Regulations for the Monitoring of Medical Assistance in Dying 2018 – Canada

Regulations for the Monitoring of Medical Assistance in Dying: SOR/2018-166
Canada Gazette, Part II, Volume 152, Number 16

Registration

July 27, 2018

CRIMINAL CODE

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

Therefore, the Minister of Health, pursuant to subsection 241.31(3) footnotea of the Criminal Code footnoteb, makes the annexed Regulations for the Monitoring of Medical Assistance in Dying.

Ottawa, July 25, 2018

Ginette Petitpas Taylor
Minister of Health

Regulations for the Monitoring of Medical Assistance in Dying

Interpretation

Definitions

1 The following definitions apply in these Regulations.

care coordination service means a service that facilitates access to medical assistance in dying. (service de coordination de soins)

Code means the Criminal Code. (Code)

eligibility criteria means the criteria set out in subsections 241.2(1) and (2) of the Code. (critères d’admissibilité)

medical certificate of death includes, in the Province of Quebec, an attestation of death. (certificat médical de décès)

patient means a person who has made a written request for medical assistance in dying. (patient)

personal information has the same meaning as in section 3 of the Privacy Act. (renseignements personnels)

practitioner means a medical practitioner or nurse practitioner. (praticien)

refer does not include referring a patient to a practitioner in order to obtain that practitioner’s written opinion, for the purposes of paragraph 241.2(3)(e) of the Code, regarding whether the patient meets all of the eligibility criteria. (aiguiller)

residential care facility means a residential facility that provides health care services, including professional health monitoring and nursing care, on a continuous basis for persons who require assistance with activities of daily living. (établissement de soins pour bénéficiaires internes)

Provision of Information

Designation of Recipients of Information
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) and (2) of the Code.

Designation — other recipients

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

(a) in respect of the information to be provided under paragraph 7(2)(b) or subsection 8(2), the Chief Coroner for Ontario;
(b) in respect of the information to be provided by a practitioner who receives a written request for medical assistance in dying in British Columbia or by a pharmacist who dispenses a substance there in connection with the provision of medical assistance in dying, the Deputy Minister of Health of British Columbia;
(c) in respect of the information to be provided by a practitioner who receives a written request for medical assistance in dying in Saskatchewan or by a pharmacist who dispenses a substance there in connection with the provision of medical assistance in dying, the Chief Executive Officer of the Saskatchewan Health Authority;
(d) in respect of the information to be provided by a practitioner who receives a written request for medical assistance in dying in Alberta or by a pharmacist who dispenses a substance there in connection with the provision of medical assistance in dying, the Minister of Health of Alberta;
(e) in respect of the information to be provided by a practitioner who receives a written request for medical assistance in dying in the Northwest Territories or by a pharmacist who dispenses a substance there in connection with the provision of medical assistance in dying, the Deputy Minister of Health and Social Services of the Northwest Territories; and
(f) in respect of the information to be provided by a practitioner who receives a written request for medical assistance in dying in Nunavut or by a pharmacist who dispenses a substance there in connection with the provision of medical assistance in dying, the Minister of Health of Nunavut.

Practitioners

Exception — no information required

3 A practitioner who has received a patient’s written request for medical assistance in dying from the patient directly or from another practitioner, a care coordination service or another person on the patient’s behalf in order to obtain the practitioner’s written opinion, for the purposes of paragraph 241.2(3)(e) of the Code, regarding whether the patient meets all of the eligibility criteria, is not required, in respect of the request, to provide information under subsection 5(1) or 6(1) or section 9.

Referral or transfer of care of patient

4 (1) A practitioner who has received a patient’s written request for medical assistance in dying and refers the patient, in respect of the request, to another practitioner or to a care coordination service, or, as a result of the request, transfers the care of the patient to another practitioner, must provide the applicable recipient designated under section 2 with the information referred to in Schedules 1 and 2 within 30 days after the day on which they refer, or transfer the care of, the patient.

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.

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 patient’s written request for medical assistance in dying that they received:

(a) the information referred to in Schedule 1;
(b) in the case where the practitioner has determined that the patient met all of the eligibility criteria, the information referred to in Schedule 3;
(c) the patient’s reasons for withdrawing the request, if known; and
(d) in the case where the patient withdrew their request after having been given an opportunity to do so under paragraph 241.2(3)(h) of the Code, an indication to that effect.
Exception — no other information required

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

Ineligibility

6 (1) A practitioner who has received a patient’s written request for medical assistance in dying and determines that the patient does not meet one or more of the eligibility criteria must provide the applicable recipient designated under section 2 with the information referred to in Schedules 1 and 3 within 30 days after the day on which the practitioner makes that determination.

Clarification

(2) For greater certainty, subsection (1) applies if the practitioner determined that the patient met all of the eligibility criteria but subsequently determines that the patient 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 section 9.

Prescribing or providing a substance — general

7 (1) A practitioner who has received a patient’s written request for medical assistance in dying and provides medical assistance in dying by prescribing or providing a substance to the patient for self-administration must provide the applicable recipient designated under section 2 with the information referred to in Schedules 1 and 3 to 5 no earlier than 90 days after the day on which the practitioner prescribes or provides the substance and no later than 120 days after that day.

