From: Michael J. Trebilcock and Kanksha Mahadevia Ghimire
To: Canadian health regulators
Date: May 9, 2019
Subject: Alternatives for alternative medicines
In many Western countries, the use of complementary and alternative medicines (CAMs) has been growing.
Individuals often use CAMs in conjunction with biomedicine (also referred to as allopathic or Western medicine), or sometimes choose to rely on CAMs as alternatives to biomedicine. The field of CAMs groups together a vast array of medical treatments such as homeopathy, chiropractic, osteopathy, naturopathy, Ayurveda, Siddha, Unani, traditional Chinese medicine, and spiritual therapies.
In most contemporary Western societies, biomedicine is relatively strictly regulated, while regulation of CAMs reflects a much less settled regulatory landscape. We detail this in our new C.D. Howe Institute Commentary.
With use of CAMs increasing and concerns about standards, there is a need for an approach to regulating certain popular forms of CAMs. The central regulatory challenge is how to provide for patient autonomy over treatment while addressing the core challenges of severe information asymmetries and negative externalities.
Regulation of CAMs should be calibrated to the degree of risk entailed, especially where CAMs are promoted as substitutes for, rather than as complements to, biomedicine in treating potentially life threatening health conditions.
A striking, even disconcerting, feature of the evolution and regulation of the various CAMs is the lack of anything approaching consistency of approach across jurisdictions and categories of CAMs. Indeed, a range of regulatory options has found favour in one or another Western jurisdiction, with little evidence of a convergence toward a dominant regulatory paradigm.
This discordance in regulatory practice is echoed in scholarly and public policy literature debating the merits of alternative regulatory approaches to CAMs. Some authors oppose regulation of CAM practitioners and products, arguing that typical forms of regulation protect mainstream biomedicine and hinder innovation and competing methods of healing, including traditional CAM practices, some of which are of cultural significance to their communities of origin even where not based upon biomedical evidence.
Other commentators argue against regulation of CAM practitioners and products from opposing premises: that any form of regulation of CAMs is likely to legitimize and promote their use, even though many, if not most, CAM practices and products lack adequate scientific justification or verification.
Among scholars who favour some form of regulation of CAM practitioners, proposals vary widely.
Some argue for state-sanctioned forms of self-regulation for individual classes of CAMs, modelled on standard approaches of self-regulation of mainstream professions. Another body of thought seeks an umbrella regulatory body that would regulate all or most forms of CAM practitioners according to a uniform and consistent set of principles.
As to what form professional regulation should take, some scholars favour a form of licencing, on the grounds that only licence regimes are capable of mandating appropriate training regimes, post-entry codes of conduct, and disciplinary and continuing education protocols. This in combination would ideally exclude inadequately trained, fraudulent, incompetent or deviant practitioners.
Other scholars argue – convincingly, in our view – that any attempt to create multiple mutually exclusive licence regimes across the entire landscape of healthcare provision inevitably would entail arbitrary boundary drawing, rigidities and interprofessional conflicts, as well as impeding innovation and discouraging the closer integration of biomedical and CAM health disciplines.
We do not presume to offer detailed regulatory protocols for each individual category of CAM, or CAMs as a broader encompassing category.
Rather, we propose general guiding regulatory principles for CAM products and practitioners. Our paper also provides a framework for governments to structure the regulation of complementary and alternative medicines and develop appropriate institutions, such as a CAM advisory council, to provide independent advice to governments on appropriate standards, especially when CAMs are promoted as alternatives to biomedical treatments for serious health conditions.
Advice on medical treatments involves significant information asymmetries and potentially engages mortal risks for individuals. A principled and restrained approach to regulating CAM would focus on calibrating regulatory responses to the seriousness of the risks involved and reflect an appropriate balance between personal autonomy/patient choice and the public interest in addressing misrepresentations.
However, although many question the legitimizing CAMs, their growth indicates that consumer demand for them is here to stay.
What is needed are clear regulatory objectives, principles and independent, expert institutions in order to shape appropriate regulation.
Michael J. Trebilcock is Professor of Law and University Professor at the Faculty of Law, University of Toronto, and a Research Fellow at the C.D. Howe Institute. Kanksha Mahadevia Ghimire is an S.J.D. Candidate, University of Toronto.
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The views expressed here are those of the authors. The C.D. Howe Institute does not take corporate positions on policy matters.