Donating and using third-party sperm or ova (eggs) for assisted human reproduction
On this page
- Donor sperm and ova (eggs)
- Donor screening and testing
- Regulating third party sperm and ova (eggs)
- Compliance monitoring activities in Canada
Donor sperm and ova (eggs)
Donor sperm and ova (eggs) are sperm and ova that are intended for use in assisted human reproduction (AHR) by a recipient who is not the spouse, common-law partner or sexual partner of the donor.
- donor sperm used in AHR techniques (e.g., in vitro fertilization)
- ova (eggs) obtained from a donor and intended for the same donor's use as a surrogate mother (via in vitro fertilization)
- donor sperm distributed by an establishment or health professional to a recipient for their personal use
Donor screening and testing
In Canada, all donor sperm and ova (egg) must meet safety standards before they can be used for AHR.
All donors must undergo a suitability assessment to identify any risk factors for infectious and genetic disease transmission, which could impact the safety of the sperm and ova.
The donor suitability assessment involves:
- a physical examination of the donor
- donor screening, using a structured questionnaire to collect information about:
- risks factors for certain genetic disease transmission
- risks factors for certain infectious disease transmission
- donor testing for infectious diseases including:
- West Nile Virus
- hepatitis B and C
The Technical Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors contains more information and a full list of testing and screening requirements.
Regulating third party sperm and ova (eggs)
The Safety of Sperm and Ova Regulations apply to establishments and health professionals who process, import, distribute or make use of donor sperm or ova for the purpose of AHR.
All establishments and health professionals that process, import, distribute or make use of donor sperm and ova (eggs) for the purpose of AHR must:
- understand their legal obligations
- comply with the Assisted Human Reproduction Act (AHR Act) and its Regulations
- must register with Health Canada
- are responsible for all processing activities
- whether they conduct the activity themselves or
- another establishment conducts the activity on their behalf
Establishments that import or distribute must notify Health Canada.
Both primary establishments and establishments that only import or distribute must submit an attestation of compliance every year.
Compliance monitoring activities in Canada
Health Canada carries out compliance monitoring activities, including inspections of regulated parties to:
- verify compliance with the AHR Actand its Regulations
- respond to issues of non-compliance
- minimize the risk posed to the health of Canadians
When Health Canada identifies a problem, it takes action in line with the level of risk to public health and safety. Actions may include:
- requesting a recall of material
- sending letters to parties to cease activities
- refusal, suspension or cancellation of a registration
- issuing public advisories or other forms of risk communication
- recommending the refusal or seizure of imports at the border
- conducting an investigation into potential offences under the AHR Act or making a referral to law enforcement
Information on all inspections conducted under the Safety of Sperm and Ova Regulations are published in the Drug and Health Product Inspections Database.
If you have questions about how donor sperm and ova (eggs) are regulated, contact Health Canada's Biologics and Genetic Therapies Directorate at firstname.lastname@example.org.
If you have questions about compliance and enforcement, contact the Biological Product Compliance Program at email@example.com.
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