Health Law and Policy Commons^™

Fighting Novel Diseases Amidst Humanitarian Crises, Lawrence O. Gostin, Neil R. Sircar, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

Humanitarian crises are becoming more prevalent and, frequently, more complex, in zones of mis-governance, lack of government presence, and even active conflict, marked by public mistrust and insecurity. The WHO and other health emergency responders lack the capacities and mandate to adequately respond. The current Ebola outbreak in an area of an active insurgency in the Democratic Republic of the Congo is just such a crisis. The State Department has banned U.S. personnel from the outbreak zone due to safety concerns, leaving the population feeling abandoned, potentially increasing the threat to the few brave health workers who remain.

We need …

Wealthy Countries Should Share Vaccine Doses Before It Is Too Late: The Greater Good Depends On Ending The Pandemic Everywhere, Lawrence O. Gostin, Eric A. Friedman, Suerie Moon

Georgetown Law Faculty Publications and Other Works

The world is on the brink of failing a critical test, which is whether the international community is willing or able to end a global pandemic without leaving anyone behind. Wealthy countries have bought up vast vaccine supplies, leaving poorer ones with extreme scarcity. An international initiative known as the COVID-19 Global Vaccine Access Facility (COVAX) aims to distribute vaccines widely and equitably, but is not only short of funds. Even if it reaches its 2021 target, COVAX will reach only a small portion of lower-income countries’ populations this year.

Along with moral demands of equitable global distribution, wealthy countries …

Living, Aging, And Dying In Healthy And Just Societies: Life Lessons From My Father, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

My father passed away at 102 years old. He lived, aged, and died well. But that is rare in the United States and globally. The World Health Organization defines palliative care “throughout the life course” as improving quality of life for patients and families and relieving pain and suffering, while paying special attention to physical, psychosocial, and spiritual functioning. That’s the global vision, but then there’s the reality. Palliative care, in practice, has been little more than pain relief at life’s end—and in much of the world, not even that.

We need to reimagine palliation, embracing a communal or relational …

Texas V United States: The Affordable Care Act Is Constitutional And Will Remain So, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On December 14, 2018, in a widely reported decision, a federal judge in Texas ruled that the entire Affordable Care Act (ACA) is unconstitutional. The judge reasoned that since the ACA’s “individual mandate” is unconstitutional, the rest of the law cannot stand without it. However, the ACA will remain in place pending appeal, and it is highly unlikely that this ruling will stand.

Health Care Costs And The Arc Of Innovation, Neel U. Sukhatme, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

Health care costs continue their inexorable rise, threatening America’s long-term fiscal stability, competitiveness, and standard of living. Over the past half-century, efforts to rein in spending have uniformly failed. In this Article, we explain why, breaking with standard accounts of regulatory and market dysfunction. We point instead to the nexus of economics, mutual empathy, and social expectations that drives medical innovation and locks in low-value technologies. We show how law reflects and reinforces this nexus and how and why health-policy-makers avert their gaze.

Next, we propose to circumvent these barriers instead of surmounting them. Rather than targeting today’s excessive spending, …

Requiring Human Papilloma Virus Vaccination For School Entry, Michelle J. Bayefsky, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Over 40,000 Americans are diagnosed as having HPV-associated cancer each year, including oropharyngeal cancer for men and cervical cancer for women. These diseases cause significant morbidity and mortality and are largely preventable if people are vaccinated against HPV before they are exposed to the virus. Unfortunately, despite strong evidence of safety and effectiveness of the HPV vaccine, vaccination rates have been disappointingly low – much lower than for the varicella, measles, mumps, rubella, and hepatitis B. The disparity in vaccination rates stem mainly from the fact that HPV vaccination is not universally required for school entry, while the other childhood …

70 Years Of Human Rights In Global Health: Drawing On A Contentious Past To Secure A Hopeful Future, Lawrence O. Gostin, Benjamin Mason Meier, Rebekah Thomas, Veronica Magar, Tedros A. Ghebreyesus

Georgetown Law Faculty Publications and Other Works

The Universal Declaration of Human Rights, adopted on Dec 10, 1948, established a modern human rights foundation that has become a cornerstone of global health, central to public health policies, programmes, and practices. To commemorate the 70th anniversary of this seminal declaration, we trace the evolution of human rights in global health, linking the past, present, and future of health as a human right. This future remains uncertain. As contemporary challenges imperil continuing advancements, threatening both human rights protections and global health governance, the future will depend, as it has in the past, on sustained political engagement to realise human …

