Canada Gazette, Part I, Volume 151, Number 50: Monitoring of Medical Assistance in Dying Regulations
December 16, 2017
Statutory authority
Criminal Code
Sponsoring department
Department of Health
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 allow eligible Canadians to access medical assistance in dying. The Act was the Government's response to a 2015 Supreme Court 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
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 safeguards to balance the competing social interests of those who might be at risk in a permissive regime with those who wish to seek medical assistance in dying.
The primary purpose of monitoring is to provide transparency and foster public trust regarding the implementation of the new law. The proposed monitoring regime would use data to build a picture of how the legislation is working — for example core statistics regarding the number of requests and their outcomes, the circumstances of patients requesting and receiving medical assistance in dying — and how the eligibility criteria are being applied. Contraventions of the legislation are currently, and would remain, under the purview of local law enforcement.
Until regulations are in force, Health Canada will issue interim reports approximately every six months. Reports were released in April 2017 and October 2017, with information for June–December 2016 and January–June 2017, respectively. These reports are based on aggregate data provided voluntarily by provincial and territorial governments. Provincial and territorial data may include the number of medically assisted deaths, underlying medical conditions leading to requests for medical assistance in dying, and basic demographic data on requestors. However, data collection is not consistent across provinces and territories.
Objectives
The proposed Regulations set out the federal monitoring regime, which would
- Support public accountability and transparency in relation to medical assistance in dying;
- Support the protection of vulnerable individuals by monitoring the application of the eligibility criteria and safeguards required by the legislation;
- Identify and monitor trends in requests for, and the provision of, medical assistance in dying;
- Help determine whether the legislation is meeting its objectives; and
- Make data available to qualified researchers for the purpose of enabling independent analysis and research.
Description
The proposed Regulations would require medical practitioners, nurse practitioners, and pharmacists to file reports containing certain information related to requests for, and the provision of, medical assistance in dying with a recipient designated in the Regulations, within prescribed deadlines.
Practitioners
Practitioners, meaning a nurse practitioner or a medical practitioner, would be 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 the request 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. (see footnote 1) Table 1 (at the end of this RIAS) provides an overview of the information required in each circumstance, as well as the reporting timelines.
The reporting requirements discussed above would cease 90 days after the practitioner received the request, except in cases where medical assistance in dying is provided.
A second practitioner who provides a written report confirming that the patient meets all of the criteria, as required as one of the safeguards under the Act, would not be required to file the reports described above.
Pharmacists
Pharmacists who dispense a substance in connection with the provision of medical assistance in dying would be required to report basic information regarding the patient, the pharmacist, and practitioner, and the date and setting in which the medication was dispensed. Schedule 8 of the proposed Regulations provides full reporting requirements for pharmacists. The report is required within 30 days of having dispensed a substance.
Recipient of reports
The proposed Regulations would designate the federal Minister of Health as the recipient for all reports, except those filed in Quebec. Reports filed in Quebec would be filed with the President of the Commission sur les soins de fin de vie.
Other provinces and territories have the opportunity to nominate a recipient to receive reports from practitioners and pharmacists in their respective jurisdictions. Those individuals would be identified as designated recipients in the final Regulations. There may be two designated recipients for practitioners and pharmacists in a province or territory, depending on their individual circumstances. For example, in provinces where medically assisted deaths are reported to the Chief Coroner, he or she may be identified as the designated recipient in cases where medical assistance in dying was provided, and another recipient may be designated for information regarding requests which did not result in death.
Where provincial or territorial recipients are designated, these recipients would be required to provide all information that must be reported by practitioners and pharmacists under the proposed Regulations to the federal Minister of Health on a quarterly basis, except information required only for administrative purposes by designated recipients.
In cases where a province or territory has not nominated a recipient, the federal Minister of Health would remain the designated recipient for all reports.
Publication of information
At least once a year, a report would be published on the Government of Canada website presenting aggregate data on information obtained under the proposed Regulations. This report would include data elements such as the number of requests made, 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 time periods relating to the handling of requests. The report would not contain any personal information.
Health Canada plans to partner with Statistics Canada to collect and analyze data for monitoring of medical assistance in dying, and produce annual reports. These activities do not form part of the Regulations. Under the authority of the Statistics Act, Statistics Canada will retain rights to the data for its own research and statistical analysis purposes.
Disclosure of information
The proposed Regulations provide specific authority 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 monitoring of medical assistance in dying. Personal information may also be disclosed for the purpose of enabling research or statistical analysis, provided that the Minister is satisfied that it is required to achieve the objectives of the research or statistical analysis. The requestor must provide a written undertaking to use the information only for the purpose it was disclosed, and not to disclose the information in a manner that could reasonably be expected to identify an individual.
“One-for-One” Rule
Measuring the administrative burden imposed by the Regulations poses unique challenges because no national monitoring system is currently in place. While the legislation has provided a national framework on medical assistance in dying since June 2016, the breadth and consistency of medical assistance in dying information reported across the country have been limited. The proposed Regulations endeavour to address that issue. Specific policies and processes related to the implementation of medical assistance in dying vary across Canada and are expected to evolve as data becomes available and jurisdictions are able to evaluate policies and delivery models.
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 culturally accepted by Canadians, and the health status of Canadians.
The valuation of the administrative burden was undertaken using the assumption that 2.05% of Canadian deaths would occur as a result of medical assistance in dying, for approximately 5 709 deaths each year. This assumption is based on the proportion of deaths resulting from medical assistance in dying in other jurisdictions. It was assumed that approximately 10 minutes are required to electronically file each report submitted by a practitioner, except in cases where a 90-day waiting period applies. In those cases, an additional 10 minutes was estimated to accommodate administrative burden associated with a waiting period. For reporting by pharmacists, it was assumed that approximately 8 minutes would be required to electronically file the report. Health Canada's 2nd Interim Report on Medical Assistance in Dying in Canada was used to characterize medical assistance in dying, for example the proportion of medical assistance in dying that occurs through self-administration of a substance.
Based on calculations carried out using the Standard Cost Model methodology, the proposed Regulations have been estimated to result in an annualized average increase in total administration costs of approximately $60,030. The annualized average increase in total administration costs per business is $5. This estimate is expressed in constant 2012 Canadian dollars, using a 7% discount rate over 10 years.
This estimate was produced using Statistics Canada data related to physician and pharmacist earnings per hour. Nurse practitioner earnings per hour were excluded from the above calculation because involvement in medical assistance in dying by nurse practitioners to date has been low. The estimate also incorporates assumptions regarding the current situation where a small number of physicians are managing a large number of cases (reducing the time required to become familiar with reporting requirements).
Small business lens
The small business lens does not apply because the total burden under the proposed Regulations, valued as described above, does not exceed $1M.
Consultation
Health Canada conducted pre-regulatory consultations with key stakeholders between April and June 2017. Stakeholders included, but were not limited to, regulators of professionals who may be involved in medical assistance in dying, federal officials including from 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.
Stakeholders were provided with a consultation document describing the proposed reporting requirements, and were invited to submit comments online or through bilateral meetings with Health Canada officials. 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 assisted death. The Working Group has held regular meetings since its inception in 2015.
The main findings of the pre-regulatory consultation process and the federal government's responses are outlined below.
- Issue: Similar data would be required from practitioners by federal and provincial/territorial governments.
- Description: Practitioners would potentially have to report similar information to provincial/territorial and federal authorities at similar intervals, creating a disproportionate administrative burden associated with providing medical assistance in dying.
- Health Canada Response: All provinces and territories were offered the option of nominating a provincial or territorial person as the recipient of information from practitioners and pharmacists in their jurisdiction, which would enable the integration of federal reporting requirements into existing provincial and territorial processes and forms. At the time of prepublication, one provincial-level recipient has been designated (for Quebec), and discussions are proceeding with a number of other provinces and territories. Those that are interested in nominating a recipient and have satisfied the conditions by the deadline stipulated by Health Canada would be incorporated into the final Regulations for publication in the Canada Gazette, Part II.
- Issue: Protecting the privacy of patients, practitioners, and pharmacists.
- Description: Given that personal information would be collected under the proposed regulations, several respondents outlined concerns about protecting the information. Some questioned why certain data elements were being collected at all — in particular socio-demographic characteristics and information allowing identification of patients, practitioners and pharmacists.
- Health Canada Response:
- (a) Protection of information: Monitoring activities are subject to all applicable federal legislation and policies that relate to the protection of personal information. Furthermore, Health Canada would undertake a privacy impact assessment to ensure that all privacy implications are appropriately identified, assessed and resolved.
- (b) Need for personal information: Personal information is necessary for the monitoring regime to function. The amount of information required is the minimum for this purpose. Patients' health insurance numbers and practitioners' and pharmacists' registration numbers serve as unique identifiers for statistical analysis purposes. Practitioners' and pharmacists' names and contact information are required for follow-up purposes, to confirm receipt of data, and in the event of missing or incomplete information.
- (c) Socio-demographic information: As medical assistance in dying involves permitting individuals to be actively involved in terminating the lives of others who request their help, the objectives of the monitoring system include seeking to understand the characteristics of individuals who request medical assistance in dying, the circumstances in which requests arise, and whether individuals are seeking assisted dying due to certain socio-demographic conditions, as opposed to suffering emanating from their medical condition and the dying process. To this end, the monitoring regime includes a number of socio-demographic elements.
- Issue: Need for clarity on reporting requirements.
- Description: A majority of respondents indicated that the proposed regulatory requirements were complex and identified components of the framework that required clarity such as the definition of a written request, and whether reporting timelines referred to calendar days or working days. Others felt that it was not always clear who was required to report, and at what point in their involvement.
- Health Canada Response: Since the pre-regulatory consultation, the data requirements have been significantly reduced and revised, and guidance documents will be developed to provide clarity on who is required to file information, and in what circumstances. Health Canada is developing an electronic reporting system in collaboration with Statistics Canada that would guide the practitioner or pharmacist through an electronic questionnaire to identify their reporting obligations when Health Canada is the designated recipient. This would include “help” and “information” features to provide definitions, outline frequently asked questions, and direct practitioners or pharmacists to where they can access additional support if required. The electronic portal will maximize the use of features such as drop-down menus to reduce the time required for completion, while ensuring consistency and ease of roll-up of data.
- Issue: Timelines for reporting by practitioners and pharmacists
- Description: The proposed timelines for reporting to Health Canada (within 10 days, in most instances) were a concern for several respondents. Given the criminal penalties for failing to report, some respondents proposed more flexible timelines. Others indicated that the timelines for reporting needed to be lengthened to better align with how requests and assessments for medical assistance in dying occur in practice.
- Health Canada response: In response to this concern, timelines were lengthened to 30 days or longer in most cases. Guidance documents for practitioners and pharmacists would explain that the Regulations do not presuppose that events occur within particular time frames.
- Issue: Communicating reporting requirements
- Description: Many respondents suggested that information about the monitoring system, including practitioners' and pharmacists' obligations, should be shared through regulatory bodies and other professional organizations. A need was identified for proactive communication to educate practitioners and pharmacists, both with respect to their reporting obligations and broader issues related to this area of medical practice.
- Health Canada Response: Health Canada would work with provincial and territorial counterparts through the Federal/Provincial/Territorial Working Group on MAID, as well as national associations, to engage regulatory colleges of medicine, nursing and pharmacy, to provide information and relevant Web links on the federal reporting requirements and systems. Where a province or territory is fulfilling the designated recipient role, communicating with practitioners and pharmacists would be the responsibility of the province or territory.
Rationale
Medical assistance in dying in Canada is permitted through exceptions to criminal laws that prohibit terminating and participating in the end of human life. A robust monitoring regime reflects the significance and gravity of permitting practitioners to help 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 sufficiently 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 proposed regime would provide Canadians with a clear picture of how the legislation is working across the country, and create universal or consistent datasets between jurisdictions and regions, which will inform future evidence-based policy discussions, and a parliamentary review. (see footnote 2) Finally, under the proposed regime, data would be made available to qualified researchers, enabling them to conduct analyses that would enrich the body of scholarly work on medical assistance in dying in Canada.
Costs
The proposed 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 requirement arises. Introducing any kind of administrative burden may prove to be a deterrent to some practitioners and pharmacists in providing medical assistance in dying.
Provincial and territorial governments may incur costs if practitioners and pharmacists are remunerated for the time required to file reports.
The federal government, as well as provinces and territories designated in the final 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 as reporting systems are operationalized.
On balance, the benefits associated with the proposed monitoring system outweigh the costs, given the magnitude of the social policy change introduced by the assisted dying legislation, and the importance of data for monitoring.
Implementation, enforcement and service standards
Implementation
The Regulations would come into force a minimum of one month after they are registered. Health Canada is working with Statistics Canada to develop an electronic portal for the receipt of data for monitoring purposes, and they will collaborate on the production of reports.
Enforcement
The Act creates an offence for practitioners or pharmacists who knowingly fail to provide information for monitoring purposes, and for others who knowingly breach the Regulations. The designated recipient for information in a province or territory — whether federal, provincial, or territorial — could bring allegations regarding such offences to the attention of local law enforcement authorities, who would ultimately make the decision about whether to lay charges.
Service standards
Service standards for the federal government are not proposed, because the proposed Regulations would stipulate timelines for the federal Minister of Health to publish reports.
Contact
Sharon Harper
Policy Director
Strategic Policy Branch
Health Canada
200 Eglantine Driveway, 4th Floor, Room 411A
Tunney's Pasture
Ottawa, Ontario
K1A 0K9
Email: End.of.life.care_soins.fin.de.vie@hc-sc.gc.ca
OUTCOME Following receipt of the patient's written request |
Basic information regarding the patient, practitioner, and request (Schedule 1) | Supplementary (socio-demographic) information regarding patient (Schedule 3) | Application of eligibility criteria (Schedule 4) | Application of safeguards (Schedule 5) | Provision of MAID — administering substance (Schedule 7) | Provision of MAID — |
Other information | Timeline to provide information |
---|---|---|---|---|---|---|---|---|
Provision of medical assistance in dying by administering a substance | ✓ | ✓ | ✓ | ✓ | ✓ | — | — | Within 10 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, 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 | ✓ |
|
— | — | — | 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 of patient to another practitioner, or care coordination service | ✓ | — | — | — | — | — | Information on referral (Schedule 2) | Within 30 days of referring or directing the patient |
Death of patient 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 |
PROPOSED REGULATORY TEXT
Notice is given that the Minister of Health, pursuant to subsection 241.31(3) (see footnote a) of the Criminal Code (see footnote b), proposes to make the annexed Monitoring of Medical Assistance in Dying Regulations.
Interested persons may make representations concerning the proposed Regulations within 60 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 Sharon Harper, Policy Director, Health Care Programs and Policy Directorate, Strategic Policy Branch, Department of Health, 200 Eglantine Driveway, Tunney's Pasture, 4th floor, Room 411A, Ottawa, Ontario, K1A 0K9 (email: End.of.life.care_Soins.fin.de.vie@hc-sc.gc.ca).
Ottawa, November 23, 2017
Ginette Petitpas Taylor
Minister of Health
Monitoring of Medical Assistance in Dying Regulations
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 request for medical assistance in dying that was made in writing. (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 the 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 — Quebec
(2) Despite subsection (1), in respect of the information to be provided by a practitioner who receives a written request for medical assistance in dying in the Province of Quebec or by a pharmacist who dispenses a substance in that province in connection with the provision of medical assistance in dying, the Chair of the Commission sur les soins de fin de vie is designated as the recipient of information for the purposes of subsections 241.31(1) and (2) of the Code.
