Health Canada's Changes to Natural Health Products Policy: Myth and reality

Natural Health Products (NHPs) include:

Vitamins and minerals

Herbal remedies

Homeopathic medicines

Traditional medicines such as traditional Chinese medicines

Probiotics, and

Other products like amino acids and essential fatty acids.

Health Minister says:
Bill C-51 will not affect the way that natural health products are regulated in Canada. The Natural Health Products Regulations, introduced in 2004, will continue to operate the same way under the proposed Bill C-51. Bill C-51 has been drafted to complement and support current policies for natural health products.

But the reality is…
Bill C-51 does not support current policies for natural health products (NHPs). Bill C-51 ignores the fact that a new category has been already created and is being regulated. Bill C-51 insistently categorizes NHPs as drugs, which ignores the significantly different nature of NHPs and Western pharmaceutical drugs.

The NHP Regulations that were introduced in 2004 followed years of consultations (see backgrounder *link) and led to the creation of a new category to control NHPs (which include traditional Chinese medicines and Chinese remedies) (see http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index_e.html). The other two categories, (Food and Drug) are subject to a different system of control. The Food category has the laxest control and the Drug category has the most stringent control, reflecting their nature.

To support the current policies for NHPs, Bill C-51 should clearly legitimize the new category for NHPs.

Health Minister says:
The Natural Health Products Regulations already recognize that natural health products are different from drugs, and that the evidence requirements for drugs are not appropriate for natural health products. Bill C-51 does not change this. In fact, Bill C-51 supports different requirements for different types of products. Therefore, the standards that are used to assess the risks and benefits of natural health products will continue to incorporate history of use, traditional uses and cultural practices.

But the reality is…
If the government really recognizes that NHPs are different from drugs, it must not place both NHPs and drugs into the same category.

By including NHPs within the Drug category, traditional Chinese medicine and Chinese herbal remedies could be considered to be potentially hazardous, which would ignore the long-proven contributions made by TCM/CHR to human health, and would also subject NHPs to clinical trials.

Health Minister says:
Will changes to the Food and Drugs Act result in a ban on natural health products? No. There is nothing in Bill C-51 that changes the regulatory status of natural health products from over-the-counter, as they are now, to prescription. Under Bill C-51, Canadians will continue to have access to natural health products that are safe, effective and of high quality.

But the reality is…
Experts estimate that more than 70% of the NHPs in the market, including those with multi-ingredients (such as traditional Chinese medicine) will become illegal. How will Canadians continue to have access to traditional Chinese medicine if the products unavailable in the market? How will TCM practitioners prescribe herbs if the TCM merchants and stakeholders cannot maintain supplies?

Health Minister says:
Is Bill C-51 targeting natural health products practitioners or consumers? No, the activities of natural health products practitioners falls under provincial jurisdiction. Personal use of products by consumers is also not affected by Bill C-51. The regulated activities for natural health products are already identified in the Natural Health Products Regulations, and remain unchanged. These activities are: manufacturing, packaging, labelling, importation and distribution of natural health products for sale.

The new definition of “sale” in Bill C-51 will not affect practitioners. The relationship between practitioner and patient for compounding falls under the definition of “practice of medicine” and is under provincial jurisdiction. Bill C-51 respects this arrangement.

But the reality is…
Traditional Chinese medicine practitioners may have the right of prescription, granted by the provincial government; however, the medicine and herbal products are controlled by Bill C-51. TCM practitioners and their patients are affected by the Bill in many fronts. First, many herbal products may be removed from the market, and the cost of the remaining products could increase dramatically. The harsh penalties for possessing unauthorized Chinese medicine or remedies, would be applied to TCM practitioners (e.g., a Health Canada agent could search a TCM clinic without a warrant and charge fines up to $5 million, or 2 years in jail for any offence.)

Health Minister says:
Will the increased enforcement powers, fines and penalties in Bill C-51 lead to more compliance action against natural health product companies? Updates to the Act will not result in more compliance and enforcement action taken for regulated products, including natural health products. A modernized Act will allow Health Canada to undertake more effective compliance and enforcement activities by providing the Department with the authority to act based on a product's level of risk.

But the reality is…
Bill C-51 gives extraordinary, unchecked, and unjustified enforcement power to the government. The Bill also removes civil rights from citizens and merchants from being able to dispute their case in court.

It is a surprising statement that Health Canada considers force and heavy penalty a modern act.

Bill C-51 will allow government agents to:

enter private property without a warrant (Section 23(4))

store property indefinitely without paying for damages, and shipping and storage fees are at owner's expense (Section 23(2)(d)) (Section 23.3(a)(b))

disclose personal and confidential business information without notifying the owner (Section 20.9) (Section 21.2)

charge fines of up to $5,000,000 or 2 years in jail or both (Section 31.1)

based on opinion, approve or disapprove market authorization and clinical trial authorization; recall products; seize and detain for any time anything connected to the Act and Regulations; or remove or destroy property at the expense of the owner. . .(Section 18.5(2)) (Section 19.6(2)) (Section 23(3)(a)(b)(c)) (Section 24(1))

A Coalition Against Bill C-51 05/29/2008