Improving the Current Cannabis Systems in Canada to Better Meet Patients' Need
After a series of public consultations, surveys of our members and the public, as well as feedback from our advisory committee members, EduCanNation has created the following detailed response to Health Canada’s draft guidance document for the personal production of cannabis for medical purposes regulations.
Please review the document below and sign here. We appreciate your support.
In this letter we cover the following issues:
How public cannabis education impacts safety and resolves many issues brought to light in this document.
The need for accountability, transparency, and oversight in all areas of the cannabis industry, including Health Canada and all levels of government.
Utilizing standardized prescribing practices and guidelines based on harm reduction, best practices, and sound, up-to-date science and research.
Harm reduction through patient, public, and healthcare access to cannabis education.
Incorporation of Certified Cannabis Educators into all levels of the cannabis systems and industry in Canada, including healthcare, adult-use/retail, and government.
Growing permits that focus on the needs of the patient first, with well-researched guidance from science, and how this will reduce criminal activity.
That increased knowledge and understanding of the Cannabis Act and the Regulations, for the general public and all levels of government, will reduce the abuse of the medical system.
With improved care of patients who are authorized to produce cannabis for medical purposes and allowing helpers (with guidelines in place), this system will allow more transparency for all parties involved to achieve improved health and overall wellness.
Education will reduce risk for all people involved.
Link to Health Canada document here.
For optimal viewing, download our full response in PDF form:
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Preamble
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.
Our issue - The average Canadian is not aware that the medical cannabis system exists, let alone that it includes the potential to grow cannabis for their own medical purposes. As cannabis educators who work with medical patients, we often deal with patients that are completely ignorant to the ACMPR (part 14 of the Cannabis Regulations) and moreover are uninformed of what rights are entitled to them through it. Many that do know the ACMPR exists have misinformed notions that a personal production permit will allow them to sell their cannabis and products they make from it legally.
In Health Canada’s 2020 survey about cannabis we see evidence of this: “The majority (of people who used cannabis for medical purposes in the last 12 months) (76%) did not have a document from a healthcare professional.”
ECN Proposed Solution
Public education campaigns through mail-outs, public broadcasting, in person / virtual talks, health and community associations that include clear descriptions of the ACMPR as well as the penalties for non-compliance.
Potential outcome
Increase in the number of patients registered with Health Canada to produce cannabis for their own medical purposes or designated growers.
Decrease in the number of misinformed patients abusing the system.
Our issue
Many of the cannabis clinics do not inform their patients of their rights to purchase cannabis from the licensed producer of their choice, never mind their right to apply to Health Canada for a personal production permit and the majority charge extra fees if the patient wishes to obtain the original medical document needed to apply (an average of $20/gram.) This is common practice because clinics rely on sales kickbacks from license producers to stay afloat. It is not in the best interest of their businesses to inform their patients of the rights to purchase products from licensed producers other than those they have contracts with, nor is it to inform them of their right to apply to Health Canada for a personal production permit.
ECN Proposed Solution
Standardized prescribing and followup practices that include proper patient education and guidance, clear descriptions of patients’ rights, the ACMPR and the Cannabis Act, transparency about business relationships between the prescribing practitioner/clinic and the license holders they are in business with, and the patient’s right to purchase cannabis from the licensed producer of their choice even if the practitioner / clinic does not receive financial gain from them.
Potential outcome
Increase in the number of patients registered with Health Canada to produce cannabis for their own medical purposes or designated growers.
Decrease in the number of misinformed patients abusing the system.
Increase in the sustainability of licensed producers businesses by spreading the number of patients out to a greater number of producers
Our issue
There are very few healthcare providers who are comfortable with prescribing cannabis to their patients which is understandable considering the complexity of the medical cannabis system and the amount of time it takes to educate a patient on how and where to obtain medical cannabis, registrations and application processes and lack of specific prescribing guidelines.
