Regulations Amending the Cannabis Regulations (Additional Period of Validity of a Medical Document): SOR/2020-149
Canada Gazette, Part II, Volume 154, Number 14
SOR/2020-149 June 26, 2020
P.C. 2020-494 June 25, 2020
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 139(1) of the Cannabis Act footnote a, makes the annexed Regulations Amending the Cannabis Regulations (Additional Period of Validity of a Medical Document).
Regulations Amending the Cannabis Regulations (Additional Period of Validity of a Medical Document)
1 Section 273 of the Cannabis Regulations footnote 1 is amended by adding the following after subsection (4):
Additional period of validity
(5) Despite subsection (4), a medical document is valid for an additional period of six months beginning
- (a) on the day on which this subsection comes into force, if the document ceases to be valid under subsection (4) on or after March 13, 2020 but before the day on which this subsection comes into force; or
- (b) on the day after the day on which the document ceases to be valid under subsection (4) if the day on which the document ceases to be valid is on or after the day on which this subsection comes into force but before October 1, 2020.
2 Paragraph 283(a) of the Regulations is replaced by the following:
- (a) if it is based on a medical document, at the end of the period of validity of the document, as determined in accordance with subsections 273(4) and (5); or
3 Paragraph 313(2)(i) of the Regulations is replaced by the following:
- (i) the date of expiry of the registration;
4 The Regulations are amended by adding the following after section 313:
Expiry of registration
313.1 The registration of a registered person expires at the end of the period of validity of the medical document that forms the basis for the registration, as determined in accordance with subsections 273(4) and (5).
Coming into Force
5 These Regulations come into force on the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
As a result of the COVID-19 pandemic and public health control measures implemented by the provinces and territories to slow the spread of COVID-19 (e.g. by observing physical distancing, self-isolating), some Canadians who require cannabis for medical purposes may face challenges in consulting their health care practitioner to obtain a new medical document to access cannabis for medical purposes. Many health care practitioners have temporarily closed their offices or restricted access to only essential health care services. Although many health care practitioners’ offices have shifted to provide care through telemedicine, this approach may not be appropriate for all Canadians (e.g. those with low computer literacy). Even with the resumption of some health services, public health officials continue to caution Canadians to limit social interactions in the community and observe physical distancing — particularly for vulnerable populations (which may include people with underlying health conditions who use cannabis for medical purposes). Further, patients that cannot consult their health care practitioner to obtain a new medical document to access cannabis for medical purposes may no longer qualify for certain benefits such as compassionate pricing programs, income tax deductions, and health care plan coverage.
On October 17, 2018, the Cannabis Act and the Cannabis Regulations came into force, creating a new legal framework for controlling the production, distribution, sale, import, export and possession of cannabis in Canada. Although the legalization and regulation of cannabis for non-medical purposes is relatively new in Canada, the legislation related to cannabis for medical purposes is the result of successive court decisions over the past 20 years, which have established that Canadians have a Charter right to reasonable access to cannabis for medical purposes. As such, the Cannabis Regulations maintain a distinct medical access framework to support patients, which is detailed in Part 14 of the Regulations.
Under the current framework, individuals must have the support of an authorized health care practitioner in order to access cannabis for medical purposes, expressed in the form of a written medical document. Among other things, the medical document specifies a daily quantity of dried cannabis, in grams, for which the patient is authorized, and indicates a period of use, which cannot exceed a year. As a result, medical documents must be renewed should a patient continue to require access cannabis for medical purposes beyond the period specified in the document, and at a minimum must be renewed on an annual basis.
On the basis of the medical document, individuals can either purchase cannabis for medical purposes directly from a holder of a licence for sale for medical purposes (i.e. licensed seller with whom they are registered), or register with the Minister of Health to grow cannabis for their own medical purposes (or have someone grow it on their behalf). In either scenario, an original, signed medical document is required. The period of use indicated in a patient’s medical document begins on the day the patient is registered. Once the period of use ends, the patient’s registration is considered expired, at which point they are required to obtain a new medical document from a health care practitioner and renew if they wish to continue accessing cannabis for medical purposes. Maintaining their registration and purchasing cannabis through the medical access program allows patients to possess in public and purchase a larger quantity of cannabis than is permitted for individuals that use cannabis for non-medical purposes (i.e. up to 150 grams of dried cannabis or its equivalent compared to 30 grams of dried cannabis or its equivalent). footnote 2
As of March 31, 2020, there were approximately 325 000 active registrations with licensed sellers and approximately 35 000 individuals registered with the Minister.
