Health Law and Policy Commons^™

Caveat Emptor, Venditor Et Praescribor: Legal Liability Associated With Methyplenidate Hydrochloride (Mph) Use By Postsecondary Students, Jocelyn Downie, Fiona Campbell, Simon Outram

Articles, Book Chapters, & Popular Press

For years, students have endured the physical and mental stress that comes as a result of the demands of post-secondary education. All -night cramming for exams and marathon paper writing sessions are considered, by many, to be a rite of passage, endured by generations of students. For many years, students have also turned to stimulants (from coffee to energy drinks and caffeine pills) to extend their physical and cognitive limits in order to better cope with the demands of school and life. In this sense, the use of stimulants as study-aids is not a new phenomenon nor has it been …

Canadian Parliament Must Act On Assisted Human Reproduction, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In the past three months, three members of the Board of Directors of Assisted Human Reproduction Canada (AHRC) have resigned. Their resignation letters include the following statements: '[that following requests for information about the Agency's spending and budget] there was much reluctance and procrastination in providing information, and that when the information was provided, there were inconsistencies in what I received and what was originally presented. This raises concerns in my mind about the prudence and diligence in managing public funds'; 'I have encountered difficulties as a board member in receiving satisfactory replies to concerns and questions I have raised …

Watch Your Language: A Review Of The Use Of Stigmatizing Language By Canadian Judges, Jocelyn Downie, Michelle Black

Articles, Book Chapters, & Popular Press

Despite ongoing advances in understanding the causes and prevalence of mental health issues, stigmatizing language is still often directed at people who have mental illness. Such language is regularly used by parties, such as the media, who have great influence on public opinion and attitudes. Since the decisions from Canadian courtrooms can also have a strong impact on societal views, we asked whether judges use stigmatizing language in their decisions. To answer this question, we conducted a qualitative study by searching through modern Canadian case law using search terms that were indicative of stigmatizing language. We found that, although judges …

Dr. Cézanne And The Art Of Re(Peat)Search: Competing Interests And Obligations In Clinical Research, Robyn Bluhm, Jocelyn Downie, Jeff Nisker

Articles, Book Chapters, & Popular Press

Clinician researchers have a number of roles, each of which carries specific obligations. There are times when these obligations may be in competition (up to and including conflict) with each other. Using a narrative case study that describes a group of colleagues discussing their clinical department's participation in an industry-sponsored research protocol, we illustrate a number of the obligations faced by clinician researchers, and discuss how competing interests and obligations can lead to ethical problems. The case study is followed by a discussion of the effect of university–industry relations on competing interests and obligations in both clinical research and the …

Law And Mental Health: A Relationship In Crisis? (Introduction), Sheila Wildeman

Articles, Book Chapters, & Popular Press

An Introduction to the Lectures of Supreme Court of Canada Chief Justice Beverley McLachlin and Nova Scotia Provincial Court Judge Anne Derrick. What is the significance of the rule of law to the area of professional knowledge and practice that is “mental health”—or to the interaction of those two aspirational, one might say euphemistically-named social systems: the mental health and justice systems? This question centres upon the rule of law—specifically, I suggest (as I relate further in closing), a thick conception of the rule of law grounded in an ideal of state-subject reciprocity1 —and not, or not directly, upon the …

Too Good To Be True: Second Thoughts On The Proliferation Of Mental Health Counts, H Archibald Kaiser

Articles, Book Chapters, & Popular Press

The last two decades have witnessed the proliferation of mental health courts, proffered by governments as an efficacious and sometimes exclusive response to the complex social dynamics causing the criminalization of persons who live with mental health problems. the ready embrace of this variant of the problem-solving-courts genre has diverted policy-makers and citizens from confronting the root causes of the challenging intersection of mental illness and crime. the new courts have acquired a legitimacy that belies a wide range of doubts about their existence and operation. this commentary will offer a counterpoint to the accelerating momentum of mental health courts. …

Eligibility For Organ Donation: A Medico-Legal Perspective On Defining And Determining Death, Jocelyn Downie, Matthew R. Kutcher, Chantelle Rajotte, Alison Shea

Articles, Book Chapters, & Popular Press

Purpose: In the context of post-mortem organ donation, there is an obvious need for certainty regarding the legal definition and determination of death, as individuals must be legally pronounced dead before organs may be procured for donation. Surprisingly then, the legal situation in Canada with regard to the definition and determination of death is uncertain. The purpose of this review is to provide anesthesiologists and critical care specialists with a medico-legal perspective regarding the definition and determination of death (particularly as it relates to non-heart-beating donor protocols) and to contribute to ongoing improvement in policies, protocols, and practices in this …

