Health Law and Policy Commons^™

Maid Legislation At A Crossroads: Persons With Mental Disorders As Their Sole Underlying Medical Condition, The Halifax Group, Melissa K. Andrew, Jennifer A. Chandler, Jocelyn Downie, Colleen M. M. Flood, Arthur Frank, Mona Gupta, Kwame Mckenzie, Tanya Park

Reports & Public Policy Documents

Legislation permitting medical assistance in dying (MAiD) came into force in Quebec in December 2015, and in the rest of Canada in June 2016. The Quebec and federal MAiD laws contain detailed eligibility criteria as well as procedural safeguards. In particular, Quebec’s MAiD legislation requires that to be eligible for MAiD, a person must be “at the end of life,” whereas the federal legislation requires that a person’s “natural death” must have become “reasonably foreseeable.” At the time the two laws were introduced, legal experts warned that some eligibility criteria would require further clarification and could even face Charter of …

End-Of-Life Decision Making: Policy And Statutory Progress (2011-2020), Jocelyn Downie, Mona Gupta, L. Wayne Sumner, Joshua Wales

Reports & Public Policy Documents

In 2009, the Royal Society of Canada (RSC) identified a series of urgent scientific and public policy questions. It established a series of five Expert Panels to study the issues and provide recommendations for next steps. It is now timely to revisit the findings of these Expert Panel Reports. What impact have they had? Have their recommendations been implemented? What are the next steps in terms of policy options?

To answer these questions, the RSC is establishing Policy Briefing Committees (PBC) to:

• describe the context, findings, and recommendations of the report;
• track policy developments in relation to the panel’s findings …

Geographical Indications Of Origin, Economic Development, And Cultural Heritage: Good Match Or Mismatch?, Irene Calboli

Faculty Scholarship

In this article, I propose that geographical indications (GIs) carry important economic benefits. First, GIs are essential instruments to facilitate investments in high-quality products and niche markets, and promote local trade and development. Second, GIs offer an additional layer of information for consumers about the geographical origin and quality of the products they identify, in turn reducing the information asymmetries between producers and consumers. Third, because of this information function, GIs can assist in rewarding or holding producers accountable for their products based on the additional information they convey to the market. Yet, GIs can also protect culture-related interests and …

The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan

Faculty Scholarship

The year 2020 marks the 25th anniversary of including intellectual property rights within the larger agenda of trade. While the marriage between trade and intellectual property was always uncomfortable, COVID-19 exposed the flaws, failures and the inadequacy of the trade agenda to harmonise intellectual property rights, particularly for patents in pharmaceuticals. Typically, the United States through its questionable United States Trade Representative (USTR) process exposed the vulnerabilities of the intellectual property systems of the rest of the world. COVID-19 exposed the manner in which the so-called ‘superior’ intellectual property regime of the US left the country with a weak health-care …

Nothing Generic About It: Promoting Therapeutic Access By Overcoming Regulatory And Legal Barriers To A Robust Generic Medical Device Market, Megan S. Wright, Zachary Shapiro, Adam Pan, Keturah James, Joseph Fins

Faculty Scholarship

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the …

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 …

Encomium For Karen Rothenberg, Ellen W. Clayton

Vanderbilt Law School Faculty Publications

Karen is also a zealous advocate in the very best sense of the word. After Struewing's article appeared, she wrote an editorial that appeared in multiple newspapers arguing that women with these variants should not lose their insurance. She became deeply involved in the National Action Plan for Breast Cancer, a powerful grass roots organization. Additionally, she became involved at the National Institutes of Health and addressed, often in leadership roles, such issues to develop strategies to prevent genetic discrimination for individuals with variants that increased the risk of developing cancer, to create tools to obtain meaningful informed consent for …

The Invisible Prison: Pathways And Prevention, Margaret F. Brinig, Marsha Garrison

Journal Articles

In this paper, we propose a new strategy for curbing crime and delinquency and demonstrate the inadequacy of current reform efforts. Our analysis relies on our own, original research involving a large, multi-generational sample of unmarried fathers from a rust-belt region of the United States as well as the conclusions of earlier researchers.

Our own research data are unusual in that they are holistic and multigenerational: The Court-based record system we utilized for data collection provided detailed information on child maltreatment, juvenile status and delinquency charges, child support, parenting time, orders of protection, and residential mobility for focal children (the …

Privacy And Pandemics, Clarisa Long

Faculty Scholarship

The beginning of 2020 marked an unexpected turn for the world, the global pandemic of COVID-19 has affected every aspect of life. It has also created an unprecedented opportunity for governments to justify the expansion of their surveillance and collection of data. The foregoing essay, which was first published in Faculty Publications at Scholarship Archive of the Columbia Law School focuses on two types of data collection – governmental mass collection of nonanonymized location data and state-collected nonanonymized data on people's health and immunity status. Several countries have applied one or both practices and it is relevant to look into …

Public Health Law Tools: A Brief Guide, Kristen Underhill

Faculty Scholarship

The COVID-19 pandemic offers a threat with few precedents in modern times and tests the tools of modern surveillance and public health law. The goal of this chapter is to provide a brief overview of the types of measures that state and federal governments can invoke to treat and prevent the spread of infectious disease. The following sections will provide an orientation to domestic public health law followed by the types of measures available to state and federal public health authorities.

