Medical Jurisprudence Commons^™

Assistance In Dying: A Comparative Look At Legal Definitions, Jocelyn Downie, Mona Gupta, Stefano Cavalli, Samuel Blouin

Articles, Book Chapters, & Popular Press

Euthanasia, assisted suicide, medical assistance in dying, death with dignity: these and many other different terms are used around the world to capture various types of assistance in dying. This diversity in terminology can create confusion both in academic debates and in policy-making if it is unclear what type of action or inaction is intended to be captured, by whom, and under what circumstances. By defining and contrasting several terms and legal status of assistance in dying in jurisdictions authorizing it, this comparative glossary aims to lay a foundation that prevents linguistic and conceptual confusion.

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 …

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 …

In The Name Of Public Health: Misoprostol And The New Criminalization Of Abortion In Brazil, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the …

Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, …

Factors Affecting Access To Administrative Health Data For Research In Canada: A Study Protocol, Cynthia Kendell, Adrian Levy, Geoff Porter, Elaine Gibson, Robin Urquhart

Articles, Book Chapters, & Popular Press

In Canada, most provinces have established administrative health data repositories to facilitate access to these data for research. Anecdotally, researchers have described delays and substantial inter-provincial variations in the timeliness of data access approvals and receipt of data. Currently, the reasons for these delays and variations in timeliness are not well understood. This paper provides a study protocol for (1) identifying the factors affecting access to administrative health data for research within select Canadian provinces, and (2) comparing factors across provinces to assess whether and how they contribute to inter-provincial variations in access to administrative health data for research.

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Articles, Book Chapters, & Popular Press

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Social Determinants Of Health And Slippery Slopes In Assisted Dying Debates: Lessons From Canada, Jocelyn Downie, Udo Schuklenk

Articles, Book Chapters, & Popular Press

The question of whether problems with the social determinants of health that might impact decision-making justify denying eligibility for assisted dying has recently come to the fore in debates about the legalization of assisted dying. For example, it was central to critiques of the 2021 amendments made to Canada’s assisted dying law. The question of whether changes to a country’s assisted dying legislation lead to descents down slippery slopes has also come to the fore—as it does any time a jurisdiction changes its laws. We explore these two questions through the lens of Canada’s experience both to inform Canada’s ongoing …

Attitudes Toward Withholding Antibiotics From People With Dementia Lacking Decisional Capacity: Findings From A Survey Of Canadian Stakeholders, Gina Bravo, Lieve Van Den Block, Jocelyn Downie, Marcel Arcand, Lise Trottier

Articles, Book Chapters, & Popular Press

Background

Healthcare professionals and surrogate decision-makers often face the difficult decision of whether to initiate or withhold antibiotics from people with dementia who have developed a life-threatening infection after losing decisional capacity.

Methods

We conducted a vignette-based survey among 1050 Quebec stakeholders (senior citizens, family caregivers, nurses and physicians; response rate 49.4%) to (1) assess their attitudes toward withholding antibiotics from people with dementia lacking decisional capacity; (2) compare attitudes between dementia stages and stakeholder groups; and (3) investigate other correlates of attitudes, including support for continuous deep sedation (CDS) and medical assistance in dying (MAID). The vignettes feature a …

Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder

Articles, Book Chapters, & Popular Press

Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …

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 …

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 …

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: …

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 …

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) …

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.

No More Chances For Lost Chances: A Weinribian Response To Weinrib, Nayha Acharya

Articles, Book Chapters, & Popular Press

Sometimes, patients who were negligently misdiagnosed by their doctors are unable to receive any compensation through tort litigation. This has led to a perception of unfairness, igniting arguments in favour of what is known as the “loss of chance” doctrine. Under this doctrine, patients would be able to claim damages for the lost chances of recovery that they suffered due to negligent misdiagnoses. British and Canadian courts have rejected this doctrine in the medical negligence context on the basis that it does not cohere with tort law principles of injury compensation. Professor Ernest Weinrib, in “Causal Uncertainty” (2016) 36:1 Oxford …

