Regulations Amending the Regulations for the Monitoring of Medical Assistance in Dying: SOR/2022-222

Canada Gazette, Part II, Volume 156, Number 23

Registration
SOR/2022-222 October 26, 2022

CRIMINAL CODE

Whereas the Minister of Health considers it necessary that the annexed Regulations be made;

Therefore, the Minister of Health makes the annexed Regulations Amending the Regulations for the Monitoring of Medical Assistance in Dying under subsection 241.31(3)footnote a of the Criminal Code footnote b.

Ottawa, October 24, 2022

Jean-Yves Duclos
Minister of Health

Regulations Amending the Regulations for the Monitoring of Medical Assistance in Dying

Amendments

1 (1) The definitions patient and refer in section 1 of the Regulations for the Monitoring of Medical Assistance in Dying footnote 1 are repealed.

(2) Section 1 of the Regulations is amended by adding the following in alphabetical order:

preliminary assessor
means a person who has the responsibility to carry out preliminary assessments of whether a person who has requested medical assistance in dying meets the eligibility criteria. (responsable des évaluations préliminaires)

2 Sections 2 to 4 of the Regulations are replaced by the following:

Designation — Minister of Health

2 (1) The Minister of Health is designated as the recipient of information for the purposes of subsections 241.31(1) to (2) of the Code.

Designation — other recipients

(2) However, the following persons are designated as the recipients of information for the purposes of subsections 241.31(1) to (2) of the Code in respect of the following information:

Practitioners and Other Persons

Exception — no information required

3 The following practitioners are not, in respect of a person’s request for medical assistance in dying, required to provide information under subsection 5(1), 6(1) or 6.1(1) or section 9:

3 (1) The portion of subsection 5(1) of the Regulations before paragraph (a) is replaced by the following:

Withdrawal of request

5 (1) A practitioner must provide the following information to the applicable recipient designated under section 2 within 30 days after the day on which the practitioner becomes aware of the withdrawal of a person’s request for medical assistance in dying that they received:

(2) Paragraphs 5(1)(b) to (d) of the Regulations are replaced by the following:

4 Section 6 of the Regulations is replaced by the following:

Ineligibility

6 (1) If a preliminary assessor, a practitioner who carries out an assessment of whether a person who has made a request for medical assistance in dying meets the eligibility criteria or a practitioner who has received a person’s written request for medical assistance in dying determines that the person does not meet one or more of the eligibility criteria, they must provide the applicable recipient designated under section 2 with the applicable information referred to in Schedules 1 and 3 within 30 days after the day on which they make that determination.

Clarification

(2) For greater certainty, subsection (1) applies if the preliminary assessor or the practitioner determined that the person met the eligibility criteria but subsequently determines that the person does not meet one or more of those criteria.

Exception — no other information required

(3) A practitioner who provides information in accordance with subsection (1) is not required to provide information under subsection 5(1) or 6.1(1) or section 9.

Safeguard not met

6.1 (1) A practitioner who has received a person’s request for medical assistance in dying and determined that the person met all of the eligibility criteria, but does not provide medical assistance in dying because they subsequently determine that a safeguard set out in subsection 241.2(3) or (3.1) of the Code, as the case may be, has not been met, must provide the applicable recipient designated under section 2 with the applicable information referred to in Schedules 1 and 3 within 30 days after the day on which they make the subsequent determination.

Exception — no other information required

(2) A practitioner who provides information in accordance with subsection (1) is not required to provide information under subsection 5(1) or 6(1) or section 9.

5 (1) Subsection 7(1) of the Regulations is replaced by the following:

Prescribing or providing a substance — general

7 (1) A practitioner who has received a person’s written request for medical assistance in dying and provides medical assistance in dying by prescribing or providing a substance to the person for self-administration must provide the applicable recipient designated under section 2 with the applicable information referred to in Schedules 1 and 3 and the information referred to in Schedule 4 or 4.1, as the case may be, and Schedule 5 no earlier than the 90th day after the day on which the practitioner prescribes or provides the substance and no later than one year after that day.

(2) The portion of subsection 7(2) of the Regulations before paragraph (a) is replaced by the following:

Prescribing or providing a substance — Ontario

(2) However, a practitioner who has received a person’s written request for medical assistance in dying and provides medical assistance in dying in Ontario by prescribing or providing a substance to the person for self-administration must provide the applicable information referred to in Schedules 1 and 3 and the information referred to in Schedule 4 or 4.1, as the case may be, and Schedule 5 no earlier than the 90th day after the day on which the practitioner prescribes or provides the substance and no later than one year after that day,

(3) Paragraph 7(2)(b) of the Regulations is replaced by the following:

(4) Subsection 7(3) of the Regulations is replaced by the following:

Exception — time to report

(3) The practitioner may provide the information earlier than the 90th day after the day on which the practitioner prescribes or provides the substance to the person who has made a request for medical assistance in dying if the practitioner knows that the person has died.

6 Section 8 of the Regulations is replaced by the following:

Administering a substance — general

8 (1) A practitioner who has received a person’s written request for medical assistance in dying and provides medical assistance in dying by administering a substance to the person must provide the applicable recipient designated under section 2 with the applicable information referred to in Schedules 1, 3 and 6 and the information referred to in Schedule 4 or 4.1, as the case may be, within 30 days after the day on which the person dies.

Administering a substance — Ontario

(2) However, a practitioner who has received a person’s written request for medical assistance in dying and provides medical assistance in dying in Ontario by administering a substance to the person must provide the recipient designated under paragraph 2(2)(a) with the applicable information referred to in Schedules 1, 3 and 6 and the information referred to in Schedule 4 or 4.1, as the case may be, within 30 days after the day on which the person dies.

7 (1) The portion of section 9 of the Regulations before paragraph (a) is replaced by the following:

Death — other cause

9 A practitioner who has received a person’s request for medical assistance in dying must, within 30 days after the day on which the practitioner becomes aware that the person died from a cause other than medical assistance in dying, provide the applicable recipient designated under section 2 with the following information:

(2) Paragraphs 9(b) and (c) of the Regulations are replaced by the following:

8 Sections 10 and 11 of the Regulations are replaced by the following:

Cessation of certain requirements

10 A practitioner who has received a person’s request for medical assistance in dying is not required to provide information under a provision of these Regulations — other than subsection 7(1) or (2) or 8(1) or (2), as the case may be — with regard to any circumstances relating to the request that the practitioner becomes aware of, or any actions that the practitioner takes in respect of the request,

Pharmacists and Pharmacy Technicians

Dispensing of substance

11 A pharmacist who dispenses a substance in connection with the provision of medical assistance in dying or a pharmacy technician who dispenses a substance to aid a practitioner in providing medical assistance in dying must provide the applicable recipient designated under section 2 with the information referred to in Schedule 7 within 30 days after the day on which they dispense the substance.

9 Section 12 of the Regulations is replaced by the following:

Personal information collected from provinces and territories

12 (1) The Minister of Health may, for the purposes of monitoring medical assistance in dying, collect personal information relating to requests for, and the provision of, medical assistance in dying from a provincial or territorial government, or any of its institutions, or from a public body established under an Act of the legislature of a province or territory.