Prescribing or providing a substance — Ontario

(2) Despite subsection (1), a practitioner who has received a patient’s written request for medical assistance in dying and provides medical assistance in dying in Ontario by prescribing or providing a substance to the patient for self-administration must provide the information referred to in Schedules 1 and 3 to 5, no earlier than 90 days after the day on which the practitioner prescribes or provides the substance and no later than 120 days after that day,

(a) to the recipient designated under subsection 2(1), except in the case referred to in paragraph (b); or
(b) to the recipient designated under paragraph 2(2)(a), in the case where, when the practitioner provides the information, the practitioner knows that the patient has died following self-administration of the substance.
Exception — time to report

(3) The practitioner may provide the information earlier than 90 days after the day on which the practitioner prescribes or provides the substance to the patient if the practitioner knows that the patient has died.

Exception — no other information required

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

Administering a substance — general

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

Administering a substance — Ontario

(2) Despite subsection (1), a practitioner who has received a patient’s written request for medical assistance in dying and provides medical assistance in dying in Ontario by administering a substance to the patient must provide the recipient designated under paragraph 2(2)(a) with the information referred to in Schedules 1, 3, 4 and 6 within 30 days after the day on which the patient dies.

Death — other cause

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

(a) the information referred to in Schedule 1;
(b) in the case where the practitioner has determined that the patient met all of the eligibility criteria, the information referred to in Schedule 3; and
(c) the date of the patient’s death, if known, and, if the patient’s medical certificate of death was completed by the practitioner, the immediate and underlying causes of death as indicated on the certificate.
Cessation of certain requirements

10 A practitioner who has received a patient’s written 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, after the 90th day after the day on which the practitioner received the request.

Pharmacists
Dispensing of substance

11 A pharmacist who dispenses a substance in connection with the provision of 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.

Collection of Information
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 written 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.

Coroners and medical examiners

(2) Without restricting the generality of subsection (1), the Minister of Health may, for the purposes of monitoring medical assistance in dying, request that the Chief Coroner or Chief Medical Examiner of a province or territory provide the Minister, on a voluntary basis, with the following information:

(a) the number of patients who died as a result of having received medical assistance in dying in the province or territory; and
(b) personal information relating to the death of patients who died as a result of having received medical assistance in dying in the province or territory, including:
(i) copies of medical certificates of death of those patients; and
(ii) the findings of any investigations undertaken by the Chief Coroner or Chief Medical Examiner in respect of the deaths of those patients.

Publication of Information
Report

13 (1) The Minister of Health must cause to be published, at least once a year, on the website of the Government of Canada a report that is based on information that the Minister obtained under these Regulations.

Content — period covered by report

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

(a) the number of requests that were made and the results of those requests;
(b) the characteristics, including medical characteristics, of patients;
(c) the nature of the intolerable physical or psychological suffering of patients who received medical assistance in dying;
(d) the reasons for which patients did not receive medical assistance in dying, including which of the eligibility criteria were not met by patients;
(e) the places in which medical assistance in dying was provided;
(f) time periods relating to the handling of requests for, and the provision of, medical assistance in dying;
(g) information as to whether practitioners consulted with other health care professionals or social workers regarding requests;
(h) the nature of involvement of practitioners in requests and the provision of medical assistance in dying, including the respective involvement of medical practitioners and nurse practitioners; and
(i) information as to whether patients consulted with practitioners concerning their health — for a reason other than seeking medical assistance in dying — before practitioners received their requests for medical assistance in dying.

Other content

(3) The report must also contain

(a) the methodology employed to arrive at any findings set out in the report;
(b) information on trends in written requests for, and the provision of, medical assistance in dying; and
(c) the period covered by the report.

Restriction

(4) The report must not include any personal information of an individual

(a) who provided information under these Regulations; or
(b) in respect of whom information was obtained by the Minister of Health under these Regulations.

Other Disclosure
Disclosure to provinces and territories

14 The Minister of Health may disclose to a provincial or territorial government, or any of its institutions, or to a public body established under an Act of the legislature of a province or territory personal information that the Minister obtained under these Regulations if the purpose of the disclosure is to support the monitoring of medical assistance in dying in the province or territory.

Research

15 The Minister of Health may disclose, for the purposes of enabling research or statistical analysis with respect to medical assistance in dying, personal information that the Minister obtained under these Regulations — other than an individual’s name — to any individual or organization if the Minister

(a) determines that the disclosure is necessary to achieve the objectives of the research or statistical analysis; and
(b) receives a written undertaking by the individual or organization
(i) to use the information only for the purpose for which it was disclosed, and
(ii) not to disclose the information in any form that could reasonably be expected to identify the individual to whom it relates.
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) of Schedule 1 and paragraphs 2(a) and (d) of Schedule 7 — that the recipient obtained under these Regulations in the preceding quarter.

Definition

(2) For the purposes of subsection (1), quarter means any period of three consecutive months beginning on January 1, April 1, July 1 or October 1.

Coming into Force
Fourth month after registration

17 (1) These Regulations, except section 13, come into force on the first day of the fourth month following the month in which they are registered.

Section 13

(2) Section 13 comes into force on the first anniversary of the day on which section 2 of these Regulations comes into force.