Ebola And War In The Democratic Republic Of Congo: Avoiding Failure And Thinking Ahead, Lawrence O. Gostin, Matthew M. Kavanagh, Elizabeth Cameron

Georgetown Law Faculty Publications and Other Works

The Ebola epidemic in the Democratic Republic of Congo (DRC) is exceptionally dangerous, occurring within active armed conflict and geopolitical volatility, including a million displaced persons. With 421 cases, 240 deaths, and the numbers increasing, this Ebola outbreak is the second deadliest in history. Recent spread to Butembo, home to 1.2 million people, raised concerns. The DRC, World Health Organization (WHO), and partners are leading a vigorous international response, yet despite deploying an experimental vaccine, cases doubled in October 2018 and many cases had unknown origin.

Uncontrolled Ebola outbreaks can expand quickly, as occurred in West Africa in 2014. Averting …

Public Health Emergency Preparedness: Globalizing Risk, Localizing Threats, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Infectious diseases are a constant reality, yet it takes a shock to jolt the public’s attention and spur political action. The past weeks saw such as a shock at busy US airports, with the emergency quarantine of 3 flights. At the same time, seemingly a world away, insecurity, weak health systems, and distrust are fueling a second major Ebola outbreak in the Democratic Republic of Congo (DRC) this year. Yet reacting to periodic shocks won’t safeguard our collective future. Emergency preparedness requires proactive planning and funding, with US leadership pivotal.

Substantial Shifts In Supreme Court Health Law Jurisprudence, Lawrence O. Gostin, James G. Hodge

Georgetown Law Faculty Publications and Other Works

President Trump’s nomination of jurist Brett Kavanaugh to the U.S. Supreme Court presents significant, potential changes on health law and policy issues. If confirmed by the U.S. Senate, Kavanaugh’s approaches as a federal appellate court judge and scholar could literally shift the Court’s balance on consequential health policies. Judge Kavanaugh has disavowed broad discretion for federal agency authorities, cast significant doubts on the constitutionality of the Affordable Care Act, and narrowly interpreted reproductive rights (most notably abortion services). He has supported gun rights pursuant to the Second Amendment beyond U.S. Supreme Court recent interpretations. His varying positions related to consumer …

Health Data And Privacy In The Digital Era, Lawrence O. Gostin, Sam F. Halabi, Kumanan Wilson

Georgetown Law Faculty Publications and Other Works

In 2010, the social networking site Facebook launched a platform allowing private companies to request users’ permission to access personal data. Few users were aware of the platform, which was integrated into Facebook’s terms of service. In 2014, Cambridge Analytica, a UK-based political consulting firm, developed a data-harvesting app. That app prompted Facebook users to provide psychological profiles, including responses such as “I get upset easily” and “I have frequent mood-swings” as part of a “research project.”

The Facebook platform allowed users to share their friends’ data as well, enabling Cambridge Analytica to access tens of millions of personal profiles, …

New Ebola Outbreak In Africa Is A Major Test For The Who, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On May 8, the Democratic Republic of Congo (DRC) notified the World Health Organization (WHO) of a confirmed outbreak of Ebola in Bikoro, on the shores of Lake Tumba in Équateur Province. Ebola in the DRC is not unexpected. The first-ever identified Ebola outbreak occurred in the DRC—then Zaire—in 1976. This is the ninth of DRC’s outbreaks, which until now have been confined mainly to rural areas. With high fatality rates, earlier outbreaks quickly burned out due to the natural firewall of remoteness.

Bikoro and a nearby village, Ikoko-Impenge, are rural, but on May 16, the WHO confirmed spread to …

Missing: Where Are The Migrants In Pandemic Influenza Preparedness Plans?, Kolitha Wickramage, Lawrence O. Gostin, Eric A. Friedman, Phusit Prakongsai, Rapeepong Suphanchaimat, Charles Hui, Patrick Duigan, Eliana Barragan, David R. Harper

Georgetown Law Faculty Publications and Other Works

Influenza pandemics are perennial global health security threats, with novel and seasonal influenza affecting a large proportion of the world’s population, causing enormous economic and social destruction. Novel viruses such as influenza A(H7N9) continue to emerge, posing zoonotic and potential pandemic threats. Many countries have developed pandemic influenza preparedness plans (PIPPs) aimed at guiding actions and investments to respond to such outbreak events.