Other information

(2) Without restricting the generality of subsection (1), the Minister of Health may, for the same purposes, request that they provide the Minister, on a voluntary basis, with the following information:

10 (1) Subsection 13(2) of the Regulations is replaced by the following:

Content — period covered by report

(2) The report must contain information relating to requests for medical assistance in dying received by preliminary assessors or practitioners, and the provision of medical assistance in dying during the period covered by the report, including

(2) Paragraph 13(3)(b) of the Regulations is replaced by the following:

11 Subsection 16(1) of the Regulations is replaced by the following:

Disclosure to Minister of Health

16 (1) A recipient designated under subsection 2(2) must disclose to the Minister of Health, within 30 days after the day on which a quarter begins, the information — other than the information referred to in paragraphs 2(a) and (g) and 2.1(a) and (d) of Schedule 1 and paragraphs 2(a) and (d) of Schedule 7 — that the recipient obtained under these Regulations in the preceding quarter.

12 Schedule 1 to the Regulations is amended by replacing the references after the heading “SCHEDULE 1” with the following:

(Paragraph 5(1)(a), subsections 6(1), 6.1(1) and 7(1) and (2), section 8, paragraph 9(a) and subsection 16(1))

13 (1) The portion of section 1 of Schedule 1 to the Regulations before paragraph (a) is replaced by the following:

1 The following information in respect of the person who made the request for medical assistance in dying:

(2) Paragraphs 1(b) to (d) of Schedule 1 to the Regulations are replaced by the following:

14 Paragraphs 2(g) and (h) of Schedule 1 to the Regulations are replaced by the following:

15 Section 3 of Schedule 1 to the Regulations is replaced by the following:

2.1 The following information in respect of the preliminary assessor:

3 The following information in respect of the request:

4 If known, an indication by the preliminary assessor or practitioner of whether the person had previously made a request for medical assistance in dying, and if so, the outcome of that request.

16 Schedules 2 to 7 to the Regulations are replaced by the Schedules 3 to 7 set out in the schedule to these Regulations.

Coming into Force

17 (1) These Regulations, except section 10, come into force on January 1, 2023.

(2) Section 10 comes into force on January 1, 2024.

SCHEDULE

(Section 16)

SCHEDULE 3

(Paragraph 5(1)(b), subsections 6(1), 6.1(1) and 7(1) and (2), section 8 and paragraph 9(b))

Eligibility Criteria and Related Information

1 An indication of whether the preliminary assessor or the practitioner consulted with other health care professionals — other than the practitioners described in section 3 of these Regulations — or social workers in order to determine whether the person who made the request for medical assistance in dying met the eligibility criteria and, if so, the professions of those persons.

2 An indication of which of the following eligibility criteria were assessed by the preliminary assessor or the practitioner and whether they were of the opinion that the person who made the request for medical assistance in dying met or did not meet each of those criteria:

3 An indication by the preliminary assessor or the practitioner of the following:

4 In the case where medical assistance in dying was provided to a person whose natural death was not reasonably foreseeable, an indication by the practitioner of the following:

5 An indication by the preliminary assessor or the practitioner of whether the person who made the request for medical assistance in dying required palliative care, if known, and if so,

6 An indication by the preliminary assessor or the practitioner of whether the person who made the request for medical assistance in dying required disability support services, if known, and if so,

7 An indication by the preliminary assessor or the practitioner of whether or not, taking into account all of the medical circumstances of the person who made the request for medical assistance in dying, their natural death was reasonably foreseeable, if known.

8 In the case where after having determined that the person who made the request for medical assistance in dying met all of the eligibility criteria, the practitioner subsequently determined that a safeguard set out in subsection 241.2(3) or (3.1) of the Code, as the case may be, had not been met, an indication of which safeguard had not been met and the reason they made that determination.

SCHEDULE 4

(Subsections 7(1) and (2) and section 8)

Procedural Requirements for Providing Medical Assistance in Dying — Natural Death Reasonably Foreseeable

1 An indication of

SCHEDULE 4.1

(Subsections 7(1) and (2) and section 8)

Procedural Requirements for Providing Medical Assistance in Dying — Natural Death Not Reasonably Foreseeable

1 An indication of

SCHEDULE 5

(Subsections 7(1) and (2))

Prescribing or Providing a Substance

1 The date on which the practitioner prescribed or provided the substance to the person who made the request for medical assistance in dying.

2 The place where the person who made the request for medical assistance in dying was staying when the practitioner prescribed or provided the substance to them.

3 The following information:

SCHEDULE 6

(Section 8)

Administering a Substance

1 The date on which the practitioner administered the substance to the person who made the request for medical assistance in dying.

2 The place where the practitioner administered the substance to the person who made the request for medical assistance in dying.

3 An indication of whether the person who made the request for medical assistance in dying was transferred from one place to another for the purposes of administering the substance to them and, if so, the reasons for the transfer, if known.

4 In the case where the practitioner administered a second substance to the person who made the request for medical assistance in dying in accordance with subsection 241.2(3.5) of the Code, an indication of whether

SCHEDULE 7

(Section 11 and subsection 16(1))

Dispensing a Substance

1 The following information in respect of the person who made the request for medical assistance in dying and for whom the substance was dispensed:

2 The following information in respect of the pharmacist or pharmacy technician:

3 The following information in respect of the practitioner who prescribed the substance or obtained the substance from the pharmacist or pharmacy technician:

4 The following information in respect of the dispensing of the substance:

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: Comprehensive monitoring and reporting on medical assistance in dying (MAID) is a critical component in supporting transparency and fostering public trust in the application of the law in Canada. The need for the consistent collection of information and public reporting reflects the seriousness of MAID as an exception to the Criminal Code prohibitions against the intentional termination of a person’s life and aiding a person to end their own life.

Description: The Regulations Amending the Regulations for the Monitoring of Medical Assistance in Dying will align with recent amendments to the Criminal Code, arising from former Bill C-7, An Act to amend the Criminal Code (medical assistance in dying), which came into force in March 2021.

The Regulations Amending the Regulations for the Monitoring of Medical Assistance in Dying will allow for the collection of data on procedural safeguards for persons whose natural death is not reasonably foreseeable, and align with the revised procedural safeguards (e.g. reducing the requirement from two witnesses to one) introduced by the legislation.

The amended Regulations will also allow for the collection of data related to gender identity, race, Indigenous identity and disability of persons requesting MAID, if the person consents to providing this information. In addition, they will permit the collection of data on all assessments following a person’s request for MAID (verbal and written) and expand reporting from medical practitioners, nurse practitioners and pharmacists to also include preliminary assessors and pharmacy technicians.

Rationale: The amended Regulations support Canada’s MAID regime by allowing for enhancements to data collection and reporting through the federal MAID monitoring regime to provide a more comprehensive picture of how MAID, with expanded eligibility, is being implemented in Canada.

The expansion of data collection is expected to benefit all Canadians by supporting transparency and public trust in how MAID is delivered. The collection of data related to gender identity, race, Indigenous identity and disability through the amended Regulations will also help the Government of Canada to determine the presence of individual or systemic inequality or disadvantage in the context of, or delivery of, MAID.

The amended Regulations will result in approximately $223,000 in administrative costs during the first year for medical practitioners, nurse practitioners and preliminary assessors to familiarize themselves with the new reporting requirements. Ongoing administrative costs of approximately $314,000 per year were estimated based on the additional time that it will take medical practitioners, nurse practitioners and preliminary assessors to complete mandatory reporting requirements. These aforementioned costs will be spread across the more than 2 000 practitioners and preliminary assessors across Canada. Implementation of the amended Regulations will result in one-time incremental costs to the federal government, provinces and territories of approximately $210,000 and ongoing costs of approximately $139,000 per year. The small business lens and the one-for-one rule apply to these amended Regulations.

