Consent for Use of Human Reproductive Material and In Vitro Embryos Regulations (SOR/2007-137)

Interpretation

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

  Act

  Act means the Assisted Human Reproduction Act. (Loi)

  common-law partner

  common-law partner, in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship at the relevant time, having so cohabited for a period of at least one year. (conjoint de fait)

  third party

  third party means

  • (a) in relation to human reproductive material,

    • (i) an individual who is not the donor of the human reproductive material or the spouse or common-law partner of that donor, or

    • (ii) a couple in respect of whom neither spouse or common-law partner is the donor of the human reproductive material; and

  • (b) in relation to an in vitro embryo,

    • (i) an individual who is not the donor of the in vitro embryo under subsection 10(1), or

    • (ii) a couple who is not the donor of the in vitro embryo under subsection 10(1). (tiers)

• (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.

• (3) For the purpose of these Regulations, the written consent of a donor must be signed by the donor and attested by a witness.

PART 1Consent Given Under Subsection 8(1) of the Act

2 This Part applies in respect of a consent given under subsection 8(1) of the Act to make use of human reproductive material for the purpose of creating an embryo.

3 Before a person makes use of human reproductive material for the purpose of creating an embryo, the person shall have a document signed by the donor of the material stating that, before consenting to the use of the material, the donor was informed in writing that

• (a) subject to paragraph (b), the human reproductive material will be used in accordance with the donor’s consent to create an embryo for one or more of the following purposes, namely,

  • (i) the donor’s own reproductive use,

  • (ii) following the donor’s death, the reproductive use of the person who is, at the time of the donor’s death, the donor’s spouse or common-law partner,

  • (iii) the reproductive use of a third party,

  • (iv) improving assisted reproduction procedures, or

  • (v) providing instruction in assisted reproduction procedures;

• (b) if the human reproductive material is to be removed from the donor’s body after the donor’s death, the material will be used in accordance with the donor’s consent to create an embryo for one or more of the following purposes, namely,

  • (i) the reproductive use of the person who is, at the time of the donor’s death, the donor’s spouse or common-law partner,

  • (ii) improving assisted reproduction procedures, or

  • (iii) providing instruction in assisted reproduction procedures;

• (c) if the donor wishes to withdraw their consent, the withdrawal must be in writing;

• (d) the withdrawal is effective only if the person who intends to make use of the human reproductive material is notified in writing of the withdrawal

  • (i) in the case of human reproductive material to be used to create an embryo for a purpose mentioned in paragraph (a) or (b), other than subparagraph (a)(iii), before the material is used, and

  • (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;

• (e) the number of in vitro embryos created with the human reproductive material may be in excess of the immediate reproductive needs of the individual or couple for whom they were created;

• (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;

• (h) if the human reproductive material is used to create in vitro embryos for the reproductive use of a third party who is a couple, along with human reproductive material from an individual who is a spouse or common law partner in the couple, the use of the in vitro embryos will be subject to the consent of that individual alone if, prior to the use of the in vitro embryos, the individual is no longer a spouse or common-law partner in the couple; and

• (i) if the donor consents to the human reproductive material being used to create an in vitro embryo for the purpose of providing instruction in assisted reproduction procedures or improving assisted reproduction procedures, no additional consent from the donor is required to permit the use of the embryo for that purpose.

• 4 (1) Before a person makes use of human reproductive material for the purpose of creating an embryo, the person shall have the written consent of the donor of the material stating that the material may be used for one or more of the following purposes:

  • (a) the donor’s own reproductive use;

  • (b) following the donor’s death, the reproductive use of the person who is, at the time of the donor’s death, the donor’s spouse or common-law partner;

  • (c) the reproductive use of a third party;

  • (d) improving assisted reproduction procedures; or

  • (e) providing instruction in assisted reproduction procedures.

• (2) A donor’s consent stating that the donor’s human reproductive material may be used for a purpose mentioned in paragraph (1)(b) or (c) shall also state whether 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.

4.1 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.

• 5 (1) If a donor wishes to withdraw their consent, the withdrawal must be in writing.

• (2) The withdrawal is effective only if the person who intends to make use of the human reproductive material is notified in writing of the withdrawal

  • (a) in the case of human reproductive material to be used to create an embryo for a purpose mentioned in paragraph 4(1)(a), (b), (d) or (e), before the material is used; and

  • (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.