Although this chapter does not consider international institutions, treaties, or norms that affect public health, these are also essential …

Who’S Afraid Of Section 1498? A Case For Government Patent Use In Pandemics And Other National Crises, Christopher J. Morten, Charles Duan

Faculty Scholarship

COVID-19 has created pressing and widespread needs for vaccines, medical treatments, PPE, and other medical technologies, needs that may conflict – indeed, have already begun to conflict – with the exclusive rights conferred by United States patents. The U.S. government has a legal mechanism to overcome this conflict: government use of patented technologies at the cost of government-paid compensation under 28 U.S.C. § 1498. But while many have recognized the theoretical possibility of government patent use under that statute, there is today a conventional wisdom that § 1498 is too exceptional, unpredictable, and dramatic for practical use, to the point …

The New "Essential": Rethinking Social Goods In The Age Of Covid-19, Olatunde C.A. Johnson

Faculty Scholarship

The Covid-19 crisis has laid bare the fragility of social insurance systems in the United States and the lack of income security and basic benefits for many workers and residents. The United States has long had weaker protections for workers compared to other liberal democracies racial and economic disparities among those most affected by these dislocations (analyses are hampered by a paucity of demographic data). Those who were socially and economically vulnerable before the pandemic (for example due to homelessness, immigration status, or incarceration) are likely to suffer the most harm. Changes in workplace conditions as a result of the …

Covid-19 And Prisoners’ Rights, Gregory Bernstein, Stephanie Guzman, Maggie Hadley, Rosalyn M. Huff, Alison Hung, Anita N.H. Yandle, Alexis Hoag, Bernard E. Harcourt

Faculty Scholarship

As COVID-19 continues to spread rapidly across the country, the crowded and unsanitary conditions in prisons, jails, juvenile detention, and immigration detention centers leave incarcerated individuals especially vulnerable. This chapter will discuss potential avenues for detained persons and their lawyers seeking to use the legal system to obtain relief, including potential release, during this extraordinary, unprecedented crisis.

Linked Fate: Justice And The Criminal Legal System During The Covid-19 Pandemic, Susan P. Sturm, Faiz Pirani, Hyun Kim, Natalie Behr, Zachary D. Hardwick

Faculty Scholarship

The concept of “linked fate” has taken on new meaning in the face of the COVID-19 pandemic. People all over the world – from every walk of life, spanning class, race, gender, and nationality – face a potentially deadly threat requiring cooperation and sacrifice. The plight of the most vulnerable among us affects the capacity of the larger community to cope with, recover, and learn from COVID-19’s devastating impact. COVID-19 makes visible and urgent the need to embrace our linked fate, “develop a sense of commonality and shared circumstances,” and unstick dysfunctional and inequitable political and legal systems.

Nowhere is …

Covid-19 And The Law: Elections, Richard Briffault

Faculty Scholarship

With one Supreme Court decision, lower federal and state court decisions, pending litigation, and proposals around the country for major changes in how elections are conducted, COVID-19 has already had and likely will continue to have a significant impact on election law.

The discussion that follows proceeds in two parts. The first addresses the initial consequences of COVID-19 as an electoral emergency. Voters were due to go to the polls in states around the country just as the pandemic was gathering force and governors and mayors were calling on people to stay at home and avoid large gatherings – which, …

Child Welfare And Covid-19: An Unexpected Opportunity For Systemic Change, Jane M. Spinak

Faculty Scholarship

The COVID-19 pandemic has already wrecked greater havoc in poor neighborhoods of color, where pre-existing conditions exacerbate the disease’s spread. Crowded housing and homelessness, less access to health care and insurance, and underlying health conditions are all factors that worsen the chances of remaining healthy.Workers desperate for income continue to work without sufficient protective measures, moving in and out of these neighborhoods, putting themselves and their families at risk. During periods of greater disruption, tensions are heightened and violence more prevalent. Already some experts are warning of an onslaught of child maltreatment cases, citing earlier examples of spikes in foster …

Driver For Contactless Payments, Ronald J. Mann

Faculty Scholarship

As a consumer, my primary experience with cash before the virus was standing in checkout lines observing the sluggish pace of cash transactions in front of me. Like so many things in our lives, the advent of the virus has changed the situation markedly. From the earliest days of infection, it has been far more unsettling to observe cash transactions knowing that the virus persists on paper and metal surfaces for days.

The dynamic that has driven the choices merchants offer in face-to-face retail transactions will change as well. Driven by the private exigencies of the retail environment, the last …

Covid-19 And Lgbt Rights, Suzanne B. Goldberg

Faculty Scholarship

Even in the best of times, LGBT individuals have legal vulnerabilities in employment, housing, healthcare and other domains resulting from a combination of persistent bias and uneven protection against discrimination. In this time of COVID-19, these vulnerabilities combine to amplify both the legal and health risks that LGBT people face.

This essay focuses on several risks that are particularly linked to being lesbian, gay, bisexual, or transgender, with the recognition that these vulnerabilities are often intensified by discrimination based on race, ethnicity, age, disability, immigration status and other aspects of identity. Topics include: 1) federal withdrawal of antidiscrimination protections; 2) …

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 …

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 …

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, …

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 …

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: …