Here is what they are saying at Health Canada. It looks exhaustive an might mean a major shake up down the road.

Current status: Open

Opened on March 8, 2021 and will close to new input on May 7, 2021.

Health Canada invites Canadians to share their perspectives on the factors that may be considered for refusal or revocation of a registration on public health and public safety grounds. These factors are set out in the draft guidance on personal production of cannabis for medical purposes.

Who is the focus of this consultation

We will engage with various groups across Canada including:

  • All interested Canadians, including Indigenous Peoples
  • Patients and patient associations
  • Provincial, territorial, and local governments
  • Cannabis industry licence holders and associations
  • Law enforcement and first responders and associations
  • Health care practitioners and health care practitioner regulatory bodies and associations

We welcome comments from any group or Canadian who may be interested in participating.

Key questions for discussion

The draft document provides guidance on the personal and designated production of cannabis for medical purposes. It also provides proposed factors that may be considered in refusing or revoking a registration. The following questions will be asked:

  • Are the listed factors clear?
  • Are there any additional factors that should also be considered?
  • Do you have any comments on other elements of this document unrelated to the factors for consideration?

The input collected will be considered before publishing the final guidance document. Health Canada will post the results of this consultation online in a “What We Heard” report. We will also publish a final version of the guidance document.

 

 

Here is their

 

Draft guidance on personal production of cannabis for medical purposes

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The draft guidance document below is being distributed for comment purposes only.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:

  • purchasing quality-controlled cannabis from a wide variety of federally licensed sellers inspected by Health Canada
  • producing a limited amount of cannabis for their own medical purposes as authorized by their health care practitioner (“personal production”)
  • designating someone to produce it for them (“designated production”)

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:

  • There has been a progressive increase in the daily amounts being authorized for individuals seeking Health Canada approval to produce cannabis for their own medical purposes or to have someone produce on their behalf. For example, the average daily amount authorized by health care practitioners for individuals who access cannabis from federally licensed sellers has remained relatively constant at 2.0 grams per day, an amount that is consistent with published evidence and guidance about the use of cannabis for medical purposes. The average daily authorized amount for personal and designated production is approximately 36 grams per day.
  • During inspection of personal and designated production sites, Health Canada inspectors have observed activities that do not comply with the Cannabis Regulations, such as unauthorized individuals tending to plants, security obligations not being met, unauthorized outdoor production, and plant counts beyond authorized amounts.
  • In recent months, there has also been an increase in law enforcement activities at some personal and designated production sites. Police have laid drug and weapon charges against some personal and designated producers, who were using their registration to cover and support large-scale illegal production and sale.

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 MinisterFootnote1 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:

  • keep cannabis out of the hands of youth
  • keep profits out of the pockets of criminals
  • protect public health and safety by allowing adults access to legal cannabis

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:

  • purchase quality-controlled cannabis from a wide variety of federally licensed sellers inspected by Health Canada
  • produce a limited amount of cannabis for their own medical purposes as authorized by their health care practitioner (“personal production”)
  • designate someone to produce it for them (“designated production”)

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:

  • provincial or territorial authorized retail outlets
  • provincial or territorial authorized online sales platforms

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.

  • To be eligible to grow for oneself, an individual must ordinarily reside in Canada, be an adult, and must not have been convicted as an adult of certain cannabis-related offences in the preceding 10 years while they were authorized to produce cannabis for medical purposes.
  • In the case of a designated person, similar eligibility criteria apply, though it is a prerequisite that the individual must not have been convicted of certain cannabis and controlled substances-related offences, regardless of whether the individual was a registered or designated person at the time.
  • A designated producer may produce for a maximum of two registrations (for themselves and one other person, or for two other persons).
  • A maximum of four registrations can be authorized at any one site.

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:

  • strong locks on the doors to all areas where cannabis is produced
  • a safe or an equally protected location that can be secured with a lock (For example: cabinet, closet or trunk) for storage, and if there are children present, use of childproof containers to avoid accidental ingestion
  • an alarm system
  • a tall fence with a locking gate if growing outside
  • an air filtration system to prevent the escape of odours from the production site to reduce the risk of alerting others to the existence and location of the production site

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:

  • must take reasonable steps to ensure the security of the cannabis in their possession that was produced by personal or designated production, and the security of their registration certificate, if they possess it.
  • must operate within the limits set out in the registration certificate, and abide by the maximum possession limit and, where applicable, maximum plant production limit.
  • cannot share, sell or provide the cannabis to anyone else. If more cannabis is produced than the registrant intends to use, the excess amount should be destroyed. Prior to disposal, proper steps should be taken to render the cannabis unfit for use or consumption.
  • is the only individual (registered person and/or designated person) authorized to possess cannabis plants or tend to them. Unauthorized persons are not entitled to handle the cannabis.
  • must report the theft or loss of any cannabis or the registration certificate, if they possess it to a police force within 24 hours and to the Minister (in writing) within 72 hours.
  • must not obstruct Health Canada inspectors who may inspect the production site.

