Law Commons^™

Medical-Legal Partnership As A Model For Access To Justice, Yael Cannon

Georgetown Law Faculty Publications and Other Works

The United States is plagued with a “justice gap” that leaves many Americans with unmet civil legal needs. Americans with low income do not receive the legal help they require for as many as 92% of their substantive civil legal problems. The justice gap requires many legal aid agencies to triage, becoming “emergency rooms” for clients with unmet legal needs. This national crisis calls for new innovations so that access to justice (A2J) can function more like primary care, promoting better use of resources and preventing legal crises that can cause long-lasting harm.

Medical-Legal Partnerships (MLPs) embed lawyers in healthcare …

The Global Health Architecture: Governance And International Institutions To Advance Population Health Worldwide, Lawrence O. Gostin, Eric A. Friedman, Alexandra Finch

Georgetown Law Faculty Publications and Other Works

Policy Points Global health institutions and instruments should be reformed to fully incorporate the principles of good health governance: the right to health, equity, inclusive participation, transparency, accountability, and global solidarity. New legal instruments, like International Health Regulations amendments and the pandemic treaty, should be grounded in these principles of sound governance. Equity should be embedded into the prevention of, preparedness for, response to, and recovery from catastrophic health threats, within and across nations and sectors. This includes the extant model of charitable contributions for access to medical resources giving way to a new model that empowers low- and middle-income …

The Academic Medical-Legal Partnership: Training The Next Generation Of Health & Legal Professionals To Work Together To Advance Health Justice, Vicki W. Girard, Deborah F. Perry, Lisa P. Kessler, Yael Cannon, Prashasti Bhatnagar, Jessica Roth

Georgetown Law Faculty Publications and Other Works

As the national medical-legal partnership (MLP) movement grows, the need for doctors, nurses, social workers, other health professionals, and lawyers who have the knowledge, skills, and experience to collaborate effectively in this holistic healthcare approach is increasing. Given the unique role that institutions of higher education play in training students as they develop their professional identities, members of the Georgetown University Health Justice Alliance sought to build on prior efforts to define the MLP model by focusing on MLPs that exist in academic settings as a specific type of MLP. This report is based on the results of an environmental …

The First 2 Years Of Covid-19: Lessons To Improve Preparedness For The Next Pandemic, Jennifer B. Nuzzo, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On December 31, 2019, the World Health Organization (WHO) Country Office in China reported novel “viral pneumonias of unknown cause” in Wuhan, but China did not confirm case clusters until January 3, 2020. Two years later, more than 285 million cases and 5.4 million deaths have been reported. As of December 2021, more than 800 000 COVID-19 deaths have occurred in the US, surpassing the 675 446 total deaths that occurred during the great influenza pandemic of 1918. The COVID-19 pandemic reduced global economic growth by an estimated 3.2% in 2020, with trade declining by 5.3%; an estimated 75 million …

No Future But A Shared Future, Lawrence O. Gostin, Kevin A. Klock, Sam F. Halabi, Katie Gottschalk, Katherine Ginsbach

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic revealed the fractured and inadequate state of national and global health law and institutions, revealing deeply embedded inequalities. In response to a World Health Assembly resolution proposing a special session to consider the benefits of developing a WHO convention or other international instrument on pandemic preparedness and response, the O’Neill Institute for National and Global Health Law and the Foundation for the National Institutes of Health (FNIH) convened 30 of the world’s leading authorities on global health law, financing, biomedical science, implementation, and emergency response along with leaders from prominent international organizations deeply engaged in responding to …

Going Global, Acting Local: How An International Pandemic Convention Can Support Regional And Community Response, Kevin A. Klock, Lawrence O. Gostin, Sam F. Halabi

Georgetown Law Faculty Publications and Other Works

A WHO pandemic convention could set in place an overarching framework needed for strengthening global health security. As the World Health Assembly (WHA) debated the merits of such an agreement, a critically important regional instrument – the Treaty for the Establishment of the African Medicines Agency (AMA Treaty) – entered into force on 5 November 2021. The new agency will, among other things, ensure there is a “common framework” for addressing “emerging issues and pandemics in the event of a public health emergency on the continent with cross border or regional implications.”

