Canada Gazette, Part I, Volume 156, Number 21: Regulations Amending the Regulations for the Monitoring of Medical Assistance in Dying

May 21, 2022

Statutory authority
Criminal Code

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

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 proposed amendments to the Regulations for the Monitoring of Medical Assistance in Dying (SOR/2018-166) would update the existing Regulations to align them 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 (proposed Regulations) will allow for the collection of data on procedural safeguards for persons whose natural death is not reasonably foreseeable, and align the Regulations with revised procedural safeguards (e.g. reducing the requirement from two witnesses to one) introduced by the legislation.

The proposed 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 proposed 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 proposed 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 proposed Regulations would result in approximately $174,000 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 $248,000 per year are estimated based on the additional time that it will take medical practitioners, nurse practitioners and preliminary assessors to complete mandatory reporting requirements. Implementation of the proposed Regulations would 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 proposed Regulations.

Issues

Health Canada is amending 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, proposes to make the annexed Regulations Amending the Regulations for the Monitoring of Medical Assistance in Dying (the proposed Regulations).

The proposed 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 proposed 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 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 proposed 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 proposed Regulations are in place, 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 proposed Regulations come into force 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

This proposal would amend the existing Regulations for the Monitoring of Medical Assistance in Dying (SOR/2018-166) to 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 proposed Regulations would

In addition, the proposed Regulations continue to

Description

The existing 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 dependant 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 proposed 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 the care team or through a care coordination service. This will help provide a clearer understanding of who is requesting MAID. The proposed 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 1 Table 1, at the end of this document, provides an overview of the information required in each scenario, as well as the proposed 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 proposed 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 proposed Regulations, a longer reporting limit of two years would 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 imminent.

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) would not be required to file the aforementioned reports.

Preliminary assessors

Recent amendments to the Criminal Code require preliminary assessorsfootnote 2 also to file reports, in accordance with existing Regulations. Under the proposed Regulations, preliminary assessors would 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 would be required to provide the applicable information referred to in schedules 1 and 3 of the proposed 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.

Pharmacists and pharmacy technicians

Under the existing 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 proposed Regulations include a requirement for pharmacy technicians to report the aforementioned information, in place 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 proposed 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 proposed Regulations, will also apply to preliminary assessors.

Repealed or discontinued reporting requirements

Health Canada is repealing one reporting requirement in the existing Regulations that is no longer necessary due to legislative changes. In order to reduce the reporting burden on practitioners, Health Canada is also proposing to repeal 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.

As part of the proposed Regulations, practitioners will no longer be required to report on

Other significant changes

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

Publication of information

The existing 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 proposed Regulations, future annual reportsfootnote 4 would include data elements pertaining to all requests for MAID (written and verbal). In addition to data elements currently reported, future annual reports would also contain findings related to race, Indigenous identity, disability, sex at birth and gender identity of persons seeking MAID. Additionally, future annual reports would include general data collection enhancements to allow Health Canada to track issues pertaining to the protection of vulnerable persons and person 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 established a partnership with Statistics Canada to create and 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

Consultation

To inform the MAID 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 are expected to have on their work and lives.

Stakeholders were asked to provide input on proposed data elements, in the form of questions, to be used for reporting on requests for MAID and whether specific questions could be posed differently for greater clarity and insight. Stakeholders were also asked to provide views on the overall implications of the proposed regulatory amendments for the federal MAID monitoring system and if they thought the monitoring system could be improved.

Health Canada received 31 submissions from stakeholders, many of which were developed through internal consultations within their respective organizations and among their members. Respondents included seven provinces and two territories; a federal government department; MAID advocacy organizations; medical and nursing associations and colleges; organizations representing persons with disabilities; pharmacy associations; and a national Indigenous organization.

Overall, most respondents understood the objectives and importance of expanding data collection, including the legislative requirements to do so, yet some expressed concerns that the proposed regulatory amendments would create a significant administrative burden for MAID assessors and providers. Many respondents provided input into how questions could be posed differently for greater clarity and provided valuable medical insight on questions pertaining to the type of serious and incurable illness; disease and disability; disability support and palliative care services; and the types of health care professionals that may be consulted during the MAID assessment process.

Stakeholder input was analyzed by Health Canada and, where appropriate, incorporated into the proposed regulatory amendments. Significant consideration was given to striking an appropriate balance between obtaining data required for aligning the proposed Regulations with the legislative changes and reporting to ensure transparency and public trust in how MAID is accessed and delivered in Canada, while addressing stakeholder concerns and respecting the privacy of individuals.

