Changes to Health Canada's Cannabis Authorization Process Medical Purposes
Health Canada has advised CPSM of upcoming changes to the federal review process for cannabis authorized for medical purposes.
Health Canada is concerned about the potential risks of high-dose cannabis authorizations that are inconsistent with available evidence. This includes the risks to public health and/or safety, including potential diversion of excess cannabis to the illicit market. There is evidence to suggest that some personal and designated production sites are used to support criminal activity. Health Canada is prepared to act on any evidence that individuals are not respecting the terms and conditions of their registrations or the federal regulatory requirements.
Please review the following updates:
- When considering the use of cannabis for medical purposes, the amount authorized must balance potential therapeutic effects with adverse effects and/or unintended consequences. Available data suggests that most individuals who use cannabis for medical purposes in Canada use an average amount between 1-3 grams of dried cannabis daily.
- Health Canada has provided updated guidance on conversions for individuals using fresh cannabis and oils. CPSM registrants should also use the equivalency factors to appropriately counsel patients on cannabis possession limits.Registrants authorizing cannabis for medical purposes are strongly encouraged to review Health Canada’s fact sheet, Important Information for Health Care Practitioners - Personal and Designated Production of Medical Cannabis. This fact sheet contains several useful links, including information about dosing equivalencies for different forms of cannabis.CPSM reminds registrants that they are professionally responsible for each medical cannabis authorization they provide patients, as stated in the CPSM Standard of Practice for Authorizing Cannabis for Medical Purposes.
- Moving forward, Health Canada may contact CPSM registrants directly to request evidence that supports the amount of cannabis authorized for a particular patient.
Registrants should be prepared to provide supporting information such as peer-reviewed data, references, or resources to support the authorized daily quantity. Gathering this evidence will help Health Canada assess potential risks to public health and safety. It will also inform new or renewal applications when individuals seek to be registered to produce cannabis for their own medical purposes. If registrants do not respond to Health Canada or cannot provide information to substantiate the amount authorized, the application may be refused.
This approach is supported by the Expert Panel that recently completed a legislative review of the Cannabis Act, which recommended that Health Canada build on recent efforts to seek additional clinical justifications from health care practitioners authorizing high daily amounts.
In the interest of patient and public safety, CPSM is aligned with Health Canada’s efforts to evaluate the potential risks associated with high-dose cannabis authorizations.
CPSM registrants can call the Prescribing Practices Program at 204-774-4344 for support or guidance in responding to Health Canada.
More Information on Authorizing Cannabis
Health Canada
Information for Health Care Practitioners - Medical Use of Cannabis
The College of Family Physicians of Canada (CFPC)
Guidance in Authorizing Cannabis Products Within Primary Care
Guide to Navigating Cannabis Use in Family Practice