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Full-Text Articles in Health Law and Policy

The Vaccine Race In The 21st Century, Ana Santos Rutschman Jan 2019

The Vaccine Race In The 21st Century, Ana Santos Rutschman

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In a world in which infectious diseases are spreading increasingly faster, the development of new human vaccines remains a priority in biopharmaceutical innovation. Legal scholars have addressed different aspects of vaccine regulation and administration, but less attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.

This Article explores the race to develop new vaccines from its beginnings through the early 21st century, with a particular focus on the progressively pervasive role of intellectual property in governing vaccine innovation. It describes the insufficiencies of current innovation regimes in ...


Vaccine Licensure In The Public Interest: Lessons From The Development Of The U.S. Army Zika Vaccine, Ana Santos Rutschman Jan 2018

Vaccine Licensure In The Public Interest: Lessons From The Development Of The U.S. Army Zika Vaccine, Ana Santos Rutschman

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Vaccines developed by the public sector are key to preventing future outbreaks of infectious diseases. However, the licensure of these vaccines to private-sector companies under terms that do not ensure both their availability and affordability compromises their development. This Essay analyzes the recent attempted licensing deal for a Zika vaccine between the U.S. Army and Sanofi, a French pharmaceutical company. The proposed grant of an exclusive license to Sanofi triggered widespread concern because none of its substantive terms were disclosed. While § 209 of the Patent Act imposes limitations on exclusive licensure, the Army released no information supporting its finding ...


Healthcare Blockchain Infrastructure: A Comparative Approach, Ana Santos Rutschman Jan 2018

Healthcare Blockchain Infrastructure: A Comparative Approach, Ana Santos Rutschman

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Blockchain has been hailed as the most disruptive technology of the next decade. One of the areas of immediate application is healthcare, where different types of blockchain applications could help streamline data sharing, protect patient privacy, and assist in the monitoring of drug shipments. This Article explores the first steps taken by healthcare companies in the United States to incorporate blockchain solutions into their business models. It then contrasts them to ongoing experiments in the European Union, with a focus on Sweden’s adoption of CareChain (a national, interoperable blockchain health data platform) and Estonia’s digitization of 95% of ...


Ip Preparedness For Outbreak Diseases, Ana Santos Rutschman Jan 2018

Ip Preparedness For Outbreak Diseases, Ana Santos Rutschman

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Outbreaks of infectious diseases will worsen, as illustrated by the recent back-to-back Ebola and Zika epidemics. The development of innovative drugs, especially in the form of vaccines, is key to minimizing future outbreaks, yet current intellectual property (IP) regimes are ineffective in supporting this goal.

IP scholarship has not adequately addressed the role of IP in the development of vaccines for outbreak diseases. This Article fills that void. Through case studies on the recent Ebola and Zika outbreaks, it provides the first descriptive analysis of the role of IP from the pre- to the post-outbreak stages, specifically identifying IP inefficiencies ...


Lessons From Ferguson And Beyond: Bias, Health, And Justice, Sidney D. Watson Jan 2017

Lessons From Ferguson And Beyond: Bias, Health, And Justice, Sidney D. Watson

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August 9, 2014, Michael Brown, an 18-year-old African American teen, killed by police in Ferguson, Missouri.

November 22, 2014, Tamir Rice, a 12-year-old African American child, killed by police in Cleveland, Ohio.

April 4, 2015, Walter Scott, a 50-year-old African American man, killed by police in Charlotte, North Carolina.

November 15, 2015, Jamar Clark, a 24-year-old African American man, killed by police in Minneapolis, Minnesota.

July 6, 2016, Philando Castile, a 32-year-old African American man, killed by police in Falcon Heights, Minnesota.

The list of Black men and women killed by police goes on and seems to grow by the ...


Exploitation In Medical Research: The Enduring Legacy Of The Tuskegee Syphilis Study, Ruqaiijah A. Yearby Jan 2017

Exploitation In Medical Research: The Enduring Legacy Of The Tuskegee Syphilis Study, Ruqaiijah A. Yearby

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For forty years, the United States government allowed economically disadvantaged African American men to be exploited in the name of research, although the research could not generate any benefit to society. Specifically, from 1932 until 1972, government funded researchers enrolled economically disadvantaged African American men in the Tuskegee Syphilis Study to document the already known course of syphilis, which led to the men suffering sores, fever, hair loss, weight loss, headaches, paralysis, blindness, dementia, and death. In exchange for free meals, medical exams, and burial insurance, the researchers promised the men that they would provide treatment for their “bad blood ...


The Priority Review Voucher Program At The Fda: From Neglected Tropical Diseases To The 21st Century Cures Act, Ana Santos Rutschman Jan 2017

The Priority Review Voucher Program At The Fda: From Neglected Tropical Diseases To The 21st Century Cures Act, Ana Santos Rutschman

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The priority review voucher program at the Food and Drug Administration (FDA) was established in 2007 to incentivize research and development (R&D) in traditionally underfunded diseases.1 While shrouded in controversy and criticism, the program has recently been bolstered by the passage of the 21st Century Cures Act,2 which prevented the vouchers from sunsetting in late 2016 and furthered the overall scope of the program.3 As it reaches the end of its first decade, this Article discusses the impact of the program, with a focus on recent developments. The Article builds on literature suggesting that the voucher ...


Medicaid Maximization And Diversion: Illusory State Practices That Convert Federal Aid Into General State Revenue, Daniel L. Hatcher Apr 2016

Medicaid Maximization And Diversion: Illusory State Practices That Convert Federal Aid Into General State Revenue, Daniel L. Hatcher

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For years, states have been using illusory schemes to maximize federal aid intended for Medicaid services-and then often diverting some or all of the resulting funds to other use. And states have help. Private revenue maximization consultants are hired by states to increase Medicaid claims, often for a contingency fee. We do not know the exact amount of federal Medicaid funds that has been diverted to state revenue and private profit each year, but it is in the billions.

The states' revenue strategies take advantage of the matching-grant structure of the Medicaid program. When state funds are spent on eligible ...


Collecting New Data On Disability Health Inequities, Elizabeth Pendo Jan 2016

Collecting New Data On Disability Health Inequities, Elizabeth Pendo

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Prior to the Affordable Care Act, disability was marginalized in data collection efforts, limiting our ability to understand and address significant health inequities experienced by millions of Americans. Now, for the first time, we can use these tools to collect valuable new data on the nature and extent of health inequities experienced by people with disabilities across the country.

This article argues that standardized health collection data is critical to health equity, and because of the ACA’s groundbreaking requirements for data collection of disability status and treatment of patients with disabilities, we now have the potential to identify, track ...


Substantial Confusion About "Substantial Burdens", Chad Flanders Jan 2016

Substantial Confusion About "Substantial Burdens", Chad Flanders

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As the Supreme Court rev1s1ts the clash between religious belief and the Affordable Care Act (ACA) in the Zubik1 case, it is worth mulling over a key phrase in the law that governs that clash: '·substantial burden." According to the Religious Freedom Restoration Act (RFRA), the government must-provided it does not meet certain other conditions, such as showing a compelling interest-make an accommodation if it places a ''substantial burden'' on a person's religious exercise.2 If the question in the Hobby Lobby case was whether a for-profit corporation could be a ''person" that ''exercised religion,"3 the question ...


Involuntary Consent: Conditioning Access To Health Care On Participation In Clinical Trials, Ruqaiijah A. Yearby Jan 2016

Involuntary Consent: Conditioning Access To Health Care On Participation In Clinical Trials, Ruqaiijah A. Yearby

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Although the controversy over the lack of consent in fetal-tissue clinical trials is relatively new, history is replete with instances of medical researchers who have conducted clinical trials with minorities and the economically disadvantaged without their consent.1 Traditionally, American bioethics has served as a safety net for the rich and powerful (for they are not forced to act as research subjects to obtain access to health care for themselves or their children) while failing to protect the vulnerable, which includes minorities and the economically disadvantaged. Without access to health care, minorities and the economically disadvantaged are unduly influenced to ...


Missing The “Target”: Preventing The Unjust Inclusion Of Vulnerable Children For Medical Research Studies, Ruqaiijah A. Yearby Jan 2016

Missing The “Target”: Preventing The Unjust Inclusion Of Vulnerable Children For Medical Research Studies, Ruqaiijah A. Yearby

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Nearly everyone has experienced a burn and the resulting pain. Now imagine that you suffer a third-degree radiation burn that injures all the layers of your skin as well as the tissue, causing you extreme pain. . The burn turns your skin white, cherry red, or black and may produce blisters that are dry, hard, and leathery-looking. The burn can also be seen on the surface of your lungs and gastrointestinal tract. If the burn is big enough you will need skin grafts and surgery to replace the skin and tissue that will never grow back, as well as treatment to ...


En-Gendering Economic Inequality, Michele E. Gilman Jan 2016

En-Gendering Economic Inequality, Michele E. Gilman

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We live in an era of growing economic inequality. Luminaries ranging from the President to the Pope to economist Thomas Piketty in his bestselling book Capital in the Twenty- First Century have raised alarms about the disparity between the haves and the have-nots. Overlooked, however, in these important discussions is the reality that economic inequality is not a uniform experience; rather, its effects fall more harshly on women and minorities. With regard to gender, American women have higher rates of poverty and get paid less than comparable men, and their workplace participation rates are falling. Yet economic inequality is neither ...