Issues

Health Canada has amended the 2018 Regulations for the Monitoring of Medical Assistance in Dying (SOR/2018-166) [the existing Regulations] to align them with recent amendments to the Criminal Code, arising from An Act to amend the Criminal Code (medical assistance in dying) [the Act], which received royal assent on March 17, 2021. Changes to the Act were made in response to the Superior Court of Quebec decision in Truchon v. Canada (Attorney General). In this decision, the Court ruled that the federal eligibility criterion that a person’s natural death be reasonably foreseeable was too restrictive and violated section 7 of the Canadian Charter of Rights and Freedoms [the Charter], which protects against deprivations of life, liberty and security of the person, and section 15 of the Charter, which guarantees the right to the equal protection and equal benefit of the law without discrimination. As a result, the federal law no longer requires that a person’s natural death be reasonably foreseeable as an eligibility criterion for MAID. Changes to the federal law also reflect improvements based on five years of experience with MAID in Canada.

The Criminal Code requires that the Minister of Health make regulations respecting the provision and collection of information for the purposes of monitoring MAID in Canada. The need for a robust monitoring regime reflects the significance and gravity of allowing medical practitioners and nurse practitioners to help end life, which is permitted through exceptions to Criminal Code provisions that prohibit counselling or aiding suicide.

To align the existing Regulations for the Monitoring of Medical Assistance in Dying (SOR/2018-166) with the recent amendments to the Criminal Code, the Minister of Health, pursuant to subsection 241.31(3) of the Criminal Code, made the annexed Regulations Amending the Regulations for the Monitoring of Medical Assistance in Dying (the amended Regulations).

The amended Regulations will continue to provide the framework for the collection, analysis and reporting of information in relation to requests for, and the provision of, MAID in Canada. Information collected through the amended Regulations will also provide important insight and contribute to producing a more comprehensive and inclusive picture of who is seeking MAID and how MAID is being implemented in Canada.

Background

The Act was informed by the Superior Court of Quebec’s decision in Truchon v. Canada (Attorney General), the Government of Canada’s legislative consultations on MAID that took place in January and February 2020, and witness testimonies and parliamentary debates on the legislation. In addition, Canadian and international research, social science evidence and reports from academia, the experience of existing international MAID regimes, and the Canadian experience over the past five years were also taken into account in the development of the Act.

The Act changed the legal framework for MAID in Canada by expanding eligibility for MAID to persons whose natural death is not reasonably foreseeable and by introducing a two-track approach to procedural safeguards based on whether or not a person’s natural death is reasonably foreseeable. This new approach to safeguards ensures that sufficient time and expertise are spent assessing MAID requests from persons whose natural death is not reasonably foreseeable, while easing certain safeguards in cases where natural death is reasonably foreseeable.

For persons whose natural death is reasonably foreseeable, existing safeguards have been maintained and, in some cases, eased as the Act removed the 10-day reflection period and reduced the requirement for two independent witnesses to one. The Act also allows for the waiver of the requirement to provide final consent immediately before receiving MAID for persons whose natural death is reasonably foreseeable if they have been assessed and approved to receive MAID, are at risk of losing decision-making capacity before their chosen date for MAID and have a written arrangement with a practitioner to waive final consent.

For persons whose natural death is not reasonably foreseeable, the Act introduced new and strengthened safeguards for eligible persons, such as requiring one of the practitioners involved in the MAID assessment to have expertise in the condition causing the person’s suffering, or to consult a third practitioner with that expertise; setting a minimum 90-day assessment period; requiring that persons be informed of, and offered access to, appropriate and available means to relieve their suffering (e.g. treatments, services, supports); and requiring that both MAID assessors agree that the person has given serious consideration to the available means to relieve their suffering.

The Act also introduced other changes, such as allowing persons approved to receive MAID who choose to self-administer the substance with the ability to make an arrangement in writing with their medical practitioner or nurse practitioner for the practitioner to administer MAID in the event of complications with self-administration.

In addition, the Act enhanced the federal MAID monitoring regime by expanding data collection and reporting to provide a more comprehensive picture of how MAID is being implemented in Canada. Changes to data collection included allowing the collection of data on all assessments following a person’s request for MAID (verbal and written) and requiring the Minister of Health to collect data on race, Indigenous identity and disability.

The federal MAID monitoring system, which was established in 2018 through the Regulations for the Monitoring of Medical Assistance in Dying, provides a robust framework for the collection, analysis and reporting of information. The existing Regulations enable Health Canada to identify and monitor trends in the delivery of MAID in Canada and assist in supporting transparency and fostering public trust in the MAID legislation and its application. The amended Regulations will enhance the federal government’s ability to provide Canadians with a more comprehensive and inclusive picture regarding the characteristics of persons requesting MAID and why they are making these requests.

MAID monitoring is fundamentally distinct from processes that assess the individual compliance of medical practitioners or nurse practitioners with the Criminal Code exemptions. Investigating instances of non-compliance with the procedural safeguards set out in the Criminal Code falls outside the scope of the federal monitoring regime, as these responsibilities are under the jurisdiction of the provinces and territories.

Until the amended Regulations are enacted, practitioners and pharmacists are required to report in accordance with the existing Regulations. Information related to the new provisions of the legislation will not be fully captured, nor will additional information be collected on race, disability and Indigenous identity until the coming into force of these regulatory amendments. When the amended Regulations are enacted on January 1, 2023, enhanced data collection requirements will begin for the 2023 calendar year and these will be reflected in the federal annual report on MAID in Canada for 2023 to be released in the summer of 2024.

Objective

The annexed Regulations Amending Regulations for the Monitoring of Medical Assistance in Dying (SOR/2018-166) will align with recent legislative changes to the MAID framework in Canada, and enhance data collection and reporting through the federal MAID monitoring regime to provide a more comprehensive picture of how MAID, with expanded eligibility, is being implemented in Canada.

More specifically, the amended Regulations will

In addition, the amended Regulations will continue to

Description

The existing 2018 Regulations require medical practitioners, nurse practitioners, and pharmacists to file reports containing certain information related to written requests for, and the provision, of MAID with designated recipients of the reports set out in the existing Regulations (i.e. provincial or territorial ministries and/or organizations, or Health Canada), within prescribed deadlines. Reporting is a comprehensive process that consists of completing forms (paper format or online) containing multiple questions and subsets of questions related to the person requesting MAID, the MAID assessment and the provision processes conducted by an authorized provider. The amount of detail required for reporting is dependent on the outcome or scenario for which the medical professional is reporting. For example, more detail is required when reporting on a request for MAID that results in the provision of MAID than for outcomes where MAID is not provided (e.g. a person is found to be ineligible for MAID, dies of natural causes or withdraws their request).

The amended Regulations will allow for the collection of data on all assessments following an individual’s request for MAID. This includes any requests that have not been put in writing and any preliminary assessments that may be undertaken by other health professionals (preliminary assessors) in a health care team or through a care coordination service. This will help provide a clearer understanding of who is requesting MAID. The amended Regulations will also require pharmacy technicians to report, in lieu of a pharmacist, when they are responsible for verifying and signing off on a substance for MAID, once it is prepared.

