Health Canada has recently announced a Notice of Intent – Consultation on the Cannabis Regulations: Cannabis research and other regulatory issues.
What are the intended changes?
- To amend the CR and regulatory framework and facilitate non-therapeutic cannabis research involving humans. Details of this include:
- Implementing appropriate health and safety controls, and
- Broadening adverse reaction reporting
- To streamline and rationalize the licensing framework under the CR to facilitate cannabis-based testing activities. Details of this include:
- Expanding production, distribution, and sale activities with cannabis reference standards and test kits, and
- Expanding the acceptable qualification of the “head of the laboratory”
The publication of this notice of intent initiated a 30 day consultation period which will end January 11, 2021, at 11:59 pm. This consultation period is in place to ensure that the proposed regulatory amendments with respect to the cannabis research and testing are both informed and responded to by the cannabis industry, cannabis researchers, other relevant stakeholders, and the public. Comments and inquiries can be sent to Health Canada via email to firstname.lastname@example.org with “notice of intent – consultation on the cannabis regulations; cannabis research and other regulatory issues” in the subject line.
This notice of intent opens up major avenues for cannabis innovators because it will allow for research into the psychological and physiological effects of cannabis from a non-therapeutic perspective. Some examples of what a non-therapeutic study might include are investigating the time to onset or duration of the effects of a cannabis product, or the impact of cannabis use on the operation of a motor vehicle.
One of the challenges researchers in our industry (including our own CRO) faces in conducting non-therapeutic cannabis research is that clinical trials with commercially available cannabis for non-therapeutic purposes are subject to Part C, Division 5 of the FCR, which the department itself admits, may not be “ideally suited to regulate research for non-therapeutic purposes” under the current legal framework. Although some interim measures are available to help facilitate non-therapeutic research, up until the announcement of this notice, conducting non-therapeutic research has largely remained an unattainable goal.
Amendments related to the micro cultivation, micro processing, and nursery licences are also considered. These changes in particular consider easing up on regulatory requirements to help enable micro-cultivators, micro-processors, and nurseries to be more competitive with larger scale players and potentially free up capital.
Other noteworthy consultations which are part of this notice include changes to public possession limits, product labelling, and COVID-19 measures.
If you have any questions about this notice or any other Cannabis Regulatory matters, feel free to contact us now.