Memorandum Re: Health Canada\u27s \u27Draft Guidance\u27 on Section 21.1(3)(C) of the Food and Drugs Act

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 Food and Drugs Act, 2d Sess., 41st Parl., 2014, c. 24, Preamble.) On March 10, 2016, Health Canada published the “Draft Guidance – Document: Disclosure of Confidential Business Information Under Paragraph 21.1(3)(c) of the Food and Drugs Act” [hereinafter “Draft Guidance”]. We submit that this Draft Guidance runs counter to both the express wording and spirit of Vanessa’s Law. Specifically, Health Canada’s position that s. 21.1(3)(c) requires those who request information pursuant to this provision to, i. Demonstrate qualifications as a health professional and research expertise; ii. Enter into a confidentiality agreement; iii. Agree not to disclose the information to any third parties; and, iv. Demonstrate prior efforts to obtain the information from alternative sources; is contrary to the express wording of section 21.1(3)(c), constitutes an ultra vires exercise of statutory authority, substantially undermines the purpose of the provision, viz. to better protect Canadians from harm, and is fundamentally at odds with the scheme and object of the F&D Act as well as the intention of Parliament in enacting Vanessa’s Law. Further, these limitations potentially violate the Charter of Rights and Freedoms. We therefore call upon Health Canada to immediately alter its approach as stated in the Draft Guidance. In this brief we show that Health Canada’s Draft Guidance improperly “reads in” four requirements into section 21.1(3)(c), which run counter to the express wording and spirit of Vanessa’s Law. We begin by explaining why Health Canada’s practice of treating safety and effectiveness data as CBI is mistaken and misguided, fails to recognize an internationally recognized need for a new approach to drug safety, and fails to live up to Vanessa’s Law’s recognition of the need for new transparency measures. Then, we describe the legislative background and purpose of Vanessa’s Law, and detail the fundamental flaws in Health Canada’s Draft Guidance

Introduction to Regulating Creation: The Law, Ethics, and Policy of Assisted Human Reproduction

In 2004, Canada\u27s Parliament passed the Assisted Human Reproduction Act. Fully in force by 2007, the act was intended to safeguard and promote the health, safety, dignity, and rights of Canadians. However, a 2010 Supreme Court of Canada decision ruled that key parts of the act were invalid. Regulating Creation is a collection of essays built around various components of the 2010 ruling. Featuring contributions by Canadian and international scholars, it offers a variety of perspectives on the role of law in dealing with the legal, ethical, and policy issues surrounding changing reproductive technologies. The book is divided in three parts. Part 1 contains a detailed discussion of the case and of constitutional and federalism issues. Part 2 discusses family law and children right\u27s perspectives of assisted human reproduction. The chapters in Part 3 elaborate on concerns around commodification, commercialization, and access to reproductive services and goods. In addition to the in-depth analysis of the Canadian case the volume reflects on how other countries, particularly the U.S., U.K. and New Zealand regulate these same issues. Combining a detailed discussion of legal approaches with an in-depth exploration of societal implications, Regulating Creation deftly navigates the obstacles of legal policy amidst the rapid current of reproductive technological innovation. The introductory chapter briefly discusses the various chapters and situates the chapters in the context of current discussions around Assisted Human Reproduction

Regulation of health professions in Ontario: self-regulation with statutory- based public accountability

The paper explores the model of regulation of health professionals in Ontario, Canada; a self-regulation model built around a detailed statutory scheme. The core of the paper consists of a discussion of Ontario’s Regulated Health Professions Act and of the key components of 26 specific health profession acts that have been enacted under its umbrella. The paper explores the role of the regulatory colleges, the role of the Ministry of Health in determining scope of practice and other components of medical practice, and the disciplinary and appeal procedures. Some other specific issues are also briefly touched upon, such as the integration into the profession of internationally trained physicians, and the government’s role in ensuring access to specialists across the province. A final section looks at the challenges and the limitations of the Ontario model, through a number of health professions-related controversies that reveal gaps in self-regulation, including: failure to set and enforce proper educational and practice standards in specific areas; failure to conduct timely investigations into potential misconduct by professionals; and failure to question professionals in a position of power. The paper also discusses briefly the implications of recognizing through legal regulation some alternative and complementary medical practices, and the challenge of regulating indigenous health care practitioners. It concludes that the primary limitations of the regulatory model arise on account of professional self-interest and power-relations impacting procedural issues, and the complexity of the regulatory model that may potentially undermine quality control. Este artigo explora o modelo de regulação dos profissionais de saúde em Ontário, Canadá, um modelo de autorregulação construído em torno de um regime estatutário específico. O foco central do trabalho é a discussão sobre a Lei de Regulamentação das Profissões de Saúde de Ontário e os principais componentes de 26 leis que foram promulgadas sob sua égide para regulamentar profissões de saúde específicas. O artigo explora a função dos colegiados regulatórios, o papel do Ministério da Saúde na determinação de escopos de prática e de outros elementos da atividade médica, e os procedimentos disciplinares e de recurso. Outras questões específicas também são brevemente abordadas como a adequação profissional de médicos treinados no exterior e a atribuição do governo de garantir o acesso a especialistas em toda a província. A seção final analisa os desafios e as limitações do modelo, levantando uma série de controvérsias relacionadas às profissões de saúde que revelam lacunas na autorregulação, incluindo: incapacidade de estabelecer e aplicar padrões educacionais e práticos adequados em áreas específicas; falha na condução de investigações em tempo hábil sobre possíveis desvios de conduta por parte dos profissionais; e falha em questionar profissionais em posições de poder. O artigo discute ainda o desafio de regular os profissionais de saúde indígenas. Conclui-se que as principais limitações do modelo regulatório surgem em razão de interesses profissionais individualistas e de relações de poder que afetam questões processuais, bem como da complexidade do modelo regulatório, que pode potencialmente prejudicar o controle de qualidade.&nbsp

