Health Law and Policy Commons^™

Consent To Psychiatric Treatment: From Insight (Into Illness) To Incite (A Riot), Sheila Wildeman

Articles, Book Chapters, & Popular Press

The aim of this chapter is to go back to the basics on consent to treatment, starting with the right to refuse and building from there. Part II addresses the leading judicial statements on the value of medical self-determination, and in light of these statements, considers what is at stake in psychiatric treatment choice. Part III explores the three core elements of valid consent to treatment -- namely that consent be voluntary, informed and capable -- with attention to variation in the law amongst provinces and territories, and some lines of analysis and critique specifically applicable to mental health care …

Carter, Medical Aid In Dying, And Mature Minors, Constance Macintosh

Articles, Book Chapters, & Popular Press

The Supreme Court of Canada’s decision in Carter v Canada (AG) decriminalized medical aid in dying in certain defined circumstances. One of those circumstances is that the person seeking assistance be an “adult.” This article argues that the regulatory response to this decision must approach the idea of “adult” in terms of the actual medical-decisional capacity of any given individual, and not rely upon age as a substitute for capacity. This article surveys jurisdictions where minors are included in physician-assisted dying regimes, and identifies what little empirical evidence exists regarding requests from minors. The heart of the article considers 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 …

Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens

Reports & Public Policy Documents

In 2014 Parliament enacted a number of amendments to the Food and Drugs Act, R.S.C. 1985, c. F-27 [hereinafter the “F&D Act”]. Known as “Vanessa’s Law,” these amendments were intended to enhance the regulation of pharmaceutical drugs and thereby protect Canadians from harm by giving the regulator, Health Canada, new powers to, inter alia, recall drugs, require active post-market surveillance, and improve the transparency of information around pharmaceutical drugs. Vanessa’s Law explicitly recognized that “new measures are required to further protect Canadians from the risks related to drugs and medical devices.” (emphasis added) (Bill C-17, An Act to Amend the …

Carter V. Canada: What’S Next For Physicians?, Jocelyn Downie

Articles, Book Chapters, & Popular Press

On Feb. 6, 2015, the Supreme Court of Canada unanimously declared that the Criminal Code prohibitions on physician-assisted dying (both assisted suicide and voluntary euthanasia) violate the Canadian Charter of Rights and Freedoms.1 The Court immediately suspended the declaration, which means that its decision does not come into effect for 12 months. Canadians therefore have a year to prepare for the reality of legal physician-assisted dying, assuming that the federal government does not invoke the notwithstanding clause. In the immediate aftermath of this decision, a key question for physicians is “what can and should physicians do over the coming months …

After Carter V. Canada, Jocelyn Downie

Articles, Book Chapters, & Popular Press

When it recently struck down the Criminal Code prohibitions on physician-assisted dying, the Supreme Court of Canada gave federal and provincial legislatures 12 months to craft new legislation to meet the conditions set out in its landmark ruling.

Why The Government Of Canada Won't Regulate Assisted Human Reproduction: A Modern Mystery, Jocelyn Downie, Dave Snow, Francoise Baylis

Articles, Book Chapters, & Popular Press

The Canadian Assisted Human Reproduction Act (AHR Act), passed in 2004, prohibits both paying consideration to a surrogate mother and purchasing sperm and ova from a donor (sections 6-7). Both prohibitions are subject to section 12, which was intended to permit reimbursement of expenditures incurred by surrogate mothers and gamete donors and reimbursement for loss of work-related income for surrogate mothers. Remarkably, more than ten years after the AHR Act received Royal Assent, and in spite of repeated calls for greater legal clarity, Health Canada has not drafted regulations pursuant to section 12 of the AHR Act, which is not …

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 …

Privacy Protection For Mobile Health (Mhealth) In Nigeria: A Consideration Of The Eu Regime For Data Protection As A Conceptual Model For Reforming Nigeria's Privacy Legislation, Olufunke Olawumi Salami

LLM Theses

The use of mobile technologies to provide and deliver healthcare is known as Mobile Health. Nigeria is one of the countries witnessing a profound use of these technologies. While discussions have focused on the potentials of this technologies to address the challenges in the health system, nothing is said about the risks from unauthorized disclosure or misuse of health information provided by users. This becomes worse when Nigeria's laws do not offer adequate protection. As Mobile Health is a novelty to Nigeria, this thesis looks to relevant international standards on privacy protection. It does this by examining the European regime …

Draft Provincial/Territorial Legislation To Implement A Regulatory Framework For Medically-Assisted Dying Consistent With Carter V. Canada (Attorney General) 2015 Scc 5 And The Final Report Of The Provincial-Territorial Expert Advisory Group On Physician-Assisted Dying, Jocelyn Downie

Reports & Public Policy Documents

On February 6, 2015, the Supreme Court of Canada unanimously declared that the Criminal Code prohibitions on physician-assisted dying (both assisted suicide and voluntary euthanasia) violate the Canadian Charter of Rights and Freedoms. They immediately suspended the declaration for 12 months thus allowing the government time to craft new legislation. This paper is a contribution to the project of meeting that deadline -- it presents draft provincial/territorial legislation. This draft legislation is based on: 1) a thorough review of existing legislation in all permissive regimes throughout the world (reviewed through a "lessons learned" lens); 2) the requirements for constitutional validity …