ECN Proposed Solution
Incorporation of certified cannabis educators into the medical system by establishing a standard of education and training based on harm reduction principles and by creating a certification board to verify that educators have met minimum requirements and regularly update their education as new evidence is made available through research studies. Requiring all cannabis practitioners/clinics to have a certified cannabis educator on staff to provide patient education and guidance.
Potential outcome
Assurance that a standard of practice and education is being provided to the patient and general public.
Decrease in the number of misinformed patients abusing the system.
Decrease in the amount of time a practitioner needs to spend with their patients when prescribing cannabis.
Increase in the number of practitioners willing to provide cannabis authorizations, education and support to their own patients.
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.
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.
Our issue - The average daily amount being authorized for purchase from a licensed producer does not necessarily reflect the actual needs of the patient. Many patients are having to fulfill their needs through the recreational market and many still use the black market.
Because our endocannabinoid systems are different and react differently to each product, so much so that a person may have extremely different reactions to products with exactly the same cannabinoid profiles, a patient may need to try many different products before finding one that is right for them.
ECN Proposed Solution - Provide healthcare practitioners with proper education on the endocannabinoid system, how a patient may need to experiment with many different products before finding success, all the different methods of intake, how prescription deductions are calculated, and how to have conversations with their patients to better understand their needs and their actual use of cannabis.
Potential outcome
Slight increase in the average authorized daily amounts for purchase from licensed producers.
Increase in patient success rates.
Reduction of patients turning to the recreational markets and black markets to fulfill their needs.
Our issue
Monthly deductions do not necessarily reflect the actual number of grams needed to produce the final product, especially with extraction based products like oils, edibles and topicals. Many licensed producers claim to use more than the indicated number of grams of flower to produce the final products. So basing authorized amounts for a permit to produce cannabis for your own medical purposes on the amount of product used by an LP will likely mean the patient will fall short.
Patients producing their own cannabis do not generally have access to the same processing equipment, nor are they allowed to use the same extraction methods so they often require more plant material to be able to obtain similar concentrations which explains why the daily amount of cannabis authorized for personal production is often much higher than the daily amount authorized for purchase from a licensed producer.
Patients do not have access to credible, reliable processing education and often waste a lot of their cannabis through improper processing techniques which leads them to needing higher daily amounts.Provide healthcare practitioners with proper education on how to gauge the amount of daily authorization based on the route of administration and potential loss through processing as well as the potential loss during growing due to moulds and pests as well difference between amounts of cannabis needed for processing into oils, edibles and topicals by an LP vs amounts needed for processing by an individual.
ECN Proposed Solution - Provide patients access to credible education on how to process their cannabis safely and effectively.
Potential outcome
Provide patients with access to daily amounts that better meet their needs.
Decrease patients’ waste of plant material thus decreasing their plant material needs.
Increase patients’ abilities to produce safe and effective products.
Our issue
Due to the fact that it is common practice for prescribing practitioners/ clinics to charge on a gram-per-day basis ($20/g average) for personal production permits, they stand to increase their financial gain according to the number of grams they authorize.
ECN Proposed Solution
Some practitioners are unwilling to authorize anything above 2g / day, despite their patents’ needs because they are unaware of the laws and are afraid to lose their licenses to practice. Put a reasonable cap on prescribing cannabis that reflects the current national average of 36g/day.
Require the authorizing practitioner to submit an application form with supporting documentation for any amount prescribed above the standard cap.
Potential outcome
Deter practitioners from authorizing unnecessarily high daily amounts of cannabis for personal financial gain.
Encourage practitioners to authorize suitable daily amounts of cannabis to meet their patients’ needs without threat to their license to practice.
Increase in the number of practitioners willing to provide cannabis authorizations, education and support to their own patients.
Our issue - Many people believe that they need a lot more plants to meet their needs than they actually do.
Proposed Solution
Provide patients access to credible education on growing cannabis safely and effectively.
