Health Law and Policy Commons^™

A Qualitative Study Of Key “Regulatory” Factors Influencing Patient Access To Medical Assistance In Dying In Canada, Ruthie Jeanneret, Eliana Close, Jocelyn Downie, Ben P. White

Dalhousie Law Journal

Medical assistance in dying (“MAiD”) was legalized federally in Canada after the landmark case, Carter v Canada (AG), 2015 SCC 5. Bill C-14 introduced a federal legislative framework for MAiD in 2016, which was amended by Bill C-7 in 2021. Some Bill C-7 amendments directly responded to the decision in Truchon c Canada (PG), 2019 QCCS 3792. Other amendments responded to several factors identified as barriers to patient access, including the requirement for two independent witnesses, the 10-day reflection period, and the requirement to provide final consent at the time of administration of MAiD medication. However, emerging literature identifies that …

Privacy, Paternalism, And Standing In Health Professions Regulation, Anthony Sangiuliano

Dalhousie Law Journal

When investigating whether a doctor has behaved unethically while treating a patient, professional regulatory colleges may search patients’ confidential medical records without patients’ consent. I argue that this practice is not paternalistic, nor does it usurp patients’ standing to decide for themselves whether to sacrifice their privacy to hold the doctor to account for professional wrongdoing. College investigations that non-consensually invade patient privacy do not express disrespect for patients’ agency because they aim to mitigate harm to the broader public. Unlike criminal prosecutions of doctors which uphold moral values pervading the public at large, college investigations enforce ethical standards within …

Escaping Quarantine: Marine Hospitals, The Constitution Act, 1867 And Canada’S First Federal Health Care Program, Dan Dwyre

Dalhousie Journal of Legal Studies

Previous scholarship has argued that the enumeration of marine hospitals as a federal head of power in the Constitution Act, 1867 reflected a national concern over immigration and quarantine. This article disputes that. Using primary sources, this paper demonstrates that Canadian marine hospitals were established in port communities to provide for the general health of itinerant merchant sailors, who would otherwise be a burden on local hospitals and charitable organizations. The article concludes that marine hospitals can be viewed in retrospect as one of Canada’s first federal health care programs.

Healthcare Discrimination Under The Canadian Charter Of Rights And Freedoms, Mélisande Charbonneau-Gravel, Sébastien Jodoin, Siobhan O’Connell

Dalhousie Law Journal

This paper explores the role that the Canadian Charter of Rights & Freedoms could and should play in addressing and redressing discrimination in the context of healthcare in Canada. Drawing on landmark as well as recent jurisprudence, we analyze how sections 7 and 15 of the Charter apply to three types of healthcare discrimination: (1) lack of access to healthcare and health services; (2) lower quality of services, and attitudes and biases faced in diagnosis and treatment; and (3) physical, verbal, psychological, and sexual abuse experienced by patients. Our analysis highlights the ongoing, problematic nature of the prevailing interpretations of …

Seeing Is Believing: Identifying The “Ideal Manifestation Of Hidden Disability” In Ontario’S And Quebec’S Social Benefits Tribunals, Pascale Malenfant

Dalhousie Law Journal

The phenomenon of disability skepticism, especially in relation to “hidden” disabilities like chronic fatigue syndrome (CFS), has fostered a culture of doubt among medical, legal, and public entities. This paper explores the intersection of such skepticism with the social benefits adjudication processes in Ontario and Quebec. In drawing parallels to feminist critiques of the “ideal victim” in sexual assault cases, it argues that the tribunals’ biased framework for believability is based on a claimant’s conformity to stereotypical expectations of what an “ideal” claimant with a hidden disability looks like. By comparatively examining 10 years worth of Ontario and Quebec tribunal …

Interest-Holder Priorities For Health Surveillance Of People Incarcerated In Canada: A Qualitative Study, Jessica Gaber, Njideka Sanya, Alice Cavanagh, Savage Bear, Sara Howdle, Iridian M. Grenada, Michelle Howard, Adelina Iftene, Fiona G. Kouyoumdjian

Articles, Book Chapters, & Popular Press

Objectives: As a core function of public health, health surveillance for people who are incarcerated could address gaps in knowledge regarding their health status. The views of people who could use these data and who are included in health surveillance data should inform health surveillance. In this study, we aimed to identify the priorities of interest-holders for health surveillance of people incarcerated in Canadian correctional facilities.

Study design: We conducted an overall qualitative descriptive study with an embedded reflexive thematic analysis and a qualitative content analysis.

