Recent industry concerns over Health Canada’s backlog of roughly 10000 so-called natural remedies awaiting pre-market review have not gone unheeded by Health Canada.
In a move reminiscent of a Kafka novel, the nation’s foremost health protection agency has decided to address the bottleneck posed by an already woefully lax screening process by simply exempting products from such review altogether for at least a couple of years.
For more than a decade, products such as herbal, homeopathic, and similar remedies have been granted special regulatory status as natural health products (NHPs). Manufacturers are permitted to market these NHPs using claims that they produce health benefits.
Currently, the standard proof of safety and effectiveness that applies to this class of products is far lower than those that apply to regular medications. Furthermore, once proper testing is done, almost all of these products fail to show compelling proof of efficacy, including products already on the market. Indeed, even after claims of health benefits are disproved, the products continue to be sold.
The problem of inadequate standards is compounded by the lack of resources at Health Canada to review and process a backlog of marketing applications.
This is not to say that unapproved natural products aren’t on the shelves. They are, but producers are concerned that Health Canada might demand that unapproved products be removed from the marketplace. Although such a move might seem to be common sense to those concerned about consumer protection, Health Canada appears to have taken a different approach.
The current NHP regulations came into force in 2004 at which time Health Canada had an estimated 40000 natural health product applications to review and provide licences for, and manufacturers had 6 years to meet Health Canada’s requirements.
Health Canada now says it will not be enforcing the now-passed 1 April 2010 deadline. The agency states that about 60% of applications it received have been processed. For the remaining 11000 NHP applications received but not yet assessed, Health Canada on 4 August introduced the Natural Health Products (Unprocessed Product Licence Applications) Regulations.
These state that these products can remain for sale to Canadians during the 21/2 years the agency believes it will take to apply the existing weak review standards for safety, efficacy, and quality. The benefits of this exemption will be huge—as far as producers are concerned. Health Canada recently estimated the retail value of the unapproved natural health products at between $200 to $930 million.
The bottom line is that thousands of products remain unapproved by Health Canada but are still openly sold to unsuspecting Canadians, who might well believe that Health Canada wouldn’t allow anything into stores unless it truly was safe and effective.
At the end of 2009, pharmacy regulators concerned for patient health and safety instructed pharmacies across the county to stop selling unapproved natural health products. Health Canada’s maneuver appears to sidestep the concerns by neatly declaring those same products “approved pending review.”
The proposal to defer the weak review process that exists within Health Canada’s Natural Health Products Directorate places Canadians in harm’s way by failing to prevent exaggerated health claims and by exposing consumers to unnecessary health risks.
Given that medical claims made on behalf of NHPs typically exceed the evidence of medical benefit, and that significant safety issues with various NHPs continue to be discovered upon proper scientific testing, many Canadians will wonder if a near-billion-dollar bonanza to industry is worth the price.
—Lloyd Oppel, MD
Chair, Allied Health Practices Committee
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