Provide patients access to credible education on how to process their cannabis safely and effectively.
Potential outcome
Decrease patients’ loss of plants, thereby, decreasing the number of plants needed.
Decrease patients’ waste of plant material, thereby decreasing their plant material needs.
Increase patients’ abilities to produce safe and effective products. Growing conditions directly affect the quality and yields of cannabis crops. Indoor only, outdoor only, and indoor/outdoor parameters do not cover all of the variables and put many patients in the position of not having enough authorized number of plants to meet their needs or, many more than they need.
Our issue
Due to colder climates, many patients with personal production permits that chose to grow their cannabis outside are required to start their seedlings inside in order to have a long enough growing season for their plants to mature which requires them to apply to Health Canada for an Indoor/Outdoor permit. The same is true for patients who have specific plant genetics they need to maintain for their conditions. Keeping “mother” plants alive year round allows them to do this but requires them to apply for an Indoor/Outdoor permit. For these reasons, many outdoor growers are forced to obtain higher daily amounts than they actually need so that they will still be able to grow a sufficient number of plants outdoors.
Example: Annie has a prescription for 2 grams per day to purchase from a licensed producer. She can no longer afford to purchase from her LP, so she chooses to apply for her permit to grow. Her doctor understands that she will need a slightly larger prescription to meet her needs so he prescribes 5g/ day. If Annie were growing indoors only, this would give her 25 plants which should be sufficient if her indoor space is large enough but Annie’s space is not so she decides to grow outdoors which would only give her 10 plants. If Annie has a large outdoor area, 10 plants may very well be sufficient but if she is only able to grow in small pots, she will not meet her needs because her yields will be significantly less. Furthermore, Annie lives in the Quebec Laurentians, so she must start her plants indoors which means she must apply for Indoor/ Outdoor; however, this permit will allow her to grow only 5 plants outdoors which will certainly not meet her needs and she does not have the space to grow another 19 indoors, even though her permit allows her to. So, in order to meet her needs, Annie must obtain a prescription for at least 10g/ day to be able to grow the minimum 10 plants that she needs to sustain herself which then gives her an additional 37 plants indoors that she does not need. With an extra 37 plants that she doesn’t need, Annie may be tempted to grow them to sell on the illicit market.
ECN Proposed Solution - The parameters used to calculate the number of plants needed for personal production of cannabis for medical purposes should take into account a much broader spectrum of variables including:
Indoor: size of the space, including the height of the ceilings (i.e.: Patient A’s 6ft ceilings will not allow for as large plants/high yields as Patient B’s 10ft ceilings so patient A will require a higher number of plants to meet their needs.)
Outdoor: size and type of space, whether the cannabis will be grown directly in the ground or in pots, size of the pots being used (i.e.: Patient A has a large, fenced in lot with full sun and is growing directly in the ground so they have the potential to grow tree sized plants with high yields. Patient B has a small yard with no fence so they are restricted to growing in 16” pots on their balcony which gives them the potential to grow much smaller plants with much lower yields. Patient B will require a higher number of plants than patient A to meet their needs.)
Indoor/Outdoor: same as above but intention should also be clearly defined. If a patient intends to grow predominantly outside/ harvest only once per year but needs to start their plants inside and/or keep mother plants to maintain genetics, the number of plants allotted should be equal to that for an outdoor-only permit with the addition of an equal amount of indoor plants, and small extra allotment to account for loss of seedlings/clones and a small allotment for mother plants. (i.e.: 5g/day allows for 10 plants outdoors only. Patient A intends to grow predominantly outdoors but needs to start their plants indoors and keep 2 to 3 different genetics mother plants. A reasonable Indoor/Outdoor permit in this scenario should include 10 plants outdoors and 20 plants indoors (2 to 3 mothers and 15 to 18 seedlings/clones to account for loss). The permit could also specify that Patient A only be allowed to have 2 to 3 mother plants growing indoors at all times while the seedling/clones can only be started 3 months prior to the outdoor growing season start.