Medical practitioners and nurse practitioners

Medical practitioners and nurse practitioners (practitioners) are required to file reports concerning requests for MAID. Reporting requirements vary based on the outcome of the request. These scenarios include the following: the practitioner determines the person is ineligible; the person withdraws their request for MAID; the person has died from a cause other than MAID; the person has been found eligible, but MAID is not provided because a safeguard has not been met; MAID is provided.footnote 2 Table 1, at the end of this document, provides an overview of the information required in each scenario, as well as the new reporting timelines.

In cases where MAID is administered by a practitioner, reporting is always required within 30 days after the day on which the person dies. Other time limitations apply when a request for MAID results in another outcome. If more than 90 days have elapsed between the time the practitioner receives the request and when they become aware of an outcome other than the provision of MAID (e.g. withdrawal, death by other cause), no reporting is required. The amended Regulations clarify that the 90-day time limit for reporting will apply in cases where a request is received from a person whose natural death is reasonably foreseeable, taking into account all of their medical circumstances. Under the amended Regulations, a longer reporting limit of two years will apply in cases where a request is received from a person whose natural death is not reasonably foreseeable. This is to account for the minimum 90-day assessment period safeguard and generally longer time that it takes practitioners to assess requests from individuals whose natural death is not reasonably foreseeable.

A practitioner whose involvement is limited to providing the written second opinion confirming whether a person meets all the eligibility criteria or who is consulted to provide expertise on the condition that is causing the person’s suffering (for persons whose natural death is not reasonably foreseeable) will not be required to file the aforementioned reports.

Preliminary assessors

Recent amendments to the Criminal Code require preliminary assessorsfootnote 3 also to file reports, in accordance with the Regulations. The amended Regulations will stipulate that preliminary assessors will only be required to report a finding of ineligibility. More specifically, preliminary assessors who determine that the person does not meet one or more of the eligibility criteria will be required to provide the applicable information referred to in schedules 1 and 3 of the amended Regulations, within 30 days after the day on which they make that determination. This will produce more complete information on the number of MAID requests in Canada, asunder the 2018 Regulations, MAID requests received by non-practitioners (e.g. through a Provincial or Territorial care coordination service) that were never reviewed by a practitioner, were not reported.

Pharmacists and pharmacy technicians

Under the existing 2018 Regulations, pharmacists who dispense a substance in connection with the provision of MAID are required to report basic information regarding the person, the pharmacist, the prescribing practitioner, and the date on which and the setting in which the substance was dispensed. Pharmacists are required to provide the information referred to in Schedule 7 of the existing Regulations within 30 days after the day on which they dispense the substance. Although multiple substances may be dispensed in the context of MAID, only one report per case is required. The dispensing pharmacist is the only pharmacist who is required to file a report.

Recent amendments to the Criminal Code have extended reporting requirements to pharmacy technicians, recognizing that they are permitted to dispense MAID-related drugs in some provinces or territories. To align with these legislative amendments, the amended Regulations include a requirement for pharmacy technicians to report the aforementioned information, in lieu of the pharmacist, if they are responsible for dispensing a substance to aid a practitioner with the provision of MAID.

New or modified reporting requirements

In order to align with recent changes to the Criminal Code and to allow Health Canada to collect additional information that will allow for more comprehensive reporting on MAID to Canadians, the amended Regulations also include a number of new or modified reporting requirements for medical practitioners and nurse practitioners, including

Some of the new reporting requirements listed above, specifically those related to data elements to be captured through Schedule 1 and Schedule 3 of the amended Regulations, will also apply to preliminary assessors.

Repealed or discontinued reporting requirements

Health Canada has repealed one reporting requirement in the amended Regulations that is no longer necessary due to legislative changes. In order to reduce the reporting burden on practitioners, Health Canada has also repealed three other reporting requirements where the data that was collected was found to be either inconsistent or not necessary for the purposes of MAID monitoring.

More specifically, as part of the amended Regulations, practitioners will no longer be required to report on

Other significant changes

The amended Regulations also include a number of other significant changes to align with the recently adopted legislation, such as

Publication of information

The existing 2018 Regulations require a comprehensive report to be published at least once a year on the Government of Canada website, which presents aggregate data on information obtained through the existing Regulations. Currently, the annual report on MAID includes data elements such as the number of written requests received by practitioners; the results of those requests; the characteristics of persons requesting and receiving MAID; the criteria that were not met in cases of ineligibility; and time periods relating to the handling of requests. The annual report excludes personal information or information that could be used to identify an individual.

Under the amended Regulations, future annual reportsfootnote 5 will include data elements pertaining to all assessments following a person’s request for MAID (written and verbal). In addition to data elements currently reported, future annual reports will also contain findings related to race, Indigenous identity, disability, sex at birth and gender identity of persons seeking MAID. Additionally, future annual reports will include general data collection enhancements to allow Health Canada to track issues pertaining to the protection of vulnerable persons and persons living with disabilities.

Using data obtained through the MAID monitoring system, Health Canada will be able to report, in aggregate form, on characteristics of persons requesting and receiving MAID, reasons for MAID requests, important factors associated with the assessment process and application of the safeguards, as well as reasons why a request did not result in the provision of MAID. This information will contribute to a more fulsome and inclusive picture of who is seeking MAID and how MAID is being implemented in Canada.

Health Canada has an established partnership with Statistics Canada to maintain a secure web-based platform for the collection and processing of MAID data for the federal MAID monitoring system. By virtue of this partnership, and under the authority of the Statistics Act, Statistics Canada can access and use the data for research and statistical analysis purposes. Both Health Canada and Statistics Canada are subject to the Privacy Act with respect to the collection, storage, use, disclosure, and disposal of personal information.

Regulatory development

Pre-regulatory consultation

To inform the regulatory amendment process, Health Canada undertook pre-regulatory consultations in summer 2021 to obtain initial feedback from a variety of stakeholders, including provinces and territories; medical and nursing associations and colleges; organizations representing persons with disabilities; pharmacy associations; national Indigenous organizations; and MAID advocacy organizations. These organizations (156 in total) were selected based on their authority, area of expertise, and the impact that the proposed regulatory amendments were expected to have on their work and lives.

Health Canada received 31 submissions from stakeholders, many of which were developed through internal consultations within their respective organizations and among their members. Stakeholder input was analyzed by Health Canada and, where appropriate, incorporated into the proposed Regulatory amendments that were published in the Canada Gazette, Part I.

Canada Gazette, Part I

The proposed amended Regulations were published in the Canada Gazette, Part I, from May 21st to June 21, 2022, for a 30-day public comment period.

Health Canada received 26 submissions from various stakeholders, including Provincial/Territorial Health Ministries and Coroner’s offices; a National Indigenous Organization; organizations representing persons with disabilities; MAID advocacy groups; and pharmacy associations/medical regulatory bodies/authorities and medical/nursing associations/colleges, pharmacy regulators/associations. Of these 26 respondents, 13 had not previously provided feedback during the pre-regulatory consultations and no submissions were received from members of the general public.

Generally, most respondents understood the objectives and importance of the proposed expanded data collection and expressed their support for the amended Regulations, yet expressed concerns that the amendments would create a significant administrative burden for MAID assessors and providers.

