Health Law and Policy Commons^™

Adjudicating Risk: Aids, Crime, And Culpability, Aziza Ahmed

Faculty Scholarship

The AIDS epidemic continues to pose significant public health challenges, especially given that the spread of the virus outpaces the AIDS response.¹ Importantly, HIV continues to disproportionately impact socially and economically marginalized communities. In countries with concentrated epidemics,² it is racial minorities, sex workers, men who have sex with men, and drug users who face the brunt of the epidemic.³ In the United States, the data is startling⁴ : 44% of new infections were among African-Americans, and among African-Americans contracting HIV, 57% were among gay and bisexual men.⁵ In 2016, the CDC found that one …

Criminal Laws On Sex Work And Hiv Transmission: Mapping The Laws, Considering The Consequence, Sienna Baskin, Aziza Ahmed, Anna Forbes

Faculty Scholarship

Lawmakers historically justify the mobilization of criminal laws on prostitution and HIV as a means of controlling the spread of disease. Over time, however, public health research has conclusively demonstrated that criminal laws on prostitution and HIV significantly impede the ability of sex workers to access services and to live without the stigma and blame associated with being a transmitter of HIV. In turn, mainstream public health approaches to sex work and HIV emphasize decriminalization as a way to improve the lives of sex workers in need of care, treatment, and services. Our current legal system, which criminalizes both prostitution …

Environmental Law, Big Data, And The Torrent Of Singularities, William Boyd

Publications

How will big data impact environmental law in the near future? This Essay imagines one possible future for environmental law in 2030 that focuses on the implications of big data for the protection of public health from risks associated with pollution and industrial chemicals. It assumes the perspective of an historian looking back from the end of the twenty-first century at the evolution of environmental law during the late twentieth and early twenty-first centuries. The premise of the Essay is that big data will drive a major shift in the underlying knowledge practices of environmental law (along with other areas …

The International Health Regulations 10 Years On: The Governing Framework For Global Health Security, Lawrence O. Gostin, Mary C. Debartolo, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

The World Health Organization (WHO) and its global health security treaty, the International Health Regulations (2005) (IHR) have lost the world's confidence after the West African Ebola epidemic. The epidemic led to several high-level reviews of the IHR and global health security more broadly. Here, we propose a series of recommendations for operational and legal reforms to enhance the functioning of the FCGH. It is critical that WHO act on them quickly, before the window of opportunity for fundamental reform closes.

WHO should ensure that all states fulfill their obligations to develop national core surveillance and response capacities, including through …

Imagining Global Health With Justice: In Defense Of The Right To Health, Eric A. Friedman, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The singular message in Global Health Law is that we must strive to achieve global health with justice—improved population health, with a fairer distribution of benefits of good health. Global health entails ensuring the conditions of good health—public health, universal health coverage, and the social determinants of health—while justice requires closing today’s vast domestic and global health inequities. These conditions for good health should be incorporated into public policy, supplemented by specific actions to overcome barriers to equity.

A new global health treaty grounded in the right to health and aimed at health equity—a Framework Convention on Global Health (FCGH)—stands …

The Dangerous Right To Food Choice, Samuel R. Wiseman

Scholarly Publications

Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right.1 The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …

Compelling Interests And Contraception, Neil S. Siegel, Reva Siegel

Faculty Scholarship

On the eve of Griswold v. Connecticut’s fiftieth anniversary, employers are bringing challenges under the Religious Freedom Restoration Act (RFRA) to federal laws requiring them to include contraception in the health insurance benefits that they offer their employees. In Burwell v. Hobby Lobby Stores, five Justices asserted that the government has compelling interests in ensuring employees access to contraception, but did not discuss those interests in any detail. In what follows, we clarify those interests by connecting discussion in the Hobby Lobby opinions and the federal government’s briefs to related cases on compelling interests and individual rights in the areas …