Patient B intends to grow both indoors and outdoors/harvest more than once per year, in this scenario the current parameters should be sufficient, allowing 19 plants indoors and 5 plants outdoors).
Potential outcome
A more detailed application form should be developed to facilitate this process which could include parameters to describe the intended growing space and the intended number of harvests for Indoor/Outdoor permit applications.
Authorized amounts and permits that better reflect the patients’ actual needs without allowing for too many extra plants that may encourage illegal activities.
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.
Our issue - In reality, tending to plants and processing them to meet an individual’s medical needs is a huge job. When it comes time to harvest, unless an individual is only growing a very small number of plants, it is almost impossible to manage alone. Just the trimming can be a full-time job that lasts for several weeks. Without help, a patient would have to take time off of work which the average person cannot afford to do. Factor in the potential for emergencies arising that may leave a patient unable to tend to their plants which would certainly result in plant loss. With permit restrictions, that patient may not be able to grow replacement plants and so may have to go without their medicine.
ECN Proposed Solution - The application for personal production should allow for a minimum number of people, other than the patient / designated grower to help tend to and process the cannabis plants. The number of people allowed to be in contact with the plants should reasonably correlate to the number of plants being produced. We believe there should be at least one helper per 5 plants (i.e.: 5 plants = 1 helper, 10 plants = 2 helpers, 15 plants = 3 helpers, etc). The “helpers” should be required to be registered with Health Canada and go through the same screening process as a designated grower does, including a police check.
Patients should be allowed to tend to their plants even when they have designated someone else to grow for them, no matter the number of plants, as horticulture therapy poses potential health benefits to patients.
https://www.actahort.org/books/639/639_21.htm
https://www.koreascience.or.kr/article/JAKO201103362187311.page
https://scholarworks.wmich.edu/ojot/vol9/iss2/8/
https://www.ahta.org/journal-of-therapeutic-horticulture-30-1---2020
https://www.ahta.org/journal-of-therapeutic-horticulture-30-1---2020
https://www.ahta.org/journal-of-therapeutic-horticulture-28-1---2018
https://www.ahta.org/journal-of-therapeutic-horticulture-28-1---2018
Potential outcome
More realistic parameters for permit holders to follow.
Increased permit holder accountability.
Decrease in the number of infractions due to more realistic parameters.
Our issue
The wording of the present regulations is unclear and does not read as enforced regulations but rather as recommendations a patient may or may not choose to follow. I.e.: “Recommended Safety and Security Measures”; “You may wish to take measures so that other people do not know you are growing marijuana or producing cannabis…” (e.g., ensuring plants cannot be seen...; You may want to consider installing a tall fence or an alarm system...; You may want to consider installing strong locks…)
ECN Proposed Solution
Change the wording to specify that a minimum number of the following recommendations must be put in place for each section: General, Outdoor Production, Indoor Production, Storage, Health, Safe Disposal.
Penalties for non-compliance should be clearly outlined on the permits.
Include these recommendations in the application and require the patient to check off / choose a minimum number of measures they agree to take in order to obtain a permit.
Potential outcome
Increased understanding of the regulations and requirements.
Increased permit holder accountability.
Our issue
Unauthorized plant counts and outdoor production may be a result of lack of public knowledge about the Cannabis Act and Cannabis Regulations. In the case of people living in provinces that do not allow 4 plants to be grown per household, many believe that they are subject to federal law and are allowed to produce these 4 plants. Public education campaigns through mail-outs, public broadcasting, in person / virtual talks, health and community associations that include clear descriptions of the ACMPR as well as the penalties for non-compliance.
ECN Proposed Solution
Penalties for non-compliance should be clearly outlined on the permits.
Potential outcome
Increased understanding of the regulations and requirements. - Increased permit holder accountability.
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.
Our issue - Lack of infrastructure and employees to manage regular checks on permit holders. Most infractions are only being recognized after the fact.
ECN Proposed Solution - Increase number of employees to do annual, unscheduled checks on all permit holders.
Potential outcome - Decreased number of violations.
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.
Our issue - Health Canada’s site is extremely difficult to navigate making access to other applicable guidance documents very difficult to find.
ECN Proposed Solution - Redesign the website to provide easier access.
Potential outcome - More people might actually consult the website for information and will thus be less likely to break the law.
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
Our issue - This statement is very misleading and goes against the previous statement that “the Act and Regulations maintain a separate system to provide patients with reasonable access to cannabis for medical purposes.” Guiding patients to obtain cannabis for medical purposes from recreational retailers and online sales platforms where they cannot obtain proper medical advice or product guidance goes against Health Canada’s mandate to ensure public/patient safety. Furthermore, it puts patients in a position where they cannot use their receipts as a medical expense on the Income taxes or with the few insurance providers that may cover cannabis for medical purposes.
ECN Proposed Solution
As cannabis educators, we often meet patients who have been misinformed by well meaning bud tenders who provide misguided “medical” advice causing patients to have bad experiences that risk their health and safety. We also meet a greater number of recreational store owners and managers that do not know how to manage the increasing number of medical patients coming to them for advice and guidance. This statement should be completely removed or measures should be put in place so that medical patients can use these receipts as they would receipts from medical licensed producers.
Medical patients should be discouraged from purchasing their cannabis from recreational stores and online platforms unless proper medical advice and guidance can be offered
OR
Incorporation of certified cannabis educators into the recreational market by establishing a standard of education and training based on harm reduction principles and by creating a certification board to verify that educators have met minimum requirements and regularly update their education as new evidence is made available through research studies. Then requiring all recreational cannabis outlets to have a certified cannabis educator on staff to provide education and guidance.
Potential outcome
Increased coverage for medical patients.
Decreased incidents of misuse of cannabis products by misinformed consumers.
Shift in liability away from the store owners and staff to the certified educator.
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.
Our issue - While much of the information and resources provided in this document are still valuable, this document has not been updated in almost 5 years so it does not include current research and data.
ECN Proposed Solution
Mandate a team of certified cannabis educators, healthcare, research and industry specialists to continually update the information provided to ensure that it is current, relevant, and based on harm reduction principles. - Better informed healthcare providers are more likely to prescribe cannabis and provide follow up care to their own patients.
Potential outcome
Decrease in the number of healthcare providers prescribing unreasonable amounts of cannabis to patients due to ignorance or financial gain.
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.
Our issue - This statement precludes that underaged patients are not eligible to produce cannabis for their own medical purposes. While it might be generally understood that a minor does not have the right to grow cannabis for themselves, they have, in the past and should maintain their right to have a responsible adult apply on their behalf and to designate an adult to grow for them. If it is the intention of Health Canada to revoke underaged patients’ rights to produce cannabis for their own medical purposes through a designated grower and force families to obtain their supply through licensed producers we highly advise against this as even Health Canada’s referred to studies on the subject indicate the need for high doses of 5 to 20 mg of CBD per kg of body weight which is completely unaffordable for many families. Maintaining the right for underaged patients to grow for themselves through a designated grower is essential and nondiscriminatory.
ECN Proposed Solution - Better wording to include underaged patients rights should be included, especially with the rise of pharmaceutical resistant childhood epileptics’ families turning to cannabis for treatment.
Potential outcome
Increased understanding of patients’ rights to access 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:
Our issue - As previously noted: The wording of the present regulations is unclear and does not read as enforced regulations but rather as recommendations a patient may or may not choose to follow. Change the wording to specify that a minimum number of the following recommendations must be put in place for each section: General, Outdoor Production, Indoor Production, Storage, Health, Safe Disposal.
ECN Proposed Solution - Clearly outline penalties for non-compliance on the permits.