The pre-regulatory consultations were very helpful in the development of the proposed Regulations. The text below provides an overview of the most prominent and recurring themes emerging from the pre-regulatory consultations and Health Canada’s response.

Demographic data elements, including disability

Many respondents expressed concerns with reporting on the proposed demographic data elements related to gender identity, sexual orientation, race, Indigenous identity and additional information on disability identification of a person requesting MAID. More specifically, respondents stated that the collection of this information (beyond the patient’s date of birth, health insurance number, province of residence, etc.) would be overly intrusive and that persons seeking MAID may not feel comfortable divulging this information due to real or perceived stigma or concerns that it may impact their eligibility for MAID. Some respondents also stated that this information has no clinical relevance to the provision of MAID, and is not information that medical practitioners would normally collect in a clinical setting.

Some respondents indicated that seeking this information would change the tone of the assessment and could potentially affect the patient-clinician relationship, be inappropriate during a difficult period in the patient’s life, when they are suffering and should be focusing on themselves and their loved ones, as well as contributing to the reporting burden on practitioners.

A number of respondents suggested that persons seeking MAID may feel coerced or intimidated into answering questions out of fear that failure to do so may affect or influence their eligibility for MAID. One stakeholder stated that seeking demographic data should be optional, as it does not specifically pertain to the monitoring of the effectiveness of the MAID legislative framework or a provider’s determination of eligibility for MAID, and that non-clinicians would be better positioned to capture such information.

On the other hand, some respondents, including organizations representing persons with disabilities, expressed their support for expanding the collection of data related to the circumstances of a person with a disability requesting MAID. These stakeholders indicated that, in addition to the demographic data to be collected through the proposed Regulations, data collection should be expanded to include information on socio-economic status and social determinants of health, such as housing, income level, institutionalization, and education level. These stakeholders stated that this data would help to address concerns that vulnerable people may seek, or may be induced to seek MAID because of a lack of adequate supports or due to the presence of systemic inequalities.

Many respondents stated that when seeking information on whether a person requesting MAID has a disability or the details regarding the disability, the perspective of vulnerable persons or persons living with a disability through “first-person narratives” is relevant and necessary, and should be sought in order to inform the “big picture” about MAID requests. Respondents also indicated that questions posed by practitioners to obtain information on a person’s disability should be in the form of self-identification questions to ensure that persons living with a disability have the opportunity to self-identify, as opposed to practitioners identifying the person as having a disability.

Health Canada response: The recent amendments to the Criminal Code include a requirement to expand data collection, through the proposed Regulations, to capture information on race, Indigenous identity and disability for the purposes of seeking to determining the presence of any inequality, including systemic inequality, or disadvantage in the delivery of MAID. Therefore, data pertaining to these elements must be collected and reported, if the person seeking MAID consents to providing it. The proposed questions pertaining to the collection of this information will be formulated to align with Statistics Canada Census questions in these areas in order to allow for comparability with Census data.

With respect to data collection on sex and gender, based on stakeholder feedback, Health Canada is proposing to amend the data elements regarding the “sex” of a person requesting MAID to “sex at birth” and “gender” to allow for greater clarity in identifying individuals whose gender identity may differ from their sex at birth. This approach is consistent with the new approach introduced by Statistics Canada in the 2021 Census and will allow for comparability with Census data.

Following the analysis of feedback received from organizations representing persons with disabilities, Health Canada is proposing to include additional disability self-identification questions. This approach will ensure that persons living with a disability have the opportunity to self-identify and provide information on the impact of their disability (or associated challenges) on their daily activities and quality of life (e.g. severity of the disability). Additional data elements will capture information on the cause and duration of a person’s disability and the types of disability support services received.

In the context of MAID, the collection of information pertaining to a person’s views and experiences of living with a disability is important. However, this type of information is qualitative in nature, and would be difficult to obtain through the MAID monitoring regime for two main reasons: (1) federal MAID data originates from practitioner or pharmacist reporting and not the person requesting MAID; and (2) data is collected using drop-down menus with limited space for supplemental information. Gathering and analyzing this deeper insight into disability in the context of MAID would be more appropriately accomplished through third-party research. Therefore, Health Canada will be supporting policy-oriented research in order to facilitate the collection of qualitative information (i.e. first-person narratives) regarding the views and experiences of persons living with disability that will inform and complement the information collected through the federal monitoring system. This research will generate evidence that responds to the concerns of organizations representing persons with disabilities and will also inform future policy development.

To further supplement 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.

Oversight and accountability

Some respondents stated that the Government of Canada should play more of an oversight role to ensure compliance with the Criminal Code and to ensure that vulnerable persons or persons living with a disability are not being induced to seek MAID.

