Safety of Sperm and Ova Regulations (SOR/2019-192)

Marginal note:Reinstatement of registration

• 14 (1) The Minister must reinstate a registration, in whole or in part, if the primary establishment makes a request to the Minister, in the form established by the Minister, and provides evidence that demonstrates that

  • (a) the primary establishment has corrected the situation that gave rise to the suspension; or

  • (b) the situation that gave rise to the suspension did not exist.

• Marginal note:Notice

  (2) The reinstatement takes effect immediately after the Minister sends to the primary establishment a notice to that effect.

• Marginal note:Exception — compliance history

  (3) The Minister may refuse to reinstate a primary establishment’s registration if its compliance history demonstrates an inability to consistently conduct its activities in accordance with these Regulations.

• Marginal note:Partial reinstatement

  (4) If the Minister does not reinstate any part of a registration that was suspended, the Minister must remove that part of the registration.

Cancellation

Cancellation Initiated by Primary Establishment

Marginal note:Cessation of activities

15 The Minister must cancel a registration if the Minister receives a notice under section 11 that the primary establishment has ceased carrying out all of the activities that are the subject of its registration.

Cancellation Initiated by Minister

Marginal note:Circumstances

• 16 (1) The Minister may cancel a registration in any of the following circumstances:

  • (a) the primary establishment has not provided the annual attestation that is required under section 20;

  • (b) the primary establishment has not complied with the requirements set out in section 21 to provide additional documents or information;

  • (c) any information provided by the primary establishment to the Minister in accordance with these Regulations proves to be false or misleading;

  • (d) the primary establishment fails to take corrective action, within the required period, in accordance with subsection (2) or paragraph 13(2)(c);

  • (e) the corrective action that was taken by the primary establishment in accordance with subsection (2) or paragraph 13(2)(c) has not corrected the situation that gave rise to a notice of suspension or cancellation of the registration;

  • (f) the registration has been suspended for a period of more than 12 months;

  • (g) the Minister has reasonable grounds to believe that the primary establishment does not meet the requirements of these Regulations.

• Marginal note:Notice

  (2) Before cancelling a registration, the Minister must send to the primary establishment a notice that

  • (a) gives the reasons for the proposed cancellation and its effective date;

  • (b) indicates that the primary establishment has an opportunity to be heard; and

  • (c) if applicable, indicates that corrective action must be taken by the primary establishment and the date by which it must do so.

Marginal note:Action following cancellation of registration

• 17 (1) If the registration is cancelled under section 16, the primary establishment must immediately take the following action:

  • (a) cease carrying out all of the activities that are the subject of its registration; and

  • (b) notify any establishment, health professional or recipient to which it has distributed the implicated sperm or ova during the period specified in the notice of the cancellation and the effective date.

• Marginal note:Action upon notice

  (2) An establishment that has been notified under paragraph (1)(b) or under this subsection must, in turn, immediately notify to the same effect any establishment, health professional or recipient to which it distributed the implicated sperm or ova.

• Marginal note:Written notice

  (3) If an establishment gives a notice verbally under this section, that notice must be confirmed in writing within 24 hours after it is given.

Notification

Marginal note:Notice before distribution or importation

• 18 (1) Before distributing or importing sperm or ova, an establishment must send to the Minister a notice, in the form established by the Minister, that contains the following information:

  • (a) the establishment’s name, telephone number, email address, postal address and, if different from the postal address, civic address;

  • (b) in the case of an establishment that previously conducted its activities under another name, either under these Regulations or the Processing and Distribution of Semen for Assisted Conception Regulations, that other name;

  • (c) the first name, last name, telephone number and email address of a person to contact for further information concerning the notice and, if different, a person to contact in case of emergency;

  • (d) a statement indicating whether the establishment proposes to distribute or import sperm or ova and the projected start date;

  • (e) the civic address of the buildings in which the establishment proposes to conduct the activities, if not already provided; and

  • (f) the name and registration number of each primary establishment that processes that sperm or those ova.

• Marginal note:Signature and attestation

  (2) The notice must

  • (a) be signed and dated by a senior executive officer; and

  • (b) include an attestation from that senior executive officer of the following:

    • (i) that the establishment has evidence demonstrating that it is able to meet the requirements of these Regulations,

    • (ii) that all information submitted in support of the notice is accurate and complete, and

    • (iii) that the senior executive officer has the authority to bind the establishment.

Marginal note:Change or cessation

• 19 (1) An establishment that distributes or imports sperm or ova and makes any change to the information provided under section 18, including the cessation of distribution or importation, must send to the Minister, within 30 days after the day on which the change occurs, a notice, in the form established by the Minister, that contains the following information:

  • (a) the name of the establishment, telephone number, email address, postal address and, if different from the postal address, civic address;

  • (b) the date on which the change or cessation became effective; and

  • (c) in the case of cessation, details of the disposition of the sperm or ova that are in the possession or control of the establishment.

• Marginal note:Signature and attestation

  (2) The notice must

  • (a) be signed and dated by a senior executive officer; and

  • (b) include an attestation from that senior executive officer of the following:

    • (i) that the establishment has evidence, if it is still distributing or importing sperm or ova, demonstrating that it meets the requirements of these Regulations,

    • (ii) that all information submitted in support of the notice is accurate and complete, and

    • (iii) that the senior executive officer has the authority to bind the establishment.

Annual Attestation

Marginal note:April 1

• 20 (1) A primary establishment and any other establishment that distributes or imports sperm or ova must send to the Minister, in the form established by the Minister, an annual attestation

  • (a) on or before April 1 of the calendar year following the year of registration or the year in which the notice of distribution or importation is sent; and

  • (b) on or before April 1 of each subsequent calendar year.

• Marginal note:Signature and attestation

  (2) The attestation must

  • (a) be signed and dated by a senior executive officer; and

  • (b) certify that

    • (i) the establishment has evidence demonstrating that it meets the requirements of these Regulations,

    • (ii) in the case of a primary establishment, any other establishment that processes sperm or ova on its behalf meets the requirements of these Regulations,

    • (iii) all information submitted in support of the attestation is accurate and complete, and

    • (iv) the senior executive officer has the authority to bind the establishment.

Marginal note:Additional documents and information

21 An establishment must provide to the Minister, on or before the date specified in the Minister’s written request to that effect, any additional relevant documents or information to demonstrate that the activities it conducts are in compliance with these Regulations.

Donor Suitability

Regular Process

Donor Suitability Assessment and Determination

Marginal note:Donor suitability assessment

22 In order to determine whether a donor is suitable, a primary establishment must ensure that a donor suitability assessment is conducted.

Marginal note:Donor screening

23 An establishment that performs donor screening must do so in accordance with the requirements set out in the Directive under the heading “Donor Screening”.

Marginal note:Physical examination

24 An establishment that performs physical examinations on donors must do so in accordance with the requirements set out in the Directive under the heading “Physical Examination”.

Marginal note:Donor testing

25 An establishment that performs donor testing must do so in accordance with the requirements set out in the Directive under the heading “Donor Testing”.

Marginal note:Donor reassessment

26 In order to determine whether a repeat donor is suitable, a primary establishment must ensure that the donor is reassessed in accordance with the requirements set out in the Directive under the heading “Donor Reassessment”.

Marginal note:Determination of donor suitability

• 27 (1) A primary establishment must ensure that its medical director determines whether a donor is suitable by reviewing the information obtained from the donor suitability assessment and, if applicable, from the donor reassessment.

• Marginal note:Donor unsuitability

  (2) A primary establishment must ensure that its medical director determines a donor to be unsuitable if

  • (a) the donor meets any criteria set out in the Directive under the heading “Donor Exclusion”; or

  • (b) the donor suitability assessment is not complete.

• Marginal note:Summary document

  (3) If a donor has been determined to be suitable, the primary establishment must ensure that its medical director creates and signs a summary document that confirms this determination and that contains

  • (a) the age of the donor;

  • (b) a statement that the donor suitability assessment and, if applicable, donor reassessment have been conducted in accordance with these Regulations; and

  • (c) the dates and results of the donor testing and the assessment of the risk of genetic disease transmission.

Quarantine

Marginal note:Requirement

• 28 (1) An establishment must quarantine all sperm and ova that it processes in the manner set out in subsection (2) until the medical director of the primary establishment that is responsible for the quarantine of that sperm and those ova has

  • (a) determined the donor to be suitable; and

  • (b) determined and documented that the sperm and ova can be released from quarantine.

• Marginal note:Segregation

  (2) The establishment must quarantine the sperm and ova by

  • (a) clearly indicating that they are quarantined;

  • (b) segregating them from sperm and ova that are not quarantined; and

  • (c) ensuring that they are not distributed or used.

Marginal note:Release from quarantine — exceptional access

• 29 (1) Despite paragraph 28(1)(a), an establishment may release sperm or ova from quarantine if the primary establishment 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 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 primary establishment must ensure that its medical director creates and signs a summary document that contains the following information:

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

  • (b) the conditions that have been met;

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

  • (d) the reasons the donor was determined to be unsuitable and a detailed explanation for each reason.

• 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.

Directed Donation Process

Donor Suitability Assessment and Confirmation

Marginal note:Application

30 Despite sections 22 to 29, the requirements set out in sections 31 to 40 with respect to sperm or ova that are intended for directed donation may instead be met if

• (a) the donor and recipient know each other; and

• (b) the health professional requests the sperm or ova from a primary establishment in the context of a directed donation.