Health Law and Policy Commons^™

Permissive Regulation: A Critical Review Of The Regulatory History Of Buprenorphine Formulations In Canada, Abhimanyu Sud, Meghan Mcgee, Barbara Mintzes, Matthew Herder

Articles, Book Chapters, & Popular Press

Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada for the treatment of opioid use disorder. The drug is considered an important response to the opioid overdose epidemic with consistent calls for wider prescribing and deregulation. The history of Suboxone regulation in Canada has not been critically examined. Part of the rationale for doing so stems from the US regulatory experience, with documented irregularities, or what some have called abuses, that support profit-making by Suboxone's manufacturers. This regulatory analysis allows us to determine how opportunities to address health crises through drug innovation are managed at a federal …

Reducing Barriers To Accessing Administrative Data On Sars-Cov-2 Vaccination For Research, Andrew Mcrae, Patrick Archambault, Patrick Fok, Hana Wiemer, Laurie Morrison, Matthew Herder

Articles, Book Chapters, & Popular Press

Public trust in scientific research, especially research regarding vaccines, has proven fragile during the COVID-19 pandemic. To counter abundant misinformation about SARS-CoV-2 vaccines, rigorous, ongoing evaluations of vaccine safety and effectiveness by independent Canadian researchers are important. However, researchers' efforts to conduct timely, national studies of vaccine effectiveness have been hindered by barriers to data sharing that have made it difficult to integrate patients' vaccination status into SARS-CoV-2 clinical and epidemiological studies. Here, McRae et al discuss how a risk-averse data-sharing culture has led to missed opportunities to conduct robust, timely, pan-Canadian SARS-CoV-2 clinical and vaccine effectiveness studies, and outline …

On What Basis Did Health Canada Approve Oxycontin In 1996? A Retrospective Analysis Of Regulatory Data, Jessie Pappin, Itai Bavli, Matthew Herder

Articles, Book Chapters, & Popular Press

The marketing and sale of oxycodone (OxyContin) by Purdue Pharma has commanded a great deal of legal and policy attention due to the drug’s central role in the ongoing overdose crisis. However, little is known about the basis for OxyContin’s approval by regulators, such as Health Canada in 1996. Taking advantage of a recently created online database containing information pertaining to the safety and effectiveness of drugs, we conducted a retrospective analysis of Purdue Pharma’s submission to Health Canada, including both published and unpublished clinical trials. None of the trials sponsored by Purdue Pharma sought to meaningfully assess the risks …

Abortion Rights Beyond The Medico-Legal Paradigm, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

Abortion rights in international law have historically been framed within a medico-legal paradigm, the belief that regulated systems of legal and medical control guarantee safe abortion. However, a growing worldwide practice of self-managed abortion (SMA) supported by feminist activism challenges key precepts of this paradigm. SMA activism has shown that more than medical service delivery matters to safe abortion and has called into question the legal regulation of abortion beyond criminal prohibitions. This article explores how abortion rights have begun to depart from the medico-legal paradigm and to support the novel norms and practices of SMA activism in a transformation …

Medicare "Bankruptcy", Matthew B. Lawrence

Faculty Articles

Medicare, the social insurance program for the elderly and disabled, is once again facing insolvency. Spending from the program’s hospital insurance trust fund is predicted to exceed the accumulated payroll taxes and other revenues that support the fund within the next five years, leaving Medicare unable to honor some of its obligations. Yet, what happens if and when Medicare becomes insolvent has not previously been explored in legal scholarship and is not addressed in statute or regulation. This Article confronts for the first time the major legal questions that Medicare insolvency would present. It explains what policymakers could do to …

Towards Racial Justice: The Role Of Medical-Legal Partnerships, Medha D. Makhlouf

Faculty Scholarly Works

Medical-legal partnerships (MLPs) integrate knowledge and practices from law and health care in pursuit of health equity. However, the MLP movement has not reached its full potential to address racial health inequities, in part because its original framing was not explicitly race conscious. This article aims to stimulate discussion of the role of MLPs in racial justice. It calls for MLPs to name racism as a social determinant of health and to examine how racism may operate in the field. This work sets the stage for the next step: operationalizing racial justice in the MLP model, research, and practice.

