Read Bill C-51

please click HERE to read

 

Backgrounder

In Canada, all natural health products (NHPs) and traditional Chinese medicine (TCM) are regulated by the federal government, while health care practices are regulated provincially. The practice of TCM is currently regulated in both BC and Ontario. In BC, the legal body is the College of TCM Practitioners and Acupuncturists of BC. While regulated TCM practitioners are allowed to prescribe herbs and other treatment modalities, non-prescribed, public accessible TCM products are regulated by the Natural Health Product Directorate (NHPD).

Natural Health Product Directorate (NHPD)
The NHPD, established in 1999 under Health Canada, held extensive stakeholder consultations in the summer of 2003, and announced regulations for licensing natural products and ingredients in Canada (NHPD, 2004). The regulations were first implemented on January 1, 2004 to "ensure all Canadians to have ready access to natural health products that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity." (NHPD, 2007)

The new NHP regulations classify NHPs as a sub-category of drugs, which includes products commonly known as herbal remedies, traditional medicines (e.g., Chinese medicine), homeopathic medicines, probiotics, vitamins and minerals, and others. Prior to January 2004, NHPs were regulated under the Food and Drugs Act, implying that either food or drug regulations were applied to NHPs, depending on the medical claims of the manufacturers. The new NHP regulations that govern the licensing, manufacture, labelling, clinical trials, and adverse reaction reporting of NHPs (NHPD, 2007), are viewed as being more strict than food regulations since the applying companies must provide evidence of safety, efficacy, and quality to Health Canada. At the same time, (the existing) NHP regulations are less strict than drug regulations (Laeeque et al., 2006). The regulations represent a pre-market approval mechanism by the government.

The standard of evidence used to regulate NHPs allows for a range of evidence (e.g., anecdotal and population studies) to support safety, efficacy, and quality of the products. Three levels of claim are possible: risk reduction, structure and function, and cure. The last category requires the same level of evidence (i.e., double-blind, randomized clinical trial) as that used for prescription drugs (NHPD, 2007).

On April 8, 2008, the Minister of Health introduced Bill C-51, an act to amend the Food and Drug Act. The legislation introduces a new definition of “therapeutic products” to encompass drugs, medical devices and cells, tissues or organs. This new definition may change the regulatory framework, which treats NHPs equally as drugs, and which implies a strict requirement of a higher level of evidence for natural health products, such as clinical trial. The new Act also adds a definition of “clinical trial” which requires authorization or approval from Health Canada to conduct a clinical trial for any therapeutic product. The act grants extraordinary authority to Health Canada and imposes heavy penalties for violation.

*provided by Dr. Lyren Chiu
Canadian Research Institute of Spirituality and Healing