Document: Consultation on Potential Market for Cannabis Health Products that would not Require Practitioner Oversight

Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. We assess the safety of drugs and many consumer products, help improve the safety of food, and provide information to Canadians to help them make healthy decisions. We work with the provinces to ensure our health care system serves the needs of Canadians.

Également disponible en français sous le titre: Consultation sur le marché potentiel des produits de santé contenant du cannabis qui n’exigeraient pas de supervision d’un praticien

To obtain additional information, please contact:

Health Canada

Address Locator 0900C2

Ottawa, ON K1A 0K9

Tel.: 613-957-2991

Toll free: 1-866-225-0709

Fax: 613-941-5366

TTY: 1-800-465-7735

E-mail: publications@hc-sc.gc.ca

This publication can be made available in alternative formats upon request.

Publication date: June 19, 2019

This publication may be reproduced for personal or internal use only without permission provided the source is fully acknowledged.

1.0 Introduction

In November 2017, Health Canada launched a public consultation to solicit input on regulations under the Cannabis Act (CA). In the summary report published in March 2018, the Government of Canada committed to maintaining existing access to prescription drugs containing cannabis and medical devices for use with cannabis. It also indicated that further consideration was necessary to determine an appropriate regulatory approach for health products with cannabis not requiring practitioner oversight, referred to as Cannabis Health Products (CHPs) for the purpose of this paper.

Under the current framework established by the CA and Food and Drugs Act (FDA), there is no legal way to sell a health product with cannabis (i.e. a drug that contains cannabis and makes a health claim) without the oversight of a practitioner (e.g., a doctor or a veterinarian). The Cannabis Regulations only authorize drugs containing cannabis to be sold with a prescription to individuals, or for animals, under the care of a practitioner.

Health Canada is aware that some Canadians are interested in potential therapeutic uses of cannabis for minor ailments for human use (e.g., sleeplessness, pain relief for sore muscles) and for animals (e.g., pain relief). Cannabis products with unauthorized health claims are also emerging on the market illegally such as cannabidiol (CBD) products claiming to provide relief from muscle aches, joint pain, and inflammation.

Any new pathway to market for CHPs must safeguard the strict controls put in place under the CA to protect youth, displace the illegal market and restrict promotion of cannabis. This new pathway must also leverage Health Canada’s established evidence-based system for controlling access to safe, effective and quality products that make health claims alleging to maintain and improve Canadians’ health.

1.1 Purpose of the Consultation

The purpose of this consultation paper is 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 CHPs be established. To provide context for Canadians and industry representatives to share their views, key parameters of a proposed approach for oversight of these products are outlined in this paper.

Further to this consultation, Health Canada intends to gather external scientific advice regarding the appropriate evidence standards for CHPs, before advancing draft regulations for consultation.

2.0 Current Regulatory Context for Cannabis in Canada

The CA and its regulations provide Canadians with strictly regulated access to cannabis products (e.g., dried cannabis, fresh cannabis, cannabis oil). Under this framework, the production, distribution, and sale of cannabis by federal licence holders is subject to strict quality and security controls to protect public health and safety. When the Cannabis Act came into force in October 2018, the following categories of products were permitted:

Cannabis products for non-medical and medical purposes; and

Prescription drugs containing cannabis

Importantly, cannabis products, whether sold for medical or non-medical purposes, cannot be sold with labels or marketed in a manner that provides information about health benefits of the product, appropriate dosing, or other information about their use as a treatment for health conditions. Operating alongside the regime established by the CA, the FDA and its regulations provide a regulatory pathway for the manufacture and sale of prescription drugs that contain cannabis. These products are subject to a scientific review by Health Canada for safety, efficacy and quality before they can be sold, and are marketed with authorized health claims supported by evidence.

Within this current framework, there is no legal pathway to market for a drug containing cannabis that makes a health claim that could be sold without the oversight of a practitioner. Rules prohibit the use of cannabis in natural health products (NHPs)Footnote 1 and similar controls are in place to prevent the use of cannabis in veterinary health products (VHPs).Footnote 2

3.0 Key Parameters

To provide context for Canadians and industry representatives to share their views about the potential market for CHPs, key parameters of a proposed regulatory framework for CHPs are outlined below.

See Table 1 (after section 3.6) for a description of the proposed category of CHPs, and comparisons to existing product categories.

