Health Law and Policy Commons^™

Geographical Indications Of Origin, Economic Development, And Cultural Heritage: Good Match Or Mismatch?, Irene Calboli

Faculty Scholarship

In this article, I propose that geographical indications (GIs) carry important economic benefits. First, GIs are essential instruments to facilitate investments in high-quality products and niche markets, and promote local trade and development. Second, GIs offer an additional layer of information for consumers about the geographical origin and quality of the products they identify, in turn reducing the information asymmetries between producers and consumers. Third, because of this information function, GIs can assist in rewarding or holding producers accountable for their products based on the additional information they convey to the market. Yet, GIs can also protect culture-related interests and …

The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan

Faculty Scholarship

The year 2020 marks the 25th anniversary of including intellectual property rights within the larger agenda of trade. While the marriage between trade and intellectual property was always uncomfortable, COVID-19 exposed the flaws, failures and the inadequacy of the trade agenda to harmonise intellectual property rights, particularly for patents in pharmaceuticals. Typically, the United States through its questionable United States Trade Representative (USTR) process exposed the vulnerabilities of the intellectual property systems of the rest of the world. COVID-19 exposed the manner in which the so-called ‘superior’ intellectual property regime of the US left the country with a weak health-care …

Public Health Law Tools: A Brief Guide, Kristen Underhill

Faculty Scholarship

The COVID-19 pandemic offers a threat with few precedents in modern times and tests the tools of modern surveillance and public health law. The goal of this chapter is to provide a brief overview of the types of measures that state and federal governments can invoke to treat and prevent the spread of infectious disease. The following sections will provide an orientation to domestic public health law followed by the types of measures available to state and federal public health authorities.

Although this chapter does not consider international institutions, treaties, or norms that affect public health, these are also essential …

Who’S Afraid Of Section 1498? A Case For Government Patent Use In Pandemics And Other National Crises, Christopher J. Morten, Charles Duan

Faculty Scholarship

COVID-19 has created pressing and widespread needs for vaccines, medical treatments, PPE, and other medical technologies, needs that may conflict – indeed, have already begun to conflict – with the exclusive rights conferred by United States patents. The U.S. government has a legal mechanism to overcome this conflict: government use of patented technologies at the cost of government-paid compensation under 28 U.S.C. § 1498. But while many have recognized the theoretical possibility of government patent use under that statute, there is today a conventional wisdom that § 1498 is too exceptional, unpredictable, and dramatic for practical use, to the point …

The New "Essential": Rethinking Social Goods In The Age Of Covid-19, Olatunde C.A. Johnson

Faculty Scholarship

The Covid-19 crisis has laid bare the fragility of social insurance systems in the United States and the lack of income security and basic benefits for many workers and residents. The United States has long had weaker protections for workers compared to other liberal democracies racial and economic disparities among those most affected by these dislocations (analyses are hampered by a paucity of demographic data). Those who were socially and economically vulnerable before the pandemic (for example due to homelessness, immigration status, or incarceration) are likely to suffer the most harm. Changes in workplace conditions as a result of the …

Linked Fate: Justice And The Criminal Legal System During The Covid-19 Pandemic, Susan P. Sturm, Faiz Pirani, Hyun Kim, Natalie Behr, Zachary D. Hardwick

Faculty Scholarship

The concept of “linked fate” has taken on new meaning in the face of the COVID-19 pandemic. People all over the world – from every walk of life, spanning class, race, gender, and nationality – face a potentially deadly threat requiring cooperation and sacrifice. The plight of the most vulnerable among us affects the capacity of the larger community to cope with, recover, and learn from COVID-19’s devastating impact. COVID-19 makes visible and urgent the need to embrace our linked fate, “develop a sense of commonality and shared circumstances,” and unstick dysfunctional and inequitable political and legal systems.

