Health Law and Policy Commons^™

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

Harm Reduction, Human Rights, And Access To Information On Safer Abortion, Joanna Erdman

Articles, Book Chapters, & Popular Press

A harm reduction and human rights approach, grounded in the principles of neutrality, humanism, and pragmatism, supports women's access to information on the safer self-use of misoprostol in diverse legal settings. Neutrality refers to a focus on the risks and harms of abortion rather than its legal or moral status. Humanism refers to the entitlement of all women to care and concern for their lives and health, to be treated with respect, worth, and dignity, and to the empowerment of women to participate in decision-making and political action. Pragmatism accepts the historical reality that women will engage in unsafe abortion, …

Consent Requirements For Pelvic Examinations Performed For Training Purposes, Elaine Gibson, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In 2010, The Society of Obstetricians and Gynaecologists of Canada (SOGC) and The Association of Professors of Obstetrics and Gynaecology of Canada (APOG) released an updated policy statement regarding pelvic examinations performed on women under anesthesia. The updated statement, unlike the previous 2006 guideline that applied to “medical trainees” (explicitly including students and residents), for the most part only applies to “medical students”. Pelvic examinations conducted for training purposes presumably constitute a battery in law, subject to the defence of consent. Residents need to be covered by an SOGC and APOG policy statement regarding pelvic examinations for training purposes with …

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 …

Understanding 'Elder Abuse And Neglect': A Critique Of Assumptions Underpinning Responses To The Mistreatment And Neglect Of Older People, Joan Harbison, Steve Coughlan, Marie Beaulieu, Jeff Karabanow, Madine Vanderplaat, Sheila Wildeman, Ezra Wexler

Articles, Book Chapters, & Popular Press

This article provides an overview of the ways in which the mistreatment and neglect of older people have come to be understood as a social problem, one which is underpinned by a variety of substantive and theoretical assumptions. It connects the process of conceptualizing elder abuse and neglect to political-economic and social evolution. The authors draw on a review of the literature, government sources, interest group websites, and their own research to provide a critical commentary illustrating how these understandings have become manifest in legislation, policies, and programs pertaining to "elder abuse and neglect" in Canada. Suggestions are provided for …

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 …

Consent Requirements For Pelvic Examinations Performed For Training Purposes, Elaine Gibson, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In 2010, The Society of Obstetricians and Gynaecologists of Canada (SOGC) and The Association of Professors of Obstetrics and Gynaecology of Canada (APOG) released an updated policy statement regarding pelvic examinations performed on women under anesthesia. The updated statement, unlike the previous 2006 guideline that applied to “medical trainees” (explicitly including students and residents), for the most part only applies to “medical students”. Pelvic examinations conducted for training purposes presumably constitute a battery in law, subject to the defence of consent. Residents need to be covered by an SOGC and APOG policy statement regarding pelvic examinations for training purposes with …

The Convention On The Rights Of Persons With Disabilities: Beginning To Examine The Implications For Canadian Lawyers' Professional Responsiblities, H Archibald Kaiser

Articles, Book Chapters, & Popular Press

The United Nations Convention on the Rights of Persons with Disabilities (hereafter the CRPD or the Convention) should herald a new epoch in the way persons with disabilities are treated throughout the world community. The entire panoply of ramifications of this Convention, the purpose of which is “to promote, protect and ensure the full enjoyment of all human rights and fundamental freedoms by all persons with disabilities, and to promote respect for their inherent dignity”, (Article 1) is as yet unascertainable. However, States Parties must “take all appropriate measures to eliminate discrimination by any person, organization or private enterprise” (Article …

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 …

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 …

Prosecutorial Guidelines For Voluntary Euthanasia And Assisted Suicide: Autonomy, Public Confidence And High Quality Decision-Making, Ben White, Jocelyn Downie

Articles, Book Chapters, & Popular Press

This article proposes offense-specific guidelines for how prosecutorial discretion should be exercised in cases of voluntary euthanasia and assisted suicide. A similar policy has been produced in England and Wales but we consider it to be deficient in a number of respects, including that it lacks a set of coherent guiding principles. In light of these concerns, we outline an approach to constructing alternative guidelines that begins with identifying three guiding principles that we argue are appropriate for this purpose: respect for autonomy; the need for high-quality prosecutorial decision-making; and the importance of public confidence in that decision-making.

