Health Law and Policy Commons^™

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 …

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.

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.

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 …

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 …

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 …

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, …

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 …

Making Informed Consent Work In Nigerian Health Care, Oluchukwu Jacinta Aniaka

LLM Theses

The notion of informed consent to medical treatment is a fundamental precept in law. It recognizes autonomy and the right to personal inviolability, irrespective of nationality, socio-economic situation and ideological orientation. A full realization of autonomy in the Nigerian legal system is severely constricted by sociological and cultural factors. Of particular concern is the impact of oppression which may arise from socialization, arbitrary disclosure practice by physicians, or as a result of legislative enactment. To remedy the elemental defects in the Nigerian Code of Medical Ethics, without addressing the impediments posed by the social environment from which a patient operates, …

Changing Tactics: Rehabilitating Canadian Justice For Traumatized Veterans, J. Jason Samson

LLM Theses

This thesis examines how military members and veterans with Operational Stress Injuries are treated by Canadian justice systems. It suggests a correlation between mental injuries sustained on operations by military personnel and propensities for military and societal misconduct. By comparing civilian and military processes with American justice counterparts, a plan to improve the existing Canadian legal landscape is proposed. Using an analysis of the underlying philosophy and purpose of military justice, a problem solving diversionary court is recommended, along with legislative and policy amendments. The use of a consent-based "Treatment Standing Court Martial" would place military justice officials parallel to …

End-Of-Life Decision-Making In Canada: The Report By The Royalsociety Of Canada Expert Panel On End-Of-Life Decision-Making, Udo Schüklenk, Johannes J. M. Van Delden, Jocelyn Downie, Sheila A. M. Mclean, Ross Upshur, Daniel Weinstock

Reports & Public Policy Documents

This report on end-of-life decision-making in Canada was produced by an international expert panel and commissioned by the Royal Society of Canada. It consists of five chapters.

Chapter 1 reviews what is known about end-of-life care and opinions about assisted dying in Canada.

Chapter 2 reviews the legal status quo in Canada with regard to various forms of assisted death.

Chapter 3 reviews ethical issues pertaining to assisted death. The analysis is grounded in core values central to Canada's constitutional order.

Chapter 4 reviews the experiences had in a number of jurisdictions that have decriminalized or recently reviewed assisted dying …

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 …

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 …

Confusion Worse Confounded: A Comment On 'Withdrawl Of Clinical Trials Policy By Canadian Research Institute Is A 'Lost Opportunity For Increased Transparency', Jocelyn Downie, Francoise Baylis

Articles, Book Chapters, & Popular Press

According to a recent BMJ article on CIHR's decision to "disappear" its policy on clinical trial registration, "Ian Graham, CIHR's vice president Knowledge Translation and Public Outreach, stated the CIHR policy was removed 'as the overlap [with Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)] will cause confusion and inconsistent application of the requirements.'"

Ironically, this explanation is itself confusing and inconsistent with previous decisions made by CIHR. There are at least three areas in which CIHR policy/guidelines overlapped with TCPS 2 (registration and results disclosure of trials, research involving Aboriginal People, and research involving human pluripotent …

Indonesia’S Refusal To Share Influenza Virus Specimens With The World: Reviving The Arguments For Justice In Influenza Pandemic Preparedness, Meena Krishnamurthy, Matthew Herder

Articles, Book Chapters, & Popular Press

Indonesia’s December 2006 decision to stop sending influenza virus specimens to the World Health Organization’s Global Influenza Surveillance Network (GISN) captured international attention. At the time, the H5N1 subtype of influenza A virus was predicted to be the basis for the next pandemic. While many accused Indonesia - the country most afflicted by the virus - of putting the rest of the world in peril by withholding virus samples, Indonesia maintained that GISN was unjust for failing to ensure equitable access to vaccines developed using those samples. The H5N1 pandemic threat eventually waned, yet international negotiations to create a just …

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 …

Defining The Role Of Mature Minors In The Medical Research Consent Process, Isabelle M. A. French

LLM Theses

In recent years, there has been an increase in the number of minors included in a broad range of medical research studies. To date, however, little attention appears to have been paid to how the role of minors in the consent process leading to participation in these studies should be defined. This thesis reviews the legal and ethical instruments and principles that define the role of mature minors in the medical research consent process in Canada at present. The thesis goes on to recommend a framework that should be added to the Tri-Council Policy Statement whereby all minors undergo a …

End-Of-Life Decision-Making In Canada: The Report By The Royal Society Of Canada Expert Panel On End-Of-Life Decision-Making, Udo Schuklenk, Johannes J. M. Van Delden, Jocelyn Downie, Sheila Mclean, Ross Upshur, Daniel Marc Weinstock