The objectives of this regulatory amendment are to support the Government of Canada’s efforts to reduce the risk of community spread of, and mortality rate due to, COVID-19, while helping to maintain reasonable access to cannabis for medical purposes for patients. This amendment facilitates patients’ ability to adhere to public health guidance to practise physical distancing by reducing their need to leave their home to obtain a new medical document from their health care practitioner for a certain period of time.
These Regulations will temporarily amend certain provisions of the Cannabis Regulations. These amendments will allow patients to continue to access cannabis for medical purposes even though they may have been, or are, unable to consult see their health care practitioner between March 13, 2020, and September 30, 2020, to obtain a new medical document.
More specifically, these amendments will
- extend the period of validity for medical documents that have expired or will expire between March 13, 2020, and September 30, 2020, for patients registered with licensed sellers and the Minister to obtain cannabis for medical purposes; and
- extend registrations for six months based on the additional period of validity of the medical documents.
Licensed sellers will be permitted to sell cannabis for medical purposes to these patients as if their medical documents were valid and their registrations were not expired. Further, patients who are registered with the Minister can continue to grow their own cannabis or have a designated person grow it on their behalf. Because existing patients’ medical documents will continue to be valid for six months, their registrations will continue to be valid for the same period of time. Therefore, these patients will not need to obtain a new medical document and apply to renew their registrations with a licensed seller or the Minister for six months. Registrations will continue to be based on the patients’ existing medical documents.
These amendments will not impact the ability of patients to obtain a new medical document, amend or transfer their registration from one licensed seller to another, or to the Minister. Patients who can safely access their health care practitioners during this time should continue to do so and may register or renew their registration on the basis of this new medical document.
These changes will take effect upon the coming into force of the amendments. For those individuals whose medical document’s period of validity expired before the coming into force of this amendment (i.e. between March 13 and coming into force), their six-month extension will start on the day that this regulatory amendment comes into force. For those individuals whose medical document’s period of validity expired on or after the coming into force of this amendment but before October 1, 2020, their six-month extension will begin on the day after its expiry (e.g. if the medical document’s validity expired on August 1, 2020, it would be extended from August 2, 2020, until February 2, 2021).
The six-month period covered by this amendment (i.e. until September 30, 2020) aligns with other targeted measures implemented by Health Canada to reduce the risk of community spread of, and mortality rate due to, COVID-19. This includes a section 56 exemption under the Controlled Drugs and Substances Act to allow pharmacists to extend and transfer prescriptions, including for narcotics. Should the pandemic continue to pose challenges to patients’ reasonable access to cannabis for medical purposes past September 30, 2020, Health Canada will re-evaluate and determine whether additional measures are required.
Due to the time-sensitive nature of this amendment, limited consultations were conducted with industry, patient advocacy groups and the medical community.
In mid-March 2020, industry and patient advocacy groups contacted Health Canada identifying challenges some patients were experiencing renewing their medical document. They requested measures to address this issue. As such, industry and patient advocacy groups are supportive of extending the validity of medical documents to support reasonable access to cannabis for medical purposes. Those consulted from the medical community noted that most health care practitioners are set up to provide medical documents via telemedicine, which should accommodate most patients; however, they recognized utilizing telemedicine may pose challenges for some patients.
Representatives from provinces and territories were consulted and did not raise any concerns.
Modern treaty obligations and Indigenous engagement and consultation
This amendment will impact any patient, including Indigenous patients, who have a medical document authorizing the use of cannabis for medical purposes if its period of validity ends between March 13, 2020, and September 30, 2020. It allows existing patients who are registered with a licensed seller or the Minister to continue accessing cannabis for medical purposes for an extended period of time, without the need to reapply.
This amendment to the Cannabis Regulations will not adversely impact potential or affirmed treaty rights protected by section 35 of the Constitution Act, 1982, modern treaties and international rights obligations.
This regulatory amendment supports measures to reduce the risk of community spread of, and mortality rate due to, COVID-19, while helping to maintain patients’ reasonable access to cannabis for medical purposes.
Other options considered included issuing an exemption under section 140 of the Cannabis Act. However, it was decided that only a regulatory amendment could achieve the desired objectives.
Benefits and costs
The regulatory amendment will impose limited costs on the Government of Canada but is expected to result in net benefits to all other affected stakeholders, including patients and licensed sellers. Overall, the regulatory amendment will create net benefits to Canadian society as a whole.
This regulatory amendment helps mitigate the challenges some patients have faced or may face between March 13, 2020, and September 30, 2020, in consulting their health care practitioner, as well as completing their application for renewal with a licensed seller or the Minister. In doing so, patients’ access to cannabis for medical purposes is uninterrupted and they do not have to expose themselves to potential public health risks by going out into the community to obtain a new medical document.
Given the six-month extension, the amendment provides greater flexibility for patients in a number of ways. If their health care practitioner’s office has to close temporarily, it will allow them to re-book an appointment when the office reopens or provide them with additional time to consult a new health care practitioner. If the patient contracts COVID-19, is caring for others who are sick with the virus, or is following public health guidance to self-isolate, it will allow them to reschedule their appointment to a time when it is safer to do so. In doing so, it will help patients adhere to public health guidance to practise physical distancing and will contribute to efforts to slow the spread of community transmission of the virus.
This regulatory amendment will allow licensed sellers to continue to sell cannabis for medical purposes to existing clients who might otherwise have had challenges maintaining their registration between March 13, 2020, and September 30, 2020. By making it easier for clients to maintain their registration, the risk of lost revenue is decreased, which represents a benefit to licensed sellers.
As per the Cannabis Regulations, licensed sellers are required to report detailed information regarding valid registrations and medical documents to the Minister via the Cannabis Tracking and Licensing System (CTLS) each month. Depending on how their data management systems are set up, it is anticipated that licensed sellers may need to modify their systems to account for patients whose registrations may appear as expired in their system, but due to this regulatory amendment are in fact still valid. Furthermore, licensed sellers may incur additional costs from updating their data management systems in order to continue to register, and sell to, clients to whom this amendment applies. It is anticipated that some licensed sellers may also incur costs associated with communicating to their clients and answering questions regarding this amendment. It is estimated that, on average, each of the approximately 50 licensed sellers will need 20 hours in total to modify their existing data management systems and operational procedures. The estimated value of the resulting compliance and operational costs, in total to the industry, is approximately $27,530 (in 2018 dollars) in present value (PV), or $3,930 annually.
Health Canada will incur some costs in implementing this regulatory amendment. However, it is estimated that these incremental costs will be low. These costs include both promotional costs and operational costs. Promotional costs include updating relevant Health Canada webpages and social media channels, contacting all relevant stakeholders to inform them of the temporary changes, and responding to inquiries from stakeholders. Operational costs include work required to verify the validity of existing registrations with the Minister in Health Canada’s database and update some of the information accordingly. This may result in 25 hours of additional work while the amendment is in place.
With regard to enforcement activities, Health Canada will not require any additional resources to continue to conduct these activities as per current practice.
Small business lens
In order to remain compliant with the reporting provisions in the Cannabis Regulations, licensed sellers, including those that are considered small businesses, will need to modify their data management systems to accurately capture all those who may appear to have an expired registration but to whom this amendment applies. However, the cost associated with this work is estimated to be limited. Overall, this amendment is expected to be beneficial to licensed sellers who are small businesses, as it will allow them to continue to serve clients who may have otherwise faced challenges registering with them.
Given the potential cost impact, Health Canada has considered alternative options for how small businesses could submit monthly data into the CTLS. However, because of the limited costs and the diversity of data management systems, it was determined that it would be preferable to rely on licensed sellers to update their systems according to their own circumstances.
The one-for-one rule does not apply since the regulatory amendment is not expected to generate administrative burden to industry stakeholders (i.e. licensed sellers).
Regulatory cooperation and alignment
This regulatory amendment is not related to a work plan or commitment under a formal regulatory cooperation forum.
Although a number of other countries have created legal frameworks for cannabis for medical purposes, Canada’s regulatory program is unique, as is the impact that COVID-19 has had on the Canadian population. Opportunities for regulatory alignment are therefore highly limited.
Strategic environmental assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.
Gender-based analysis plus (GBA+)
The policy objectives of this amendment are to support the Government of Canada’s efforts to reduce the risk of community spread of, and mortality rate due to, COVID-19, while helping maintain reasonable access to cannabis for medical purposes for patients. It is anticipated that this regulatory amendment will particularly impact patients who are 65 years and older, have pre-existing health conditions, and/or live in certain regions. These patients’ potential exposure to COVID-19 will be reduced by minimizing their need to leave their home to renew their medical documents. This approach is consistent with the Government of Canada’s recommendations on how to prevent the spread of COVID-19 by staying at home, avoiding all nonessential trips in your community, and limiting contact with people at higher risk, such as older adults and those in poor health. footnote 3
Canadian surveys of cannabis use generally suggest that overall cannabis use is found to be higher among males and people who identify as lesbian, gay, and bisexual. footnote 4 However, with respect to the use of cannabis for medical purposes, the 2019 Canadian Cannabis Survey demonstrates that there is no significant difference in using cannabis for medical purposes (with a medical document) in the past 12 months between males (4%) and females (4%). footnote 5 There is not sufficient data on the use of cannabis for medical purposes by other sexual and gender minorities within the context of COVID-19, but it is known that pandemics can compound existing inequalities for girls, women, sexual and gender minorities and other at-risk populations. footnote 6
Sex-disaggregated data demonstrate that more males are being hospitalized, and being admitted to intensive care units (ICU) as a result of COVID-19, compared to females. footnote 7, footnote 8 However, across Canada, a higher proportion of confirmed COVID-19 cases and deaths are among females, compared to males. footnote 9 Similarly, in Indigenous populations, a higher proportion of confirmed COVID-19 cases are being observed among females, compared to males. footnote 10 Gender roles may put women at a higher risk of exposure to COVID-19 due to their greater involvement in the health care sector and with household/caregiver responsibilities. footnote 11, footnote 12 Furthermore, in Canada, women outlive men by an average of four years and thus are more likely to constitute a higher proportion of older adults (and residents in long-term care facilities), who are particularly impacted by the pandemic. footnote 13
Age- and health status–related considerations
While Canadian cannabis surveys generally suggest that cannabis use rates are higher among younger people, footnote 14, footnote 15, footnote 16 according to the National Cannabis Survey (third quarter, 2019), cannabis for medical purposes use was reported to be more common among older adults (65 years and older) compared to younger adults. footnote 17 Those using cannabis for medical purposes may experience higher rates of health conditions compared to the general population. With respect to COVID-19, elderly people and those with pre-existing health conditions are among the most vulnerable and least likely to recover from the virus. footnote 18 According to epidemiological data released from the Public Health Agency of Canada, individuals over the age of 60 account for the highest rates of COVID-19-related hospitalizations, ICU admissions, and deaths. footnote 19
Geographic region-related considerations
There are regional differences in the use of cannabis for medical purposes and the prevalence of COVID-19. According to the 2019 Canadian Cannabis Survey, the past 12-month use rates of cannabis for medical purposes were the highest in the Territories (24%), Nova Scotia (21%), and British Columbia (19%), while Quebec (7%), Manitoba (11%) and Prince Edward Island (13%) had the lowest rates. footnote 20 Regional differences in cannabis for medical purposes use rates may be indicative of disproportionate health care funding and resource allocation. Quebec and Ontario have the highest number of total confirmed cases of COVID-19, and New Brunswick and Prince Edward Island have the lowest. footnote 21
Implementation and compliance and enforcement
This amendment comes into force as soon as it is registered. Industry, patient advocacy groups, the medical community, provinces and territories, municipalities and law enforcement will be notified and guidance on its implementation will be provided.
Compliance and enforcement
Compliance and enforcement measures, including reporting requirements, will be the same as those already set out in the Cannabis Act and the Cannabis Regulations.
The Controlled Substances and Cannabis Branch (CSCB) Compliance and Enforcement Directorate, as well as the Regulatory Operations and Enforcement Branch (ROEB, Health Canada), which is responsible for inspections, will continue their regular enforcement and compliance activities, taking into account the extended timeframe for the validity of medical documents.
Strategic Policy, Cannabis
Controlled Substances and Cannabis Branch
Address Locator: 0302I