Health Law and Policy Commons^™

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 …

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 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 …

Influenza A(H1n1) And Pandemic Preparedness Under The Rule Of International Law, Lawrence O. Gostin

O'Neill Institute Papers

A novel strain of Influenza A (H1N1) spread rapidly through Mexico in April 2009 and now spans the globe. By the time WHO was notified and responded, geographical containment was not feasible, leading the agency to call for mitigation. The international outbreak of SARS in 2003 and the more recent Influenza A (H5N1) among birds with limited transmission to humans helped prepare the world for the current pandemic threat. SARS galvanized the WHO to revise the antiquated International Health Regulations (IHR) in 2005, which took effect June 15, 2007. Governments instituted preparedness plans in response to avian influenza.

Despite increased …

Medical Device Safety Act Of 2009: Hearing Before The Subcomm. On Health Of The H. Comm. On Energy And Commerce, 111th Cong., May 12, 2009 (Statement Of David C. Vladeck, Prof. Of Law, Geo. U. L. Center), David C. Vladeck

Testimony Before Congress

I start with a brief history of the Medical Device Amendments of 1976 and explain why that history demonstrates that Congress quite clearly intended to preserve state liability law, not wipe it away. I will then turn to the Court's ruling in Riegel and address why the Court's wooden, textual approach to the Amendments -- which ignores their purpose -- led the Court to conclude, wrongly, that Congress intended the Amendments to preempt state liability claims for devices approved by FDA under the pre-market approval process. Next, I discuss the impact Riegel has had in the courts, resulting in the …

The Constitutionality Of Mandates To Purchase Health Insurance, Mark A. Hall

O'Neill Institute Papers

Health insurance mandates have been a component of many recent health care reform proposals. Because a federal requirement that individuals transfer money to a private party is unprecedented, a number of legal issues must be examined.

This paper analyzes whether Congress can legislate a health insurance mandate and the potential legal challenges that might arise, given such a mandate. The analysis of legal challenges to health insurance mandates applies to federal individual mandates, but can also apply to a federal mandate requiring employers to purchase health insurance for their employees. There are no Constitutional barriers for Congress to legislate a …

Insurance Discrimination On The Basis Of Health Status: An Overview Of Discrimination Practices, Federal Law And Federal Reform Options, Sara Rosenbaum

O'Neill Institute Papers

Actuarial underwriting, or discrimination based on an individual’s health status, is a business feature of the voluntary private insurance market. The term “discrimination” in this paper is not intended to convey the concept of unfair treatment, but rather how the insurance industry differentiates among individuals in designing and administering health insurance and employee health benefit products.

Discrimination can occur at the point of enrollment, coverage design, or decisions regarding scope of coverage. Several major federal laws aimed at regulating insurance discrimination based on health status focus at the point of enrollment. However, because of multiple exceptions and loopholes, these laws …

Privacy And Health Information Technology, Deven Mcgraw

O'Neill Institute Papers

The increased use of health information technology (health IT) is a common element of nearly every health reform proposal because it has the potential to decrease costs, improve health outcomes, coordinate care, and improve public health. However, it raises concerns about security and privacy of medical information.

This paper examines some of the “gaps” in privacy protections that arise out of the current federal health privacy standard, the Health Insurance Portability and Accountability (HIPAA) Privacy Rule, the main federal law which governs the use and disclosure of health information.

Additionally, it puts forth a range of possible solutions, accompanied by …

Executive Authority To Reform Health: Options And Limitations, Madhu Chugh

O'Neill Institute Papers

Presidential power has provoked increasingly vigorous debate since the turn of this century. In recent years, scholars and lawyers have been grappling with how Congress's dictates may limit the President's Commander-in-Chief power to detain enemy combatants at Guantanamo Bay, to fight wars abroad, and to conduct intelligence activities at home. But policymakers have not yet explored the many possibilities for invoking the President's "Take Care" power to change health care policy.

