In April of this year the Harper government introduced Bill C-51: An Act to amend the Food and Drugs Act. The bill was intended to update consumer protection legislation dating from the 1950s and to bring Canada’s legislative framework in line with the international community. The bill covers all therapeutic products and devices including regular drugs and natural health products.
The bill adds the following elements to the regime that currently governs medicinal products and medical devices:
• The power to issue mandatory recalls (at present, Health Canada has only the power to issue a warning if a drug or natural health product is found to be tainted or unsafe).
• An increase in the fines for offences committed under the Food and Drugs Act.
• The ability to enforce the existing standards that apply to claims of effectiveness.
Section 14 of Bill C-51 states:
No person shall manufacture, process, label, package, sell, import for sale or advertise a therapeutic product in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its benefits, risks, conditions of use, quality, quantity, composition, design, construction, performance, origin or authorization status.
While the above language would seem to be a commonsense standard that any country should employ, the requirement for even a modest measure of truth in advertising appears to have triggered an avalanche of antipathy from proponents of natural health products. A simple Google search of the term “Bill C-51” uncovers a boiling cauldron of paranoia, vitriol, and anti-science that makes the X-Files look downright scholarly.
It is perhaps understandable that the natural health product sector would feel surprised by the suggestion of a restriction placed on advertised benefits. Intense lobbying by proponents of herbal medicine in the late 1990s led to regulatory changes at Health Canada that saw a dramatic reduction in the levels of proof required for natural remedies.
Standards of clinical evidence are much lower than those for regular medications, and many health claims can now be allowed if remedies have simply been part of what is called “traditional use.” As well, a new bureau—the Natural Health Products Directorate—has been created to adjudicate and administer the new weakened regulations. This body is led by proponents of alternative medicine. Yet Health Canada does not have enough staff to evaluate and enforce even these low standards.
The sale of natural health products is big business—and many of the producers are owned by so-called big pharma. Canadians spend over $2 billion yearly on natural health products ranging from herbal preparation to homeopathic remedies.
Health Minister Tony Clement’s assertion that Bill C-51 will not have much effect on the rules around the sale of and claims allowed for herbal remedies is likely correct. Although the language in Section 14 is in the right form to protect Canadians, it is in the subsequent regulations where the real test of consumer protection lies—and these regulations are not slated to change.
Yet there is still fear within the natural health product community. There is acute anxiety that even if the current regulations were enforced, up to 60% of natural remedies would be removed from the shelves. One has to wonder what percentage would be left if we not only enforced the current low standards but also required the sort of genuine scientific testing that would truly protect the public.
—Lloyd Oppel, MD Chair, Council on Health Promotion