3.1 Legal Oversight

Given the public health and safety risks of cannabis, certain controls under the CA would still apply to CHPs. In addition, certain measures under the FDA would allow for the approval of health claims supported by scientific evidence to ensure their safety, efficacy, and quality.

3.2 Health Claims

Under the FDA, Health Canada is responsible for reviewing applications for the approval of new drugs prior to their sale in Canada in order to determine whether the evidence provided supports the safety, efficacy and quality of the product. Given the restrictive approach taken to protect young people and others from promotions and other types of inducements, an evidence-based approach is proposed for CHPs to ensure that health claims are not used as a way to promote or normalize cannabis consumption.

This approach would include restrictions on the types of health claims that would be permitted, along with strict evidence requirements to support the health claim.

In particular:

General health claims would not be permitted (i.e., claims with low therapeutic value). These include claims related to general health maintenance, support and promotion.

Specific health claims would need to be supported by scientific evidence. CHPs would not be authorized based on evidence of traditional use only.

Cannabis must be listed as an active ingredient and could not be included without a direct link to the health claim. Evidence would need to sufficiently demonstrate the association of the ingredient (i.e., specific phytocannabinoid) with the health claim.

In order to ensure the evidence bar for these types of products is appropriate, Health Canada will seek expert advice regarding the level of scientific evidence necessary to show that products could be used safely, and consider how both existing and new scientific studies could be incorporated into the review process.

3.3 Ingredients

As CHPs would be subject to a pre-market review for their safety, efficacy, and quality, Health Canada proposes to allow them to include any cannabis ingredient or substances extracted from cannabis, as well as other medicinal and non-medicinal ingredientsFootnote 3 supported by robust scientific evidence. Robust scientific evidence would be required to demonstrate that the interaction of the different substances would be safe and effective. This potential to mix cannabis with safe and effective ingredients would provide Canadians with access to a greater variety of options for treating minor ailments.

3.4 Retail Environment

Under the CA, cannabis can be sold by a provincially, territorially or federally licensed retailer/seller. Health Canada is proposing to maintain these same restrictions regarding the place of sale for CHPs in order to protect against the public health and safety risks that may be present.

Under this proposed approach, companies who are authorized to sell cannabis by their province or territory would be able to sell CHPs in the same way they sell cannabis. This means that provincially authorized cannabis retailers would have to prevent the display of CHPs to young persons, maintain adequate security, keep appropriate records, and also respect any provincial or territorial rules.

Federally licensed cannabis sellers would also be able to sell CHPs in much the same way as they sell cannabis products for medical purposes to registered clients. CHPs could be ordered online or by phone, and would be delivered securely by mail or courier.

It should be noted that provinces and territories have a significant degree of flexibility in establishing their cannabis sales regimes as long as the provincial law respects the conditions of the CA.

Provinces and territories would continue to have the flexibility to authorize CHP sellers operating at any physical location. This could allow for CHPs for human and veterinary uses to be sold at pharmacies, veterinary clinics, pet stores, or livestock medicine outlets under strict conditions that respect federal requirements. Strictly controlled online sales would also remain possible.

3.5 Protecting Young Persons

Unrestricted access to CHPs by young persons may induce or normalize the use of cannabis, counter to the objectives of the CA. To prevent this and respect the public health and safety objectives of the CA, Health Canada is proposing the oversight of a responsible adult intermediary, such as a parent or guardian, in order for young persons to access CHPs. In addition, the prohibition on promotions, packaging and labelling that are appealing to youth would be maintained for CHPs.

Requiring the involvement of a responsible adult in order for a young person to access CHPs would support appropriate use of these products for treatment of minor ailments and prevent problems related to their misuse. Under this approach, it is proposed that the intermediary would be able to purchase a CHP from one of the retailers mentioned above, and then distribute the CHP to a young person for whom they are responsible.

3.6 Packaging and Labelling

The CA and its regulations set out comprehensive requirements for packaging and labelling for all cannabis products to protect young persons and support adult consumers in making informed decisions about cannabis use.

Under the FDA, health product labelling requirements, such as dosing information, directions for use of the product, listing of ingredients, and any pertinent side effects or warnings, are in place to support informed consumer choice, and safe and effective use. Label information is tailored to each health product, based on a pre-market review by Health Canada.

Health Canada is proposing that all packaging and labelling requirements for health products under the FDA would apply to CHPs, including a pre-market review of the label. Labelling requirements from the cannabis frameworkthat help to protect young persons could also apply, such as a standardized cannabis symbol and health warning messages, where appropriate.