Some respondents mentioned that they were pleased that previous comments submitted during pre-regulatory consultation were taken into consideration in the proposed regulatory amendments, and as such had no further input to provide.

Stakeholder input was analyzed and significant consideration was given to striking an appropriate balance between obtaining data required for aligning the amended Regulations with the legislative changes and expanding reporting to ensure transparency and public trust in how MAID is accessed and delivered in Canada, while addressing stakeholder concerns about practitioner burden and respecting the privacy of individuals. Where appropriate, Health Canada incorporated stakeholder input into the amended Regulations.

Demographic data elements

The majority of respondents who provided feedback regarding the collection of data related to race, Indigenous identity and gender were in agreement that this information would be helpful in determining whether the presence of individual or systemic inequality exists within the context of MAID. However, some respondents expressed concern with requiring practitioners to collect this information.

Some respondents stated that demographic data collection for the purpose of federal monitoring is not necessarily relevant to the patients themselves or to their health. Respondents also had concerns that asking these questions may have a negative impact on clinician-patient relationships.

Respondents felt that this sensitive and personal information needs to be provided by the persons themselves. Many recommended that the collection of demographic data occur earlier on in the process or during another interaction with the health care system (e.g. as part of a general clinical care process or on a separate standardized form).

Health Canada response: The recent amendments to the Criminal Code include a requirement to expand data collection, through the Regulations for the monitoring of MAID, to capture information on race, Indigenous identity and disability. As a result, data pertaining to these elements must be collected and reported, if the person seeking MAID consents to providing it. Health Canada will provide guidance on how to ask these questions in a culturally appropriate way.

The questions pertaining to these data elements will be formulated as self-identification questions and as such will be answered by the person. Individual jurisdictions may determine how they intend on collecting this information and it is expected that varying approaches will likely be used by jurisdictions (e.g. through an electronic survey or through a provincial or territorial care coordination service).

Disability, disability support services and palliative care

Many respondents, including organizations representing persons with disabilities, suggested adding a definition of disability, disability support services and palliative care to ensure uniformity in data collected by the clinicians. It was also indicated by some respondents that the data collected through the MAID monitoring system on disability support services and palliative care is limited and does not cover the aspects of access, quantity and quality of care specific to a person’s needs. It was recommended that this information be obtained directly from the persons seeking MAID themselves, in their own words.

Respondents also recommended expanding data collection to include information on the person’s living arrangements and financial situation and stated that it would be useful to know if the person seeking MAID has sufficient financial resources to meet their needs, including disability-related income supports.

Health Canada response: Health Canada already provides a definition of disability support services and palliative care, in the context of MAID, in federal practitioner reporting forms and in its regulatory guidance document. To support MAID assessors and providers in fulfilling their responsibilities under the Regulations, Health Canada plans to include direction on a number of elements through its updated “Guidance Document on Reporting Requirements” and will work with Provinces and Territories to ensure that practitioners and preliminary assessors are aware of this regulatory guidance document and can easily access it.

With respect to data on access, quality and quantity of disability support services and palliative care, and whether these services meet a person’s needs, the collection of this information requires a much more qualitative approach, which is difficult to obtain through the MAID monitoring system. Obtaining and analyzing more qualitative and quantitative information regarding the views and experiences of persons living with a disability in the context of MAID would be more appropriately accomplished through third-party research. Therefore, Health Canada will examine providing support for policy-oriented research in order to facilitate the collection of qualitative and quantitative information on these topics, which will complement the information collected through the federal MAID monitoring system. This will enhance the federal government’s ability to provide Canadians with a more comprehensive and inclusive picture regarding the characteristics of persons requesting MAID and why they are making these requests. This approach will help address concerns raised by organizations representing persons with disabilities and will inform future policy development.

In addition to the data elements on disability (referenced in the proposed amended Regulations posted in the Canada Gazette, Part I, in May 2022), Health Canada will include a provision to capture data on the length of time the person has been living with their disability in the amended Regulations. Following the analysis of feedback received from organizations representing persons with disabilities, Health Canada will also include an additional provision to capture information on a person’s usual place of residence and current living arrangements in the amended Regulations, as it is an important aspect to be considered in relation to social isolation.

Finally, Health Canada recognizes that information on a person’s financial resources is an important factor that is often associated with systemic inequality in the delivery of MAID. Hence, to further supplement the information collected through the federal monitoring system, Health Canada is currently exploring linking MAID monitoring data with other databases (e.g. Canada Revenue Agency income tax data) in order to support aggregate reporting on issues such as the link between socio-economic factors and MAID.

Preliminary assessors / preliminary assessment

The use of the terms “preliminary assessors” and “preliminary assessment” has been a reoccurring theme among many respondents. Respondents have raised concerns that these new terms, not previously used in the former legislation, are not clearly defined and confusing, and will potentially be problematic for those reporting given the current use of the term assessor in clinical practice. All respondents that have raised this issue as a concern have strongly recommended that Health Canada find another term to use, which would be more in line with the responsibilities of non-clinicians (e.g. coordinator, reviewer, screener, intake or triage person).

Some respondents also had concerns with someone other than a practitioner or nurse practitioner assessing a person for eligibility. Many respondents requested guidance with respect to the responsibilities of a preliminary assessor and who could assume such a role since colleges/associations of nurses in some jurisdictions have provided specific directives that nurses should not be making determinations/assessments or evaluating eligibility for MAID, including conducting a preliminary assessment.

Health Canada’s response: Using an alternate term for “preliminary assessment” would result in inconsistencies in the language used in the legislation/Criminal Code and the language in the amended Regulations. As a result, Health Canada must continue to use “preliminary assessment” in the amended Regulations and will offer general regulatory guidance on the term and on reporting obligations for persons who have the responsibility to carry out preliminary assessments of whether a person meets the eligibility criteria for MAID.

With respect to defining “preliminary assessor” and establishing who has the responsibility to carry out preliminary assessments, Health Canada recommends that individual jurisdictions (i.e. provinces and territories), in collaboration with colleges/associations of nurses, develop policies or guidance governing the qualifications and/or role of the preliminary assessor in the MAID assessment process.

Reporting burden arising from expanded data collection

Many respondents expressed continued concerns with the administrative burden associated with the collection and reporting of additional information, over and above that which is needed from a clinical perspective. Some respondents were of the opinion that the new administrative burden may dissuade some assessors/providers from continuing to assess for or provide MAID, negatively impacting MAID access across Canada.

Concerns were also raised regarding the reporting timeline that ceases if no reportable outcome occurs within two years of receiving a written/verbal request in the case of a person whose natural death is not reasonably foreseeable (Track 2). Clinicians felt that this obligation to follow Track 2 patients for a period of two years would add undue burden and may be difficult, especially in cases where the MAID assessor is not the person’s primary care physician.

Health Canada response: Health Canada acknowledges the concerns raised by the medical community with respect to the additional reporting obligations. Many of these reporting obligations are directly related to the new Criminal Code provisions and associated procedural requirements. Health Canada has tried balancing the interests of practitioners who are legally obligated to provide this data and the need for transparency and public trust in how MAID is accessed and delivered. Consideration has been given to striking the right balance between collecting data in a manner that is respectful of individuals and their privacy, while meeting the stated objective of determining the presence of any systemic inequalities in the assessment and delivery of MAID.

