Health Canada provides draft guidance on personal production of cannabis for medical purposes

Kevin Landry and  Emily Murray

On March 8, 2021, Health Canada released draft guidance on personal production of cannabis for medical purposes (“Guidance Document”).  At present, the Guidance Document is being circulated for public comment for a 60-day period ending May 7, 2021.

Why is public consultation being sought?

This consultation is a step towards addressing the growing concerns regarding misuse of Canada’s access to cannabis for medical purposes framework (“Framework”).  Health Canada maintains that it is “committed to protecting patients’ rights to reasonable access to cannabis for medical purposes and recognizes that most patients are using the program for its intended purposes.” It also recognizes, however, that “abuse of the medical purposes framework undermines the integrity of the system that many patients and health care practitioners rely on to access cannabis to address their medical needs.”

Health Canada identified several growing areas of concern with respect to potential misuse of the Framework that it intends to address with the Guidance Document:

• The progressive increase in the daily amounts being prescribed to people seeking Health Canada approval to produce medical cannabis on their own or through a Designated Person (as defined in the Cannabis Regulations).
• Increases in activities that do not comply with the Framework such as unauthorized individuals permitted access to personal and designated growing sites, unmet security obligations, unauthorized outdoor production, and plant counts beyond authorized amounts.
• Increased drug and weapon charges against personal and designated producers who were using the Framework to support large-scale illegal production and sale.

The Guidance Document compiles information on the Framework into one place and “sets out, for the first time, proposed factors that Health Canada may consider in making decisions to refuse or revoke a registration on public health and public safety grounds”.

What factors will be considered by Health Canada in refusing or revoking a license for personal production?

Health Canada still maintains the ability to consider all relevant factors, including public health and safety grounds, in making decisions to issue, renew, or revoke licenses under the Cannabis Regulations but has provided examples of other factors that may be considered:

1. Amount of daily authorized cannabis by the health care practitioner and information to support the amount authorized:

1. 1. Is the authorized daily amount of cannabis supported by credible clinical evidence and/or published treatment guidelines?
   2. Is the amount of daily authorized cannabis considered reasonable, after taking into account the route of administration and potential for product loss from processing activities?

2. Non-compliance or history of non-compliance with the Cannabis Act and Cannabis Regulations by the Designated Person, including the relevant circumstances:

1. 1. What is the overall history of non-compliance, including the number, nature and severity of previous instances of non-compliance? How much time has elapsed since the last non-compliance, and how has the person responded to previous non-compliance?
   2. Is the Designated Person growing, or have they grown, more than the amount authorized by the registration?
   3. Is the Designated Person taking, or have they taken, reasonable steps to ensure the security of the cannabis in their possession?
   4. Is someone other than the Designated Person tending, or has someone other than them tended, to the cannabis plants?
   5. Is the Designated Person “selling or renting”, or has the Designated Person “sold or rented”, their registration?
   6. Is there, or has there been, an apparent, intentional effort on the part of the Designated Person to circumvent the Cannabis Act or Cannabis Regulations such as obstruction of Health Canada inspectors?

3. Criminal activity and/or diversion of cannabis:

1. 1. Is the production site linked, or has it been linked, to the diversion of cannabis, a controlled substance or a precursor, or to criminal activities?
   2. Is the Designated Person, the owner of the production site, or an individual with another direct link to the site or operation involved in the diversion of cannabis, a controlled substance or a precursor, or have they been involved in or do they contribute or have they contributed to such diversion?
   3. Is the production site linked, or has it been linked, to organized crime? Is the Designated Person, the owner of the production site, or an individual with another direct link to the site or operation associated with organized crime or have they been associated with organized crime?

4. Heath care practitioner is or has been involved with criminal activities or has been subject to disciplinary review or action by a licensing authority in relation to their prescribing practices with cannabis or controlled substances:

• 1. Has a provincial licensing authority investigated or disciplined the health care practitioner in relation to their prescribing practices with cannabis or other controlled substances?
  2. Is or has the health care practitioner been involved in or contributed to activities prohibited by or conducted in contravention of the Cannabis Act or the Controlled Dugs and Substances Act?
  3. Is or has the health care practitioner been a member of a criminal organization as defined in subsection 467.1(1) of the Criminal Code, or is or has been involved in, or contributes or has contributed to, the activities of such an organization?

This update is intended for general information only. If you have questions about the above, please contact a member of our Cannabis Group.