Health Law and Policy Commons^™

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: …

Assisted Dying For Prison Populations - Lessons From And For Abroad, Jocelyn Downie, Adelina Iftene, Megan Steeves

Articles, Book Chapters, & Popular Press

No abstract provided.

Developing Product Label Information To Support Evidence-Informed Use Of Vaccines In Pregnancy, Terra A. Manca, Janice E. Graham, Ève Dubé, Melissa Kervin, Eliana Castillo, Natasha S. Crowcroft, Deshayne B. Fell, Michael Hadskis, Jaelene M. Mannerfeldt, Devon Greyson, Noni E. Macdonald, Karina A. Top, On Behalf Of The Canadian Vaccine Product Monograph Working Group

Articles, Book Chapters, & Popular Press

Background: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.

Purpose: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.

Methods: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) …

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

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Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

The Gender Injustice Of Abortion Laws, Joanna Erdman

Articles, Book Chapters, & Popular Press

This commentary is a response to Katarzyna Sękowska-Kozłowska’s article on the treatment of criminal abortion laws as a form of sex discrimination under international human rights law through a study of the communications, Mellet v. Ireland and Whelan v. Ireland. The commentary offers a reading of these communications, and specifically the sex discrimination analysis premised on inequalities of treatment among women, as an engagement with the structural discrimination that characterises abortion laws, and asa radical vision for gender justice under international human rights law.

The Intersection Of Indigenous Public Health With Law And Policy In Canada, Constance Macintosh

Articles, Book Chapters, & Popular Press

This chapter presents an overview of the law, policy and governance practices that are most directly implicated in the population health of Indigenous people who reside in Canada. The first section provides a general description of the socio-legal categories that are drawn upon in health policy, programming and legislation regarding Indigenous peoples. It briefly describes roles in funding and delivering community health services and programming, as well as disputes about responsibilities and some shortcomings.

The second section provides an overview of the population health status of Indigenous peoples. Epidemiological data is presented, and select social determinants of health are also …

Refusing Care As A Legal Pathway To Medical Assistance In Dying, Jocelyn Downie, Matthew J. Bowes

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Can a competent individual refuse care in order to make their natural death reasonably foreseeable in order to qualify for medical assistance in dying (MAiD)? Consider a competent patient with left-side paralysis following a right-brain stroke who is not expected to die for many years; normally his cause of death would not be predictable. However, he refuses regular turning, so his physician can predict that pressure ulcers will develop, leading to infection for which he will refuse treatment and consequently die. Is he now eligible for MAiD? Consider a competent patient with spinal stenosis (a non-fatal condition) who refuses food …

Incarceration In Canada: Risks To And Opportunities For Public Health, Adelina Iftene

Articles, Book Chapters, & Popular Press

In their introduction to the latest edition of Public Health Law and Policy in Canada, the editors are unequivocal about the importance of this area of growing interest and scholarship. This text, they explain, “explores a range of perspectives that examine how law, in many forms and contexts, plays a critical role in protecting the public from known and emerging threats and promoting conditions for health.”

Written and edited by leading health law scholars and featuring contributions from legal and health experts from across the country, this book provides a comprehensive overview of our Canadian public health law and policy …

Illness, Injury And Medical Deportations At The Frontier: The Canadian Legal Regime For Health Care Protections For Agricultural Migrant Workers, Constance Macintosh

Articles, Book Chapters, & Popular Press

This paper explores how health interests and rights play out in the temporary agricultural worker regime. In particular, it illustrates how a system that–as discussed below–is formally positioned as granting such workers the same rights as nationals, may not in practice provide equivalent or meaningful protections. The assessment is not just about the social exclusion challenges that often undermine the ability or possibility of migrant workers to activate their legal rights (which is the usual critique of why post-national citizenship writing is overly optimistic), but about how the legal and regulatory system itself misses the mark.

