Health Law and Policy Commons^™

International Rights Affecting The Covid–19 Vaccine Race, Samantha Johnson

University of Miami Inter-American Law Review

The impact of the COVID–19 pandemic has been felt world-wide, and despite having several vaccines in the market at this point, there are still issues of accessibility for certain countries. International intellectual property law has been a breeding ground for the exploration of intellectual curiosity and creation as it provides strong protections to creators. These strong protections have allowed for the monopolization of certain goods, such as vaccines, under the concept of patents. While patents are important to incentivize pharmaceutical companies to create life–saving medicines, these protections have also become a barrier for access to medicines, especially in less–developed countries. …

Comparative Laws In Public Health Unmasked, Christine Chasse

University of Miami International and Comparative Law Review

The COVID-19 pandemic lay bare the vulnerabilities of some countries’ public health responses and praise for others. Comparative law review in public health responses may glean lessons for the United States. For example, the United States had not had a pandemic of this magnitude in over a century and was reluctant to institute early masking policies. Meanwhile, the world raced for a COVID-19 vaccine. This begs the question of who will take the vaccine. Will—or can—governments force their citizens to be inoculated? Global comparisons in personal liberty, freedom, bodily autonomy, and how to parent intersect at the right to (or …

Immunization And Indemnification: Rethinking The Us Approach To Liability Protections For Vaccine Manufacturers During The Covid-19 Pandemic, Samantha Topper Berns

University of Miami International and Comparative Law Review

This note analyzes the legal mechanisms in the United States that provide compensation for vaccine injuries sustained as a result of inoculation against pandemic viruses when a public health emergency has been declared. While the United States has an every-day compensation scheme that deters litigation by providing just compensation yet upholds the right of injured parties to seek damages in court, it has a special compensation scheme applicable to vaccines developed to address public health emergencies that bars litigation by effectively providing vaccine manufactures with complete indemnification and severely restricts the ability of injured parties to receive compensation. Meanwhile, in …

Inoculating The Next Generation Of Lawyers: Mandating Substances Use And Mental Health Education For Law Students, Janet Stearns

Articles

No abstract provided.

Rationing Healthcare During A Pandemic: Shielding Healthcare Providers From Tort Liability In Uncharted Legal Territory, Frederick V. Perry, Miriam Weismann

University of Miami Business Law Review

As the coronavirus pandemic intensified, many communities in the U.S. experienced shortages of ventilators, ICU beds, and other medical supplies and treatment. There was no single national response providing guidance on the allocation of scarce healthcare resources. There has been no consistent state response either. Instead, various governmental and nongovernmental state actors in several but not all states formulated “triage protocols,” known as Crisis Standards of Care, to prioritize patient access to care where population demand exceeded supply. One intended purpose of the protocols was to immunize or shield healthcare providers from tort liability based on injuries resulting from a …

Legal And Ethical Implications Of U.S. And Canadian Vaccine Contracts: The Impact Of Vaccine Nationalism On The Global Pandemic Response, Ryan S. Tahiri

University of Miami Inter-American Law Review

This note explores the COVID-19 vaccine contracts between the U.S. and Canada and the impact of these types of agreements on the global pandemic response. These “pre-purchases,” many of which were executed before the development of a vaccine, have afforded a select few nations the opportunity to stockpile vaccines, while other nations with fewer resources are unable to secure any doses. An effective method to counter the effects of the pandemic is the creation of a global vaccine network that provides equitable access to vaccine doses for nations in need. COVAX was launched to ensure that lower and middle-income nations …

Privacy As The Price Of Drug Access, Laura Karas

Articles

In response to the recent increase in FDA-approved specialty drugs and escalating specialty drug prices, drug companies now offer patient support programs ("PSPs") for eligible patients prescribed a particular pharmaceutical drug. Such programs encompass both financial assistance for the purchase of a specialty drug and behavioral services, including nursing support and injection training, intended to improve drug adherence. Although ostensibly gratuitous, these programs have a steep and underappreciated cost: disclosure of protected health information. In effect, patient support programs compel patients to trade protected health information for drug access. This Article provides the first in-depth examination of the legal and …

Equality And Sufficiency In Health Care Reform, Gabriel Scheffler

Articles

Most Americans believe that health care is a right, not a privilege. Yet debates over health care reform frequently fail to distinguish between two distinct conceptions of the right to health care: one which focuses on sufficient access to health care-what I refer to as the Right to a Decent Minimum-and a second which focuses on equality in access to health care what I refer to as the Right to Equal Access. These two conceptions of the right to health care in turn support two distinct categories of proposals for expanding health insurance coverage. The Right to Equal Access justifies …

Pandemics And International Law: The Need To Strengthen International Legal Frameworks After The Covid-19 Global Health Pandemic [Sierra Leone], Charles C. Jalloh

Articles

No abstract provided.