These recommendations should be included in the application and require the patient to check off/choose a minimum number of measures they agree to take in order to obtain a permit. - Increased understanding of the regulations and requirements.
Potential outcome
- Increased permit holder accountability.
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.
Our issue - The Cannabis Act clearly provides guidelines for the gifting/sharing of cannabis between recreational users. If recreational users are allowed to gift/share cannabis, medical patients should also be allowed to gift/share their cannabis following those same guidelines, especially with other registered medical cannabis patients. In provinces where growing four plants per household is legal, how is law enforcement expected to tell the difference between cannabis that is being gifted from a recreational plant and a medical plant?
ECN Proposed Solution - Allow medical patients to be subject to the same gifting/sharing regulations as recreational users.
Potential outcome
Decreased number of violations and unjust incarceration for minor cannabis offences.
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.
Our issue - As previously mentioned: In reality, tending to plants and processing them to meet an individual’s medical needs is a huge job. When it comes time to harvest, unless an individual is only growing a very small number of plants, it is almost impossible to manage alone. Just the trimming can be a full-time job that lasts for several weeks. Without help, a patient would have to take time off of work which the average person cannot afford to do. Factor in the potential for emergencies arising that may leave a patient unable to tend to their plants which would certainly result in plant loss. With permit restrictions, that patient may not be able to grow replacement plants and so may have to go without their medicine.
ECN Proposed Solution - The application for personal production should allow for a minimum number of people, other than the patient/designated grower to help tend to and process the cannabis plants. The number of people allowed to be in contact with the plants should reasonably correlate to the number of plants being produced. We believe there should be at least one helper per 5 plants (i.e.: 5 plants = 1 helper, 10 plants = 2 helpers, 15 plants = 3 helpers, etc). The “helpers” should be required to be registered with Health Canada and go through the same screening process as a designated grower does, including a police check.
Patients should be allowed to tend to their plants even when they have designated someone else to grow for them, no matter the number of plants.
Potential outcome
More realistic parameters for permit holders to follow.
Increased permit holder accountability.
Decrease in the number of infractions due to more realistic parameters.
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.
Our issue - Misleading wording requires clarification. While it is reasonable to not allow people to use organic solvents because of significant safety risks, indicating that making oils and butters is a risk is very confusing because many people make their products by infusing oils and butters with cannabis which is a completely different, relatively safe process.
ECN Proposed Solution - Clear definitions of safe processing and unsafe processing practices should be included using language and terms that are known by the general public, including slang terms that are commonly used. Example: “Making cannabis concentrates like FECO (full extract cannabis oil), RSO (Rick Simpson oil), Phoenix Tears, Honey Oil, Hashish, Hash, Hash Oil, Bubble Hash, BHO (butane hash oil), Wax, Budder, Shatter, honeycomb, etc.; the use of organic solvents such as butane, isobutane, propane or propylene is not permitted. However, it is permitted to make these types of concentrates with the use of water, heat presses, and alcohol. It is also permitted to infuse fats, oils, butters, alcohols, vinegars and glycerine with cannabis, adding cannabis to food and to topical recipes.”
Potential outcome Providing patients access to credible education on how to process their cannabis safely and effectively.
Increased understanding of safe practices.
Increasing patients’ abilities to produce safe and effective products.
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?
Our Issue
As previously noted: While much of the information and resources provided in this document are still valuable, this document has not been updated in almost 5 years so it does not include current research and data.
ECN Proposed Solution - Mandate a team of certified cannabis educators, healthcare, research and industry specialists to continually update the information provided to ensure that it is current, relevant, and based on harm reduction principles.
Potential outcome - Better informed healthcare providers are more likely to prescribe cannabis and provide follow up care to their own patients.
- Decrease in the number of healthcare providers prescribing unreasonable amounts of cannabis to patients due to ignorance or financial gain.
[EduCanNation had no further issues with the remainder of the regulation]
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.