PART 2Consent Given Under Subsection 8(2) of the Act

6 This Part applies in respect of a consent given under subsection 8(2) of the Act to remove human reproductive material from a donor’s body after the donor’s death for the purpose of creating an embryo.

7 Before a person removes human reproductive material from a donor’s body after the donor’s death for the purpose of creating an embryo, the person shall have a document signed by the donor stating that, before consenting to the removal, the donor was informed in writing that

• (a) the human reproductive material will be removed in accordance with the donor’s consent to create an embryo for one or more of the following purposes, namely,

  • (i) the reproductive use of the person who is, at the time of the donor’s death, the donor’s spouse or common-law partner,

  • (ii) improving assisted reproduction procedures, or

  • (iii) providing instruction in assisted reproduction procedures;

• (b) if the donor wishes to withdraw their consent, the withdrawal must be in writing;

• (c) the withdrawal is effective only if the person who intends to remove the human reproductive material is notified in writing of the withdrawal before the removal of the material; and

• (d) human reproductive material removed from the donor cannot be used for a purpose mentioned in paragraph (a) unless the person who intends to make use of the material has the donor’s written consent under Part 1 respecting the use of the material.

8 Before a person removes human reproductive material from a donor’s body after the donor’s death for the purpose of creating an embryo, the person shall have the donor’s written consent respecting the removal of the material and the donor’s written consent under Part 1 respecting the use of the material.

• 9 (1) If a donor wishes to withdraw their consent respecting the removal of human reproductive material after their death, the withdrawal must be in writing.

• (2) The withdrawal is effective only if the person who intends to remove the human reproductive material is notified in writing of the withdrawal before the removal of the material.

PART 3Consent Given Under Subsection 8(3) of the Act

• 10 (1) Subject to section 15, in this Part, donor means the following individual or individuals for whose reproductive use an in vitro embryo is created:

  • (a) the individual 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

  • (b) subject to subsection (3), the couple who are spouses or common-law partners at the time the in vitro embryo is created, regardless of the source of the human reproductive material used to create the embryo.

• (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.

• (3) In the case of an in vitro embryo created using human reproductive material from only one of the individuals in the couple that was the donor of the embryo at the time it was created, that individual becomes the donor of the embryo under paragraph (1)(a) if, before the use of the embryo, the individual is no longer a spouse or common-law partner in the couple.

11 This Part applies in respect of a consent given under subsection 8(3) of the Act to make use of an in vitro embryo.

12 Before a person makes use of an in vitro embryo, the person shall have a document signed by the donor of the embryo stating that, before consenting to the use of the embryo, the donor was informed in writing that

• (a) the in vitro embryo will be used in accordance with the donor’s consent for one or more of the following purposes, namely,

  • (i) the donor’s own reproductive use,

  • (ii) the reproductive use of a third party,

  • (iii) improving assisted reproduction procedures,

  • (iv) providing instruction in assisted reproduction procedures, or

  • (v) a specific research project, the goal of which is stated in the consent;

• (b) if the donor wishes to withdraw their consent, the withdrawal must be in writing; and

• (c) the withdrawal is effective only if the person who intends to make use of the in vitro embryo is notified in writing of the withdrawal

  • (i) in the case of an in vitro embryo to be used for the purpose mentioned in subparagraph (a)(i), before the use of the embryo,

  • (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,

  • (iii) in the case of an in vitro embryo to be used for the purpose mentioned in subparagraph (a)(iii), before the later of the following occurrences, namely,

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

    • (B) the beginning of the process of thawing the in vitro embryo for the purpose of improving assisted reproduction procedures,

  • (iv) in the case of an in vitro embryo to be used for the purpose mentioned in subparagraph (a)(iv), before the later of the following occurrences, namely,

    • (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

    • (B) the beginning of the process of thawing the in vitro embryo for the purpose of providing instruction in assisted reproduction procedures, and

  • (v) in the case of an in vitro embryo to be used for the purpose mentioned in subparagraph (a)(v), before the latest of the following occurrences, namely,

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

    • (B) the beginning of the process of thawing the in vitro embryo for the purpose of research, and

    • (C) the creation of a stem cell line using the in vitro embryo.

• 13 (1) Before a person makes use of an in vitro embryo, the person shall have the written consent of the donor of the embryo stating that the embryo may be used for one or more of the following purposes:

  • (a) the donor’s own reproductive use;

  • (b) the reproductive use of a third party;

  • (c) improving assisted reproduction procedures;

  • (d) providing instruction in assisted reproduction procedures; or

  • (e) a specific research project, the goal of which is stated in the consent.

