Issue
There are concerns with the changes being imposed by Health Canada on the Self-care Framework, particularly actions related to the imposition of additional new fees for natural health product businesses; new regulatory burdens on natural health product businesses; and inequitable authority over the natural health product community.

Background

In Canada, oversight of Natural Health Products (NHPs) falls under the Natural Health Products Regulations (NHPR)¹ of the Food and Drugs Act. These regulations came into effect on January 1, 2004, after consultation with stakeholders and the public to determine an appropriate regulatory framework for NHPs. At that time, it was agreed that it was not proper to regulate natural products under the same regulations as chemical drugs or impose the same standards of evidence onto natural health products.

In 2017, Health Canada launched a consultation on the regulation of self-care products². In 2021, Health Canada conducted consultations regarding proposed regulations to amend the Natural Health Products Regulations with the purpose of gathering feedback on proposed improvements to natural health product labelling³. In addition, it was cited that the proposed amendments were anticipated to decrease the regulatory burden and costs to businesses, as well as introduce greater efficiencies for businesses.

Since then, new proposed regulations were introduced creating concerns around the future of Natural Health Products (NHP) in the Canadian Market, from new fees and charges imposed, to the increased regulatory burden and the inequitable treatment of natural health care products. Most recently, in 2023⁴, Health Canada provided information related to the fee proposal with the intention to start charging new fees on April 1, 2025, in addition to increasing the regulations.

Dating back to 1998, with the report of the Standing Committee on Health, Natural Health Products: A New Vision.⁵, it has been recognized that there is a legislative and regulatory regime required to govern traditional medicines (including, but not limited to, traditional herbal remedies, traditional Chinese, Ayurvedic and Native North American medicines), homeopathic preparations and vitamin and mineral supplements, taking into account the needs of associations, consumers, manufacturers, distributors, growers, importers, exporters, retailers and practitioners. The guiding principle since that time has been to establish a regulatory framework for NHPs that (1) protects the health of consumers (2) respects consumers' access to products and (3) guarantees product safety and quality.

With limited implementation timelines, exorbitant fee increases and additional regulatory burdens, the new standards will cause significant issues within the industry and government. The fees, regulations and compliance costs are viewed as unnecessary changes to a system that was deemed to be working after the Natural Health Products Regulation in 2004.

As of 2022, Health Canada had licensed over 120,000 NHPs5. With the increased demand for Natural Health Products and Practices and the increasing regulatory environment, there has been increased awareness regarding the need for legislation that will ensure a better regulatory environment for Natural Health Products and Practices, including calls for a proposed Charter of Health Freedom Act6. The health and wellness industry recognizes the need for a more balanced regulatory environment and structure, built in consultation with industry, while still achieving the guiding principles of protecting the health of consumers, respecting consumers’ access to products and guaranteeing product safety and quality.

Businesses in the health and wellness sector understand the regulations imposed in 2004, citing that they have been the best regulatory regime of NHPs in the world with the expertise and time invested in that process. However the most recent cost recovery model and amendments to the Food and Drugs Act, as of December 22, 2023, will not achieve the desired outcomes without the same due diligence and consultation as previously conducted with industry.

Recommendations

The Southeast Alberta Chamber of Commerce recommends the Government of Canada:

1. Conduct an impact analysis on the cost recovery policy and the consequences to different segments of the Natural Health Product industry;

2. Eliminate additional fees, while re-examining fee levels in consultation with industry;

3. Introduce legislation that is globally competitive while adequately protecting Natural Health

4. Implement the Standing Committee on Health’s recommendations from the report: Natural Health Products: A New Vision.8;

5. Only implement new regulatory changes once backlogs are cleared, operations run efficiently, and policies and procedures are in place to ensure stable operations continue for Natural Health Products.

References

1 Natural Health Products Regulation: https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/
2 Consultation on the regulation of self-care products: https://www.canada.ca/en/health-canada/programs/consultation-regulation-self-care-products.html
3 Forward Regulatory Plan 2023-2025: Regulations Amending the Natural Health Products and the Food and Drug Regulations (Self-Care Framework
https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/forward-regulatory-plan/plan/self-care-framework.html 
4. Natural Health Productions: A New Vision - Report of the Standing Committee on Health - Recommendations: https://www.ourcommons.ca/documentviewer/en/36-1/HEAL/report-2/page-126More Information: https://www.canada.ca/en/health-canada/topics/self-care-products.html
5. Proposed fees for natural health products: Overview: https://www.canada.ca/en/health-canada/programs/consultation-proposed-fees-natural-health-products/overview.html
6. Charter of Health Freedom: https://www.charterofhealthfreedom.org/the-charter/
7. Food and Drug Act, current to 2024-04-16 and last amended on 2023-12-22 https://laws-lois.justice.gc.ca/eng/acts/f-27/ 
8. Natural Health Productions: A New Vision - Report of the Standing Committee on Health - Recommendations: https://www.ourcommons.ca/documentviewer/en/36-1/HEAL/report-2/page-126 
More Information: https://www.canada.ca/en/health-canada/topics/self-care-products.html

Date Approved: June 19, 2024