Health Canada response: MAID monitoring is fundamentally distinct from the processes that assess individual medical practitioner or nurse practitioner compliance with the Criminal Code exemptions for counselling or aiding suicide. Oversight of compliance and investigating instances of possible non-compliance with the eligibility criteria and safeguards set out in the Criminal Code falls outside of the scope of the federal government and the federal MAID monitoring regime, as these responsibilities are under the jurisdiction of public authorities in the provinces and territories.

With respect to oversight, some jurisdictions, such as Manitoba, Saskatchewan, Alberta, and British Columbia have implemented review committees to ensure MAID is being provided in accordance with federal and provincial requirements. In Ontario, all MAID deaths are reported to the Chief Coroner’s Office who is also responsible for oversight. The regulatory bodies for medicine, nursing and pharmacy in each province and territory are also responsible for promoting the lawful practice of MAID and ensuring that health professionals act in accordance with principles of professional conduct and established standards of care.

Privacy concerns

Some respondents raised concerns with privacy issues. One respondent mentioned that the sensitivity of some of the proposed data elements, such as gender identity, Indigenous identity and race, may raise privacy concerns. Another respondent stated that the privacy of persons seeking MAID may be compromised, as collecting information about a person’s gender identity, race, Indigenous identity and disability could make them more easily identifiable.

Health Canada response: Health Canada and Statistics Canada are both subject to the Privacy Act and Government of Canada policies, which seek to protect personal information.

In this context, Health Canada follows a rigorous process when handling and analyzing data and preparing the Annual Report on MAID to ensure accuracy and privacy in the aggregate data that is published. This methodology protects confidentiality by suppressing data in instances where data within an aggregate is limited and could risk identifying a specific case or individual.

As part of the regulatory process, Health Canada is reviewing its Privacy Impact Assessment (PIA) to identify any potential privacy impacts associated with the proposed regulatory amendments, and to determine appropriate mitigation measures to protect the privacy of individuals, should any privacy impacts be identified.

With respect to the storage of information, Health Canada collaborates with Statistics Canada to leverage its expertise and existing infrastructure, systems and technology for the secure storage and transmission of MAID-related data, and data processing activities. Data reported online by practitioners and pharmacists through Statistics Canada’s Collection Management Portal is automatically submitted into an e-vault, via a highly secure information exchange system. Specific authorization-based access and security controls in the following areas are in place with respect to the safeguarding of MAID information: physical access; IT storage and transmission; physical storage; information copying; and retention and records management. Through the use of these secure systems, rigorous access controls, and other security controls on the data and systems housing that data, Statistics Canada ensures that MAID-related data is kept secure in an identical manner to the data collected through all Statistics Canada surveys. In addition, Health Canada follows rigorous data-handling procedures when accessing and using this information for data analysis.

Reporting burden arising from expanded data collection

There were concerns raised among some respondents in the medical community regarding the additional reporting burden on practitioners as a result of expanded data collection requirements. Respondents felt that the current MAID reporting obligations already place a significant burden on practitioners and believe that the addition of new reporting requirements, coupled with insufficient practitioner remuneration for MAID assessment and provision, could negatively impact access to MAID for Canadians. Many respondents indicated that in provinces and territories where practitioners do not have the support of care coordination services, the impacts of additional reporting could be significant.

Respondents also cautioned that the expanded reporting requirements would likely be particularly problematic for persons requesting MAID, many of whom may have difficulty responding to practitioners’ questions due to language barriers, cognitive issues or physical limitations.

Health Canada response: Health Canada acknowledges the concerns raised by the medical community with respect to the additional reporting obligations. Many of these obligations are directly related to the new Criminal Code provisions and the associated procedural requirements. In its proposed amendments to the Regulations, the Department has sought to balance 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.

Based on feedback received from the medical community, Health Canada is proposing to remove the collection of some data elements previously captured under the existing Regulations which did not provide meaningful information, and streamline certain data requirements to reduce practitioner burden. 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.

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 proposed 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 proposed 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 is currently engaging with the Indigenous government whose treaty rights may be impacted by the proposed Regulations to provide an opportunity for a dialogue on the proposed Regulations and to seek their views on the collection and reporting of data related to Indigenous identity. In addition, as Health Canada starts 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 would be appropriate in this case.

Regulatory analysis

Benefits and costs

Benefits

Collecting, analyzing and publicly reporting on data for monitoring purposes is 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 proposed 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.

Findings emerging from the data collected through the proposed Regulations will be communicated to Canadians through the Annual Report on MAID in 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 classes of MAID requestors.

