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Articles 1 - 13 of 13
Full-Text Articles in Law
Concepts Of Bias And Appointments To The Governing Council Of The Canadian Institutes Of Health Research, Elaine Gibson
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 …
Approval Of New Pharmacogenomic Tests: Is The Canadian Regulatory Process Adequate?, Yann Joly, Emma Ramos-Paque
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 …
Patient Safety Law: Regulatory Change In Britain And Canada, Fiona Mcdonald
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
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 …
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
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
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 …
Too Good To Be True: Second Thoughts On The Proliferation Of Mental Health Counts, H Archibald Kaiser
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. …
Watch Your Language: A Review Of The Use Of Stigmatizing Language By Canadian Judges, Jocelyn Downie, Michelle Black
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 …
Law And Mental Health: A Relationship In Crisis? (Introduction), Sheila Wildeman
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 …
Caveat Emptor, Venditor Et Praescribor: Legal Liability Associated With Methyplenidate Hydrochloride (Mph) Use By Postsecondary Students, Jocelyn Downie, Fiona Campbell, Simon Outram
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
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 …
Dr. Cézanne And The Art Of Re(Peat)Search: Competing Interests And Obligations In Clinical Research, Robyn Bluhm, Jocelyn Downie, Jeff Nisker
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 …