Debunking The Standardized Nature Of Insurance Policies, Elizabeth Sousa

Fordham Journal of Corporate & Financial Law

This article discredits the conventional view of insurance policies as standardized contracts that do not vary across insurance companies and policyholders. Contrary to this view, there are wide variations in policy language in both the admitted and non-admitted insurance markets. These deviations reduce the perceived benefit of insurance policies as standardized contracts intended to promote predictability and lower transaction costs for policyholders by focusing only on the most salient terms. Nowhere is this deviation more apparent than with Commercial General Liability (CGL) policies defendants are turning to in the current opioid litigation.

The opioid epidemic has been plaguing the United …

Patient Referral Failures, Jessica L. Mantel, Leah R. Fowler

Health Matrix: The Journal of Law-Medicine

No abstract provided.

No-Fault Vaccine Injury Compensation Systems Adopted Pursuant To The Covid-19 Public Health Emergency Response, Sam Halabi, Katherine Ginsbach, Katie Gottschalk, John Monahan, Judith Murungi

Emory International Law Review

No-fault vaccine injury compensation systems have developed over the course of the twentieth century, mostly in the richest countries in the world. Acknowledging that severe reactions to vaccines are rare, but can result in serious and sometimes complex injury, these systems provide financial and social support for those suffering these rare side effects. During the COVID-19 pandemic, and the rapid development and deployment of vaccines using novel technologies, these systems have proliferated not only among wealthy countries, where in their modern form they originated and spread, but also low- and middle-income ones. Adopting varying approaches to funding, eligibility, administration, process, …

Stifling Innovation: How Global Data Protection Regulation Trends Inhibit The Growth Of Healthcare Research And Start-Ups, Ryan Preston

Emory International Law Review

No abstract provided.

Boarding Mental Health Patients In Minnesota Emergency Departments--The Unintended Consequence Of An Inadequate Mental Health System, Jordan Engler

Mitchell Hamline Law Review

No abstract provided.

Stumbling Over Trips: The International Intellectual Property Waiver Petition And The U.S. Executive, Jordan Paradise, Christina Conroy

Faculty Publications & Other Works

This article examines the relationship among intellectual property (IP) law protections; United States (U.S.) and international law and policy; and the actualization of diagnostics, drugs, and vaccines in the time of the COVID-19 coronavirus. Two key international treaties that relate to IP law--The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) - establish international norms for the protection of IP. Core aspects of each of these treaties are described along with the role of the World Trade Organization (WTO) and concepts of compulsory licensing. As a result …

Stumbling Over Trips: The International Intellectual Property Waiver Petition And The U.S. Executive, Jordan Paradise, Christina Conroy

Faculty Publications & Other Works

This article examines the relationship among intellectual property (IP) law protections; United States (U.S.) and international law and policy; and the actualization of diagnostics, drugs, and vaccines in the time of the COVID-19 coronavirus. Two key international treaties that relate to IP law--The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) - establish international norms for the protection of IP. Core aspects of each of these treaties are described along with the role of the World Trade Organization (WTO) and concepts of compulsory licensing. As a result …

Biosimilar Bias: A Barrier To Addressing American Drug Costs, Cynthia M. Ho

Faculty Publications & Other Works

Forty percent of spiraling US drug costs are based on a mere two percent of all drugs –biologic drugs (biologics) made from living cells that are administered by injection or infusion. These costs will continue to balloon as new biologics are approved; the recently approved Alzheimer’s drug is expected to result in a 50% increase in Medicare spending and cost individuals 40% of their annual income. These drugs are expensive because they cannot be mass-produced, and their cost places important treatments for conditions such as arthritis (Humira) and cancer (Herceptin) out of reach for many Americans. Fortunately, just as there …

An Attempt To Bring Modern Workplace Realities To The Social Security Disability Adjudication System, Robert E. Rains

Dickinson Law Review (2017-Present)

No abstract provided.

Comment: On Patents And Appropriations—And Tragedies, David O. Taylor

Washington and Lee Law Review

I write to provide a few remarks concerning Sasha Hoyt’s illuminating work published in the pages of this journal. In it, Hoyt addresses the impact of the Supreme Court’s patent eligibility decisions on private investment in the development of medical diagnostic technologies. As an initial matter, I want to congratulate Hoyt for tackling an important topic. As Hoyt discusses, medical diagnostic technologies enable the diagnosis of diseases and other medical conditions such as genetic disorders, and early and accurate diagnosis may lead to early treatments and, ultimately, at least in some cases, saved lives. But the creation of medical diagnostic …

Points Of No Return: How The Ninth Circuit’S New Voluntary Undertaking Doctrine Changes Return-To-Play In Sports, Sam C. Ehrlich

University of San Francisco Law Review

No abstract provided.