Safety First: Recognizing And Managing The Risks To Child Participants In Magnetic Resonance Imaging Research, Matthias Schmidt, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Specialized and up-to-date knowledge is required to identify and manage the risks associated with advanced biomedical research. Additional complexities need to be considered when the research involves infants or young children. In this article, we focus on recent information about the physical risks of pediatric magnetic resonance imaging research and highlight information gaps. With an eye to assisting institutional review boards and researchers, we consider strategies for the management of these risks and formulate key questions aimed at exposing hidden hazards. Institutional review boards should ask these questions, and researchers should bear them in mind as they develop research protocols.

Glass Houses: The Power Of Money In Bioethics Research, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In this paper I explore the power of money in bioethics research and ask whether, while casting stones regarding financial conflicts of interest in health research, bioethics researchers are in fact living in glass houses. I first review the need for money in bioethics research, the sources of money, and key features of the money (specifically, the amount of money involved and the fact that the money often is embedded, encumbered, and required to be matched). Next, I explore a range of possible objectives for the money transfer. I then examine the effects of this transfer and raise some questions …

The Manitoba College Of Physicians And Surgeons Position Statement On Withholding And Withdrawal Of Life-Sustaining Treatment (2008): Three Problems And A Solution, Jocelyn Downie, Karen Mcewen

Articles, Book Chapters, & Popular Press

The College of Physicians and Surgeons of Manitoba (CPSM) recently issued a Statement on Withholding and Withdrawl of Life-Sustaining Treatment (2008). The College should be given enormous credit for trying to provide guidance with respect to physicians' obligations in an area of great confusion and controversy. Unfortunately, however, there are some very serious flaws in the Statement. In this paper, we describe three major problems with it that we believe make the case for the claim that the Statement must be revised. We then provide a revised statement that, if adopted, could represent significant progress as it would provide: greater …

Public Health Protection And Drinking Water Quality On First Nation Reserves: Considering The New Federal Regulatory Proposal, Constance Macintosh

Articles, Book Chapters, & Popular Press

In January 2009, the federal government issued a discussion paper that details its preferred regulatory route for enabling a legislative framework. This route is to referentially incorporate provincial legislation regarding operational standards through a framework statute, and then develop the details of the regime through regulations to be developed in consultation with First Nations over the next few years. Importantly, the opening sentence of the discussion paper's executive summary expressly connects water and public health. It reads: "The provision of safe drinking water and the effective treatment of wastewater are critical in ensuring the health and safety of First Nations …

Demythologizing Phosita: Applying The Non-Obviousness Requirement Under Canadian Patent Law To Keep Knowledge In The Public Domain & Foster Innovation, Matthew Herder

Articles, Book Chapters, & Popular Press

The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical “selection patent” case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped the Court’s attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the “person having ordinary skill in the art” (PHOSITA) for the purpose of the obviousness inquiry. The article argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation, …

Human Rights In Health Equity: Cervical Cancer And Hpv Vaccines, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article seeks to demonstrate that health equity, as an empirical and normative concept, is reflected in the human rights to health and equality under international law. The obligations on government that flow from health equity as a human right are then examined. These include the obligation to act in pursuit of health equity as a policy objective, and the obligation to enact measures to ensure health equity as a policy outcome. These obligations are considered in relation to a promising remedial measure for social disparities in cervical cancer: HPV vaccines.

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 …

Moral Authority In English And American Abortion Law, Joanna Erdman

Articles, Book Chapters, & Popular Press

In R. (on the application of Axon) v. Secretary of State for Health & Another, the English High Court affirmed that young women are entitled to seek and receive sexual health care, including abortion care, without parental notification. This chapter examines the Court’s use of comparative constitutional authorities in its reasoning, focusing on the rejection of American authorities. Contrast and rejection, it is argued, can be an exercise in self-reflection, revealing how a court understands its own constitutional approach. Aversive constitutionalism presents opportunities to deconstruct claimed similarities and differences in constitutional approaches, to uncover and contest characteristics and assumptions otherwise …

Family Override Of Valid Donor Consent To Postmortem Donation: Issues In Law And Practice, Jocelyn Downie, Chantelle Rajotte, Alison Shea

Articles, Book Chapters, & Popular Press

In 2005, 3974 Canadians were on waiting lists for organ transplants and 275 patients died while waiting. Canada's organ shortage has led to calls for changes to Canada's organ donation system and its legal framework. Herein we examine an issue in which law reform could both increase the number of available organs and better align practice with respect for autonomy, a core value underpinning the Canadian legal system: the issue of family overrides of a valid donor consent to postmortem donation. That is, we examine what should happen when an individual consented to postmortem donation but the family would like …

Health Equity, Hpv And The Cervical Cancer Vaccine, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the relationship between technological innovation and health inequity. It examines in particular the relationship between the vaccine against human papillomavirus (HPV) infection, the cause of cervical cancer, and inequity in cervical cancer incidence and mortality. In Canada, screening programs have drastically reduced the incidence of cervical cancer, but their benefits have been unequally distributed. Prevention efforts have disproportionately failed women of disadvantaged social groups. Technological innovation alone will not remedy this inequity. The HPV vaccine merely expands the available means for reducing or increasing health inequity depending on its implementation. For this reason, the article looks beyond …

Health Equity, Hpv And The Cervical Cancer Vaccine, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the relationship between technological innovation and health inequity. It examines in particular the relationship between the vaccine against human papillomavirus (HPV) infection, the cause of cervical cancer, and inequity in cervical cancer incidence and mortality. In Canada, screening programs have drastically reduced the incidence of cervical cancer, but their benefits have been unequally distributed. Prevention efforts have disproportionately failed women of disadvantaged social groups. Technological innovation alone will not remedy this inequity. The HPV vaccine merely expands the available means for reducing or increasing health inequity depending on its implementation. For this reason, the article looks beyond …

Prenatal Management Of Anencephaly, Rebecca J. Cook, Joanna Erdman, Martin Hevia, Bernard M. Dickens

Articles, Book Chapters, & Popular Press

About a third of anencephalic fetuses are born alive, but they are not conscious or viable, and soon die. This neural tube defect can be limited by dietary consumption of foliates, and detected prenatally by ultrasound and other means. Many laws permit abortion, on this indication or on the effects of pregnancy and prospects of delivery on a woman's physical or mental health. However, abortion is limited under some legal systems, particularly in South America. To avoid criminal liability, physicians will not terminate pregnancies, by induced birth or abortion, without prior judicial approval. Argentinian courts have developed means to resolve …

Barriers To Access To Abortion Through A Legal Lens, Jocelyn Downie, Carla Nassar

Articles, Book Chapters, & Popular Press

In addressing whether the procedure for obtaining abortions was operating equitably across Canada, the 1977 Badgley Report concluded that for many women, access to abortion was “practically illusory.” Sadly, although abortion on request became legally permissible for Canadian women in 1988, access to a safe and legal abortion remains practically illusory for many women today. A woman seeking an abortion in Canada must overcome numerous barriers. She must find a way to secure for herself some of the limited resources that our health care system provides for abortion. She must also expend her own, often scarce, personal resources: her time, …

Relational Theory And Health Law And Policy, Jennifer Llewellyn, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Relational theory starts from an understanding of human selves as relational. This theory informs some significant current developments in the areas of philosophy, ethics and legal theory that re-envision key concepts including autonomy, equality, rights, justice, memory, trust, judgment and identity. In this paper we introduce relational theory and begin to explore some of its implications for health law and policy. In doing so, we hope to show the relevance of each field to the other and to persuade those interested in health law and policy to take up the challenge to pursue the transformative potential of relational theory through …

Rodriguez Redux, Jocelyn Downie, Simone Bern

Articles, Book Chapters, & Popular Press

Assisted suicide has once again surfaced as an issue of public attention. Just in the past year, four cases have been in the news. In addition the results of a major study on the attitudes of cancer patients in palliative care towards euthanasia and physician-assisted suicide and the results of an Ipsos Reid public opinion poll on assisted suicide were released. Vigorous calls both for and against the decriminalization of assisted suicide followed. Given that it has been fifteen years since the release of the most famous assisted suicide case in Canada, and given this recent spate of attention, we …