Costs

The proposed Regulations would 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 proposed 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 fulfil the objectives of the proposed 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 proposed Regulations would add approximately $174,000 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 $248,000 per year are estimated based on the additional time that it will take practitioners and preliminary assessors to complete mandatory reporting requirements.

Provincial and territorial governments that are not designated recipients of MAID data under the proposed Regulations will bear minimal additional costs relating to the processing of additional data collected as a result of the proposed 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 provisions.

Small business lens

The small business lens applies because small businesses would face increased administrative costs under the proposed 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 proposed 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 proposed 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 for 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 proposed Regulations are the result of amendments to the Criminal Code, potential reporting flexibilities for small businesses were limited. Complying with all of the proposed 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 proposed Regulations. The total present value of costs to small business owners is $708 per owner or $101 per small business annualized.

One-for-one rule

The one-for-one rule applies to the proposed 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 proposed 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 this is estimated to rise again to 3.2% of all deaths in 2021. 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, but that do not result in a MAID death. These include requests for MAID that have been declined due to a person being found ineligible; requests for MAID that are withdrawn by the person; situations where a person was found eligible for MAID, but the practitioner found that one or more of the procedural safeguards could not be met; and requests for MAID where the person died prior to MAID being provided. The Second Annual Report on MAID (2020) showed that these scenarios represent approximately 21.2% 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 Second Annual Report on MAID (2020) reported that 68% 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 7.2% 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 proposed Regulations would add on average another 4 minutes to the total completion time. It was also assumed that practitioners and preliminary assessors would need on average 30 minutes to familiarize themselves with the new reporting requirements.

Total reporting time for pharmacists would not increase under the proposed 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 proposed Regulations have been estimated to result in an annualized average increase in total administration costs of approximately $118,177. The annualized average increase in total administration costs per business is $43.05. 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 implications or anticipated environmental effects or risks were identified or associated with the regulatory proposal.

Gender-based analysis plus

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

As previously stated, the proposed 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 preregulatory consultations.

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 Health Canada’s annual MAID reports will contain a number of data elements related to characteristics that are specific to individuals within these groups and communities. As such, Health Canada does not anticipate gender, diversity or race concerns or potential differential or adverse outcomes to Canadians, as no GBA+ impacts have been identified for this proposal.

Implementation, compliance and enforcement, and service standards

Implementation

The proposed Regulations would come into force starting in January 2023. Health Canada will work with Statistics Canada to update the online MAID reporting portal to include all of the new reporting elements in the proposed Regulations. Health Canada will also work 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 will be updated, and the privacy impact assessment that was done for the current Regulations will be 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 anticipates updating its online and written guidance documents on MAID reporting and undertaking 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

Lindy VanAmburg
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
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 b1 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 b1 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 N/A Within 30 days after the day on which the subsequent determination is made
Person withdrew request for MAID Required Required table b1 note c
if patient had been found eligible prior to withdrawal		 N/A 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 b1 note d
if person had been found eligible prior to dying		 N/A 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 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 N/A Required Within 30 days after the day on which the substance is dispensed

Table b1 note(s)

Table b1 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 b1 note a referrer

Table b1 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 b1 note b referrer

Table b1 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 b1 note c referrer

Table b1 note d

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

Return to table b1 note d referrer

PROPOSED REGULATORY TEXT

Notice is given that the Minister of Health, pursuant to subsection 241.31(3)footnote a of the Criminal Code footnote b, proposes to make the annexed Regulations Amending the Regulations for the Monitoring of Medical Assistance in Dying.

Interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Lindy VanAmburg, Director of Policy, Health Care Programs and Policy Directorate, Strategic Policy Branch, Department of Health, 200 Eglantine Driveway, 4th floor, Room 411A, Tunney’s Pasture, Ottawa, Ontario K1A 0K9 (email: maid.report-rapport.amm@hc-sc.gc.ca).

Ottawa, May 3, 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 5 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, 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, 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 and 3, the information referred to in Schedule 4 or 4.1, as the case may be, and the applicable information referred to in Schedule 6 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 and 3, the information referred to in Schedule 4 or 4.1, as the case may be, and the applicable information referred to in Schedule 6 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 (1) Subsection 12(1) of the Regulations is replaced by the following:

Information 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.

(2) Paragraphs 12(2)(a) and (b) of the Regulations are replaced by the following:

10 (1) The portion of subsection 13(2) of the Regulations before paragraph (a) 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) Paragraphs 13(2)(b) to (d) of the Regulations are replaced by the following:

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

(4) 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 In the case where the preliminary assessor or the practitioner assessed

4 An indication by the practitioner of the following in respect of the assessment:

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: