Health Law and Policy Commons^™

Regulate Physician Restrictive Covenants To Improve Healthcare, Judy Ann Clausen

UF Law Faculty Publications

The U.S. healthcare reform agenda seeks to expand patient choice and access, improve quality, and control costs. This Article argues these goals should govern enforceability of physician non-compete and non-solicitation agreements (restrictive covenants). Most jurisdictions apply a reasonableness test to assess the enforceability of physician restrictive covenants. Some jurisdictions hold physician non-competes per se invalid. Courts applying the reasonableness test often disrupt continuity of care and harm patients; continuity of care is key to patient health. Moreover, physicians departing a practice have an ethical obligation to notify patients of the physician's departure and how to transfer to the physician's new …

How Come Mary-Jane Is Not On Workers’ Comp?: Requiring Rhode Island Workers’ Compensation Insurers To Reimburse Employees For Medical Marijuana, Devon Q. Toro

Roger Williams University Law Review

No abstract provided.

Nonexcludable Surgical Method Patents, Jonas Anderson

Utah Law Faculty Scholarship

A patent consists of only one right: the right to exclude others from practicing the patented invention. However, one class of patents statutorily lacks the right to exclude direct infringers: surgical method patents are not enforceable against medical practitioners or health care facilities, which are the only realistic potential direct infringers of such patents. Despite this, inventors regularly file for (and receive) surgical method patents. Why would anyone incur the expense (more than $20,000 on average) of acquiring a patent on a surgical method if that patent cannot be used to keep people from using the patent?

The traditional answer …

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

Saving Money On Health Insurance Just Got A Lot Easier . . . Or Did It?: The Preserving Employee Wellness Programs Act And Its Impact On The Future Of Employee Health, Zachary Maciejewski

Indiana Law Journal

This Note addresses the growing use of employer-sponsored wellness programs in the American workplace and the concomitant harms and risks these programs impose on employee privacy and insurance costs. Specifically, this Note analyzes the Preserving Employee Wellness Programs Act (PEWPA)—a proposed law that would allow employers to require employees to disclose genetic information to qualify for an employer-sponsored wellness program (and the program’s associated insurance premium benefits). This Note ultimately argues that employees and employee advocacy groups must work to thwart PEWPA to preserve employee privacy in the face of mounting corporate pressure to alter the structure of employer-sponsored health …

Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval …

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …

Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder

Articles, Book Chapters, & Popular Press

Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …

Editorial, Lucie Guibault

Articles, Book Chapters, & Popular Press

1 This issue marks the tenth month into the COVID-19 pandemic. Since March 2020, we have learned to live with the more or less strict public health measures put in place to ‘flatten the curve’ of infection from the virus. Words like ‘social distancing’, ‘mask wearing’, and ‘lockdowns’ have taken an entirely new meaning. In spite of these measures, the human toll is huge, most clearly among frontline workers and vulnerable people. While the curve is far from flat in most countries, the pandemic has brought to light the long time unacknowledged persistence of systemic inequalities: figures show that poorer, …

Covid-19 Vaccines As Global Public Goods, Jason W. Nickerson, Matthew Herder

Articles, Book Chapters, & Popular Press

Vulnerable: The Law, Policy and Ethics of COVID-19 confronts the vulnerabilities that have been revealed by the pandemic and its consequences. It examines vulnerabilities for people who have been harmed or will be harmed by the virus directly and those harmed by measures taken to slow its relentless march; vulnerabilities exposed in our institutions, governance, and legal structures; and vulnerabilities in other countries and at the global level where persistent injustices affect us all. COVID-19 has forced us to not only reflect on how we govern and how we set policy priorities, but also to ensure that pandemic preparedness, precautions, …

Fighting For Deinstitutionalization In Nova Scotia: Emerald Hall Human Rights Case, Sheila Wildeman

Articles, Book Chapters, & Popular Press

Those who have not been following the human rights complaint, MacLean v Nova Scotia, should start paying attention now. The case will be heard at the Nova Scotia Court of Appeal in November. People First Canada, CACL and the Council of Canadians with Disabilities will intervene.

At stake is whether institutionalization counts as discrimination - and what, if anything, human rights can do to respond.

Beth MacLean, Joey Delaney and Sheila Livingstone, all persons labeled with intellectual disabilities, brought the complaint to the Nova Scotia human rights commission in 2014. The Disability Rights Coalition [DRC] joined in the complaint.

MacLean, …

Surfacing Contexts Of Violence In Novel Forms Of The Reproductive Justice Framework Through Lessons From Latin America: A Study Of Brutality, Migration And Bodily Autonomy And Progressive Solutions For Use In Public Health, Angelica M. Campos

CMC Senior Theses

In the last 5 years, Latin America has witnessed a tenacious wave of pañuelo verde and #NiUnaMenos activism. Sparked by increasing mortality rates associated with unsafe, clandestine abortions and femicide, the praxes and fundamental elements of these social movements have proven themselves useful not only in garnering international attention on issues relating to bodily autonomy, but in the synthesis of their respective sociopolitical solutions as well. In the United States, similar efforts have been spearheaded by the lauded reproductive justice framework, which has often been credited for centering the plight of women of color in both reproduction and social justice. …

Assisted Dying And Evidence-Based Law-Making: A Critical Analysis Of An Article’S Role In New Zealand’S Referendum, Ben White, Lindy Willmott, Jocelyn Downie, Andrew Geddis, Colin Gavaghan

Articles, Book Chapters, & Popular Press

Aim: To critically analyse the reliability of an article which claims to be evidence that the End of Life Choice Act 2019 provides a “potential hotspot for family, community and social discord that may not be easily remedied” should the legislation receive public support in New Zealand’s September 2020 referendum.

