Health Law and Policy Commons^™

The Role Of State Attorneys General In Improving Prescription Drug Affordability, Michelle M. Mello, Trish Riley, Rachel Sachs

Scholarship@WashULaw

Impact litigation initiated by state attorneys general has played an important role in advancing public health goals in contexts as diverse as tobacco control, opioids, and healthcare antitrust. State attorneys general also play a critical role in helping governors and legislatures advance health policies by giving input into their drafting and defending them against legal challenges. State attorneys general have entered the prescription drug affordability arena in both these ways—for example, by initiating lawsuits relating to price fixing by generic drug manufacturers and defending state laws requiring disclosures of pharmaceutical prices. Yet the scope of their collective efforts is not …

New Innovation Models In Medical Ai, W. Nicholson Price Ii, Rachel Sachs, Rebecca S. Eisenberg

Scholarship@WashULaw

In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …

Romanian Government Will Implement Measures To Prevent Further Violations Of Rightsof People With Mental Health Conditions Or Disabilities In Accord With The Decision Of The European Court Of Human Rights, Tesa Hargis

Human Rights Brief

On June 21 and 22, the European Court of Human Rights (ECtHR) and Romania discussed reform measures based on various judgements delivered during the nine-year period between 2012 and 2021. At issue before the ECtHR’s Department for Execution of Judgments was insufficient legal protection, lack of medical and social care, deficiencies in the legal framework governing involuntary placement, inadequate management of psychiatric conditions of detainees, and overcrowding and poor conditions in Romanian mental health facilities.

When Jail & Prison Sentences Become Death Sentences: How Willfully Exposing Incarcerated Persons To Covid-19 Amounts To Cruel & Unusual Punishment, Arielle Aboulafia

Human Rights Brief

Eric Warner called his older brother Hank from San Quentin State Prison almost every Sunday. Though the prison only allowed the brothers to speak for fifteen minutes each week, the two spoke about their lives. In June 2021, Eric stopped calling, and Hank became worried. Hank tried to get in touch with the prison. However, his calls were met with a dead-end voicemail each time. He recalls that he “knew, by not hearing anything, that something was not good.” The following month, prison personnel returned Hank’s calls and told him that his brother Eric had been hospitalized. Later that month, …

Fostering Production Of Pharmaceutical Products In Developing Countries, William Fisher, Ruth L. Okediji, Padmashree Gehl Sampath

Michigan Journal of International Law

The ways in which pharmaceutical products are currently developed, manufactured, and distributed fail to meet the needs of developing countries. The recent emergence of new infectious diseases, the associated surge of healthcare nationalism, and the prevalence of substandard and falsified drugs have strengthened substantially the net benefits of augmenting the capacity of developing countries to produce such products locally. Most previous efforts to do so have foundered. The chance of success in the future would be maximized by the adoption of five strategies : (a) clarifying the zones of discretion created by the relevant treaties to ensure that local firms …

First Amendment Challenges To State Vaccine Mandats: Why The U.S. Supreme Court Should Hold That The Free Exercise Clause Does Not Require Religious Exemptions, Donna M. Gitter

American University Law Review

The U.S. Supreme Court has never issued a judicial opinion on the merits declaring that the First Amendment Free Exercise Clause permits states to mandate vaccinations without offering religious exemptions. However, in two recent cases, the Court in brief orders declined applications for emergency relief to block state vaccine mandates, and the petitioners have vowed to continue to pursue these cases.

This Article explores how the seemingly sudden onset of the coronavirus pandemic, coupled with its protracted duration, has occasioned both emergency and enduring state regulation of religious behavior in a way that exposes deep divides in our society’s views …

A Review On Drug Regulation Policy In The Netherlands And India: The History Of Current Policy Development, And Policy Analysis, Tapashi Adhikary, Pratik Kumar Bal, Kumar Sumit

Manipal Journal of Nursing and Health Sciences

Background

Drug use and illicit trafficking of drugs have been a common problem in both the Netherlands and India since historical times. The Dutch Drug Policy (DDP) model is a combination of both leniency and strict laws whereas the Indian Narcotic Drugs and Psychotropic Substances Act (NDPS Act) went from being a stringent policy in the past to a more flexible lenient policy in recent years. The objective of the current review was to explore the history of the development of the Netherlands and India's drug regulating policies, followed by the analysis of the policies using the Walt & Gilson …

A Zebra's Trust: How Rare Disease Communities' Participation In Data Trusts' Governance Builds Trust And Drives Research, Samantha C. Smith