Génétique et assurance vie : analyse comparative

[À l'origine dans / Was originally part of : CRDP - Droit, biotechnologie et rapport au milieu]Le débat autour du rôle de l’assurance vie, de la nécessité de recourir à un processus de sélection des risques et de la notion de discrimination acceptable a suscité un questionnement sur le rôle social de l’assurance. Ce débat a été exacerbé par les récents développements dans le domaine de la génétique humaine permettant aux assureurs d’utiliser les résultats de tests génétiques dans le processus de sélection des risques. Cet article présente une étude comparative des positions adoptées sur l’assurance et la génétique dans plusieurs pays. Nous analyserons les positions de 43 pays sélectionnés et commenterons leur capacité à assurer un accès plus équitable aux candidats à l’assurance vie

Genetics and Life Insurance: A Comparative Analysis

[À l'origine dans / Was originally part of : CRDP - Droit, biotechnologie et rapport au milieu]The debate surrounding the role of life insurance, the necessity of risk rating, and the notion of “acceptable discrimination” has raised questions about the larger social role of insurance. Recent developments in the field of genetics, allowing insurers to make use of genetic testing technology as a new underwriting tool, have reinvigorated this debate. This article presents a comparative study of positions taken in countries on issues in genetics and life insurance. We will analyze the 43 selected countries and comment on their potential for ensuring a more equitable access for life insurance applicants

Consent for Nondiagnostic Research Biopsies: A Pilot Study of Participant Recall and Therapeutic Orientation

A growing number of clinical trials incorporate invasive procedures like nondiagnostic tumor biopsies for biomarker or pharmacodynamic analysis.1 Such invasive research procedures are ethically contentious. Tumor biopsies involve pain and complication risk,2 and at least one procedure-related death has been reported.3 However, nondiagnostic tumor biopsies obtained in the research context generally have no value for managing the participant’s medical condition. Some commentators therefore argue that research biopsies “take” from participants without “giving in return.”4 Because such procedures are conducted contrary to research participants’ medical interests, an ethical framework for enrolling patients in studies that include a research biopsy rides heavily on informed consent. In particular, study participants should understand that research biopsies are nontherapeutic and burdensome and that participation is discretionary in studies involving them. Yet little is known about whether decisions to enroll in a study that involves a research biopsy, including those that permit participants to opt out of the procedure, meet thresholds of consent validity, in other words, whether individuals sufficiently understand and appreciate the consequences of their decision and whether they are not unduly influenced.5 Some studies about research biopsies suggest that individuals often misconstrue nondiagnostic biopsies as therapeutic; 6 others suggest the contrary.7 Interpreting these findings is further complicated by the fact that because participants were often enrolled in clinical drug trials, they might have legitimately imputed therapeutic value to research biopsies when receiving access to investigational drugs was conditioned on providing a biopsy for research.8 There are at least three reasons that clinical trials that include research biopsies might present challenges for consent validity. First, because procedures are burdensome, individuals who enroll in these trials might do so under the mistaken belief that the biopsies provide a therapeutic benefit to them. Second, biopsies are often conducted proximate to therapeutic encounters, where patients undergoing a biopsy might be focused on a recent diagnosis and on management options, not on their role as a research participant. Last, some argue that because research participants often conflate research with clinical care,9 they might fail to appreciate the nontherapeutic nature of a research biopsy. To investigate these issues, we used semistructured interviews to probe recalled perceptions, motivations, and consent quality for research participants in a cancer biomarker study involving nondiagnostic biopsies