Health Law and Policy Commons^™

Moving Global Health Law Upstream: A Critical Appraisal Of Global Health Law As A Tool For Health Adaptation To Climate Change, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

The relatively new discipline of global health law is a potentially powerful tool for promoting health adaptation to climate change. Unfortunately, global climate change will intensify exactly those health threats that have not been adequately addressed by multilateral cooperation with respect to health in the past, which has been dominated by security-based and treatment-focused approaches. Recent focus on biosecurity concerns such as the global spread of emerging infectious diseases and biological terrorism has further entrenched a security-based approach to global health law and policy that has origins in the earliest attempts at international health cooperation and is currently embodied in …

Mitigation/Adaptation And Health: Health Policymaking In The Global Response To Climate Change And Implications For Other Upstream Determinants, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Assessing The Impact Of Federal Law On Public Health Preparedness, Lindsay Wiley, Ben Berkman, Susan C. Kim

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Special 301 And Access To Medicine In The Obama Administration, Sean Flynn

Scholarly Articles in Law Reviews & Journals

I. Introduction

This article examines the history and current use of the Special 301 program to restrict access to generic medicines in developing countries, specifically the 2009 and 2010 reports released under the Obama Administration. The news for access to medicines advocates is not good overall. Both reports continue the previous Administration’s policies of using Special 301 to promote Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) policies (“TRIPS-plus”) endangering access to medicines for millions of people worldwide. These policies violate not only the Obama Administration’s pledges to promote access to affordable medications in developing countries, but also U.S. commitments under …

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

Scholarly Articles in Law Reviews & Journals

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 …

Conceivable Changes: Effectuating Infertile Couples' Emotional Ties To Frozen Embryos Through New Disposition Options, Jody L. Madeira

Articles by Maurer Faculty

No abstract provided.

Negotiating Equitable Access To Influenza Vaccines: Global Health Diplomacy And The Controversies Surrounding Avian Influenza H5n1 And Pandemic Influenza H1n1, David P. Fidler

Articles by Maurer Faculty

No abstract provided.

Protecting Privacy In Health Research: The Limits Of Individual Choice, Fred H. Cate

Articles by Maurer Faculty

No abstract provided.

Scientific Understandings Of Postpartum Illness: Improving Health Law And Policy?, Stacey A. Tovino

Faculty Articles

In its broadest sense, this Article examines the relationship between science and the law in the context of postpartum illness. From classical antiquity to the present day, physicians and scientists have investigated the causes, correlates, and consequences of the depressions and psychoses that develop in some women following their transition to motherhood. The scientific investigation of postpartum illness has been characterized by an open-ended search for knowledge with the recognition that scientific findings published one day are subject to revision the next. Legislators and judges also have sought to understand postpartum illness as necessary to make laws that affect and …

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 …

Promoting Public Health Through Clinical Legal Education: Initiatives In South Africa, Thailand, And Ukraine, Tamar Ezer

Articles

No abstract provided.

Mapping The Issues: Public Health, Law And Ethics, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The field of public health is typically regarded as a positivistic pursuit and, undoubtedly, our understanding of the etiology and response to disease is heavily influenced by scientific inquiry. Public health policies, however, are shaped not only by science but also by ethical values, legal norms, and political oversight. Public Health Law and Ethics: A Reader (expanded and updated 2nd ed., 2010) probes and seeks to illuminate this complex interplay, through a careful selection of government reports, scholarly articles, and court cases together with discussion and analysis of critical problems at the interface of law, ethics, and public health. The …

Health Care Reform In Transition: Incremental Insurance Reform Without An Individual Mandate, Lawrence O. Gostin, Elenora E. Connors

Georgetown Law Faculty Publications and Other Works

A major access problem exists in the private insurance market for individuals with preexisting conditions, who are either denied coverage or charged exorbitant premiums. In effect, individuals are denied coverage for exactly what they need, which jeopardizes their health and the financial security of their family. Before health reform passed, discussions surrounding incremental reform took place, including perhaps the most politically compelling – prohibiting insurers from denying coverage to those with preexisting health conditions. Insurance is based upon the principles of spreading risk of individuals across a population to ensure that everyone can afford medical care when he or she …

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 …

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 …

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 …

Putting The Community Back Into The "Community Benefit" Standard, Jessica Berg

Georgia Law Review

Disputes about tax exemption for hospitals are occurring all over the country. Local tax authorities have revoked tax- exempt status for some hospitals. State governments are considering whether to require minimum amounts of charity care in exchange for tax exemption. Congress is debating whether hospitals should remain a part of the nonprofit sector at all. At the same time, uninsured individuals are suing hospitals for unfair billing and collection practices. Creative accounting and expansive definitions of "free" care have led to a variety of non ideal practices by hospitals in order to balance their bottom line, while maintaining tax-exempt status. …