This paper explores the scope and limits of President Barack Obama's ability to invoke his executive authority to reform health care. Specifically, it identifies ways the Obama Administration can …

Health Insurance Exchanges: Legal Issues, Timothy S. Jost

O'Neill Institute Papers

Health insurance exchanges (HIE) are entities that organize the market for health insurance by connecting small businesses and individuals into larger pools that spread the risk for insurance companies, while facilitating the availability, choice and purchase of private health insurance for the uninsured. While there are legal issues that warrant consideration under a federal, state, or private exchange framework, those issues are not insurmountable barriers to implementation.

The Role Of Erisa Preemption In Health Reform: Opportunities And Limits, Peter D. Jacobson

O'Neill Institute Papers

The Employee Retirement Income Security Act (ERISA) is a federal law regulating the administration of private employer-sponsored benefits including health benefits (i.e., health insurance offered by an employer). In general, since the federal government has exercised its authority to preempt state regulation of the administration of private employer-sponsored health plans, states are blocked from enforcing laws interfering with ERISA.

As many states pursue health care reform experiments, ERISA preemption becomes relevant as a potential limit on the scope and type of reforms states are able to enact. The dominant trend in ERISA litigation has been to preempt state legislation and …

The Purchase Of Insurance Across State Lines In The Individual Insurance Market, Stephanie W. Kanwit

O'Neill Institute Papers

Proposals to allow the purchase of insurance across state lines (PASL) have gained some support in recent years. Health insurers have traditionally been allowed to sell a policy only within the state that approved and regulates that particular policy. PASL would allow insurers to sell a policy approved in one state to people residing in any state.

Any federal legislation to enact PASL in an individual insurance market would have to address two main legal considerations: 1) the McCarran-Ferguson Act, which allows the states to retain their regulatory authority over insurance, and 2) a constitutional prohibition against the commandeering of …

A Broader Liberty: Js Mill, Paternalism, And The Public’S Health, Lawrence O. Gostin, Kieran G. Gostin

O'Neill Institute Papers

Is the ‘harm principle’, famously propounded by JS Mill and widely adopted in bioethics, an appropriate principle to guide public health regulation? The harm principle limits liberty-limiting interventions to only those instances where the person poses a significant risk of harm to others. However, much of public health regulation is not primarily directed to avert risk to others, but to safeguard the health and safety of the individual him or herself. Think about regulations regarding seatbelts, motorcycle helmets, or the fluoridation of water as illustrations of pervasive public health regulations that are primarily intended to safeguard the individual’s own health …

Science, Politics, And Values: The Politicization Of Professional Practice Guidelines, Lawrence O. Gostin, John D. Kraemer

O'Neill Institute Papers

The Connecticut Attorney General’s recent allegations that the Infectious Disease Society of America violated antitrust law through its treatment guidelines for Lyme disease were neither based in sound science or appropriate legal judgment. Strong scientific evidence favors IDSA’s position that chronic infection with the etiologic agent of Lyme disease does not occur in the absence of objective signs of ongoing infection and that long-term antibiotic use to treat dubious infection, recommended in the quasi-scientific guidelines put forth by the International Lyme and Associated Diseases Society (ILADS), are of no benefit. In siding with ILADS and other chronic Lyme disease advocates, …

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 …

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 …

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 …

Male Circumcision As An Hiv Prevention Strategy In Sub-Saharan Africa: Socio-Legal Barriers, Lawrence O. Gostin

O'Neill Institute Papers

UNAIDS and WHO recommend safe, voluntary male circumcision as an additional, important strategy for the prevention of heterosexually-acquired HIV in men in areas with high HIV prevalence and low levels of male circumcision. Comprehensive male circumcision services should include HIV testing and counseling, partner reduction, and male and female condom use. Yet, male circumcision can have deep symbolic meaning that could pose barriers to implementation. In some parts of the world, it is a traditional practice with religious or cultural significance, in others it is a common hygiene intervention, and in yet others it is unfamiliar or foreign. Consequently, the …

President’S Emergency Plan For Aids Relief: Health Development At The Crossroads, Lawrence O. Gostin

