Order Fixing (1) the First Anniversary of the Day on which this Order is Made as the Day on which Section 12 of that Act Comes into Force; and (2) the Day on which this Order is Made as the Day on which Sections 45 to 58 of that Act Come into Force: SI/2019-38

Canada Gazette, Part II, Volume 153, Number 13

Registration
SI/2019-38 June 26, 2019

ASSISTED HUMAN REPRODUCTION ACT

Order Fixing (1) the First Anniversary of the Day on which this Order is Made as the Day on which Section 12 of that Act Comes into Force; and (2) the Day on which this Order is Made as the Day on which Sections 45 to 58 of that Act Come into Force

P.C. 2019-749 June 9, 2019

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 78 of the Assisted Human Reproduction Act, chapter 2 of the Statutes of Canada, 2004, fixes

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

This Order fixes the first anniversary of the day on which this Order is made as the day on which section 12 of the Assisted Human Reproduction Act (the Act) comes into force. Section 12 addresses the reimbursement of expenditures of sperm and ova donors, persons that maintain or transport in vitro embryos (IVEs), and surrogate mothers, as well as reimbursement of loss of work-related income for surrogate mothers. Section 12 prohibits such reimbursements except when they are made in accordance with the Regulations.

This Order fixes the day that this Order is made as the day that sections 45 to 58 of the Assisted Human Reproduction Act come into force. Together, sections 45 to 58 set out a framework for designated inspectors to monitor compliance, as well as for enforcement activities in relation to the Act. These sections include provisions that set out the activities that designated inspectors can undertake to verify compliance, or to prevent non-compliance, with section 8 on matters of consent, section 10 on matters of safety of donor sperm or ova for the purpose of assisted human reproduction, and section 12 on matters of reimbursement.

Objective

It is necessary to bring into force these sections of the Assisted Human Reproduction Act at the same time as the supporting regulations for section 12 of the Act in the Reimbursement Related to Assisted Human Reproduction Regulations and the supporting regulations for subsections 51(1) and 52(3) and section 54 of the Act in the Administration and Enforcement (Assisted Human Reproduction Act) Regulations.

The Reimbursement Related to Assisted Human Reproduction Regulations, which will come into force with section 12, set categories of allowable expenditures that may be reimbursed in relation to the donation of sperm and ova, the maintenance and transport of IVEs, and surrogacy, as well as set out the process for the reimbursement of loss of work-related income for surrogate mothers. The Regulations also establish requirements for documentation and record keeping.

The Administration and Enforcement (Assisted Human Reproduction Act) Regulations, which come into force with sections 45 to 58, set out details that must be included in notices to the Minister for application for the restoration of seized information or material, requirements that must be respected prior to undertaking further measures with respect to certain seized material, as well as defining the designated officer who may provide directions related to seized or forfeited information or material under the Act.

Background

The Assisted Human Reproduction Act, including sections 12 and 45 to 58, was enacted in 2004. After portions of the Act were deemed unconstitutional by the Supreme Court of Canada, sections 45 to 58 were then amended in 2012 to narrow inspection powers to sections 8, 10, and 12 of the Act and remove references to the Assisted Human Reproduction Agency of Canada, which closed that year. Sections 12 and 45 to 58 did not come into force immediately, but were to come into force on a date fixed by the Governor in Council to allow the time for supporting regulations to be developed.

Implications

Bringing into force section 12 with supporting regulations will provide clarity to stakeholders on the allowable reimbursements that are set out in section 12.

Bringing into force sections 45 to 58 with supporting regulations allows Health Canada to implement administration and enforcement oversight of assisted human reproduction at the federal level.

Consultation

A detailed description of the consultations and comments from stakeholders is included in the Regulatory Impact Analysis Statement accompanying the Safety of Sperm and Ova Regulations, which also discusses the Reimbursement Related to Assisted Human Reproduction Regulations and the Administration and Enforcement (Assisted Human Reproduction Act) Regulations. The regulations were prepublished in the Canada Gazette, Part I, on October 27, 2018.

In general, stakeholders were supportive of the Administration and Enforcement (Assisted Human Reproduction Act) Regulations. A large number of comments were provided on the Reimbursement Related to Assisted Human Reproduction Regulations and they varied widely, as while many respondents welcomed their introduction, many others did not support them based on their view that payment to donors and surrogate mothers should be permitted. Health Canada considered these comments and made certain revisions with the goal that the overall approach most effectively balances permitting surrogate mothers and donors to be reimbursed for reasonable expenditures incurred in relation to their surrogacy or donation, while supporting the key principles of the Act.

Departmental contact

Bruno Rodrigue
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Department of Health
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca