Health Canada progressing towards allowing the sale of Cannabis Health Products without the need for medical practitioner oversight

Last June, Health Canada launched a consultation to seek feedback from Canadians, as well as the cannabis and health products industries, regarding the kinds of products they would be interested in purchasing, manufacturing, or selling, should a legal pathway to market for cannabis health products (“CHPs”) be established.

The establishment of this consultation was a welcomed development by many in the cannabis and health product industries given that all medical cannabis products in Canada currently need to be purchased with the oversight of a medical practitioner.

The consultation closed on September 3, 2019, and many, myself included, were optimistic that the government would release draft regulations pertaining to CHPs by the end of 2019 with products hitting the shelves in 2020. On September 16, 2020, Health Canada released the results of its consultation. While we will almost certainly not be seeing CHP products on store shelves in 2020, the results of the consultation are highly encouraging and Health Canada has indicated that it intends to create a scientific advisory committee before the end of the year to seek external scientific advice that will support consideration of appropriate safety, efficacy and quality standards for health products containing cannabis that would be safe for use without practitioner oversight. The work of this committee will, according to Health Canada, “help inform a potential path forward.”  Notably, Health Canada has indicated that it “intends to gather external scientific advice on the appropriate evidence standards required to demonstrate safety, efficacy and quality.”

Purpose of Consultation

The nature and purpose of the consultation was discussed on the Torkin Manes’ Cannabis Blog when the consultation was launched last year.  

As a brief refresher, Health Canada indicated that it was aware that some Canadians were, and are, interested in the potential therapeutic uses of cannabis for purposes such as pain relief for human and animal use, without the need for practitioner oversight. The consultation sought feedback from Canadians on the kinds of products they would be interested in if such products were made legally available in Canada. Health Canada held five information sessions by teleconference for parties interested in CHPs for human use or for use in animals. Participants were asked to provide feedback by answering questions posed in the consultation, or by emailing a written submission.

1,104 respondents completed the online consultation. 62% of participants identified as consumers interested in purchasing CHPs. 23% of participants identified themselves as industry representatives interesting in manufacturing or selling CHPs. 15% of participants identified themselves as other interested parties.

Highlights of Findings

All of the findings can be found in Health Canada’s Summary Report, however below we have highlighted some findings that we found of particular interest.

Responses from Consumer Participants

• A majority of both consumer respondents (61%) and industry representatives (62%) indicated an interest in both CHPs for human use and for use in animals.
• 93% of consumer respondents demonstrated a positive level of interest in purchasing or learning more about CHPs to treat minor ailments with only 2% strongly opposed. 
• Consumers who demonstrated a positive level of interest in CHPs considered cannabis, and in particular CBD, as a natural remedy. They also noted their preference for greater access to natural alternatives to pharmaceutical drugs. These respondents encouraged Health Canada’s approval of CHPs to ensure safety and quality, while allowing consumer choice and increased access to a wider array of products without practitioner oversight.
• Some consumers indicated that if CHPs were not affordable or covered by insurance they would be more likely to, or will continue to, seek cheaper, unapproved products from the illicit market.
• 85% of consumer respondents indicated a desire for CHPs to treat issues relating to pain and inflammation. Mental health issues, such as anxiety, depression or stress, were also identified as a reason for interest for CHPs, as was trouble sleeping. 82% of consumer respondents described more than one purpose of interest (i.e. an interest in using CHPs for multiple purposes).
• 61% of consumers were interested in products that could be taken orally, particularly as extracts, tinctures, oils, capsules or in sublingual formats.  41% of consumers were interested in topicals, such as creams or lotions.  24% either were interested in all formats or did not state a preference and 18% were interested in CHPs edibles or beverages that would be easy to use. About 10% of consumer respondents indicated that they preferred to continue smoking or vaping cannabis.
• Consumer response generally “affirmed high demand for making CHPs legally available for both human and animal use”.
• Only 10% of consumer respondents indicated that place of sale was a concern and in particular they felt that the retail environment for CHPs should be similar to that of over-the-counter drugs or natural health products and should not be restricted to provincially or territorially authorized retailers or federally licensed cannabis sellers. 
• Allowing CHPs to be sold at pharmacies, health stores or other retailers would improve availability and deter from the stigma associated with cannabis use.
• Consumer respondents recommended an alternative approach to the regulation of CBD, separate and apart from the regulation of products containing THC. Consumers indicated that CBD should not be regulated in the same fashion as THC, alcohol or pharmaceutical drugs, which they view to be more harmful than CBD.
• Overall, consumer participants felt that cannabis is safer or healthier to use than pharmaceuticals and would prefer to access products approved for safety and efficacy without the need for additional practitioner oversight.