Methods: We conducted virtual or phone-based focus groups and interviews with people across Canada, …

Prescription Practices, Anti-Psychotics, And Covid-19: An Intersectional Examination Of The Long-Term Care Home Setting In Canada, Olivia Ramos

Dalhousie Journal of Legal Studies

Public discourse and concern over the state of long-term care homes in Canada has been ongoing over the last two decades. One of the main sources of these concerns is the off-label prescription of anti-psychotic medications to long-term care home residents. Off-label use of pharmaceuticals is common and can be beneficial in certain contexts, however, there is a risk of anti-psychotics being used as an inappropriate means of managing patients chemically in the long-term care home setting. This paper engages in three lines of inquiry: first, the regulatory landscape of on and off-label prescription in Canada; second, the off-label use …

Fighting For Abortion Access In Canada: A Constitutional Analysis, Jordana Borzellino

Dalhousie Journal of Legal Studies

Access to abortion is a controversial matter that creates a labyrinth of polarizing issues. Perspectives on abortion range from anathema to overzealous support, with stakeholders occasionally resorting to legal avenues to control access one way or another. This paper will explore the possibility of protecting and expanding access to abortion through constitutional mechanisms in the Canadian legal landscape. By analyzing Canada's current degree of access, this paper will explain that abortion services for those in need are inadequate. In order to advocate for greater access, this paper examines a multitude of legal tools and doctrines to constitutionally protect access to …

Mind The Gap: Toussaint And The Reception Of International Human Rights Law In Canada, Karinne Lantz

Articles, Book Chapters, & Popular Press

This article explores the reception of international human rights law (“IHRL”) in Canada and the enforcement gap that may arise when legislation is not passed expressly implementing human rights treaties that Canada has ratified. Despite establishing a variety of interpretive methods that may result in Canada’s binding IHRL obligations having domestic effect even when they are not expressly implemented, Canadian courts have struggled to provide clear and consistent guidance on how IHRL applies in Canada. The selective approach in Canada to implementing legislatively IHRL obligations may give rise to an enforcement gap when rights individuals purportedly enjoy under international law …

Making "Medical": How Psychedelics Are Becoming Legal In Canada, Agnieszka Doll

Dalhousie Law Journal

As legal restrictions loosen, psychedelic-assisted therapies are advancing at an unprecedented pace and scope in Canada and the US. Presented as a miracle cure for post-traumatic stress, depression, and other psychological disorders, psychedelics are being touted to treat post-pandemic mental health crises. In this paper, drawing on Science and Technology Studies, I ethnographically trace the ongoing process and practices involved in transforming illegal psychedelics into a regulated medicine in Canada, paying particular attention to regulatory pathways and the development of networks involved in psychedelic advocacy. Using these pathways as a methodological “sampling device,” I map the main actors, their mutual …

Twenty Years After Krieger V Law Society Of Alberta: Law Society Discipline Of Crown Prosecutors And Government Lawyers, Andrew Flavelle Martin

Articles, Book Chapters, & Popular Press

Krieger v. Law Society of Alberta held that provincial and territorial law societies have disciplinary jurisdiction over Crown prosecutors for conduct outside of prosecutorial discretion. The reasoning in Krieger would also apply to government lawyers. The apparent consensus is that law societies rarely exercise that jurisdiction. But in those rare instances, what conduct do Canadian law societies discipline Crown prosecutors and government lawyers for? In this article, I canvass reported disciplinary decisions to demonstrate that, while law societies sometimes discipline Crown prosecutors for violations unique to those lawyers, they often do so for violations applicable to all lawyers — particularly …

Conditions Of Confinement In Nova Scotia Jails Designated For Men: East Coast Prison Justice Society Visiting Committee Annual Report 2021-2022, Sheila Wildeman, Harry Critchley, Hanna Garson, Laura Beach, Margaret-Anne Mchugh

Reports & Public Policy Documents

This is the second Annual Report of the East Coast Prison Justice Society (“ECPJS”) Visiting Committee (“VC”).

The purpose of the ECPJS VC is to bring increased accountability and transparency to the Nova Scotia correctional system in light of human rights standards, domestic and international. While the Elizabeth Fry Society of Mainland Nova Scotia provides human rights monitoring of conditions of incarceration experienced by women and non-binary people in federal prisons and provincial jails in the Atlantic region, and the federal Office of Correctional Investigator provides further oversight of conditions in federal prisons, there is no comparable independent oversight of …

‘A Most Equitable Drug’: How The Clinical Studies Of Convalescent Plasma As A Treatment For Sars-Cov-2 Might Usefully Inform Post-Pandemic Public Sector Approaches To Drug Development, Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway

Articles, Book Chapters, & Popular Press

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021. We found that studies were mobilized and scaled at record pace due to well-connected investigators who engaged in widespread sharing of clinical trials resources, regulatory facilitators, and …

'More Of The Same, But Worse Than Before': A Qualitative Study Of The Challenges Encountered By People Who Use Drugs In Nova Scotia, Canada During Covid-19, Emilie Comeau, Matthew Bonn, Sheila Wildeman, Matthew Herder

Articles, Book Chapters, & Popular Press

Background

To learn about the experiences of people who use drugs, specifically opioids, in the Halifax Regional Municipality (HRM), in Nova Scotia, Canada during the COVID-19 pandemic through qualitative interviews with people who use drugs and healthcare providers (HCP). This study took place within the HRM, a municipality of 448,500 people. During the pandemic many critical services were interrupted while overdose events increased. We wanted to understand the experiences of people who use drugs as well as their HCPs during the first year of the pandemic.