Legal Preparedness And Ebola Vaccines, Sam F. Halabi, John T. Monahan

Faculty Publications

On Dec 9, 2014, US Secretary of Health and Human Services Sylvia Burwell issued a declaration under the US Public Readiness and Emergency Preparedness Act to provide immunity from legal claims in the USA related to manufacturing, testing, development, distribution, and administration of three candidate Ebola vaccines except in instances of willful misconduct. Although progress in combating Ebola in west Africa has shifted public attention away from vaccine development and deployment, we should not forget that the management of legal liabilities related to vaccines has been an important subject of discussion between national governments, international organizations, vaccine manufacturers, and other …

Sharing The Burden Of Ebola Vaccine Related Adverse Events, Sam F. Halabi, John Monahan

Faculty Publications

Based upon past experience with other vaccines, the proposed administration of Ebola vaccines (once testing has been completed) will inevitably result in at least some adverse events that will give rise to legal liabilities of only crudely estimable magnitude at this time. Manufacturers, beneficiary governments (e.g., Guinea, Liberia, Sierra Leone), supporting governments (e.g. U.S., U.K.), individuals suffering adverse events, and populations benefiting from widespread vaccination against the Ebola virus all have a shared interest in recognizing, understanding, and managing potential liability as effectively as possible within the framework of a global public health response. There are multiple options available to …

Ebola, Quarantine, And Flawed Cdc Policy, Robert Gatter

All Faculty Scholarship

The CDC’s Interim Guidance for Monitoring and Movements of Persons with Potential Ebola Virus Exposure is deeply flawed because it disregards the science of Ebola transmission. It recommends that officials quarantine individuals exposed to the virus but who do not have any symptoms of illness, ignoring the fact that only those with Ebola symptoms can communicate the virus to others. Consequently, any quarantine order based on the Guidelines is surely unconstitutional and illegal under most states’ public health statutes — as exemplified by the State of Maine’s failed petition to quarantine Nurse Kaci Hickox in October 2014. This article examines …

Deregulation, Distrust, And Democracy, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

Environmental, public health, alternative food, and food justice advocates are working together to achieve incremental agricultural subsidy and nutrition assistance reforms that increase access to fresh fruits and vegetables. When it comes to targeting food and beverage products for increased regulation and decreased consumption, however, the priorities of various food reform movements diverge. This article argues that foundational legal issues, including preemption of state and local authority to protect the public's health and welfare, increasing First Amendment protection for commercial speech, and eroding judicial deference to legislative policy judgments, present a more promising avenue for collaboration across movements than discrete …

Under Containment: Preempting State Ebola Quarantine Regulations, Eang Ngov

Faculty Articles

The outbreak of Ebola in Africa and its recent emergence in America has brought to light that the ambit of state sovereignty in the face of federal policy is unsettled in the public health field. Quarantine laws have historically been recognized as an exercise of state police powers and, absent discriminatory uses, courts have afforded much deference to states when the federal government is dormant. This article explores federalism implications when federal and state sovereigns contest the purview of regulating Ebola, other epidemics, and quarantine. This article examines how the federal government can assert supremacy to regulate treatment of epidemics …

Sickeningly Sweet: Analysis And Solutions For Adverse Dietary Consequences Of European Agricultural Law, Emilie K. Aguirre

Faculty Scholarship

Sixty-nine percent of adults in the United States, sixty-four percent in the United Kingdom, and over one-third worldwide are overweight or obese. These staggering figures continue to grow, with accompanying emotional, physical, and economic consequences, both for individuals and society as a whole. The role law plays in facilitating this global trend is significant, and yet puzzlingly, little recognized or understood. The current food system is profoundly structurally flawed: it establishes unhealthy dietary behaviors as the default option for consumers. This Article is the first to examine how agricultural law has facilitated these unhealthier diets for the past fifty years, …

Crowdsourcing Public Health Experiments: A Response To Jonathan Darrow's Crowdsourcing Clinical Trials, Ameet Sarpatwari, Christopher Robertson, David Yokum, Keith Joiner