Artificial Intelligence In Canadian Healthcare: Will The Law Protect Us From Algorithmic Bias Resulting In Discrimination?, Bradley Henderson, Colleen M. Flood, Teresa Scassa

Canadian Journal of Law and Technology

In this article, we canvas why AI may perpetuate or exacerbate extant discrimination through a review of the training, development, and implementation of healthcare-related AI applications and set out policy options to militate against such discrimination. The article is divided into eight short parts including this introduction. Part II focuses on explaining AI, some of its basic functions and processes, and its relevance to healthcare. In Part III, we define and explain the difference and relationship between algorithmic bias and data bias, both of which can result in discrimination in healthcare settings, and provide some prominent examples of healthcare-related AI …

A Health Justice Response To School Discipline And Policy, Thalia Gonzalez, Alexis Etow, Cesar De La Vega

American University Law Review

Inequities in school discipline and policing have been long documented by researchers and advocates. Longitudinal data is clear that Black, Indigenous, people of color (BIPOC) students are punished and policed at higher rates than their white classmates. For students who have disabilities, especially those with intersectional identities, the impact of school discipline and policing is amplified, with disparities existing at some of the highest rates across multiple categories. And this disproportionality has not diminished during short- and long-term school closures resulting from the COVID-19 pandemic. In fact, schools have employed new models of exclusion in the pandemic setting that operate …

Survival Voting And Minority Political Rights, Douglas M. Spencer, Lisa Grow Sun, Brigham Daniels, Chantel Sloan, Natalie Blades

American University Law Review

The health of American democracy has literally been challenged. The global pandemic has powerfully exposed a long-standing truth: electoral policies that are frequently referred to as “convenience voting” are really a mode of “survival voting” for millions of Americans. As our data show, racial minorities are overrepresented among voters whose health is most vulnerable, and politicians have leveraged these health disparities to subordinate the political voice of racial minorities.

To date, data about racial disparities in health has played a very limited role in assessing voting rights. A new health lens on the racial impacts of voting rules would beneficially …

Patent Eligibility And Cancer Therapy, Christopher B. Seaman

Washington and Lee Law Review

As an empirical legal scholar, I am pleased to report that Sasha Hoyt has done what very few law students—and even many law professors—could achieve. She successfully conducted a novel empirical study to assess the real-world impact of a U.S. Supreme Court decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc., on venture capital (VC) investment in startups and other companies that develop medical diagnostic technology.

As Ms. Hoyt notes, patent protection is particularly important for startup companies, as it can help protect their innovations from unauthorized use, attract funding and other investments, and foster collaboration with third parties. In …

Masthead, Volume 32 (2022)

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Volume 32 (2022), Health Matrix: Journal Of Law-Medicine

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Public Citizen's Advocacy Campaign Opposing Fda Approval Of Aducanumab For Alzheimer's Disease: The Fight Against Regulatory Capture, Michael A. Carome

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Diversity's Pandemic Distractions, Jonathan Kahn

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Anti-Vax Fear* Speech: A Public-Health-Driven Policy Initiative When Counter-Speech Won't Work (*Fake, Flawed, Fraudulent, False, Endangering, And Reckless), Barbara Pfeffer Billauer

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Treating For Two: Reforming Maternal Substance Abuse Policy, Katherine Drabiak

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Filling In The Gaps: Inaccurate Medical Records In Adoption, Leah Rothfeld

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Elevated Blood Lead Levels As Eligibility Criteria For Early Intervention Programs, Meghan Sink

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Expanding Medicaid In The Postpartum Period, Madison P. Harrell

Law Student Publications

This Comment will discuss how the current Medicaid law is insufficient to address the issue of disappointing maternal health outcomes in the United States and how the federal government should begin to remedy the problem. First, I will shed light on the maternal health crisis in the United States, before discussing the history of pregnancy and postpartum Medicaid coverage. Then, I will outline the enactment of the Affordable Care Act, the subsequent court battle over its constitutionality, and the effects of that decision on the current landscape of pregnancy and postpartum Medicaid coverage. Finally, I will detail my proposal for …