Responses from Industry Participants

• Overall feedback from industry participants demonstrated a strong desire to bring to market a new range of cannabis products.
• 62% of industry participants stated an interest in CHPs for both human use and use in animals. 
• Industry participants identified restricting the sale of CHPs to provincially and territorially authorized retailers or federally licensed sellers as a major disincentive for them to bring new products to market. Many noted the lack of health training among current cannabis retail employees and the risk of confusion for customers between non-medical cannabis products and CHPs if the two products were to be sold from the same location.
• Almost 40% of all types of industry participants recommended that CHPs be sold in pharmacies, veterinary clinics or health stores.
• Approximately 50% of industry participants expressed a preference for a broader ability to promote and distinguish their products on the market and are of the view that packaging and labelling requirements for CHPs should be similar to any other natural health product (“NHP”) or over-the-counter drug.
• Approximately 50% of the submissions from the cannabis and NHP industries proposed creating two distinct pathways for CHPs that appropriately reflect their risk profiles. In particular, these respondents suggested establishing one regime for CHPs with THC and another for CHPs with CBD, with each regime having its own distinct requirements for packaging and labelling, retail environment, youth access and evidence standards.
• In general, industry respondents indicated they were working to generate evidence, and recommended further guidance from Health Canada, including guidance on how to conduct research involving cannabis.

Responses from All Other Interested Parties

(participants in this category include healthcare professionals, veterinary professionals, academics, researches, members of governmental and non-governmental organizations, advocacy group members and regulatory consultants and legal representatives)

• Nearly 70% of respondents in this category indicated that they were aware of sub-populations (e.g. seniors, people with chronic medical conditions, etc.) or groups that would be interested in CHPs for both human use or use in animals.
• 70% of healthcare professional respondents indicated an interest in CHPs for mental health purposes.
• Overall feedback from this group generally indicated that this group perceived anyone suffering from chronic conditions or in pain would benefit from CHPs, particularly seniors, the aging population, or pets.
• 72% of respondents from healthcare associations or health professionals disclosed health and safety concerns with CHPs. Healthcare association representatives highlighted the need for a cautious approach, and recommended having CHPs available only as scientific evidence becomes available to support (or refute) health claims.
• Less than half of all healthcare professional respondents, and only a third of all respondents who are representatives from healthcare associations, recommended the need for practitioner oversight for CHPs.
• 14% of veterinary professionals and 40% of representatives from veterinary associations indicated that they were not interested in selling CHPs on the Canadian market due to a lack of evidence to support claims for use in animals.
• Health and veterinary organizations and professionals generally remain in favour of strict packaging and labelling requirements in order to prevent ingestion or accidental consumption by children and to enhance consumer safety.
• Overall, industry groups and representatives from healthcare organizations demonstrated support for further research and evidence on the safety and efficacy of cannabis in producing a specific health effect for humans or in animals. Written submissions from all government respondents emphasized the need for strong evidence requirements.

Summary

In many respects the results are not surprising for anyone who has been following the industry for any period of time. Consumers have a strong desire to see CHPs come to market, industry participants are eager to bring them to market and are supportive of less restrictions on advertising, labeling and packaging, whereas the health care and veterinary world are certainly interested in advancing the discussion, but are much more cautious in their proposed approach and are desirous of scientific backing.  While there is variation amongst the different groups of respondents as to their levels of support and their particular concerns, generally speaking all groups are supportive of developing a path forward for bringing CHPs to market.

More important is the takeaway on the path forward for Health Canada as the Summary Report signals a clear intention to seek external scientific advice to help create a path forward for CHPs coming to market. While it seems clear that CHPs will at some point be permitted to be sold in Canada, what remains to be seen is how the science will inform the timing and parameters under which CHPs will be produced and sold into the Canadian marketplace.