Nowhere is …

“Unusual Care”: Groupthink And Willful Blindness In The Support Study, George J. Annas, Catherine L. Annas

Faculty Scholarship

The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group 2010). We previously suggested that the researchers in SUPPORT were "legally blind" in failing to understand that the "standard" that defines the content of informed consent is set by law, including the federal regulations, not by what physicians "usually" do or don't do (Annas and Annas 2013). Macklin and Natanson, also early critics of the SUPPORT study's failure to disclose the increased risk of death posed by the study, (Macklin et al. 2013) attack …

First Man And Second Woman: Reflections On The Anniversaries Of Apollo 11 And Cruzan, George J. Annas

Faculty Scholarship

THE United States Supreme Court's decision in Cruzan v. Director, Missouri Department of Health marks its thirtieth anniversary in 2020.' This follows closely after the fiftieth anniversary of the Apollo 11 moon landing.² Anniversaries provide an opportunity for reflection and to gain perspective. We can, I suggest, gain deeper insights regarding human life and death by considering these two anniversaries together. Apollo 11 may seem far from Nancy Cruzan-but the discovery of disturbing details about the death of Neil Armstrong, the first man on the moon, is a productive introduction to the topic of death in a modern American …

Is Tort Law The Tool For Fixing Reproductive Wrongs?, Christopher Robertson

Faculty Scholarship

In his 2019 book, Birth Rights and Wrongs: How Medicine and Technology are Remaking Reproduction and the Law, Dov Fox offers a compelling argument for new torts allowing recovery for wrongful reproduction. These torts would include three sorts of cases, those where wrongdoing (whether negligent, reckless, or intentional) caused undesired reproduction; stymied desired reproduction; or confounded reproduction, causing birth of a child different than that intended by the parents. The likely defendants in these torts are gynecologists, urologists, sperm banks, and IVF clinics.

Federalism, Erisa, And State Single-Payer Health Care, Erin C. Fuse Brown, Elizabeth Mccuskey

Faculty Scholarship

While federal health reform sputters, states have begun to pursue their own transformative strategies for achieving universal coverage, the most ambitious of which are state-based single-payer plans. Since the passage of the Affordable Care Act in 2010, legislators in twenty-one states have proposed sixty-six unique bills to establish single-payer health care systems. This paper systematically surveys those state legislative efforts and exposes the federalism trap that threatens to derail them: ERISA's preemption of state regulation relating to employer-sponsored health insurance. ERISA's expansive preemption provision creates a narrow, risky path for state regulation to capture the employer health care expenditures crucial …

Evaluating For-Profit Public Benefit Corporations As An Additional Structure For Antibiotic Development And Commercialization, Kevin Outterson, John H. Rex

Faculty Scholarship

While antibiotics are a key infrastructure underpinning modern medicine, evolution will continue to undermine their effectiveness, requiring continuous investment to sustain antibiotic effectiveness. The antibiotic R&D ecosystem is in peril, moving towards collapse. Key stakeholders have identified pull incentives such as Market Entry Rewards or subscription models as the key long-term solution. If substantial Market Entry Rewards or other pull incentives become possible, there is every reason to expect that for-profit companies will return to the antibiotic field. However, the political and financial will to develop such Market Entry Rewards or other similar incentives may be difficult to muster in …

Antibiotic Development — Economic, Regulatory And Societal Challenges, Christine Årdal, Manica Balasegaram, Ramanan Laxminarayan, David Mcadams, Kevin Outterson, John H. Rex, Nithima Sumpradit

Faculty Scholarship

Antibiotic resistance is undoubtedly one of the greatest challenges to global health, and the emergence of resistance has outpaced the development of new antibiotics. However, investments by the pharmaceutical industry and biotechnology companies for research into and development of new antibiotics are diminishing. The public health implications of a drying antibiotic pipeline are recognized by policymakers, regulators and many companies. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the national and international initiatives aimed at incentivizing research and the development of new antibiotics to improve the …

Is Medicare For All The Answer? Assessing The Health Reform Gestalt As The Aca Turns 10, Nicole Huberfeld

Faculty Scholarship

As presidential candidates debate health reform, the expression “Medicare for All” (“M4A”) is on repeat, yet few appear to understand precisely what Medicare is or what M4A would mean. Even more striking is that Americans are vigorously debating health reform when the ACA – President Obama’s signature legislation and a health reform effort on a scale not seen in decades – turns 10 on March 23.