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 …

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 …

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

Articles, Book Chapters, & Popular Press

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 …

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

Articles, Book Chapters, & Popular Press

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 …

Interpreting Canada's Medical Assistance In Dying Legislation, Jocelyn Downie, Jennifer A. Chandler

Reports & Public Policy Documents

When the Canadian medical assistance in dying (MAiD) legislation came into force in June 2016, it was widely noted that the meaning of some of its key terms and phrases was unclear. For example, questions were immediately raised about the meaning of “incurable illness, disease, or disability,” “advanced state of irreversible decline in capability,” and “natural death has become reasonably foreseeable.” Interpretation challenges are not uncommon with new legislation. However, in the context of something as significant as access to MAiD and potential criminal liability for getting the meaning of the legislation wrong, these challenges must be confronted by those …

Constitutionalizing Abortion Rights In Canada, Joanna Erdman

Articles, Book Chapters, & Popular Press

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 …

Next Up: A Proposal For Values-Based Law Reform On Unilateral Withholding And Withdrawal Of Potentially Life-Sustaining Treatment, Jocelyn Downie, Lindy Willmott, Ben White

Articles, Book Chapters, & Popular Press

As the legalization of assisted dying shifts from a project for law reform to one of implementation, the gaze for Canadian end of life law and policy academics and practitioners should be turned quickly to another pressing issue – the unilateral withholding and withdrawal of potentially life-sustaining treatment. What should happen when the health care team believes that treatment should not be provided and the patient’s loved ones believe that it should? While the future of end of life law and policy no doubt includes many other issues, this is an urgent and immediate horizon issue for Canada as well …

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 …

Human Rights Education In Patient Care, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores how human rights education in the health professions can build knowledge, change culture, and empower advocacy. Through a study of educational initiatives in the field, the article analyzes different methods by which health professionals come to see the relevance of human rights norms for their work, to habituate these norms in everyday practice, and to espouse these norms in advocacy for social justice. The article seeks to show the transformative potential of education for human rights in patient care.

A Test For Freedom Of Conscience Under The Canadian Charter Of Rights And Freedoms: Regulating And Litigating Conscientious Refusals In Health Care, Jocelyn Downie, Francoise Baylis

Articles, Book Chapters, & Popular Press

Conscientious refusal to provide insured health care services is a significant point of controversy in Canada, especially in reproductive medicine and end-of-life care. Some provincial and territorial legislatures have developed legislation or regulations, and some professional regulatory bodies have developed policies or guidelines, to better reconcile tensions between health care professionals’ conscience and patients’ access to health care services. As other groups attempt to draft standards and as challenges to existing standards head to court, the fact that the meaning of “freedom of conscience” under the Canadian Charter of Rights and Freedoms is not yet settled will become ever more …

The Law Of Stigma, Travel, And The Abortion-Free Island, Joanna Erdman

Articles, Book Chapters, & Popular Press

In 1988, the Supreme Court of Canada decriminalized abortion in R. v. Morgentaler. Almost immediately thereafter, the Maritime province of Prince Edward Island ("P.E.I.") passed a legislative resolution opposing the provision of abortion services on the Island except to save the life of a pregnant woman. P.E.I. is a small pastoral province of rolling hills and ocean coves in the St. Lawrence Gulf, and since 1988, through various regulatory actions, its government has honored this policy promise to keep the Island abortion-free and to preserve its moral landscape.

The same year that abortion was banished from P.E.I., Prince Edward Islanders …

International Human Rights And The Mistreatment Of Women During Childbirth, Rajat Khosla, Christina Zampas, Joshua P. Vogel, Meghan A. Bohren, Mindy Roseman, Joanna Erdman

Articles, Book Chapters, & Popular Press

International human rights bodies have played a critical role in codifying, setting standards, and monitoring human rights violations in the context of sexual and reproductive health and rights. In recent years, these institutions have developed and applied human rights standards in the more particular context of maternal mortality and morbidity, and have increasingly recognized a critical human rights issue in the provision and experience of care during and after pregnancy, including during childbirth. However, the international human rights standards on mistreatment during facility-based childbirth remain, in an early stage of development, focused largely on a discrete subset of experiences, such …