SCHEDULE 1
(Subsection 4(1), paragraph 5(1)(a), subsections 6(1) and 7(1) and (2), section 8, paragraph 9(a) and subsection 16(1))

Basic Information — Request for Medical Assistance in Dying
1 The following information in respect of the patient:

(a) date of birth;
(b) sex;
(c) health insurance number and the province or territory that issued it or, in the case where they do not have a health insurance number, the province or territory of their usual place of residence on the day on which the practitioner received the request;
(d) the postal code associated with the patient’s health insurance number or, in the case where they do not have a health insurance number, the postal code of their usual place of residence on the day on which the practitioner received the request.
2 The following information in respect of the practitioner:

(a) name;
(b) an indication of whether they are a medical practitioner or nurse practitioner;
(c) if they are a family physician, an indication to that effect;
(d) if they are a medical practitioner other than a family physician, their area of specialty;
(e) the province or territory in which they practise and, if they practise in more than one province or territory, the province or territory in which they received the request;
(f) the licence or registration number assigned to them in the province or territory in which they received the request;
(g) the mailing address and email address that the practitioner uses for work;
(h) to the best of their knowledge or belief, an indication of whether, before they received the request, the patient consulted them concerning the patient’s health for a reason other than seeking medical assistance in dying.
3 The following information in respect of the request:

(a) the date on which the practitioner received the request;
(b) an indication of whether the practitioner received the request from the patient directly, another practitioner, a care coordination service or another third party.

SCHEDULE 2
(Subsection 4(1))

Referral or Transfer of Care of Patient
1 The date on which the practitioner referred, or transferred the care of, the patient.

2 An indication of whether the practitioner referred, or transferred the care of, the patient for any of the following reasons, and if so, an indication of the reason:

(a) the referral or transfer of care was the result of the application of the policies on medical assistance in dying of a hospital, a residential care facility or a palliative care facility, in the case where the patient was in a hospital or such a facility;
(b) providing medical assistance in dying to the patient or assessing the patient to determine whether they meet the eligibility criteria would have been contrary to the practitioner’s conscience or beliefs;
(c) the patient asked the practitioner to refer them or transfer their care;
(d) the practitioner was of the view that they lacked the relevant expertise to provide medical assistance in dying.
3 An indication of whether the practitioner had determined that the patient met or did not meet all of the eligibility criteria before they referred, or transferred the care of, the patient.

SCHEDULE 3
(Paragraph 5(1)(b), subsections 6(1) and 7(1) and (2), section 8, and paragraph 9(b))

Eligibility Criteria and Related Information
1 An indication of whether the practitioner consulted with other health care professionals — other than a practitioner who received the patient’s written request for medical assistance in dying as described in section 3 of these Regulations — or social workers in order to determine whether the patient 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 practitioner and whether the practitioner was of the opinion that the patient met or did not meet each of those criteria:

(a) the patient was eligible — or, but for any applicable minimum period of residence or waiting period, would have been eligible — for health services funded by a government in Canada;
(b) the patient was at least 18 years of age;
(c) the patient was capable of making decisions with respect to their health;
(d) the patient made a voluntary request for medical assistance in dying that, in particular, was not made as a result of external pressure and, if the practitioner assessed this criterion and was of the opinion that the patient met it, the reasons why the practitioner was of that opinion;
(e) the patient gave informed consent to receive medical assistance in dying after having been informed of the means that are available to relieve their suffering, including palliative care;
(f) the patient had a serious and incurable illness, disease or disability and, if the practitioner assessed this criterion and was of the opinion that the patient met it, a description of the illness, disease or disability;
(g) the patient was in an advanced state of irreversible decline in capability;
(h) the illness, disease or disability or state of decline caused the patient enduring physical or psychological suffering that was intolerable to them and that could not be relieved under conditions that they considered acceptable and, if the practitioner assessed this criterion and was of the opinion that the patient met it, the patient’s description of the suffering;
(i) the patient’s natural death had become reasonably foreseeable, taking into account all of their medical circumstances.
3 An indication of whether the patient received palliative care, if known, and

(a) if the patient received palliative care, how long the patient received it, if known; or
(b) if the patient did not receive palliative care, an indication of whether, to the best of the practitioner’s knowledge or belief, palliative care was accessible to the patient.
4 An indication of whether the patient required disability support services, if known, and if so,

(a) if the patient received disability support services, how long the patient received those services, if known; or
(b) if the patient did not receive disability support services, an indication of whether, to the best of the practitioner’s knowledge or belief, disability support services were accessible to the patient.
5 In the case where the practitioner determined that the patient met all of the eligibility criteria but subsequently determines that the patient does not meet one or more of those criteria, an indication of

(a) whether the patient lost the capacity to make decisions with respect to their health; and
(b) whether the practitioner became aware that the patient’s request was not voluntary.

SCHEDULE 4
(Subsections 7(1) and (2) and section 8)

Procedural Requirements — Providing Medical Assistance in Dying
1 An indication of

(a) whether the practitioner was of the opinion that the patient met all of the eligibility criteria;
(b) whether the practitioner ensured that the patient’s request was made in writing and was signed and dated by the patient or by another person who met the requirements set out in subsection 241.2(4) of the Code;
(c) whether the practitioner ensured that the request was signed and dated after the patient was informed by a practitioner that the patient had a grievous and irremediable medical condition;
(d) whether the practitioner was satisfied that the request was signed and dated by the patient — or by another person who met the requirements set out in subsection 241.2(4) of the Code — before two independent witnesses who met the requirements set out in subsection 241.2(5) of the Code and who then also signed and dated the request;
(e) whether the practitioner ensured that the patient was informed that they may, at any time and in any manner, withdraw their request;
(f) whether the practitioner ensured that another practitioner provided a written opinion confirming that the patient met all of the eligibility criteria and, if so, an indication of whether the other practitioner is a medical practitioner or nurse practitioner and the date on which the other practitioner signed that opinion;
(g) whether the practitioner was satisfied that they and the practitioner referred to in paragraph (f) were independent within the meaning of subsection 241.2(6) of the Code;
(h) whether the practitioner ensured that at least 10 clear days elapsed between the day on which the request was signed by or on behalf of the patient and the day on which the medical assistance in dying was provided or, in the case where the practitioner considered a shorter period appropriate in the circumstances, an indication of which of the following was the basis for that determination:
(i) the patient’s death was imminent,
(ii) the loss of the patient’s capacity to provide informed consent was imminent;
(i) whether the practitioner, immediately before providing the medical assistance in dying, gave the patient an opportunity to withdraw their request and ensured that the patient gave express consent to receive medical assistance in dying;
(j) whether in the case where the patient had difficulty communicating, the practitioner took all necessary measures to provide a reliable means by which the patient could have understood the information that was provided to them and communicated their decision; and
(k) whether the practitioner informed a pharmacist, before the pharmacist dispensed the substance that the practitioner prescribed or obtained for the patient, that the substance was intended for the purpose of providing medical assistance in dying.
2 The date on which the request was signed by the patient or by another person who met the requirements set out in subsection 241.2(4) of the Code.

