Health Canada is proposing a complete overhaul of the regulatory framework for "self-care products," a category which encompasses natural health products, non-prescription/over-the-counter drugs ("OTCs") and cosmetic products. If implemented, the new framework (called the "Self-Care Framework") could have far-reaching implications for NHPs and Canadian consumers.

Current Regulatory Framework

For the last 12 years, NHPs have been subject to a pre-market approval process under the Natural Health Product Regulations. This process is rooted in the findings of the Standing Committee on Health ("SCOH"), which conducted a fulsome investigation into the historical significance of NHPs, and concluded that NHPs should be regulated differently than OTCs and foods. 

To bring an NHP to market, an applicant must submit an application for a product licence, complete with evidence to support the safety and efficacy of the product, to the Natural and Non-Prescription Health Products Directorate ("NNHPD"). The NNHPD then assesses the evidence to ensure that it supports the safe use of the product and the claims being made on the product label. The level of evidence required varies based on the nature of the NHP and the types of claims it makes (e.g. traditional health claims vs. modern health claims vs. homeopathic health claims). The evidence required may include clinical trial data, or references to published studies, journals, pharmacopoeias and traditional resources; however, the only types of licence applications that are exempt from providing scientific evidence are those that confirm compliance with monographs and abbreviated labelling standards published by the NNHPD.

Proposed Self-Care Framework

The Self-Care Framework would replace this NHP-specific process with a single, risk-based approval system for all self-care products. Health Canada believes that this overhaul is necessary to rectify what it believes is a lack of knowledge and confusion on the part of consumers about the evidence submitted to support NHP applications compared to the evidence submitted to support OTC ones. What is problematic is the reality that these beliefs appear to be substantiated by a single Consumer Survey. In contrast to Health Canada's SCOH approach, no additional research was conducted and no alternative proposals were made. Notably, in the new system:

  • The NNHPD would remove its regulatory oversight of NHPs that are classified as "low-risk" and preclude such products from making therapeutic claims. For example, a traditional medicine, such as a Chinese, Ayurvedic or Aboriginal medicine, would not be allowed to include "remedies back pain" on its label, despite its many centuries of use as a treatment for this particular ailment. Consumers will either have to know or guess what products that fall into the low-risk category do.
  • Conversely, the NNHPD would heighten its regulatory oversight of NHPs that are classified as "medium-risk" or "high-risk", by subjecting them to the same evidentiary thresholds as OTCs, which the proposal equates to prescription drugs.

Moreover, the adoption of the Self-Care Framework is likely to have a negative effect on the number of products available for sale in Canada, resulting in a less diverse and inclusive marketplace for health products in Canada. Consequently, apart from having a discriminatory impact on Aboriginal and other traditional medicines, the Self-Care Framework could also greatly curtail Canadian consumers' freedom of choice.

We strongly encourage you to read the proposal document, "Consulting Canadians on the Regulation of Self-Care Products in Canada" (available online). The consultation closed on Oct. 24, 2016, so we are eagerly awaiting Health Canada's next steps. If you would like to make comments on the same, you can always send an email to Health Canada at nnhpd_consultation_dpsnso@hc-sc.gc.ca or Info@hc-sc.gc.ca. Alternately, write a letter to the Minister of Health. 

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