Law Commons^™

'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 …

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 …

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.

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 …

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, …

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 …

Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley

Articles

As Americans report ever-growing difficulty affording their prescription drugs, President Donald Trump has come under increasing pressure to act. To date, the Trump administration has attempted to advance a number of policy initiatives by means of executive action, but it has not yet adopted a program that would meaningfully assist patients. Most recently, the administration proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada, with the intent of reducing spending on drugs by U.S. patients and states and increasing access for patients.

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 …

Fighting For Deinstitutionalization In Nova Scotia: Emerald Hall Human Rights Case, Sheila Wildeman

Articles, Book Chapters, & Popular Press

Those who have not been following the human rights complaint, MacLean v Nova Scotia, should start paying attention now. The case will be heard at the Nova Scotia Court of Appeal in November. People First Canada, CACL and the Council of Canadians with Disabilities will intervene.

At stake is whether institutionalization counts as discrimination - and what, if anything, human rights can do to respond.

Beth MacLean, Joey Delaney and Sheila Livingstone, all persons labeled with intellectual disabilities, brought the complaint to the Nova Scotia human rights commission in 2014. The Disability Rights Coalition [DRC] joined in the complaint.

MacLean, …

Covid-19 Vaccines As Global Public Goods, Jason W. Nickerson, Matthew Herder

Articles, Book Chapters, & Popular Press

Vulnerable: The Law, Policy and Ethics of COVID-19 confronts the vulnerabilities that have been revealed by the pandemic and its consequences. It examines vulnerabilities for people who have been harmed or will be harmed by the virus directly and those harmed by measures taken to slow its relentless march; vulnerabilities exposed in our institutions, governance, and legal structures; and vulnerabilities in other countries and at the global level where persistent injustices affect us all. COVID-19 has forced us to not only reflect on how we govern and how we set policy priorities, but also to ensure that pandemic preparedness, precautions, …

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 …

A Constitutional Future For Abortion Rights In Canada, Joanna Erdman

Articles, Book Chapters, & Popular Press

In 2015, Abortion Access Now PEI legally challenged the restrictive abortion policy of Prince Edward Island. This article studies their challenge as a unique case in the building of a constitutional future for abortion rights in Canada. The article tracks how AAN PEI drew on classic rule of law arguments of transparency, accountability, and constitutional justice to shape and claim abortion rights as democratic rights, an entitlement to fully and equally participate in and benefit from the health care system as a fundamental social institution of the state.

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 …

Smoking On The Margins: A Comprehensive Analysis Of A Municipal Outdoor Smoke-Free Policy, Ann Pederson, Chizimuzo T. C. Okoli, Natalie Hemsing, Renée O'Leary, Amanda T. Wiggins, Wendy Rice, Joan L. Bottorff, Lorraine Greaves

Nursing Faculty Publications

Background: This study examined the formulation, adoption, and implementation of a ban on smoking in the parks and beaches in Vancouver, Canada.

Methods: Informed by Critical Multiplism, we explored the policy adoption process, support for and compliance with a local bylaw prohibiting smoking in parks and on beaches, experiences with enforcement, and potential health equity issues through a series of qualitative and quantitative studies.

Results: Findings suggest that there was unanimous support for the introduction of the bylaw among policy makers, as well as a high degree of positive public support. We observed that smoking initially declined following the ban’s …

Immigration And Disability In The United States And Canada, Mark Weber

College of Law Faculty

Disability arises from the dynamic between people’s physical and mental conditions andthe physical and attitudinal barriers in the environment. Applying this idea aboutdisability to United States and Canadian immigration law draws attention to barriers toentry and eventual citizenship for individuals who have disabilities. Historically, NorthAmerican law excluded many classes of immigrants, including those with intellectualdisabilities, mental illness, physical defects, and conditions likely to cause dependency.Though exclusions for individuals likely to draw excessive public resources and thosewith communicable diseases still exist in Canada and the United States, in recent yearsthe United States permitted legalization for severely disabled undocumented immigrantsalready in the …

House Of Commons’ Standing Committee On Health: Development Of A National Pharmacare Program, Matthew Herder

Reports & Public Policy Documents

Canada should implement national pharmacare consistent with the principles outlined in the Pharmacare 2020 report. (Morgan et al. 2015a) The best evidence we have shows that national pharmacare will save approximately $7 billion and — more importantly — hundreds of lives each year. (Morgan et al. 2015b)

The issue, then, is not whether to institute national pharmacare, but how. For, even though the need for national pharmacare has been plain since the 1964 Hall Commission, the landscape of medicine and pharmaceuticals has changed dramatically since then.