Vanderbilt Journal of Transnational Law

Data sharing plays an increasingly prominent role in society, but it remains a necessary component of rare disease research. Because rare diseases are--as the name indicates-- rare, researchers have only a small number of patients from whom to collect data, and the expense of cross-border data sharing to increase research data is significant. Nevertheless, the rise of artificial intelligence and precision medicine increases the need for usable rare disease data. Current legislation and regulations aimed at addressing rare diseases fall short in addressing these data sharing needs for rare disease research. While the European Union (EU) has invested in rare …

Your Body, Your Cells? Direct-To-Consumer Marketing Of Autologous Stem Cell Therapies In The United States, Japan, And Australia, Kathleen C. Laird

Vanderbilt Journal of Transnational Law

Stem cell tourism has relocated; patients in search of stem cell therapies to treat nearly any disease can find clinics selling miracle cures without traveling beyond their national borders. Businesses marketing unproven autologous stem cell therapies are now plentiful in highly regulated, wealthy countries, including the United States, Japan, and Australia. Despite regulatory oversight of stem cell therapies and strong support for scientific innovation in these countries, the internet and social media have facilitated the rapid growth and success of a new industry selling unproven treatments directly to consumers. Clinics selling unproven autologous stem cell therapies have succeeded by developing …

The Duties Of Occupying Powers In Relation To The Prevention And Control Of Contagious Diseases Through The Interplay Between International Humanitarian Law And The Right To Health, Dr. Marco Longobardo

Vanderbilt Journal of Transnational Law

This Article explores the rules governing the prevention and control of contagious diseases in occupied territory under international law. Although the Article refers to the ongoing COVID-19 pandemic, its scope is broader and encompasses instances of state practice that have occurred over the last two centuries. After a careful analysis of the relevant treaties and episodes of state practice, the Article concludes that occupying powers have duties under international humanitarian law and international human rights law to prevent and control contagious diseases, through cooperating with the local authorities and bringing the necessary medical supplies in the occupied territory. The Article …

From Zero-Sum To Economic Partners: Reframing State Tax Policies In Indian Country In The Post-Covid Economy, Pippa Browde

Faculty Law Review Articles

The disparate impact COVID-19 has had on Indian Country
reveals problems centuries in the making from the legacy of
colonialism. One of those problems is state encroachment in
Indian Country, including attempts to assert taxing authority
within Indian Country. The issue of the reaches of state taxing
authority in Indian Country has resulted in law that is both
uncertain and highly complex, chilling both outside investment
and economic development for tribes.
As the United States emerges from COVID-19, to focus only on the
toll exacted on tribes and their peoples ignores the tremendous
opportunities for states to right these historical …

Eviscerating Patent Scope, Shahrokh Falati

Articles & Chapters

The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …

An Immigration Solution For Improving Rural Healthcare, Kit Johnson

Faculty Articles

If you are one of the more than 249 million people who live in urban areas of the United States, more than 80% of the U.S. population, you’ve likely never thought much about your physical proximity to a doctor. Primary care physicians and medical specialists abound in urban America. But if you are among the more than 59 million people who live in rural areas of the country, you may well know the struggle of finding primary care, a specialist, or a dentist. That is because there is a worrying shortage of medical professionals in rural America. There is a …

Aging, Health, Equity, And The Law: Foreword, Joan C. Foley

Touro Law Review

No abstract provided.

Fertility Care: Essential Or Non-Essential? Lessons From The Covid-19 Pandemic, Rebecca S. Feinberg

Scholarly Works

At the beginning of the COVID-19 pandemic, in an effort to allocate medical resources towards the anticipated influx of patients infected with the novel virus, many non-essential healthcare services were temporarily paused. The American Society of Reproductive Medicine led the move to halt infertility care in all but the most extreme cases. This cessation of infertility care, compounded by the unknown duration of this recommendation, added to the already high level of stress and anxiety that fertility patients experience and in cases of advanced maternal age or diminished ovarian reserve potentially resulted in suboptimal clinical outcomes. There was vocal disagreement …

Safeguarding The Public: Why Workers’ Rights Education Should Be Required Learning For Nurses, Esperanza N. Sanchez

Touro Law Review

Nurses are integral to the delivery of quality health care in this country. They set aside their own needs and fears to provide care and other social services to people across a multitude of settings, taking on the burdens and stresses of others. However, our profit-driven health care system incentivizes employers to maximize productivity at reduced costs by asking nurses to do more with less. Nurses are expected to endure harsh working conditions, proven to be harmful to the nurses’ health and well-being, despite evidence showing that poor working conditions can lead to poor patient outcomes.

There are numerous worker …

How Covid-19 Put The Spotlight On The Emtala, Ikra Kafayat

Touro Law Review

There was a time when those that were unable to afford medical care risked being denied treatment in emergency situations. Before Congress passed Emergency Medical Treatment & Labor Act (EMTALA), patients were being transferred to different hospitals, without being screened, because they did not have insurance and could not afford the treatment. Hospitals are no longer allowed to transport patients without properly screening and stabilizing them. Patients can bring a suit against a hospital if they believe the hospital violated EMTALA, however, in certain circuits the patient will need to prove that hospital had an “improper motive” for failing to …

Compulsory Licensing Of Patents In Times Of Public Health Emergency, Kelsey Truglio

Touro Law Review

In March 2020, the United States shut down to avoid the continued spread of the COVID-19 virus as it spread globally. In December 2020, the first COVID-19 vaccines were granted emergency usage authorization in the United States. Wealthy nations were able to quickly purchase and hoard vaccines for public distribution, leaving many third-world countries and developing nations struggling to continue to survive the pandemic without vaccination.

Compulsory licensing should be allowed on otherwise patented or patentable new technology in times of global health emergency, regardless of which entity creates the technology. This will enable governments of countries spanning all wealth …

Crisis Pregnancy Centers: An Inherently Unjust Limitation To Reproductive Rights, Rebecca Feinberg, Danielle Pacia

Scholarly Works

This paper’s purpose is two-fold. First, it presents an ethical analysis that details why the current practices of Crisis Pregnancy Centers (CPCs) are unethical and violate women’s reproductive freedom. Second, it proposes policy solutions to mitigate inequities and disinformation caused by the practices of CPCs, in an attempt to protect the women who, fall prey to their services

Viral Injustice, Brandon L. Garrett, Lee Kovarsky

Faculty Scholarship

The COVID-19 pandemic blighted all aspects of American life, but people in jails, prisons, and other detention sites experienced singular harm and neglect. Housing vulnerable detainee populations with elevated medical needs, these facilities were ticking time bombs. They were overcrowded, underfunded, unsanitary, insufficiently ventilated, and failed to meet even minimum health-and-safety standards. Every unit of national and sub-national government failed to prevent detainee communities from becoming pandemic epicenters, and judges were no exception.

This Article takes a comprehensive look at the decisional law growing out of COVID-19 detainee litigation and situates the judicial response as part of a comprehensive institutional …

Hiv No Longer A Death Sentence But Still A Life Sentence: The Constitutionality Of Hiv Criminalization Under The Eighth Amendment, Lauren Taylor

Georgia Law Review

When the HIV/AIDS epidemic began in the 1980s in the United States, there was mass confusion and hysteria regarding HIV transmission and prevention, leading many states to enact HIV criminalization statutes to prosecute persons living with HIV who either exposed another person to HIV or put someone in danger of being exposed to HIV. Yet, almost forty years later, these statutes are still used to criminalize and control the behaviors of people living with HIV, and in some cases, impose lengthy prison sentences hinging on the possibility of exposure. These HIV criminalization statutes and subsequent criminal cases often do not …

Unpacking The Influence Of Islamic Religious Culture And Individual Religious Affiliation On Testing Hiv-Positive, Brittany Hayes, Amy Adamczyk

Publications and Research

The distribution of HIV cases varies cross-nationally. We separate the influences of Islam at the macro-and micro-levels to understand the role of religion in shaping the spread of HIV. Drawing on biomarker data from the Demographic and Health Surveys, we construct a multilevel database (Individual N= 568,476; Country N= 30). We examine a series of national-and individual-level predictors that may mediate the relationship between Islam and testing HIV-positive. Individual religious affiliation and proportion Muslim retained their risk-reducing effects even when accounting for a range of mediators and suppressors. Islam has a sui generis effect on testing HIV-positive.

