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Consent to Use Human Reproductive Material and In Vitro Embryos

Background

In 1989, the Government of Canada asked the Royal Commission on New Reproductive Technologies to consider the latest medical developments in infertility treatment (e.g., in vitro fertilization). Based on the ethical, social and economic issues linked to infertility treatment, policies and safeguards were suggested and developed.  In addition to considering the recommendations of the Commission's final reportFootnote 1 the Government worked with health professionals, researchers, ethicists and individuals, using or thinking about using assisted human reproduction to build their families, to develop its approach to infertility treatment.  The result was the Assisted Human Reproduction Act (AHR Act) which became law in March 2004.

The law respects Canadians' values, and sets out broad principles to guide how Health Canada applies and enforces the Act and its regulations. Health Canada also encourages health professionals, researchers and other interested groups to follow the principles (stated below) while carrying out AHR based activities.

Principles

  • In the use of AHR technologies, children's health and well-being must come first;
  • Using appropriate measures will help protect the health, safety, dignity and rights of people affected by the use of AHR technologies;
  • Because women, not men, are more significantly affected by AHR technologies, their health must be protected;
  • Free and informed consent must always be given before these technologies can be used;
  • People who use AHR technologies must not be discriminated against;
  • Commercial trade and abuse of the reproductive capabilities of children, women and men is, for health and ethical reasons, a crime;
  • Preservation and protection of human individuality and diversity must be upheld.

Consent to Use

Under section 8 of the AHR Act, donors of human reproductive material and in vitro embryos must provide their written consent before their material can be used to create an embryo(s) or to use their in vitro embryo(s) for any purpose. No person shall:

  • Make use of human reproductive material to create an embryo unless the donor of the material has given written consent on its use for that purpose, as required under the law;
  • Remove human reproductive material from a donor's body after the donor's death in order to create an embryo unless the donor of the material gave written consent for its removal for that purpose, as required under the law;
  • Make use of an in vitro embryo for any purpose unless the donor has given written consent on its use for that purpose, as required under the law.

Related Regulations

Section 8 of the AHR Act and the related Next link will take you to another Web site Assisted Human Reproduction (Section 8 Consent) Regulations (Consent to Use Regulations) came into force on December 1, 2007.

The Consent to Use Regulations set out rules about:

  • How the consent to use someone's reproductive material or in vitro embryos (or withdrawal of such consent) must be given; and
  • The purposes for which consent to use can be provided.

These requirements must be met before a person, such as a clinic or doctor, can use a donor's reproductive material or in vitro embryo.

This fact sheet describes some of the requirements of these regulations.

Definitions

Certain terms used in this fact sheet (e.g., donor, in vitro embryo and common-law partner), are defined in the AHR Act or the Consent to Use Regulations and can be found in Appendix I.

Reason for these prohibitions

The prohibitions are in keeping with the guiding principles in the AHR Act.  Free and informed consent must be respected as a necessary condition of the use of AHR technologies.

Consent

Consent is based on the principle that the consent to use a donor's gametes (sperm or eggs) or in vitro embryo must be fully informed (i.e., based on all of the information available), must be freely given by the donor, and follow all related laws and guidelines.

In this context, consent means:

  • Consent given by someone who is legally competent;
  • Consent given without undue pressure or promise of a reward; and
  • Consent given by a person after receiving information meant to help the person understand his or her choices. In this context, the Consent to Use Regulations explain:
    • What information must be given to donors before they allow their reproductive material or embryos to be used, and that
    • Donors must provide a written statement confirming they received information on their choices.

Other consent requirements under federal, provincial or territorial law or by professional regulatory bodies may also apply.

Consent given under Section 8

The AHR Act prohibits a person from using human reproductive material (e.g., sperm and eggs) to create an in vitro embryo (e.g., through in vitro fertilization) or an in utero embryo ( e.g., through assisted insemination) in Canada unless the donor has given written consent for their reproductive material to be used for purposes outlined in the Consent to Use Regulations. In this situation:

  • The donor is the person from whose body the sperm or eggs were obtained, even when the reproductive material is for the donor's own reproductive use;
  • The person using the sperm or eggs to create the embryo using assisted human reproduction must have the donor's written consent before creating the embryo for one or more of the following purposes:
    • The donor's own reproductive use;
    • The reproductive use of a third party;
    • Improving assisted reproduction procedures,
    • Providing instruction in assisted human reproduction procedures; or,
    • 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.
  • Use of sperm or eggs for a purpose other than to create an embryo (e.g., research) does not fall within the scope of the consent to use rules under the AHR Act, although other provisions of the Act may apply.  See fact sheet on Prohibitions Related to Purchasing Reproductive Material or Purchasing or Selling In Vitro Embryos.

Minimum age to be a sperm or egg donor

In cases where sperm and eggs are received and used to create an embryo, section 9 of the AHR Act also applies:

9. No person shall obtain any sperm or ovum from a donor under 18 years of age, or use any sperm or ovum so obtained, except for the purpose of preserving the sperm or ovum for the purpose of creating a human being that the person reasonably believes will be raised by the donor.