Faculty Scholarship

We are pleased to have this opportunity to respond to Jonathan Darrow's article, Crowdsourcing Clinical Trials (CCT).' We seek to highlight its important contributions and to commence debate over some of its arguments. In particular, we qualify the ethical arguments that characterize early clinical use of drugs as if they were research, and suggest instead that, in either domain, the ethical (and legal) analysis should remain focused on whether all material information is provided so patients may make informed decisions. We also highlight the limits of what can be gleaned from the observational data collection efforts envisioned by CCT.

Ultimately, …

Multipolarity, Intellectual Property, And The Internationalization Of Public Health Law, Sam F. Halabi

Michigan Journal of International Law

The cause of global health today is arguably the most influential human rights movement ever seen, mobilizing vast flows of direct and indirect aid to the developing world to fight disease and build health care infrastructure; prompting the establishment of international organizations like UNAIDS and the Global Fund to fight AIDS, Tuberculosis and Malaria (Global Fund); including global health as a priority in major diplomatic summits; and driving the formation and implementation of international agreements to address global health threats. Champions of this movement claim that the diverse and influential state and non-state actors participating in the development of the …

A Cost-Benefit Analysis Of Sugary Drink Regulation In New York City, Shi-Ling Hsu

Journal of Food Law & Policy

New York City Mayor Bill de Blasio spent much of his time during his successful 2013 campaign positioning himself as the populist candidate, pointedly contrasting himself with the outgoing mayor, billionaire Michael Bloomberg. There is one Bloomberg initiative, however, that de Blasio has committed to carry forward: the city-wide size restriction on sales of "sugary drinks," most commonly, carbonated sodas. On city public health issues such as the sugary drink policy, the populist de Blasio and the billionaire Bloomberg would appear to have much in common. "People are dying every day, this is not a joke," remarked Bloomberg in striking …

Keynote Remarks At The University Of Michigan Environmental Law And Public Health Conference, Gina Mccarthy

Michigan Journal of Environmental & Administrative Law

The following are the prepared remarks delivered at the University of Michigan Law School’s 2013 Environmental Law and Public Health Conference on September 26, 2013.

Protecting Human Health And Stewarding The Environment: An Essay Exploring Values In U.S. Environmental Protection Law, Tracy Bach

Michigan Journal of Environmental & Administrative Law

The purpose of this conference is to explore “the relationship between environmental protection and public health and how it should inform our efforts to become better stewards of the environment.” No one would disagree with the assertion that during the last forty years of federal environmental protection, air and water quality have improved and led to concomitant improvements in human health. Exploring the contours of this “relationship,” Environmental Protection Agency (EPA) Administrator Gina McCarthy said in her keynote speech that “[t]he thing is, the word ‘relationship’ is too neutral. The link between the health of our planet and the health …

Environmental Law, Public Health, And The Values Conundrum, David M. Uhlmann

Michigan Journal of Environmental & Administrative Law

In September 1996, when I was nearing the end of my sixth year as a Justice Department environmental crimes prosecutor, one of my colleagues sent me an email that there was a “good-sounding RCRA [Resource Conservation and Recovery Act] knowing endangerment case developing in Idaho.” A twenty-year-old man named Scott Dominguez had collapsed inside a storage tank at an Idaho fertilizer manufacturing facility called Evergreen Resources. Mr. Dominguez could not be rescued for nearly an hour, because firefighters who responded to the scene did not know what was in the tank and what safety precautions they needed to take before …

The Medical Assumption At The Foundation Of Roe V. Wade And Its Implications For Women's Health, Clarke Forsythe

Washington and Lee Law Review

No abstract provided.

The Case For Flexible Intellectual Property Protections In The Trans-Pacific Partnership , Matthew E. Silverman

Journal of Law and Health

The United States and eleven other countries are currently in the end stages of negotiating the Trans-Pacific Partnership (TPP)—the largest free trade agreement (FTA) in U.S. history—which incorporates a range of trade topics, including the protection and enforcement of intellectual property rights (IPRs). Although the negotiations have been highly secretive, negotiating texts of the agreement leaked as recently as November 2013 have suggested that the United States is proposing IPR provisions, specifically relating to patent protection, that are stronger and less flexible than IPR provisions included within three of the four most recent U.S. FTAs. This paper addresses and analyzes …

Sex, Science, And The Age Of Anxiety, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

This article examines the question of whether the HPV vaccine should be mandated (for girls and/or boys) in the context of declining rates of childhood immunization, and the potential threat to public health that this decline poses. The article addresses two interconnected legal issues: first, is mandating vaccines to prevent the spread of disease constitutional under substantive due process and equal protection principles, and second, should parents be permitted to “opt out” of mandatory vaccination on their children’s behalf, either for all vaccines or those which prevent particular diseases. The article addresses these issues in the context of America’s growing …

Health Insurance Is Dead; Long Live Health Insurance, Wendy K. Mariner

Faculty Scholarship

Today, health insurance is no longer simply a class of insurance that covers risks to health, and it has not been so for many years. Health insurance has become a unique form of insurance — a mechanism to pay for healthcare that uses risk spreading as one of several pricing methods. The Affordable Care Act builds on this important payment function to create a complex social insurance system to finance healthcare for (almost) everyone. This article examines how the ACA draws on various conceptions of insurance to produce a quasi-social insurance system. This system poses new challenges to laws governing …

Health Law As Social Justice, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

Health law is in the midst of a dramatic transformation. From a relatively narrow discipline focused on regulating relationships among individual patients, health care providers, and third-party payers, it is expanding into a far broader field with a burgeoning commitment to access to health care and assurance of healthy living conditions as matters of social justice. Through a series of incremental reform efforts stretching back decades before the Affordable Care Act and encompassing public health law as well as the law of health care financing and delivery, reducing health disparities has become a central focus of American health law and …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Akron Law Faculty Publications

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Limiting “Sugary Drinks” To Reduce Obesity — Who Decides?, Wendy K. Mariner, George J. Annas

Faculty Scholarship

When a judge struck down the New York City Board of Health's partial ban on selling “sugary drinks” in containers of more than 16 fluid ounces, the reaction was swift. The Portion Cap Rule was widely viewed as a signature accomplishment of Mayor Michael Bloomberg's third term as the “public health mayor,” and he vowed to appeal, saying, “I've got to defend my children, and yours, and do what's right to save lives. Obesity kills.” But the question before the judge was not about the health risks posed by obesity or even the relationship between obesity and access to large …

Hiv Reporting In California: By Name Or By Number?, Nicole Kamm

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Taxing Food And Beverage Products: A Public Health Perspective And A New Strategy For Prevention, Jennifer L. Pomeranz

University of Michigan Journal of Law Reform

The power to tax and spend is considered a primary government power, and the use thereof is associated with great public health achievements. The greatest public health challenge at present stems from the increase in obesity and chronic diseases due to poor nutrition. Several taxation strategies have emerged in the health and economic literature to raise revenue, deter consumption, and address food prices and obesity directly. These proposals include taxing obese individuals, taxing problematic food products, and instituting a tax based on certain food components. This article weighs each proposal's value and disadvantages and concludes by proposing a new tax …

All Roads Lead From Vietnam To Your Home Town: How Veterans Have Become Casualties Of The War On Drugs, Susan Stuart

Law Faculty Publications

No abstract provided.

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, James Ming Chen, Jay Dratler Jr., Thomas Folsom, Timothy S. Hall, Yaniv Heled, Frank A. Pasquale Iii, Elizabeth A. Reilly, Jeffrey Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine A. Van Tassel

Law Faculty Scholarship

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …