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.
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:
Section 8 of the AHR Act and the related 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:
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.
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.
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 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:
Other consent requirements under federal, provincial or territorial law or by professional regulatory bodies may also apply.
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:
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.
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:
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:
In this situation:
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.
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.
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:
Address Locator 0900C2
Telephone: (613) 957-2991
Toll Free: 1-866-225-0709
Facsimile: (613) 941-5366
Teletypewriter: 1-800-465-7735 (Service Canada)
3. The following definitions apply in this Act.
1. (1) The following definitions apply in these Regulations.
(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
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.
Final Report of the Royal Commission on New Reproductive Technologies, Proceed With Care, vol.1 and 2, 1993.