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 patient.

2 The place where the patient was staying when the practitioner prescribed or provided the substance to the patient.

3 The following information:

(a) an indication of whether the patient self-administered the substance, if known;
(b) in the case where the practitioner knows that the patient self-administered the substance,
(i) an indication of whether the practitioner was present when the patient self-administered the substance,
(ii) the date on which the patient self-administered the substance, if known, and
(iii) the place where the patient self-administered the substance, if known;
(c) in the case where, to the best of the practitioner’s knowledge or belief, the patient did not self-administer the substance,
(i) an indication of whether the patient has died, if known, and
(ii) in the case where the patient has died, the date of death, if known.

SCHEDULE 6
(Section 8)

Administering a Substance
1 The date on which the practitioner administered the substance to the patient.

2 The place where the practitioner administered the substance to the patient.

SCHEDULE 7
(Section 11 and subsection 16(1))

Dispensing a Substance
1 The following information in respect of the patient for whom the substance was dispensed:

(a) date of birth;
(b) health insurance number and the province or territory that issued it or, in the case where they do not have a health insurance number or the pharmacist does not know the patient’s health insurance number, the province or territory of their usual place of residence on the day on which the pharmacist dispensed the substance.
2 The following information in respect of the pharmacist:

(a) name;
(b) the province or territory in which they practise and, if they practise in more than one province or territory, the province or territory in which they dispensed the substance;
(c) the licence or registration number assigned to the pharmacist in the province or territory in which they dispensed the substance;
(d) the mailing address and email address that the pharmacist uses for work.
3 The following information in respect of the practitioner who prescribed the substance or obtained the substance from the pharmacist:

(a) name;
(b) the licence or registration number assigned to the practitioner in the province or territory in which they received the request.
4 The following information in respect of the dispensing of the substance:

(a) the date on which the substance was dispensed;
(b) an indication of which of the following places describes where the pharmacist dispensed the substance or, if they dispensed the substance elsewhere, a description of that place:
(i) hospital pharmacy,
(ii) community pharmacy.

REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)

Issues
On June 17, 2016, An Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying) [the Act] came into force. The Act creates exemptions to certain criminal offences in order to enable physicians and nurse practitioners to provide medical assistance in dying to eligible individuals. The Act was the Government’s response to a 2015 Supreme Court of Canada decision [Carter v. Canada (Attorney General)].

The Act requires the federal Minister of Health to make regulations he or she considers necessary respecting the provision, collection, use and disposal of information for the purpose of monitoring medical assistance in dying.

A pan-Canadian monitoring system to collect and analyze data on requests for, and the provision of, medical assistance in dying in Canada is widely recognized as critical to fostering transparency and public trust.

Background
When it struck down the complete prohibition on medical assistance in dying in Carter v. Canada, the Supreme Court indicated that risks associated with physician-assisted death can be limited through a carefully designed and monitored system of safeguards. The new federal legislation includes eligibility requirements and procedural safeguards to balance the competing interests of those who might be at risk in a permissive regime, those who wish to seek medical assistance in dying, and society as a whole.

The primary purposes of monitoring are to provide transparency and foster public trust regarding the implementation of the new law. The monitoring regime would use data to build a picture of how the legislation is working — for example, core statistics regarding the number of written requests and their outcomes, the circumstances of patients requesting and receiving medical assistance in dying, the socio-demographic characteristics of those who request medical assistance in dying — and how the eligibility criteria are being applied.

The monitoring regime is aimed at gathering and analyzing data about medical assistance in dying from a societal perspective. It is fundamentally distinct from a process that seeks to assess individual medical or nurse practitioners’ compliance with the Criminal Code exemptions. Investigating instances of non-compliance with the eligibility criteria and procedural safeguards set out in the Criminal Code falls outside of the scope of the federal monitoring regime, and is under the purview of local law enforcement.

Until the Regulations for the Monitoring of Medical Assistance in Dying (the Regulations) are in force, Health Canada will issue interim reports approximately every six months. Reports have been released semi-annually since April 2017. These reports are based on aggregate data that is publicly available or provided voluntarily by provincial and territorial governments. Provincial and territorial data may include the number of medically assisted deaths, the underlying medical conditions leading to requests for medical assistance in dying, and the basic demographic data on requestors. However, data collection is not consistent across provinces and territories, and the data set that can be reported is limited.

Objectives
The Regulations set out in the federal monitoring regime would

support public accountability and transparency in relation to medical assistance in dying in order to build public trust;
support the protection of vulnerable individuals by monitoring the application of the eligibility criteria and procedural safeguards required by the legislation;
identify and monitor trends in requests for, and the provision of, medical assistance in dying;
help determine whether the 2016 amendments to the Criminal Code are meeting their objectives; and
make data available to qualified researchers for the purpose of enabling independent analysis and research.
Description
The Regulations require medical practitioners, nurse practitioners, and pharmacists to file reports containing certain information related to written requests for, and the provision of, medical assistance in dying with a recipient designated in the Regulations, within prescribed deadlines.

Practitioners
Practitioners, meaning nurse practitioners or medical practitioners, are required to file reports concerning written requests for medical assistance in dying. Reporting requirements vary based on the outcome of the request, i.e. whether the practitioner refers or transfers the patient to another practitioner; the patient withdraws the request; the practitioner determines the patient is, or has become, ineligible; the patient has died from a cause other than medical assistance in dying; or medical assistance in dying is provided. référence1 Table 1 (at the end of this Regulatory Impact Analysis Statement) provides an overview of the information required in each circumstance, as well as the reporting timelines.

In cases where medical assistance in dying is provided, reporting is always required. Time limitations apply when a request results in another outcome. If more than 90 days have passed between when the practitioner receives the written request and when they become aware of an outcome resulting from the request (e.g. referral, withdrawal, death by other cause), no reporting is required.

A practitioner whose involvement is limited to providing the written second opinion required under the Criminal Code, confirming that the patient meets all of the eligibility criteria, is not required to file the reports described above.

Pharmacists
Pharmacists who dispense a substance in connection with the provision of medical assistance in dying are required to report basic information regarding the patient, the pharmacist, and practitioner, and the date and setting in which the medication was dispensed. Schedule 7 of the Regulations includes the reporting requirements for pharmacists. The report is required within 30 days after having dispensed a substance. Though multiple substances may be dispensed in the context of medical assistance in dying, only one report per case is required. The dispensing pharmacist is the only pharmacist who is required to file a report.

Recipient of reports
To avoid requiring practitioners to report similar information to different authorities (i.e. both to provincial/territorial and federal governments), some provinces and territories have nominated a recipient to receive reports from practitioners and pharmacists within their respective jurisdictions. Ontario, British Columbia, Saskatchewan, Alberta, the Northwest Territories and Nunavut have a provincial or territorial designated recipient in the final Regulations. This means that practitioners and pharmacists in those jurisdictions would file their report with the provincial or territorial authority designated in the Regulations, rather than with the federal Minister of Health. In Ontario, the Chief Coroner is identified as the designated recipient in cases where the practitioner knows death occurred as a result of medical assistance in dying (either by clinician-administration or self-administration). All other reports must be directed to the federal Minister of Health.

Where provincial or territorial recipients are designated, those recipients are required to provide the required information to the federal Minister of Health on a quarterly basis.

In cases where a province or territory has not nominated a recipient, the federal Minister of Health is the designated recipient for all reports.

Publication of information
The Regulations require a monitoring report to be published at least once a year on the Government of Canada website presenting aggregate data on information obtained under the Regulations. This report will include data elements such as the number of written requests received by practitioners, the results of those requests, characteristics of patients requesting and receiving medical assistance in dying, criteria that were not met in cases of ineligibility, and periods relating to the handling of requests. The report will not contain any personal information, or information that could be used to identify an individual.

Health Canada has partnered with Statistics Canada to establish an online portal for the collection of data for monitoring of medical assistance in dying. Under the authority of the Statistics Act, Statistics Canada will be able to use the data for its own research and statistical analysis purposes. Health Canada and Statistics Canada are subject to the constraints of the Privacy Act with respect to the collection, storage, use, disclosure, and disposal of personal information.

Disclosure of information
The Regulations provide specific authorities for the federal Minister of Health to disclose personal information in certain circumstances. Personal information may be disclosed to provincial or territorial authorities for the purpose of supporting the monitoring of medical assistance in dying in that province or territory. Personal information may also be disclosed to those who request it for research purposes, provided that the Minister is satisfied that the particular information to be provided is required to achieve the objectives of the research or statistical analysis. The requestor must commit in writing to using the information only for the purpose for which it was disclosed, and not to disclose the information in a manner that could reasonably be expected to identify an individual. Names of individuals will not be disclosed for research purposes.

“One-for-One” Rule
The “One-for-One” Rule applies to these 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.

Measuring the administrative burden imposed by the Regulations poses unique challenges because no national monitoring system for medical assistance in dying is currently in place in Canada. While the legislative changes have been in place since June 2016, the extent and consistency of medical assistance in dying information reported has varied among provinces and territories. The Regulations address this issue by setting out national reporting requirements.

Policies and processes related to the implementation of medical assistance in dying vary across Canada and are expected to evolve as data becomes available. This is expected to affect how medical assistance in dying is delivered in Canada, which in turn could affect estimates of administrative burden. In addition, the extent of the administrative burden imposed by the Regulations will be affected by cultural and social factors, such as the extent to which medical assistance in dying is accepted by Canadians, and the health status of Canadians. Health Canada’s interim reports on medical assistance in dying 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 of 2.05% of total deaths attributed to medical assistance in dying. This assumption is based on the proportion of deaths resulting from medical assistance in dying in other jurisdictions that permit medical assistance in dying. The projected number of deaths was multiplied by a factor of 1.75 to account for the fact that some reporting requirements are triggered by receipt of a written request, rather than death as a result of medical assistance in dying.

Labour costs were determined using Statistics Canada data related to physician and pharmacist earnings per hour, converted to 2012 dollars to align with the Standard Cost Model methodology and the Red Tape Reduction Act. An average of specialist and general practitioner rates of pay was used to determine the average practitioner labour costs per hour. The nurse practitioner labour cost per hour was not included because nurse practitioners have provided medical assistance in dying in less than 5% of reported cases since the implementation of the changes to the Criminal Code in 2016.

It was assumed that approximately 10 minutes are required to electronically file each report submitted by a practitioner familiar with the reporting requirements, except in cases where a 90-day waiting period applies. In those cases, an additional 10 minutes of administration was estimated to accommodate managing a waiting period for reporting. It was assumed that practitioners would need one hour to familiarize themselves with reporting requirements upon receipt of their first written request. It was further assumed that in 46% of cases the written request would be handled by a practitioner who has already spent time becoming familiar with the reporting requirements, based on estimates of the number of cases per practitioner to date, determined through discussion with a practitioner group.

For reporting by pharmacists, it was assumed that approximately 30 minutes would be required to become familiar with the reporting requirements, and 8 minutes would be required to electronically file the report. Calculations were carried out using the Standard Cost Model methodology, in constant 2012 Canadian dollars, using a 7% discount rate over 10 years. The Regulations have been estimated to result in an annualized average increase in total administration costs of approximately $66,511. The annualized average increase in total administration costs per business is $6. These estimates of administrative burden represent an average over 10 years, and recognize that administrative burden will diminish as implicated practitioners and pharmacists become familiar with reporting requirements during the first year.

Small business lens
The small business lens does not apply, because the total burden, valued as described above, does not exceed $1M.

Consultation
In April and June 2017, Health Canada engaged key stakeholders for feedback on a document summarizing the proposed reporting requirements. Stakeholders included, but were not limited to, regulators of professionals who may be involved in medical assistance in dying; the Office of the Privacy Commissioner of Canada; groups representing Canadian medical, nursing and pharmacist professions; legal professionals; and the Canadian Association of MAID Assessors and Providers. Twenty-two stakeholder groups provided written submissions, many of which were developed through internal consultations within their organizations.

In addition, Health Canada compiled feedback from discussions with the Federal/Provincial/Territorial Working Group on Medical Assistance in Dying, which brings together officials from federal, provincial and territorial health and justice departments and ministries to discuss issues surrounding medically assisted death. The Working Group has held regular meetings since its inception in 2015.

In response to the submissions and discussions described above, the regulatory proposal allowed for designation of provincial and territorial designated recipients to avoid requiring professionals to report similar information to different levels of government. Information to be reported was reduced and revised, and some reporting timelines were lengthened. Further, Health Canada indicated that it would publish guidelines on reporting requirements, undertake a Privacy Impact Assessment, and collaborate with key health professional stakeholders to educate regulated professionals on the reporting requirements.

Prepublication in the Canada Gazette, Part I
The proposed Regulations were prepublished in the Canada Gazette, Part I, on December 16, 2017, followed by a 60-day comment period. Health Canada also undertook technical briefings with regulators of medicine, nursing, and pharmacy, to outline regulatory requirements in order to support the provision of robust feedback.

A total of 43 responses were received during the comment period. Of the 43 respondents, 11 were practitioners or organizations representing practitioners, 4 were organizations representing pharmacists, 7 were from provincial or territorial governments, 4 were from Offices of Privacy Commissioners, 5 were from research or academic organizations, 3 were from advocacy groups, 6 were from individuals, and 3 were categorized as “other” (a registered nurse, the Canadian Bar Association, and the United Church).

Overall, respondents supported the creation of a federal monitoring regime for medical assistance in dying. Respondents differed on how best to strike an appropriate balance between reporting burden and obtaining data that is required to ensure transparency in how medical assistance in dying is provided.

Issue: Many respondents felt that only the information required for robust monitoring of requests for and provision of medical assistance in dying should be requested of providers.

Department of Health Response: Information that might not be evident to the practitioner and require time to obtain, i.e. occupation during working life, was removed from reporting requirements in favour of using linkages with existing federal data sets. (Please see the Department of Health response below.) Other measures to streamline reporting, such as designating provincial and territorial recipients of data, and facilitating reporting through an online portal for those reporting to the federal Minister of Health, are key measures to help mitigate reporting burden. However, scrupulous monitoring of the implementation of exemptions to serious criminal offences necessarily involves some measure of burden on those seeking to avail themselves of these exemptions.

Issue: Some respondents indicated that information collected under the regulatory framework should be substantially expanded in order to better understand how medical assistance in dying is being implemented in Canada and the impact it could be having on vulnerable populations.

Department of Health response: Questions on palliative care were revised to capture the length of time the patient received palliative care, and similarly formulated questions on access to disability supports were added. Responses available to characterize suffering have been expanded based on feedback from stakeholders. The requirement to provide a description of the patient’s decline was deleted because responses now overlap with those relating to suffering.

Finally, socio-demographic questions have been removed in favour of collecting the postal code for each patient, which will enable enhanced linkages with other data (census records, income tax records) held by Statistics Canada. Such linkages will give more reliable indications of socio-demographic information than those in the former Schedule 3. This will in turn enhance insight into which subsections of the Canadian population are requesting and receiving medical assistance in dying.

Issue: Respondents in the medical community indicated that estimates of time by which medical assistance in dying would shorten a patient’s life are difficult to make and often inaccurate.