Review: Wendy A. Bach, Prosecuting Poverty, Criminalizing Care, Anna Arons

Faculty Publications

(Excerpt)

“Lock ’em up, clean ’em up, and start over” (145). This is how a drug treatment coordinator in a court in East Tennessee sums up her approach to provisioning substance use services to poor Tennesseans. If someone needs treatment, the most expeditious route—often, the only route—is through the criminal legal system. First, the court administrator casts about for a criminal charge, hopefully a “little charge,” that the person can be arrested on. Then, once they are arrested, they can be brought to jail where they can detox, with no medical supervision and no medication to ease the detox. And …

Medicare Disadvantaged: A Raft Of Lawsuits Exposes Fraud In Medicare Part C, John J. Locurto

Faculty Articles

Healthcare fraud is a massive and stubborn problem that can be confirmed by examining the annual Health Care Fraud and Abuse Control Program Report that the United States Departments of Justice and Health and Human Services prepare.

One Age Does Not Fit All: Late Career Practitioner Policies And Managed Care, Adella Katz, John J. Locurto

Faculty Articles

A late career practitioner policy (LCPP) is an age-based approach to screening physicians for physical, cognitive, and other limitations that could impact patient care. What makes LCPPs controversial is that they subject physicians to heightened or more frequent screenings based on arbitrary age thresholds, without specific evidence that their skills have diminished, their acuity has declined, or their performance has deteriorated. Supporters justify LCPPs based on data showing that capabilities decline with age. Aging is natural, they contend, and physicians are not immune to its effects. Critics call LCPPs discriminatory, the embodiment of capricious action that stigmatizes older practitioners by …

Righting Health Policy: Bioethics, Political Philosophy, And The Normative Justification Of Health Law And Policy, D. Robert Macdougall

Publications and Research

In Righting Health Policy, D. Robert MacDougall argues that bioethics needs but does not have adequate tools for justifying law and policy. Bioethics’ tools are mostly theories about what we owe each other. But justifying laws and policies requires more; at a minimum, it requires tools for explaining the legitimacy of actions intended to control or influence others. It consequently requires political, rather than moral, philosophy. After showing how bioethicists have consistently failed to use tools suitable for achieving their political aims, MacDougall develops an interpretation of Kant’s political philosophy. On this account the legitimacy of health laws does …

Exclusion Cycles: Reinforcing Disparities In Medicine, Ana Bracic, Shawneequa L. Callier, Nicholson Price

Articles

Minoritized populations face exclusion across contexts from politics to welfare to medicine. In medicine, exclusion manifests in substantial disparities in practice and in outcome. While these disparities arise from many sources, the interaction between institutions, dominant-group behaviors, and minoritized responses shape the overall pattern and are key to improving it. We apply the theory of exclusion cycles to medical practice, the collection of medical big data, and the development of artificial intelligence in medicine. These cycles are both self-reinforcing and other-reinforcing, leading to dismayingly persistent exclusion. The interactions between such cycles offer lessons and prescriptions for effective policy.

Pursuing A Right To Genetic Happiness, George P. Smith Ii

Scholarly Articles

With the continued expansion of assisted reproductive technology (ART), and society's inability to regulate it, complex medico-legal issues and ethical and social dilemmas are arising. Although the desire to prevent or limit genetic disease by, for example, gene editing and mitochondrial transfer is noble, what has been termed the "customization" of birth, raises the fundamental issue of procreative liberty, and, more specifically, the extent to which the state is obligated to assist in the use of ART which, in turn, validate the quest for genetic happiness. There is a current notion that reproductive freedom includes, within it, a right to …

Identity By Committee, Scott Skinner-Thompson

Publications

Even in school districts with relatively permissive approaches to defining and embodying gender, the identities of transgender and gender variant students are often governed by complex regulatory protocols. Ensuring that a student is able to live their gender at school can involve input from a host of purported stakeholders including medical providers, mental health professionals, school administrators, the student’s parents, and even the broader community. In essence, trans and gender variant students’ identities are governed by committee, which reduces students’ control over their lives, inhibits self-determination, constricts the scope of permissible gender identities, subjects them to incredible degrees of state …

Making Sex Work Safe: Using A Consensus-Based Approach To Create Meaningful Policy For Sex Workers, Alexandra Sandler

Cardozo Journal of Conflict Resolution

Sex work has been described as the world's oldest profession, yet it has remained nearly unchanged in the U.S., largely due to the conflation between sex work and sex trafficking. The term "sex worker" refers to a person who willingly works in the industry to make a living. Sex trafficking, though, is a form of modern-day slavery, in which an individual performs commercial sex as a result of force, fraud, or coercion. The conflation of sex work and sex trafficking in the U.S. has resulted in oppressive policies that undermine the rights and safety of sex workers. With the exception …