Health Canada has announced that a 30-day consultation on Cannabis regulatory issues has opened as of Saturday December 12th, 2020. This consultation can prompt changes in the regulations for cannabis research, product labelling, beverage limits, and more. Comments, questions, and further input can be submitted to Health Canada until January 11th, 2021.
The notice provides interested stakeholders with the information they need to act on this opportunity to comment on Health Canada’s intent to amend the Cannabis Regulations and associated regulatory frameworks to allow for non-therapeutic cannabis research involving human participants and cannabis testing. Opportunities are also available to comment or provide feedback for any additional regulatory issue as well.
Health Canada will be looking to engage with all Canadians, including; provinces, territories and municipalities, Indigenous peoples, industry, academia, the public health community, law enforcement, etc.
The consultation will focus on the following areas within the Cannabis Regulations. The input that is gathered through this process will be used to inform further regulatory development.
- non-therapeutic cannabis research involving human participants
- cannabis testing
- public possession limits (namely, amounts of various classes of cannabis that are equivalent to 1 gram of dried cannabis, as set out in Schedule 3 to the Cannabis Act)
- product labelling requirements
- micro-class and nursery licensing regime
- measures to support cannabis licence holders with difficulties they might have because of COVID-19
At this point in time, Health Canada has announced two main proposed amendments that will be evaluated throughout this consultation focusing on furthering cannabis research and testing activities.
- Non-therapeutic cannabis research involving human participants will be facilitated by implementing appropriate health and safety controls and broadening any adverse reaction reporting wherever necessary.
- Licensing framework will be streamlined in order to facilitate cannabis-based testing activities, not limited to;
- Expanding the production, distribution and sale activities for cannabis reference standards and test kits.
- Expanding the acceptable qualifications for the “head of laboratory” position.
Questions to guide interested parties;
Health Canada has also released some key questions that hold particular interest for them. That being said, all input is welcome and should not be limited to responses to these questions only. Send an email with your comments along with any provided rationale and/or evidence to support your views to cannabis.consultation@canada.ca. (The title of the notice (Notice of intent —Consultation on the Cannabis Regulations: Cannabis research and other regulatory issues) should be included in the subject line).
1. How likely would you conduct non-therapeutic cannabis research involving human participants? How many studies do you envision conducting in a year?
2. Should the requirements to conduct non-therapeutic cannabis research involving human participants under the CR be similar to those that currently apply to clinical trials under the FDR (e.g. protocol review by a research ethics board, submission of extensive quality [chemistry and manufacturing] information, review of written informed consent, and submission of an investigator’s brochure)? If the requirements should differ, how?
3. Should non-therapeutic research involving human participants be restricted to certain participants (e.g. exclude individuals with previous/current mental health or substance use disorders, age restrictions)?
4. Should there be restrictions on the types of cannabis used in non-therapeutic cannabis research involving human participants? If so, under what circumstances? What should the quality requirements be for cannabis derived from synthetic sources?
5. Should there be restrictions on the dosage, frequency, duration and route of administration (e.g. smoking or vaping) of cannabis used in non-therapeutic cannabis research involving human participants?
6. Should adverse reaction reporting for non-therapeutic cannabis research involving human participants be treated in a similar manner as adverse reaction reporting for clinical trials under the FDR? Why or why not?
7. What are your thoughts on expanding the production, distribution and sale activities of cannabis reference standards and test kits? What are the potential risks and benefits of this approach (e.g. by exempting reference standards from GPP requirements)?
8. Are there any impediments stemming from the current requirements for the “head of laboratory” under the CR?
9. Do you think the public possession statement on cannabis product labels helps adults comply with the public possession limit?
10. Currently, the CR require labels to display a statement to express the amount of cannabis a product is equivalent to in terms of grams of dried cannabis. Do you see any issues with this approach? Are there any benefits or challenges you think an adult may have in interpreting this information on different kinds of cannabis products (e.g. edible cannabis, cannabis topicals, vaping products, etc.)?
11. Do you think the current public possession limit for cannabis beverages (which is currently approximately 2 litres) should be increased? If yes, please explain what you think an appropriate public possession limit would be for these products and why.
12. Should Health Canada require product labels to display information about other cannabinoids and terpenes (e.g. quantity or concentration)? Why or why not? If yes, which cannabinoids and terpenes and why?
13. Is there any other labelling information that would help consumers make decisions to support informed and responsible use?
14. Are the regulatory requirements for the micro-cultivation, micro-processing and nursery licences (e.g. cultivation and processing limits) appropriate given their scale?
15. Are there any elements of the regulatory framework that put micro-cultivation, micro-processing and nursery licence holders at a competitive disadvantage compared to larger companies? If so, how, and what adjustments would you propose?
16. Are there any measures that should be made permanent? What would be the impact if these measures were not continued? Are there any risks of making a measure permanent and how should they be mitigated?
Interested parties will have until January 11, 2021 to submit any input.
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References
https://www.canada.ca/en/health-canada/programs/consultation-cannabis-regulatory-issues.html
http://www.gazette.gc.ca/rp-pr/p1/2020/2020-12-12/html/notice-avis-eng.html#nb1