A Critique Of Canadian Jurisprudence On The Therapeutic Privilege Exception To Informed Consent, Michael Hadskis

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The Supreme Court of Canada’s landmark decisions in Hopp v Lepp and Reibl v Hughes furnished a general analytical framework for informed consent actions that remains fully intact today. This article sets its gaze on a specific aspect of the framework, dubbed “therapeutic privilege,” that permits physicians to deviate from their general duty to disclose material, treatment-related risks to competent patients. Specifically, the privilege allows information about material risks to be withheld or generalized if physicians believe their patients are “unable to cope” with receiving such information. It is argued that the Supreme Court’s terse and vaguely-articulated exception to truth …

Access To Knowledge And The Global Abortion Policies Database, Joanna Erdman, Brooke Johnson

Articles, Book Chapters, & Popular Press

Research shows that women, healthcare providers, and even policy makers worldwide have limited or inaccurate knowledge of the abortion law and policies in their country. These knowledge gaps sometimes stem from the vague and broad terms of the law, which breed uncertainty and even conflict when unaccompanied by accessible regulation or guidelines. Inconsistency across national law and policy further impedes safe and evidence‐based practice. This lack of transparency creates a crisis of accountability. Those seeking care cannot know their legal entitlements, service providers cannot practice with legal protection, and governments can escape legal responsibility for the adverse effects of their …

Understandings Of Self-Managed Abortion As Health Inequity, Harm Reduction And Social Change, Joanna Erdman, Kinga Jelinska, Susan Yanow

Articles, Book Chapters, & Popular Press

This commentary explores how self-managed abortion (SMA) has transformed understandings of and discourses on safe abortion and associated health inequities through an intersection of harm reduction, human rights and collective activism. The article examines three primary understandings of the relationship between SMA and safe abortion: first SMA as health inequity, second SMA as harm reduction, and third SMA as social change, including health system innovation and reform. A more dynamic understanding of the relationship between SMA, safe abortion and health inequities can both improve the design of interventions in the field, and more radically reset reform goals for health systems …

Constitutionalizing Abortion Rights In Canada, Joanna Erdman

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This article endeavours to understand the feminist activism from which constitutional abortion rights in Canada were born in the landmark Supreme Court case of R v Morgentaler 1988, and the influence of these rights on continued feminist activism for reproductive justice. Part I reviews abortion practice in the ‘back-alley’ prior to and immediately after the 1969 criminal reform with attention to the direct service activism of liberation feminists in their campaign to repeal the abortion law as a matter of constitutional justice. Part II turns to adjudication in the courts to study how judicial reasoning channelled these constitutional claims, exploring …

Access To Knowledge And The Global Abortion Policies Database, Joanna Erdman, Brooke Johnson

Articles, Book Chapters, & Popular Press

Research shows that women, healthcare providers, and even policy makers worldwide have limited or inaccurate knowledge of the abortion law and policies in their country. These knowledge gaps sometimes stem from the vague and broad terms of the law, which breed uncertainty and even conflict when unaccompanied by accessible regulation or guidelines. Inconsistency across national law and policy further impedes safe and evidence‐based practice. This lack of transparency creates a crisis of accountability. Those seeking care cannot know their legal entitlements, service providers cannot practice with legal protection, and governments can escape legal responsibility for the adverse effects of their …

Social Science Evidence In Charter Litigation: Lessons From Carter V Canada (Attorney General), Jocelyn Downie

Articles, Book Chapters, & Popular Press

In this paper, I offer the reflections of an academic who wandered well out of her wheelhouse. While I have graduate training in both philosophy and law, I am not an expert on the use of social science and humanities evidence in litigation. But, through the course of working on Carter v Canada (Attorney General), I had the opportunity to participate directly in the process of marshalling, preparing, analyzing, and critiquing the evidence. My hope is that, through this paper, I can bring a perspective that may be useful both for practitioners who might (or, I would say, should) be …

Template Policy Re: Access To Medical Assistance In Dying In Publicly-Funded Institutions, Jocelyn Downie

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Patients are being denied access to assessments for, and provision of, medical assistance in dying (MAiD) in publicly-funded institutions in Canada. Health authorities should implement policies that prohibit forced transfer for MAiD (assessments and provision) unless it can be achieved without undue delay or harm to the patient (as determined by the MAiD Program, not the institution). This is a template policy that health authorities could adopt to ensure access to a legal health service in all publicly-funded institutions (including faith-based institutions) under their authority.

An Alternative To Medical Assistance In Dying? The Legal Status Of Voluntary Stopping Eating And Drinking (Vsed), Jocelyn Downie

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Medical assistance in dying (MAiD) has received considerable attention from many in the field of bioethics. Philosophers, theologians, lawyers, and clinicians of all sorts have engaged with many challenging aspects of this issue. Public debate, public policy, and the law have been enhanced by the varied disciplinary analyses. With the legalization of MAiD in Canada, some attention is now being turned to issues that have historically been overshadowed by the debate about whether to permit MAiD. One such issue is voluntary stopping eating and drinking (VSED) as an alternative to MAiD. In this paper, I will apply a legal lens …

The Legal Status Of Deep And Continuous Palliative Sedation Without Artificial Nutrition And Hydration, Jocelyn Downie, Richard Liu

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Deep and continuous palliative sedation combined with the withholding or withdrawal of artificial nutrition and hydration (collectively termed “PSs̄ANH”) is an important aspect of high-quality end-of-life care. It is one means of alleviating suffering. Unfortunately, the legality of this practice has been under-researched and PSs̄ANH is not yet appropriately regulated in Canada. In this paper, we explore the legal status of PSs̄ANH where it (1) will not hasten death (Type 1 PSs̄ANH); (2) might, but is not certain to, hasten death (Type 2 PSs̄ANH); or (3) is certain to hasten death (Type 3 PSs̄ANH). It is clear that Type 1 …

Medical Assistance In Dying: Lessons For Australia From Canada, Jocelyn Downie

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Canada has recently witnessed dramatic changes in end-of-life law and policy. Most notably, we have moved from a prohibitive to a permissive regime with respect to medical assistance in dying (MAiD). As a number of Australian states are actively engaged in debates about whether to decriminalise MAiD, it is worth reviewing the Canadian experience and drawing out any lessons that might usefully inform the current processes in Australia.

The Governance Of Indigenous Health, Constance Macintosh

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This chapter explores these dynamics of Indigenous health governance in Canada. It opens by describing how Indigenous peoples have successfully used constitutional arguments to assert their own vision of well-being, within the broader context of colonial oppression and attempts to erase Indigenous knowledge and culture. The chapter then tracks federal initiatives on Indigenous health, in their design and outcomes, and how they evolved into the contemporary state governance regime. The next part turns to provincial and self-government initiatives that have expanded, but also complicated, Indigenous health governance in Canada. The chapter closes by considering different ways in which provinces, territories …

Indigenous Mental Health: Imagining A Future Where Action Follows Obligations And Promises, Constance Macintosh

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This article considers what it would mean if Canada fulfilled select existing commitments and obligations concerning the mental health needs of Indigenous peoples, as identified through current programs and recent jurisprudence: that is, where would we be if Canada carried through on existing commitments? After identifying the role of law in perpetuating poor mental well-being, it assesses programs for First Nations and Inuit peoples and determines they are unlikely to be effective without operational changes and responsive funding. The article then turns to the situation of Metis and non-status First Nations and the implications ofDaniels v. Canada for changing …

Should Medical Assistance In Dying Be Extended To Incompetent Patients With Dementia? Research Protocol Of A Survey Among Four Groups Of Stakeholders From Quebec, Canada, Gina Bravo, Claudie Rodrigue, Vincent Thériault, Marcel Arcand, Jocelyn Downie, Marie-France Dubois, Sharon Kaasalainen, Cees M. Hertogh, Sophie Pautex, Lieve Van Den Block

Articles, Book Chapters, & Popular Press

Background: Alzheimer’s disease and related disorders affect a growing number of people worldwide. Quality of life is generally good in the early stages of these diseases. However, many individuals fear living through the advanced stages. Such fears are triggering requests for medical assistance in dying (MAiD) by patients with dementia. Legislation was recently passed in Canada and the province of Quebec allowing MAiD at the explicit request of a patient who meets a set of eligibility criteria, including competence. Some commentators have argued that MAiD should be accessible to incompetent patients as well, provided appropriate safeguards are in place. Governments …