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 …

Cutting The Gordian Knot Of Futility: A Case For Law Reform On Unilateral Withholding And Withdrawal Of Potentially Life-Sustaining Treatment, Jocelyn Downie, Lindy Willmott, Ben White

Articles, Book Chapters, & Popular Press

In this paper, we propose law reform with respect to the unilateral withholding or withdrawal of potentially life-sustaining treatment in Australia and New Zealand. That is, where a doctor withholds or withdraws potentially life-sustaining treatment without consent from a patient or a patient’s substitute decision-maker (where the patient lacks capacity), or authorisation from a court or tribunal, or by operation of a statute or justifiable government or institutional policy. Our proposal is grounded in the core values that do (or should) underpin a regulatory framework on an issue such as this; these values are drawn from existing commitments made by …

In Defence Of Consent And Capacity Boards For End-Of-Life Care, Jocelyn Downie, Michael Hadskis

Articles, Book Chapters, & Popular Press

In Cuthbertson v. Rasouli, the Supreme Court of Canada (SCC) found that, in Ontario, it is the Consent and Capacity Board (CCB) and not the courts per se who will resolve conflicts between substitute decision-makers (SDMs) and health practitioners regarding the withdrawal of lifesustaining treatment from incapable patients. This finding was based on the SCC’s interpretation of the Ontario Health Care Consent Act (HCCA). Hawryluck et al. express concern about the SCC’s determination that the CCB is charged with resolving such conflicts since, in their view, this body is ill-equipped to fulfill this role. Instead, they take the position that …

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 …

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 …

Toward A Jurisprudence Of Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from clinical trials — whether positive (i.e. product approvals) or negative (i.e. abandoned products, product refusals, and withdrawals) — are …

Report As To Proposed Pilot Project On The Electronic Monitoring Of Forensic Mental Health Patients, Elaine Gibson, Leah Hutt, Sheila Wildeman, Constance Macintosh

Reports & Public Policy Documents

This report was undertaken in response to a request from the Nova Scotia government for assistance in identifying and analyzing legal issues related to the potential establishment of a pilot project. The project would involve the use of electronic monitoring (EM) of forensic mental health patients (patients) detained at the East Coast Forensic Hospital (ECFH) who are exercising indirectly supervised and unescorted community access (community access). The purpose of our analysis is not to determine if an EM policy or its application violates any laws. Rather, the purpose is to consider whether there are factors that may support legal challenges …

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 …

Moving Forward With A Clear Conscience: A Model Conscientious Objection Policy For Canadian Colleges Of Physicians And Surgeons, Jocelyn Downie, Jacquelyn Shaw, Carolyn Mcleod

Articles, Book Chapters, & Popular Press

In 2008, one of us (JD) together with the former Dean of Law at the University of Ottawa (Sanda Rodgers), wrote a guest editorial for the Canadian Medical Association Journal on the topic of access to abortion in Canada. In the editorial, we argued, among other things, that "health care professionals who withhold a diagnosis, fail to provide appropriate referrals, delay access, misdirect women or provide punitive treatment are committing malpractice and risk lawsuits and disciplinary proceedings." In response to a series of letters to the editor written about our editorial, we wrote that, under the CMA Code of Ethics …

Protecting Rights And Building Capacities: Challenges To Global Mental Health Policy In Light Of The Convention On The Rights Of Persons With Disabilities, Sheila Wildeman

Articles, Book Chapters, & Popular Press

The World Health Organization (WHO) has in the last decade identified mental health as a priority for global health promotion and international development, to be targeted through promulgation of evidence-based medical practices, health systems reform, and respect for human rights. Yet these overlapping strategies are marked by tensions as the historical primacy of expert-led initiatives is increasingly subject to challenge by new social movements — in particular, disabled persons’ organizations (DPOs). These tensions come into focus upon situating the WHO’s contributions to the analysis of global mental health in light of the negotiation and early stages of implementation of the …

When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder

Articles, Book Chapters, & Popular Press

Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in this paper I argue that a new approach to rare, orphan diseases is needed. The current model, first signaled by the United States’ Orphan Drug Act and subsequently emulated by several other jurisdictions, relies on a set of open-ended criteria and market-based incentives in order to define and encourage drug therapies for rare, orphan diseases. Given a) the biopharmaceutical industries’ growing interest in orphan diseases, b) progress in the sphere of personalized medicines enabling more and more …

Updated Who Guidance On Safe Abortion: Health And Human Rights, Joanna Erdman, Teresa Depiñeres, Eszter Kismodi

Articles, Book Chapters, & Popular Press

Since its first publication in 2003, the World Health Organization's “Safe abortion: technical and policy guidance for health systems” has had an influence on abortion policy, law, and practice worldwide. To reflect significant developments in the clinical, service delivery, and human rights aspects of abortion care, the Guidance was updated in 2012. This article reviews select recommendations of the updated Guidance, highlighting 3 key themes that run throughout its chapters: evidence-based practice and assessment, human rights standards, and a pragmatic orientation to safe and accessible abortion care. These themes not only connect the chapters into a coherent whole. They reflect …

Legislating Interprofessional Regulatory Collaboration In Nova Scotia, William Lahey Prof.

