planet, Healthy People: Integrating Global Health Into The International Response To Climate Change, Lindsay F. Wiley

Georgetown Law Faculty Publications and Other Works

The potentially groundbreaking negotiations currently underway on the international response to climate change and national implementation of commitments under the United Nations Framework Convention on Climate Change (UNFCCC) include a number of hotly contested issues: (1) what degree of climate change is acceptable as a basis for emissions targets, (2) to what extent and in what ways climate change mitigation should incorporate emissions reductions or increased sinks for developing countries, (3) whether the legal regime governing mitigation can take advantage of the huge mitigation potential of changed practices in the land use and agricultural sectors, (4) how adaptation should be …

The Emergent Logic Of Health Law, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The American health care system is on a glide path toward ruin. Health spending has become the fiscal equivalent of global warming, and the number of uninsured Americans is approaching fifty million. Can law help to divert our country from this path? There are reasons for deep skepticism. Law governs the provision and financing of medical care in fragmented and incoherent fashion. Commentators from diverse perspectives bemoan this chaos, casting it as an obstacle to change. I contend in this Article that pessimism about health law’s prospects is unjustified, but that a new understanding of health law’s disarray is urgently …

Empirical Health Law Scholarship: The State Of The Field, Michelle M. Mello, Kathryn Zeiler

Georgetown Law Faculty Publications and Other Works

The last three decades have seen the blossoming of the fields of health law and empirical legal studies and their intersection--empirical scholarship in health law and policy. Researchers in legal academia and other settings have conducted hundreds of studies using data to estimate the effects of health law on accident rates, health outcomes, health care utilization, and costs, as well as other outcome variables. Yet the emerging field of empirical health law faces significant challenges--practical, methodological, and political.

The purpose of this Article is to survey the current state of the field by describing commonly used methods, analyzing enabling and …

Assessing Laws And Legal Authorities For Obesity Prevention And Control, Lawrence O. Gostin, Jennifer L. Pomeranz, Peter D. Jacobson, Richard N. Gottfried

Georgetown Law Faculty Publications and Other Works

This is the first paper in a two part series on the laws and legal authorities for obesity prevention and control, which resulted from the National Summit on Legal Preparedness for Obesity Prevention and Control in 2008. In this paper, the authors apply the “laws and legal authorities” component of the Centers for Disease Control and Prevention (CDC) legal framework on public health legal preparedness to demonstrate the essential role that law can play in the fight against obesity. Their analysis identified numerous laws and policies in the three vital domains of healthy lifestyles, healthy places, and healthy societies. For …

Improving Laws And Legal Authorities For Obesity Prevention And Control, Lawrence O. Gostin, Jennifer L. Pomeranz

Georgetown Law Faculty Publications and Other Works

This is the second paper in a two part series on the laws and legal authorities for obesity prevention and control. In this paper, the authors present the applicable laws and legal authorities that public health professionals and lawyers can consider implementing to close the legal gaps identified in the first paper (“Assessing Laws and Legal Authorities for Obesity Prevention and Control”). This set of legal action items encompass the federal, tribal, state, local, and community levels and should be considered when developing, implementing, and evaluating obesity prevention and control strategies and interventions.

The paper organizes the action items within …

Socioeconomic Disparities In Health: A Symposium On The Relationships Between Poverty And Health, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The disparities in health between the rich and poor are so striking, and the results so dire, that reducing the gap is an ethical imperative.

A strong and consistent finding of epidemiological research is that socioeconomic status (SES) is correlated with morbidity, mortality, and functioning. SES is a complex combination of income, education, and occupation. Theorists posit that material disadvantage, diminished control over life's circumstances, and lack of social acceptance all contribute to poor health outcomes. The relationship between SES and health often is referred to as a "gradient" because of the graded and continuous nature of the association; health …

National And Global Health Law: A Scholarly Examination Of The Most Pressing Health Hazards, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The health of individuals, families, and communities has deep, intuitive meaning. So much of what we aspire to be as individuals or as members of society relies on health. Our shared intuitions about the value of health manifest themselves in public and political concerns. The media widely reports threats to the public's health, such as a traveler with multi-drug resistant tuberculosis, E-coli from contaminated spinach, miners' deaths, unsafe children's toys, and dangerous pharmaceuticals. Election years predictably spur new, or refashioned, proposals for health care reform. And there remain enduring, intractable health hazards, such as tobacco, obesity, motor vehicle crashes, and …

Risk Governance And Deliberative Democracy In Health Care, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

I argue in this article that the concept of risk-centered governance is the best theoretical paradigm for understanding health law and the health care system. Over the past 20 years, an insurance-inflected discourse has migrated from the purely financial side of the health system into the heart of traditional medicine - the doctor-patient relationship. Rather than focus on doctrinal strands, I argue that scholars should analyze the law of health care as a set of governance practices organized around managing and allocating financial, as well as clinical, risk.

Over the same period, the body of law that structures most private …

Global Regulatory Strategies For Tobacco Control, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Recent tobacco control regulation in North America and Western Europe has had a salutary effect, even if smoking remains a pressing public health hazard. But in the 21st century, the tobacco industry has quietly moved its locus of activity to lucrative, emerging markets: the vast populations in Africa, Asia, Eastern Europe, and Latin America. The poorest, least educated, and sickest people on earth inhabit these regions. "Big Tobacco's" new marketing strategy will cause untold morbidity for the world's most vulnerable.

However, there are a variety of effective tobacco control policies that nations can and should enact. The World Health Organization …

Public-Private Health Law: Multiple Directions In Public Health, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

No public law is more public than public health law. Its defining subject is the use of state power to control and prevent death and disease. Its primary institutions are a cluster of state actors, the governmental agencies that comprise the American public health "system.,, The system grew out of the eighteenth century boards of health that produced the beginnings of administrative law. Public health law is grounded on statutory provisions that authorize various forms of state action and on judicial decisions that resolve constitutional challenges to those actions.

Mris And The Perception Of Risk, Steven Goldberg

Georgetown Law Faculty Publications and Other Works

The most important safety decision concerning MRIs was to change the name of the procedure. In the late 1970s, the procedure known as nuclear magnetic resonance (NMR) became magnetic resonance imaging (MRI) because of the negative connotations the word “nuclear” invited. The change was understandable since MRIs do not expose patients to dangerous radiation: “nuclear” was in the original name because basic research on the atomic nucleus led to the development of MRIs. The main cost of the name change was to obscure the important link between basic research and useful medical technologies.

In recent years, however, MRIs, a generally …

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 …