The ACA pioneered universal coverage, but it also ratcheted up health care complexity by building new scaffolding around an old foundation. This fragmented landscape has been exacerbated by a crazy quilt of implementation crafted …

A Public Health Law Path For Second Amendment Jurisprudence, Michael Ulrich

Faculty Scholarship

The two landmark gun rights cases, District of Columbia v. Heller and McDonald v. City of Chicago, came down in 2008 and 2010, respectively. In the decade that has followed, two things have become abundantly clear. First, these cases provide little clarity about the nature and scope of Second Amendment rights, resulting in chaos and circuit splits in the lower courts. Second, growing empirical evidence has revealed that, in the background of the debate on individual constitutional rights, a serious gun violence epidemic is intensifying around the country. In one corner, gun rights advocates worry that increased firearm regulation will …

Pedagogy And Policy: A Tribute To Karen Rothenberg’S Contributions To Health Law, Michael Ulrich

Faculty Scholarship

Professor Karen Rothenberg has had a significant influence on my life, impacting my education, my career, and the way I think. Professor Rothenberg has been a pillar in the health law community, but perhaps her most lasting impact for myself was creating the health law program at the University of Maryland, Francis King Carey School of Law. This nationally recognized program grew from her passion, expertise, and recognition of the importance of health, and is the reason I chose to attend the University of Maryland. The curriculum, faculty, and experience made it one of the best decisions of my life …

Federalism Complicates The Response To The Covid-19 Health And Economic Crisis: What Can Be Done?, Nicole Huberfeld, Sarah H. Gordon, David K. Jones

Faculty Scholarship

Federalism has complicated the US response to the novel coronavirus. States’ actions to address the pandemic have varied widely, and federal and state officials have provided conflicting messages. This fragmented approach has cost time and lives. Federalism will shape the long-term health and economic impacts of COVID-19, including plans for the future, for at least two reasons: First, federalism exacerbates inequities, as some states have a history of underinvesting in social programs, especially in certain communities. Second, many of the states with the deepest needs are poorly equipped to respond to emergencies due to low taxes and distrust of government, …

Liquid Gold, Katrice Bridges Copeland

Faculty Scholarship

According to federal health and census data, addiction treatment was a $21 billion business in 2003. By 2020, it is expected to double to $42 billion. The opioid crisis has fueled the growth of the industry by increasing the demand for residential drug treatment programs. Astronomical growth of an industry, however, often invites bad actors.

Bad actors have swarmed the residential drug treatment industry. One category of bad actors includes patient brokers, who recruit drug addicts with health insurance to residential drug treatment centers for sizeable kickbacks. Another category of bad actors are the owners and operators of treatment centers …

The Enhanced Danger Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of …

Accountability, Secrecy, And Innovation In Ai-Enabled Clinical Decision Software, Arti K. Rai, Isha Sharma, Christina Silcox

Faculty Scholarship

This article employs analytical and empirical tools to dissect the complex relationship between secrecy, accountability, and innovation incentives in clinical decision software enabled by machine learning (ML-CD). Although secrecy can provide incentives for innovation, it can also diminish the ability of third parties to adjudicate risk and benefit responsibly. Our first aim is descriptive. We address how the interrelated regimes of intellectual property law, Food and Drug Administration (FDA) regulation, and tort liability are currently shaping information flow and innovation incentives. We find that developers regard secrecy over training data and details of the trained model as central to competitive …

Tensions And Exclusions: The Knotty Policy Encounter Between Sexual And Reproductive Health And Rights And Hiv, Susana T. Fried, Aziza Ahmed, Luisa Cabal

Faculty Scholarship

The International Conference on Population and Development or ICPD (Cairo, 1994) provided a global policy framework centred on reproductive rights instead of population control. Global standards on sexual and reproductive health and rights (SRHR) and on HIV rapidly expanded throughout the 1990s.1 Considerable activist mobilisation in both arenas advanced health issues as politically salient decision-making venues where human rights and health advocacy were urgently needed, rather than scientific and technical showcases.

The ICPD, quickly followed by the Fourth World Conference on Women (1995), stressed that reproductive rights are anchored in governments’ human rights obligations and development commitments, including to …

Digital Health Privacy In Active-Aging Settings: Will The Law Let You Age Well?, Tara Sklar, Richard Carmona, Kathie Insel, Christopher Robertson

Faculty Scholarship

What is privacy and how are our interpretations of it changing with advances in technology? This question, and concerns around potentially violating a person’s right to privacy, have been emerging across industries around the world. Senior living providers have increased their exposure to privacy risks with the shift to implementing sensors throughout their communities. Typically located in digital health devices that can be worn on the body or placed in the environment, these sensors are capable of collecting and tracking data relevant to a person’s health and well-being on a continuous monitoring basis.
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Affordability Boards: The States’ New Fix For Drug Pricing, Tara Sklar, Christopher Robertson

Faculty Scholarship

A new Maryland law that creates a prescription-drug affordability board to help the state regulate drug prices may be a harbinger of what’s to come in drug-pricing legislation. The law permits cost reviews when drug prices or price increases exceed specified thresholds. Establishing affordability boards may be a natural next step that more states take to exert a stronger influence over price spikes and still survive legal challenges.