This exception applies, for example, in the case of a person under 18 undergoing treatment that may affect his or her reproductive capabilities (e.g., cancer therapy).  The intent of the person obtaining the sperm or egg from the minor is to preserve it for the minor's own future reproductive use.

Consent to removal of human reproductive material after death

The AHR Act states that removing sperm or eggs from the body of someone who has died in order to create an embryo (including an in vitro embryo) is against the law in Canada. The only exception to this rule is in cases where the person had, before their death, given his or her written and informed consent in agreement with the Consent to Use Regulations to:

  • Removal of their sperm or eggs after death, and to
  • Use of the removed sperm or eggs to create an embryo for one or more of the following purposes identified in the Consent to Use Regulations:
    • The reproductive use of the person who is their spouse or common-law partner at the time of their death;
    • Improving assisted reproduction procedures; or
    • Providing instruction in assisted reproduction procedures.

Consent to use an in vitro embryo

Making use of an in vitro embryo in Canada for any purpose is illegal unless the donor has given written consent as set out in the Consent to Use Regulations to use of the in vitro embryo for one or more of the following purposes:

  • The donor's own reproductive use;
  • The reproductive use of a third party;
  • Improving assisted reproduction procedures;
  • Providing instruction in assisted reproduction procedures; or
  • A specific research project when the goal of the research project is stated in the consent to use document.

In this situation:

  • the donor is the individual or couple for whose reproductive use the in vitro embryo has been created, regardless of the source of the sperm or egg used to create the embryo;
  • The person using the in vitro embryo must have the written consent of the donor before using the embryo for any purpose; and
    • In the case of consent for improving or providing instruction in assisted reproduction procedures or for research purposes, both the donor of the in vitro embryo(s) (no longer required for reproductive purposes) and, the persons whose reproductive material were used to create the in vitro embryo must provide their written consent to such use.

Withdrawal of Consent to Use

Even if written consent was given, donors may change their mind and refuse to allow their sperm or eggs or in vitro embryo to be used as long as certain timing requirements are met. The withdrawal must be provided in writing to the person (i.e., doctor, clinic or researcher) who will be using the material or in vitro embryo. Where an in vitro embryo is created for a couple, either person may withdraw their consent to the use of that embryo.  If only one of the person's gametes (sperm or eggs) in the couple were used to create the embryo, that person is the only person allowed to withdraw consent if, before the use of the embryo, the individual is no longer a spouse or common-law partner in the couple.

Effective Date

The Assisted Human Reproduction (Section 8 Consent) Regulations became law on December 1, 2007.  Therefore, these rules do not apply to the use of material or in vitro embryos before December 1, 2007, but do apply to the use of material or embryos after that date. Where material was donated before December 1, 2007 but used after that date to create an embryo, the donor's written consent is required.  The same rule applies if an in vitro embryo was created before December 1, 2007 but used for any purpose after that date.

Compliance

Any person in Canada, who breaks the law under the AHR Act concerning consent to use human reproductive material and in vitro embryos, is committing a crime.  If found guilty, the person could be fined up to $250,000, jailed for up to five years, or both.

As with any criminal act, if a person is actively helping or advising another person who has committed an offence under the AHR Act, the person giving the help could be considered an accomplice to the crime. Any such judgment would be based on the particular facts of the situation and the level of knowledge of the person giving the help.

If you need more information on the application of the Act or its regulations, please contact Health Canada in one of the following ways:

By Mail:

Health Canada
Address Locator 0900C2
Ottawa, Ontario
K1A 0K9

Email: Info@hc-sc.gc.ca
Telephone: (613) 957-2991
Toll Free: 1-866-225-0709
Facsimile: (613) 941-5366
Teletypewriter: 1-800-465-7735 (Service Canada)

Appendix I Definitions

Under the AHR Act:

3. The following definitions apply in this Act.

"donor"
in relation to human reproductive material means the individual from whose body it was obtained, whether for consideration or not; and, in relation to an in vitro embryo, a donor as defined in the regulations.
"embryo"
means  a human organism during the first 56 days of its development following fertilization or creation, excluding any time during which its development has been suspended, and includes any cell derived from such an organism that is used for the purpose of creating a human being.
"human reproductive material"
means a sperm, ovum or other human cell or a human gene, and includes a part of any of them.
"in vitro embryo"
means an embryo that exists outside the body of a human being.

Under the Consent to Use Regulations:

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

"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.
"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),

(2) "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.

10. "donor" in relation to an in vitro embryo means:

1) 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 consent of each spouse or common-law partner must be compatible in order for the consent of the donor to comply with the requirements of this Part.

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.

Footnotes

Footnote 1

Final Report of the Royal Commission on New Reproductive Technologies, Proceed With Care, vol.1 and 2, 1993.

Return to footnote 1 referrer