The quantity of reporting is generally proportionate to the seriousness of the outcome, and, as such, there are fewer reporting requirements for outcomes not resulting in MAID provision. To facilitate ease of reporting, questions and responses will continue to be formulated with drop-down menus.

The cessation of reporting requirements for Track 2 patients has been extended to two years, in contrast to 90 days for Track 1 patients, after the day on which the practitioner received the request. This extended reporting period for Track 2 cases takes into account the complexity of assessments for this stream and the length of time required for practitioners to ensure that all additional safeguards introduced for Track 2 cases have been met, such as discussing the means available to relieve the person’s suffering and offering consultations with relevant professionals providing these services. Health Canada does not expect practitioners to actively follow up with Track 2 cases where a person is found eligible, but does not pursue a date for MAID provision. It is recommended that the patient file remain open and the practitioner is only required to submit information should they become aware of a reportable outcome within the two-year reporting period.

Role of the pharmacy technician

One respondent felt that the proposed amended Regulations did not accurately reflect the role of pharmacy technicians in dispensing MAID substances. They stated that in pharmacy practice, there are two types of verifications required prior to dispensing medications: (1) a verification of the technical aspects by a pharmacy technician or pharmacist and (2) the verification of clinical/therapeutic appropriateness by a pharmacist. They further stated that a prescription cannot be dispensed without a pharmacist having completed the verification of appropriateness. Therefore, the wording in the regulations is not reflective of current pharmacy practice, as a pharmacy technician is never solely responsible for dispensing or “signing off” on a substance, as this verification must always be done in collaboration with a pharmacist.

Health Canada response: The Regulations must align with the Criminal Code, and the wording in the Code makes reference to a pharmacy technician dispensing a substance to aid a medical practitioner or nurse practitioner in providing a person with MAID. As such, Health Canada will work with regulatory bodies to provide clear guidance to pharmacists and pharmacy technicians on this issue.

Request for clarification/guidance

Many respondents stated that guidance would be required on a number of elements to ensure a consistent understanding and application across all jurisdictions. Some of the topics identified as elements requiring the development of further guidance include clarification on what constitutes an intentional request for MAID versus a request for information and what triggers a reporting obligation under the regulations; how questions meant to capture new demographic data should be posed in the context of a MAID assessment; how to address potential circumstances where respondents may be hesitant to provide this information out of fear that their responses may negatively impact their eligibility, and what constitutes practitioner “expertise” in the condition causing the person’s suffering.

Health Canada response: Health Canada will update its regulatory Guidance Document to address these and other concerns.

Modern treaty obligations and Indigenous engagement and consultation

Recent legislative changes include the requirement to expand data collection for the purpose of monitoring MAID to capture information respecting the race or Indigenous identity of a person who requests or receives MAID, if the person consents to providing this information. Therefore, Health Canada completed an Assessment of Modern Treaty Implications pursuant to the Cabinet Directive on the Federal Approach to Modern Treaty Implementation. The objective of this assessment was to determine whether the collection of data related to Indigenous identity could impact data sovereignty rights of modern treaty partners and to ensure that the amended Regulations are developed and implemented in a way that respects and complies with modern treaty provisions and the rights of modern treaty partners.

As part of the Assessment of Modern Treaty process for this regulatory initiative, Health Canada, in collaboration with Crown-Indigenous Relations and Northern Affairs Canada, conducted a thorough assessment of whether amended data collection pertaining to Indigenous identity through the federal MAID monitoring regime could impact data sovereignty rights of modern treaty partners. This analysis was accomplished by conducting a review of modern treaties and self-government agreements pertaining to the inclusion of provisions regarding health services or jurisdiction over health services, and whether these provisions established any linkages with data collection and dissemination.

As a result of this exercise, departmental officials identified three modern treaties or self-government agreements containing provisions related to data collection or references to health information. Only one agreement was identified as having possible treaty implications with respect to data sovereignty rights. The scope of this particular agreement is very broad and does not specifically refer to the collection of data in the context of health. However, Health Canada has chosen to interpret this clause as being inclusive of all Indigenous data collection, transfer and exchange.

Health Canada has engaged with the Indigenous government whose treaty rights may be impacted by the amended Regulations to provide an opportunity for a dialogue on the amended Regulations and to seek their views on the collection and reporting of data related to Indigenous identity. In addition, as Health Canada commences to collect data related to Indigenous identity, the Department will consult with national Indigenous organizations and other Indigenous organizations working on data sovereignty issues to obtain advice on the analysis and reporting of this data.

Instrument choice

The Criminal Code obligates the Minister of Health to make regulations respecting the collection of information related to requests for, and the provision of, MAID. The Minister of Health is also obligated to make regulations respecting the use, analysis and interpretation of that information, including for the purposes of determining the presence of any inequality or disadvantage based on race, Indigenous identity, disability or other characteristics in MAID. Therefore, given the legislative obligations, no other instrument type was appropriate in this case.

Regulatory analysis

Benefits and costs

Benefits

Collecting, analyzing and publicly reporting on data for monitoring purposes are critical to fostering public trust and providing transparency and accountability in relation to the Criminal Code changes to the MAID regime. Data collected through the amended Regulations will provide Canadians with a clear picture of how the legislation is working across the country, and create consistent data sets among jurisdictions and regions. Information generated through the federal monitoring system will inform evidence-based policy and planning decisions at the federal as well as the provincial/territorial levels and contribute to the legislated parliamentary review of the legislation. The expansion of data collection related to race, Indigenous identity, disability and gender will also assist Health Canada in assessing the presence of any individual or systemic inequality or disadvantage in the context of MAID delivery in Canada.

Findings emerging from the data collected through the amended Regulations will be communicated to Canadians through the Annual Report on MAID in Canada published by Health Canada. Data will also be made available to qualified researchers, enabling them to conduct analyses that will enrich the body of scholarly work on MAID in Canada. MAID providers, their professional associations and medical regulatory authorities will also use the data to improve the clinical practice of MAID and sharpen their awareness of issues affecting certain populations of MAID requestors.

Costs

The amended Regulations have cost implications for implicated practitioners and preliminary assessors by requiring them to spend time becoming familiar with the new reporting requirements, and complying with them whenever they are required to report. The amended Regulations do not impose additional costs on pharmacists. In fact, because pharmacy technicians are now required to complete and submit MAID reporting forms when they dispense substances for the purposes of providing MAID, overall costs for pharmacies are expected to be reduced.

Several other steps will be taken to minimize the administrative burden on practitioners and preliminary assessors, while collecting the data required to fulfill the objectives of the amended Regulations. These include updating the existing online Health Canada MAID reporting portal and federal reporting forms, and the removal and streamlining of data elements, where possible.

Health Canada estimates that the amended Regulations would add approximately $223,000 in administrative costs during the first year for practitioners and preliminary assessors to familiarize themselves with the new reporting requirements. These costs would be spread out across the approximately 1 900 practitioners and 200 preliminary assessors who are estimated to be involved in MAID assessments and provisions during the first year that the regulatory amendments come into force. Ongoing administrative costs of approximately $314,000 per year are estimated based on the additional time that it will take practitioners and preliminary assessors to complete mandatory reporting requirements. These ongoing costs will also be spread out across all assessors and providers.