How The Covid-19 Pandemic Has And Should Reshape The American Safety Net, Gabriel Scheffler, Andrew Hammond, Ariel Jurow Kleiman

Articles

No abstract provided.

Federal Ignorance And The Battle For Supervised Injection Sites, Ben Longnecker

University of Miami Law Review

From 1999 to 2017, over 400,000 people have died from opioid overdoses. The federal government recognizes the opioid epidemic as a crisis, yet it has failed to slow the surge of overdose deaths. Some states are, therefore, looking at the implementation of supervised injection sites. There are over 100 supervised injection sites around the world in twelve different countries, and these sites have produced hopeful data on counteracting the opioid crisis’s negative societal effects. However, the federal government has seemingly ignored any empirical evidence and continues to threaten state-sponsored supervised injection sites with criminal prosecution. This Note argues that any …

The Neglect Of Persons With Severe Brain Injury To The United States: An International Human Rights Analysis, Tamar Ezer, Megan S. Wright, Joseph J. Wright

Articles

Brain injury contributes more to death and disability globally than any other traumatic incident. While the past decade has seen significant medical advances, laws and policies remain stumbling blocks to treatment and care. The quality of life of persons with severe brain injury often declines with unnecessary institutionalization and inadequate access to rehabilitation and assistive technologies. This raises a host of rights violations that are hidden, given that persons with severe brain injury are generally invisible and marginalized. This article highlights the current neglect and experiences of persons with severe brain injury in the United States, analyzing the rights to …

The Dynamism Of Health Law: Expanded Insurance Coverage As The Engine Of Regulatory Reform, Gabriel Scheffler

Articles

Can law improve the delivery of health care? The predominant view is that law serves as a barrier to reforming the health care delivery system. Health law scholars of all stripes blame regulations for impeding innovation, limiting competition, and exacerbating fragmentation in health care.

I argue that this view neglects an important-but overlooked-feature of health law: the dynamic relationship between laws that expand health insurance coverage and laws that regulate the delivery of health care. By expanding health insurance coverage and increasing the demand for health care, laws such as Medicare, Medicaid and the Affordable Care Act catalyze policymakers to …

Centering Race At The Medical-Legal Partnership In Hawai’I, Dina Shek

University of Miami Race & Social Justice Law Review

No abstract provided.

Addiction-Informed Immigration Reform, Rebecca Sharpless

Articles

Immigration law fails to align with the contemporary understanding of substance addiction as a medical condition. The Immigration and Nationality Act regards noncitizens who suffer from drug or alcohol substance use disorder as immoral and undesirable. Addiction is a ground of exclusion and deportation and can prevent the finding of "good moral character" needed for certain immigration applications. Substance use disorder can lead to criminal behavior that lands noncitizens, including lawful permanent residents, in removal proceedings with no defense. The time has come for immigration law to catch up to today's understanding of addiction. The damage done by failing to …

Pharmaceutical Industry Funding To Patient-Advocacy Organization: A Cross-National Comparison Of Disclosure Codes And Regulation, Laura Karas, Robin Feldman, Bai Ge, So Yeon Kang, Gerard F. Anderson

Articles

Transparency has become one of the primary themes in health care reform efforts in the United States and across the world. In the face of exorbitant drug prices, high levels of patient cost-sharing, and pharmaceutical expenditures that consume a growing proportion of public sector budgets, much attention has been drawn to the pharmaceutical industry. Congressional investigations, academic publications, and news articles have endeavored to reveal the extent of drug and device industry influence on health care actors. In response, several nations, including the United States, have passed legislation mandating disclosure of drug company payments to physicians. In the United States, …

Section 1332 State Innovation Waivers: Waiving Goodbye To Cooperative Federalism And Hello To Collaborative Federalism, Brittany Hynes

University of Miami Business Law Review

No abstract provided.

Regulating Sugar-Sweetened Beverages, Tyler Rauh

University of Miami Business Law Review

American waistlines are an international punchline, and United States taxpayers spend hundreds of billions of dollars each year to combat medical complications resulting from obesity. The personal costs are financial, emotional, and mortal. Projections insist that it will become worse. Section I details the obesity epidemic and ponders why the United States is uniquely unhealthy.

The reason could be that America consumes more sugar than any other country. In recent years, some municipal policymakers have attempted to restrain America’s sweet tooth by taxing sugar-sweetened beverages. Initial responses are polarizing. Chicago’s tax did not last three months before its abolishment. Philadelphia’s …

The Dark Side Of The Pharmaceutical Industry: A Compound Of Issues, Geoffrey A. Marcus

University of Miami Inter-American Law Review

No abstract provided.

