Guidance on personal production of cannabis for medical purposes

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Disclaimer

This document provides guidance on the access to cannabis for medical purposes program, and 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 a registration or are authorized to access cannabis for medical purposes by growing it themselves or by designating someone to grow it for them. Some of this guidance can also be found in other documents on Health Canada's website or that are sent to applicants or registered persons. This information has been brought together in this one document to better support applicants and registered persons 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 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 the Cannabis Act, the Cannabis Regulations, and 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 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 authorized to use cannabis for medical purposes may also access cannabis by purchasing it directly from:

Registration with the MinisterFootnote 1 for personal or designated production is subject to a limited number of requirements set out in the Regulations. The 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.

Health Canada administers the Act and Regulations. In doing so, it is responsible for administration of the Medical Access Program, and uses authorities under the Act and Regulations to undertake activities such as:

The Regulations specify the information that Health Canada may disclose to a Canadian police force or member in the context of an active law enforcement investigation, and on the condition the information is only used for the purposes of the investigation or the administration and enforcement of the Act or the Regulations. Health Canada supports law enforcement representatives by confirming, when necessary, that specific individuals are authorized to possess or produce a limited amount of cannabis for medical purposes. In the context of an investigation, law enforcement also has the ability to enter residences and any production sites.

Registering with Health Canada to produce cannabis for medical purposes

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 practitioner

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 amount of dried cannabis (expressed in grams) that the health care practitioner authorizes and the period of use, which cannot exceed one year.

Upon receiving an application, Health Canada may require the submission of any additional information from the patient and / or health care practitioner that is necessary to consider the application.

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. While the appropriate measures to secure cannabis should be assessed on a case-by-case basis, some examples of best practices include installing:

The application and related documents may also be submitted by an adult who is responsible for the applicant. This may occur, for example, if the applicant is a child. The role of the responsible adult includes more than completing and signing the application form on behalf of an applicant. It carries a degree of responsibility for the individual, such as a willingness to:

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:

Additional guidance on how to safely and securely grow cannabis can be found on the Health Canada website.

In some cases, Health Canada may request additional information with respect to an application. It is the responsibility of the registered or designated person to meet all regulatory requirements and respond to any requests for additional information from Health Canada in a timely manner. In the event that there is a change to the information contained in a registration certificate, the registered person or an adult who is responsible for them, must submit an application to amend the registration certificate to ensure it is kept current at all times.

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

Circumstances in which a registration must be refused or revoked

Sections 317 and 318 of 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:

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:

In order to seek additional information regarding the amount of daily authorized cannabis, Health Canada may request this information in writing in the application form and / or may contact the applicant or their health care practitioner. Supporting information could, among other things, include data, references or sources to support the authorized daily amount.

Examples of these sources include, but are not limited to, documents published by Health Canada, the provincial / territorial medical licensing authorities, or other research findings by research or health organizations.

Health Canada will examine submitted information, and will consider the source and quality of the information, including whether the information is sourced from peer-reviewed published clinical trials, treatment guidelines, or observational studies.

The Minister's authority is exercised on a case-by-case basis taking into consideration all available information, including answers to the questions above. As such, there is no pre-determined number of non-compliance events that may result in the refusal to issue, renew, amend or revoke a registration.

If the applicant or registered person is notified in writing of the intent to refuse or revoke their application or registration on the basis of this factor, they will be provided with the opportunity to seek and submit another medical document from a different health care practitioner in support of their application or registration.

These factors may overlap, they are not exhaustive, and other relevant factors could be considered in assessing the risk to public health or public safety. The number of factors present, as well as the circumstances of any events that may be relevant to the determination of the risk, 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.

In addition to considering the risks to public health and public safety, other relevant information, including information about the extent to which a negative decision would impair an individual's ability to access cannabis for medical purposes, could be considered before making a decision to revoke or refuse to issue, renew or amend a registration. 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(4):

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.

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 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 and further to the purposes of the Act, taking into consideration the facts of each case.

The information contained in this document is intended to provide applicants, registered persons and stakeholders with information about the powers to refuse or to revoke a registration on public health or public safety grounds 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 registered person's name and the subject of the correspondence in the subject line of the email.

If you have concerns or complaints about cannabis in your community, you may contact Health Canada via the Cannabis Reporting Form.

Footnotes

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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