Draft guidance on personal production of cannabis for medical purposes

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Preamble

The draft guidance document below is being distributed for comment purposes only. This section of the document provides supporting information about the public consultation and will be removed from the final guidance document.

Under the Cannabis Act and Cannabis Regulations, patients with a signed medical document from their health care practitioner can access cannabis for medical purposes by:

As of September 2020, approximately 420,000 Canadians have an authorization from a health care practitioner to use cannabis for medical purposes. While most patients buy their cannabis from federally licensed sellers (approximately 377,000), approximately 10% (approximately 43,000) are registered with Health Canada to produce cannabis for themselves or to have someone produce it on their behalf.

Health Canada 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.

Since the coming into force of the Cannabis Act and the Cannabis Regulations, however, Health Canada has seen a concerning trend with the size of certain personal and designated production sites and issues associated with them. For example:

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.

In order to support collective efforts to address potential misuse of Canada's access to cannabis for medical purposes program, while preserving reasonable access for those who need it, Health Canada has developed a guidance document on the personal and designated production of cannabis for medical purposes.

This document provides guidance regarding the access to cannabis for medical purposes program, and brings information together, into one document, to support applicants and registrants, and promote understanding of the program requirements among other stakeholders, including authorizing health care practitioners.

This document also 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. These proposed factors address areas that the MinisterFootnote 1 has jurisdiction and authority over.

Health Canada invites interested stakeholders to share their perspectives on the guidance document, and in particular the factors that may be considered when assessing the risks to public health and public safety via a 60-day public consultation (consultation will close on May 7, 2021). Following this consultation, Health Canada intends to finalize this guidance document and make it publicly available on its website.

Disclaimer

This document provides guidance on the access to cannabis for medical purposes program, and in particular, on the provisions of the Cannabis Regulations to refuse (to issue, renew, amend) or to revoke a registration to produce cannabis for medical purposes. This includes registration by individuals to produce cannabis for their own medical purposes or to designate someone to produce it for them.

In the event of any inconsistency or conflict between the Cannabis Act and the Cannabis Regulations and this document, the aforementioned legislation will take precedence.

This document is not intended to provide legal advice regarding the interpretation of the Cannabis Act and the Cannabis Regulations. If an individual has questions about their legal obligations or responsibilities under the Cannabis Act and the Cannabis Regulations, they should consider seeking the advice of legal counsel.

Health Canada reserves the right to modify this document as appropriate and without notice.

Purpose

This document is meant to provide guidance regarding the Cannabis Act and the Cannabis Regulations to individuals who apply for authorization or are authorized to access cannabis for medical purposes by growing it themselves or by designating someone to grow it for them. Some of the guidance can also be found in other documents on Health Canada's website or that are sent to applicants or registrants. It has been brought together in this one document to better support applicants and registrants and to promote understanding among other stakeholders.

This document also provides guidance on factors that Health Canada may consider in making decisions to refuse or revoke a registration on public health and public safety grounds pursuant to the Cannabis Regulations.

Health Canada may request or consider information not specifically described in this and other guidance and registration application documentation in order to make decisions respecting an application for or an existing registration.

Guidance documents are administrative instruments not having force of law. Alternative approaches to the principles, factors and practices described in this document could be used. This document should be read in conjunction with other applicable guidance documents.

Background

The Cannabis Act (the Act) and the Cannabis Regulations (the Regulations) came into force on October 17, 2018. The purpose of the Act is to protect public health and public safety. The Act creates a strict legal framework for controlling the production, distribution, sale and possession of cannabis across Canada. The Act aims to accomplish 3 goals:

Consistent with the advice of the Task Force on Cannabis Legalization and Regulation, which was mandated to consult and provide advice to the Government of Canada on the design of a legislative and regulatory framework for legal access to cannabis in Canada, the Act and the Regulations maintain a separate system to provide patients with reasonable access to cannabis for medical purposes.

The Act and the Regulations give patients that have a signed medical document from their health care practitioner the following options to access cannabis for medical purposes:

Subject to the legal age limit in their province or territory, individuals who use cannabis for medical purposes may also access cannabis by purchasing it directly from:

Registration with the Minister for personal or designated production is subject to a limited number of requirements set out in the Regulations. These regulations also provide the Minister with the authority to refuse or to revoke a registration in certain circumstances where public health or public safety concerns exist.

Registering with Health Canada to produce cannabis for medical purposes

The Act and the Regulations establish requirements for patients to register with Health Canada to produce their own cannabis for medical purposes or designate someone to produce it for them. Detailed information on how to register with Health Canada can be found on the Health Canada website.

Authorization from a health care provider:

Patients who wish to register to produce cannabis for their own medical purposes or to designate someone to produce it for them require a medical document provided by a health care practitioner. The Regulations set out the information that must be included in the medical document. For example, the medical document must include the daily quantity of dried cannabis (expressed in grams) that the health care practitioner authorizes and the period of use, which cannot exceed one year.

Health Canada has published documents on its website for health care practitioners, that provide information on research into the medical use of cannabis, dosing and administration and patient information. Many provincial and territorial licensing bodies, as well as the College of Family Physicians of Canada, have published their own guidance for health care practitioners.

Requirements:

Individuals must meet the requirements of the Regulations to produce cannabis for their own medical purposes or to designate someone to produce it for them.

The individual signing the application must attest that they will take reasonable steps to ensure the security of the cannabis in their possession. If the individual signing the application is not the applicant, they must attest that they will ensure that the applicant takes reasonable steps to ensure the cannabis in the applicant's possession is secure and inaccessible, by other people, including children. While the appropriate measures to secure cannabis should be assessed on a case-by-case basis, some examples of best practices include installing:

Personal and/or designated production can take place indoors or outdoors (although not at the same time), and can take place in a residence or at an alternate production site. The authorized location of activities will be set out on the registration.