Book Review: Body Banking From The Bench To The Bedside, Natalie Ram Dec 2015

Book Review: Body Banking From The Bench To The Bedside, Natalie Ram

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How much is a kidney worth? An ounce of breast milk? Genetic material from an individual facing a Parkinson's diagnosis? In today's America, it depends on who is selling. One might think that such body products are beyond value or that their value depends on the individual characteristics of the supplier. But under existing American law and practices, what matters more is whether the seller is also the supplier of that body product, or whether the seller is another entity, such as a pharmaceutical company, hospital, or biobanker.


A Private Right Of Action For Informed Consent In Research, Valerie Gutmann Koch Jan 2015

A Private Right Of Action For Informed Consent In Research, Valerie Gutmann Koch

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No abstract provided.


The Four Stages Of Youth Sports Tbi Policymaking: Engagement, Enactment, Research, And Reform, Hosea H. Harvey, Dionne L. Koller, Kerri M. Lowrey Jan 2015

The Four Stages Of Youth Sports Tbi Policymaking: Engagement, Enactment, Research, And Reform, Hosea H. Harvey, Dionne L. Koller, Kerri M. Lowrey

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This article advances, for the first time, a framework for situating public health law interventions as occurring in a predictable four-stage process. In this article, written in connection with our panel at the Public Health Law Research Conference (2014), we briefly apply this four-stage framework to youth sports TBI laws, and conclude that public health lawmaking in this area is consistent with prior high-visibility public health law interventions.


Out Of The Black Box And Into The Light: Using Section 1115 Medicaid Waivers To Implement The Affordable Care Act's Medicaid Expansion, Sidney D. Watson Jan 2015

Out Of The Black Box And Into The Light: Using Section 1115 Medicaid Waivers To Implement The Affordable Care Act's Medicaid Expansion, Sidney D. Watson

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What price Medicaid expansion? The Supreme Court's decision in National Federation of Independent Business (NFIB) v. Sebelius,' sparked intense debate about how the Secretary of Health & Human Services (HHS) would respond to pressure from recalcitrant states. Policy experts and Sunday-moming pundits predicted that Red States would demand Section 1115 waivers of federal Medicaid rules as the quid pro quo for implementing the Affordable Care Act's (ACA) Medicaid expansion that covers adults with incomes up to 133% of the federal poverty level (FPL). They prophesized that the Obama Administration, desperate to move implementation forward, would have little leverage in ...


Ebola, Quarantine, And Flawed Cdc Policy, Robert Gatter Jan 2015

Ebola, Quarantine, And Flawed Cdc Policy, Robert Gatter

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


What Patients With Disabilities Teach Us About The Everyday Ethics Of Health Care, Elizabeth Pendo Jan 2015

What Patients With Disabilities Teach Us About The Everyday Ethics Of Health Care, Elizabeth Pendo

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In Healers: Extraordinary Clinicians at Work, by David Schenck and Dr. Larry Churchill, and in What PatientsTeach: The Everyday Ethics of Health Care, their follow-up with Joseph Fanning, the authors look at theeveryday experience of health care and the relationships that shape it. This article expands upon that inquiry by exploring the experiences and challenges of patients with disabilities and by exploring what patients withdisabilities can teach us about the everyday ethics of health care.

The authors of What Patients Teach provide a framework in which to focus on the everyday experience ofhealth care from the perspective of patients. This ...


Sick And Tired Of Being Sick And Tired: Putting An End To Separate And Unequal Health Care In The United States 50 Years After The Civil Rights Act Of 1964, Ruqaiijah A. Yearby Jan 2015

Sick And Tired Of Being Sick And Tired: Putting An End To Separate And Unequal Health Care In The United States 50 Years After The Civil Rights Act Of 1964, Ruqaiijah A. Yearby

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Since the end of the Civil War in 1865, the U.S. health care system has been structured to be racially separate and unequal. Ninety-nine years later, the enactment of Title VI of the Civil Rights Act of 1964 (Title VI) was supposed to put an end to this racially separate and unequal health care system by mandating equal access to health care for all races. However, fifty years later, African Americans continue to receive separate and unequal treatment compared to Caucasians, in hospitals, nursing homes, and physician offices. As a result, racial disparities in health status and access to ...


A Policy In Flux: New York State’S Evolving Approach To Human Subjects Research Involving Individuals Who Lack Consent Capacity (Forthcoming), Valerie Gutmann Koch Oct 2014

A Policy In Flux: New York State’S Evolving Approach To Human Subjects Research Involving Individuals Who Lack Consent Capacity (Forthcoming), Valerie Gutmann Koch

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No abstract provided.


Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin Oct 2014

Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin

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As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant ...


“Of Vital Importance”: The New York State Task Force On Life And The Law’S Report And Recommendations For Research With Human Subjects Who Lack Consent Capacity (With Susie A. Han), Valerie Gutmann Koch Jan 2014

“Of Vital Importance”: The New York State Task Force On Life And The Law’S Report And Recommendations For Research With Human Subjects Who Lack Consent Capacity (With Susie A. Han), Valerie Gutmann Koch

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No abstract provided.


Medicaid, Marketplaces, And Premium Assistance: What Is At Stake In Arkansas? The Perils And Pitfalls Of Medicaid Expansion Through Marketplace Premium Assistance, Sidney D. Watson Jan 2014

Medicaid, Marketplaces, And Premium Assistance: What Is At Stake In Arkansas? The Perils And Pitfalls Of Medicaid Expansion Through Marketplace Premium Assistance, Sidney D. Watson

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On September 27, 2013, Arkansas became the first state to obtain federal approval for a Section 1115 demonstration waiver to require adults eligible for the Affordable Care Act's (ACA) Medicaid Expansion to enroll in private plans offered through the State's new Health Insurance Marketplace rather than traditional Medicaid.2 Hailed as a "game changer," Republican lawmakers dubbed this Marketplace Premium Assistance approach a new Medicaid "private option."' 3 Others described it as a potential "middle ground" in efforts to expand Medicaid that may be more politically palatable for those who oppose "Obamacare."...


When Is A Change Going To Come?: Separate And Unequal Treatment In Health Care Fifty Years After Title Vi Of The Civil Rights Act Of 1964, Ruqaiijah A. Yearby Jan 2014

When Is A Change Going To Come?: Separate And Unequal Treatment In Health Care Fifty Years After Title Vi Of The Civil Rights Act Of 1964, Ruqaiijah A. Yearby

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ON June 19, 1963, when the Civil Rights Act was first introduced, President John F. Kennedy said in a message to Congress:

Events of recent weeks have again underlined how deeply our Negro citizens resent the injustice of being arbitrarily denied equal access to those facilities and accommodations, which are otherwise open to the general public. That is a daily insult, which has no place in a country proud of its heritage-- the heritage of the melting pot, of equal rights, of one nation and one people. No one has been barred on account of his race from fighting or ...


Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge Jan 2014

Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge

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In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.


The Dangers Of Psychotropic Medication For Mentally Ill Children: Where Is The Child’S Voice In Consenting To Medication? An Empirical Study, Donald H. Stone Oct 2013

The Dangers Of Psychotropic Medication For Mentally Ill Children: Where Is The Child’S Voice In Consenting To Medication? An Empirical Study, Donald H. Stone

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When a child with a mental illness is being prescribed psychotropic medication. who decides whether the child should take the medication — the parent or the child? What if the child is sixteen years of age? What if the child is in foster care: Should the parent or social service agency decide? Prior to administering psychotropic medication, what specific information should be provided to the person authorized to consent on behalf of the child? Should children be permitted to refuse psychotropic medications? If so, at what age should a child he able to refuse such medication What procedures should be put ...


Forgotten Fathers, Daniel L. Hatcher May 2013

Forgotten Fathers, Daniel L. Hatcher

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Poor fathers like John are largely forgotten, written off as a subset of the unworthy poor. These fathers struggle with poverty – often with near hopelessness – within multiple systems in which they are either entangled or overlooked, such as child-support and welfare programs, family courts, the criminal justice system, housing programs, and the healthcare, education, and foster-care systems. For these impoverished fathers, the “end of men” is often not simply a question for purposes of discussion but a fact that is all too real. In the instances in which poor fathers are not forgotten, they are targeted as causes of poverty ...


Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin May 2013

Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin

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Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v ...


Why Broccoli? Limiting Principles And Popular Constitutionalism In The Health Care Case, Mark D. Rosen, Christopher W. Schmidt Jan 2013

Why Broccoli? Limiting Principles And Popular Constitutionalism In The Health Care Case, Mark D. Rosen, Christopher W. Schmidt

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Crucial to the Court’s disposition in the constitutional challenge to the Affordable Care Act (ACA) was a hypothetical mandate to purchase broccoli, which Congress never had considered and nobody thought would ever be enacted. For the five Justices who concluded the ACA exceeded Congress’s commerce power, a fatal flaw in the government’s case was its inability to offer an adequate explanation for why upholding that mandate would not entail also upholding a federal requirement that all citizens purchase broccoli. The minority insisted the broccoli mandate was distinguishable. This Article argues that the fact that all the Justices ...