An improved worldwide health security strategy is essential …

Pediatric Covid-19 Vaccines: What Parents, Practitioners, And Policy Makers Need To Know, William J. Moss, Lawrence O. Gostin, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

The US Food and Drug Administration (FDA) granted Emergency Use Authorization for Pfizer-BioNTech’s mRNA COVID-19 vaccine (BNT162b2) for children 5 to 11 years of age on October 29, 2021. The Centers for Disease Control and Prevention recommended use of the vaccine among children in this age group on November 2, 2021. Approximately 28 million children are now eligible for vaccination, with only those younger than 5 years remaining excluded from vaccine eligibility. The benefits of pediatric COVID-19 vaccines are clear. Vaccinations protect children, decrease spread to families and communities, and ensure educational continuity. What do parents, practitioners, and policy makers …

Twenty Years After The Anthrax Terrorist Attacks Of 2001: Lessons Learned And Unlearned For The Covid-19 Response, Lawrence O. Gostin, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

The 20th anniversary of the terrorist attacks on September 11, 2001, resulted in deep national reflection. Less remembered are the events that began to unfold 7 days later as anonymous letters laced with deadly anthrax (Bacillus anthracis) spores began arriving at postal facilities, media companies, and congressional offices. The first death from inhaled anthrax exposure occurred on October 5, with an additional 4 deaths and 17 infections over the ensuing months.

The anthrax attacks exposed a health system ill-equipped to respond to acute emergencies. This article explores the lessons learned, and unlearned, from the anthrax attacks, through to …

Covid-19 Vaccine Mandates—A Wider Freedom, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

President Biden has required COVID-19 vaccinations across much of the US workforce, reaching nearly 100 million workers. Opponents call it unconstitutional, a violation of personal freedom, and even “un-American.” The truth is that vaccine mandates are lawful and deeply entrenched in US history and values. They constitute a “wider freedom” so that everyone in society can feel safer where they work, learn, worship, and live.

The Supreme Court, The Texas Abortion Law (Sb8), And The Beginning Of The End Of Roe V Wade?, I. Glenn Cohen, Eli Y. Adashi, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Thirteen states have enacted so-called “fetal heartbeat” laws banning abortions once embryotic cardiac activity can be detected. Courts have enjoined their enforcement as unconstitutional. However, on September 1, 2021, the Supreme Court declined to block a Texas fetal heartbeat law, which virtually eliminates access to abortion services. Texas Governor Greg Abbott signed SB8 into law on May 19th, with an effective date of September 1st. The law essentially prohibits abortion after 6 weeks of gestational age, before most women know they are pregnant.

Texas’ fetal heartbeat law has a unique feature. It empowers private individuals to bring civil lawsuits not …

An International Agreement On Pandemic Prevention And Preparedness, Lawrence O. Gostin, Sam F. Halabi, Kevin A. Klock

Georgetown Law Faculty Publications and Other Works

During late 2021, national delegations are, or have, met at the United Nations General Assembly, the G20, and, most importantly, the Special Session of the World Health Assembly in November to determine whether the world needs a new international agreement to address pandemic prevention, preparedness, and response. The current international agreement, the International Health Regulations (2005), failed to work effectively – SARS-CoV-2 was not detected sufficiently early, relevant information was not shared efficiently, and the global response has not been coordinated. Even the most basic investigations were inadequate such as to discover the origins of SARS-CoV-2. Current proposals focus on …

9 Steps To End Covid-19 And Prevent The Next Pandemic: Essential Outcomes From The World Health Assembly, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

A year ago, the World Health Assembly (WHA) met virtually for the first time since the creation of the World Health Organization (WHO) in 1948. Last year’s WHA adopted a resolution asking states to intensify action to fight COVID-19. Yet a year on, there have been 3.7 million deaths reported, with the real number estimated as more than 7 million. From May 24-31, 2021, the 74th WHA (WHA74) was again held virtually amidst this historic pandemic. The WHA created a member states working group on strengthening WHO preparedness for and response to health emergencies to make recommendations to next year’s …