Practitioners
Exception
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 sections 5, 6, and 9.
Referral of patient
4 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 must provide the recipient designated under section 2 with the information referred to in Schedules 1 and 2 within 30 days after the day on which they referred the patient.
Withdrawal of request
5 A practitioner must provide the following information to the recipient designated under section 2 within 30 days after the day on which the practitioner became 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:
- (i) the information referred to in Schedule 3, to the best of the practitioner's knowledge or belief,
- (ii) the information referred to in Schedule 4;
- (c) the patient's reasons for withdrawing the request, if known;
- (d) an indication of whether the patient withdrew their request after having been given an opportunity to do so under paragraph 241.2(3)(h) of the Code.
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 recipient designated under section 2 with the information referred to in Schedules 1 and 4 within 30 days after the day on which the practitioner made that determination.
Clarification
(2) For greater certainty, subsection (1) applies if, after having determined that the patient met all of the eligibility criteria, the practitioner determines that the patient no longer meets one or more of those criteria.
Prescribing or providing a substance
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 must provide the recipient designated under section 2 with the following information no earlier than 90 days after the day on which the practitioner prescribed or provided the substance and no later than 120 days after that day:
- (a) the information referred to in Schedules 1 and 4 to 6;
- (b) the information referred to in Schedule 3, to the best of the practitioner's knowledge or belief.
Exception — time to report
(2) The practitioner may provide the recipient designated under section 2 with the information referred to in subsection (1) earlier than 90 days after the day on which the practitioner prescribed or provided the substance to the patient if the practitioner is aware that the patient has died.
Administering a substance
8 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 a patient must provide the recipient designated under section 2 with the following information within 10 days after the day on which the patient died:
- (a) the information referred to in Schedules 1, 4, 5 and 7;
- (b) the information referred to in Schedule 3, to the best of the practitioner's knowledge or belief.
Death — other cause
9 (1) A practitioner who has received a patient's written request for medical assistance in dying and becomes aware that the patient died from a cause other than medical assistance in dying must provide the recipient designated under section 2 with the following information within 30 days after the day on which the practitioner became aware that the patient died:
- (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:
- (i) the information referred to in Schedule 3, to the best of the practitioner's knowledge or belief,
- (ii) the information referred to in Schedule 4;
- (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.
Exception
(2) The practitioner is not required to provide information under subsection (1) if the practitioner provided information in accordance with section 4 or 5, subsection 6(1) or section 7.
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 the recipient designated under section 2 with information under a provision of these Regulations — other than sections 7 and 8 — with regard to any circumstances relating to the request that the practitioner becomes aware of 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 recipient designated under section 2 with the information referred to in Schedule 8 within 30 days after the day on which they dispensed 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 him or her, on a voluntary basis, with 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:
- (a) the number of patients who died;
- (b) copies of medical certificates of death of those patients;
- (c) the finding 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 locations in which medical assistance in dying was provided;
- (f) time periods relating to the handling of requests and the provision of medical assistance in dying;
- (g) the nature of consultations by practitioners 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
- (i) the respective involvement of medical practitioners and nurse practitioners, and
- (ii) the existence of therapeutic relationships between patients and practitioners before requests were made.
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 section 2, other than the Minister of Health, must disclose to the Minister of Health, within 30 days after the day on which a quarter begins, information — other than the information referred to in paragraphs 2(a) and (g) of Schedule 1 and paragraphs 2(a) and (d) of Schedule 8 — 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
Second month after registration
17 (1) These Regulations, except section 13, come into force on the first day of the second 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
(Section 4, paragraph 5(a), subsection 6(1) and paragraphs 7(1)(a), 8(a), and 9(1)(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.
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 the practitioner in the province or territory in which they received the request;
- (g) work address and, if applicable, work email address;
- (h) an indication of whether, before receiving the request, they had a therapeutic relationship with the patient.
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
(Section 4)
Referral of Patient
1 The date on which the patient was referred.
2 If the practitioner received the request in a hospital, a residential care facility or a palliative care facility, an indication of whether the decision to refer the patient was the result of the application of the policies on medical assistance in dying of the hospital or facility.
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 the patient.
SCHEDULE 3
(Subparagraph 5(b)(i), paragraphs (7)(1)(b) and 8(b) and subparagraph 9(1)(b)(i))
Supplementary Information About Patient
1 An indication of which of the following locations describes the patient's usual place of residence or, if their usual place of residence is elsewhere, a description of that location:
- (a) residential care facility;
- (b) private residence.
2 The postal code of the patient's usual place of residence.
3 The patient's marital status.
4 The patient's principal occupation during their working life, if applicable.
SCHEDULE 4
(Subparagraph 5(b)(ii) subsection 6(1), paragraphs 7(1)(a) and 8(a) and subparagraph 9(1)(b)(ii))
Eligibility Criteria and Related Information
1 An indication of whether the practitioner consulted with other health care professionals 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, the reasons why the practitioner was of that opinion, including a description of the illness, disease or disability;
- (g) the patient was in an advanced state of irreversible decline in capability 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, including a description of the decline;
- (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 reasons why the practitioner was of that opinion, including 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 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, including the practitioner's estimate as to the amount of time by which medical assistance in dying, if provided, would shorten the patient's life and the practitioner's anticipation of the likely cause of natural death of the patient.
3 An indication of whether the patient received palliative care, if known, and, if they 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 In the case where the practitioner, after having determined that the patient met all of the eligibility criteria, determines that the patient no longer meets one or more of those criteria, an indication of whether the patient lost the capacity to make decisions with respect to their health.
SCHEDULE 5
(Paragraphs 7(1)(a) and 8(a))
Procedural Requirements — Providing Medical Assistance in Dying
1 An indication of whether
- (a) the practitioner was of the opinion that the patient met all of the eligibility criteria;
- (b) 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) 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) 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) the practitioner ensured that the patient was informed that they may, at any time and in any manner, withdraw their request;
- (f) 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) 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) 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) 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) in the case where the patient had difficulty communicating, the practitioner took all necessary measures to provide a reliable means by which the patient may have understood the information that was provided to them and communicated their decision;
- (k) 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 6
(Paragraph 7(1)(a))
Prescribing or Providing a Substance
1 The date on which the practitioner prescribed or provided the substance to the patient.
2 An indication of which of the following locations describes where the practitioner prescribed or provided the substance to the patient or, if they prescribed or provided the substance elsewhere, a description of that location:
- (a) medical office;
- (b) hospital;
- (c) palliative care facility;
- (d) residential care facility;
- (e) private residence.
3 The following information:
- (a) an indication of whether the patient self-administered the substance, if known;
- (b) in the case where 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,
- (iii) an indication of which of the following locations describes where the patient self-administered the substance or, if they self-administered the substance elsewhere, a description of that location, if known:
- (A) hospital,
- (B) palliative care facility,
- (C) residential care facility,
- (D) private residence;
- (c) in the case where the patient did not self-administer the substance,
- (i) an indication of whether the patient has died, if known,
- (ii) in the case where the patient has died, the date of death, if known.
SCHEDULE 7
(Paragraph 8(a))
Administering a Substance
1 The date on which the practitioner administered the substance to the patient.
2 An indication of which of the following locations describes where the practitioner administered the substance to the patient or, if they administered the substance elsewhere, a description of that location:
- (a) hospital;
- (b) palliative care facility;
- (c) residential care facility;
- (d) private residence.
SCHEDULE 8
(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.
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) work address and, if applicable, work email address.
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 locations describes where the pharmacist dispensed the substance or, if they dispensed the substance elsewhere, a description of that location:
- (i) hospital pharmacy,
- (ii) community pharmacy.