The Parity Cure: Solving Unequal Treatment Of Mental Illness Health Insurance Through Federal Legislation, Christopher J. Churchill

Georgia Law Review

American health care reform has drawn both impassioned critics and vociferous supporters. Although underinsured and uninsured Americans face a dire plight, the mentally ill-even those with private health insurance-confront even greater hurdles. While drawing substantially less outcry, many insurance plans place limits on mental illness coverage that do not apply to physical illnesses. Though Congress recently passed the Mental Health Parity and Addiction Equity Act of 2008 (the MHPAEA), it did not solve the problem. The MHPAEA eliminates some disparity-such as higher deductibles for mental health treatment-but still allows insurers to impose unequal annual coverage limits. Furthermore,the MHPAEA shares the …

Phase Six Pandemic: A Call To Re-Evaluate Federal Quarantine Authority Before The Next Catastrophic Outbreak, John T. Clarkson

Georgia Law Review

At some point in the future, the United States will confront a deadly pandemic. One potential response to blunt the impact of an outbreak may be the use of a large-scale quarantine. The current statutory framework governing federal quarantine authority, however, is outdated and in need of revision. Any reform must acknowledge that the federal government may be best positioned to respond to national health threats and must simultaneously create limits on federal power to ensure a proper balance of power remains between the states and the federal government. This Note proposes that Congress focus its reform efforts on adding …

Taking From Trailblazers: Learning From Those Who Have Gone Before When Approving Biosimilars, John A. Little, Jr.

Georgia Law Review

The creation of an approval pathway for biosimilar biologicalproducts holds tremendous promise for increased competition in the biopharmaceutical market and financial savings to the health care system. Yet, safely achieving these promised benefits depends heavily on the Food and Drug Administration's ability to evaluate and compare these complicated molecules to previously approved products. Because biosimilars are different than generic drugs, the FDA's current practice of considering only its prior finding of safety and efficacy of a reference product is ill-suited for approval of biosimilars. Unfortunately, the new pathway included in recently enacted health care reform legislation ignores this distinction and …

State Of Emergency: Why Georgia's Standard Of Care In Emergency Rooms Is Harmful To Your Health, Jason R. Graves

Georgia Law Review

Patients injured by medical negligence have historically
been able to recover for the injuries they sustained. In
2005, however, the Georgia General Assembly passed
Georgia Senate Bill 3, which gave virtual immunity to
emergency room doctors and those practicing in obstetrics
wards. The Bill requires a showing of gross negligence by
clear and convincing evidence to prevail on a medical
malpractice claim against those protected by the statute.
The law prevents injured patients who cannot meet this
standard from recovering any damages, even
compensation for medical bills arising from the negligent
act. The legislature enacted the Bill in an effort …

Penetrating The Silence In Sierra Leone: A Blueprint For The Eradication Of Female Genital Mutilation, Chi Adanna Mgbako, Meghna Saxena, Anna Cave, Nasim Farjad, Helen Shin

Faculty Scholarship

The African grassroots movement to eradicate female genital mutilation (also known as “female genital cutting” and “female circumcision,” hereinafter “FGM”) is widespread. While many African countries and grassroots organizations have made great strides in their efforts to eliminate FGM, Sierra Leone lags behind. In Sierra Leone, FGM is practiced within the bondo secret society, an ancient, all-female commune located in West Africa and also known as the sande. The bondo society’s traditional role was to direct girls’ rites of passage into adulthood. In order to become a member of the bondo, a girl or woman must undergo various rituals, the …

Pregnant Man?: A Conversation, Darren Rosenblum, Noa Ben-Asher, Mary Anne Case, Elizabeth Emens, Berta E. Hernández-Truyol, Vivian M. Gutierrez, Lisa C. Ikemoto, Angela Onwuachi-Willig, Jacob Willig-Onwuachi, Kimberly Mutcherson, Peter Siegelman, Beth Jones

Faculty Publications

(Excerpt)

I'm a law professor who works on gender, sexuality, and culture in the international and comparative context. That's my head working. In "real" life, my partner, Howard, and I have been engaged in having a baby together for several years, a project that came to fruition with the birth of our daughter Melina. Of course, such a project evokes intensely complex feelings and thoughts. Beyond a simple transposition of the personal onto the political, I feel so fortunate to have engaged in myriad conversations with a variety of friends and colleagues who think much more carefully about the family …

Land Use And Water Supply, Susan Kelly, Joanne Hilton

Water Matters!

As New Mexico grows and develops, there is a continuing increase in water demand and the need to provide additional supplies. Recent studies estimate the current population of the State to be about two million people, and the population is expected to grow to approximately 3,400,000 by 2050. Regional water plans project water demands for 16 regions within New Mexico. The total projected new water use associated with population growth—the public water supply and associated commercial sectors, exclusive of agriculture, mining, or other industries—ranges from 280,000 to 380,000 acre-feet per year of new water supply needed in the next 40 …