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.
regulation, governance, unproven medical interventions
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