REGULATION AND GOVERNANCE OF ACCESS TO UNPROVEN MEDICAL INTERVENTIONS IN CANADA; A CASE STUDY ANALYSIS

This research used case studies to identify and explore lessons from past regulation and governance of access to unproven medical interventions provided by physicians in Canada, with the goal of informing and strengthening future strategies. The examples selected were chelation therapy for applications other than treating heavy metal toxicity, liberation therapy for multiple sclerosis, and unproven stem cell interventions. For each case study, a systematic data collection strategy was used that included academic literature from relevant disciplines, legislation, government documents, records of legislative and parliamentary debates, jurisprudence, professional regulatory decisions and guidance, news media, and patient advocacy activity. The role of law helped set boundaries for the data collection and analysis, which focused primarily on regulatory and governance tools and strategies that use or are empowered or constrained by law. A second objective of this research was to develop theoretical insights regarding the use of regulation and governance as frameworks for understanding complex policy issues. Drawing on the fields of regulation and governance, a conceptual framework was developed to guide the case study analyses. This conceptual framework was revised iteratively throughout the work. The key features of regulation and governance that were identified and explored through each case study were actors, instruments, purposes, legitimacy, and responsiveness and adaptability. Following the individual case study analyses, which developed a deep understanding of each case, a cross-case analysis was conducted to identify features of the Canadian context that future regulation and governance of access to unproven medical interventions will likely need to account for to be successful. These features include our decentralized healthcare system, the importance of medical professional regulation, and our independent judicial processes. There are also several areas of focus that the findings from this research suggest may strengthen future regulation and governance of access to unproven medical interventions provided by physicians in Canada. These priorities include maximizing the potential of collaborative distributed governance, emphasizing protection of the public interest in renewal of medical professional regulation, prioritizing fairness and transparency in stakeholder engagement practices, promoting the need for clarity and nuance in discussions about evidence, and supporting strong science and health communication practices. The conceptual framework developed in this work provided a systematic approach for identifying and analyzing the field of influence over the complex issues at the heart of this research and it may prove useful for future study in other fields. Bridging the fields of regulation and governance in this way also added richness and nuance to key concepts in each domain. In so doing, this research responded to calls for work that uses regulation and governance theory to inform and strengthen practice, and vice versa

Navigating Physicians’ Ethical and Legal Duties to Patients Seeking Unproven Interventions Abroad

Medical tourism (MT), the practice of traveling to another country to access medical care that is paid for out of pocket, has received considerable attention in the Canadian news media.Media and industry information sources, which are commonly accessed by medical tourists, might inadequately inform Canadians about MT safety concerns. As a result, there is concern among Canadian physicians and health and safety professionals that prospective medical tourists might not be well placed to make informed decisions about their care. As gatekeepers in the health care system and the first source of interaction between the health care system and patients, family physicians are well positioned to inform Canadians about these safety risks

Professional Regulation: A Potentially Valuable Tool in Responding to “Stem Cell Tourism”

The growing international market for unproven stem cell-based interventions advertised on a direct-to-consumer basis over the internet (“stem cell tourism”) is a source of concern because of the risks it presents to patients as well as their supporters, domestic health care systems, and the stem cell research field. Emerging responses such as public and health provider-focused education and national regulatory efforts are encouraging, but the market continues to grow. Physicians play a number of roles in the stem cell tourism market and, in many jurisdictions, are members of a regulated profession. In this article, we consider the use of professional regulation to address physician involvement in stem cell tourism. Although it is not without its limitations, professional regulation is a potentially valuable tool that can be employed in response to problematic types of physician involvement in the stem cell tourism market

Health Misinformation and the Power of Narrative Messaging in the Public Sphere

Numerous social, economic and academic pressures can have a negative impact on representations of biomedical research. We review several of the forces playing an increasingly pernicious role in how health and science information is interpreted, shared and used, drawing discussions towards the role of narrative. In turn, we explore how aspects of narrative are used in different social contexts and communication environments, and present creative responses that may help counter the negative trends. As traditional methods of communication have in many ways failed the public, changes in approach are required, including the creative use of narratives