If producing outdoors, the production site cannot be adjacent to a school, public playground, daycare facility or other public place frequented mainly by persons under 18 years of age.

Once registered for personal or designated production, a person:

In addition to the requirements set out in the Regulations, a registered or designated person remains responsible for complying with all relevant provincial/territorial and municipal laws including building codes and local bylaws about zoning, electrical safety and fire safety, together with all related inspection and remediation requirements and orders.

An individual can take a number of simple precautions to reduce risks to health and safety. If an individual:

Authorities to refuse to issue, renew, amend or revoke a registration

Circumstances in which a registration must be refused or revoked

The Regulations specify circumstances in which the Minister must refuse (to issue, renew, amend) or revoke a registration:

The Minister must refuse to issue, renew or amend a registration where:

Similarly, the Minister must revoke a registration where:

These requirements are set out in sections 317 and 318 of the Regulations.

Circumstances in which a registration may be refused or revoked on public health and public safety grounds

The purpose of the Act and the Regulations is to protect public health and public safety, including reducing the risk of cannabis being diverted to the illegal market. In keeping with the purpose of the Act, the Regulations include authorities to refuse or revoke a registration for personal or designated production on public health or public safety grounds.

In particular, subsection 317(2) of the Regulations states that the Minister may refuse to register an applicant or to renew or amend a registration if, in the case where cannabis is to be produced by the applicant or a designated person, the registration, renewal or amendment is likely to create a risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.

Subsection 318(3) of the Regulations states that the Minister may revoke a registration if, in the case where the registered person or designated person is authorized to produce cannabis, the Minister has reasonable grounds to believe that the revocation is necessary to protect public health or public safety, including to prevent cannabis from being diverted to an illicit market or activity.

Factors which may be considered in assessing the risk to public health or public safety

The following information is intended to assist applicants, registered or designated persons and other stakeholders in understanding some of the possible factors that could be considered in assessing public health and public safety concerns in relation to decisions made under subsections 317(2) and 318(3) of the Regulations.

The Minister's authority is exercised on a case-by-case basis. When making decisions under subsections 317(2) or 318(3) of the Regulations, the Minister may examine all factors that are relevant to assessing the risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.

Examples of the factors that may be considered include, but are not limited to:

These are not exhaustive factors, and other relevant factors could be considered. The numbers of factors present, as well as the circumstances of any events that may be relevant to the determination, such as the seriousness, recentness, number and frequency may be considered. If a factor listed above is satisfied, this does not necessarily mean that there will be a refusal or revocation. The Minister will consider the totality of the circumstances.

Information related to these and other factors not listed could be obtained from a wide variety of sources, including but not limited to: an inspection, law enforcement, an international organization, local authority, regulatory or licensing authority or body, the public, or from online sources, amongst other sources of information.

In addition to considering the risks to public health and safety, other relevant information, including the extent to which a negative decision would impair an individual's ability to access cannabis for medical purposes will be considered. For example: Is the applicant or registered person able to access cannabis for medical purposes through alternate means? Does the applicant or registered person intend to produce a variety of cannabis or a cannabis product that is not available through other legal access channels?

The circumstances of every application or registration are different and no two cases are identical. As such, the overall merits of each individual application or registration must be assessed on its own, in accordance with the facts that are presented.

Notice of refusal

In the case where the intention is to refuse (to issue, renew, amend) or revoke a registration due to a risk to public health or public safety, the following steps will be taken as per the regulations s.317(3) and s.318(3):

If a decision to refuse (to issue, renew or amend) or revoke a registration is made, a notice of the decision will be sent to the applicant or the registered person (as applicable).

If an applicant or registered person does not agree with a decision made by Health Canada and wishes to challenge it, this is generally done by way of judicial review in Federal Court. If you are considering challenging a decision made by Health Canada, you may wish to seek legal advice as soon as possible.

Health Canada publishes administrative data on the personal and designated production program on its website, including the number of personal or designated refusals and revocations.

Conclusion

The Act and the Regulations maintain a separate system to provide patients with reasonable access to cannabis for medical purposes. This document provides guidance on the access to cannabis for medical purposes program, and in particular, on the provisions of the Regulations to refuse (to issue, renew, amend) or to revoke a registration to produce cannabis for medical purposes.

To achieve the objectives of protecting public health and public safety, including reducing the risk of cannabis being diverted to the illegal market, the Regulations provide the authority to refuse (to issue, renew, amend) or to revoke a registration for personal or designated production on public health or public safety grounds. Any determination on the use of the power to refuse or revoke on these grounds will be made in accordance with the authority set out in the Regulations, taking into consideration the facts of each case.

The information enclosed is intended to provide applicants, registrants and stakeholders with information about the powers to refuse or to revoke a registration on public health or public safety ground in the Regulations.

Contact us

For questions related to a specific application or registration, please contact us directly at 1-866-337-7705 or an email may be sent to cannabis@canada.ca. The email should clearly indicate the application file number, the applicant or registrant's name and the subject of the correspondence in the subject line of the email.

Footnote

Footnote 1

Throughout this guide, there are references to actions that would be taken by the Minister under the Cannabis Act and the Cannabis Regulations in the context of decision-making. In many cases, it is anticipated that the decision-making function would not be exercised personally by the Minister, but instead by an official in the Department of Health.

Return to footnote 1 referrer

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