Reports & Public Policy Documents

This report on end-of-life decision-making in Canada was produced by an international expert panel and commissioned by the Royal Society of Canada. It consists of five chapters: Chapter 1 reviews what is known about end-of-life care and opinions about assisted dying in Canada, Chapter 2 reviews the legal status quo in Canada with regard to various forms of assisted death, Chapter 3 reviews ethical issues pertaining to assisted death. The analysis is grounded in core values central to Canada’s constitutional order, Chapter 4 reviews the experiences had in a number of jurisdictions that have decriminalized or recently reviewed assisted dying …

Concepts Of Bias And Appointments To The Governing Council Of The Canadian Institutes Of Health Research, Elaine Gibson

Articles, Book Chapters, & Popular Press

In October 2009, the academic health research community and the pharmaceutical industry were brought closer together with the appointment of Dr. Bernard Prigent, vice-president of Pfizer Canada, to the Governing Council of the Canadian Institutes of Health Research (CIHR). This bridging of the two worlds has stirred up considerable debate before the House of Commons Standing Committee on Health, in letters to CMAJ and in an online petition that garnered more than 4400 signatures. There are at least two distinct and vocal camps in the debate: those categorically in favour (including the federal minister of health and the president of …

Patient Safety Law: Regulatory Change In Britain And Canada, Fiona Mcdonald

PhD Dissertations

Did governments in different countries regulate common concerns about patient safety differently? If so how and why did they do this? This thesis undertakes a historical comparison of the regulation of patient safety in Britain and Canada between 1980 and 2005. These jurisdictions began the period with very similar regulatory frameworks, but by 2005 there were distinct differences in each jurisdiction‘s regulatory response to patient safety. Britain was very actively regulating all aspects of service provision within its health system in the name of patient safety, whereas Canada‘s regulatory direction showed adherence to the 1980s model with only scattered incremental …

Governance Of Health Research Involving Humans In Developing Countries: The Nigerian Example, Cheluchi Onyemelukwe

PhD Dissertations

An intense debate has occurred regarding research involving humans in developing countries in recent years. Research in this area has focused mainly on examining the ways in which the economic inequalities in healthcare between developing countries and developed countries have affected the types of research conducted in developing countries by external sponsors. Research has also focused on how these inequalities, and the difficulties in applying the international ethical guidelines, give rise to ethical concerns and controversies. Recent literature has therefore examined several ethical concerns in health research in developing countries. What is missing in the literature on research oversight in …

Approval Of New Pharmacogenomic Tests: Is The Canadian Regulatory Process Adequate?, Yann Joly, Emma Ramos-Paque

Canadian Journal of Law and Technology

In the first part of our analysis, we will examine the impact which pharmacogenomics is expected to have on drug research and development, on the drug approval process and on post-marketing surveillance and clinical practice. This will allow us to show how pharmacogenomic testing could be beneficial to drug companies, regulatory bodies, and patients. The second part of our analysis will focus on the regulatory framework applicable to the approval of pharmacoge- nomic tests in Canada, although we are aware of the fact that most manufacturers decide to approve their tests outside of Canada. As mentioned, the applicable regu- lations …

A Conflict By Any Other Name Would Smell As Foul: A Comment On The Appointment Of A Vice-President Of Pfizer To The Cihr Governing Council, Jocelyn Downie

Articles, Book Chapters, & Popular Press

If one had to pick the pharmaceutical company most associated with unethical and illegal conduct this past year, it would likely be Pfizer. So it seems reasonable to respond with disbelief and outrage to the federal government’s October 5, 2009 appointment of Dr. Bernard Prigent – Vice President, Medical Director and registered lobbyist for Pfizer Canada – to the Canadian Institutes of Health Research Governing Council (CIHR GC). This is the body that sets the strategic direction for most federally funded health research in Canada. A senior executive from a for-profit pharmaceutical company should not be given a seat at …

Canadian Personal Data Protection Legislation And Electronic Health Records: Transfers Of Personal Health Information In It Outsourcing Agreements, Dara Lambie

Canadian Journal of Law and Technology

Personal data protection and privacy of personal health information in the electronic era is a broad topic that includes consent, security measures and access considerations. The focus of this article is on one component of the larger picture: data transfers of personal health information that occur in the context of informa- tion technology (“IT”) outsourcing. If the societal good envisioned by an inter-jurisdictional EHR is to be fully realized, then the necessity of outsourcing is a reality that must be addressed.

A Bitter Pill To Swallow: Canadian Drug Regulation, Michael Duncan Taylor

LLM Theses

This thesis assesses the current status of Canadian prescription drug regulation and the policy drivers that guide this process. This analysis is accomplished by first providing a general survey of the steps, law, and institutional players involved in the full life-cycle of a drug. Next the evolution of current clinical trials and the gaps that the present legal regime creates in the scientific standards employed in clinical research is reviewed. This is followed by a discussion of how commercialization (innovation) and speed of approval (market access) are slowly becoming the dominant policy drivers for the Canadian regime. Finally a discussion …