Department of Health response: The requirement to estimate the amount of time by which MAID, if provided, would shorten a patient’s life, was initially included as a way to gather information about the timing of requests for MAID in relation to the trajectory of the patient’s decline. It was removed due to the medical community’s concerns regarding the difficulties associated with making such assessments in a variety of circumstances.

Issue: Some respondents indicated that the Regulations do not contain key measures that are required to protect personal information.

Department of Health response: Health Canada and Statistics Canada are subject to the Privacy Act and Government of Canada policies which seek to protect personal information. Further, Health Canada will undertake a Privacy Impact Assessment to identify high-risk areas and mitigation measures required to protect the privacy of individuals.

Issue: Some respondents indicated that there is a need to provide written guidance to regulated practitioners and pharmacists, and others requested clarity with respect to how the Regulations would be enforced.

Department of Health response: Health Canada plans to publish guidance documents for practitioners and pharmacists to support them in understanding and complying with reporting requirements. Where Health Canada is the designated recipient, officials may review reports and follow up with practitioners and pharmacists in the event that a report appears to be incomplete. Where a province or territory has a designated recipient, they may follow up with the responsible person when reports appear to be incomplete. If Health Canada, or a provincial or territorial designated recipient, became aware of failures to apply the eligibility requirements or safeguards in the Criminal Code, failures to report, or continued or egregious omissions in reports, a situation could be referred to law enforcement.

Issue: Some respondents indicated that practitioners should not be required to report on cases that do not result in medical assistance in dying.

Department of Health response: Collecting data on cases where medical assistance in dying is requested but not provided yields important insight into the circumstances of those who have made the requests and whether the legislation is working effectively. Requirements have been maintained to report in cases where a written request was made but medical assistance in dying was not provided.

Issue: Some respondents indicated that reporting timelines are confusing and should not be shorter than 30 days.

Department of Health response: The timeline for reporting on cases where medical assistance in dying was provided by administering a substance (i.e. clinician-administered medical assistance in dying) was extended from 10 days to 30 days. This brings the former 10-day reporting timeline into alignment with timelines for reporting outcomes where medical assistance in dying was not provided. A 90- to 120-day reporting “window” remains for cases where medical assistance in dying was provided by prescribing or providing a substance for self-administration. Given uncertainty over when selfadministration may occur, the reporting “window” will increase the proportion of cases in which the outcome is known at the time of reporting, which supports the overall goal of understanding how the legislation is being implemented.

Issue: Some respondents felt that time estimates for the completion of forms were not accurate, and the final annual estimate of administrative burden per business was too low. Other respondents felt that administrative burden should not have been considered as extensively as it was.

The Department of Health is required to calculate and offset administrative burden within the federal Health Portfolio under the Red Tape Reduction Act. Data that may not be evident from a patient’s file, and thus be more time consuming to report, has been removed from the reporting obligations. The original time estimates were maintained. The change in the amount of administrative burden since prepublication is the result of a decrease to the projected volume of reports that would be filed with a provincial designated recipient.

In addition to the changes described above, other changes have been made to clarify and/or refine the regulatory text.

The title of the Regulations in English was revised from the Monitoring of Medical Assistance in Dying Regulations to the Regulations for the Monitoring of Medical Assistance in Dying to better convey the Regulations’ intent to provide insight into the implementation of the legislation. In French, the title did not require revision.
Provincial and territorial designated recipients were identified as per communication from provincial and territorial governments. Please refer to the description section above for details. The prepublished version of the Regulations included a provincial-level recipient for pharmacists and practitioners in Quebec. The government of Quebec has indicated that performing this role would not be achievable by the time the Regulations come into force. As a result, practitioners and pharmacists in Quebec will report to the federal government until suitable arrangements can be made for designating a provincial-level designated recipient in Quebec.
In response to questions from respondents, the parts of the Regulations relating to referral were clarified to include transfer of care, where the reason for the transfer of care was a request for medical assistance in dying. The data to be reported regarding the reason for referral, or transfer of care in response to a request for medical assistance in dying, were expanded.
Reporting requirements were clarified in the Regulations to indicate that, once a report has been filed, subsequent reports are not required for outcomes that do not entail the provision of medical assistance in dying. For example, in a case where referral has occurred and been reported on, and the reporting practitioner subsequently becomes aware of the patient’s death from a cause other than medical assistance in dying, that practitioner is not required to file a second report.
References to the patient’s usual place of residence have been revised, because the usual place of residence can be complex in end-of-life situations. Instead, practitioners will report on either the patient’s usual place of residence at a particular point in time, or the patient’s location, depending on the particular reporting requirement.
The former Schedule 3 was deleted because data elements it requested were either moved or removed.
In cases where a patient becomes ineligible, practitioners are now required to report on whether their assessment of the voluntariness of the request changed.
In response to questions from respondents, the references to the term “therapeutic relationship” were revised to indicate care provided outside the context of a request for medical assistance in dying.
In response to a comment received during the consultation, Section 1 of the current Schedule 3 was reworded to clarify that it excludes consultations with practitioners for the purpose of the second opinion required under the Criminal Code.
In response to questions from consultation respondents, paragraphs (f), (g), and (h) of the former Schedule 4, now Schedule 3, have been revised. The prior version of the Regulations required that the practitioner report on whether the patient met a particular eligibility criteria, how they met it, and the reason for the practitioner’s opinion. In the revised version, the requirement to report on the reason for their opinion was removed.
An issue that was raised frequently, but is outside federal jurisdiction, was remuneration of practitioners for complying with reporting requirements. Some respondents addressed issues relating to the effectiveness and clarity of the legislation, which were also out of scope for the regulatory proposal.