Provincial and territorial governments that are not designated recipients of MAID data under the amended Regulations will bear minimal additional costs relating to the processing of additional data collected as a result of the amended Regulations, as practitioners and pharmacists in these provinces and territories submit data directly to Health Canada. For the five provinces that are currently designated recipients of MAID data under the existing Regulations, it is estimated that a one-time cost of approximately $25,000 per jurisdiction will be borne to update their MAID reporting forms and/or systems for a total of $125,000. It is anticipated that ongoing costs related to the analysis and reporting of the additional data would be approximately $20,000 per jurisdiction for a total cost of $100,000. For the two territories that are designated recipients, it is estimated that a one-time cost of $5,000 per jurisdiction will be borne for a total of $10,000. There would also be approximately $2,000 in ongoing costs related to analysis and reporting for a total of $4,000.

The federal government will also incur a one-time cost of approximately $75,000 to update its current online MAID reporting portal and to update reporting templates and forms. It is anticipated that ongoing costs to analyze and report on the additional data that would be collected will be approximately $35,000 per year.

On balance, the benefits associated with the changes to the MAID monitoring system far outweigh the costs, given the magnitude of the social policy change introduced by the recent Criminal Code changes, and the importance of data for monitoring the implementation of these new regulatory provisions.

Small business lens

The small business lens applies because small businesses would face increased administrative costs under the amended Regulations, as most medical practitioners fall into the category of a small business. Administrative costs include any upfront costs associated with learning about the new reporting requirements and ongoing costs related to the extra time associated with the new reporting requirements.

The amended Regulations establish the requirements that medical practitioners, nurse practitioners, preliminary assessors, pharmacists and pharmacy technicians must follow. Health Canada has considered, and reduced, the potential burden that the amended Regulations may impose on small businesses by creating an online MAID reporting portal for practitioners and pharmacists in jurisdictions that report directly to Health Canada. Other regulatory changes, such as allowing pharmacy technicians to report on the dispensing of MAID substances, will also reduce the overall burden on small businesses.

As most reporting requirements contained in the amended Regulations are the result of amendments to the Criminal Code, potential reporting flexibilities for small businesses were limited. Complying with all of the new reporting requirements is essential, as open, transparent and timely reporting on MAID assessment and provision is critical to supporting transparency and public trust in how MAID is accessed and delivered in Canada.

In total, it is estimated by Health Canada that there are 2 437 small businesses who would be subject to the amended Regulations. The total present value of costs to small business owners is $992 per owner or $141 per small business annualized.

One-for-one rule

The one-for-one rule applies to the amended Regulations. They are considered an “IN” for the purpose of measuring administrative burden under the Red Tape Reduction Act. The estimated administrative burden will be offset by an equivalent reduction in administrative burden from regulations within the health portfolio.

Policies and processes related to the implementation of MAID vary across Canada and are expected to continue to evolve as data becomes available. This is expected to affect how MAID is delivered in Canada, which in turn could affect estimates of administrative burden. In addition, the extent of the administrative burden imposed by the amended Regulations will be affected by cultural and social factors, such as the extent to which MAID continues to be accepted by Canadians, including the likelihood of wider acceptance of MAID over time. Health Canada’s annual reports on MAID were used to make assumptions for the purpose of generating estimates.

The valuation of the administrative burden was undertaken using the assumption that Canada would reach a steady state growth in total deaths attributed to MAID from 2023 to 2033, reaching 4% of total deaths in 2033. This assumption is based on the current growth of MAID deaths in Canada as a proportion of overall deaths. In 2019, MAID deaths were 2% of all deaths, while in 2020 this number rose to 2.5% of all deaths, and in 2021 it rose again to 3.3% of all deaths. Death rates were also examined in other jurisdictions having similar MAID regimes to Canada (e.g. the Netherlands and Belgium) in order to arrive at the 4% estimation.

There are also a number of other reportable outcomes related to the assessment of MAID that may lead to increased administrative burden, yet do not result in a MAID death. These scenarios include a request for MAID has been declined as a result of the person being found ineligible; a request for MAID is withdrawn by the person; situations where a person was found eligible for MAID, but MAID was not provided, as the practitioner determined that one or more procedural safeguards could not be met, and an eligible person died prior to MAID being provided. The Third Annual Report on MAID (for calendar year 2021) showed that these scenarios represent approximately 19% of all reportable outcomes. It was assumed that this percentage would remain stable throughout the 10-year period that was used to estimate the administrative burden; therefore, a factor of 1.2 was used to calculate the administrative burden related to the increase in other reportable scenarios.

Labour costs were determined using Statistics Canada data related to physician, nurse practitioner and nurse earnings per hour, converted to 2012 Canadian dollars to align with the Standard Cost Model methodology and Red Tape Reduction Act. The Third Annual Report on MAID (2021) reported that 68.2% of practitioners that provided MAID were general practitioners (i.e. family medicine), with specialists such palliative care, anesthesiology, internal medicine, critical care and emergency medicine making up the rest of the providers. As such, labour rates for general practitioners were used as a baseline with an adjustment to account for the higher rates of specialist pay. Nurse practitioners delivered 8.4% of MAID procedures and, as such, average rates of pay for nurse practitioners were used. Finally, average salaries of professional occupations in nursing were used to estimate administrative burden calculations for preliminary assessors.

Analysis of the data from the Health Canada online MAID reporting portal showed that a median time of 9 minutes is required for a practitioner to electronically complete each report under the existing Regulations. Using this as a baseline, it was then estimated that the reporting requirements related to the amended Regulations would add on average another 5 minutes to the total completion time. It was also assumed that practitioners and preliminary assessors would need on average 40 minutes to familiarize themselves with the new reporting requirements.

Total reporting time for pharmacists would not increase under the amended Regulations, as only minor changes have been made to pharmacist reporting requirements. In fact, the overall cost of reporting should be reduced for pharmacies, as pharmacy technicians will now be able to submit reports when a substance is dispensed for the purpose of MAID.

Calculations were carried out using the Standard Cost Model methodology, in constant 2012 Canadian dollars, using a 7% discount rate over 10 years. The amended Regulations have been estimated to result in an annualized average increase in total administration costs of approximately $165,203. The annualized average increase in total administration costs per business is $60.08. These estimates of administrative burden represent an average over 10 years, and recognize that administrative burden will diminish as implicated practitioners and preliminary assessors become familiar with reporting requirements during the first year.

Regulatory cooperation and alignment

This regulatory proposal is not related to a work plan or commitment under a formal regulatory cooperation forum (the Canada–U.S. Regulatory Cooperation Council, the Canadian Free Trade Agreement Regulatory Reconciliation and Cooperation Table, etc.).

Strategic environmental assessment

Pursuant with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, Health Canada conducted a preliminary scan for the scoping of potential environmental effects associated with the regulatory proposal to determine whether a more detailed and rigorous strategic environmental assessment would be necessary to evaluate the impacts of identified environmental effects.

Based on the results of the preliminary scan, and in accordance with the Cabinet Directive, a strategic environmental assessment was not required as no environmental effects, either positive or negative, were identified or associated with the regulatory amendments.

Gender-based analysis plus

The Government of Canada’s health portfolio uses sex and gender-based analysis plus (SGBA+) to strengthen the integration and application of SGBA+ in all health portfolio activities to advance equity, diversity and inclusion. A SGBA+ analysis was conducted to seek to identify potential gender, diversity or race concerns with the amended Regulations, and if any were found, whether the identified SGBA+ impacts could have potential differential or adverse outcomes to Canadians.

