Health Law and Policy Commons^™

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, …

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

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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 …

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

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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 …

‘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

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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

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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

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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.

On What Basis Did Health Canada Approve Oxycontin In 1996? A Retrospective Analysis Of Regulatory Data, Jessie Pappin, Itai Bavli, Matthew Herder

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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 …

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

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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

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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

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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

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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

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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

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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 …

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

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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

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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

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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 …

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

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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, …

Legislative Options To Address Institutional Objections To Voluntary Assisted Dying In Australia, Ben P. White, Lindy Willmott, Eliana Close, Jocelyn Downie

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Voluntary assisted dying is being considered by parliaments and law reform bodies across Australia. Although individual conscientious objection is routinely considered in these deliberations, an institution’s desire to object to providing voluntary assisted dying has received very little attention. After briefly considering the concept of institutional objection in voluntary assisted dying, this article examines the available (albeit limited) Australian evidence on this practice. Institutional objection is happening in Victoria (where voluntary assisted dying is lawful) and is likely to occur in other Australian states. The article proposes that regulation is needed and presents three models for parliaments and law reformers …

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

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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

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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.

From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham

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Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Om- nibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, how- ever, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. …

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

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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 …

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

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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 …

An Abortion Law Preformed, Joanna Erdman

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This article engages the transcribed testimony of Carolyn Egan and Janice Patricia Tripp in R v Morgentaler as a critical moment of lawmaking. There is something revealing, often amusing, and sometimes devastating, when a lawyer asks a non-lawyer, in this case, a social worker: “What is the law?” The article focuses on those moments in their testimony when Egan and Tripp answered questions about the 1969 abortion law that made the law itself, its rules and procedures, the subject of examination, and in doing so, constructed new meanings of the law and social action in relation to it in the …

Securing Safe Supply During Covid-19 And Beyond: Scoping Review And Knowledge Mobilization, Matthew Bonn, Natasha Touesnard, Brianna Cheng, Michael Pugliese, Emilie Comeau, Claire Bodkin, Thomas D. Brothers, Leah Genge, Matthew Herder, Candis Lepage, Ayden Scheim, Dan Werb, Sheila Wildeman

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Background

Safe supply is defined as the legal and regulated provision of drugs with mind and/or body altering properties that have been typically accessible only through the illegal drug market. In response to the coronavirus disease 2019 (COVID-19) pandemic and related social/physical distancing measures, efforts have been made to scale up and increase access to safe supply programs in an effort to reduce overdose and other drug- and drug policy-related risks. However, it remains unclear whether these efforts taken thus far have meaningfully mitigated the barriers to safe supply experienced by People Who Use Drugs (PWUD), both during and beyond …

Dispute Settlement Under The African Continental Free Trade Area Agreement: A Preliminary Assessment, Olabisi D. Akinkugbe

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The African Continental Free Trade Area Agreement (AfCFTA) will add a new dispute settlement system to the plethora of judicial mechanisms designed to resolve trade disputes in Africa. Against the discontent of Member States and limited impact the existing highly legalized trade dispute settlement mechanisms have had on regional economic integration in Africa, this paper undertakes a preliminary assessment of the AfCFTA Dispute Settlement Mechanism (DSM). In particular, the paper situates the AfCFTA-DSM in the overall discontent and unsupportive practices of African States with highly legalized dispute settlement systems and similar WTO-Styled DSMs among other shortcomings. Notwithstanding the transplantation of …

Covid-19 Provincially Incarcerated Individuals - A Policy Report, Adelina Iftene

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This document is the result of an investigation into the impact of the COVID-19 pandemic on provincially incarcerated individuals and the Nova Scotia government’s responses relating to its prison population. It was supported by the Nova Scotia COVID-19 Health Research Coalition. In this memorandum, we describe the results of the investigation and propose solutions to better prepare for the second wave of COVID-19 or an alike pandemic situation.

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

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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

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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

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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 …