Methodology

We conducted a qualitative study using semi-structured interviews with 13 people who use …

Advocates’ Perspectives On The Canadian Prison Mother Child Program, Martha Paynter, Clare Heggie, Ruth Martin-Misener, Adelina Iftene, Gail Tomblin Murphy

Articles, Book Chapters, & Popular Press

Over twenty years ago, Correctional Services Canada launched the Mother Child Program (MCP) to mitigate harms of separating incarcerated mothers from their babies. It has never been subjected to internal evaluation or independent study. The aim of the qualitative study was to explore the experiences of advocates employed by Elizabeth Fry Societies (EFS), community organizations dedicated to the support of incarcerated women, with respect to supporting people who were pregnant or had young children while federally incarcerated and did or did not participate in the MCP.

Assessing The Constitutional Validity Of Substantiation Laws For Medical Device Safety And Effectiveness Under The Medical Devices Regulations And The Food And Drugs Act, Victoria Kongats

LLM Theses

This thesis examines federal scientific evidence requirements for medical device safety and effectiveness under the mainstream market entry licensing pathway under Part 1 of the Medical Devices Regulations, and under the new ‘agile’ market entry pathway, the Advanced Therapeutic Products Amendments, which amended the Food and Drugs Act. Apart from a narrow category of medical devices (near patient in vitro diagnostic devices), scientific evidence requirements are vague and do not enumerate explicit expectations for methodologically rigorous forms of scientific evidence. Medical device safety and effectiveness could be more predictable with explicit expectations for scientific rigour. The thesis analyzes if this …

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 …

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 …

Recommendations On Mature Minors, Constance Macintosh

Reports & Public Policy Documents

Recommendation: The Committee should remove the requirement from the Criminal Code that candidates for Medical Assistance in Dying (MAID) be at least 18 years old. This is for the following reasons, elaborated upon below.

1.The MAID regime should always turn on the actual capacity of any person requesting MAID

2.The MAID regime’s approach to consent and capacity should be consistent with Canadian law on health care decision-making by minors

3.The MAID regime will likely be found unconstitutional if it maintains an age-based bar

4.The vulnerability of youth may require a different approach but does not justify an age-based bar

5.Removing …

'The Perfect Shouldn't Be The Enemy Of The Good' — What Canada Can Do Today, Tomorrow & Next Week To Enhance Equitable Access To Covid-19 Biopharmaceutical Interventions, Matthew Herder

Reports & Public Policy Documents

There is overwhelming evidence of inequitable access to a range of COVID-19 targeting biopharmaceutical interventions, including not only vaccines but also anti-viral drug therapies, diagnostic tests, and various materials that are incorporated into these products. As recently explained by Yamey et al. in the British Medical Journal, inequitable access is baked into every phase of the biopharmaceutical system—from production and allocation to affordability and deployment. Yet, it is still possible to improve access to these critically important biopharmaceutical interventions in low and middle-income countries (LMICs). Intellectual property (IP) rights are one crucial site where policy intervention can make an immediate …

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.

Regulation Of Health-Related Artificial Intelligence In Medical Devices: The Canadian Story, Michael Da Silva, Colleen M. M. Flood, Matthew Herder

Articles, Book Chapters, & Popular Press

Artificial Intelligence (AI) may transform Canadian healthcare. The hope is that AI will enable more accurate and efficient care, thereby solving many access, quality, and safety problems. Yet, despite this tantalizing prospect, there are risks of unsafe AI harming patients, algorithmic bias, and threats to privacy. This work begins analysis of whether applicable Canadian laws are up to the task of ensuring Canadians can benefit from effective health-related AI while minimizing AI-related risks. It focuses on Health Canada’s regulation of medical devices, a ‘first line of defence’ that decides which devices are safe, effective, and thus permitted for trade in …

Protecting Expert Advice For The Public: Promoting Safety And Improved Communications, Julia M. Wright, Wendy Hui Kyong Chun, Amanda Clarke, Matthew Herder, Howard Ramos

Articles, Book Chapters, & Popular Press

The drivers of the harassment and intimidation of researchers are complex, widespread, and global in their reach and were being studied across many disciplines even before COVID-19. This policy briefing reviews some of the scholarship on this wide-ranging problem but focuses on what can be done to help ensure that Canadians fully benefit from the work of Canada’s researchers while also preserving the security and safety of those researchers. It identifies policies and actions that can be implemented in the near term to gather information on the problem, better frame public research communications, and ensure that mechanisms are readily available …

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 …

Conflicts Of Interest In Self-Regulating Health Professions Regulators, Andrea Macgregor

Dalhousie Law Journal

This article analyzes a set of related complaints and informal reports made to the Nova Scotia College of Chiropractors with respect to an alleged breach of the College’s advertising policy. This analysis assessed situational elements of conflicts of interest in the complaint process, particularly dual roles and competing professional interests, against the Childress et al framework of ethical public health decision-making and the conflict-of-interest standards in the Nova Scotia Chiropractic Act and Regulations.

The analysis concludes that the legislative scheme fails to adequately regulate conflicts of interest and bias in the College’s disciplinary decision-making processes through weak or unarticulated standards …

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 …

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 …