Judicial Reasoning About Pregnancy And Choice, Jocelyn Downie, Chris Kaposy

Articles, Book Chapters, & Popular Press

Women in Canada are at risk of abortion becoming increasingly difficult to access. In its landmark 1988 ruling, R. v. Morgentaler, the Supreme Court of Canada struck down the prohibition of abortion in section 251 of the Criminal Code on the grounds that it violated a section of the Charter of Rights and Freedoms which guarantees, among other things, "security of the person". However, all of the justices who ruled that section 25 unconstitutional nonetheless claimed that protecting the fetus is a valid objective of federal legislation, leaving open the possibility that a different and carefully crafted law against abortion …

Asking For Money Back - Chilling Commercialization Or Recouping Public Trust In The Context Of Stem Cell Research?, Matthew Herder

Articles, Book Chapters, & Popular Press

As publicly funded institutions have increasingly embraced the goal of commercializing scientific research, concerns about private appropriation have become familiar refrain. One commonly suggested remedy is to create some kind of 'recoupment' provision whereby the State, on behalf of the public, receives a certain percentage of profits realized. The Bayh-Dole Act originally included a recoupment provision but it was deleted by a legislative committee. Countries around the globe attempting to emulate Bayh-Dole have, whether by design or default, reinforced the underlying logic against recoupment, which is essentially as follows: obligations to provide direct financial returns undermine the commercialization process and …

Prenatal Management Of Anencephaly, Rebecca Cook, Joanna Erdman, Martin Hevia, Bernard Dickens

Articles, Book Chapters, & Popular Press

About a third of anencephalic fetuses are born alive, but they are not conscious or viable, and soon die. This neural tube defect can be limited by dietary consumption of foliates, and detected prenatally by ultrasound and other means. Many laws permit abortion, on this indication or on the effects of pregnancy and prospects of delivery on a woman's physical or mental health. However, abortion is limited under some legal systems, particularly in South America. To avoid criminal liability, physicians will not terminate pregnancies, by induced birth or abortion, without prior judicial approval. Argentinian courts have developed means to resolve …

Access To Medical Records For Research Purposes: Varying Perceptions Across Research Ethics Boards, Donald Willison, Claudia Emerson, Karen Szala-Meneok, Elaine Gibson, Lisa Schwartz, Karen Weisbaum, François Fournier, Kevin Brazil, Michael Coughlin

Articles, Book Chapters, & Popular Press

Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. Results: Fourteen sites (47%) required individual patient …

Who's Minding The Shop? The Role Of Canadian Research Ethics Boards In The Creation And Uses Of Registries And Biobanks, Elaine Gibson, Kevin Brazil, Michael Coughlin, Claudia Emerson, François Fournier, Lisa Schwartz, Karen Szala-Meneok, Karen Weisbaum, Donald Willison

Articles, Book Chapters, & Popular Press

Background: The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks.

Methods: Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were …

The Therapeutic Misconception: A Threat To Valid Parental Consent For Paediatric Neuroimaging Research, Michael Hadskis, Nuala Kenny, Jocelyn Downie, Matthias Schmidt, Ryan D'Arcy

Articles, Book Chapters, & Popular Press

Neuroimaging research has brought major advances to child health and well-being. However, because of the vulnerabilities associated with neurological and developmental conditions, the parental need for hope, and the expectation of parents that new medical advances can benefit their child, pediatric neuroimaging research presents significant challenges to the general problem of consent in the context of research involving children. A particular challenge in this domain is created by the presence of therapeutic misconception on the part of parents and other key research stakeholders. This article reviews the concept of therapeutic misconception and its role in pediatric neuroimaging research. It argues …

Final Report Of The Experts Committee For Human Research Participant Protection In Canada, Jocelyn Downie

Reports & Public Policy Documents

The Experts Committee for Human Research Participant Protection in Canada presents herewith its final report and recommendations concerning the development of a new comprehensive system in Canada. The final report is the product of some twenty months work. Beginning in September, 2006 and ending February, 2007 the Committee held monthly face-to-face meetings which it supplemented by conference calls and the circulation of draft texts by various members. During the course of its work, the Committee assessed the concerns that had been raised about the existing Canadian governance arrangements and then examined alternative models that might serve to deal effectively with …

Inadmissible, Eh?, Jocelyn Downie, Ronalda Murphy

Articles, Book Chapters, & Popular Press

In this commentary, we respond to Stacey Tovino's invitation to reflect further on specific legal issues she raises in relation to functional magnetic resonance imaging (fMRI) and the law (Tovino 2007). Specifically, we take up the issue of evidence law. We do this from a Canadian perspective because, unlike in the United States, this topic has not "been debated for almost 10 years" here (Tovino 2007, 44).