Of particular note is the pharmaceutical industry’s growing interest in drugs that target relatively …

Denaturalizing Transparency In Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current policy initiatives. Transparency is predominantly understood in terms of information disclosure. Requirements to register clinical trials, publish summary results, share clinical trial data, and disclose physician-industry relationships as well as rationales behind regulatory decision making are each predicated upon this idea that imparting information will both inform and deter unwanted behaviours. In this paper, I argue that understanding transparency qua disclosure has clear limitations and suggest transparency can and should serve an additional function - namely, of enabling standard setting through a more participatory, public …

Aboriginal Food Security In Northern Canada: An Assessment Of The State Of Knowledge, Harriet Kuhnlein, Fikret Berkes, Laurie Hing Man Chan, Treena Wasonti:Io Delormier, Asbjørn Eide, Chris Furgal, Murray Humphries, Henry Huntington, Constance Macintosh, Ian Mauro, David Natcher, Barry Prentice, Chantelle Richmond, Cecilia Rocha, Kue Young

Reports & Public Policy Documents

As the world’s population increases, as global markets become more interconnected, and as the effects of climate change become clearer, the issue of food insecurity is gaining traction at local, national, and international levels. The recent global economic crisis and increased food prices have drawn attention to the urgent situation of the world’s 870 million chronically undernourished people who face the number one worldwide risk to health: hunger and malnutrition. Although about 75% of the world’s undernourished people live in low-income, rural regions of developing countries, hunger is also an issue in Canada. In 2011, 1.6 million Canadian households, or …

The Right To Safe Water And Crown-Aboriginal Fiduciary Law: Litigating A Resolution To The Public Health Hazards Of On-Reserve Water Problems, Constance Macintosh

Articles, Book Chapters, & Popular Press

Canada is at a crossroads. The gap between our national self-image as a country that respects human rights and the reality of socio-economic inequality and exclusion demands a re-engagement with the international human rights project and a recommitment to the values of social justice and equality affirmed in the early years of the Canadian Charter of Rights and Freedoms. This book sketches a blueprint for reconceiving and retrieving social rights in diverse spheres of human rights practice in Canada, both political and legal. Leading academics and activists explore how the Charter and administrative decision making should protect social rights …

Achieving National Altruistic Self-Sufficiency In Human Eggs For Third-Party Reproduction In Canada, Jocelyn Downie

Articles, Book Chapters, & Popular Press

To avoid the commercialization of reproduction, the Canadian Assisted Human Reproduction Act (AHR Act 2004) prohibits the purchase of human eggs. We endorse this legal prohibition and moreover believe that this facet of the law should not be allowed to have as an unintended consequence an increase in transnational trade in human eggs. In an effort to avoid this consequence, and to be consistent with the AHR Act, we advocate a system of national altruistic self-sufficiency. This article briefly outlines a number of strategies to increase the domestic altruistic supply of third-party eggs and decrease the domestic demand for third-party …

The Making Of A Myth: Unreliable Data On Access To Palliative Care In Canada, Jocelyn Downie, Georgia Lloyd-Smith

Articles, Book Chapters, & Popular Press

Assisted death is now the subject of conversation in the media, in public meetings, and around kitchen tables across the country. A frequent part of many conversations about assisted death law reform is access to quality palliative care in Canada. Throughout the literature and other forms of media, the claim is made that only 16-30% of Canadians have access to palliative care (or, its derivative, 70% are without access). The “16-30%” claim has been widely accepted as a fact. But is it, in fact, true? We are driven to the conclusion that the oft-repeated claim that only 16-30% of Canadians …

Unlocking Health Canada’S Cache Of Trade Secrets: Mandatory Disclosure Of Clinical Trial Results, Matthew Herder

Articles, Book Chapters, & Popular Press

Health Canada should publicly disclose information about the safety and efficacy of pharmaceuticals, biologics and medical devices, and should especially disclose the designs and results of clinical trials. This disclosure is necessary to preserve public trust, address weaknesses in the evidence base, and protect Canadians from harm.