Method: The subject article was reviewed multiple times by all authors and critiqued against three criteria: a reliability pyramid developed to weigh evidence about assisted dying; principles that guide the conduct of social science research; and the use of reliable and current social science literature to support factual claims.

Results: …

From Discovery To Delivery: Public Sector Development Of The Rvsv-Zebov Ebola Vaccine, Matthew Herder, Janice Graham, Richard Gold

Articles, Book Chapters, & Popular Press

The discovery and development of the Ebola rVSV-ZEBOV vaccine challenge the common assumption that the research and development for innovative therapeutic products and vaccines is best carried out by the private sector. Using internal government documents obtained through an access to information request, we analyze the development of rVSV-ZEBOV by researchers at Canada’s National Microbiology Laboratory beyond its patenting and licensing to a biotech company in the United States in 2010. According to government documentation, the company failed to make any progress toward a phase 1 clinical trial until after the WHO Public Health Emergency of International Concern freed substantial …

Dementia, Autonomy, And Supported Healthcare Decisionmaking, Megan S. Wright

Faculty Scholarship

Healthcare providers often rely on surrogates to decide on behalf of their patients with dementia who are deemed incapable of exercising autonomy. There is a longstanding debate about the appropriate standard of surrogate healthcare decisionmaking for these patients. Many influential scholars argue that the precedent autonomy of the person with dementia should be respected, and healthcare decision-making laws generally reflect this principle. These laws direct surrogate decisionmakers to follow instructions in living wills or to decide on the basis of the wishes and values of the person before the onset of dementia.But other prominent scholars have questioned whether surrogates should …

Covid-19 Business Interruption Insurance Losses: The Cases For And Against Coverage, Christopher French

Faculty Scholarship

The financial consequences of the government-ordered shutdowns of businesses across America to mitigate the COVID-19 health crisis are enormous. Estimates indicate that small businesses have lost $255 to $431 billion per month and more than 44 million workers have been laid off. When businesses have requested reimbursement of their business interruption losses from their insurers under business interruption policies, their insurers have denied the claims. The insurance industry also has announced that business interruption policies do not cover pandemic losses, so they intend to fight COVID-19 claims “tooth and nail.” More than 450 lawsuits throughout the country already have been …

End-Of-Life Care For Federally Incarcerated Individuals In Canada, Adelina Iftene, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In this article, we review the current legislation, policies, and practices related to end- of-life care for federally incarcerated individuals as set out in statutes, guidelines, and government reports and documents that were either publicly available or obtained through Access to Information requests from the Parole Board of Canada and Correctional Service of Canada (CSC). Based on this review, we describe the status quo, identify gaps, and offer reflections and raise concerns regarding end-of-life care for federally incarcerated individuals. We conclude that there are significant information gaps about the number of people seeking end-of-life care and about how CSC is …

Reducing Unnecessary Caesarean Sections: Scoping Review Of Financial And Regulatory Interventions, Newton Opiyo, Claire Young, Jennifer Harris Requejo, Joanna Erdman, Sarah Bales, Ana Pilar Betrán

Articles, Book Chapters, & Popular Press

Background: Caesarean sections (CS) are increasing worldwide. Financial incentives and related regulatory and legislative factors are important determinants of CS rates. This scoping review examines the evidence base of financial, regulatory and legislative interventions intended to reduce CS rates.

Methods: We searched MEDLINE, EMBASE, CINAHL and two trials registers in June 2019. Both experimental and observational intervention studies were eligible for inclusion. Primary outcome measures were: CS, spontaneous vaginal and instrumental birth rates. We assessed quality of evidence using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method.

Results: We identified 9057 articles and assessed 65 full-texts. We included 16 …

Covid-19 In Canadian Prisons: Policy, Practice And Concerns, Adelina Iftene

Articles, Book Chapters, & Popular Press

Correctional Service of Canada and the provincial prison systems have a duty to provide incarcerated individuals with health services that are comparable to those in the community, but they have failed to do so during the COVID-19 pandemic. There are inherent practical difficulties to implementing health care in prisons. In addition, prison demographics include a higher proportion of populations that are vulnerable to disease. These factors together mean that the prison response to COVID-19 must involve depopulation and the implementation of guidelines provided by public health agencies in all institutions. So far, the measures taken have been insufficient, as is …

International Economic Law In The Global South And Covid-19, James Thuo Gathii, Olabisi D. Akinkugbe, Nthope Mapefane, Ohio Omiunu, Titilayo Adebola

Articles, Book Chapters, & Popular Press

The COVID-19 pandemic has disrupted all facets of human relations on a magnitude not witnessed in the post-World War II era. Due to the interdependence of countries in the international system, it is not surprising that the unfolding public health crisis has had significant ramifications for the functioning of the global economy as well. In responding to this global health crisis, and the associated fallouts, the academic community has a crucial role to play in finding solutions to the hydra-headed problems we all face.

Driven by this sense of urgency and responsibility, AfronomicsLaw put out a call for contributions in …