O'Neill Institute Papers

The President’s Emergency Plan for AIDS Relief (PEPFAR) was the largest commitment by any nation to combat a single disease in human history, authorizing up to $15 billion over 5 years. On July 30, 2008, President Bush signed into law the historic reauthorization of PEPFAR, dramatically increasing the financial commitment by authorizing up to $48 billion over 5 years, including $5 billion for Malaria and $4 billion for Tuberculosis. PEPFAR’s global targets are inspiring: treat 3 million people; prevent 12 million new HIV infections, and care for 12 million people, including 5 million orphans and vulnerable children. But, PEPFAR has …

Global Health Law: Health In A Global Community, Lawrence O. Gostin

O'Neill Institute Papers

The examination of public health law traditionally focuses on constitutions, statutes, regulations, and common law at the national and sub-national level. However, the determinants of health (e.g., pathogens, air, food, water, even lifestyle choices) do not originate solely within national borders. Health threats inexorably spread to neighboring countries, regions, and even continents. Peoples’ lives are profoundly affected by commerce, politics, science, and technology from all over the world. Global integration and interdependence occur “as capital, traded goods, persons, concepts, images, ideas, and values diffuse across state boundaries.” It is for this reason that law and policy need to be transnational, …

The Deregulatory State, Lawrence O. Gostin

O'Neill Institute Papers

Public health can be achieved only through collective action, not through individual endeavor. Collective goods are essential conditions for health, but can be secured only through a well-regulated society. Yet, successive governments have eroded health and safety protections, with serious consequences. Think about the death of miners, lead in children’s toys, industrial solvents in toothpaste, salmonella in peanut butter, e-coli in spinach, and unsafe or ineffective pharmaceuticals such as COX-2 inhibitors or non-statin cholesterol medications.

Conservatives have waged a campaign against the administrative state that has created and reinforced deep-seated concerns about over-bearing government, particularly at the national level. The …

Global Health Law: A Definition And Grand Challenges, Lawrence O. Gostin, Allyn L. Taylor

O'Neill Institute Papers

It has been only recently that scholars have engaged in a serious discussion of "public health law." This academic discourse examines the role of the state and civil society in health promotion and disease prevention within the country. There is an important emerging literature on the international dimensions of health, but no similar systematic definition and exposition of a field we call "global health law." In this article we aim to fill this gap by defining global health law and characterizing the grand challenges. Given the rapid and expanding globalization that is a defining feature of today's world, the need …

Global Health Law Governance, Lawrence O. Gostin

O'Neill Institute Papers

The field of public health law traditionally focuses on law at the national and sub-national level. National legal systems, however, are inadequate to deal with major threats to humans. Despite the inadequacies of national governance, there are fundamental questions that need resolution in the field of global health law: Why should governments care about the health of people far away? Are profound health disparities just and, if not, is there a corresponding obligation to redress the injustice? Can international law effectively bind governments, foundations, and corporations to act for the global good? This article, based on a lecture at Emory …

A Theory And Definition Of Public Health Law, Lawrence O. Gostin

O'Neill Institute Papers

The literature, both academic and judicial, on the intersection of law and health is pervasive. The subject of law and health is widely taught, practiced, and analyzed. The fields that characterize these branches of study are called health law, health care law, law and medicine, forensic medicine, and public health law. Do these names imply different disciplines, each with a coherent theory, structure, and method that sets it apart? Notably absent from the extant literature is a theory of the discipline of public health law, an exploration of its doctrinal boundaries, and an assessment of its analytical methodology.

Public health …

The International Migration And Recruitment Of Nurses: Human Rights And Global Justice, Lawrence O. Gostin

O'Neill Institute Papers

The international migration of health workers – physicians, nurses, midwives, and pharmacists – leaves the world’s poorest countries with severe human resource shortages, seriously jeopardizing the achievement of the U.N. health Millennium Development Goals (MDGs). Advocates for global health call active recruitment in low-income countries a crime. Despite the pronounced international concern, there is little research and few solutions. This commentary focuses on the international recruitment of internationally educated nurses (IENs) from the perspective of human rights and global justice. It explains the complex reasons for nurse shortages in rich and poor countries; the duties of source and host countries; …