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.

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 …

Bad News About Bad News: The Disclosure Of Risks To Insurability In Research Consent Processes, Victoria Smith Apold, Jocelyn Downie

Articles, Book Chapters, & Popular Press

One of the phenomena associated with research is “incidental findings,” that is, unexpected findings made during the research, and outside the scope of the research, which have potential health importance. One underappreciated risk of incidental findings is the potential loss of the research subject's insurability; or if a research subject fails to disclose incidental findings when applying for insurance, the insurance contract may be voidable by the insurer. In this article, we seek to explain the insurability risks associated with incidental findings and to make recommendations for how researchers and research ethics committees should address the issue of disclosure of …

Access To Information On Safe Abortion: A Harm Reduction And Human Rights Approach, Joanna Erdman

Articles, Book Chapters, & Popular Press

With convergence-divergence as an organizing theme, this Article explores harm reduction and human rights as conceptual approaches to and discourses about unsafe abortion. The vehicle for this exploration is access to safer-use information on medication abortion, namely women’s self-administration of the drug misoprostol. More specifically, this Article focuses on the Sanitary Initiative Against Unsafe Abortion (“the Uruguay Model”) as an actualized model or prototype of access to information through physician-patient consultation in restrictive legal environments. On convergence, this Article seeks to test the claim that international human rights law imposes government obligations to provide, and to refrain from interfering with …

Are Canadians Providing Advance Directives About Health Care And Research Participation In The Event Of Decisional Incapacity?, Gina Bravo, Marie-France Dubois, Carole Cohen, Sheila Wildeman, Janice Graham, Karen Painter, Suzanne Bellemare

Articles, Book Chapters, & Popular Press

Objective: Advance planning for health care and research participation has been promoted as a mechanism to retain some control over one’s life, and ease substitute decision making, in the event of decisional incapacity. Limited data are available on Canadians’ current advance planning activities. We conducted a postal survey to estimate the frequency with which Canadians communicate their preferences about health care and research should they become incapacitated. Method: We surveyed 5 populations (older adults, informal caregivers, physicians, researchers in aging, and research ethics board members) from Nova Scotia, Ontario, Alberta, and British Columbia. We asked respondents whether they had expressed …

Restorative Justice, Euthanasia, And Assisted Suicide: A New Arena For Restorative Justice And A New Path For End Of Life Law And Policy In Canada, Jennifer Llewellyn, Jocelyn Downie

Articles, Book Chapters, & Popular Press

This article examines the current Canadian legal approach to euthanasia and assisted suicide, highlights some of the problems with it, and offers a novel alternative to the current traditionally criminalized prohibitive regime. The authors first describe a restorative justice approach and explain the differences between such an approach and the traditional approach currently in use. They then explain how a restorative justice approach could be implemented in the arena of assisted death, acknowledging the potential challenges in implementation. The authors conclude that taking a restorative justice approach to euthanasia and assisted suicide could enable movement in the seemingly intractable public …

Restorative Justice, Euthanasia, And Assisted Suicide: A New Arena For Restorative Justice And A New Path For End Of Life Law And Policy In Canada, Jennifer Llewellyn, Jocelyn Downie

Articles, Book Chapters, & Popular Press

This article examines the current Canadian legal approach to euthanasia and assisted suicide, highlights some of the problems with it, and offers a novel alternative to the current traditionally criminalized prohibitive regime. The authors first describe a restorative justice approach and explain the differences between such an approach and the traditional approach currently in use. They then explain how a restorative justice approach could be implemented in the arena of assisted death, acknowledging the potential challenges in implementation. The authors conclude that taking a restorative justice approach to euthanasia and assisted suicide could enable movement in the seemingly intractable public …