Articles, Book Chapters, & Popular Press

To shift health professions regulation from traditional to ‘collaborative’ self-regulation, Nova Scotia has adopted legislation which will: make all self-regulating health professions members of the Regulated Health Professions Network; mandate the Network to facilitate voluntary collaboration among its members; and enable regulators to work together on investigations of patient complaints, to adjust scopes of practice on an ongoing basis and to adjudicate appeals of unsuccessful applicants for registration. The goals are to give health professions regulation the capacity to enable and support the functioning of interprofessional teams. The legislation was adopted primarily for two reasons: collaborative development and unanimous support …

Protecting Rights And Building Capacities: Challenges To Global Mental Health Policy In Light Of The Convention On The Rights Of Persons With Disabilities, Sheila Wildeman

Articles, Book Chapters, & Popular Press

The World Health Organization (WHO) has in the last decade identified mental health as a priority for global health promotion and international development, to be targeted through promulgation of evidence-based medical practices, health systems reform, and respect for human rights. Yet these overlapping strategies are marked by tensions as the historical primacy of expert-led initiatives is increasingly subject to challenge by new social movements – in particular, disabled persons’ organizations (DPOs). These tensions come into focus upon situating the WHO’s contributions to the analysis of global mental health in light of the negotiation and early stages of implementation of the …

The Speakers’ Bureau System: A Form Of Peer Selling, Lynette Reid, Matthew Herder

Articles, Book Chapters, & Popular Press

Physicians need to stay abreast of information about emerging drugs and devices, but the time pressures of clinical practice may limit their ability to do so independently. The companies that manufacture and sell these products have the resources and the motivation to “educate” physicians but cannot be expected to distinguish their marketing goals from physicians’ educational needs. Physicians’ professional associations and regulatory bodies, as well as medical journal publishers and editors, drug and device regulatory agencies, and academic medical institutions, have long debated their respective roles and responsibilities in ensuring the safety, efficacy, and probity of prescribing in light of …

Regulating Prescription Drugs For Patient Safety: Does Bill C-17 Go Far Enough?, Matthew Herder, Elaine Gibson, Janice Graham, Joel Lexchin, Barbara Mintzes

Articles, Book Chapters, & Popular Press

Canada was the last developed country in the world to remove thalidomide from the market, and doing so required an Act of Parliament. At the request of Health Canada’s then Food and Drug Directorate, thalidomide’s two manufacturers voluntarily withdrew the drug from the market on Mar. 2, 1962. However, most of the drug’s distribution was in the form of free samples to medical professionals, which the directorate had no legal authority to control. Therefore, to avoid similar situations in the future and to stop sales of thalidomide, on Dec. 4, 1962, the Parliament of Canada amended the Food and Drugs …

Science On Law's Terms: Implications Of Procedural Legitimacy On Scientific Evidence, Nayha Acharya

LLM Theses

Scientific evidence is relied on more and more in litigation. Discussions and debates aimed at enabling courts to make the best use scientific evidence are increasingly critical. This thesis adds the perspective of procedural legitimacy to the science and law discussion. Procedural Legitimacy is the concept that consistent adherence to legal procedure maintains the overall legitimacy of the legal system, and the validity of its outcomes. I argue that the integrity of legal procedures must be maintained where scientific evidence is presented, so that judicial decisions that rely on scientific evidence are legitimate.

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

Articles, Book Chapters, & Popular Press

Objective: To review the empirical claims made in: Pereira J. Legalizing euthanasia or assisted suicide: the illusion of safeguards and controls. Curr Oncol 2011;18:e38–45.

Design: We collected all of the empirical claims made by Jose Pereira in “Legalizing euthanasia or assisted suicide: the illusion of safeguards and controls.” We then collected all reference sources provided for those claims. We compared the claims with the sources (where sources were provided) and evaluated the level of support, if any, the sources provide for the claims. We also reviewed other available literature to assess the veracity of the empirical claims made in the …

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 …

Substitute Decision-Making About Research: Identifying The Legally Authorized Representative In Four Canadian Provinces, Sheila Wildeman, Gina Bravo, Marie-France Dubois, Carole Cohen, Janice Graham, Karen Painter, Suzanne Bellemare

Articles, Book Chapters, & Popular Press

When an adult is legally incapable of deciding whether to participate in health research, who (if anyone) has the legal authority to make that decision? Furthermore, how well do Canadians with a stake in health research, such as older adults, informal caregivers of older persons with cognitive impairments, researchers in aging, and members of research ethics boards (“REBs”), understand the state of the law on this question? These two interrelated matters are addressed by our study. We find that the laws of the four provinces we target are frequently unclear as to whether, or in what circumstances, a guardian, proxy …