Lockdowns, Quarantines, And Travel Restrictions, During Covid And Beyond: What’S The Law, And How Should We Decide?, Lawrence O. Gostin, Meryl Chertoff

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic ushered in vast deprivations of liberty previously unthinkable: lockdowns, business closures, travel restrictions, and quarantines. Even witnessing China’s January 2020 lockdown of 11 million people in Wuhan, it seemed wholly implausible that London, Rome, or New York would shut down. But they did, and much more. At the initial height of the pandemic in April 2020, more than 3.9 billion people, about half the world's population, were under stay-at-home orders. That same month, 43 US states were under stay-at-home orders.

What are the scientific, public health, and ethical justifications for various forms of liberty deprivations? Are they …

Mandating Covid-19 Vaccines, Lawrence O. Gostin, Daniel A. Salmon, Heidi J. Larson

Georgetown Law Faculty Publications and Other Works

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic, and help restore normal social and economic life. The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for 2 mRNA vaccines and will likely issue full biologics licenses in the coming months. Anticipating vaccine scarcity, the Advisory Committee on Immunization Practice (ACIP) published guidance on vaccine priorities.

Data show 95% efficacy for vaccines granted an EUA, but even highly effective vaccines cannot curb the pandemic without high population coverage and maintenance of other mitigation strategies. Recent data from 1,676 adults surveyed November 30-December …

Is It Lawful And Ethical To Prioritize Racial Minorities For Covid-19 Vaccines?, Harald Schmidt, Lawrence O. Gostin, Michelle A. Williams

Georgetown Law Faculty Publications and Other Works

Coronavirus disease 2019 (COVID-19) has disproportionately affected racial minorities in the United States resulting in higher rates of infection, hospitalization, and death. With a limited supply after the initial approval of a safe and effective vaccine, difficult legal and ethical choices will have to be made on priority access for individuals. The National Academies of Sciences, Engineering, and Medicine (NASEM) has recommended prioritization of racial minorities who are “worse off” socioeconomically and epidemiologically. TheWorld Health Organization (WHO) similarly cautioned that “colorblind” allocation frameworks could perpetuate or exacerbate existing injustices. Both NASEM and WHO urge policy makers to allocate vaccines in …

The Kids Are Not Alright: Leveraging Existing Health Law To Attack The Opioid Crisis Upstream, Yael Cannon

Georgetown Law Faculty Publications and Other Works

The opioid crisis is now a nationwide epidemic, ravaging both rural and urban communities. The public health and economic consequences are staggering; recent estimates suggest the epidemic has contracted the U.S. labor market by over one million jobs and cost the nation billions of dollars. To tackle the crisis, scholars and health policy initiatives have focused primarily on downstream solutions designed to help those who are already in the throes of addiction. For example, the major initiative announced by the U.S. Surgeon General promotes the dissemination of naloxone, which helps save lives during opioid overdoses.

This Article argues that the …

The Joint Action And Learning Initiative: Towards A Global Agreement On National And Global Responsibilities For Health, Lawrence O. Gostin, Eric A. Friedman, Gorik Ooms, Thomas Gebauer, Narendra Gupta, Devi Sridhar, Wang Chenguang, John-Arne Røttingen, David Sanders

O'Neill Institute Papers

A coalition of civil society organizations and academics is initiating a Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI) to research key conceptual questions involving health rights and responsibilities, with the goal of securing a global health agreement andsupporting civil society and community mobilization around the human right to health. The social mobilization is critical to creating the political space that would make such an agreement possible and to ensuring its implementation.

This agreement, such as a Framework Convention on Global Health, would inform post-Millennium Development Goal global health commitments, be grounded in the right …

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 …

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 …

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 …

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 …

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 …

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 …

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, …

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 …

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 …

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 …