Canada’s First Step Towards Permitting Consumer Health Products Containing Cannabis
Today Health Canada completed its first step towards regulating this potential market. Here, David Skinner and Elaine Larsen offer a summary of the state-of-play.
Today Health Canada concludes its consultation on a potential market for consumer and veterinary health products containing cannabis, marking a significant first step towards the regulation of this market of health products, and Canada’s leadership in this space.
One of Health Canada’s core responsibilities as a regulator is to provide Canadians with access to safe, effective, quality health products and to protect Canadians from unsafe products. In this context, the imperative to regulate consumer health products containing cannabis arises from concern that some Canadians are already using cannabis for its perceived health benefit. However, the therapeutic benefits of cannabis products, and potential risks associated with use, have not yet been evaluated by Health Canada.
The substance’s historical prohibition means there is limited research available on its therapeutic benefit and long-term effects. In response, Health Canada welcomes all existing scientific and clinical evidence on the therapeutic benefits of cannabis and supports its continued research. The regulator intends to form an external advisory body of scientific experts this winter, which will be tasked with evaluating existing evidence in order to create appropriate evidence standards required to support a health claim for this class of health product.
It is the department’s intention that a manufacturer’s health claim will be validated by evidence supporting safety, efficacy, and quality before entering the market. A risk-based approach to evaluating a health claim requires different evidence standards proportional to the seriousness of the claim and associated risks of use. This approach would be similar to how Health Canada approaches other consumer health products such as those you will find on the shelves of pharmacies, natural health stores, and pet stores. In this context, it is reasonable to expect that health products containing psychoactive properties such as THC will be regulated differently than health products which induce no psychoactive effect.
Health Canada intends to include the Cannabis Act as part of the policy framework for health products containing cannabis. The existing regulatory framework for prescription drugs containing cannabis provides an example of how the CA can intertwine with the Food and Drugs Act, which regulates all health products.
We are at the starting block of this important and meaningful regulatory process towards a marketplace allowing cannabis products which have a health claim that has been validated for safety, efficacy, and quality by Health Canada.