Deploying Mindfulness To Gain Cognitive Advantage: Considerations For Military Effectiveness And Well-Being, Amishi P. Jha, Scott L. Rogers, Eric Schoomaker, Edward Cardon

Articles

Mindfulness involves paying attention to present moment experience without discursive commentary or emotional reactivity. Mindfulness training (MT) programs aim to promote this mental mode via introduction to specific mindfulness exercises, related in-class discussion, and ongoing engagement in mindfulness exercises. MT is being increasingly offered to high-demand, high-stress military/uniformed and civilian cohorts with a wide array of reported benefits. Herein, we begin by discussing recent theoretical models regarding MT’s mechanisms of action from a cognitive training/cognitive neuroscience perspective, which propose that MT engages and strengthens three key processes [e.g., 1]. These are: 1) attentional orienting, which is the ability to select …

Occupational Licensing And The Limits Of Public Choice Theory, Ryan Nunn, Gabriel Scheffler

Articles

No abstract provided.

Unlocking Access To Health Care: A Federalist Approach To Reforming Occupational Licensing, Gabriel Scheffler

Articles

No abstract provided.

Mitochondrial Replacement Therapy: How A Government For The People, Failed The People, Jeffery Mark Sauer

University of Miami Law Review

Despite having the potential to significantly reduce the passage of many lethal diseases and devastating birth defects, mitochondrial replacement therapy—a controversial medical procedure in which mitochondrial RNA from a healthy female replaces the mitochondrial RNA from the intended mother in vitro—will have no place in the United States anytime soon. Under the guise of purported safety concerns and ethical dilemmas, the Republican Congress used its “power of the purse” to halt any and all research furthering mitochondrial replacement therapy, notwithstanding the fact that many leaders in the medical community have advocated for further research. Several developed countries have already implemented …

Brazil’S Zika Epidemic And Its Effects On The Criminalization Of Abortion, Laura M. Monteiro

University of Miami Inter-American Law Review

No abstract provided.

Will The Zika Virus Enable A Transplant Of Roe V. Wade To Brazil?, Amanda Greenberg

University of Miami Inter-American Law Review

No abstract provided.

Big Data: Destroyer Of Informed Consent, A. Michael Froomkin

Articles

The 'Revised Common Rule' took effect on January 21, 2019, marking the first change since 2005 to the federal regulation that governs human subjects research conducted with federal support or in federally supported institutions. The Common Rule had required informed consent before researchers could collect and use identifiable personal health information. While informed consent is far from perfect, it is and was the gold standard for data collection and use policies; the standard in the old Common Rule served an important function as the exemplar for data collection in other contexts. Unfortunately, true informed consent seems incompatible with modern analytics …

Strategic Litigation To Advance Public Health, Tamar Ezer, Priti Patil

Articles

The HIV movement has relied on strategic litigation as an important tool to develop and enforce legal protections critical to health. This experience contains lessons on the potential of strategic litigation to advance public health more generally. Beyond impacting laws and policies, strategic litigation can change practice, breathing life into existing legal rules never implemented. While cases may target a particular law, policy, or practice, indirect impacts beyond a particular court decision on future cases, other branches of government, and the public record may be just as important. Each case is only one step towards change, and a judgment can …

The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid

University of Miami Business Law Review

In recent years, some pharmaceutical companies have started increasing the price of their existing drugs to exorbitant levels. Often, these drugs are medically necessary for patients, who are left to take on the high costs of the medicine. One recent example is Mylan, who raised the price of the EpiPen by four hundred percent, solely for the profit of its own company and to the detriment of consumers who rely on the EpiPen. Similar patterns of drug price increases have occurred in the past and will likely happen again in the future. This Comment will seek to identify the common …

A Call To Higher Action: Cannabis Prohibition In The United States And Canada Makes For An Uncertain Future, Carlos Alvarez

University of Miami International and Comparative Law Review

No abstract provided.

Circumcision: Immigration, Religion, History, And Constitutional Identity In Germany And The U.S., David Abraham

Articles

A four-year-old Muslim boy was brought to a local Cologne emergency room by his mother, who was concerned about minor bleeding around the site of a circumcision. A District Court there found that circumcision, notwithstanding parental consent or religious motivation, constituted a criminal bodily injury and child abuse. Ultimately, on July 19, 2012 the Bundestag resolved that "Jewish and Muslim religious life be viable in Germany," and in December a bill was passed that legislatively overrode the ruling of the District Court and recognized circumcision as a non-punishable undertaking when undertaken for religious reasons by someone professionally trained. Two years …