Law Commons^™

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.

'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 …

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 …

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 …

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 …

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 …

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 …

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

Articles, Book Chapters, & Popular Press

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 …

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

Articles, Book Chapters, & Popular Press

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

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 …

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 …

An Abortion Law Preformed, Joanna Erdman

Articles, Book Chapters, & Popular Press

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

Articles, Book Chapters, & Popular Press

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 …

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 …

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 …

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, …

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 …

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.

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

Articles, Book Chapters, & Popular Press

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

Articles, Book Chapters, & Popular Press

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.

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

Reports & Public Policy Documents

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

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

Reports & Public Policy Documents

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

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

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