As previously stated, the amended Regulations (once in force) would capture enhanced information in a number of areas including, but not limited to, data related to race, Indigenous identity, gender identity and expanded data on disability, collected with consent from the person. Health Canada is proposing to capture this information, via questions that are similar to those posed by Statistics Canada in the Census, which will ensure historical data comparability. This information, which will be reflected for the first time in Health Canada’s 2023 annual report on MAID (to be released in the summer of 2024) and future annual reports, will enhance the federal government’s ability to provide Canadians with a more comprehensive and inclusive picture regarding the characteristics of whom is requesting MAID and why.

Health Canada will also be supporting research to fill information gaps not available through the MAID monitoring system. Specifically, Health Canada will be supporting policy-oriented, third-party research to provide more qualitative information regarding the views and experiences of persons living with disabilities that will inform and complement the information collected through the MAID monitoring system. This research will generate evidence that responds to the concerns of organizations representing persons with disabilities, and will inform future policy development. For example, the collection of “first-person narratives” concerning the lived experiences of persons requesting MAID and their family/friends is important to help understand the reasons why persons may be seeking MAID and help to address some of the concerns that organizations representing persons with disabilities raised during Health Canada’s pre-regulatory consultations and those raised during the Canada Gazette, Part I, 30-day public comment period.

In addition to information gathered through the federal monitoring system and policy-oriented research, Health Canada is also exploring linking MAID data with other databases (e.g. Canada Revenue Agency income tax data) in order to support broader reporting on issues such as the link between socio-economic conditions and MAID. Together, these three sources of information will provide a comprehensive picture of potential factors, including socio-economic circumstances, that may be contributing to MAID requests and in turn help establish whether there exists any systemic discrimination or inequality with respect to access to or the delivery of MAID in Canada, and thus informing future policy decisions.

Health Canada is also funding the development of a national MAID curriculum for medical professionals in Canada. This training will help to ensure that MAID assessors and providers are informed about particular vulnerabilities in the context of MAID assessment and provision and assist medical professionals in addressing these issues in the context of their work.

Groups such as racialized Canadians, Indigenous peoples, members of the 2SLGBTQ2+ community as well as persons living with a disability are expected to benefit from the expanded data collection, as, moving forward, Health Canada’s annual MAID reports will contain a number of SGBA+ data elements related to characteristics that are specific to individuals within these groups and communities.

Implementation, compliance and enforcement, and service standards

Implementation

The amended Regulations will come into force in January 2023. Health Canada is working with Statistics Canada to update the online MAID reporting portal to include all of the new reporting elements in the amended Regulations. Health Canada is also working with the respective provincial and territorial organizations to provide them with the information that they need to update their MAID reporting systems and reporting forms.

The protection of personal information and privacy is a primary consideration in operationalizing all aspects of the collection, storage, access to, use and disclosure of data. Program processes are being updated, and the privacy impact assessment that was done for the 2018 Regulations is being updated to identify and mitigate privacy risks.

Where Health Canada is the designated recipient for MAID reporting, officials will continue to review reports and follow-up with practitioners, preliminary assessors, pharmacists and pharmacy technicians in the event that a report appears to be incomplete or if errors are identified. The designated recipient for MAID reporting for a province or territory — whether federal, provincial, or territorial — takes similar steps. In some cases, a designated recipient may identify a need to refer a situation to the appropriate law enforcement agency, who would determine what steps are required, as the Criminal Code contains an offence for medical practitioners, nurse practitioners, preliminary assessors, pharmacy technicians and pharmacists who knowingly fail to provide information required under the Regulations.

Health Canada is updating its online Guidance Documents on MAID reporting and will undertake outreach and engagement activities during the coming-into-force period, to support medical practitioners, nurse practitioners, preliminary assessors, pharmacists and pharmacy technicians in complying with the Regulations.

Contact

Pamela Simpson
Acting Director of Policy
Health Care Programs and Policy Directorate
Strategic Policy Branch
Health Canada
200 Eglantine Driveway, 4th Floor, Room 411A
Tunney’s Pasture
Ottawa, Ontario
K1A 0K9
Email: maid.report-rapport.amm@hc-sc.gc.ca

Table 1: Information requirements for federal monitoring of MAID FIXED
OUTCOME Basic info re: person, practitioner, preliminary assessor, request (Schedule 1) Eligibility Criteria and Related Information
(Schedule 3)		 Procedural requirements — Reasonably forseeable natural death
(Schedule 4)		 Procedural requirements — Non-reasonably forseeable natural death
(Schedule 4.1)		 Prescribing/providing a substance
(Schedule 5)		 Administering a Substance
(Schedule 6)		 Dispensing a Substance
(Schedule 7)		 Timeframe to provide information table c1 note a
Practitioners – a medical or nurse practitioner who received a person’s request for MAID must provide the following information, depending on the outcome of the request:
Person found ineligible Required Required N/A N/A N/A N/A Within 30 days after the day on which the determination is made
Provision of MAID to eligible person by administering a substance Required Required Required Schedule 4 or 4.1 as applicable N/A Required
(applicable sections)		 N/A Within 30 days after the day on which the person dies
Provision of MAID to eligible person by prescribing or providing a substance for self-administration Required Required Required Schedule 4 or 4.1 as applicable Required N/A N/A No earlier than 90 days, and no later than one year, after prescribing or providing the substance table c1 note b
Person found eligible but MAID not provided because the practitioner subsequently determined that a safeguard had not been met Required Required N/A N/A N/A N/A Within 30 days after the day on which the subsequent determination is made
Person withdrew request for MAID Required Required table c1 note c if patient had been found eligible prior to withdrawal N/A N/A N/A N/A Within 30 days of becoming aware of the person’s withdrawal of the request
Person died from a cause other than MAID Required Required table c1 note d if person had been found eligible prior to dying N/A N/A N/A N/A Within 30 days after the day on which the practitioner becomes aware that the person died
Preliminary Assessors – a preliminary assessor who carried out an assessment of whether a person who has made a request for MAID meets the eligibility criteria and determined that the person did not meet one or more of the eligibility criteria must provide the following information:
  Required Required (applicable sections) N/A N/A N/A N/A Within 30 days after the day on which the determination is made
Pharmacists and Pharmacy Technicians – a pharmacist who dispensed a substance in connection with the provision of MAID or a pharmacy technician who dispensed a substance to aid a practitioner in providing MAID must provide the following information:
  N/A N/A N/A N/A N/A Required Within 30 days after the day on which the substance is dispensed

Table c1 note(s)

Table c1 note a

The requirement to report ceases for practitioners if none of the outcomes described in this table have occurred within 90 days of receiving a written/verbal request (in the case of a person whose natural death is reasonably foreseeable) or within two years (in the case of a person whose natural death is not reasonably foreseeable), with the exception of "provision of MAID" (whether by administering a substance or by prescribing/providing a substance for self-administration), for which the requirement to report does not cease.

Return to table c1 note a referrer

Table c1 note b

In the event that the practitioner becomes aware of the person’s death from any cause, they may provide information prior to the 90 days.

Return to table c1 note b referrer

Table c1 note c

Practitioner must also provide the reasons for the withdrawal, if known, and the means that were chosen by the person to relieve their suffering, if applicable.

Return to table c1 note c referrer

Table c1 note d

Practitioner must also provide the date and cause of death (immediate and underlying), if known.

Return to table c1 note d referrer