Humanizing Work Requirements For Safety Net Programs, Mary Leto Pareja

Faculty Scholarship

This Article explores the political and policy appeal of work requirements for public benefit programs and concludes that inclusion of such requirements can be a reasonable design choice, but not in their current form. This Article’s proposals attempt to humanize these highly controversial work requirements while acknowledging the equity concerns they are designed to address. Drawing on expansive definitions of “work” found in guidance published by the Centers for Medicare and Medicaid (“CMS”) and in various state waiver applications, this Article proposes that work requirements be approved for Medicaid (as well as other benefit programs) only if they encompass various …

Designing Development Programs For Non-Traditional Antibacterial Agents, John H. Rex, Holly Fernandez Lynch, I. Glen Cohen, Jonathan J. Darrow, Kevin Outterson

Faculty Scholarship

In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and nontraditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits …

A Public Health Approach To Gun Violence, Legally Speaking, Michael Ulrich

Faculty Scholarship

The call for a public health approach to gun violence has largely ignored what role the nascent Second Amendment jurisprudence will play in hindering change. Given the state interest for infringing on Second Amendment rights is nearly always public safety, public health law doctrine provides an apt framework for analysis.

Epilogue: Health Care, Federalism, And Democratic Values, Nicole Huberfeld

Faculty Scholarship

Is the United States experiencing a “crisis of democracy in health care”? This symposium's central question can only begin to be addressed here. The answer depends, in part, on where we look and how we measure democracy.

Democracy is a complex ideal often said to be promoted by federalism. In health care, each level of government exercises power because federalism is a default choice in health reform efforts. This default enables state governments and the federal government to create, enforce, and adjudicate health law and policy - democratic operations at the national and the subnational levels. But on each democratic …

Tax Reform, Mixed‐Entity Markets, And Hospitals: How The 2017 Tax Cuts And Jobs Act Favors The For‐Profit Hospital Model, Elizabeth King

Faculty Scholarship

When the U.S. Congress passed the Tax Cuts and Jobs Act in 2017 (the “TCJA”), it achieved a significant tax cut for corporations. In doing so, however, Congress simultaneously reshaped the landscape for mixed‐entity markets—that is, industries like healthcare and education in which nonprofit, for‐profit, and government entities coexist and compete. This is particularly true for the hospital market in which the TCJA’s provisions have subtly but decidedly tilted market conditions towards a for‐profit hospital model.

While scholars may debate the benefits of a nonprofit versus a for‐ profit entity model, the reality is that the majority of U.S. hospitals, …

Women's Rights, Human Rights And The Criminal Law Or, Feminist Debates And Responses To [De]Criminalization And Sexual And Reproductive Health, Aziza Ahmed

Faculty Scholarship

My comments today seek to highlight how social and economic rights advocates, particularly those concerned with the right to health, engage with ongoing debates about the role of criminal law in human rights. In particular, I emphasize how many “right to health” campaigns fight for the decriminalization of laws that result in the arrest of marginalized communities or health workers. This trend within right to health advocacy complicates what has been called the anti-impunity turn in human rights. In other words, although many scholars have correctly highlighted the rise of a carceral agenda in human rights, there is also ongoing, …

Stewart V Azar And The Purpose Of Medicaid: Work As A Condition Of Enrollment, Nicole Huberfeld

Faculty Scholarship

On June 29, 2018, a federal district court found that the US Department of Health and Human Services (HHS) did not properly approve Kentucky’s application for a controversial Medicaid waiver, the first to require work as a condition of eligibility.¹ Because HHS’s approval was vacated, Kentucky’s Medicaid program was required to continue as if no waiver existed, but 3 other states had already received HHS approval to proceed with work requirements. This article provides context for understanding the relevance of work requirements to implementation of Medicaid expansion under the Patient Protection and Affordable Care Act (hereinafter, Affordable Care Act), …

Informed Consent: Does “Ok” Really Mean “Ok?”, Michael Flynn

Faculty Scholarship

No abstract provided.