Safety of Sperm and Ova Regulations

Marginal note:Release from quarantine — exceptional access

• 66 (1) Despite section 65, an establishment and a health professional may release sperm or ova from quarantine if the establishment or health professional that is responsible for their quarantine receives a request from a health professional for exceptional access to that sperm or those ova and if one of the following conditions is met:

  • (a) the recipient has previously been exposed to sperm or ova from that donor and the risk profile of the requested sperm or ova, based on the results of any part of the donor suitability assessment is at least equivalent to the risk profile of the sperm or ova to which the recipient has previously been exposed, based on the results of any part of the donor suitability assessment that was conducted at that time; or

  • (b) sperm or ova from that donor have previously been used to create a child for an individual or a couple and the requested sperm or ova are to be used for the purpose of creating another child for that individual or couple.

• Marginal note:Summary document

  (2) Before the sperm or ova are released from quarantine, the establishment or health professional that is responsible for the quarantine must create and sign a summary document that contains the following information:

  • (a) the age of the donor, if known;

  • (b) the condition that has been met;

  • (c) the dates and results of any donor screening, physical examination or donor testing; and

  • (d) a description of the suspected error or accident and an explanation of how human health and safety or the safety of the sperm or ova might have been compromised.

• Marginal note:Storage

  (3) An establishment and a health professional must ensure that sperm or ova that are in their possession or control and are intended for exceptional access are segregated from sperm and ova that are not intended for exceptional access.

• Marginal note:Communication of risk

  (4) A health professional must meet the following requirements before making use of the sperm or ova or distributing the sperm to a recipient for their personal use:

  • (a) create a document that states that, based on the summary document and any risk mitigating measures with respect to that sperm or those ova, in their medical opinion, the use of the sperm or ova would not pose a serious risk to human health and safety; and

  • (b) create a document that states that the health professional has informed the recipient of the risks that the use of the sperm or ova could pose to human health and safety and that the health professional has obtained written consent from the recipient.