Healthcare & FDA attorney Michael H Cohen spoke in Riyadh, Saudi Arabia, at the invitation of the World Health Organization, the Gulf Cooperation Council, and the Saudi National Center for Complementary and Alternative Medicine (NCCAM), Ministry of Health, on healthcare law and regulation. The talks were:
- Setting the Foundation, Standards, Rules and Regulations for Practicing Complementary and Alternative Medicine: The U.S. Experience.*
- Balancing Regulatory Authority and Patient-Centered Care: Global Models of Access to Complementary and Alternative Medicine.*** This talk describes the U.S. experience in regulating CAM Practice, Practitioners, and Products. In the U.S., CAM regulation focuses on: (1) licensing practitioners and setting forth their authorized practice boundaries; (2) setting professional standards of care, such that practitioners who fail to adhere to these standards of care pay the penalty (including possible loss of licensure); and (3) regulating dietary supplements, cosmetics, and medical devices. In general, CAM regulation in the U.S. is part of healthcare law and not separately regulated. U.S. regulation and policy-making are complicated by several factors, including: (1) multiplicity of regulatory bodies and overlapping jurisdiction; and (2) the interplay between legal and medical communities regarding CAM regulation. This seems to be a shared challenge internationally. This talk draws lessons from the U.S. experience with respect to developing specific legal rules and guidelines for regulating CAM, including licensure and monitoring of individuals and institutions, and, regulation of herbal medicine.
** This talk addresses the regulatory challenge in balancing the mandate to regulate and monitor CAM practice (and safeguard patient safety), against the interest in patient-centered care. Selecting a few representative nations, we will review global models of CAM regulation to expand our understanding of different ways to draw the regulatory balance. Among other things, we will explore these questions: (1) Given that more than 75% of patients are using traditional medicine in various countries, what can we learn from international experience in CAM regulations, especially in countries with similar backgrounds? (2) Should regulation of traditional and complementary medicine be separate from regulation of conventional medical care? Or is an integrated regulatory model preferred? (3) Can we identify a uniform set of regulatory principles that can more or less apply across nations and regions (with suitable modifications for individual peoples and cultures)? In the U.S., the Institute of Medicine (IOM) at the National Academy of Sciences convened a Committee on Use of Complementary and Alternative Medicine (CAM) by the American Public, to study use of CAM therapies; identify major scientific, policy, and practice issues; and develop conceptual models or frameworks to guide decision-making. The idea was to create an authoritative document to guide national policy, despite fragmented approaches among states. A key chapter (Chapter 6) described five major ethical commitments to guide CAM research, practice, and policy. We will discuss and evaluate the conclusions of the IOM Committee, in terms considering foundational principles and frameworks for balancing the various values and interests when regulating CAM.
Michael H Cohen is the credible, authoritative voice on today’s key healthcare legal issues, such as: FDA regulation of dietary supplements, cosmetics, & medical devices; telemedicine law; regulation of anti-aging, cosmetic, behavioral health, & complementary & integrative medicine; & other strategic healthcare business & legal issues. Book Michael for Speaking, or watch Michael’s Demo Reel.
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