The World Health Organization (WHO) has called for the increased statutory regulation of traditional and complementary medicine practitioners and practices, currently implemented in about half of nations surveyed. According to recent WHO data, however, the absence of policy guidelines in this area represents a significant barrier to implementation of such professional regulations. This commentary reviews several key challenges that distinguish the statutory regulation of traditional medicine practitioners and practices from biomedical professional regulation, providing a foundation for the development of policy making parameters in this area. Foremost in this regard are the ongoing impacts of the European colonial encounter, which reinforce biomedicine's disproportionate political dominance across the globe despite traditional medicine's ongoing widespread use (particularly in the global South). In this light, the authors discuss the conceptual and historical underpinnings of contemporary professional regulatory structures, the tensions between institutional and informal traditional medicine training pathways, and the policy challenges presented by the prospect of standardizing internally diverse indigenous healing approaches. Epistemic and evidentiary tensions, as well as the policy complexities surrounding the intersection of cultural and clinical considerations, present additional challenges to regulators. Conceptualizing professional regulation as an intellectual property claim under the law, the authors further consider what it means to protect traditional knowledge and prevent misappropriation in this context. Overall, the authors propose that innovative professional regulatory approaches are needed in this area to address safety, quality of care, and accessibility as key public interest concerns, while prioritizing the redress of historical inequities, protection of diverse indigenous knowledges, and delivery of care to underserved populations.
Several United Nations bodies have advised countries to actively preserve Traditional Medicine (TM) knowledge and prevent its misappropriation in regulatory structures. To help advance decision-making around this complex regulatory issue, we examine the relationship between risk discourse, epistemology and policy. This study presents a critical, postcolonial analysis of divergent risk discourses elaborated in two contrasting Ontario (Canada) government reports preceding that jurisdiction's regulation of acupuncture, the world's most widely practised TM therapy. The earlier (1996) report, produced when Ontario's regulatory lobby was largely comprised of Chinese medicine practitioners, presents a risk discourse inclusive of biomedical and TM knowledge claims, emphasizing the principle of regulatory 'equity' as well as historical and sociocultural considerations. Reflecting the interests of an increasingly biomedical practitioner lobby, the later (2001) report uses implicit discursive means to exclusively privilege Western scientific perspectives on risk. This report's policy recommendations, we argue, suggest misappropriation of TM knowledge. We advise regulators to consider equitable adaptations to existing policy structures, and to explicitly include TM evidentiary perspectives in their pre-regulatory assessments.
Objectives: This scoping review evaluates two decades of methodological advances made by “whole systems research” (WSR) pioneers in the fields of traditional, complementary, and integrative medicine (TCIM). Rooted in critiques of the classical randomized controlled trial (RCT)'s suitability for evaluating holistic, complex TCIM interventions, WSR centralizes the principle of “model validity,” representing a “fit” between research design and therapeutic paradigm. Design: In consultation with field experts, 41 clinical research exemplars were selected for review from across 13 TCIM disciplines, with the aim of mapping the range and methodological characteristics of WSR studies. Using an analytic charting approach, these studies' primary and secondary features are characterized with reference to three focal areas: research method, intervention design, and outcome assessment. Results: The reviewed WSR exemplars investigate a wide range of multimodal and multicomponent TCIM interventions, typified by wellness-geared, multitarget, and multimorbid therapeutic aims. Most studies include a behavioral focus, at times in multidisciplinary or team-based contexts. Treatments are variously individualized, often with reference to “dual” (biomedical and paradigm-specific) diagnoses. Prospective and retrospective study designs substantially reflect established biomedical research methods. Pragmatic, randomized, open label comparative effectiveness designs with “usual care” comparators are most widely used, at times with factorial treatment arms. Only two studies adopt a double-blind, placebo-controlled RCT format. Some cohort-based controlled trials engage nonrandomized allocation strategies (e.g., matched controls, preference-based assignment, and minimization); other key designs include single-cohort pre–post studies, modified n-of-1 series, case series, case report, and ethnography. Mixed methods designs (i.e., qualitative research and economic evaluations) are evident in about one-third of exemplars. Primary and secondary outcomes are predominantly assessed, at multiple intervals, through patient-reported measures for symptom severity, quality of life/wellness, and/or treatment satisfaction; some studies concurrently evaluate objective outcomes. Conclusions: Aligned with trends emphasizing “fit-for-purpose” research designs to study the “real-world” effectiveness of complex, personalized clinical interventions, WSR has emerged as a maturing scholarly discipline. The field is distinguished by its patient-centered salutogenic focus and engagement with nonbiomedical diagnostic and treatment frameworks. The rigorous pursuit of model validity may be further advanced by emphasizing complex analytic models, paradigm-specific outcome assessment, inter-rater reliability, and ethnographically informed designs. Policy makers and funders seeking to support best practices in TCIM research may refer to this review ...
BackgroundIn line with recent World Health Organization recommendations, many jurisdictions are taking steps to regulate practitioners of traditional, complementary and alternative medicine (TCAM). Previous studies have examined TCAM practitioners’ generally-supportive views about professional regulation; however, little research has been conducted on TCAM practitioners’ experiences and perspectives amidst an active regulatory process. In 2006 and 2007, the province of Ontario, Canada announced it would grant self-regulatory status to three TCAM practitioner groups - homeopaths, naturopaths and Chinese medicine practitioners/acupuncturists.MethodsIn 2011 and 2012, part-way through each group’s regulatory process, we surveyed all practitioners from these three groups (n = 1047) that could be identified from public registries and professional associations. The data presented here are derived from the sub-sample of homeopaths (n = 234), naturopaths (n = 273) and Chinese medicine practitioners/acupuncturists (n = 181) who provided answers to an open-ended question about their opinions of the regulatory process at the end of the survey. An inductive, thematic analysis of qualitative survey responses was conducted.ResultsSurvey responses affirmed a pro-regulatory stance across all groups, but revealed considerable ‘worry’ amongst practitioners as to how the regulations might be implemented. Four primary ‘worry-related’ themes emerged: a) regulation’s potential administrative and financial burden on practitioners; b) scope-related concerns; c) implementation of fair registration standards; and d) whether regulation might erode the groups’ distinctive worldviews. Some occupationally-specific concerns appeared related to each group’s particular stage of professionalization. Other ‘worries’ may be related to the relative marginality of TCAM practitioner groups within biomedically-dominant national health care systems, and the possibility that inter-professional hierarchies may be emerging between particular TCAM groups. Specific concerns around overlapping practice scopes between TCAM and other professions raised questions about the implementation of non-monopolistic regulatory models such as Ontario’s.ConclusionsOverall, this study will help inform regulators and TCAM practitioner groups to navigate the unique challenge of regulating health care providers long excluded from national health care systems, who frequently work from within paradigms distinct from mainstream biomedicine.
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