Migrant and mobile population groups—such as migrant workers, cross-border frontier workers, refugees, asylum seekers, and other non-citizen categories residing within national boundaries—may be disproportionately affected in the event of health emergencies, with irregular/undocumented migrants experiencing even greater …

Banning Abortion In Cases Of Down Syndrome: Important Lessons For Advances In Genetic Diagnosis, Rebecca Reingold, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

In December 2017, Ohio passed into law legislation that prohibited physicians from performing abortions if the pregnant woman’s decision was influenced by her belief that the fetus has Down syndrome. Physicians who perform abortions in these cases would face fourth-degree felony charges and revocation of their medical license. No other state bans abortion specifically for Down syndrome, but several ban abortions in cases of genetic diseases. Lower courts have struck down most such laws, holding they violate the constitutional rights of women. In February 2018, a federal district court judge blocked enforcement of Ohio’s law pending a final determination.

This …

Big Food And Soda Versus Public Health: Industry Litigation Against Local Government Regulations To Promote Healthy Diets, Sarah A. Roache, Charles Platkin, Lawrence O. Gostin, Cara Kaplan

Georgetown Law Faculty Publications and Other Works

Diets high in fats, sugars, and sodium are contributing to alarming levels of obesity, cardiovascular disease, type 2 diabetes, and certain cancers throughout the United States. Sugary drinks, which include beverages that contain added caloric sweeteners such as flavored milks, fruit drinks, sports drinks, and sodas, are the largest source of added sugar in the American diet and an important causative factor for obesity and other diet-related diseases.

City and county governments have emerged as key innovators to promote healthier diets, adopting menu labeling laws to facilitate informed choices and soda taxes, warnings labels, and a soda portion cap to …

Legal Capacities Required For Prevention And Control Of Noncommunicable Diseases, Roger S. Magnusson, Benn Mcgrady, Lawrence O. Gostin, David Patterson, Hala Abou Taleb

Georgetown Law Faculty Publications and Other Works

Law lies at the centre of successful national strategies for prevention and control of noncommunicable diseases. By law we mean international agreements, national and subnational legislation, regulations and other executive instruments, and decisions of courts and tribunals. However, the vital role of law in global health development is often poorly understood, and eclipsed by other disciplines such as medicine, public health and economics. This paper identifies key areas of intersection between law and noncommunicable diseases, beginning with the role of law as a tool for implementing policies for prevention and control of leading risk factors. We identify actions that the …

Reaching For Mediocrity: Competition And Stagnation In Pharmaceutical Innovation, Son Le, Neel U. Sukhatme

Georgetown Law Faculty Publications and Other Works

Patents might incentivize invention but they do not guarantee firms will invest in projects that maximize social utility. We model how risk-neutral firms’ ability to obtain substantial private returns on marginal new technologies causes them to “reach for mediocrity” by investing in socially-suboptimal projects, even in the presence of competition and new entrants. Focusing primarily on pharmaceutical innovation, we analyze various policy interventions to solve this underinvestment problem. In particular, we describe a new approach to patents – a value based patent system, which ties patent protection to the underlying invention’s social value – and show how it incentivizes socially-optimal …

Presidential Immigration Policies Endangering Health And Well-Being?, Lawrence O. Gostin, Katharina Ó Cathaoir

Georgetown Law Faculty Publications and Other Works

Since assuming office, President Trump has issued a series of executive orders transforming United States immigration policy. From building a border wall to banning entry to the US based on nationality, these executive orders are likely to profoundly impact health and wellbeing. Are these actions legal, ethical, and what are the likely effects on US health care?

The implications of the proposed expansion of the border wall between Mexico and the US, new rules on deportation and detention, and the proposed ban on immigration from certain Muslim-majority countries are discussed. These actions run contrary to available evidence on protecting the …

Reimagining Who: Leadership And Action For A New Director-General, Lawrence O. Gostin, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

Three candidates to be the next WHO Director-General remain: Tedros Adhanom Ghebreyesus, David Nabarro, and Sania Nishtar. The World Health Assembly’s ultimate choice will lead an Organization facing daunting internal and external challenges, from its own funding shortfalls to antimicrobial resistance and immense health inequities. The new Director-General must transform WHO into a 21^st century institution guided by the right to health. Topping the incoming Director-General’s agenda will be a host of growing threats—risks to global health security, antimicrobial resistance, non-communicable diseases, and climate change—but also the transformative potential of the Sustainable Development Goals, including their universal health coverage …

Advancing The Right To Health: The Vital Role Of Law, Lawrence O. Gostin, Oscar A. Cabrera, David Patterson, Roger Magnusson, Helena Nygren-Krug

Georgetown Law Faculty Publications and Other Works

Effective laws and an enabling legal environment are essential to a healthy society. Most public health challenges – from infectious and non-communicable diseases to injuries, from mental illness to universal health coverage – have a legal component. At global, national and local levels, law is a powerful tool for advancing the right to health. This tool is, however, often underutilized.

This report aims to raise awareness about the role that public health laws can play in advancing the right to health and in creating the conditions for all people to live healthy lives. The report provides guidance about issues and …

A Mental Health Checkup For Children At The Doctor’S Office: Lessons From The Medical-Legal Partnership Movement To Fulfill Medicaid’S Promise, Yael Cannon

Georgetown Law Faculty Publications and Other Works

Traumatic childhood events and the stress they cause can negatively affect health over a lifetime. For children with Medicaid coverage, visits to the doctor’s office present an opportunity to improve this trajectory. Medicaid’s Early Periodic Screening Diagnostic and Treatment (EPSDT) mandate requires that children receive more than a basic physical when they see a doctor for regular “well-child checks.” As part of a comprehensive look at their development, they should receive mental health check-ups that could identify childhood trauma, its impacts, and the interventions that could help improve health and mental health. Data suggests that many children do not receive …

Global Health Security In An Era Of Explosive Pandemic Potential, Lawrence O. Gostin, Ana Ayala

Georgetown Law Faculty Publications and Other Works

Pandemics pose a significant risk to security, economic stability, and development. Annualized expected losses from pandemics are estimated at $60 billion per year. Despite the certainty and magnitude of the threat, the global community has significantly underestimated and underinvested in avoidance of pandemic threats.

We cannot wait or continue with the status quo, in which we pay attention to infectious disease threats only when they are at their peak and then are complacent and remain vulnerable until the next major outbreak. To reinforce and sustain international focus, funding, and action, it is crucial that pandemics rise to the level of …

The Next Who Director-General’S Highest Priority: A Global Treaty On The Human Right To Health, Lawrence O. Gostin, Eric A. Friedman, Paulo Buss, Mushtaque Chowdhury, Anand Grover, Mark Heywood, Churnrurtai Kanchanachitra, Gabriel Leung, Judith Mackay, Precious Matsoso, Sigrun Mogedal, Joia S. Mukherjee, Francis Omaswa, Joy Phumaphi, K. Srinath Reddy, Mirta Roses Periago, Joe Thomas, Oyewale Tomori, Miriam Were, Debrework Zewdie

Georgetown Law Faculty Publications and Other Works

Amidst the many challenges facing the next WHO Director-General, the new WHO head should find WHO’s foremost priority in its most important constitutional pillar: the right to health. The centerpiece of this endeavor should be leadership on the Framework Convention on Global Health (FCGH), the proposed global treaty based in the right to health and aimed at national and global health equity. The treaty would reform global governance for health to enhance accountability, transparency, and civil society participation and protect the right to health in trade, investment, climate change, and other international regimes, while catalyzing governments to institutionalize the right …

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Zika Virus And Global Health Security, Lawrence O. Gostin, James G. Hodge Jr.

Georgetown Law Faculty Publications and Other Works

Americans are largely apathetic about the risks of Zika virus and Congress cannot agree on preparedness funding. Strategies to counter the spread of Zika by the World Health Organisation (WHO) grossly underestimate the disease’s impact. WHO and member countries lack sufficient resources to respond. Consequences of fiscal apathy can be measured in lives lost and long-term disabilities. Zika prevention is a matter of global health security.

The epidemiologic brunt of Zika in South America falls largely on vulnerable women at heightened risk of exposure through mosquitoes and sexual transmission. Resulting transmission to fetuses and infants will have generational impacts in …

Women's Health And Abortion Rights: Whole Woman's Health V Hellerstedt, Lawrence O. Gostin, Rebecca B. Reingold

Georgetown Law Faculty Publications and Other Works

Nearly a quarter century ago, the Supreme Court asked pro-choice and right-to-life advocates “to end their national division by accepting a common mandate rooted in the Constitution.” Nothing of the sort materialized. If anything, the social and political battles intensified, with states enacting 1074 abortion restrictions. The Court has not considered various appeals in the face of an avalanche of legislation, but on June 27, 2016, it struck down 2 onerous restrictions on physicians and clinics offering abortion services.

In Whole Woman’s Health v Hellerstedt, the Court found Texas’s requirements that physicians conducting abortions obtain admitting privileges at local …

Toward A Common Secure Future: Four Global Commissions In The Wake Of Ebola, Lawrence O. Gostin, Oyewale Tomori, Suwit Wibulpolprasert, Ashish K. Jha, Julio Frenk, Suerie Moon, Joy Phumaphi, Peter Piot, Barbara Stocking, Victor J. Dzau, Gabriel M. Leung

Georgetown Law Faculty Publications and Other Works

The world is becoming increasingly vulnerable to pandemics resulting from globalization, urbanization, intense human/animal interchange, and climate change. A series of global health crises have emerged since 2000, ranging from Severe Acute Respiratory Syndrome (SARS) and its phylogenetic cousin Middle East Respiratory Syndrome (MERS), to pandemic Influenza A (H1N1), Ebola, and the ongoing Zika virus epidemic. The Ebola epidemic gave rise to four global commissions proposing a bold new agenda for global health preparedness and response for future infectious disease threats.

Four global commissions reviewing the recent Ebola virus disease epidemic response consistently recommended strengthening national health systems, consolidating and …

A Yellow Fever Epidemic: A New Global Health Emergency?, Lawrence O. Gostin, Daniel Lucey

Georgetown Law Faculty Publications and Other Works

The worst yellow fever epidemic in Angola since 1986 is rapidly spreading, including the capital, Luanda. In Angola, the epidemic began in December 2015 and the laboratory-confirmed outbreak was reported to the World Health Organization (WHO) on January 21, 2016. Angola has had 2023 suspected cases and 258 deaths as of April 26, 2016. China, the Democratic Republic of Congo, and Kenya also have reported cases arising from infected travelers from Angola. Namibia and Zambia also share a long border with Angola, with considerable population movement between the countries. Similar to other recent epidemics, quick and effective action to stop …

Is The United States Prepared For A Major Zika Virus Outbreak?, Lawrence O. Gostin, James G. Hodge Jr.

Georgetown Law Faculty Publications and Other Works

Zika virus has emerged as a global public health crisis with active transmission in the Americas and Caribbean. The World Health Organization (WHO) declared a Public Health Emergency of International Concern (PHEIC), and recently WHO reported there is a scientific consensus that Zika is a cause of microcephaly and Guillain-Barré syndrome (GBS). In the U.S. the Centers for Disease Control and Prevention (CDC) activated its emergency operations center at its highest capacity. President Obama requested $1.86 billion in emergency funding. Shamefully, Congress has yet to appropriate the funding needed for Zika preparedness, and the President has had to reallocate Ebola …

Disrupting The Path From Childhood Trauma To Juvenile Justice: An Upstream Health And Justice Approach, Yael Cannon, Andrew Hsi

Georgetown Law Faculty Publications and Other Works

A groundbreaking public health study funded by the U.S. Centers for Disease Control and Prevention (CDC) and the Kaiser Foundation found astoundingly high rates of childhood trauma, including experiences like abuse, neglect, parental substance abuse, mental illness, and incarceration. Hundreds of follow-up studies have revealed that multiple traumatic adverse childhood experiences (or “ACEs”) make it far more likely that a person will have poor mental health outcomes in adulthood, such as higher rates of depression, anxiety, suicide attempts, and substance abuse. Interestingly, the original ACE Study examined a largely middle-class adult population living in San Diego, but subsequent follow-up studies …

The United Nations Sustainable Development Goals: Achieving The Vision Of Global Health With Justice, Eric A. Friedman, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

We are resolved to free the human race from the tyranny of poverty and want and to heal and secure our planet” (UN General Assembly, 2015, September 25, preamble). So pronounces the 2030 Agenda, the United Nations declaration on the Sustainable Development Goals (SDGs), adopted on September 25, 2015, succeeding the Millennium Development Goals (MDGs). If achieved, the SDGs will secure an improved level of health, development, and global justice. However, if the international community fails to live up to its commitments, an untold number of people will likely perish prematurely, people’s opportunities to thrive will be cut off, social …