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:

  • is growing cannabis plants indoors, they should ensure that there is enough ventilation to remove excess moisture and humidity to stop mold from building up on the cannabis plants or in the building.
  • makes changes to the structure of a home or electrical system, it may require a building permit or other authorization. It is recommended that advice be sought from a licensed professional to ensure compliance with municipal bylaws and provincial/territorial building codes.
  • plans to use chemical products, such as pesticides, ensure that these products are safe for use on a plant that could be eaten or vaporized. Health Canada’s homeowner guidelines for using pesticides should be consulted for more information about using pesticides safely.
  • is making a product containing cannabis, such as oil or butter, the use of an organic solvent, such as butane, isobutene, propane or propylene, is not permitted. Organic solvents pose significant safety risks, such as fire and explosion. They also pose health risks if the product contains residue from the production process.

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:

  • the applicant or the designated person is not eligible pursuant to the Regulations
  • the medical document does not meet all the regulatory requirements or is no longer valid
  • at the time the medical document was provided to an applicant, the individual who provided it was not a health care practitioner, or was not entitled to practise their profession in the province in which the applicant consulted them
  • the health care practitioner who provided the medical document notifies the Minister in writing that the use of cannabis by the applicant is no longer supported for clinical reasons
  • the given name, surname or date of birth of the applicant is different than what appears on the medical document
  • the Minister has reasonable grounds to believe that false or misleading information has, or false or falsified documents have, been provided in, or in support of, the application
  • the registration, renewal or amendment would result in the applicant or designated person being authorized to produce cannabis plants under more than two registrations, or where it would result in the proposed site being authorized under more than four registrations

Similarly, the Minister must revoke a registration where:

  • the registered person or the designated person are not eligible pursuant to the Regulations
  • the registration was issued, amended or renewed on the basis of false or misleading information or false or falsified documents
  • the health care practitioner who provided the medical document notifies the Minister in writing that the use of cannabis by the registered person is no longer supported for clinical reasons
  • the registered person or the adult who is named in the registration document requests revocation in writing
  • the registered person dies

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:

  • Amount of daily authorized cannabis by the health care practitioner and information to support the amount authorized:
    • Is the authorized daily amount of cannabis supported by credible clinical evidence and/or published treatment guidelines?
    • Is the amount of daily authorized cannabis considered reasonable, after taking into account the route of administration and potential for product loss from processing activities?
  • Non-compliance or history of non-compliance with the Cannabis Act and Regulations by the registered or designated person, including the relevant circumstances:
    • What is the overall history of non-compliance, including the number, nature and severity of previous instances of non-compliance? How much time has elapsed since the last non-compliance, and how has the person responded to previous non-compliance?
    • Are the registered or designated person growing, or have they grown, more than the amount authorized by the registration?
    • Are the registered or designated person taking, or have they taken, reasonable steps to ensure the security of the cannabis in their possession?
    • Is someone other than the designated or registered person tending, or has someone other than them tended, to the cannabis plants?
    • Is the registered person “selling or renting”, or has the registered person “sold or rented”, their registration?
    • Is there, or has there been, an apparent, intentional effort on the part of the registered or designated person to circumvent the Act or Regulations such as obstruction of Health Canada inspectors?
  • Criminal activity and/or diversion of cannabis:
    • Is the production site linked, or has it been linked, to the diversion of cannabis, a controlled substance or a precursor, or to criminal activities?
    • Are the registered or designated person, the owner of the production site or an individual with another direct link to the site or operation involved in the diversion of cannabis, a controlled substance or a precursor, or have they been involved in or do they contribute or have they contributed to such diversion?
    • Is the production site linked, or has it been linked, to organized crime? Are the registered or designated person, the owner of the production site or an individual with another direct link to the site or operation associated with organized crime or have they been associated with organized crime?
  • Heath care practitioner is or has been involved with criminal activities or has been subject to disciplinary review or action by a licensing authority in relation to their prescribing practices with cannabis or controlled substances:
    • Has a provincial licensing authority investigated or disciplined the health care practitioner in relation to their prescribing practices with cannabis or other controlled substances?
    • Is or has the health care practitioner been involved in or contributed to activities prohibited by or conducted in contravention of the Cannabis Act or the Controlled Dugs and Substances Act?
    • Is or has the health care practitioner been a member of a criminal organization as defined in subsection 467.1(1) of the Criminal Code, or is or has been involved in, or contributes or has contributed to, the activities of such an organization?

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):

  • The applicant or registered person will be notified in writing of the intent to refuse or to revoke a registration. If applicable, the designated person would be notified in writing of a proposed revocation.
  • The notice will set out the reason for the proposed refusal or revocation and the applicant or registered person will be given an opportunity make written representations. If applicable, the designated person will be notified in writing of the intent to revoke.
  • The notice will generally specify a period to make representations and that a final decision on the application or registration will not be made until the representations have been received and considered. If no representations are made within the period of time specified in the notice, a final decision will not be made before the period of time has expired.

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.