A prime example of the need for this disclosure involves selective serotonin reuptake inhibitors (SSRIs). Health Canada did not authorize SSRIs for sale to people younger than 19 years because of data from clinical trials showing risks of harm, including self-harm, associated with use of SSRIs in that age group. But Health Canada …

Pereira's Attack On Legalizing Euthanasia Or Assisted Suicide: Smoke And Mirrors, Jocelyn Downie, Kenneth Chambaere, Jan L. Bernheim

Articles, Book Chapters, & Popular Press

In a paper published in Current Oncology, University of Ottawa palliative care physician Jose Pereira states that the, “laws and safeguards [in countries in which euthanasia or assisted suicide have been legalized] are regularly ignored and transgressed in all the jurisdictions, and that transgressions are not prosecuted.” He purports to demonstrate that the safeguards and controls put in place in the permissive jurisdictions are an “illusion.”

In the present paper, we expose problems with the evidence base provided and relied upon by Pereira. It should be noted that we provide only examples of each of the categories of mistakes made …

Prosecutorial Discretion In Assisted Dying In Canada: A Proposal For Charging Guidelines, Jocelyn Downie, Ben White

Articles, Book Chapters, & Popular Press

English Abstract: An Expert Panel of the Royal Society of Canada and a Select Committee of the Québec National Assembly both recently recommended the issuance of permissive guidelines for the exercise of prosecutorial discretion on voluntary euthanasia and assisted suicide and “medical aid in dying” respectively. It seems timely, therefore, to propose a set of offence-specific guidelines for how prosecutorial discretion should be exercised in cases of voluntary euthanasia and assisted suicide in Canadian provinces and territories. We take as our starting point the only existing guidelines of this sort currently in force in the world (i.e. the British Columbia …

Recent Crime Legislation: The Challenge For Prison Health Care, Adelina Iftene, Allan Manson

Articles, Book Chapters, & Popular Press

This article reviews the potential effects of Bill C-10 and related legislation that provide for more legal minimum sentences and reduce the possibility of conditional release. Without more resources overcrowding - an already pressing issue in Canadian corrections - will increase. We further review the potential effects of overcrowding as exemplified in other jurisdiction.

Recent Crime Legislation: The Challenge For Prison Health Care, Adelina Iftene, Allan Manson

Articles, Book Chapters, & Popular Press

This article reviews the potential effects of Bill C-10 and related legislation that provide for more legal minimum sentences and reduce the possibility of conditional release. Without more resources overcrowding - an already pressing issue in Canadian corrections - will increase. We further review the potential effects of overcrowding as exemplified in other jurisdiction.

Health Care And The Illegal Immigrant, Patrick J. Glen

Georgetown Law Faculty Publications and Other Works

The question of whether illegal immigrants should be entitled to some form of health coverage in the United States sits at the uneasy intersection of two contentious debates: health reform and immigration reform. Befitting this place, the rhetoric surrounding the issue has been exponentially heightened by the multiplying effects of combining two vitriolic debates. On one side, it is argued that the United States has a moral obligation to provide health care to all those within its borders needing such assistance. On the other, it is argued with equal force that those illegally present in this country should not be …

In The Back Alleys Of Health Care: Abortion, Equality And Community In Canada, Joanna Erdman

Articles, Book Chapters, & Popular Press

The decriminalization of abortion in Canada ensured neither its availability nor accessibility as an integrated and publicly funded health service. While Canadian women are increasingly referred to or seek abortion services from single-purpose clinics, their exclusion from public health insurance often render these services inaccessible. This article considers denied funding for clinic abortion services from the perspective of the Canadian constitutional guarantee of sex equality. The article focuses on the 2004 Court of Queen's Bench's judgment in Jane Doe I v. Manitoba, which framed denied public funding for clinic abortion services as a violation of women's equality rights under the …

Is American Health Care Uniquely Inefficient?, Alan M. Garber, Jonathan Skinner

Dartmouth Scholarship

No abstract provided.