Marketing of unproven stem cell-based interventions:A call to action

Commercial promotion of unsupported therapeutic uses of stem cells is a global problem that has proven resistant to regulatory efforts. Here, we suggest a coordinated approach at the national and international levels focused on engagement, harmonization, and enforcement to reduce the risks associated with direct-to-consumer marketing of unproven stem cell treatments

The Stem Cell Research Environment:A Patchwork of Patchworks

Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a 'patchwork of patchworks'. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application

Saskatchewan Joins British Columbia in Introducing an Immunize or Mask Policy

Seasonal influenza is a contagious respiratory infection for which certain populations, particularly seniors in long-term care and medically vulnerable individuals receiving care as in-patients in health care facilities, are at heightened risk for serious complications. Accordingly, annual influenza vaccination is a public health objective. In September 2014, Saskatchewan joined British Columbia and became the second Canadian province to implement a so-called “immunize or mask” policy that applies to individuals in patient care locations including, but not limited to, health care workers. The policy is focused on promoting patient safety by reducing the transmission of influenza in regional health authority facilities. On its face, this policy aligns well with the Ministry of Health’s commitments to patient-centered care, to quality improvement, and to thinking and acting as one system. The policy will be adopted and implemented by each of the 13 regional health authorities and the single cancer agency in the province. Preliminary evaluation is anticipated after this first year of policy implementation

Saskatchewan Joins British Columbia in Introducing an Immunize or Mask Policy

Seasonal influenza is a contagious respiratory infection for which certain populations, particularly seniors in long-term care and medically vulnerable individuals receiving care as in-patients in health care facilities, are at heightened risk for serious complications. Accordingly, annual influenza vaccination is a public health objective. In September 2014, Saskatchewan joined British Columbia and became the second Canadian province to implement a so-called “immunize or mask” policy that applies to individuals in patient care locations including, but not limited to, health care workers. The policy is focused on promoting patient safety by reducing the transmission of influenza in regional health authority facilities. On its face, this policy aligns well with the Ministry of Health’s commitments to patient-centered care, to quality improvement, and to thinking and acting as one system. The policy will be adopted and implemented by each of the 13 regional health authorities and the single cancer agency in the province. Preliminary evaluation is anticipated after this first year of policy implementation. La grippe saisonnière est une infection respiratoire contagieuse qui peut engendrer de sérieuses  complications pour certaines populations, particulièrement les personnes âgées dépendantes et les individus médicalement vulnérables recevant des soins hospitaliers en établissement. C'est pour cette raison que la vaccination annuelle contre la grippe est un objectif de santé publique. Le Saskatchewan a rejoint la Colombie Britannique en septembre 2014 pour devenir la seconde province du Canada à mettre en place une politique dite “le vaccin ou le masque” s'appliquant aux personnes fréquentant les établissements de soins, entre autres les professionels de soins. Cette politique vise à promouvoir la santé des patients en réduisant la transmission de la grippe au sein des établissements de soins publics. À première vue, elle s'aligne bien avec les objectifs affichés par le Ministère de la Santé de soins centrés sur le patient, d'amélioration de la qualité des soins, et d'unité de pensée et d'action du système. La politique sera adoptée et mise en place par chacune des 13 autorités régionales de santé et l'unique agence pour le cancer de la province. Une première évaluation est attendue un an après la mise en place

Medical tourism and national health care systems: an institutionalist research agenda

Abstract Although a growing body of literature has emerged to study medical tourism and address the policy challenges it creates for national health care systems, the comparative scholarship on the topic remains too limited in scope. In this article, we draw on the existing literature to discuss a comparative research agenda on medical tourism that stresses the multifaceted relationship between medical tourism and the institutional characteristics of national health care systems. On the one hand, we claim that such characteristics shape the demand for medical tourism in each country. On the other hand, the institutional characteristics of each national health care system can shape the very nature of the impact of medical tourism on that particular country. Using the examples of Canada and the United States, this article formulates a systematic institutionalist research agenda to explore these two related sides of the medical tourism-health care system nexus with a view to informing future policy work in this field