Regulations Amending the Assisted Human Reproduction (Section 8 Consent) Regulations: SOR/2019-195

Canada Gazette, Part II, Volume 153, Number 13

Registration

SOR/2019-195 June 10, 2019

ASSISTED HUMAN REPRODUCTION ACT

P.C. 2019-753 June 9, 2019

Whereas, pursuant to subsection 66(1) of the Assisted Human Reproduction Act ^{footnote a}, the Minister of Health has laid a copy of the proposed Regulations Amending the Assisted Human Reproduction (Section 8 Consent) Regulations before each House of Parliament, substantially in the annexed form;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 65(1) ^{footnote b} of the Assisted Human Reproduction Act ^{footnote a}, makes the annexed Regulations Amending the Assisted Human Reproduction (Section 8 Consent) Regulations.

Regulations Amending the Assisted Human Reproduction (Section 8 Consent) Regulations

Amendments

1 The title of the Assisted Human Reproduction (Section 8 Consent) Regulations ^{footnote 1} is replaced by the following:

Consent for Use of Human Reproductive Material and In Vitro Embryos Regulations

2 (1) Subparagraph 3(d)(ii) of the Regulations is replaced by the following:

• (ii) in the case of human reproductive material to be used to create an embryo for the purpose mentioned in subparagraph (a)(iii),
  • (A) before the third party acknowledges in writing that the material has been obtained for their reproductive use, or
  • (B) if the material to be used has not yet been removed or collected but the third party has acknowledged in writing that the material is to be obtained for their reproductive use, before the removal or collection;

(2) Paragraphs 3(f) and (g) of the Regulations are replaced by the following:

• (f) if the human reproductive material is used to create in vitro embryos for a third party’s reproductive use and there are in vitro embryos in excess of the third party’s reproductive needs, the excess in vitro embryos will be used in accordance with the third party’s consent and, if the use is providing instruction in assisted reproduction procedures, improving assisted reproduction procedures or other research, the consent of the donor in accordance with section 4 or 4.1;
• (g) if the human reproductive material is used to create in vitro embryos for the reproductive use of the person who, at the time of the donor’s death, is the donor’s spouse or common-law partner and there are in vitro embryos in excess of the spouse or common-law partner’s reproductive needs, the excess in vitro embryos will be used in accordance with the spouse or common-law partner’s consent and, if the use is providing instruction in assisted reproduction procedures, improving assisted reproduction procedures or other research, the consent of the donor in accordance with section 4 or 4.1;

3 The Regulations are amended by adding the following after section 4:

4.1 Despite sections 3 and 4, if a person who makes use of human reproductive material for the purpose of creating an embryo cannot obtain the written consent of the donor for that use because the material was donated on the condition of anonymity, the person shall have instead, before making use of that material, a document signed by the person who originally obtained consent from the donor, attesting to the following:

• (a) that the donor provided a signed document stating that they had been informed, in writing, of the information set out in section 3 prior to consenting to the use of their human reproductive material;
• (b) that the donor gave written consent to the use of their human reproductive material for the purpose of creating an embryo for the purposes referred to in paragraph (c);
• (c) the purposes indicated in the written consent of the donor; and
• (d) if the donor provided consent to the use of their human reproductive material for the purpose of creating embryos for the reproductive use of a third party, stating whether the donor consented that any in vitro embryos that are not required for that purpose may be used for providing instruction in assisted reproduction procedures, improving assisted reproduction procedures or other research.

4 Paragraph 5(2)(b) of the Regulations is replaced by the following:

• (b) in the case of human reproductive material to be used to create an embryo for the purpose mentioned in paragraph 4(1)(c)
  • (i) before the third party acknowledges in writing that the material has been obtained for their reproductive use, or
  • (ii) if the material to be used has not yet been removed or collected but the third party has acknowledged in writing that the material is to be obtained for their reproductive use, before the removal or collection.

5 Subsection 10(2) of the Regulations is replaced by the following:

(2) If the donor is a couple, the in vitro embryo shall be used only for the purposes to which both spouses or common-law partners have consented.

6 (1) Subparagraph 12(c)(ii) of the Regulations is replaced by the following:

• (ii) in the case of an in vitro embryo to be used for the purpose mentioned in subparagraph (a)(ii), before the third party acknowledges in writing that the embryo has been obtained for their reproductive use,

(2) Clause 12(c)(iii)(A) of the Regulations is replaced by the following:

• (A) the person acknowledges in writing that the in vitro embryo has been obtained for the purpose of improving assisted reproduction procedures, and

(3) Clause 12(c)(iv)(A) of the Regulations is replaced by the following:

• (A) the person acknowledges in writing that the in vitro embryo has been obtained for the purpose of providing instruction in assisted reproduction procedures, and

(4) Clause 12(c)(iv)(B) of the French version of the Regulations is replaced by the following:

• (B) le processus de décongélation de l’embryon est amorcé en vue de l’apprentissage des techniques de procréation assistée,

(5) Clause 12(c)(v)(A) of the Regulations is replaced by the following:

• (A) the person acknowledges in writing that the in vitro embryo has been obtained for the purpose of research,

7 Subsection 13(2) of the Regulations is repealed.

8 The Regulations are amended by adding the following after section 13:

13.1 Despite section 12 and subsection 13(1), if a person who makes use of an in vitro embryo cannot obtain the written consent of the donor for that use because the embryo was donated on the condition of anonymity, the person shall have instead, before making use of that embryo, a document signed by the person who originally obtained consent from the donor, attesting to the following:

• (a) that the donor provided a signed document stating that they had been informed, in writing, of the information set out in section 12 prior to consenting to the use of their embryo;
• (b) that the donor gave written consent to the use of their embryo for the purposes referred to in paragraph (c); and
• (c) the purposes indicated in the written consent of the donor.

13.2 (1) Before a person makes use of an in vitro embryo for a purpose mentioned in paragraph 13(1)(c), (d) or (e), the person shall have, for each of the persons whose human reproductive material was used to create the embryo,

• (a) their written consent for that use, provided in accordance with section 4; or
• (b) if the donation of material was made on the condition of anonymity, the document referred to in section 4.1 that attests to the consent for that use by that person.

(2) Subsection (1) does not apply if the persons whose human reproductive material was used to create the embryo have already consented to that use as the donor of the embryo.

9 (1) Paragraph 14(2)(b) of the Regulations is replaced by the following:

• (b) in the case of an in vitro embryo to be used for the purpose mentioned in paragraph 13(1)(b), before the third party acknowledges in writing that the embryo has been obtained for their reproductive use;

(2) Subparagraph 14(2)(c)(i) of the Regulations is replaced by the following:

• (i) the person acknowledges in writing that the in vitro embryo has been obtained for the purpose of improving assisted reproduction procedures, and

(3) Subparagraph 14(2)(c)(ii) of the French version of the Regulations is replaced by the following:

• (ii) le processus de décongélation de l’embryon est amorcé en vue de l’amélioration des techniques de procréation assistée;

(4) Subparagraph 14(2)(d)(i) of the Regulations is replaced by the following:

• (i) the person acknowledges in writing that the in vitro embryo has been obtained for the purpose of providing instruction in assisted reproduction procedures, and

(5) Subparagraph 14(2)(e)(i) of the Regulations is replaced by the following:

• (i) the person acknowledges in writing that the in vitro embryo has been obtained for the purpose of research,

10 Section 15 of the Regulations is replaced by the following:

15 For the purpose of sections 12 to 14, in the case of an in vitro embryo created using human reproductive material that is to be used for a purpose mentioned in paragraph 4(1)(d) or (e), the persons whose reproductive material was used to create the embryo are the donor of the embryo and the document and the consent provided under sections 3, 4 and 4.1 in respect of the use of their human reproductive material for the purpose of creating the embryo constitute, respectively, the document and the consent required under section 12, subsection 13(1) and section 13.1 with respect to the use of the embryo.

11 The Regulations are amended by adding the following after section 15:

PART 4

Records

15.1 A person who makes use of human reproductive material from a donor under Part 1 shall keep, for each use of that material, a record of all the documents required under that Part for a period of 10 years following the day on which that material is used.

15.2 A person who removes human reproductive material from a donor under Part 2 shall keep a record of all the documents required under that Part for a period of 10 years following the day on which that material is removed.

15.3 A person who makes use of an in vitro embryo under Part 3 shall keep a record of all the documents required under that Part for a period of 10 years following the day on which the embryo is used.

12 The portion of subsection 16(2) of the Regulations before paragraph (a) is replaced by the following:

(2) Despite sections 12, 13 and 13.2, in the case of an in vitro embryo created before the coming into force of these Regulations, a person may make use of the embryo for

13 The Regulations are amended by adding the following after section 16:

16.1 (1) Despite section 4.1 and subsection 16(1), a person may make use of human reproductive material obtained before December 1, 2007, to create an embryo for a purpose mentioned in any of paragraphs 4(1)(c) to (e) without having obtained the required consent from a donor who donated the material on the condition of anonymity if the person making use of the embryo has a document signed by the person who originally obtained the written consent of the donor, attesting that the donor provided written consent, dated prior to December 1, 2007, for that use.

(2) Despite sections 13.1 and 13.2 and subsection 16(2), a person may make use of an in vitro embryo created before December 1, 2007, for a purpose mentioned in any of paragraphs 16(2)(a) to (c) without having obtained the required consent from the donors referred to under the applicable paragraph who donated the embryo or the human reproductive material on the condition of anonymity if the person making use of the embryo has for each of those donors, a document signed by the person who originally obtained the written consent of the donor, attesting that the donor provided written consent, dated prior to December 1, 2007, for that use.

(3) Despite section 4.1 and subsection 16(3), a person may make use of an in vitro embryo created after December 1, 2007, for a purpose referred to in that subsection, using human reproductive material obtained before that date without having obtained the required consent from the donors who donated the material on the condition of anonymity if the person making use of the embryo has, for each of those donors, a document signed by the person who originally obtained the written consent of the donor attesting that the donor provided written consent, dated prior to December 1, 2007, for that use.

Coming into Force

14 These Regulations come into force on the day that, in the sixth month after the month in which they are published in the Canada Gazette, Part II, has the same calendar number as the day on which they are published or, if that sixth month has no day with that number, the last day of that sixth month.

N.B. The Regulatory Impact Analysis Statement for these Regulations appears following SOR/2019-192, Safety of Sperm and Ova Regulations.