Table 1: Comparison of product categories Key Parameters Cannabis Products for Non-medical and Medical Purposes Proposed Category: Cannabis Health Products Prescription Drugs Containing Cannabis Legal Oversight Cannabis Act Would be subject to the evidence-based approach of the Food and Drugs Act while respecting objectives of the Cannabis Act Cannabis Act and the Food and Drugs Act Health Claims CANNOT make health claims Would make authorized health claims to treat minor ailments based on evidence CAN make authorized health claims based on evidence Ingredients Subject to restrictions on product composition and ingredients, as set out in the Cannabis Regulations Would include cannabis, and could also include other medicinal and non-medicinal ingredients supported by evidence Any cannabis substance and other medicinal and non-medicinal ingredients supported by evidence Retail Environment: Provincially & territorially authorized retailers Can sell cannabis products Would be able to sell CHPs Available at a pharmacy with a prescription from a practitioner for use by humans or via a veterinarian with a prescription for use in animals Retail Environment: Federally licensed sellers of cannabis for medical purposes Can sell cannabis products for human use when authorized by a healthcare practitioner Would be able to sell CHPs for use by humans or in animals without the need for a prescription Protecting Young Persons Youth can only access cannabis for medical purposes when authorized by a health care practitioner Oversight by a responsible adult intermediary would be required for youth access (e.g., parent or guardian) Youth are able to access with a prescription from a practitioner, similar to any other prescription drug Packaging and Labelling Requirements Information on: product contents and

their health risks Cannot appeal to youth



No pre-market review or approval Would support: informed consumer choice and

safe and effective use Cannot appeal to youth



Information based on pre-market review Supports: informed consumer choice and

safe and effective use Information based on pre-market review

4.0 Potential Products

Health Canada is interested in receiving feedback on what potential products industry may be seeking to bring to market, and what consumers would be interested in purchasing, to better understand the types of product formats and health claims that would be of interest to Canadians in this retail environment.

Questions for Consumers:

Would you be interested in purchasing a product approved by Health Canada that contains cannabis and is intended to treat minor ailments (e.g., a CHP approved to treat muscle pain)? Why or why not? Are there particular purposes, or types of health claims, for which you are most likely to seek out CHPs (e.g. pain relief for sore muscles)? Do you have preferred product formats for CHPs (e.g., cannabis extracts, topicals, tinctures, or others)? Are you aware of specific sub-populations or groups that would be particularly interested in CHPs? (e.g., seniors, those with chronic conditions) If so, for what purpose? Is there any additional feedback that you would like to share on the potential market for CHPs?

Questions for Industry:

Are you interested in manufacturing and selling CHPs on the Canadian market? Why or why not? If so, what products are you the most likely to pursue bringing to market in Canada? More specifically, what types of formats, with which cannabis ingredients, and with what health claims? What scientific evidence is currently available that demonstrates the efficacy of cannabis in producing a specific health effect (e.g. relief of headaches, mild muscle pain)? Does your organization currently have scientific evidence of safety and efficacy without the oversight of a practitioner to support the approval of a CHP in Canada? Are you working to generate any evidence? Are there elements of the proposed approach that would create a particular incentive or disincentive for seeking to bring a CHP to market in Canada? If so, what elements and why? Are there any other specific elements of the retail environment for cannabis that would present unique benefits or challenges to the sale of CHPs? Is there any additional feedback that you would like to share on the potential market for CHPs?

Questions for all interested parties

Are you aware of any scientific evidence that demonstrates the efficacy of cannabis in producing a specific health effect (e.g. relief of headaches, mild muscle pain)?

Are you aware of specific sub-populations or groups that would be particularly interested in CHPs? (e.g., seniors, those with chronic conditions)? If so, what purpose?

Is there any additional feedback that you would like to share on the potential market for CHPs?

5.0 How to Take Part

Instructions for submitting comments

Health Canada encourages all Canadians to provide feedback using the online consultation.

Or to provide written submissions to hc.hpfb.engagement-mobilisation.dgpsa.sc@canada.ca or:

Health Canada

Address Locator 2005 A

250 Lanark Avenue

Ottawa, ON, K1Z 1G4

Canada

Attention: Policy Planning and International Affairs Directorate

Health Canada will accept comments until September 3, 2019

To safeguard privacy, you should ensure that any written comments you may provide are sufficiently general that you cannot be identified as the author and that personal information is not disclosed.