Rationale
Medical assistance in dying in Canada is permitted through exceptions to criminal laws which prohibit intentionally ending or helping to end another person’s life. A robust monitoring regime reflects the significance and gravity of permitting practitioners to intentionally end life.

Monitoring is a key component in virtually all jurisdictions that permit medical assistance in dying, and information from monitoring reports in permissive jurisdictions (e.g. Netherlands, Oregon) was closely scrutinized in the Carter decision and in the development of the Canadian legislation. It is critical that the outcomes of the Canadian regime are scrupulously monitored.

Benefits
Collecting, analyzing and publicly reporting on data for monitoring purposes is critical to foster public trust, and provide transparency and accountability in relation to the legislation. The regime would provide Canadians with a clear picture of how the legislation is working across the country, and create consistent data sets among jurisdictions and regions. This will inform evidence-based policy discussions and a parliamentary review of the legislation. footnote2 Finally, under the regime, data would be made available to researchers, enabling them to conduct analyses that would enrich the body of scholarly work on medical assistance in dying in Canada.

Costs
The Regulations would create costs to implicated practitioners and pharmacists by requiring them to spend time becoming familiar with the reporting requirements, and complying with them whenever the need arises. As outlined in this document, several steps have been taken to minimize the administrative burden while collecting the data required to fulfil the objective of the Regulations.

Provincial and territorial governments may incur costs if practitioners and pharmacists are remunerated for the time required to file reports.

The federal government, and other recipients designated in the Regulations, would incur costs to establish and administer reporting systems (or, in the case of provincial or territorial designated recipients, modify existing systems). These costs are expected to decrease after the first few years as reporting systems are operationalized.

On balance, the benefits associated with the monitoring system outweigh the costs, given the magnitude of the social policy change introduced by the medical assistance in dying legislation, and the importance of data for monitoring its implementation.

Implementation, enforcement and service standards
The Regulations come into force on the first day of the fourth month after they were registered. Health Canada is working with Statistics Canada to develop an online portal for the receipt of data for monitoring purposes. In addition to providing explanatory guidance in the portal, Health Canada plans to publish guidance documents for practitioners and pharmacists to support their understanding of reporting requirements.

The protection of personal information and privacy is a primary consideration in operationalizing all aspects of collection, storage, access to, use, and disclosure of data. Program processes will be developed, and a Privacy Impact Assessment will be undertaken to identify and mitigate privacy risks.

Where Health Canada is the designated recipient, officials may review reports and follow-up with practitioners and pharmacists in the event that a report appears to be incomplete. The designated recipient for information in a province or territory could take 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 were required, as the Criminal Code creates an offence for practitioners and pharmacists who knowingly fail to provide information required under the Regulations. Health Canada anticipates publishing guidance documents, and undertaking outreach and engagement activities during the coming-into-force period to support practitioners and pharmacists in complying with the Regulations.

Contact

Sharon Harper
Policy Director
Strategic Policy Branch
Health Canada
200 Eglantine Driveway, 4th Floor, Room 411A
Tunney’s Pasture
Ottawa, Ontario
K1A 0K9

 

TABLE 1: INFORMATION REQUIREMENTS FOR FEDERAL MONITORING OF MEDICAL ASSISTANCE IN DYING

OUTCOME Following receipt of the patient’s written request	Basic information regarding the patient, practitioner, and request (Schedule 1)	Application of eligibility criteria and related information (Schedule 3)	Application of procedural requirements (Schedule 4)	Provision of MAID — administering substance (Schedule 6)	Provision of MAID — prescribing/ providing substance (Schedule 5)	Other information	Timeline to provide information
Provision of medical assistance in dying by administering a substance	✓	✓	✓	✓	—	—	Within 30 days of administering a substance
Provision of medical assistance in dying by prescribing or providing a substance for self-administration	✓	✓	✓	—	✓	—	90–120 days after prescribing or providing a substance, unless the practitioner becomes aware of death from any cause in <90 days
Determination of ineligibility	✓	✓	—	—	—	Whether patient became ineligible after previously being found eligible	Within 30 days of the determination of ineligibility
Withdrawal of request by the patient	✓	✓ If patient had been found eligible prior to withdrawal	—	—	—	Reasons for withdrawal, if known; whether withdrawal occurred after having been given an opportunity to do so per the Criminal Code	Within 30 days of becoming aware of the patient’s withdrawal of the request
Referral or transfer of care in response to the written request	✓	—	—	—	—	Information on referral (Schedule 2)	Within 30 days of referring or directing the patient
Death of patient from another cause	✓	✓ If patient had been found eligible prior to death from another cause	—	—	—	Date and cause of death (immediate and underlying), if known	Within 30 days of practitioner becoming aware of the patient’s death from another cause

Footnotes

S.C. 2016, c. 3, s. 4

R.S., c. C-46

Under the legislation, medical assistance in dying may be provided in two ways: by administering a substance to the patient, or prescribing or providing a substance to the patient for the purpose of self-administration. In the latter scenario, provision of medical assistance in dying may not necessarily result in the death of the patient (e.g. the patient may not follow through with self-administration), or there may be a significant time lag between provision and death, depending on the patient’s actions.

The legislation requires a parliamentary review of its provisions, to commence at the start of the fifth year after royal assent (June 2020).