• (2) [Repealed, SOR/2019-195, s. 7]

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.

• 14 (1) If a donor wishes to withdraw their consent, the withdrawal must be in writing.

• (2) The withdrawal is effective only if the person who intends to make use of the in vitro embryo is notified in writing of the withdrawal

  • (a) in the case of an in vitro embryo to be used for the purpose mentioned in paragraph 13(1)(a), before the use of the embryo;

  • (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;

  • (c) in the case of an in vitro embryo to be used for the purpose mentioned in paragraph 13(1)(c), before the later of the following occurrences, namely,

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

    • (ii) the beginning of the process of thawing the in vitro embryo for the purpose of improving assisted reproduction procedures;

  • (d) in the case of an in vitro embryo to be used for the purpose mentioned in paragraph 13(1)(d), before the later of the following occurrences, namely,

    • (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

    • (ii) the beginning of the process of thawing the in vitro embryo for the purpose of providing instruction in assisted reproduction procedures; and

  • (e) in the case of an in vitro embryo to be used for the purpose mentioned in paragraph 13(1)(e), before the latest of the following occurrences, namely,

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

    • (ii) the beginning of the process of thawing the in vitro embryo for the purpose of research, and

    • (iii) the creation of a stem cell line using the in vitro embryo.

• (3) If the donor is a couple, the consent of the donor may be withdrawn by either spouse or common-law partner.

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.

PART 4Records

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.

Transitional

• 16 (1) Despite sections 3 and 4, in the case of human reproductive material obtained before the coming into force of these Regulations, a person may make use of the human reproductive material to create an embryo for a purpose mentioned in any of paragraphs 4(1)(b) to (e) if the person has the written consent of the persons whose human reproductive material was used to create the embryo, dated before the coming into force of these Regulations, stating that the human reproductive material may be used for that purpose.

• (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

  • (a) the purpose mentioned in paragraph 13(1)(b) if the person has the written consent of the donor of the embryo, dated before the coming into force of these Regulations, stating that the embryo may be used for that purpose;

  • (b) a purpose mentioned in paragraph 13(1)(c) or (d) if the person has

    • (i) in the case of the embryo having been created for that purpose, the written consent of the persons whose human reproductive material was used to create the embryo, dated before the coming into force of these Regulations, stating that their human reproductive material may be used to create an in vitro embryo for that purpose, or

    • (ii) in the case of the embryo having been created for another purpose but not required for the purpose for which it was created,

      • (A) the written consent of the donor of the embryo, dated before the coming into force of these Regulations, stating that the embryo may be used for the purpose mentioned in paragraph 13(1)(c) or (d), as the case may be, and

      • (B) the written consent of the persons whose human reproductive material was used to create the embryo, dated before the coming into force of these Regulations, stating that if the embryo is not required for the purpose for which it was created, it may be used for the purpose of providing instruction in assisted reproduction procedures or improving assisted reproduction procedures, as the case may be, unless those persons have already consented to that use as the donor of the embryo;

  • (c) the purpose mentioned in paragraph 13(1)(e), if the person has

    • (i) the written consent of the donor of the embryo, dated before the coming into force of these Regulations, stating that the embryo may be used for that purpose, and

    • (ii) the written consent of the persons whose human reproductive material was used to create the embryo, dated before the coming into force of these Regulations, stating that if the embryo is not required for the purpose for which it was created, it may be used for research, unless those persons have already consented to that use as the donor of the embryo.

• (3) Despite sections 3 and 4, in the case of an in vitro embryo created after the coming into force of these Regulations using human reproductive material obtained before the coming into force of these Regulations, a person may make use of the embryo for a purpose mentioned in paragraph 13(1)(c), (d) or (e) if

  • (a) the requirements of sections 12 and 13 are satisfied; and

  • (b) the person has the written consent of the persons whose human reproductive material was used to create the embryo, dated before the coming into force of these Regulations, stating that if the embryo is not required for the purpose for which it was created, it may be used for the purpose of providing instruction in assisted reproduction procedures, improving assisted reproduction procedures or other research, as the case may be, unless those persons have already consented to that use as the donor of the embryo.

• 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

17 These Regulations come into force on December 1, 2007.