Canada Gazette, Part I, Volume 152, Number 43: Regulations on the Administration and Enforcement of the Assisted Human Reproduction Act

October 27, 2018

Statutory authority

Assisted Human Reproduction Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see the Safety of Sperm and Ova Regulations.

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 65(1) ^{footnote a} of the Assisted Human Reproduction Act ^{footnote b}, proposes to make the annexed Regulations on the Administration and Enforcement of the Assisted Human Reproduction Act.

Interested persons may make representations concerning the proposed Regulations within 75 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 Bruno Rodrigue, Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Department of Health, 11 Holland Avenue, Suite 14, Address Locator: 3000A, Ottawa, Ontario K1A 0K9 (email: hc.lrm.consultations-mlr.sc@canada.ca).

Ottawa, October 18, 2018

Jurica Čapkun
Assistant Clerk of the Privy Council

Regulations on the Administration and Enforcement of the Assisted Human Reproduction Act

Interpretation

Definitions

1 (1) The following definitions apply in these Regulations.

Act means the Assisted Human Reproduction Act. (Loi)

common-law partner has the same meaning as in subsection 10(5) of the Act. (conjoint de fait)

donor, in relation to an in vitro embryo, means

• (a) in the case of an in vitro embryo that is created for reproductive use
  • (i) the individual for whom the embryo is created and who has no spouse or common-law partner at the time the in vitro embryo is created, regardless of the source of the human reproductive material used to create the embryo, or
  • (ii) subject to subsection (3), the couple for whom the embryo is created and who are spouses or common-law partners at the time the embryo is created, regardless of the source of the human reproductive material used to create the embryo; and
• (b) in the case of an in vitro embryo that is created for the purpose of improving or providing instruction in assisted reproduction procedures, the persons whose human reproductive material is used to create the embryo. (donneur)

Interpretation

(2) In these Regulations, the term spouse does not include a person who, at the relevant time, lives separate and apart from the person to whom they are married because of the breakdown of their marriage.

Donor of in vitro embryo — specific case

(3) If the donor of an in vitro embryo is a couple at the time the embryo is created and if the embryo is created using human reproductive material from only one of the individuals in the couple, that individual becomes the donor of the embryo under paragraph (a) of the definition of donor in subsection (1) for the purposes of section 54 of the Act and these Regulations if, before any further measure with respect to the administration or enforcement of the Act is taken, that individual is no longer a spouse or common-law partner in the couple.

Designated officer

(4) For the purposes of subsection 52(3) and section 54 of the Act and these Regulations, designated officer means the person who is the Director General responsible for overseeing compliance and enforcement of the Act.

Application for Restoration

Service of notice

2 (1) A notice referred to in subsection 51(1) of the Act must be served by any method that provides proof of delivery on the Minister at least 15 clear days before the day on which the application for an order of restoration is to be made to the provincial court judge.

Contents of notice

(2) The notice must specify

• (a) the provincial court judge to whom the application is to be made;
• (b) the date and time when and the place where the application is to be heard;
• (c) the material or information seized in respect of which the application is to be made; and
• (d) the evidence on which the applicant intends to rely to establish that the applicant is entitled to possession of the material or information seized in respect of which the application is to be made.

Section 54 of the Act

Consent of donor — in vitro embryo created for reproductive use

3 (1) For the purposes of section 54 of the Act, if an in vitro embryo is created for a couple's reproductive use, in order for a measure that may be taken with respect to the embryo to be consistent with the consent of the donor, the measure must be consistent with the consent of each spouse or common-law partner.

Non-application

(2) For greater certainty, subsection (1) does not apply to a donor of an in vitro embryo referred to in subsection 1(3).

Consent of donor — in vitro embryo created for improving or providing instruction in assisted reproduction measures

(3) For the purposes of section 54 of the Act, if an in vitro embryo is created for the purpose of improving or providing instruction in assisted reproduction procedures, in order for a measure that may be taken with respect to the embryo to be consistent with the consent of the donor, the measure must be consistent with the consent of each person whose human reproductive material is used to create the embryo.

Written consent

(4) For the purposes of section 54 of the Act and these this section, the donor's consent must be in writing, signed by the donor and attested by a witness or, if the seized sperm, ova or in vitro embryo was donated under the condition of anonymity in the context of assisted human reproduction, the consent must be attested to in a document, signed by the person who originally obtained consent in that context from the donor.

Disposal — impossibility of obtaining consent

4 If it is impossible to obtain the consent of the donor in relation to any sperm, ovum or in vitro embryo that was forfeited, the designated officer may direct an inspector to dispose of them only after a 60 day period following their forfeiture.

Coming into Force

5 These Regulations come into force on the day on which they are published in the Canada Gazette, Part II.