Canada Gazette, Part I, Volume 152, Number 43: Regulations Amending the Assisted Human Reproduction (Section 8 Consent) Regulations

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

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, Address Locator: 3000A, 11 Holland Avenue, Suite 14, 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 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), before the third party acknowledges in writing that the material has been obtained for their reproductive use;

(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 section 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 section 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 is donated on the condition of anonymity, the person shall have, before making use, a document signed by the person who originally obtained consent from the donor, attesting to the following:

• (a) that prior to consenting to the use of their human reproductive material, the donor has provided a signed document stating that he or she was informed, in writing, of the information set out in section 3;
• (b) that the donor has given 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 has provided consent to the use of their human reproductive material for the purpose of creating embryos for the reproductive use of a third party, whether the donor has 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), before the third party acknowledges in writing that the material has been obtained for their reproductive use.

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

(2) If the donor is a couple, the in vitro embryo shall only be used 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 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 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 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 is donated on the condition of anonymity, the person shall have, 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 prior to consenting to the use of their embryo, the donor has provided a signed document stating that he or she was informed, in writing, of the information set out in section 12;
• (b) that the donor has given 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 also have, for each of the persons whose human reproductive material was used to create the embryo,

• (a) the written consent, provided in conformity with requirements under section 4, of the person whose human reproductive material was used to create the embryo for that use; or
• (b) if the donation of material has been made under 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 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 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 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 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 by them 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, 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 was 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 date of the use of the embryo.

12 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 has a document signed by the person who originally obtained the written consent of the donor, attesting that written consent, dated prior to December 1, 2007, was provided for the use of the material for that purpose.

(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 instead, for each of those donors, a document signed by the person who originally obtained the written consent of the donor attesting that written consent, dated prior to December 1, 2007, was provided for that use.

(3) Despite section 4.1 and subsection 16(3), a person may make use of an in vitro embryo for a purpose referred to in that subsection, that was created after December 1, 2007, 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 instead, for each of those donors, a document that is signed by the person who originally obtained the written consent of the donor, dated prior to December 1, 2007, attesting that written consent was provided for that use.

Coming into Force

13 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.